Medical Ethics, Law and Human Rights: A South African Perspective [2 ed.] 0627034667

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TABLE OF CONTENTS CHAPTER 1: A place for ethics, law and human rights in healthcare .................................. 1 CHAPTER 2: Ethics and Philosophy .......................................................................................... 4 2.1 PHILOSOPHY, ETHICS AND MEDICINE ............................................................................ 4 2.2 THINKING ABOUT THINKING: CONCEPTS AND IDEAS .................................................... 4 2.3 WHY IS PHILOSOPHY IMPORTANT IN MEDICINE?........................................................... 5 2.4 WHAT IS ETHICS? ............................................................................................................. 6 2.5 FACTUAL AND MORAL QUESTIONS................................................................................ 6 2.6 MORALITY AND ETHICS ................................................................................................... 7 2.7 LAW AND ETHICS ............................................................................................................ 7 2.8 MORAL RESPONSIBILITY AND THE NEED TO ARGUE ...................................................... 7 2.9 BUILDING MORAL ARGUMENTS ..................................................................................... 8 2.10 CONCLUDING REMARKS .............................................................................................11 CHAPTER 3: Ethics Theories and the Principlist Approach in Bioethics ...............................12 3.1 INTRODUCTION ..............................................................................................................12 3.2 UTILITARIANISM ...............................................................................................................13 3.2.1 only consequences, happiness and numbers matter morally ...........................13 3.2.2 problems with utilitarianism ...................................................................................15 3.3 KANTIAN DEONTOLOGY ................................................................................................16 3.3.1 strengths of kantian deontology............................................................................18 3.3.2 shortcomings of kantian deontology ....................................................................19 3.4 VIRTUE ETHICS .................................................................................................................20 3.4.1 what is a virtue? ......................................................................................................20 3.4.2 benefits of virtue ethics ..........................................................................................21 3.4.3 shortcomings of virtue ethics .................................................................................22 3.5 SOCIAL CONTRACT THEORY .........................................................................................22 3.6 LIBERAL INDIVIDUALISM .................................................................................................24 3.7 COMMUNITARIANISM ....................................................................................................25 3.8 THE ETHICS OF CARE ......................................................................................................25 3.9 CASUISTRY ......................................................................................................................26 3.10 PRINCIPLISM .................................................................................................................26 CHAPTER 4: African Philosophy and Medical Ethics ............................................................29

4.1 INTRODUCTION ..............................................................................................................29 4.2 UBUNTU ...........................................................................................................................30 4.3 PERSONHOOD IN AFRICAN PHILOSOPHY ....................................................................31 4.4 AFRICAN PHILOSOPHY AND MEDICAL ETHICS .............................................................32 4.5 CONCLUDING REMARKS ...............................................................................................36 CHAPTER 5: Respect for Patient Autonomy ...........................................................................37 5.1 INTRODUCTION ..............................................................................................................37 5.2 AUTONOMY....................................................................................................................38 5.2.1 Informed consent....................................................................................................38 5.2.2 Confidentiality .........................................................................................................44 5.2.3 Truth telling ..............................................................................................................47 5.2.4 Communication ......................................................................................................48 5.3 CONCLUDING REMARKS ...............................................................................................49 CHAPTER 6: Beneficence ........................................................................................................51 6.1 INTRODUCTION ..............................................................................................................51 6.2 CLINICAL COMPETENCE ...............................................................................................52 6.3 RISK-BENEFIT ANALYSIS ...................................................................................................52 6.4 PATERNALISM .................................................................................................................53 6.4.1 Active paternalism .................................................................................................54 6.4.2 Passive paternalism ................................................................................................55 6.5 CONCLUDING REMARKS ...............................................................................................56 CHAPTER 7: Non-maleficence ...............................................................................................57 7.1 INTRODUCTION ..............................................................................................................57 7.2 RULES OF NON-MALEFICENCE ......................................................................................57 7.3 MEDICAL ERROR, SAFETY AND QUALITY OF HEALTHCARE ..........................................58 7.3.1 System or latent errors ............................................................................................58 7.3.2 Individual errors ......................................................................................................59 7.4 RESOLVING MEDICAL ERROR AND MINIMISING HARM ...............................................63 7.4.1 Disclosure of medical error ....................................................................................63 7.4.2 Practical tips on the disclosure of mistakes ..........................................................64 7.4.3 Disclosure of mistakes made by other doctors ....................................................65 7.5 CONCLUDING REMARKS ...............................................................................................65 CHAPTER 8: Justice..................................................................................................................66

8.1 INTRODUCTION ..............................................................................................................66 8.2 LEGAL JUSTICE ...............................................................................................................66 8.3 RIGHTS JUSTICE...............................................................................................................66 8.4 DISTRIBUTIVE JUSTICE ......................................................................................................67 8.4.1 Theories of distributive justice ................................................................................67 8.5 CONCLUDING REMARKS ...............................................................................................75 CHAPTER 9: Human Rights: The Relevance for South African Health Professionals ...........76 9.1 INTRODUCTION ..............................................................................................................76 9.2 WHAT ARE HUMAN RIGHTS?..........................................................................................77 9.3 WHO IS RESPONSIBLE FOR HUMAN RIGHTS? ................................................................80 9.4 HEALTH AS A RIGHT ........................................................................................................83 9.5 THE SOUTH AFRICAN CONSTITUTION AND THE BILL OF RIGHTS ...................................84 9.6 LIMITING RIGHTS IN THE PUBLIC INTEREST ......................................................................90 9.7 DUAL LOYALTY AND THE HEALTH PROFESSIONAL ........................................................92 9.8 CONCLUDING REMARKS ...............................................................................................94 CHAPTER 10: Law and the Health Professional in South Africa ............................................95 10.1 INTRODUCTION TO GOVERNANCE AND LAW IN SOUTH AFRICA .............................95 10.1.1 Governance in South Africa ................................................................................95 10.1.2 Law in South Africa ...............................................................................................96 10.1.3 Sources of South African law ...............................................................................97 10.1.4 Medical law vs health law ...................................................................................98 10.2 THE DOCTOR-PATIENT RELATIONSHIP..........................................................................98 10.2.1 Parties to the treatment contract .........................................................................98 10.3 INFORMED CONSENT .................................................................................................101 10.3.1 The duty to inform ............................................................................................... 101 10.3.2 Legal requirements of informed consent .......................................................... 101 10.3.3 Informed consent and criminal law ..................................................................105 10.3.4 Informed consent and mental healthcare patients .........................................105 10.3.5 Informed consent and children .........................................................................106 10.3.6 Remedies for violating a patient’s right to informed consent ......................... 113 10.4 CONFIDENTIALITY .......................................................................................................113 10.4.1 Confidentiality and privacy distinguished ........................................................ 113 10.4.2 Confidentiality, disclosure and the common law ............................................114

10.4.3 Confidentiality and privacy: constitutional and statutory provisions .............114 10.4.4 Confidentiality and privilege .............................................................................115 10.4.5 Confidentiality and disclosure: statutory obligations .......................................116 10.4.6 Confidentiality, disclosure and professional codes of conduct .....................118 10.4.7 Disclosures in court ............................................................................................. 118 10.4.8 Moral, social and legal duty to disclose ........................................................... 119 10.4.9 Access to health records, confidentiality and disclosure ............................... 121 10.4.10 Involuntary disclosure of confidential genetic information to related third parties ............................................................................................................................. 123 10.5 MEDICAL MALPRACTICE ........................................................................................... 123 10.5.1 Standard of care .................................................................................................124 10.5.2 Vicarious liability .................................................................................................124 10.6 CONSUMER LAW AND HEALTHCARE ........................................................................124 10.7 CONCLUDING REMARKS ........................................................................................... 125 CHAPTER 11: Professionalism ................................................................................................ 126 11.1 INTRODUCTION ..........................................................................................................126 11.2 WHAT IS REGARDED AS UNPROFESSIONAL CONDUCT? .........................................126 11.3 FEATURES TYPICAL OF PROFESSIONS ........................................................................127 11.4 THE HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA (HPCSA) ......................... 131 11.4.1 A typical complaints procedure .......................................................................131 11.5 OVERSERVICING ........................................................................................................132 11.5.1 Important questions to ask before embarking on a treatment plan ..............133 11.6 IMPAIRED STUDENTS AND COLLEAGUES ..................................................................133 11.6.1 Perverse incentives ............................................................................................. 135 11.7 CONCLUDING REMARKS ........................................................................................... 138 CHAPTER 12: Resolving ethical dilemmas – An Approach to decision making ..............139 12.1 INTRODUCTION ..........................................................................................................139 12.2 STEP 1: IDENTIFY AND ARTICULATE THE MORAL DILEMMA .......................................139 12.3 STEP 2: ESTABLISH ALL THE NECESSARY INFORMATION ............................................140 12.3.1 Scientific and medical information ...................................................................140 12.3.2 Legal questions ...................................................................................................140 12.3.3 Ethical questions .................................................................................................141 12.4 STEP 3: ANALYSE THE INFORMATION .........................................................................143

12.5 STEP 4: FORMULATE SOLUTIONS, MAKE RECOMMENDATIONS, THEN ACT .............143 12.6 STEP 5: IMPLEMENT POLICY........................................................................................ 144 12.7 THE OUTCOME OF THE CASE .....................................................................................144 12.8 CONCLUDING REMARKS ........................................................................................... 150 CHAPTER 13: Ethics in the Consulting rooms .......................................................................151 13.1 ETHICAL STANDARDS AND NORMS OF A MEDICAL PRACTICE ............................... 151 13.1.1 Advertising services ............................................................................................ 151 13.1.2 Privacy in the reception area ............................................................................152 13.1.3 Privacy in the consulting rooms .........................................................................153 In all consultations it is imperative that the patient is granted privacy to undress and is provided with an examination gown. It is also essential that patients are not overexposed during the examination. This is crucial when patients are required to have intimate examinations, such as vaginal or rectal examinations and Pap smears............................................................................................................................. 154 13.1.4 Non-payment of consulting fees .......................................................................154 13.1.5 Employees and vicarious liability ......................................................................156 13.1.6 Sexual harassment in the practice ....................................................................158 13.1.7 Access to medical records ................................................................................160 13.2 CONCLUDING REMARKS ........................................................................................... 162 CHAPTER 14: Paediatric Ethics ............................................................................................. 163 14.1 INTRODUCTION ..........................................................................................................163 14.2 CHILDREN’S RIGHTS AND HEALTHCARE ....................................................................163 14.2.1 Children’s rights in South Africa .........................................................................164 14.3 HOW ARE DECISIONS MADE FOR PATIENTS? ........................................................... 164 14.3.1 The concept of “best interests”..........................................................................165 14.3.2 The “harm principle”........................................................................................... 166 14.4 CHILD ABUSE AND NEGLECT .....................................................................................167 14.5 CHILDREN AND CONSENT: ETHICS ............................................................................169 14.6 CHILDREN AND CONSENT: THE LAW .........................................................................172 14.7 CONSENT IN THE AFRICAN CONTEXT ........................................................................173 14.8 WHEN PARENTS AND CHILDREN REFUSE TREATMENT ...............................................174 14.9 NEONATAL CIRCUMCISION FOR THE PREVENTION OF HIV AND URINARY TRACT INFECTIONS ........................................................................................................................ 175 14.10 END-OF-LIFE ISSUES AND CHILDREN ........................................................................175

14.10.1 Withholding and withdrawing life-sustaining therapy (LST) ........................... 175 14.11 TRUTH TELLING ..........................................................................................................177 14.12 CONFIDENTIALITY .....................................................................................................177 14.13 THE CHILD AND RESEARCH...................................................................................... 177 14.14 CONCLUDING REMARKS ......................................................................................... 178 CHAPTER 15: Ethics in Mental Healthcare ...........................................................................179 15.1 INTRODUCTION ..........................................................................................................179 15.2 PSYCHIATRIC PRACTICE VS GENERAL MEDICAL PRACTICE ....................................179 15.3 SUMMARY OF GOOD CLINICAL CARE .....................................................................182 15.4 THE TOOLS OF BIOETHICAL DELIBERATION ............................................................... 182 15.5 COMPETENCE IN MENTAL HEALTHCARE ..................................................................185 15.6 HIV TESTING IN THE INCOMPETENT PATIENT .............................................................. 186 15.7 PREGNANCY IN THE INCOMPETENT PATIENT ............................................................ 187 15.8 SUBSTANCE ABUSE AND MENTAL ILLNESS .................................................................187 15.9 SPECIFIC ISSUES IN THE FIELD OF PSYCHIATRY .......................................................... 188 15.9.1 Children with psychiatric disorders ...................................................................188 15.9.2 Demented and intellectually disabled (ID) patients ........................................190 15.9.3 Anxiety-, mood-, stress-related and other non-psychotic disorders .............190 15.9.4 Substance-induced disorders ............................................................................192 15.9.5 Personality disorders ........................................................................................... 193 15.10 CONCLUDING REMARKS ......................................................................................... 194 CHAPTER 16: HIV/AIDS in South Africa: An Exploration of the Ethical Options .................195 16.1 INTRODUCTION ..........................................................................................................195 16.2 ORIGINS OF HIV INFECTION....................................................................................... 195 16.3 ETHICAL ISSUES RELATING TO HIV/AIDS IN THE CLINICAL CONTEXT ........................ 196 16.4 HIV/AIDS CARE AND ETHICS...................................................................................... 197 16.4.1 Informed consent and HIV testing .....................................................................197 16.4.2 Confidentiality vs disclosure with regard to HIV status ....................................201 16.4.3 Treatment access ............................................................................................... 208 16.4.4 Treatment adherence......................................................................................... 209 16.4.5 Children and HIV.................................................................................................210 16.4.6 Reproductive rights of HIV-positive couples ....................................................212 16.4.7 HIV, stigma and the punishment theory of disease .........................................213

16.5 CONCLUDING REMARKS ........................................................................................... 214 CHAPTER 17: Reproductive Ethics ........................................................................................ 215 17.1 INTRODUCTION ..........................................................................................................215 17.2 REPRODUCTIVE CHOICE ........................................................................................... 215 17.3 CONTRACEPTION ......................................................................................................216 17.4 PREGNANCY ..............................................................................................................217 17.5 ABORTION ..................................................................................................................217 17.5.1 Moral status of the foetus vs the moral status of the newborn ........................ 217 17.5.2 Abortion and the law .......................................................................................... 219 17.5.3 Feticide ................................................................................................................222 17.6 ASSISTED REPRODUCTION ......................................................................................... 223 17.7 POSTHUMOUS REPRODUCTION.................................................................................225 17.8 PREIMPLANTATION GENETIC DIAGNOSIS (PGD) ...................................................... 226 17.9 ETHICS OF THE PELVIC EXAMINATION .......................................................................226 17.10 CONCLUDING REMARKS ......................................................................................... 227 CHAPTER 18: Ethics at the End of Life ...................................................................................228 18.1 HISTORICAL PERSPECTIVE .......................................................................................... 228 18.2 END-OF-LIFE ISSUES – A CLINICAL PERSPECTIVE ....................................................... 230 18.2.1 Passive euthanasia ............................................................................................. 231 18.2.2 Active euthanasia............................................................................................... 236 18.2.3 Physician-assisted dying ....................................................................................237 18.3 CONCLUDING REMARKS ........................................................................................... 240 CHAPTER 19: Organ Transplant Ethics and Law ..................................................................241 19.1 INTRODUCTION ..........................................................................................................241 19.2 IS IT ETHICAL TO BUY AND SELL BODY PARTS FOR TRANSPLANT? ............................ 243 19.3 PRESUMPTIVE CONSENT: THE OPT-OUT SYSTEM ........................................................ 244 19.4 ORGAN DONATION AND RELIGION .........................................................................245 19.5 RESOURCE ALLOCATION ........................................................................................... 245 19.6 NON-LIFE-SAVING ORGAN TRANSPLANTS ................................................................ 246 19.6.1 Penile transplants and ethics .............................................................................247 19.6.2 Uterus transplants ................................................................................................ 247 19.7 ORGAN TRANSPLANTS AND THE LAW.......................................................................248 19.8 CONCLUDING REMARKS ........................................................................................... 249

CHAPTER 20: Genetics and Ethical complexity ..................................................................250 22.1 INTRODUCTION ..........................................................................................................250 22.2 HISTORICAL PERSPECTIVE .......................................................................................... 250 22.2.1 Eugenics in the US ............................................................................................... 251 22.2.2 Eugenics in Germany ......................................................................................... 251 22.2.3 Eugenics in South Africa .....................................................................................251 22.3 GENETIC INFORMATION AND TESTING .....................................................................252 22.4 GENETIC EXCEPTIONALISM........................................................................................ 253 22.4.1 Pedigree sensitivity ............................................................................................. 253 22.4.2 Ethical concerns raised by genetic testing ...................................................... 253 22.5 DISCRIMINATION ........................................................................................................255 22.6 MISATTRIBUTED PATERNITY ......................................................................................... 256 22.7 CARRIER TESTING AND INFORMED CONSENT .......................................................... 257 22.8 PREDICTIVE TESTING IN CHILDREN.............................................................................257 22.9 GENETIC COUNSELLING ............................................................................................ 259 22.10 CONCLUDING REMARKS ......................................................................................... 261 CHAPTER 21: Research ethics and Scientific Integrity........................................................ 262 20.1 INTRODUCTION ..........................................................................................................262 20.2 A HISTORICAL PERSPECTIVE....................................................................................... 263 20.2.1 The Tuskegee Syphilis Study ...............................................................................263 20.2.2 The syphilis study in Guatemala ........................................................................264 20.2.3 The Nazi experiments ......................................................................................... 264 20.2.4 The thalidomide disaster ....................................................................................265 20.2.5 The Declaration of Helsinki – 1964 .....................................................................265 20.3 THE EVOLUTION OF GOOD CLINICAL PRACTICE (GCP) .........................................266 20.3.1 The United States .................................................................................................266 20.3.2 Japan and Europe .............................................................................................. 267 20.3.3 The International Conference on Harmonisation (ICH) ...................................267 20.3.4 GCP in South Africa ............................................................................................ 267 20.4 THE PRINCIPLES OF GCP ............................................................................................ 267 20.5 WHAT HAPPENS WHEN GCP IS NOT FOLLOWED? ....................................................268 20.6 WHAT MAKES CLINICAL RESEARCH ETHICAL? ......................................................... 272 20.6.1 Relevance and scientific, clinical and social value ........................................272

20.6.2 Scientific validity .................................................................................................273 20.6.3 Fair subject selection of a vulnerable group ....................................................273 20.6.4 Risk-benefit ratio .................................................................................................274 20.6.5 Independent review ........................................................................................... 274 20.6.6 Informed consent................................................................................................ 275 20.6.7 Respect for participants .....................................................................................275 20.6.8 Action – policy and publication ........................................................................275 20.7 PUBLICATION ETHICS..................................................................................................275 20.7.1 Integrity in scientific writing ................................................................................275 20.7.2 Research misconduct......................................................................................... 276 20.7.3 Scientific papers .................................................................................................278 20.8 CONCLUDING REMARKS ........................................................................................... 279 CHAPTER 22: Global Health & Global Health Ethics ........................................................... 280 21.1 GLOBAL HEALTH: WHERE TO NOW? .........................................................................280 21.1.1 Introduction .........................................................................................................280 21.1.2 On the threshold of a new era ...........................................................................280 21.2 TRENDS IN GLOBAL HEALTH ....................................................................................... 281 21.3 UNDERSTANDING THE WORLD AS AN UNSTABLE, COMPLEX ORGANIC SYSTEM ...282 21.4 THE GLOBAL POLITICAL ECONOMY AND HEALTH ...................................................282 21.4.1 Comparative healthcare expenditure .............................................................. 284 21.4.2 Military expenditure and foreign aid ................................................................ 285 21.4.3 Some other comparative expenditures ............................................................ 285 21.4.4 Responsibility for global health ..........................................................................285 21.5 PROGNOSIS FOR IMPROVED GLOBAL HEALTH ........................................................ 286 21.6 A VISION FOR THE FUTURE IN A CHANGING WORLD ...............................................286 21.7 THE WAY FORWARD: CHALLENGING BUT POSSIBLE .................................................288 21.7.1 Global health ethics ........................................................................................... 288 21.7.2 Global political economy and sustainability ...................................................288 21.8 CONCLUDING REMARKS ........................................................................................... 289 CHAPTER 23: New and emerging technologies in healthcare in the 21st century ...........290 23.1 INTRODUCTION ..........................................................................................................290 23.2 SYNTHETIC BIOLOGY ..................................................................................................290 23.3 NEW GENETIC TECHNOLOGIES .................................................................................291

23.3.1 Pharmacogenomics and precision medicine: the ethical, legal and social challenges of the application of new technologies ...................................................291 23.3.2 Genome-wide screening ...................................................................................294 23.3.3 Ethical perspectives on cloning and stem cell research ................................ 296 23.4 BIOBANKING ..............................................................................................................302 23.5 CONCLUDING REMARKS ........................................................................................... 303

CHAPTER 1: A place for ethics, law and human rights in healthcare (Author: Keymanthri Moodley) In the 4th century bc, Hippocrates, philosopher and physician, known also as the father of Western medicine, addressed important ethical questions in healthcare. The Hippocratic Oath, which is regarded as the first written document pertaining to the ethical practice of medicine, was written by him or one of his students. The basis of this oath was the concept of primum non nocere or “above all, do no harm”. Philosophy is the study of fundamental concepts and ideas about existence, values, knowledge, mind and language. Ethics is a branch of philosophy and is sometimes referred to as moral philosophy. Various literary sources indicate that philosophy thrived in Egypt from around 3400 to 343 bc. From 500 to 300 bc, a period of intense intellectual activity was occurring in various parts of the world. The history of Western philosophy is contested in the literature. While the origins of Western philosophy are attributed to ancient Greece, some argue that it may have its origins in the Kemetic civilisations of ancient Egypt, North Africa (Letseka 2014). In 390 bc, Plato visited Egypt to learn more about Kemetic culture and civilisation (Letseka 2014). In The Columbia history of Western philosophy, Richard Popkin (2006:1) describes extensively how Oriental and Egyptian thought influenced early philosophy as a result of widespread Greek trade and commerce throughout the Mediterranean region as follows: As with many of the arts and sciences that make up Western civilization and culture, philosophy was first defined as such by the Greeks around the fifth century B.C.E. However, evidence suggests that many of the problems, concepts, and approaches that became known as philosophy in Greece originated in other places and times. Of these sources, three are particularly notable: “Asian” or “oriental” (including Phoenician, Assyrian, Hittite, and Iranian influences); Hebrew (or biblical); and Egyptian. Approximately 2500 years ago the ancient Greek philosophers – Socrates, Plato and Aristotle – debated questions about morality, which still trouble us today: What does it mean to live a good life? What does it mean to be a good doctor? What is right? How do we know it is right? What is justice? Globally, different philosophical systems have raised similar questions as various points in time, with some philosophical systems predating Western philosophy. African philosophy, Confucian ethics, Buddhist and Hindu philosophy and Middle Eastern philosophies have all posed fundamental questions about the meaning of life. It is interesting to note that Socrates was only 10 years old when Confucius died in 479 bc (Yu 2005). Hence Confucian ethics clearly predates Greek philosophy. In the Western world in the 1960s the invention of the Scribner shunt for renal dialysis and the first heart transplant by Professor Christiaan Barnard raised new ethical questions in healthcare, namely distributive justice and the definition of brain death. Since then, further technological advances in the health sciences have brought with them new and more complex ethical questions. Changing relationships between healthcare professionals and the pharmaceutical industry have raised important new ethical questions. Complex relationships between the healthcare profession and medical funders raise ethical questions around patient confidentiality and justice on a regular basis. Ethics has been defined in various ways over time. The World Medical Association (WMA) defines it as follows: “Ethics is the study of morality – careful and systematic reflection on and analysis of moral 1

decisions and behaviour, whether past, present or future” (Williams 2009). Using this definition, morality refers to the value dimension of human decision making and behaviour. In discussing morality, the following words are frequently used: “rights”, “responsibilities”, “virtues”, “good” and “bad”, “right” and “wrong”, “just” and “unjust”. Ethics refers to what we ought to do in a particular situation. Hence, ethics is a matter of knowing what the right thing is to do, while morality is a matter of doing the right thing. Ethics is a large and very complex field of study as it deals with all aspects of human behaviour and decision making. Bioethics deals with the moral issues raised by developments in the biological sciences at a more general level. Medical ethics explores the responsibility of the doctor and members of the healthcare team in their roles as professionals involved in clinical care and medical research. This book examines the ethical principles and values that underpin good clinical practice in healthcare and health research. Healthcare professionals encounter challenging clinical and ethical questions on a regular basis. Clinical dilemmas arise when there is uncertainty about the best treatment option to use in a particular patient with a particular health problem. Such dilemmas are resolved using evidence derived from sound research in clinical medicine. Ethical conflict arises when one has to choose between two or more equally important but competing values. Rational moral reasoning and analysis guide decision making when ethical dilemmas like these arise: Could a doctor refuse to treat an HIV-positive patient? Is trust important in the doctor-patient relationship? Is a medical receptionist obliged to maintain the confidentiality of patient information? When is medical care regarded as negligent? Should a request for euthanasia be granted? How do we respond to complaints about impaired colleagues? Medicine is a profession. It is a profession because of its commitment to serving the public so that patients derive the benefits of health. Previous generations of doctors committed to ethical conduct have earned the profession trust in the eyes of society. In order to maintain the professional reputation of medicine it is essential that each new generation of doctors understands the ethical obligations that members of the medical profession incur. These obligations are not simply the rules and codes of conduct laid down by professional bodies. Each member of the healthcare team needs to take responsibility for his or her own performance and that of colleagues. Inculcating a sense of professionalism drives doctors and other healthcare professionals to deliver high standards of care. It is on this basis that patients are willing to place their trust in the healthcare profession. Responsibility in healthcare therefore implies that doctors and the healthcare team be held accountable for their decisions and actions. In other words, we need to justify all our decisions – clinical and moral decisions alike. A body of ethical theory assists with such justification. Meta-ethics is a field of ethics that studies and develops theoretical approaches to solving ethical problems. Much of the theoretical development in ethics started with broad-based universal ethical theories grounded in Western philosophy (Beauchamp & Childress 2013). The ancient Greek philosophers as well as those in Africa, China, India, Japan, the Middle East and other countries have made enormous contributions to the development of a theoretical basis for ethics. In particular, virtue ethics appears to be common to many of the different philosophical systems that exist in the world. Over the centuries, various philosophers have attempted to answer these perplexing questions as the field of ethics is firmly situated within the discipline of philosophy. The systems of moral reasoning 2

developed by these philosophers are referred to as ethics theories. These will be discussed in detail in Chapter 3. Medical care has traditionally been based on the principle of primum non nocere or “do no harm”. In 1803, British physician Thomas Percival published the first medical ethics book in which he described the doctor’s main obligation as doing good and avoiding harm rather than giving in to the patient’s requests. Today we follow a more patient-centred holistic approach in healthcare, and respect for patient autonomy is a more dominant principle. The four-principles approach developed in the US is based on four common basic moral principles – respect for autonomy, beneficence, non-maleficence and justice. Ethical dilemmas often involve conflict among these principles. The dominant principle that emerges in decision making may depend on various factors. Along with other theories like consequentialism and deontology, the four principles may be regarded as a principle-based theory. Although controversial and by no means a complete moral system on its own, the four-principles approach provides an analytical framework that will assist you to organise your thoughts around many of the ethical problems you will encounter in your practice. These principles, although controversial, provide a culturally neutral approach to considering ethical dilemmas. The four principles will be explored in detail in the chapters that follow. As healthcare professionals it is essential to think critically about ethical issues. It is necessary to reflect on your own values and belief systems – religious or secular. Engaging in debates on moral issues is healthy – building arguments to justify an ethical viewpoint or decision is essential. Knowing your responsibilities and professional obligations is crucial. Furthermore, it is the responsibility of all healthcare workers to be aware of the laws that govern the practice of medicine. While ethics and law are completely separate disciplines, significant overlap exists. In resolving ethical dilemmas, the consideration of morally acceptable laws is imperative. The law alone, however, is inadequate to resolve all ethical challenges in medicine. This is so because the law changes from time to time and from one country to another. In some instances there is no legislation to justify our actions. Consider the challenges in the field of HIV/AIDS – under such conditions we are guided by the principles and theories in ethics. It remains the responsibility of all healthcare professionals to be familiar with the law and to incorporate legal considerations into ethical deliberations. Medical ethics is a subject that is intensive, extensive and value laden, and it is often difficult to teach without provoking emotional reactions among teachers and students alike. As such, you may encounter material in this book that you will not necessarily be in agreement with. However, one of the goals of a discourse in ethics is to promote tolerance for ambiguity and disagreement! “It is the mark of an educated mind to be able to entertain a thought without accepting it.” - Aristotle It is our sincere hope that this book will sensitise you to the ethical and moral dimensions of medical practice, that it will stimulate your moral imagination and that you will develop skills to identify, analyse and solve your ethical dilemmas. May you enjoy many hours of deep and insightful reflection!

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CHAPTER 2: Ethics and Philosophy (Author: Anton van Niekerk) By the end of this chapter you should be able to • • • • • •

explain what philosophy is explain what is meant by concepts and ideas as the foci of philosophy explain what ethics is distinguish between factual and moral questions, as well as between ethics and law explain why and how ethics springs from our sense of responsibility illustrate how to build a moral argument, with reference to a clear example or case.

2.1 PHILOSOPHY, ETHICS AND MEDICINE There is good reason, when we embark on a book about medical ethics, to start off by talking about philosophy as ethics is a subdiscipline of philosophy in the same way that surgery is a subdiscipline of the science of medicine. Ethics has been around since the dawn of both philosophy and all other recognised intellectual activities of the West in ancient Greece – it constitutes a significant part of the thinking of the best-known Greek philosophers such as Socrates, Plato and, in particular, Aristotle. Furthermore, it is worth noting that philosophy (in the form of ethics) and medicine itself constitute two of the very oldest intellectual (and practical!) activities of mankind. In one of our civilisation’s oldest texts, the Code of Hammurabi (2500 bc), we read ethical admonitions with regard to medicine. Hippocrates, generally regarded as the founder of the tradition of Western medicine, also predates the golden age of Greek philosophy (470–350 bc) by almost 100 years. The Hippocratic Oath is arguably the best-known ethics document in the medical world. It deals almost exclusively with ethical issues, such as abortion, euthanasia and the undesirability of a doctor having sex with patients. In the time of Hippocrates and the Greek philosophers – in fact, right up to the advent of the modern world (i.e. the 17th century) – the difference between philosophy and all the other sciences, including medicine, was not at all clear, and that difference remains a source of controversy. We can, however, broadly identify the difference between philosophy and all other sciences (with the exception of mathematics, which is a unique phenomenon) as a difference of focus. Most sciences (most certainly medicine) are focused on phenomena or things in the world that we can observe through our senses in order to ascertain what the regularities are in terms of which they operate or function. Some of medicine’s greatest achievements include the acquisition of knowledge about what the circulatory system is and how it works or, more recently, how a certain cancer develops and according to which chemotherapeutical or radiotherapeutical regimen it can be arrested, controlled and even destroyed. Most of the sciences, like medicine, are characterised by the attitude of “ask the right questions, then look and see”; the world “out there” will eventually provide the answers to those who are bright and patient enough to discern them.

2.2 THINKING ABOUT THINKING: CONCEPTS AND IDEAS Philosophy, in turn, entails a quite different kind of activity. It is not primarily focused on the world of sense experience (although sense experience often does feed into philosophical reflection), but rather on the process of human thinking. Put as simply as possible: philosophy is about what and how we think. It is a so-called “meta-activity” by means of which we reflect back on that which all of us inadvertently 4

already do every conscious moment, namely think! It asks: What do we do when we think?; How do we think?; How can we know that we are making sense when we think? Hence the term for philosophical activity: reflection, which means: thinking about thinking (even better in Afrikaans: denke oor denke or na-denke). It turns out that, when we reflect on how and what we think, the philosophical tradition has identified two basic instruments or structures that we utilise when we think. The one is concepts and the other is ideas. We cannot make any thinking sense of the world without utilising both. Concepts are the remarkable thought structures by means of which we are able to identify and classify things in the world. It is because all of us, for example, are in possession of the concept “tree” that we are able to identify the vast array of phenomena in the world (ranging from the huge and age-old “Big tree” in the Knysna forest to a bonsai) as “trees”. The same goes for cars, students, buildings, etc. If we did not know how to apply general concepts, we could make no sense of our field of everyday experience, since a new concept would then need to be created for every single thing that we encounter. Although concepts and words are, strictly speaking, not the same, we have access to concepts via language, which is the articulation of concepts. Philosophers are interested in the meaning of concepts and in the rules for their legitimate application because these rules and applications are so often in dispute. Concrete concepts such as trees and wheelbarrows are not controversial and are not the object of philosophical reflection. Rather, philosophers are interested in the more abstract concepts, such as democracy, freedom, right, harm, person, autonomy, virtue, soul, science, rationality and God. The rules for the legitimate use of these concepts remain in dispute. That does not necessarily mean that we therefore have to relinquish the use of these concepts, since what they encapsulate often represents matters and values that are of the gravest importance for people. Our second essential thought structure or instrument is ideas. We also, necessarily, think by means of ideas. Ideas are the thought structures by means of which we interpret things in the world. Interpretation is a different activity from identification and classification which we achieve through the application of concepts. When we interpret, we confer value on what we experience. Interpretation is the process in which we establish the relative value, importance or relevance of whatever we encounter. Note the following example of an idea: “Democracy is the best and the fairest form of government that there is”. This is an evaluation of the phenomenon of democracy that is so prevalent in most of the Western world currently; it does not identify or classify anything, like a concept does, but it makes a value judgement. As such, it always requires justification; it does not contain a self-evident truth (such as two plus three equals five – the kind of statement (often called “tautologies”) that underlies mathematics). Without interpretation, we cannot think in a human way. We, unlike most animals, do not live instinctively. We think about whatever we encounter; we wish to make sense of it all, even if it concerns the satisfaction of an instinctive trait such as hunger; think of all the ideas in terms of which we try to eat well and sensibly!

2.3 WHY IS PHILOSOPHY IMPORTANT IN MEDICINE? Philosophy, as has been shown, is reflection on concepts and ideas: what they are, what rules govern their application, and how applicable, relevant and valid they are. The outcome of philosophical 5

reflection has, for better or worse, been immensely influential in history. Some of that influence can be ably illustrated with reference to the history of medicine. For example, René Descartes (1596–1650), the famous founder of modern philosophy, launched the idea that human beings are essentially constituted by two entities, body and soul, that are incommensurable; they are two fundamentally different types of things (“beings”), and the way in which they come together and interact remains an unfathomable mystery. This idea exerted tremendous influence on the process through which medicine, in the centuries after Descartes, came to think of itself – as essentially a natural science that only deals with the body, understood as an intricate, but perfectly understandable and predictable machine. It was only in the course of the 20th century that this idea was subjected to rigorous criticisms that resulted in a reevaluation of the idea of humanness that ought to underlie clinical medicine and research. A statement of Karl Popper (1902–1994), one of the 20th century’s best-known philosophers of science, is worth noting in this regard: We all have our philosophies, whether or not we are aware of this fact, and our philosophies are [often] not worth very much. But the impact of our philosophies upon our actions and our lives is often devastating. This makes it necessary to try to improve our philosophies by criticism. This is the only apology for the continued existence of philosophy which I am able to offer (Popper 1983: 33).

2.4 WHAT IS ETHICS? Ethics, as we said earlier, is a subdiscipline of philosophy. Ethics is the outcome of reflection on the meaning of the concepts “good” and “bad” or “right” and “wrong”, as well as on a range of ideas about what confers value or disvalue on human action. It is a form of reflection born from our universal discernment that human action is not simply something that happens beyond the conscious control and choices of the actors, as often occurs in the animal world (a lioness will instinctively and without reflection lash out and kill whenever she is hungry or perceives her cubs to be threatened). That is not the case with humans. We not only know what we do when we act, but we, universally, submit our actions to the measure or criterion of obligation. Put more simply: all humans, unless they are psychopaths (i.e. people without a conscience), ask the question: What ought I (or others) to do? Is what I am doing the right thing?

2.5 FACTUAL AND MORAL QUESTIONS Such questions are moral questions, and as such are to be clearly distinguished from factual questions. A factual question (e.g. Which city has the most people, New York or London?) can only be answered by observation and the establishment of the relevant factual information. But moral questions cannot be answered that way. Take, for example, the well-known moral question: Is abortion murder? A lot of facts can be established in connection with abortion as a practice. People can have consensus that human life with the potential to grow into a fully fledged person starts at conception; that an embryo can only develop to term if it attaches to a woman’s womb; that the embryo’s central nervous system only starts developing with the advent of the primal streak, and that before that happens (which is after about 6–8 weeks gestation) the embryo does not have the capacity to feel and can therefore not experience any pain; that a foetus is viable (with help from advanced medical technology) separate from its mother’s womb after 22 weeks of gestation, etc. And yet, in spite of complete consensus about all these facts, people will differ sharply about the answer to the question: Is abortion murder? That is because the latter is not a factual question, but a philosophical and more particularly a moral one. As a philosophical/moral question, it can only be 6

answered if we focus not on yet more establishable facts, but on the rules for the legitimate use of the concept “murder”. When can this concept legitimately be used or applied to a phenomenon in the world? While we are agreed that the death of John F. Kennedy was an instance of murder (and therefore morally reprehensible), we are less certain that the notion of “murder” applies to soldiers killing one another in war (incidentally: When is armed struggle duly acknowledged as “war”? Think of the armed struggle against apartheid!) or to an executioner decapitating Mary Queen of Scots. Similarly, do the rules for the legitimate use of the notion “murder” apply to deliberately aborting a six-week-old foetus? What are these rules?

2.6 MORALITY AND ETHICS When we engage with these questions, we engage in ethics. Ethics is that philosophical discipline that is the outcome of such reflections. It is useful to distinguish between the notions of “ethics and “morality”. “Morality” refers to actual human practices in the world that are informed by values, such as the generally preferred and legally enforceable practice that people should not drink and drive. In so far as this practice occurs, it is part of “morality” as a phenomenon “out there” in the world. Ethics, on the other hand, is a philosophical discipline that is the outcome of a systematic and rationally justifiable process of reflection. In short, morality is what people in fact do, whereas ethics is what they think they should do and how the latter is reflectively and systematically motivated.

2.7 LAW AND ETHICS A further important distinction to bear in mind is that between law and ethics. They are not the same thing, even if it is a fact that they often overlap. What is demanded or forbidden by law is not necessarily always demanded or forbidden by ethics. Take the practice of telling lies. Most ethical theories regard lying as morally forbidden, yet it is not illegal to lie (unless one makes a false sworn statement or lies as a witness in a court of law). Similarly, it may be immoral to smoke (since it harms the smoker and/or other people inhaling the smoke) or watch pornography. Yet, few people would argue that all smoking (except in public areas) or pornography should be made illegal. Similarly, actions may be required or forbidden by law but not by ethics. This particularly occurs when unjust laws are promulgated. In South Africa’s history, both sex and marriage between black and white people were, in terms of the official law of the land, illegal between the late 1940s and the middle of the 1980s. This is a law that very few people would nowadays defend; in fact, the overwhelming consensus is that these laws (also those confining racial groups to “group areas” or prohibiting black and white people from having a drink together) were grossly immoral. Law and ethics can (and do) often overlap, but that need not be the case. This can be further illustrated by bearing in mind the differing consequences of legal and ethical infringements. In the case of illegal activities or felonies, the consequence is punishment. In the case of unethical behaviour, the consequence is blame.

2.8 MORAL RESPONSIBILITY AND THE NEED TO ARGUE In most of the examples of ethical issues discussed up till now, it is important to notice that there are seldom clear-cut or definitive answers. Ethics, as part of philosophy, is born from humankind’s perpetual, seemingly infinite, struggle to come to grips with the fundamental uncertainties that accompany our existence in the world. Mainly because of the achievements of science, we know an enormous amount – so much more than our ancestors of all ages could ever dream of. Yet the more we know, the more we realise that we have only scratched the surface, and that entire new worlds of knowledge await unravelling, such as stem cell therapies and nanotechnology. At the same time, 7

fundamental uncertainties, often to do with issues that we value the most in life, remain. Why this universe, and why us? What are our origin and our destiny (if any)? What is of real value in life? How should we live? What sense can be made of the seemingly impenetrable mystery underlying our existence on earth? These questions are the realm of philosophy and ethics. Because of the difficulty in finding definitive answers to them, many people dismiss them as unanswerable and therefore not worth pursuing. But as a species we cannot indefinitely avoid these questions; they remain with us and perplex us through the ages. In the sphere of ethics, what drives our inquiries in the last analysis is not only our sense of wonder (that which, according to Plato, instigates all philosophical reflection), but also and in particular our sense of responsibility. The impulse to act ethically comes from our sense that we are accountable to ourselves and other people for what we do and how we live (and possibly even to some higher power, as religious people would claim). It is easy to see this in the field of medical science and practice. These are activities directly attuned to the greatest possible benefit for our patients – those who are in need and are utterly dependent on healthcare workers for their care and, if possible, the restoration of their normal bodily functions. Healthcare workers remain responsible for and accountable to the sick. Being ethical in the sense of being responsible means that one must always be able to argue clearly, systematically and rationally (i.e. be able to provide good and persuasive reasons) for whatever one does and for whatever view one takes. Ethics, as part of philosophy, is an enterprise that, in the first and final analysis, deals in and engages with arguments. Arguments are central exactly because real ethical issues cannot be settled definitively by recourse to facts, even though it must be admitted that facts often feed into and support or challenge ethical positions. To give an example: before the advent of antiretroviral drugs (ARVs), when the diagnosis of HIV/AIDS was generally deemed to be a death sentence, it was very difficult to argue for routine HIV testing because of the stigma and concomitant fear associated with the disease. The subsequent development and application of ARVs have now dispelled the need to look upon HIV/AIDS as a death sentence. On condition that informed consent be obtained and counselling be available, the ethical argument for the offering of routine HIV tests for all patients requiring a blood test is therefore considerably strengthened by the fact of the availability of ARVs. Hence our claim: ethical arguments cannot be settled by facts but can be supported or strengthened by them.

2.9 BUILDING MORAL ARGUMENTS To argue – more particularly, to be able to argue well and persuasively – is essential and indispensable for ethical reasoning and practice. Let us briefly look at a case study, and then note how an ethical argument could be construed or built in response to it. The case is known as “In re AC” and concerns the tragic final episode in the personal history of a woman called Angela Carder. Consider the following case CASE STUDY 2.1: IN re AC Angela Carder was first diagnosed with bone cancer at the age of 13. She underwent major surgery several times and, in the process, had a leg amputated. She also underwent multiple radiation and chemotherapy treatments. When she was 27 and in remission, she married and became pregnant. She was happy about the pregnancy and, according to testimony later given in court, “very much wanted the child”.

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In the 26th week of her pregnancy (on 9 June 1987) she was admitted to the high-risk unit of the obstetrics department at George Washington University Hospital, and was found to have a recurrence of disease. An apparently inoperable tumour filled her right lung. On 11 June, her physicians asked if she wanted the baby and she said that she did. On 15 June, Angela was informed by her physicians that her illness was terminal. She agreed to palliative treatment to extend her life until at least the 28th week of pregnancy. When asked if she still wanted to have the baby, she said: “I don’t know, I guess so” or words to that effect. Later the same day, however, her condition deteriorated and she consented to intubation. In addition, she was heavily sedated in order to relieve her pain and to keep her “physiologically compliant” with the respirator. Physicians alleged that she could not carry on a meaningful conversation and they did not believe that sedation could be decreased to a point where she could. On 26 June, the hospital administrator petitioned the court for a declaratory judgment allowing physicians to remove the 28-week-old foetus by Caesarean section. The judge went to the hospital that day for the hearing. Physicians were agreed that the surgery would probably shorten her life. Even without the Caesarean section, she was expected to die within 24–48 hours. A neonatologist testified that the foetus’s chances of survival if delivered immediately were not good – perhaps 50 to 60 per cent because of the gestational age and the mother’s poor condition. One physician estimated that the chance of substantial impairment to the foetus, if it were delivered immediately, was approximately 20 per cent. One of the woman’s obstetricians observed that any further delay would further worsen the foetus’s chance of survival. Another of the treating physicians stated that the “department as a whole” had concluded that they wanted to abide by the wishes of the patient’s family. The views of the patient herself were difficult to elicit because she was heavily sedated and intubated. When she was able to communicate, she seemed to give differing views about saving the foetus. During one conscious period, a physician asked her if they could perform a Caesarean section if it represented the foetus’s only chance of survival, even if it could shorten her own life. Angela said yes, but later the same day when her physicians sought to confirm her consent, she weakly but clearly said: “I don’t want it done, I don’t want it done”. Then she lapsed back into unconsciousness. Other than on these two occasions, she did not speak and only rarely opened her eyes. Angela’s mother and husband opposed the Caesarean section delivery, arguing that she would not have consented to the surgery. Her mother explained that her daughter wanted “to live long enough to hold that baby”. Since it was clear that she would not have that opportunity, the mother felt that Angela would not have chanced the delivery of a substantially impaired infant or subjected herself to painful surgery that would shorten her life. One of her physicians agreed that, given Angela’s own experience with lifelong medical problems, she would not have chosen to deliver a child with a substantial degree of impairment. After hearing the case at the hospital, the judge ordered the surgery. Attorneys for the family appealed the decision, but the Appeals Court concurred with the lower court. The infant died two hours after delivery, and the mother two days later. On the death certificate the Caesarean section was listed as a “contributing cause” of her death. COMMENTARY What would the morally justifiable course of action be for the healthcare personnel and hospital administrator in dealing with this situation? The first issue is to ascertain exactly what the moral problem in this case is. Some would argue that this is a typical example of a “maternal-foetal conflict”, i.e. a situation where the interests of a mother and her 9

foetus are in conflict: the removal of the foetus is not in its interest, but in the interest of the mother. As both sets of interests cannot be served simultaneously, the case is therefore a typical moral dilemma. The situation is, however, slightly different in this case. Here, the removal of the foetus via Caesarean section indeed seems to be more in the interest of the foetus than that of the mother, even though the chance remains that it will be impaired if removed at such an early stage. Yet not being removed means certain death for the foetus since its mother is about to die. The moral difficulty in this case is exacerbated by the fact that the mother was mostly incoherent in the expression of her preference, although in her lucid moments she stated that she did not want the Caesarean section (and, by implication, wished the foetus to die with her). When a patient is incompetent (as Angela increasingly, though not wholly, seemed to be), the medical personnel rely on her surrogate decision maker(s) or proxy, which in this case was her husband and family. Under US law, they are not supposed to express their personal wish, but the wish that they surmise the patient would have expressed in this situation. That wish, according to them, was that Angela did not want the Caesarean section to be done because of the pain it would cause in her last hours and the fact that she did not want a baby that she would not be able to hold or that was impaired. This was acceptable to the medical staff, but not to the hospital administrator, who found it unacceptable to leave a foetus of such late term to die because of its mother’s demise. What then is the moral issue? It is not a typical maternal-foetal conflict, but rather the question as to whether the decision-making authority of the patient (as also represented by her proxies) about what is to be done to her body is to be taken more seriously than the hospital administrator’s position which values the possible (not guaranteed!) life of the foetus as of more worth or importance than the mother’s/family’s wishes. In short, the issue is whether the mother’s right to autonomy and informed consent in this situation weighs more heavily than the idea that one saved life is morally more valuable than two deaths. Now the question becomes: What are our action guides when having to make a moral decision here in South Africa? We, like the people of the US, live in a culture in which the idea of individual human rights is quite important. That was the position taken by the family and the medical staff. The hospital administrator argued differently. He was motivated by what he felt was the greatest good for the greatest number involved. The “greatest good” or the supreme value at stake in this case was human life itself. His argument was that it was a huge tragedy that Angela was terminally ill, and that a Caesarean section would cause her even more pain in her last hours or day. But her death need not have necessitated a second death. The foetus could (it was hoped, but not certainly) be saved. In a situation where death threatens two lives simultaneously, it surely is (morally) better to save at least one of them if at all possible. In Chapter 3 which deals with ethical theories, we shall recognise the staff’s position (i.e. a position that supports the wishes of the patient) as typical of a human rights approach to moral reasoning (respectively a “principlist” or “deontological” approach – these terms will be explained later on). The argument of the administrator, in turn, is typical of a utilitarian approach, i.e. an approach that heeds the rights of individuals much less than it heeds the overall consequences of our actions when we try to confer moral status on acts. It is not easy to decide who was right in this case. As the text indicated, the administrator was vindicated up to the level of the Court of Appeals. What was left out of the text is the last part: this case was finally argued in the Supreme Court of the US, which ruled in favour of the family and the medical staff, eventually requiring the hospital to pay damages of quite a considerable sum.

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2.10 CONCLUDING REMARKS Of importance in concluding this chapter is to note how a moral argument is built. First, one has to identify the real and relevant moral issue. Second, one has to be satisfied with some or other framework of moral reasoning (or moral theory) that is appropriate for approaching this issue. It is, in addition, preferable that one does not appropriate different moral approaches or theories for each and every moral dilemma that one encounters. One of the most significant challenges of moral reasoning is consistency and coherence. The great moral philosophers of the tradition, such as Aristotle, Kant, Mill and Rawls, are great exactly because they developed frameworks for moral reasoning that claim to be applicable to all moral problems. For that very reason it is of great importance that a person who aspires to become involved in moral decision making, as is the destiny of all healthcare professionals, be broadly familiar with these overarching theories, as well as with their strengths and shortcomings, in order to develop argumentative strategies that will facilitate and not hinder informed reflection on the recurrent moral dilemmas that the healthcare professions increasingly encounter. Finally, one also has to be sensitive to the shortcomings of arguing from a certain perspective, and to critically ask whether another approach might not yield a more satisfactory result. This, of course, implies that the search for absolute consistency in terms of an approach to moral problems may sometimes be futile, however desirable it may be. One could, with reference to Case study 2.1, for example, point out that the hospital administrator did possibly not argue from a utilitarian perspective, but from fear of potential litigation if the foetus was left to die, or even from a human rights approach which simply regards the foetus’s “right to life” as being as compelling as that of anyone else. The latter would not be a persuasive argument in terms of South African law, since our law stipulates that only persons have a right to life, and a foetus is not regarded as a person. Howsoever the case may be, the building of a moral argument always entails critical self-reflection on the merits and applicability of each step. Sometimes the consequences or logical implications of approaching a moral problem from a certain perspective unmask the untenability of the approach for a certain problem, if not the untenability of the approach as such. In ethics, final and definitive judgements are not the rule, but the exception. We have to learn to live with such uncertainties; it is an integral part of the business of ethics.

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CHAPTER 3: Ethics Theories and the Principlist Approach in Bioethics (Author: Anton van Niekerk) By the end of this chapter you should be able to • • • • • • •

understand what a moral theory is explain what is meant by utilitarianism, Kantian deontology, virtue ethics, social contract theory and principlism discuss the key concepts and ideas in each of these theories reconstruct the main points of criticism levelled at each of these theories provide a comparative discussion of utilitarianism, Kantian deontology and virtue ethics approach a moral problem independently using one of these theories have a basic understanding of social contract theory, liberal individualism, communitarianism, the ethics of care and casuistry.

3.1 INTRODUCTION We have now seen what philosophy is, what ethics is, and what the nature of moral problems and the basics of moral argumentation amount to. The next question is: How do we go about approaching moral problems or dilemmas when they confront us? When trying to answer this question, the first issue to address is: What are the action guides in terms of which moral decision making might be directed? Put differently: What concerns need to be brought into play once one tries to come to moral decisions? These questions are normally answered by drawing on some or other moral or ethics theory. A moral theory is a conceptual framework in terms of which action guides or norms for action are formulated, as well as certain rules in terms of which those action guides are to be applied. This chapter will discuss a number of such moral theories. The history of ethics has seen a wide range of ethics theories produced by a wide range of philosophers, varied in disposition, time and place. In this chapter the following theories will be discussed: utilitarianism, Kantian deontology, virtue ethics, social contract theory, liberal individualism, communitarianism, ethics of care, casuistry and principlism. Of these, the first three as well as principlism have been significantly more influential in the sphere of bioethics than the others, and they will consequently be dealt with in more detail. As regards the first three, it must be pointed out that, historically speaking, what will later in this chapter (see Section 3.4) be called “virtue ethics” is the oldest ethics theory known to the tradition of Western philosophy, since it was introduced by the founding fathers of Western philosophy in the time of ancient Greece, particularly Aristotle. We, however, will only discuss it after utilitarianism and Kantianism – theories more closely associated with the advent of modern times – have been dealt with. The reason for that is the renewed interest we see nowadays in virtue ethics is by and large the outcome of quite recent (i.e. belonging to the latter half of the 20th century) developments in moral theorising. We will then first deal with utilitarianism and Kantian deontology. They are both closely associated with the advent of the modern world (the time that started in the first part of the 17th century), and, more particularly, the Enlightenment in Western Europe (broadly the 18th century). These two theories are by far the best-known approaches to moral reasoning in current-day ethics literature. After these two as well as virtue ethics have been discussed, we will briefly outline the main tenets of the other theories. The chapter will be concluded by a discussion of principlism, an approach that has been very influential 12

in bioethical circles. Our discussion of principlism in this chapter will only be about the main assumptions and broad outline of the approach. The actual four principles and their application to bioethical problems will be discussed in later chapters.

3.2 UTILITARIANISM Utilitarianism refers to an ethics theory that, strictly speaking, forms a subcategory of a group of theories known as consequentialism. Consequentialism as an approach to moral theorising simply means that the consequences of actions are to be taken, and taken exclusively, as the only concern in terms of which the moral status (i.e. the moral rightness or wrongness) of an action is to be decided. An example of a morally (very) controversial event in recent history that has often been justified by consequentialist reasoning goes as follows: The dropping of two atomic bombs on the cities of Hiroshima and Nagasaki in Japan in August 1945 is generally regarded as the direct cause of Japan’s surrender to the US in World War II, and thus as the cause of the end of the war itself. Those who argue in consequentialist terms point out that, although the explosions caused horrific suffering to immediate victims (more or less 170 000 people died in the immediate aftermath of the two explosions), the cost in human life and suffering would have been significantly worse had the bombs not been dropped. When one argues consequentially, the only issue that matters is the net effect of pain or suffering vis-àvis happiness. According to this argument, prolonging the war against Japan by conventional means would cause more suffering, and thus less happiness, than dropping the atomic bombs. Hence the use of nuclear force in that situation could be morally justified. Consequences of actions can, of course, be widely varied. In the example discussed, the terms “happiness” and “suffering/pain” are used as indicative of the kind of consequences that are particularly to be taken seriously when one argues consequentially. The specific consequentialist theory that argues that the relative amount of happiness or pain brought about by our actions is the most important indicator of moral worth is known as utilitarianism. This is the best-known version of consequentialism that we find in the literature and it will be the theory that concerns us in the rest of this section. Utilitarianism is a theory, the advent of which is closely associated with the contributions of two thinkers of the late 18th and 19th centuries, namely Jeremy Bentham (1748–1832) and John Stuart Mill (1806– 1873). Rachels and Rachels (2010) formulate the following three claims as the core of utilitarianism: a) Actions are to be judged right or wrong solely by virtue of their consequences; nothing else matters. b) In assessing consequences, the only thing that matters is the amount of happiness or unhappiness that is created; everything else is irrelevant. c) Each person’s happiness counts the same. Thus, right actions are those that produce the greatest balance of happiness over unhappiness, with each person’s happiness counted equally important (Rachels & Rachels 2010: 109).

3.2.1 only consequences, happiness and numbers matter morally We all have an almost intuitive sense that the consequences of our actions ought to count in a moral sense. If what we do clearly harms another person, it must, generally speaking, be wrong in some sense. At the same time, what can we make of the idea that an action is right if that rightness does not, in some way or another, translate into a feeling of happiness? Yet the question remains whether the amount of happiness or unhappiness brought about by our actions can be the only thing of moral 13

importance about them. And can we look only at consequences? Utilitarianism is a quite radical – some will even claim crass – position in moral philosophy. When it claims that only consequences count, that is meant quite literally – so literally that, in view of the fact that “the greatest balance of happiness over unhappiness” is sought, and that each one’s happiness counts the same, all other aspects of an action are ignored, including the question as to whether there might not perhaps be something inherently wrong about actions, irrespective of the consequences they might have. Can it ever be right to lie, to kill, to steal or to torture – even if it might be shown that there could be circumstances where acts of lying, stealing or torture bring about more happiness for the most people involved? Utilitarianism defends the idea that acts like lying, stealing and torturing can sometimes, depending on their consequences, be right, and that there is therefore nothing inherently wrong about them. All that matters is what they bring about. The actions of Robin Hood, who stole from the rich and “redistributed” to the poor, are a case in point. Because more people gained happiness from his actions than those who were made unhappy, his actions would be deemed right by classical act utilitarianism. But are they? Let us look at another example, recounted by Brody (1983): A ship, the William Brown, sank on the high seas in 1841 (Brody 1983: 10), and 30 people (including the captain) ended up in a lifeboat that would, with that load, certainly capsize, since it could hold only 20 people. Would it have been right for the captain to throw ten people overboard so that the remaining 20 had a reasonable chance of survival? The utilitarian argument in this case is that the sure survival of 20 and the demise of ten represent a “better balance of happiness over unhappiness”, and would therefore be the right thing for the captain to do – even if it sounds quite counterintuitive to us. In order to come to moral decisions, utilitarianism has no problem literally to “count heads”! A similar argument would apply in the following situation: A man is caught making a telephonic bomb threat to the police in a stadium where 40 000 people are watching a rugby game and there would not be time to evacuate the stadium before the bomb explodes. Would it be morally right to torture such a person if he refuses to tell where the bomb is hidden? We have deep moral sentiments against torture; yet, for the utilitarian, it would be no moral problem to encourage the police to torture in such circumstances. The pain of one criminal does not weigh up to the safety and thus happiness of 40 000. The reason is that, according to utilitarianism, inherent characteristics of an act contribute nothing to the moral status of that act; all that matters are the happiness-producing and suffering-preventing consequences for the majority of people who experience the effects of the act. Utilitarianism has been an extremely influential theory, not only in the history of ethics, but particularly in the sphere of moral deliberation about public policy. Whenever a politician talks about the “public interest” or the “greater benefit of society” when justifying a policy decision, he or she invokes a utilitarian argument of some sort. It seems inevitable. We know that consequences must, in some way or another, be taken into account when we try to establish the moral worth of what people do. Some of the worst moral monsters in the history of the world, such as Hitler and Stalin, are remembered as monsters for no other reason than the monstrous consequences their actions had for the millions 14

affected by them. In as far as utilitarianism insists that consequences matter morally, it has a point and has to be taken seriously.

3.2.2 problems with utilitarianism The question remains, however, as to whether both happiness and consequences are the only issues of importance when we argue morally. That can also be strongly contested. In order to show that happiness is not the only value at play when we argue morally, Rachels and Rachels (2010) refer to the situation of a concert pianist who loses the use of her hands (Rachels & Rachels 2010: 110–111). What is the really bad thing about her situation – merely the fact that she has become unhappy? Suppose that we could find other things to restore her happiness, such as money or friends? Would that be an adequate restoration of the “balance of happiness over unhappiness”? That must be doubted. Her tragedy does not primarily lie in the loss of happiness, but in the loss of her hands! In fact, when she had the full use of her hands, and could practise for the long, strenuous hours that pianists need to do in order to perform at their best, it can well be imagined that she was not happy all the time. People can make themselves pretty miserable in the pursuit of talents or skills that they and others cherish highly. Yet the talents and skills are often the entities that, in the end, carry value – more than the alleged “happiness” that they bring about. At the same time, consequences cannot be the only factor in establishing moral worth. The main reason for that is that circumstances are conceivable where the idea of the best consequences for the most involved is clearly at loggerheads with competing values that are arguably of more importance in the circumstances. Let us restrict ourselves to two examples of such values, namely justice and human rights, and discuss two instances. Suppose a very valuable resource textbook disappears from the university library one night and the identity of the 20 students that visited the library that night could be established with certainty. Suppose, in a disciplinary action against them, the culprit is asked to come forward. He or she refuses, and all 20 are consequently found guilty and punished. Note how the utilitarian would defend such action: The thief is punished justly: that is achieved, with certainty, by punishing all 20 accused. A possible 19 people are unjustly punished, but that does not weigh up against the interests of the 22 000 other students and staff at the institution for whom the secure maintenance of important resources is of the utmost importance for them to do their academic work. Here it is clear: the “greater balance of happiness over unhappiness” can sometimes be at odds with the demands of the value of justice. This is a classic problem that utilitarianism runs into. The same goes for human rights. Consider the following example: There is a huge shortage of donor kidneys in South Africa. The care of end-stage renal failure patients is in addition very expensive, and the disease, since it is terminal, is extremely stressful for both patients and their families. Yet there exists a certain cure, namely a kidney transplant. Would it not be a prudent policy for the government to demand forced tissue samples from randomly selected healthy patients with two kidneys in order to identify suitable donors, thus solving the very costly and distressful problem of care for end-stage renal failure? Again, if utilitarianism’s obsession with “the greatest balance of happiness over unhappiness” is granted, this argument can hardly be faulted, since the distress of the coerced donors (who only suffer temporary discomfort, and can continue normal lives with one kidney) does not weigh up to the greater good 15

achieved for renal patients, their families and society at large. Yet few people would defend this argument. It shows the crassness to which sustained utilitarianism can seemingly lead. What is the problem with the argument? It is the simple fact that the individual human right of the coerced donors (their right to bodily integrity, i.e. the right to give consent for all medical procedures done on one’s body) is forfeited in the situation sketched? Utilitarianism and human rights are seldom compatible. The philosopher Bernard Williams (Williams & Strong 1973: 98–100) has pointed to a last serious problem with utilitarianism, namely the way in which it dismisses the influence of the past on determining the morality of our actions, and thus can prevent us from acting with integrity. Utilitarianism has scant respect for the past; it seems only to be interested in the future. It asks only about the consequences of actions, which belong to the future, and not to the promises or commitments that one might have made or had in the past and that have effects on what we are morally supposed to do here and now. Williams uses the example of a man called Jim. Jim arrives in some authoritarian South American republic and is forcibly introduced to a military leader who, after the proceedings of a kangaroo court, is about to shoot ten (probably) innocent men lined up against a wall. On meeting Jim, he announces that this might just be the prisoners’ lucky day: Jim is invited to shoot one of them at random, in which case the leader will save the other nine’s lives. Should Jim, however, refuse to shoot one, all ten will be executed by the leader himself. The moral impossibility of Jim’s position is clear. If utilitarianism is to be consistently applied, to shoot one person in order to save ten is seemingly in order. Yet, something must be seriously wrong here. Some would argue that this is a case of having to “dirty one’s hands”, i.e. it requires the need to “do wrong in order to do right” (De Wijze 1994). But, as Williams rightly points out, the problem is deeper. Jim’s moral distress is evoked by the fact that, if/when he shoots, he is forced to act against the person that he is, and against the most basic values that he holds, i.e. those of a person who does not randomly shoot people. He is placed in an impossible position because he cannot act with integrity. Whatever else might be claimed for integrity, it must be noted that it always is a value that exhibits an important moral hold that the past can exert on the future (think of the moral hold that promises made in the past have on us in the present). To the extent that utilitarianism cannot account for integrity in action, a serious flaw in its sustainability as an approach to moral reasoning is revealed.

3.3 KANTIAN DEONTOLOGY The second extremely influential moral theory, closely (though not exclusively) associated with the advent of the modern world, is Kantian deontology. The term “Kantian” refers to this theory’s most eloquent and influential exponent, the German philosopher of the Enlightenment period, Immanuel Kant (1724–1804). An alternative name of this approach is “rule morality”, since it emphasises the role of strict rules of behaviour in conferring moral status on actions. In direct opposition to the claims of utilitarianism, deontology asserts that deeds indeed have inherent moral worth. There is, in themselves, something wrong with acts such as stealing, lying, cheating, and the like, irrespective of the consequences that these deeds may have. The fact that Robin Hood’s acts of stealing led to a better distribution of wealth in the Nottingham society of the mythical story is immaterial in determining the rightness or wrongness of his deeds. Stealing is wrong, period, and cannot be justified by pointing to its possible advantageous consequences. 16

While this position clearly resonates better with the moral intuitions that most of us have and have been raised with, in relation to morality the question remains: Why are these deeds wrong? If the answer is because they transgress moral rules, it is hardly helpful, since that answer only shifts the issue to the question: Why are these rules (“stealing, lying and cheating is wrong”) valid and binding? Some would argue that moral rules derive their authority from some divine being or metaphysical principle (“God”), who pronounces these rules in widely accepted moral codes such as the Ten Commandments. This answer is philosophically not entirely persuasive, since it still leaves us with the question: Are the rules valid (simply) because God promulgates them, or does God promulgate them because they are valid and reflect a higher moral order to which even God Himself is subordinate? If the former, it opens the door to the possibility that God might randomly pronounce anything He wishes to be moral, including acts that we would regard as immoral. If the latter, God is in effect not the creator of morality, but merely the agent of a higher order to which He Himself is subordinate – an idea that is strange to most versions of religious belief. It is in this respect that Kant’s ideas, as a justification of morality that does not draw on religious ideas, have become enormously influential in our culture. Kant argues that our insight into the moral character of deeds of honesty, integrity and altruism derives not from any intellectual source outside of ourselves, but indeed from our universal rational capacity as human beings. It is because we are rational that we have the ability to distinguish between right and wrong. Morality, for Kant, is grounded in our two most basic capacities as human beings, namely our capacity for reason and our capacity for freedom. Sandel (2009) explains Kant’s grounding of morality as follows: “Kant argues that every person is worthy of respect, not because we own ourselves, but because we are rational beings, capable of reason; we are also autonomous beings, capable of acting and choosing freely” (Sandel 2009: 107). To act freely for Kant is to act autonomously. Unlike animals, we are, for Kant, autonomous beings. “Autonomy” for him simply means our capacity to morally “legislate” for ourselves. In Sandel’s words: … to act autonomously is to act according to a law I give myself – not according to the dictates of nature or social convention … Here then, is the link between freedom as autonomy and Kant’s idea of morality. To act freely is not to choose the best means to a given end; it is to choose the end itself, for its own sake – a choice that human beings can make and billiard balls (and most animals) cannot (Sandel 2009: 109). For Kant, we act morally when we act on the right motive, and that motive must always be to do one’s duty. For him, to do one’s duty means doing the right thing for the right reason. Morally right deeds are done because they are the right thing to do and not because they give us pleasure or achieve anything but the fulfilment of our inalienable sense of duty. But what is this sense of duty and how can we know it? According to Kant, reason commands the human will by means of what he calls the “categorical imperative”, i.e. an unconditional demand, the validity of which we have to see if we are rational human beings. While space does not allow a more comprehensive discussion of the role of the “good will” in morality, as well as of the relationship between the categorical imperative and hypothetical imperatives (i.e. conditional imperatives, such as: “If you want to pass at university, work hard”), we can only point out that Kant broadly formulated two versions of the categorical imperative: ▪

“Act only on that maxim through which you can at the same time will that it should become a universal law” (Kant 1964: 88 [52]3) 17

▪

“Act in such a way that you always treat humanity, whether in your own person or in the person of any other, never simply as a means, but always at the same time as an end” (Kant 1964: 96 [67]).

The first of these demands that our actions only have moral status if they are universalisable, i.e. if we are able to see, with rational necessity, that a course of action that we take ought to be the course taken by everybody else in a similar situation. This categorical imperative emphasises the need for a thorough rational grounding of all moral actions. We can only act morally on the basis of being rational and of attaining insight into the universalisable rationality of all moral action. The second version of the categorical imperative emphasises the fact that moral action is based on freedom, and freedom in turn is based on our (and every human being’s) autonomy – an autonomy that invites and requires unconditional respect. It is interesting to note that Kant also requires that respect for autonomy for ourselves as individuals. Suicide would therefore always be morally reprehensible for him, because, as Sandel explains, “If I end my life to escape a painful condition, I use myself as a means for the relief of my own suffering” (Sandel 2009: 122). The imperative, however, forbids us ever to use anybody, including ourselves, as a means to something else. “Kantian respect is respect for humanity as such, for a rational capacity that resides, undifferentiated, in all of us” (Sandel 2009: 123).

3.3.1 strengths of kantian deontology When compared to utilitarianism, we can see that Kantianism has a few distinct advantages. As a theory, it does not seem to be as counterintuitive as utilitarianism, i.e. it does not (seek to) justify acts that seem on the face of it to be, and probably are, immoral, such as lying and stealing. Kantianism argues that utilitarianism conceives the moral life in terms of means-to-ends reasoning. Kant thinks this is a mistake because it presupposes a greater capacity to predict and control future outcomes of events than we are capable of – a fundamental problem of utilitarianism is how complete our knowledge of possible consequences can be. Kantianism also explains the role that moral rules clearly and mostly play in people’s lives. It shows why consequences cannot be the only things that count morally. It shows the shortcomings of projecting self-interest as a motive for moral action. Above all, it explains moral motivation more impressively than most other theories. This motivation, according to Kantianism, stems from an inalienable sense of duty. That sense of duty in turn springs from the respect that we are morally obliged to have for autonomous human persons. We respect persons because they are rational beings, i.e. self-legislators who partake in the moral life purely on the basis of their universally shared rational powers and insight. Rachels and Rachels (2010) formulate the central insight of Kant’s categorical imperative as follows: If you accept any considerations as reasons in one case, you must also accept them as reasons in other cases … Moral reasons, if they are valid at all, are binding on all people at all times. This is a requirement of consistency, and Kant was right to think that no rational person may deny it (Rachels & Rachels 2010: 134). Because duty plays such a pivotal role in Kantianism (a famous invocation of Kant is: “Do your duty, even if the heavens fall!”), it is, unlike utilitarianism, able to explain why the past can play an important role in determining moral actions in the present and future. The past can play this role because we act not from self-interest or for the sake of optimal consequences, but for the sake of duty and duty alone. When, for 18

example, we make a promise to people, the fulfilment of that promise becomes a duty that binds us morally until fulfilled.

3.3.2 shortcomings of kantian deontology That Kantianism has these strengths does, on the other hand, not mean that it is devoid of serious shortcomings. Kantian deontology makes an excellent case for the philosophical and rational basis of morality. The question, however, is whether Kantianism can easily translate, from the level of abstract theory, into practical action guides in a particular situation. Another serious problem with the theory is whether, when it does formulate practical guidelines for moral behaviour, it does not become too hopelessly inflexible to indeed be of significant practical use in ordinary life. Yet another critical question often levelled at Kantianism is whether, in real practice, consequences can consistently be avoided when we try to confer moral status on actions. All three of these critical concerns can, in a sense, be illustrated by drawing on a practical example that Kant himself discusses in his work. The case of the inquiring murderer (Kant 1949) Suppose someone is running away from a murderer who has threatened to kill her. She arrives at your home and begs you to hide her from this murderous pursuer. You do that, and within ten minutes there is a knock at the door. It is the murderer and he asks you whether the person that he is following is in your house. What are you to do? May you lie to this murderer? The remarkable thing about Kant’s own position in this case is that he judges that you are morally obliged to tell the murderer the truth in spite of the undoubted detrimental consequences that such an action might have for the potential victim. Kant, however, is not even in this case moved by a concern for consequences. The duty to tell the truth is overriding and binding; to tell the truth is not so much done from respect for the killer, but from respect for the dictates of reason that require us to be able to universalise our actions. Besides (Kant speculates rather hopefully!), we cannot know all the consequences of an act. It is possible that by the time the murderer reaches the victim the latter might have escaped. Or: telling the murderer the truth does not entail allowing him to enter one’s home. Consequences, according to Kant, will take care of themselves; as moral actors, we are only compelled to act according to the requirements of duty. Says Kant: “To be truthful … in all deliberations … is a sacred and absolutely commanding decree of reason, limited by no expediency” (Kant 1949: 348). This example gives an excellent illustration of the morally highly problematic excesses to which consistent Kantianism can lead. Surely in this situation we do not only have a responsibility to tell the truth, but also a responsibility to protect an innocent victim against violent death. Put differently, we cannot, in this case, only have a responsibility to truth at the cost of ignoring consequences; surely we must also take responsibility for ignoring the consequences. Inasmuch as Kantianism yields strict moral rules that ought to be universally applied, a similar problem arises. Is it always clear which rule to apply? Are rules not sometimes in conflict with one another? Take the case of the HIV-positive patient who refuses to inform his sex partners about his status and also, in the name of the rule of doctor-patient confidentiality, forbids his doctor to inform these partners. Here we have a clash of two moral rules: 19

1. The duty to prevent harm to people 2. Doctor-patient confidentiality To which should the doctor adhere? Kantianism struggles to empower us to make a prudent choice in this regard. Many critics have argued that the categorical imperative is too formally and abstractly formulated. In the case of the inquiring murderer, a rule that states: “Always tell the truth, unless telling the truth directly jeopardises the life and safety of another human being” is clearly much more practicable. But such a rethinking of Kantianism implies that somewhat more of a hypothetical element, as well as some regard for the moral import of consequences, ought to be incorporated in its revised version.

3.4 VIRTUE ETHICS As indicated at the beginning of this chapter, virtue ethics is the oldest form of ethics to be found in the Western tradition. It is often also called “character ethics”, since it is primarily focused not so much on the qualities of acts as on the character traits of people. It is the kind of ethics theory most closely associated with the ancient Greek philosophers, of which Aristotle is the most prominent in this regard. Virtue ethics is, however, also interesting in the sense that it was actively and prominently rekindled in the course of the 20th century, particularly by well-known moral philosophers such as Elizabeth Anscombe (Anscombe 1958) and Alasdair MacIntyre (1982). The fundamental assumption of a virtue approach to ethics is that moral status is conferred on acts, not because of some characteristic of the act (as deontology asserts) or because of the consequences of the act (as utilitarianism asserts), but because of the character traits of the actor himself or herself. Put differently, the most important question in moral theory is not what makes an act right or wrong, but the character of the actor, since it is the virtuousness of that character that, above all else, confers moral status on what the actor eventually does. To act right is to act with virtue, and to act wrongly is to act without virtue or viciously. Put differently yet again: virtue ethics requires us to be less concerned with ethical rules or possible consequences of deeds; it simply claims that what matters most morally is the quality of character of moral actors. If we are dealing with good people, we have the guarantee that we will see right deeds that produce good in the world and thus prevent or minimise harm.

3.4.1 what is a virtue? This claim raises the question as to what we are talking about when we consider virtue as the central category of morality and ethics. It is worth our while to note the classical definition of virtue produced by Aristotle. He develops his notion of virtue in a context where he asks about the “good for man”. The good for man for Aristotle is “an activity of soul in accordance with virtue” (Aristotle 1976: 76 [1098a8– 27]4). This is best summarised by Rachels and Rachels as “a character trait that is manifested in habitual [i.e. sustained or maintained] action, that it is good for a person to have” (Rachels & Rachels 2010: 161). A person does not act virtuously if he or she only does good deeds occasionally; the action must be “sustained”. And even sustained action can be bad or wrong; it must be actions that are “good for a person to have”, i.e. that are such that they are acknowledged as the right thing to do and are therefore cherished and appreciated. Only then are we dealing with virtues. But Aristotle’s circumscription of virtues does not stop here. In a famous passage he continues to give flesh to his notion of virtue: 20

So virtue is a purposive disposition lying in a mean that is relative to us and determined by a rational principle, and by that which a prudent man would use to determine it. It is a mean between two kinds of vice, one of excess and the other of deficiency; and also for this reason, that whereas these vices fall short of or exceed the right measure in both feelings and actions, virtue discovers the mean and chooses it. Thus, from the point of view of its essence and the definition of its real nature, virtue is a mean; but in respect of what is right and best, it is an extreme (Aristotle 1976: 102 [1107a1–27]). Virtues are therefore those dispositions of character which we attain midway between two non-virtuous extremes that ought, normally, both to be avoided. Aristotle illustrates this important claim by pointing out that the virtue of courage is the mean between cowardice and foolhardiness; the virtue of generosity is the mean between stinginess and extravagance; prudence is the mean between recklessness and the avoidance of danger at all costs; and pride is the mean between exaggerated humility and vanity.

3.4.2 benefits of virtue ethics There is a lot to be said in favour of virtue ethics. We intuitively tend to concur with the claim that good people will do good deeds, and that in assessing moral status it is at least as important to be able to trust good people than it is to test acts against formal and sometimes abstract theories such as Kantianism. Rachels and Rachels (2010: 168–170) also point out that virtue ethics provides a better account of moral motivation than most other moral theories. Their point is that in assessing the moral status of some act it is often not enough to consider only what is actually being done, irrespective of the motive with which it is done. Imagine our response if a person who does, on a weekly basis, some voluntary community service in a slum area (e.g. runs a soup kitchen) is asked why she does it, and her answer is: “I do it because it is my duty. I absolutely hate doing it, but I nevertheless do it because it is the right thing to do.” Surely we would have questions about the moral status of what is happening here! The reason is that we feel uncomfortable with the idea of moral actions that seemingly amount to no more than blindly following prescribed procedures without the moral actor’s “heart being in it”, as it were. Surely morality has to do not only with what we do but also with the good intentions or motives with which we embark on moral action. It is in this respect that virtue ethics proves to be superior to Kantianism, which is only concerned with duty, or utilitarianism, which is only concerned with consequences. If morality has anything to do with motive, the virtues account well for it since the virtues relate to “people’s hearts”, i.e. to characteristics that motivate us on the deepest and most sincere level of existence. A second advantage of virtue ethics, also noted by Rachels and Rachels (2010), is the fact that this approach solves some of the problems raised by the insistence of other theories, particularly utilitarianism, on “impartiality” in ethics, i.e. the claim that everybody counts for one, and no one can, in morally problematic situations, make “special claims” on us. This requirement seems, on the face of it, plausible until we consider some possibilities that problematise the claim. Suppose I walk home one day past a dam where my son is playing and swimming with his friends, and I suddenly notice that he and two other friends are in trouble in deep water. Would it be morally in order for me to jump in and save my own child before I save the others – if at all? 21

From a utilitarian perspective, no case can be made for “special obligations” towards people close to us or to whom we have a special responsibility, because “everyone counts the same”. As Bernard Williams once put it: “The phrase: ‘because it’s my child/friend/student/parent!’ may not ever be the justification of a utilitarian’s actions.” But this sounds very counterintuitive; how would we in fact look upon a father who, in the situation sketched, does not first and foremost save his own child? Would we in fact not abhor such behaviour on moral grounds? In this respect, virtue ethics works better – it acknowledges virtues, such as loyalty and love, that commit us to the interests of those closest to us before we are obliged to help other people. The law that relieves spouses of giving evidence against each other in a criminal case in most countries is a case in point that recognises this basic moral intuition that most people share.

3.4.3 shortcomings of virtue ethics Virtue ethics thus has some distinct advantages over some other approaches to moral reasoning, but it also has distinct shortcomings. The first of these is that, while well attuned to the requirement of moral motives, virtue ethics does not that easily translate into clear prescriptives for actual moral action. It is one thing to know that a person has the virtues of courage and friendliness, but that in itself gives no clear indication as to what a person is, morally speaking, to do in a morally problematic situation. Take again, as an example, our doctor and his HIV-positive patient who refuses to have his sexual partners informed about his HIV status. This doctor may be a virtuous man in many respects. He may be trustworthy, which will make him incline towards respecting doctor-patient confidentiality, and he may be altruistic, which might incline him towards informing the spouse. The question remains: What is he to do? To merely emphasise his virtues in this case is not going to solve the problem as to what is, morally speaking, actually to be done in practice. Not only does virtue ethics not really provide reliable moral action guides, but it also has shortcomings when appealed to as an approach on the basis of which to formulate morally justified public policy. This also applies in the field of healthcare. It is one thing to emphasise the need for virtuous healthcare personnel, but something else to delineate policies, for example for TB or HIV screening and management, when one only has virtue ethics to rely on. Many authors have therefore argued that virtue ethics is hardly a complete moral theory. It has excellent qualities for the sake of supplementing existing theories, for example for explaining the need for adequate motivation in moral conduct, as has been pointed out. However, as a theory that has to stand on its own exclusive legs, it is not satisfactory. The moment the idea of virtuous action has to be given a more specific content (e.g. what does it, in practice, mean to be honest?), one inevitably finds it necessary to start drawing on other theories. This makes virtue ethics, although useful and supplementary in many respects, incomplete in the final analysis (Rachels & Rachels 2010: 170–172).

3.5 SOCIAL CONTRACT THEORY Utilitarianism, Kantian deontology and virtue ethics are not the only moral theories in the literature, although they are arguably the best known and the most influential, particularly in bioethics. Another popular approach is the social contract theory, originally linked to the work of the 17th century English philosopher John Hobbes (1588–1679), but also later to the French thinker Jean-Jacques Rousseau 22

(1712–1778), and nowadays mostly to the ground-breaking work of the American philosopher of the 20th century, John Rawls, who developed his theory in his famous book A theory of justice. All of these theories assert that morality is in one way or another the outcome of a contract that people engage in, in order to make life tolerable. For Hobbes, humankind in our “original (primitive) state” was in a bellum omnium contra omnes (a war of all against all) in which our natural inclination was only to fend for ourselves and to destroy whomsoever came in the way of that purpose. Life in the original situation was therefore “nasty, brutish and short”. In time, people started realising that if a state of perpetual warfare continued, in which “man is for man a wolf” (homo homini lupus), no one would survive. That realisation causes humans to enter into a contract with one another in which they recognise the authority of a supreme ruler who has the power to formulate laws that prevent us from destroying one another (Leviathan, which is the title of Hobbes’ famous book (Hobbes 1946)). Thus, law and morality are born from the fear we incur when we realise how dangerous life would be if we were to be a law unto ourselves. Law and morality originated to protect us from ourselves and from other people. Rawls’ ideas about our original state are less bloodthirsty, but related. His basic assumption, akin to that of Hobbes and Rousseau, is that a society is a communal effort or arrangement to advance the good of all members of society. People’s inequalities of birth, natural endowments and historical circumstances are undeserved and, in a society where the cooperative nature of action to promote justice is taken seriously, every effort should be made to make more equal the unequal situation of people who have been disadvantaged by the mentioned factors (Rawls 1972: 100–108). Advantages that people have over others that are the result of “accidents of biology and history” seem, for Rawls, arbitrary from the moral point of view and should therefore as far as possible be redressed. “The idea is to redress the bias of contingencies [i.e. the inequalities of birth and natural endowment] in the direction of equality” (Rawls 1972: 100–102). Another central claim of Rawls is that all vital economic goods and services should be distributed equally, unless their unequal distribution works to everyone’s advantage in that society. The distribution of these goods ought to be the result of a social contract to which all who are affected by its contents should contribute equally. How can this contract be set up in a way that will have an equitable outcome for everyone? It is in this respect that Rawls suggests the thought experiment of members of society freely negotiating the position of people accommodated by a future society behind a “veil of ignorance” (Rawls 1972: 136–142). This means that everyone has to decide on what an acceptable society should look like and what the rules of this society should be, when they have no idea where in this society they will end up; in other words, they are behind a “veil of ignorance”. The argument in this respect is that the veil of ignorance will guarantee a process of mutual bargaining that will accomplish two things. First of all, it will maximise the fulfilment of the essential needs of everyone. Behind the veil of ignorance, everyone has a maximum interest to maximise the primary goods available in society in order to protect future society members’ vital interests in potentially adverse contexts. Put differently, behind the veil of ignorance there is no vital incentive to negotiate for luxuries that might well be forfeited when other essential needs crop up in real life. Secondly, because no participant in the negotiations behind the veil of ignorance has any idea of what his or her position in society is likely to be (Rawls 1972: 137), there is every incentive to ensure that the position of persons who will be worse off in the actual society will be as tolerable as possible. As Rawls formulates it: “The 23

veil of ignorance makes possible a unanimous choice of a particular conception of justice. Without these limitations on knowledge the bargaining problem of the original position would be hopelessly complicated” (Rawls 1972: 140).

3.6 LIBERAL INDIVIDUALISM Liberal individualism is a theory in which the freedom and rights of individuals are deemed the most important moral values. It is a theory that draws very strongly on the ideas of two of the most important modern English philosophers, namely John Locke (a 17th century thinker) and John Stuart Mill (a 19th century figure). A central claim of the theory is formulated in a famous statement from Mill’s essay On liberty (Mill 1976). It says the following: The object of this essay is to assert one very simple principle, as entitled to govern absolutely the dealings of society with the individual in the way of compulsion and control, whether the means used be physical force in the form of legal penalties, or the moral coercion of public opinion. That principle is that the sole end for which mankind are warranted, individually or collectively, in interfering with the liberty of action of any of their number, is self-protection. That the only purpose for which power can be rightfully exercised over any number of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral, is not a sufficient warrant (Mill 1976: 13, author’s italics). The implication of this claim is that individual freedom is humankind’s most important value. Our freedom to decide what is good for us may never be interfered with except in cases where the exercise of our freedom may limit or threaten someone else’s freedom or safety; power may only be exerted to curb our freedom when not to do so might bring harm to others. In other words, we have a right to freedom, as well as to a number of other fundamental human rights that, in modern democracies influenced by liberal individualism, are normally formulated in a Bill of Rights (e.g. that of the US or South Africa) and enforced by an independent judiciary and security forces. Rights can indeed be regarded as enforceable entitlements that we have recourse to in order to trump illegitimate efforts (by other people or even by governments) to curtail our own freedom. This theory has many implications for the practice of healthcare. The principle of respect for autonomy, one of the four principles of biomedical ethics to be discussed later on, requires respect for individuals’ right to be informed and to be co-deciders about their healthcare. Rights can be negative or positive. Negative rights refer to people’s entitlement to refuse things, including healthcare. For example a terminal cancer patient has the right to refuse further chemotherapy. Positive rights are entitlements in the sense of claims to benefits. For example, in terms of the South African Constitution, people have the right of access to healthcare services, including reproductive health, and may not be refused emergency medical treatment (Article 27). How exactly such rights are enforceable in a resource-constrained society such as South Africa is, however, not always clear, hence the limitation clause in the Constitution, which specifies that rights may be claimed subject to availability of resources.

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3.7 COMMUNITARIANISM Communitarianism is a philosophy in terms of which the rights of individuals are made subservient to the interests of the community in which individuals live and participate. This is an approach that is popular in Africa, where the philosophy of Ubuntu is often quite prevalent, expressed in the well-known phrase: “people are people through other people”. However, long before Ubuntu was hailed as a central tenet of “African” philosophy, communitarianism was a moral theory propagated by Western thinkers such as Charles Taylor and Alasdair MacIntyre. Communitarians emphasise the pivotal role played by human communities in shaping values and in the formation of individual selves. The role of the family is given significant prominence. It is argued that our sense of self is a comparatively late development in the formation of personality. We have no sense of self before language is acquired (Van Niekerk 1986), and the acquisition of language is only possible on the basis of close social relationships in a community. Communitarians also argue that communities are, as identifiable entities, much more than the simple sum of their constituent individuals. Rather, a community is an organic and often dynamic whole that actively forms individuals, cultivates values and instills a sense of security and continuity to people’s lives. Applied to the healthcare setting, one often comes across the argument that Western notions of human rights, individual autonomy and informed consent need to be adapted to more communitarian perspectives as they are particularly prevalent in Africa. It is then suggested that, for example, Africans are often uncomfortable with a practice and idea of informed consent that presupposes that every individual can, of his or her own accord, make an independent decision about what is good for him or her. The suggestion is then that the community from which one originates might play a more prominent role in formulating an individual’s informed consent. Exactly how this community involvement ought to operate in practice is not always made clear. Would it, for example, imply that community leaders can or ought to play a central role in providing informed consent? Does such “communal consent” imply that decisions can be made with which the patient involved might disagree? It seems that, while a critique of the “atomistic” nature of Western perceptions of self might well be warranted, these questions about the application of communitarian ideas in the practice of healthcare still require more critical reflection. Such reflection is provided in Chapter 4 on African philosophy.

3.8 THE ETHICS OF CARE The perspective called the “ethics of care” emanates from feminist perspectives on and ideas about medical ethics. It springs from a resistance to the fact that male authors, up until recently (the situation is rapidly changing), dominated the production of bioethics literature. Feminists are of the opinion that certain moral theories and approaches, particularly deontology, utilitarianism and principlism (see Section 3.9), are expressive of a kind of masculine theorising that is alien to the kinds of concerns that women are inclined to value more. These male-oriented approaches tend, for example, to be more authoritarian and inflexible than approaches that appeal to women. The ultimate example of this is Kant’s inflexible argument about the duty of truth telling in the “Case of the inquiring murderer” discussed above. Not only is this “case” drenched in the imagery of male demagoguery, but, so the

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argument goes, it shows no sensitivity for the kind of value orientation that women (can) contribute to moral reflection. Consequently, the notion of “care” attains centre stage in this approach. “Care” as a moral category is less concerned with the obsession, at the level of ideas, to be consistent and coherent, and more concerned with the interests and needs of the complete human person. In the healthcare setting, the approach and practice of nurses are pertinent to this theory. Nurses are not powerful figures who see patients once a day and who issue authoritative instructions to underlings. Nurses spend the entire day (and night!) with patients; they concern themselves not only with the patients’ diseases, but with the whole person and the full complement of needs that that person might have. They interact with both patients and families on a sustained level, listen to life stories and histories, console patients and family members who are desperate and disoriented – in short, they “care” for the whole. This is an approach to moral theorising that is gaining prominence in our time.

3.9 CASUISTRY All the approaches/theories discussed until now (with the possible exception of the ethics of care) share one common presupposition: when engaging in bioethics, we are supposed to master the theoretical perspectives first, and move from there to the demands of practice. This could indeed be called a topdown approach: start with theory and end up with its application in practice. Casuistry is an approach to moral reasoning that operates in the opposite direction: it starts with practice and ends with theory. Casuistry is the approach where we learn ethical insights primarily by studying cases. The assumption is that theory is too abstract and without content to help us much when we are dealing with real problems in real life. Ethics proceeds best when we start out with a case, think about its moral issues and challenges, try to compare aspects of the case with other cases that we also might have encountered, and thus slowly build up a more comprehensive perspective that can assist us in future. Every case, however, is regarded as unique, and the challenges and insights that it yields should in every case be made to feed into the overall perspective that slowly emerges. The assumption here is that, just as little effective doctoring can be learnt by only studying textbooks and attending lectures without the actual bedside experience of attending rounds and noting and discussing concrete cases, so little can ethics succeed if one does not take one’s point of departure in the study of and reflection on actual morally problematic cases. Ethics, like medicine, is therefore to be primarily studied “at the bedside”.

3.10 PRINCIPLISM The last theory or approach that we discuss briefly will be principlism, so called since it primarily refers to the approach to moral argumentation developed by Tom Beauchamp and James Childress in their book Principles of biomedical ethics (Beauchamp & Childress 2001), a work that has seen six more editions since it was first published in 1979, and that has attained significant status as a formative textbook for students in bioethics worldwide. The idea of the “Four principles of biomedical ethics” will guide the discussion in the next few chapters of this book. We shall therefore, in this section, not discuss

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the four principles as such, but will only make a few brief remarks about the broad approach to moral reasoning suggested by principlism. The basic idea behind this approach is that moral problems can best be approached (though not always solved) by applying one or more of four basic “moral principles” to them. These principles are: respect for autonomy, non-maleficence, beneficence and justice. A chapter will be devoted to each of these principles in the rest of this book. By “principles” Beauchamp and Childress mean action guides that operate at quite a high level of abstraction, and that can be further specified in terms of more specific action guidelines. The term “principles” derives from the Latin word principia, which denotes directives that operate “at the beginning”. There is significant controversy in the debate about principlism about the question of exactly at what level of abstraction the principles in fact operate. Up to the fourth edition of their book, Beauchamp and Childress stuck with a scheme of deductivist reasoning in terms of which ethics theory (e.g. utilitarianism or social contract theory) was regarded as the highest level of abstraction, followed by principles, then rules and, lastly, particular moral judgements. For example: suppose that utilitarianism as an overarching moral theory proclaims utility as the ultimate moral value, as we have seen. From that the principle of beneficence is then derived. It states that to benefit a fellow human being is fundamental to the moral life. From this principle a specific rule for moral action is in turn deduced: “Always try to maximise the net aggregate of good and to minimise suffering.” Lastly, on the basis of this rule a particular judgement is then made: “It is better (i.e. morally preferable) to let Terri Schiavo die than to keep her alive.” One of the main reasons for the emphasis on principles is the fact that it is so difficult to attain consensus on the most appropriate and universalistically applicable moral theory. Our intuitions guide us sometimes to see the unavoidable validity of, for example, the Kantian emphasis on truth telling (based on respect for people), and yet at the same time the need sometimes not to tell the truth in view of the need of overall utility (e.g. Kant’s example of the pursuing murderer). Beauchamp and Childress make the point that, while it is nigh impossible to consistently and coherently defend one single moral theory, it is remarkable that almost all the known theories yield insight into the general validity of the four principles. Therefore, while we can agree to disagree about the possibility of consistently upholding one single moral theory, we can agree that the “common morality” compels us to embrace the four principles. The implication of principlism is the outright rejection of the need for an overarching moral theory that definitively grounds moral convictions and judgements. Principlism much rather, as we have seen, draws on the idea of a common morality. The idea of a common morality is that we all participate in a general, historically constituted, pretheoretical framework of moral convictions that are best integrated into the four principles. Common morality theories claim that we are all informed by ordinary shared moral beliefs without making any claims to pure reason, rationality, natural law, a special moral sense, and the like. All common morality theories hold that any ethics theory that cannot be made consistent with these pretheoretical common sense moral judgements falls under suspicion. All common morality theories are

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pluralistic: “Two or more non-absolute (prima facie) principles form the general level of normative statement.” What then do we do when we are uncertain as to which principle applies to a situation and, if more than one applies, which is to have preference? To this Beauchamp and Childress answer that we are called upon to weigh the principles in the situation. A principle is valid unless another principle clearly has more force in the situation. As the authors argue: “Principles need to be made specific for cases, and case analysis needs illumination from general principles”. For the resolution of possible conflicts between principles, they draw on Rawls’ idea of “reflective equilibrium” as a model: weigh the principles until some equilibrium is found in which their relevant weights come to rest. But all decisions taken in this way will always remain open to revision; the equilibrium is never entirely stable. As they argue: “A moral framework is more a process than a finished product, and moral problems … should be considered projects in need of continual adjustment by reflective equilibrium” (Beauchamp & Childress 2001: 398). Many criticisms have been levelled at the principlist approach. It is claimed that as an approach it rests on intuitions of basic moral duties (the intuitionist W.D. Ross is acknowledged by Beauchamp and Childress as a major influence on their theory). However, the question is: Do/can we know that these intuitions are reliable? To this, the authors answer that we can indeed never be certain, yet the common morality from which the principles are derived nevertheless shows a remarkable consensus about these duties. Another critical question is: How do we know how to apply which principle, or are all principles always applicable to any moral dilemma? (For example, ought all of beneficence, non-maleficence and respect to have been applied to the situation of the conspirators that planned to murder Hitler? The answer is not self-evident.) Another critical question is: What ought to happen in situations where the application of different principles leads to contradictory conclusions and thus moral conflict? (Again, we note the classic case of the HIV-positive patient who refuses to allow his sex partners to be informed – here the principles of non-maleficence and respect for autonomy are clearly at loggerheads.) Beauchamp and Childress will, in this situation, implore us to “weigh” and “seek equilibrium.” However, how, or in light of which concerns, must we “weigh” or seek balance? How do we avoid undue reliance on “mere intuition”? In spite of these and many other criticisms to which principlism has and can be subjected, it remains a very popular and widely utilised approach, since it identifies and exploits a few relatively simple tools of moral reasoning that most people can identify with. Even if one remains aware of the approach’s shortcomings, it provides a simple and versatile apparatus that has attained enormous acclaim with people who have to make everyday practical moral decisions all over the world.

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CHAPTER 4: African Philosophy and Medical Ethics (Author: Matsephe M. Letseka & Wandile Ganya) By the end of this chapter you should be able to • • • •

explain what African philosophy encompasses understand the concept of Ubuntu as a component of African philosophy explain the different conceptions of personhood discuss the relationship between African philosophy and medical ethics.

4.1 INTRODUCTION In this chapter we explore the potential link between African philosophy and medical ethics. Contemporary times provide an opportune moment for the intellectual advancement of African philosophy in medical ethics in South Africa. The explosion of opposition voices among student organisations and in the realm of national politics, and the constitution of such voices as the counterhegemonic force create spaces for profound and fascinating challenges to taken-for-granted assumptions and views on medical expertise. Examples are not hard to find. For instance, the #FeesMustFall movement that exploded in South Africa and spread to some parts of the world; the incessant disruptions of parliament and the presumed parliamentary codes of etiquette by newcomers, the Economic Freedom Fighters (EFF); and the recent ruling by the Constitutional Court of South Africa against the country’s sitting president are indications of the ushering in of a new era that renders old metanarratives open to criticism with a view to creating new perspectives, and/or new forms of understanding. Dating as far back as the 1980s, medical ethics and the rights of the patient have become topical issues, mainly as a result of endemic ethical problems that often lead to conflict (Veatch 1981), and concomitant efforts to make sense of medical ethics (Johnson & Johnson 2007). For instance, Johnson and Johnson (2007) grapple with seemingly intractable issues such as autonomy and consent, beneficence, confidentiality, justice and fairness, and truth and integrity, and whether there is a possibility for consensus when there is a conflict of ethics. Brannan et al. (2012) note that although medical ethics focuses on the duties of doctors, it overlaps with “healthcare ethics” and “bioethics”. They argue that: the original Greek and Latin expressions for “ethics” and “morals” conveyed the same idea of a code of conduct acceptable to a particular group. Nowadays, “ethics” can either mean conforming to recognised standards of practice or describe the general study of morality (Brannan et al. 2012: 26). They point out that “traditionally, professional ethics was what doctors defined for themselves, from their own perspective. Their duty was to work to the standards established by their peers and avoid any action that would bring the profession into disrepute”, but modern ethics is different. It deals with “everyday practice as well as with the unusual, dramatic and contentious. It involves a search for morally acceptable and reasoned answers in situations where different moral concerns, interests or priorities conflict”. Brannan et al. underscore the centrality of the principles of self-determination or autonomy; honesty or integrity; confidentiality; fairness and equity; and harm and benefit to medical ethics (Brannan et al. 2012). We will say more on these principles in the penultimate section of the chapter. 29

What we attempt to do in this chapter is to appeal to African philosophical thought with a view to attaining new discernments that would enable us to manage medical ethical conflicts and dilemmas. The pertinence of this attempt cannot be overemphasised, given the evidence of the robust activism demarcated above. Such activism calls for a reimagined notion of medical ethics in an African context that is caught up in the whirlwind of a fast-changing, globalised and interconnected world. What happens on a global scale has to be cast into the African context and internalised, just as what happens in the African context has to take cognisance of global developments. The African context can never exist as a silo, but as an integral part of the global community. The purpose of this chapter is therefore to serve as an introductory exploration of some of the normative issues pertaining to medical ethics and African philosophy. It is hoped that the reader will appreciate the relevance of this chapter as an intellectual enterprise that seeks to weave together the contributions of African philosophy to contemporary medical ethical discourse. This chapter is divided into five sections. In the first section we shall introduce the notion of Ubuntu, understood as humanness – an ethics of care and “a theory of right action” (Metz 2007: 323). We shall argue that Ubuntu is a normative concept that encapsulates moral norms and values such as “kindness, generosity, benevolence, courtesy, and respect for and concern for others”(Letseka 2000: 180). Waghid and Smeyers (2012: 20) argue that “ubuntu as a particular ethic of care, through its reliance on empathy and relational autonomy, is a very persuasive approach”. In the second section we tease out the notion of personhood in African philosophy. We shall draw on the work of two distinguished African philosophers who have written extensively on the issue, namely Kenyan philosopher Dismas Masolo (2010) and Nigerian poet and philosopher Ifeanyi Menkiti (2004). In the third section we debate the synergy that ought to exist between African philosophy and medical ethics. We shall argue that if, on the one hand, the assumption that medical ethics ought to be predicated on the principles of selfdetermination or autonomy; honesty or integrity; confidentiality; fairness and equity; and harm and benefit, which are subsumed in humanness and, on the other hand, Ubuntu is understood as humanness because it encapsulates the ethics of care, kindness, generosity, benevolence, courtesy and respect for persons, then there is reason to argue that in an African context such as South Africa, medical ethics and African philosophy ought to complement each other. In the fourth and final section we shall provide some concluding remarks.

4.2 UBUNTU The notion of Ubuntu has been widely theorised by African scholars. Some of them described it as a moral theory, or “a theory of right action” (Metz & Gaie 2010; Metz 2007; Letseka 2000; 2012; 2013; Shutte 1994; Teffo 1994), while others regard it as an interactive ethic in which our humanity is shaped by our interaction with others as co-dependent beings (McCluskey & Lephalala 2010; Cornell & Van Marle 2005). Still others regard Ubuntu as a potential communal public policy (Nkondo 2007) and as a notion of communal justice in African communities (Letseka 2014; Keevy 2008). Retired South African Constitutional judge, Justice Yvonne Mokgoro (1998: 17), has strongly argued that “group solidarity, conformity, compassion, respect, human dignity, humanistic orientation and collective unity have, among others, been identified as key social values of ubuntu”. The underlying concern of Ubuntu (humanness) is with the welfare of others (Letseka 2000: 184). Letseka (2000: 186) argues that the reason for this is that “ubuntu prescribes desirable and acceptable forms of human conduct in a particular community of people”.

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In southern Africa, the notion of African philosophy encompasses the concept of ubuntu (Nguni), or botho (Sotho), whose main concern is with human welfare or humanness. Ghanaian philosopher Kwame Gyekye (1997: 158) observes that “if one were to look for a pervasive and fundamental concept in African socioethical thought generally – a concept that animates other intellectual activities and forms of behaviour, including religious behaviour – that concept would most probably be humanness”. In the African frame of thought, humanness refers to “a philosophy that sees human needs, interests and dignity as of fundamental importance and concern” (Letseka 2000: 182). The notion of Ubuntu is best understood through the African communal interdependence maxim, umuntu ngumuntu ngabantu (Nguni), or its Sotho variation, motho ke motho ka batho, whose English translation approximates “a person is a person through other persons”. The above views on Ubuntu can be traced to the work of other African scholars who have made substantive contributions on the concept. For instance, Chachine (2008: 74) argues that Ubuntu “articulates a view of oneself in the realm of social interdependence”. Along the same lines, Beets (2011: 80) contends that Ubuntu implies that “each individual’s humanity is ideally expressed in relationships with others”. The Ubuntu realm of social interdependence referred to above manifests in belonging to and being grounded in one’s community. In the Ubuntu conceptual scheme, community is “central to the African understanding of person, where the individual is conceived of as attaining the idea of himself or herself in terms of his or her continuing engagement within the web of social relationships”. In the same vein, Ramose (2002: 380) argues that “ubuntu as a concept and experience is linked epistemologically to umuntu [person]. On the basis of this link umuntu posits Ubuntu as its basic normative category of ethics”. It can therefore be reasonably argued that Ubuntu implies an interactive ethic in which our humanity is shaped by our interaction with others as co-dependent beings (McCluskey & Lephalala 2010; Cornell & Van Marle 2005). For Sindane (1994: 8–9), according to Ubuntu, to be fully a human being is to affirm one’s humanity by recognising the humanity of others, and by so doing, establishing humane relations with them. Ubuntu inspires us to expose ourselves to others to encounter the difference of their humanness in order to inform and enrich our own.

4.3 PERSONHOOD IN AFRICAN PHILOSOPHY The pertinence of the notion of personhood to African philosophy in general, and to Ubuntu in particular, cannot be overemphasised. This is because Ubuntu articulates social interdependence and a deep rootedness in community (Chachine 2008; Adonis 2008). The notion of African communal interdependence finds expression in the family, especially the extended family. Lauras-Lecoh (1990: 480) argues that “worldwide Africa is seen as one of the sanctuaries of the extended family. It is the continent where the nuclear family, reduced to a couple and their offspring, is still a rarity”. While for Gyekye (1997: 292–293), “one outstanding cultural value of the traditional African society that is a feature of ever-present consciousness of ties of kinship is the emphasis on the importance of the family – the extended family”. The family has been described as a “microcosm of the wider society” (Mbiti 1975: 176), the “raison d’être of all social co-operation” (Ayisi 1992: 16), “the primary institution of formative moral development” and “the school of justice” (Okin 1989: 22). According to Ubuntu, therefore, the self or individual can only be constituted by its relationships with others, hence the African communal interdependence adage, umuntu ngumuntu ngabantu or “a person is a person through others”. Mbiti (1989: 106) provides another interpretation of this notion of African communal interdependence in his maxim: I am, because we are; and since we are, therefore I am. Thus the Ubuntu perception of personhood “acknowledges the irreducibility of the other – that is, it never reduces the 31

other to any specific characteristic, conduct or function” (Louw 2006: 168). As Letseka (2013: 339) neatly sums it up, “within traditional African thought ubuntu/botho can be said to articulate our communal inter-connectedness, our common humanity, our interdependence and our common membership to a community”. Against the above backdrop of the centrality of “the family” to the interdependent African communal livelihood, it is our submission in this chapter that the African notion of personhood can only be realised within “the family”. In his book Self and community in a changing world, Kenyan philosopher Dismas Masolo (2010: 156) argues a case for “the biological constitution of humans as a necessary but not sufficient basis of personhood, because human beings require gradual socio-genic development to become persons”. It is Masolo’s (2010: 154) contention that “persons are products of community”. He posits that personhood is constituted by the interplay between the culturally objectified perceptions of persons and the subjectively apprehended aspects of social life through which individuals express their subjectivity in opposition to or conformity to the conventionally defined roles, rules, and regulations of the habitus (Masolo, 2010: 218). From this premise, Masolo makes a case for the link between personhood and morality. He writes that “the metaphysics of personhood, the relational nature of the person sheds a new light on how we understand the foundations of morals”. He argues that this enables us to see the origin of moral principles as emanating not from the idea of an autonomous and transcendent mind that is endowed with the capability of “discovering” correspondingly transcendental and objective laws and truths of conduct stacked away in the “objective world of norms” but rather as emanating from the socially conditioned and located persons whose minds are the capacities of their bodily lives and experiences (Masolo 2010: 172). Masolo’s views above on personhood are echoed by Nigerian-born professor of philosophy at Wellesley College in Massachusetts, USA, Ifeanyi Menkiti (2004: 326), who argues that “in the stated journey of the individual toward personhood … the community plays a vital role both as catalyst and as prescriber of norms. The idea is that in order to transform what was initially biologically given into full personhood, the community, of necessity, has to step in, since the individual, himself or herself, cannot carry through the transformation unassisted”.

4.4 AFRICAN PHILOSOPHY AND MEDICAL ETHICS In this penultimate section, we highlight the potential link between African philosophy and medical ethics, with special reference to the notion of Ubuntu and an African-inspired principlism. On the one hand, it is our considered view that central to both African philosophy and medical ethics is the issue of human dignity. As Bessler (2008: 43) puts it, “ubuntu is the capacity to express compassion, justice, reciprocity, dignity, harmony and humanity in the interests of building, maintaining and strengthening the community”. Metz (2007: 340) argues that Ubuntu is “a theory of right action”. He contends that the most justified normative theory of right action that has an African pedigree is the requirement to produce harmony and to reduce discord. In this regard, Ubuntu is fundamentally a matter of reverence of human life. Metz (2007: 329) refers to a Constitutional Court of South Africa judgment by Justice Mokgoro in which she states that life and dignity are like two sides of a coin, but the concept of Ubuntu embodies both. In the same vein, Letseka (2000: 179) makes a case for Ubuntu as pervasive and fundamental to African socioethical thought, as illuminating the communal rootedness and

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interdependence of persons; as highlighting the importance of human relationships; and as an important measure of human wellbeing or human flourishing in traditional African life. A newly qualified medical doctor stationed at a clinic somewhere in rural Eastern Cape or KwaZulu-Natal will at first be immensely challenged to gain a grasp on that particular community’s culture or way of life. The reason for this is that most human interactions in the most rural communities are based on principles of communalism and the notion of the extended family. Within Africanist scholarship these are regarded as cornerstones of the African livelihood. In such contexts the prevalence of the notion of Ubuntu is pervasive. We should hasten to mention that Ubuntu has a strong ethical orientation. As Waghid and Davids (2014) put it, the notion of botho or Ubuntu is constitutive of African political, social and ethical thought, often illuminating the communal interdependence of persons geared towards the cultivation of human flourishing in indigenous African societies. On the other hand, medical ethics endeavours to secure for the individual an environment in which he or she is treated in the most ethical, humane and dignified manner possible. This requires compliance with specific codes of ethical conduct. Brannan et al. (2012) demarcate the following ethical codes as integral to medical ethics: self-determination or autonomy; confidentiality; honesty and integrity; fairness and equity; and harm and benefit. In their ethical theory of principlism, Beauchamp and Childress (2009) also argue for the foregoing codes of ethical conduct. In contrast to the traditional treatment thereof, here we shall discuss aspects of principlism in the purview of African philosophical values encompassed in Ubuntu, communalism and personhood, and later argue for an African-inspired principlism. The ability to think, choose, decide and act for oneself constitutes self-determination or autonomy. There is a moral obligation to respect people’s self-determination as long as it does not impinge on the rights or welfare of someone else. Respect for autonomy means that competent and informed individuals can accept or refuse treatment without having to explain why. They can choose things that are harmful or bad for themselves, but they do not have the same liberty to choose things that would harm others. They can also choose whether or not they want to participate in research. Jegede (2009) cautions that applying the Western concept of autonomy to research involving human subjects in the African context without adequate consideration for the important role of the community is inappropriate. The reason for this is that in Western terminology, autonomy is taken to mean “self-rule” or “self-governance”. However, it is Jegede’s (2009: 246) considered view that: … though communalism is the basis of existence in most African societies, individual autonomy is not compromised. Generally, the word autonomy is a relative concept in that community members defend the right of the individual as epitomized by the role of community leaders. Even though Western medical ethics demands that all patients be entitled to confidentiality, confidentiality as a right is not absolute, especially if other people are at serious risk of harm as a result. Cases arise where an overriding public interest would necessitate breach of confidentiality. Although this is one of the oldest values reiterated in ethical codes, it is increasingly difficult to define in practical terms as notions of public interest change. Metz and Gaie (2010: 278–279) indicate that confidentiality is even more difficult in African communities where other individuals, especially family members, will be involved in taking care of those who are ill. Since other members of the community have a stake in the health of individuals, many Africans think that they ought to be aware of any illness and play a role in discussing how to treat it. This means that confidentiality in the Western sense takes a back bench and 33

ceases to be morally binding. In the spirit of Ubuntu, caring for other individuals is more important than maintaining confidentiality. To demonstrate this point further, let us consider the model adopted by African traditional doctors. Consistent with the notion of Ubuntu, traditional doctors adopt a holistic approach to disease, appealing to the notion of maintaining the relational harmony between humans, the environment and the spiritual realm (Murove 2009). As illness of the individual is often seen as something of communal concern, consultations often involve the family. In general, for a society to subsist it ought to provide the conditions for the flourishing of its members in the employment of a fair and equitable means of governance and distribution of scarce communal resources – in other words, a system of justice – and for human persons to flourish in society, they must at the outset be guaranteed the conditions necessary for self-preservation, including access to basic healthcare. Since justice is broadly concerned with the equitable distribution of welfare, we argue that it is, conceivably, in consonance with the notion of Ubuntu (Letseka 2014; Keevy 2008; Behrens 2013). However, we must make plain that justice as conceived from Western bioethical scholarship may not wholly be adaptable to the African context. As Chukwuneke, Umeora, Maduabuchi and Egbunike write: The notion of justice in African construct especially in health matters holds that, as a result, of common needs and interests, the community comes together to improve its aggregate health by reducing morbidity and mortality. This principle asks if the program meets public health goals and furthers the health of the population at large (Chukwuneke, Umeora, Maduabuchi & Egbunike 2014). The notions of public health, “equal access to health care, involvement of the family in decision making, and shared consensus about public policies” are central in the African communitarian view of justice (Ogubanjo & Knaap 2005: 53), and only those actions which are most conducive to the communal good are deliberated. Hence the conception of justice proper in the African context – seen as solidarity – relies on the principle of utility (Chukwuneke et al. 2014), as shown in the foregoing, which dictates that in the province of ethical decision making the right action is that which provides the greatest utility for the greatest number of persons – that is, the community. With regard to harm and benefit, notions of maximising benefit and minimising harm (beneficence and non-maleficence) can be among the trickiest aspects of modern medical ethics. These values have always been central to traditional medical ethics and are expressed in professional statements in all cultures and epochs. Keeping people alive and functioning has been what most doctors understood by the obligation to avoid “harm” and promote “benefit”, but although the terminology easily crossed cultural and historical divides, interpretation of the terms has not necessarily done so. Nowadays, the usual interpretation is that an action is only harmful if the person experiencing it believes it to be so. Patients choose for themselves what is a harm or benefit in their own circumstances. Among the controversies brewing in medical ethics, for example, is that concerning the status of male infant circumcision, which some people classify as a non-therapeutic and therefore harmful assault on a child and others see as conferring a range of benefits, including social integration and cultural acceptance. Although they can be slippery, notions of “harm” and “benefit” continue to feature strongly in the British Medical Association’s problem-solving methodology and increasingly preoccupy the courts, even though there is no clear and universal definition. Interpretation of the terms depends on different contexts and on a number of variables, including individuals’ perceptions, and legal and professional benchmarks.

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That having been said, our consternation as regards the theory of principlism proposed by Beauchamp and Childress (2009) and its orientation to medical ethics lies in the presupposition and perhaps to some measure aggrandisement of the sovereignty of the individual in contemporary ethical discourse, and its failure to acknowledge the communal nature of persons and the moral status of the interdependent relationships they share with others. We argue, therefore, that since moral principles naturally emanate from a social milieu constituted of persons who share interdependent relationships rather than “autonomous and transcendent minds” (Masolo 2010: 172), our approach to medical ethics, at least in the African context, ought to be established upon communitarian principles and values. In pursuit of a communal orientation to resolving contemporary medical ethical dilemmas, Behrens (2013: 34) proposes an African-inspired principlism in which he includes beneficence and maleficence, and replaces individual autonomy with respect for persons, and justice with harmony as this “acknowledges the importance of relationality and taking cognisance of the individual’s being embedded in community and family” and “[s]ince justice is an important aspect of harmonious relationships in society, everything entailed by the principle of justice would be included in the new principle of harmony”. Behrens (2013: 34) argues that such a project is of great import given Africa’s long history of denigration and derision as a means of reclaiming the dignity of the African and their intellectual heritage, and to counter the rampant excesses of colonial imperialism and disenfranchisement. However, we prefer in this chapter to speak broadly of respect for life wherein persons are also included, and further propose that an African-inspired principlism or preferably a community-oriented principlism, which arguably better represents the existential reality of man’s social and moral life, ought to be conceived from the vantage point of Ubuntu. We are reminded here of the words of Steve Biko who once said: The colonialists … turned to the past of the oppressed and distorted, disfigured and destroyed it. No longer was reference made to African culture, it became barbarism. Africa was the “dark continent”. Religious practices and customs were … superstition … No wonder the African child learns to hate his heritage (Behrens 2013: 32). And later, Biko offers a way forward to counter such inferioration by adding that “[t]he first step … is to make the black man come to himself; pump life back into his empty shell; to infuse him with pride and dignity” (Behrens 2013: 32). But how can a community-oriented principlism help find noteworthy discernments in contemporary medical ethical dilemmas? Let us demonstrate our response in the context of abortion and experimentation on human embryos. Are we morally justified in aborting a living foetus? This question requires us to revisit the principle of respect for life we alluded to above, and moral status as conceived from an African philosophical perspective. The African value for human life is founded on the notion of Ubuntu, and as Andoh (2011: 72) writes: At the centre of traditional African morality is human life which is a priceless gift. The sacredness of human life and human worth form the fundamental values and pillar of ethical thinking in Africa. Ubuntu states that there is intrinsic value to something about human nature that demands honouring. Africans recognize the dignity of the human being and, in consequence, hold a deep and unrelenting concern for human welfare and happiness. Recognition of the value of humanity is intrinsically linked with recognition of the unity of all people, whether or not they are biologically related … [t]he promotion of 35

life is therefore the determinant principle of African traditional morality and this promotion is guaranteed only in the community. It is clear that it would be morally impermissible to willfully end the life of a foetus when argued from a community-oriented principlism. This stance becomes clearer when one considers the issue of moral status, separate perhaps from personhood, from an African philosophical perspective. Tangwa (2000: 39; 2007: 455–457) argues that human beings possess equal moral status simply because they are human beings: Human beings who are not persons are capable only of being human moral patients, liable to be acted upon by persons but incapable of acting competently and responsibly. This lack in no way diminishes their moral status and worth as human beings and the moral consideration with which they should be treated. He draws his basic assumptions from the Nso’ adage (an indigenous African cultural group in Cameroon): A human being is a human being is a human being, simply by being a human (Tangwa 2000). Tangwa (2007) further asserts that since we fail to make a morally significant distinction between human embryos and full human beings, which he argues possess equal moral status, [a]ny attempted justification of cloning and/or human embryonic stem cell research should face squarely the human moral status and worth of every human embryo, irrespective of how it happens to come about, irrespective of the aims and purposes of its creator (Tangwa 2007: 456).

4.5 CONCLUDING REMARKS What we attempted to do in this chapter is to explore the potential link between African philosophy, especially the notion of Ubuntu and a community-oriented principlism, with medical ethics’ pursuit of the rights of the patient. On the one hand, we established that Ubuntu is understood as humanness, as an ethics of care, and “a theory of right action”. We also established that Ubuntu is fundamentally a matter of reverence of human life. On the other hand, medical ethics is concerned with the rights of the patient, especially when there is a conflict of ethics. We showed that medical ethics encompasses issues such as the patient’s “autonomy and consent”; “beneficence”; “confidentiality”; “justice and fairness”; and “truth and integrity”. We did raise concerns as regards the individualistic orientation of the business of ethics, hence the introductory remarks on an African-inspired principlism. Our conclusion is therefore that it seems prudent to suggest that African philosophy, especially the notion of Ubuntu, and medical ethics should always endeavour to serve as complementary variables in medical practice.

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CHAPTER 5: Respect for Patient Autonomy (Author: Keymanthri Moodley) By the end of this chapter you should be able to • understand the meaning of autonomous choice of patients • list the obligations created by respect for autonomy • discuss the process of informed consent • understand the concept of confidentiality • appreciate the need for truthfulness and effective communication in healthcare.

5.1 INTRODUCTION Principlism is an approach in ethics that has been introduced in previous chapters. Although controversial, it is widely used globally and helps to simplify thinking around ethical dilemmas. We shall now discuss each of the four principles in detail in the chapters that follow. These are the following: 1. Respect for patient autonomy 2. Beneficence (doing good) 3. Non-maleficence (doing no harm) 4. Justice Ethical dilemmas often involve conflict between these principles. The dominant principle that emerges in decision making may depend on various factors. For example, when a patient is able to make his or her own decisions, respect for autonomy is dominant. However, where young children are concerned, paternalistic healthcare may be necessary and healthcare workers may sometimes need to act in the best interests of children, even when parents refuse treatment for them. Along with other theories like consequentialism and deontology, the four principles may be regarded as a principle-based theory. While this is by no means a complete moral system on its own, the four-principles approach provides an analytical framework that will assist you to organise your thoughts around many of the ethical problems you will encounter in medical practice and medical research. The four principles will be discussed as follows: Informed consent Confidentiality Respect for autonomy Truth telling Communication Beneficence

Do good

Non-maleficence

Do no harm Rights justice

Justice

Legal justice Distributive justice

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5.2 AUTONOMY In a companion to bioethics, Kuhse and Singer (1998: 441) quote Isaiah Berlin (1969) as follows: I wish my life and decisions to depend on myself, not on external forces of whatever kind. I wish to be the instrument of my own, not of other men’s acts or will. I wish to be a subject, not an object: to be moved by reasons, by conscious purposes, which are my own, not causes which affect me, as it were from outside. I wish to be somebody, not nobody: a doer – deciding, not being decided for, self-directed and not acted upon by external nature or by other men as if I were a thing, or an animal, or a slave … I wish, above all, to be conscious of myself as a thinking, willing, active being, bearing responsibility for my choices and able to explain them by references to my own ideas and purposes. Autonomy literally means “self-rule”. It refers to the right of every individual to make decisions for himor herself. In healthcare this would entail allowing the patient to make the final decision regarding his or her treatment after providing all the necessary and relevant information. This principle should not be used for persons who are not autonomous as a result of their being immature, incapacitated, ignorant, coerced into a decision or exploited. This includes infants and young children, suicidal individuals, some drug-dependent patients, and patients with a severe psychiatric illness that would render them incompetent. The following rules are justified by the principle of respect for autonomy (Beauchamp & Childress 2013: 107): 1. 2. 3. 4. 5.

Tell the truth. Respect the privacy of others. Protect confidential information. Obtain consent for interventions with patients. When asked, help others make important decisions.

These rules and the principle of respect for autonomy are not absolute, but rather prima facie. A prima facie rule refers to one that must be fulfilled unless it conflicts on a particular occasion with an equal or stronger rule. Respect for autonomy creates the following obligations: 1. 2. 3. 4.

Informed consent Confidentiality Truth telling Effective communication

5.2.1 Informed consent Before subjecting patients to any investigations or treatment, we need to obtain their agreement. This is both an ethical and a legal requirement. Informed consent has been described as a process consisting of the following elements: Threshold elements • Competence (to understand and decide) 38

• Voluntariness (in deciding) Information elements • Disclosure (of information) • Recommendation (of a plan) • Understanding (of information and plan) Consent elements • Decision (against or in favour of a plan) • Authorisation (of the plan) Hence it is clear that informed consent is not an event that is over within a few minutes. In communities where individuals are not able to make important decisions without consulting spouses, members of the extended family and community elders, this process may be prolonged. Decisions around elective procedures in healthcare may therefore be prolonged. Truly informed consent is a process and may be unavoidably time-consuming. The pretest counselling protocol used to obtain informed consent from patients prior to HIV testing is an excellent example of the process of informed consent and illustrates this point. Prior to testing patients for HIV, the following information has to be discussed with them: 1. 2. 3. 4. 5. 6. 7. 8. 9.

Need for testing Their understanding of HIV/AIDS Information about the test Advantages and disadvantages of testing How the test is done Implications of a positive result Consent Time to reflect Time for questions

Consider the following case Case study 5.1 A 32-year-old lady, Mrs G, has been married for seven years and has no children. She wishes to make an appointment at an infertility clinic. Mrs G is a domestic worker who has worked for the same family for three years. Her employer, a medical doctor, assisted her by making an appointment for her at the infertility clinic. The nurse at the clinic requested that the couple have the following tests before presenting to the clinic: a Pap smear for the wife and STD tests including HIV testing for the couple. The employer, aware of the long waiting time at the public health clinics, completed the forms for the tests and counselled his domestic worker regarding all the tests. He requested that the husband, Mr G, come to see him as well. This did not happen. Eventually the employer made an appointment for his employee at the pathology laboratory, paid for the tests and gave her the forms. Mrs G assured her employer that Mr G was informed about the tests and grudgingly participated in the testing. A few weeks later the employer received the blood results. Mrs G was HIV-negative and Mr G was HIVpositive. Mr G refused to see the employer for further management. ETHICAL CONFLICT 39

In his attempt to do good (beneficence) and assist his employee – Mrs G – did he respect the autonomy of her husband – Mr G? PERPLEXING QUESTIONS 1. Was the autonomy of Mr G taken into account with respect to informed consent prior to HIV counselling as outlined above? 2. Should the employer/doctor disclose the results of Mr G’s HIV test to Mrs G? In his capacity as an employer, should he also function as a doctor to his employee? COMMENTARY As a point of departure, the employer intended to help his employee navigate a public health system that is challenging to most patients in South Africa. He acted out of a sense of duty to his employee. The consequences of his actions, however, became a source of intense ethical conflict. He followed a consent process with Mrs G prior to sending her for the blood tests. Although he intended to do the same with Mr G, this did not materialise. Clearly the failure to cooperate on the part of Mr G was not expected or anticipated. Once the results were known to the employer, the ethical dilemma emerged. On the one hand, he wanted to protect his employee by disclosing her husband’s HIV status to her. However, in so doing he was uncertain of how Mr G would react. If Mrs G confronted her husband and he reacted violently, the employer would have caused more harm than good. This was not his intention. Technically, he arranged for HIV testing of Mr G without pretest counselling and without his consent. This in itself had the potential to result in legal consequences for the employer. OUTCOME After considerable thought and consultation with colleagues, the employer decided not to disclose Mr G’s results to his employee. He arranged an appointment for her at the local day hospital and advised that she and her husband have the tests done there to make sure of the results. He also realised the need to separate his role of employer from his role as doctor. Clearly the position of dual loyalty in this case convinced him of the need to function only as an employer to Mrs G. QUESTION If you were the employer, what would you have done? As is evident in the above case, informed consent is complex and challenging. If it is omitted altogether, the consequences are dire – both ethically and legally. If the elements of consent outlined above are not followed, it is equally problematic. Taking consent from a patient who lacks the capacity to consent can be regarded as ethically equivalent to not taking consent at all. Informed decision making in healthcare rests on the precondition that a patient is competent to consent. The terms “competence” and “capacity” are often used in decision making in healthcare. Capacity refers to a clinical judgement while competence refers to a legal judgement of an individual’s ability to decline or provide consent. These terms are frequently used interchangeably. It is critical to establish whether a patient is competent to consent in order to balance the conflict that exists between respecting autonomy and acting beneficently (in the best interests of a cognitively impaired patient). 40

Criteria for assessment of competence A competent patient will be able to: • • • •

communicate a choice understand the information given to him or her appreciate the medical consequences of the situation reason about treatment options

In the assessment of competence, the Mini-Mental State Examination (MMSE) has been found to correlate with clinical judgements of incapacity. MMSE scores range from 0–30. Scores lower than 19 are highly likely to be associated with incompetence (Appelbaum 2007). Several formal assessment tools for competence also exist – the most widely used is the MacArthur Competence Assessment Tool for Treatment (Appelbaum 2007). This is a structured interview tool that takes about 20 minutes to administer and score. The following four areas of competence are assessed: 1. 2. 3. 4.

Understanding information related to the condition and the recommended treatment Reasoning about the potential risks and benefits of their choices Appreciating the nature of their situation and the consequences of their choices Expressing a choice

In situations where patients lack competence to consent, surrogate decision makers must be consulted. When dealing with a competent patient we must ensure that consent is voluntary, i.e. the patient must not be manipulated or coerced into consenting. Once this requirement is satisfied, it is essential that the patient is given all the relevant information related to the procedure or treatment in language that is easily understandable. The risks and benefits of the intervention must be clearly stated and the doctor’s recommendation is also important. This is especially relevant in South Africa where the concept of autonomy is not fully developed and where patients still place high value on the advice of their doctors. Hence, in advising our patients it is essential that we are always motivated by the patient’s best interests. A recommendation motivated by, for example, the financial gain of the doctor, is therefore problematic. The doctor should always treat the patient as an end in himself or herself and never as a means to an end. In other words, advice given to patients must always be in their best interests. In cultures where Western individualism is not prominent, patients might want to discuss the issue with family members before making a decision. This must be allowed for and respected in the South African context where extended family structures are common and high value is placed on the opinions of spouses, parents and elders in some traditional communities. It is also important to ensure that the information given has been correctly understood and that an opportunity for questions has been provided. Finally, the patient will make a decision, and either authorise the intervention or decline the procedure or the treatment. The patient can also withdraw consent. Competent patients can make “wrong” decisions. If the condition is not life threatening, an informed “wrong” decision should be respected. Sometimes doctors have a tendency to become paternalistic when a patient makes a decision that is not in keeping with their knowledge, experience or worldview. Consider the following case 41

Case study 5.2 Mr A is a 42-year-old patient with type 2 diabetes mellitus. He consulted his family doctor, Dr Z, for a checkup three months after his previous visit. His diabetes had generally been poorly controlled despite constant counselling. Over the three months between visits he developed a diabetic foot which had been worsening progressively. Dr Z mentioned the possibility of an amputation, but Mr A was adamant that this would not be an option for him. He visited the practice two months later instead of a week later as requested by Dr Z. By this stage his foot was gangrenous, and he was pyrexial and hyperglycaemic. Dr Z arranged for admission to the local hospital. In hospital his condition deteriorated but he continued to decline an amputation. His refusal was noted in his hospital records. When Mr A became septicaemic and comatose, his family pleaded with the hospital staff to proceed with the amputation. The hospital doctors referred the case to the hospital ethics committee for urgent advice. ETHICAL CONFLICT The patient’s refusal of treatment (autonomy) conflicts with the doctors’ need to do good and prevent harm (beneficence) and with the family’s request to save his life. PERPLEXING QUESTIONS • • • • •

Does Mr A have the capacity to refuse or consent to treatment? Is there an underlying untreated depressive disorder? Is there any cognitive impairment? Has Mr A been adequately counselled regarding the consequences of his refusal of amputation? Has the consequence of death at age 42 been appreciated by Mr A?

COMMENTARY The hospital doctors were plagued by the above questions, and their conflict was escalated in accepting the unnecessary loss of life in a relatively young patient in the setting of a preventable but traumatic intervention. A further layer of conflict was added by the family’s request which conflicted with that of the patient. Whose request should carry more weight? A doctor’s primary responsibility lies with his or her patient. However, when patients are unable to consent, doctors depend on family members to assist with decision making. We know what Mr A wanted before he went into the coma. However, we are not sure if he had made a properly informed decision. We are also not sure if he had communicated his decision to his family. In the event of surrogate decision making, the following question needs to be posed to the family: If Mr A could wake up from his comatose state for 15 minutes and understand his condition fully and then had to return to a comatose state, what would he decide? Such an autonomy-based approach is valid in an individualistic society that defines a person as rational, autonomous, individual and separate from others. Other more traditional notions of personhood are relational, communitarian and extended (Mkize 2006). The family and community are regarded as the moral agent because the family is the most important aspect of identity. In such settings family decisions are likely to carry substantial weight. In this case the individual decision of the patient had been articulated. However, his capacity to have made such a decision is called into question. This was a difficult decision for the hospital ethics committee. Opinion was split between respecting Mr A’s decision and acting in his best interests despite his decision. Members in favour of respecting autonomy 42

argued that Mr A had been counselled by his family practitioner and the hospital doctors on two separate occasions and he had refused the amputation on both. Furthermore, the law makes provision for the right of refusal of treatment by a patient. Hence with correct documentation, one cannot be faulted for respecting autonomy and withholding treatment. Those members who supported the amputation argued that Mr A was a relatively young patient with a reversible cause of coma and hence should be treated. They also felt that he may have changed his mind in the previous ten days. Most importantly, these members held the opinion that the capacity of this patient to consent was questionable. They argued that depression had not been excluded. In particular, they were concerned that this patient may not have been adequately counselled by a psychologist or social worker. Hence in their minds, significant doubt existed regarding the validity of the patient’s pre-existing expressed wishes. Based on this doubt they argued that the patient should be treated. From a legal perspective, may we treat patients without their consent? The National Health Act No. 61 of 2003, Chapter 2 section 7, indicates the following: If a patient is unable to consent: Consent may be obtained from a person mandated by the patient in writing to grant consent on his or her behalf or by a person authorised to give consent in terms of any law or court order. If no person is mandated or authorised to give consent, consent may be given by the spouse or partner of the patient, a parent, grandparent, adult child, or brother or sister, in that specific order. Provision of health service without informed consent may occur if it is authorised in terms of a law or court order. If failure to treat the patient will result in a serious risk to public health, treatment must be provided. If any delay in the provision of the health service to the user might result in his or her death or irreversible damage to his or her health and the patient has not refused such treatment, treatment must be provided. In this case subsections 2 and 5 apply. According to subsection 2, obtaining spousal consent is acceptable. In terms of subsection 5, delay in treatment will lead to death and even though the patient has refused treatment, it could be argued that this is not a properly informed decision. The verdict: Based on a thorough examination of the case, the committee decided that beneficence must prevail and the surgical team was advised to perform the amputation. Mr A’s wife consented. The outcome: Mr A made an uneventful recovery from the surgery. A week later he was still unhappy about the amputation but was nevertheless glad to be alive. His family was particularly pleased with the decision. QUESTION Do you agree with the committee’s decision? Consider the following case Case study 5.3 A 74-year-old gentleman, Mr M, was brought to the hospital casualty department by ambulance. Several family members accompanied him. He had a known history of chronic obstructive pulmonary disease complicated by 43

right-sided cardiac failure – cor pulmonale. Mr M was tachypnoeic and hypoxic, and had a tachycardia. His blood gas was as follows: pH 7.22 Pa CO2 of 57mmHg and SaO2 of 71%. He required intubation and ventilation. The gentleman whispered to the doctor: “Please leave me alone.” One of the family members produced a living will signed by the patient indicating that he did not want further treatment. They, however, asked the doctor to save the old man and to disregard the document. COMMENTARY This case reflects the documented wishes of an elderly patient with irreversible cardiopulmonary disease. Again, the doctor was faced with a family whose wishes conflicted with those of the patient. Fortunately, the patient was still able to vocalise his wishes, and these were consistent with the wishes documented in his living will. In this case the doctor decided to respect his autonomy and treat him conservatively. Mr M was treated with steroids, bronchodilators and oxygen but was not ventilated. He died two hours later.

5.2.2 Confidentiality Medical confidentiality is another way of respecting the patient’s autonomy. Doctors explicitly or implicitly promise their patients that they will keep confidential the information provided to them. In the absence of such promises of confidentiality, patients are unlikely to divulge highly private and sensitive information that is needed for their optimal care. According to the National Health Act No. 61 of 2003, Chapter 2, section 14, the only exceptions to maintaining confidentiality are as follows: 1. The patient consents to the disclosure in writing. 2. A court order or any law requires the disclosure. 3. Non-disclosure of the information represents a serious threat to public health. The ICD 10 coding system used in private medical practices in South Africa clearly illustrates points 1 and 2 above. The system requires the insertion of a code onto a patient’s account that is sent to the medical aid scheme. As each code is linked to a diagnostic category, the patient’s diagnosis is indirectly disclosed to the medical scheme. Firstly, this disclosure is required by law, namely the Medical Schemes Amendment Act No. 55 of 2001, which requires that the coding system is used to facilitate payment of private health expenses. In addition, most private practices request written consent from patients to disclose their diagnosis via the coding system. Twenty centuries ago, Hippocrates, thinker, philosopher, doctor and great advocate for ethics in medicine, said: In my attendance of the sick, or even apart therefrom, whatsoever things I see or hear, concerning the life of men, which ought not to be noised abroad, I will keep silence thereon, counting such things to be as sacred secrets. The Declaration of Geneva, adopted by the World Medical Association in 1983, proceeds further in saying that: “I will respect the secrets which are confided in me, even after the patient has died.” The International Code of Medical Ethics (1949, 1968, 1983) states that: “A physician shall preserve absolute confidentiality on all he knows about his patient even after the patient has died.” The above statements are expressed in “absolutist or near absolutist” terms. However, most arguments support prima facie as 44

opposed to absolute rules of confidentiality. Rule 16 of the Health Professions Council of SA (HPCSA) respects the patient’s right of privacy after death as confidential medical information about a patient may only be divulged with the consent of the next of kin or the executor of his or her estate. We can hence see the ethical dilemma that arises when a doctor is expected to complete a death notification form for a patient in which the cause of death must be stated. This is problematic especially where the cause of death is of a sensitive nature as in the case of HIV/AIDS. The new death notification form – BI 1663 – introduced in South Africa in 1998 requires the exact cause of death to be written on page 2 of the document. This is intended to be a “confidential document” as page 2 must be completed, placed in a sealed envelope and forwarded to the Department of Home Affairs by the family or person delegated by the family, such as the undertaker. This page of the death certificate has on occasion been opened by a family member or undertaker. In one particular instance the undertaker had, as a result of his knowledge of the information on “page 2” of the new death certificate, labelled the box in which the body was transported to the family home as “HIV-positive”. Hence it is evident that even though the new death certificate was intended to have a “confidential” component, there are several loopholes in the system, and confidentiality of patient information cannot be ensured after death. Death notification forms must be completed accurately and truthfully, and every attempt must be made to ensure that the forms, once completed, are handled confidentially. Likewise, strict rules of confidentiality must be maintained when completing “sick certificates” or medical certificates. It is not necessary to write the patient’s diagnosis on a medical certificate. In fact, the certificate must be completed in consultation with the patient and a diagnosis may be written only with his or her permission. It is sufficient to inform the employer that the patient has visited the doctor without divulging the reason for the visit. We have already discussed Hippocrates’ view on confidentiality where he refers to all information received in our attendance to the sick as “sacred secrets”. A strict rule of medical confidentiality may be justified by the following arguments: •

Consequentialist arguments. There is a notion that if patients fear disclosure or breach of confidentiality, they will not present for treatment and many diseases will be undiagnosed. It is believed that if it were common practice to override obligations of confidentiality, the fiduciary relation between doctor and patient would erode and collapse. This claim has, however, not been adequately tested.

•

Arguments from autonomy and privacy rights. Breaches of confidentiality are viewed as primary violations of privacy and personal integrity (autonomy). The principal thesis is that the value of privacy gives considerable weight to the rules of confidentiality that protect it.

•

Fidelity-based arguments. Fidelity to implicit and explicit promises in the context of the doctor-patient relationship is important, and the patient has a right to expect confidentiality.

Consider the following case Case study 5.4 Mr S is a 39-year-old director at a health centre. He has consulted Dr A at the staff clinic for many years and has always been very animated during consultations. On his most recent visit, however, he appeared quiet and 45

withdrawn. He answered questions with monosyllabic responses. Dr A commented on his unusual demeanour and Mr S then revealed that a loved one had died in a motor vehicle accident six months previously. On further enquiry Mr S confirmed that the “loved one” was his male companion with whom he had shared a relationship for the past five years. He had found out from another friend, after the funeral, that the partner may have been HIVpositive. Since then he has been sad, tearful, has lost his appetite and has been unable to sleep. Mr S wanted to have himself tested for HIV. He did not, however, want any of his work colleagues to know about this and he requested that Dr A not make any notes in his patient folder at the health centre. He also did not want any of his data entered on the computerised record system of the centre. Dr A had by now diagnosed him with a major depressive disorder and needed to prescribe an antidepressant. What should Dr A do? COMMENTARY Dr A is concerned about the following issues: • • •

What are the ethical implications of Mr S’s request? What are the legal implications? What should he do?

Clearly, Mr S has disclosed very private information to Dr A based on a relationship of trust, which he may not have disclosed if he had believed that Dr A would not keep it confidential (see “Consequentialist arguments” for maintaining confidentiality above). However, the obligation of confidentiality extends beyond simply keeping patient information confidential; it also includes a responsibility to ensure that patient records are stored securely. Mr S’s request for omission of notes from his patient record and the computerised record system is based on his knowledge of the lack of confidentiality within the healthcare centre. As an insider he is aware that many people within the centre may have access to his medical records. He is also afraid that his colleagues may learn of his homosexuality and his possible HIV-positive status. Seeking healthcare within an occupational healthcare centre is always problematic in this regard. Dr A, on the other hand, is obliged to keep patient notes as evidence that he has assessed the patient, made a diagnosis and prescribed treatment. This is a medico-legal requirement. At the same time, he too is aware that confidentiality of medical records may be breached at the healthcare centre even though this should not be the case. The National Health Act stipulates in Chapter 2, section 17, that control measures must be in place to “prevent unauthorised access to records and to the storage facility in which, or system by which, records are kept”. Failure to do this results in “a fine or to imprisonment for a period not exceeding one year or to both a fine and such imprisonment”. As a compromise Dr A decides to develop a duplicate record in which he makes confidential detailed medical notes and locks this record up himself. He knows that only he has access to this patient record. In this setting it is the only way in which he can assure the patient of confidential medical treatment. If he needs to refer Mr S to another doctor, he will need consent from Mr S before he discloses his HIV status to the other doctor. QUESTION If you were Dr A, what would you have done?

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5.2.3 Truth telling Respect for patient autonomy requires us not to deceive patients. This means telling them the truth about their illness unless they specifically indicate that they do not wish to know. This is especially important where terminal illness is concerned. Concealing the diagnosis from the patient is clearly unacceptable unless there are very good and exceptional reasons for doing so. Patients need to know the truth so that they can plan for their future. “Kindness” on the part of the doctor can go terribly wrong. Compassion requires one to know what the right thing is to do and to pursue this action even if it is difficult for both doctor and patient. Consider the following case Case study 5.5 Mr C was a 62-year-old clerk who suffered from exercise-induced angina. He had several risk factors for ischaemic heart disease – diabetes mellitus, smoking and hypercholesterolaemia. A coronary angiogram confirmed triple vessel coronary artery disease with a left ventricular ejection fraction of 45 per cent. Mr C was referred to Dr F, a cardiothoracic surgeon, who advised a coronary artery bypass graft (CABG). He explained the risks of the operation, including the risk of death which was below 3 per cent. Mr C underwent the triple bypass and made a good recovery. A chest X-ray done after the surgery showed an elevation of the left hemidiaphragm. Dr F and his team decided not to inform the patient in order to “avoid giving him unnecessary reasons for concern”. Six weeks later Mr C visited the doctor and complained of moderate dyspnoea on exertion. He was told that this was part of his recovery and that he would improve, and he was discharged back to the care of his general practitioner. However, the dyspnoea persisted and he was referred to a cardiologist who investigated him further. An echocardiogram showed significant dyskinesis in the inferior and lateral walls of the left ventricle, and a lung function test showed mild reduction in total lung capacity. A chest fluoroscopy test revealed paralysis of the right hemidiaphragm. He had right phrenic nerve palsy secondary to surgical damage. Mr C lodged a claim against the cardiothoracic surgeon because of the damage to his right phrenic nerve during the operation – a complication that had not been disclosed to him after the surgery Source: Adapted from MPS Casebook 2010, 18(1): 22 COMMENTARY The HPCSA General Ethical Guidelines for doctors indicate that truthfulness is a core ethical value for good practice. In section 1.2, the council states that “in professional relationships with patients, regard the truth and truthfulness as the basis of trust”. The surgeon decided to withhold the truth from Mr C to protect him from unnecessary worry (as an act of beneficence) and this conflicted with Mr C’s right to full and truthful information (autonomy). Alternatively, we may also surmise that the surgeon withheld information from his patient due to fear and self-protection. This calls into question the concept of virtue ethics and whether this is what the “good doctor” should have done. QUESTIONS Two questions spring to mind: 1. Was the complication of phrenic nerve palsy discussed? 2. Was written consent information regarding complications given to the patient?

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The surgeon was not truthful about the complication. It was his duty to inform the patient as soon as the complication arose. It is also possible that the patient expected full recovery after the operation and may not have anticipated the presence of residual symptoms. Consider the following case Case study 5.6 Mrs V is 45 years old. She has been under psychiatric care and on antidepressants since the tragic death of her son two years previously. She has attempted suicide on two occasions already. Dr B has been seeing her for a few weeks for a non-healing ulcer on her left forearm. Biopsy reveals advanced squamous cell carcinoma. Her husband has specifically requested that the doctor discuss the results with him first, and Dr B explains both the diagnosis and poor prognosis. Mr V asks Dr B not to discuss the diagnosis with his wife as she is psychologically fragile. He feels that this diagnosis will precipitate another suicide attempt. COMMENTARY Which ethical principles are in conflict? From an ethical perspective, respect for autonomy requires the doctor to tell the patient the truth. However, non-maleficence requires that he does not cause her harm. Balancing these two principles means that he may decide to withhold the correct diagnosis for the time being in order to prevent his patient from harming herself. Ethically, this would be a reasonable decision to make. From a legal perspective, “therapeutic privilege” is acknowledged. According to the National Health Act No. 61 of 2003, Chapter 2 section 6, “every health care provider must inform a user [patient] of the user’s health status except in circumstances where there is substantial evidence that the disclosure of the user’s health status would be contrary to the best interests of the user”. In this situation, consultation with the oncologist and psychiatrist would guide the timing and content of disclosure.

5.2.4 Communication The patient-centred approach used in medicine is in keeping with the principle of respect for autonomy. Listening to the patient enables the doctor to decide what information the patient needs, how this information should be transmitted to the patient and what the patient’s preferences are. Good communication makes it possible to compile a complete and accurate patient history and makes the patient feel reassured and cared for. Consider the following case Case study 5.7 A three-year-old boy, Tom, was taken to the emergency room by his mother with a history of having swallowed a little Lego block while playing. They brought a similar piece to the hospital. The boy was examined and a chest Xray (CXR) was done. This was considered to be normal. Two months later Tom became ill with a cough and a high temperature. The CXR showed right lower lobe pneumonia. Tom’s mother repeated the history that he had swallowed a building block two months previously. During the next two years Tom had recurrent episodes of pneumonia and attended the hospital five times. He saw a different doctor on every occasion and had five more CXRs. All of them were reported as right lower lobe pneumonia with collapse and some pleural fluid. Eventually 48

Tom was referred to a paediatrician who suspected a foreign body. An urgent bronchoscopy was done and a piece of plastic was removed. Tom required further surgery – the foreign body had caused fibrosis of the lung, which required excision. Tom’s mother made a claim against the hospital and all hospital doctors involved during those two years Source: Adapted from MPS Casebook 2010, 18(1): 19 COMMENTARY The information regarding the foreign body was volunteered by Tom’s mother on several occasions. During these consultations this information was repeatedly disregarded. As a result, an incomplete history was obtained and an obvious diagnosis was missed. Even in the presence of a history of foreign body inhalation, the object may not show up on CXR if it is radiolucent, as was the case with Tom. X-raying the patient and the foreign body will inform the doctor of whether the object is radiolucent or not. Review of the previous notes and previous X-rays was critical to making this diagnosis. In this case poor communication resulted in poor treatment and eventually harm to this little boy. Several studies have indicated that doctors do not listen to their patients. On the contrary, they frequently interrupt patients. The open-ended initial question to patients often is: “And what brings you to see me today?” A study conducted in 1984 in the US found that only 25 per cent of patients were allowed to complete their reply to the question without interruption. The average time from posing the question to interrupting was 18 seconds. Patients who were allowed to complete their opening statement without interruption were given less than 60 seconds on average to do so (Beckman & Frankel 1984). A similar study conducted in 2004 in an emergency department showed that the average time before an interruption by a doctor was 12 seconds. Giving instructions on discharge took on average 76 seconds. Only 16 per cent of patients were asked if they had any questions (Rhodes et al. 2004). Active, attentive listening is critical to successful doctor-patient communication. In the South African setting where we have 11 different official languages, communication is often compromised. Involving translators and interpreters in the consultation adds a new level of ethical complexity in terms of privacy and the confidentiality of patient information. Occasionally, inaccurate information may be transmitted, or information from patients may be interpreted by the translator before it is passed on to the doctor. This has the potential to compromise patient safety. It is therefore incumbent upon all doctors practising in South Africa to learn at least one indigenous language so that communication with their patients can be enhanced. It is advisable that students and doctors learn the most common indigenous language that is spoken in the region of their training or practice. This will improve the ability of doctors to respect the autonomy of their patients. In the last decade, considerable efforts have been made at medical schools in South Africa to include communication skills as a tangible part of the undergraduate curriculum. This has occurred because good communication is a necessary prerequisite for responsible decision making. Effective and empathic communication is the key to negotiating and resolving many difficult clinical and ethical problems in medicine. Developing good communication in the context of the doctor-patient relationship is an ethical requirement.

5.3 CONCLUDING REMARKS In this chapter we have examined consent, confidentiality, truth telling and communication as important obligations created by the principle of respect for autonomy. Respecting patient autonomy is becoming increasingly important in the context of the doctor-patient relationship. Honouring the patients’ right to 49

self-determination or to making their own informed choices and to living their lives by their own beliefs, values and preferences is encouraged by the HPCSA (booklet 1, section 1.2). However, respecting autonomy will often conflict with one or more of the other principles as we have seen in the case studies in this chapter. Balancing the weight of autonomy with other principles, like beneficence and non-maleficence is often necessary, and this should be considered on a case-by-case basis. In some traditional communities in South Africa, individual decision making and individual autonomy may not be culturally acceptable. In such instances, adequate time must be allotted for family consultation in nonemergency situations.

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CHAPTER 6: Beneficence (Author: Keymanthri Moodley) By the end of this chapter you should be able to: • • •

understand the importance of competence in medicine as a manifestation of the principle of beneficence discuss the risk-benefit ratio in healthcare understand the role of paternalism in medical practice.

6.1 INTRODUCTION Beneficence refers to doing good and the active promotion of goodness, kindness and charity. All doctors have a responsibility to provide beneficial treatment and to avoid or minimise harm. Provision of beneficial treatment requires rigorous and effective education. Clinical competence is therefore an ethical requirement. We need to look briefly at the rules of beneficence (Beauchamp & Childress 2013): 1. 2. 3. 4. 5.

Protect and defend the rights of others. Prevent harm from occurring to others. Remove conditions that will cause harm to others. Help persons with disabilities. Rescue persons in danger.

Beneficence or doing good is often a complex principle to unpack. When are we doing good and when are we “playing God”? Often, we inadvertently prolong life with the intention of doing good but end up reducing quality of life and prolonging suffering. On other occasions, we may need to intervene to hasten death for the prime purpose of ending suffering. Professional duties of doctors require that they promote life and prevent harm. According to the World Medical Association Declaration on Terminal Illness, adopted in 1983 and revised in 2006, the “duty of physicians is to heal, where possible, to relieve suffering and to protect the best interests of their patients” (World Medical Association 2006). This statement in and of itself does not exclude assisted dying, which is intended to relieve suffering and to protect the best interests of the patient. Beneficence extends beyond our interactions with individual patients. At a global level, the international community has a collective duty of care to ensure that effective affordable measures are available to those most in need. A duty of care and the duty to rescue dictate that effective immunisations against direct disease threats should be available to those at risk of communicable diseases. The duty of care is based on the principle of beneficence, which legitimises the offer of care to those in need. It originates from compassion for humanity and generosity of spirit. The rule of rescue is “the imperative that people feel to rescue identifiable individuals facing avoidable death” (Jonsen 1986). As the risk of communicable diseases during humanitarian emergencies is often extreme, the duty of care principle demands that effective vaccinations against these disease threats should be available to those at risk. Beneficent care of patients has three important dimensions: 1. Clinical competence

2. Risk-benefit analysis

3. Paternalism

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6.2 CLINICAL COMPETENCE One needs to be competent to do good and to minimise harm; if harm is not minimised it may result in negligence. The doctor’s responsibility is to benefit the patient by not inflicting harm, by preventing harm, by removing harm and by providing beneficial treatment. In medicine this means that all students must ensure that they receive sound medical training in terms of knowledge and skills. It remains the student’s responsibility to attend lectures and tutorials, clerk patients in the hospital and practise procedures till perfection is attained. In addition they must also pay attention to keeping medical records that are legible, contemporaneous and complete. As medical science continues to advance, it is imperative that doctors continue to develop their knowledge and skills by participating in continuing professional development (CPD) activities that provide information, strengthen clinical competencies and enhance professional judgement. While it is not possible for all doctors to be abreast of all advancements, doctors should make every effort to be, at minimum, familiar with clinical developments that may potentially affect their specific area of practice. Maintaining competence requires a commitment to lifelong learning. Doctors should maintain basic levels of competence and restrict patient care to areas in which they are competent. This means that doctors must know the boundaries of their competence, including their abilities and limitations. Competence requires both an acceptable standard of care and appropriateness of that care. Competence also requires continual self-assessment about outcomes of patient care. Civil society is becoming increasingly sensitised to the competence of their healthcare providers. In the 21st century, patients often Google their doctors, searching for websites where other patients may have commented on the care received from specific doctors. They look at the Health Professions Council of South Africa (HPCSA) website to see if any judgements exist against specific doctors and abroad, and investigate scoring systems used to rate the competence of their doctors. The Surgeon’s Scorecard is such an example. In addition to competence, judgement is always involved when we apply our knowledge, skills and experience to treatment. Even the best clinical abilities are misused if employed with unsound judgement. Sound judgement is critical to the provision of quality healthcare. In Chapter 7 on non-maleficence it will become clear that failure to provide competent medical care of the highest possible standard at all times results in harm to patients and violates the basis of medical practice – first do no harm.

6.3 RISK-BENEFIT ANALYSIS Whenever we try to help others, we inevitably risk harming them (Gillon 1994). In medicine it is essential to balance the principles of beneficence and non-maleficence to achieve net benefit for the patient. The risk-benefit ratio related to any intervention is therefore crucial. Consider the following examples: 1. X-rays are very useful in investigating patients and their diseases. However, unnecessary frequent radiation is harmful due to its potential to cause malignancies in the long term. In an adult suspected of having a pleural effusion or pneumothorax, a chest X-ray is extremely useful and the risk of radiation is outweighed by the benefit that will result. However, in a 12-month-old child in whom the diagnosis of sinusitis is suspected, an X-ray 52

of the frontal sinuses will cause more harm than good as the risk of radiation trumps the resultant benefit. This is so because the frontal sinuses will not be visible on a skull X-ray in a child of this age. 2. In the past decade, several drugs have been withdrawn from the market due to their risks exceeding their benefits: •

Vioxx® (rofecoxib), due to the high incidence of myocardial infarction which outweighed the benefit of pain relief for arthritis

•

Fen-Phen (fenfluramine and phentermine), a popular weight-reduction drug which resulted in patients developing valvular heart disease

•

Rimonabant (cannabinoid receptor antagonist), developed originally to produce loss of weight in patients with syndrome X. It was removed from the European market due to side effects of anxiety, insomnia, depression and potential suicide. Clearly, the 5 kg loss of weight experienced by patients could not be justified by the serious psychiatric side effects.

•

Rosiglitazone was tested and marketed as a new drug to treat diabetes mellitus. However, the side effect of possible myocardial infarction was regarded as serious enough to override the benefit of blood sugar control in the context of other drugs that could have the same positive effect without this serious side effect.

Balancing the principles of beneficence (doing good) and non-maleficence (avoiding or minimising harm) is critical in immunisation. Efficacious, appropriate vaccines of proven benefit should be offered to patients. Immunisation is beneficial to individuals who are directly protected from specific diseases. However, community benefit is also conferred via herd immunity. In order to provide beneficent care to patients, it is always important to weigh the risks and benefits of any intervention carefully before advising or prescribing treatment. As an act of beneficence and to protect the public, regulatory agencies like the Food and Drug Administration (FDA) in the US and the Medicines Control Council (MCC) in South Africa will withdraw registration of a drug that has been found to cause more harm than good.

6.4 PATERNALISM Historically, doctors relied almost exclusively on their own judgement about patient diagnosis, need for information and treatment. This was based to a large extent on acting in the “best interests” of patients. In recent times, increased emphasis on respecting patient autonomy has reduced paternalism in medicine. However, there are instances when it is necessary for doctors to act paternalistically towards patients. Paternalism is defined as “the intentional overriding of one person’s known preferences or actions by another person, where the person who overrides justifies the action by the goal of benefiting or avoiding harm to the person whose preferences or actions are overridden” (Beauchamp & Childress 2013).

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6.4.1 Active paternalism Here a doctor may override a patient’s choice to decline an intervention because the doctor thinks the intervention will be beneficial. Weak (soft) paternalism The doctor intervenes to prevent substantially non-voluntary conduct in order to protect persons against their own substantially non-autonomous decisions. Examples of this are as follows: 1. Consent or refusal that is not adequately informed 2. Severe depression that prevents rational decision making 3. Addiction or substance abuse that impacts on free choice and action Strong (hard) paternalism The doctor intervenes to benefit a patient despite the fact that the person’s risky choices and actions are informed, voluntary and autonomous. Examples of this are as follows: 1. Parental refusal on religious grounds of life-saving treatment for a child 2. Parental refusal of immunisation for a child in a serious infectious-disease outbreak 3. Refusal to respect an advance directive Consider the following case Case study 6.1: Hay v B 2003 In 2003 baby B was referred to Garden City Clinic in Johannesburg with neonatal sepsis. There was bone marrow suppression due to the sepsis and as a result he was anaemic. His paediatrician discussed a blood transfusion with his parents, who objected because the grandparents of the baby belonged to the Jehovah’s Witness faith. They were also concerned about the transmission of infection to the baby via the transfused blood. The parents themselves were not Jehovah’s Witnesses. The paediatrician initially administered erythropoietin but the baby’s haemoglobin had dropped low enough to precipitate cardiac failure. At this stage the doctor knew that he would die within 3–4 hours if he did not receive a blood transfusion. She then made an urgent application to the high court for permission to administer the life-saving transfusion. ETHICAL CONFLICT Administering the blood transfusion would save the life of the child (beneficence) but conflicts with the autonomy of the parents/grandparents (based on their religious beliefs). PERPLEXING QUESTIONS 1. What benefits and risks does the blood transfusion pose to baby B? 2. Should the parents’ wishes be disregarded? 54

3. Should the transfusion be administered on ethical grounds? 4. Is it necessary to get a court order to administer the blood? COMMENTARY As a point of departure it is necessary to calculate the risk-benefit ratio of a transfusion in this child. The major medical benefit of a blood transfusion to the baby in this case is mortal life. Minor medical risks could include a chance of contracting an infection such as hepatitis or HIV, or a transfusion reaction due to the wrong blood type being transfused. However, these risks are minimised by rigorous testing of the blood and procedures in the ward relating to blood typing and transfusion. A social risk to the baby and family could be rejection by the Jehovah’s Witness community. A spiritual risk could include denial of eternal salvation, which does not quite apply in this case as the baby and his parents are not confirmed members of the Jehovah’s Witness faith. Under these circumstances, the doctor decided that the benefit of a transfusion to the child outweighed the risks and the autonomous decision by the parents. Ethically the baby had not yet developed a belief system to choose eternal salvation over continued life on earth. The doctrine of the best interests of the child is the only basis on which substituted judgement may occur (Macklin 2003). From a legal perspective, according to the South African Constitution the child’s “best interests” are of paramount importance. The right to life is a basic constitutional value and the baby’s right to life could not be violated. In this case while the grandparents’ religious beliefs had to be respected they were not reasonable and justifiable and could not override the baby’s right to life (McQuoid-Mason 2005). The Children’s Act No. 38 of 2005 states in section 129(10) that no parent, guardian or caregiver of a child may refuse to assist a child or withhold consent by reason only of religious or other beliefs, unless that parent or guardian can show that there is a medically accepted alternative choice to the medical treatment or surgical operation concerned. The high court in South Africa is regarded as the upper guardian for all minors. In this case the judge ruled in favour of the doctor. She was then able to administer the transfusion and the baby survived. This case has set a legal precedent in South Africa and in cases where the grounds for refusal of treatment are based solely on religion, it is no longer necessary for doctors to seek a court order to overturn parents’ refusal as such refusal is unlawful (McQuoid-Mason 2005).

6.4.2 Passive paternalism A doctor refuses to perform an intervention or provide treatment for reasons of patient-centred beneficence. Consider the following case Case study 6.2 A young male in his early 20s had a drinking binge, passed out, vomited and aspirated. The resulting hypoxia left him with central neurological deficits resulting in balance, speech and hearing problems. The neurology report revealed post-hypoxic cerebellar and pyramidal tract damage. The family heard about hyperbaric oxygen (HBO) therapy being offered at a medical institution and wanted the young man to be treated. They were willing to spend in the region of R30 000 over several weeks for such treatment. If this unit refused treatment, they were willing to access the treatment via one of the diving schools which also offered such treatment. The hyperbaric unit had the capacity to treat this patient but felt that he

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would not benefit as his hypoxic event had occurred nine months previously. Should they decline treatment or provide treatment? COMMENTARY Discussions around passive paternalism are often related to medical futility. In this case the doctors were of the opinion that the treatment would not harm the patient, but it would also not benefit him. At the same time they were aware that the family was desperate and were hoping for a miracle. The doctors wanted to be careful not to exploit the vulnerability of the family, but they were also concerned that if the family accessed the HBO treatment via less reputable institutions, harm might befall the patient. The doctors in the hyperbaric oxygen unit could exercise the options of declining or providing treatment. Declining HBO treatment would be an act of passive paternalism. Providing HBO treatment could only proceed with full informed consent from the parents, making sure they understood the possibility of no benefit being derived even after they spent R30 000.

6.5 CONCLUDING REMARKS Most medical students start off their careers with “a large measure of sympathy for people afflicted by illness and a desire to commit their working lives to helping them” (Gillon 1985). Many doctors make a considered choice to place the interests of their patients above their own. In most instances, illness afflicts people without warning at a time when they least expect it, exposing their vulnerability. Under these circumstances, beneficent care of patients is a non-negotiable obligation that can only be fulfilled with excellent clinical training and skills.

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CHAPTER 7: Non-maleficence (Author: Keymanthri Moodley) At the end of this chapter you should be able to: • • • • •

understand how incompetent medical practice harms patients understand how both omissions and commissions cause harm understand how medical error impacts on the quality and safety of healthcare understand how to deal with medical mistakes appreciate the importance of a sound and rigorous medical training.

7.1 INTRODUCTION Medical practice is firmly rooted in the principle of primum non nocere – first do no harm. Although the primary duty of healthcare professionals is to help patients by optimising health and wellbeing, and alleviating pain and suffering (beneficence), we may inadvertently cause harm. Avoiding or minimising harm to patients is a fundamental obligation of all practitioners, and requires thorough, sound and rigorous medical training. In South Africa, we need to consider harm in the context of African philosophy. This means that in addition to harm to individuals, we also need to consider collective harm – to families and communities.

7.2 RULES OF NON-MALEFICENCE The rules of non-maleficence are as follows (Beauchamp & Childress 2013): •

Do not kill.

•

Do not cause pain or suffering to others.

•

Do not incapacitate others.

•

Do not cause offence to others.

•

Do not deprive others of the goods of life.

Irrespective of the philosophical system we support, these rules are universal. However, they are not absolute but rather prima facie. In some circumstances it is difficult to decide where benefit ends and harm begins. In one’s attempt to alleviate pain and suffering, the outcome may be death. Is this “killing” or “letting die”? In practising euthanasia – active or passive – are we doing good or causing harm? (See Chapter 18.) Similarly, in termination of pregnancy (TOP), this dichotomy arises again. One is doing good to the mother and harming the foetus simultaneously. The rights of the mother conflict unavoidably with those of the foetus. This will be discussed later – see Chapter 17. Harm is caused to patients as a result of a distortion in the risk-benefit assessment. When risk exceeds benefit, we need to assess whether this was unavoidable or intentional. The philosopher Morrheim identified five levels of adverse outcomes in order to separate ordinary mishaps from real mistakes indicating incompetence:

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Accidental adverse events occur. These are usually out of the hands of the doctor, such as equipment failure (provided the practice/hospital had a standard operating procedure in place to ensure that equipment was regularly serviced and checked). A well-justified decision turns out badly, such as anaphylaxis after antibiotic treatment of a patient with no known history of drug allergies. There are disagreements about treatment due to a difference of opinion. It is not uncommon in the field of medicine to have differing opinions on the efficacy of a particular procedure. This occurs when there is no consensus on the best treatment option in a particular situation. A doctor may exercise poor judgement or skill. If it is a single error it may be pardoned. However, if this is repetitive it becomes problematic. Outrageous violations occur where the health or life of a patient is threatened (adapted from Morrheim 1993).

All interventions in healthcare carry an element of risk (examples of risk-benefit ratios are discussed in Chapter 6). Doctors are obligated to warn patients of “material risks” inherent in a proposed treatment or procedure. Risks are regarded as “material” if: a) a reasonable person in the position of the patient, if warned of the risk, would attach significance to it b) the medical practitioner concerned should have been reasonably aware that the patient, if warned of the risk, would attach significance to it (Castell v De Greef 1994 – see Chapter 10 for details).

7.3 MEDICAL ERROR, SAFETY AND QUALITY OF HEALTHCARE In 1999, the Institute of Medicine (IOM) in the US compiled a report titled “To err is human: building a safer healthcare system”. Two studies found that between 44 000 and 98 000 people die in hospitals each year in the US due to medical error. In 2015, the Institute of Medicine highlighted the importance of diagnostic error in healthcare. Both reports emphasise the trust that patients place in the profession when they enter into a relationship of care and the reciprocal obligation of healthcare providers to promote safety, maximise quality of care and minimise harm. In South Africa, the Office for Health Standards Compliance (OHSC) was established in terms of the National Health Amendment Act No. 12 of 2013. The office strives to protect and promote the health and safety of patients in all healthcare establishments in South Africa by monitoring compliance of hospitals and investigating complaints. Harm can result from acts of omission and commission. A medical error may be defined as a commission or an omission with potential negative consequences for the patient that would have been judged wrongly by skilled and knowledgeable peers at the time it occurred (Wu et al. 1997). Errors may also be classified as follows:

7.3.1 System or latent errors These errors derive from flaws in the system of medical practice. The system “sets up” doctors to make mistakes – for example, through the unavailability of medical records, confusing labelling of medications, long working hours, a gas leak in theatre, depleted supplies of oxygen, faulty equipment, etc. Doctors share responsibility for these with other elements of the healthcare delivery system. 58

7.3.2 Individual errors These errors result from omissions or commissions due to the doctor’s own lack of knowledge, skill or attentiveness, and the doctor is primarily responsible for them. The following omissions may compromise patient safety and the quality of healthcare, and cause harm: • • • • • • • • •

Failure to correctly identify a patient Failure to take an adequate history Failure to conduct a thorough examination of a patient Failure to order the correct investigations Failure to check blood tests or other results Failure to make the correct diagnosis Failure to treat Failure to follow up a patient Failure to keep good medical records (not recording negative findings, not recording discussions about risks, benefits and refusal of treatment, not recording drug allergies)

Commissions include the following: • • • • • • •

Keeping illegible or poor medical records Reaching an incorrect diagnosis Prescribing treatment incorrectly – wrong drug/wrong dose/frequency Operating on the wrong limb Overcharging or over servicing patients Altering notes after the event Using equipment without the necessary training, skill and experience

Clearly, harm can range from simple preventable failings such as poor medical records to grossly negligent treatment of a disease resulting in death or morbidity. Consider the following cases: Case study 7.1 Clare and Richard Bowen, a British couple, had three children, all of whom had spherocytosis. As a result, they all had anaemia requiring repeated blood transfusions. In January 2006, William had a splenectomy and did well thereafter. So, in July 2007, their eldest daughter, Beth, was booked for a splenectomy. She went into theatre at 13:00 and at 18:00 the doctors emerged with terrible news for the family. Beth was dead as a result of uncontrollable blood loss during surgery. COMMENTARY In an article in the MPS Casebook (Dawson 2014) Clare Bowen commented on the lack of communication from the medical team: “In the weeks after Beth’s death we received no answers from the hospital – it was very difficult to get them to talk to us.”

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The family managed to collect information over time and eventually, it emerged that Beth’s death resulted from the use of a piece of equipment called a morcellator – similar to an apple corer – that was used, at the last minute, to remove chunks of spleen through a laparoscopic porthole. It also emerged that the surgeon who conducted the laparoscopy had only done three such procedures before. Soon after the inquest, when post-mortem pictures were displayed, Richard Bowen died of a myocardial infarction at the age of 31 years. Clare Bowen commented as follows: “Attitudes need to change. Some medical professionals are too arrogant to believe they can be any better and that they can make mistakes. With this attitude you blind yourself to mistakes, and you won’t see one heading straight for you. Medical professionals should be confident in their ability, but they should understand their limitations” (Dawson 2014).

Case study 7.2 Meagan was seven years old and complained to her mother about a sore tummy. Her mother, Mrs VS, called her GP, Dr B, who advised paracetamol syrup but did not document the conversation in his notes. The next day Meagan was still in pain so Mrs VS asked if Dr B could pay a home visit. The GP went to the home and diagnosed a urinary tract infection (UTI) without examining the girl. He prescribed trimethoprim. Dr B made brief notes about the abdominal pain and the antibiotics. He did not test her urine. Mrs VS asked about appendicitis to which the GP replied that she was “too young for that”. The next day Meagan started to vomit – her pain had worsened and she had developed a fever. On calling the surgery, Mrs VS was told by another doctor that “antibiotics take time to start working”. Again the GP failed to make notes related to this telephone call. Three days after the pain began Mrs VS took her daughter to the emergency department of a local hospital. She was pale and in severe pain. Acute peritonitis was diagnosed and Meagan was taken to theatre immediately. Laparotomy revealed a perforated appendix. Source: Adapted from MPS Casebook 2010, 18(1) COMMENTARY In order to establish if Dr B was negligent in this case, we need to ask ourselves two important questions: 1. Was he able to foresee the harm that would come to Meagan based on her symptoms and signs? 2. Did he take steps to prevent such harm? Dr B would be found negligent if he failed to foresee the possibility of harm occurring to Meagan in circumstances where a reasonable general practitioner would have foreseen it and taken steps to prevent it. This case is an example of individual error, and is riddled with errors of omission and commission: telephonic prescription without examining the patient, failure to document notes, failure to examine the patient and investigate appropriately (a urine dipstick test was not done), telephonic advice without examining the patient, and making assumptions that the previous diagnosis by a colleague was correct. Clearly there was no beneficent treatment in this case and considerable harm was caused to the patient as a little girl and later on when she wanted to start a family. At the age of 29, Meagan had an exploratory laparotomy for infertility and was found to have blocked Fallopian tubes and pelvic adhesions. As an adult she successfully sued both doctors involved in her management of abdominal pain when she was a child, even though one of them had since died. 60

Case study 7.3 Mr K was 74 years old. He had several chronic diseases – hypertension, ischaemic heart disease, peripheral vascular disease, chronic obstructive lung disease, mechanical backache and prostate cancer – and was on chronic medication for all these conditions. For many years, he had been a smoker. He consulted with an orthopaedic surgeon who referred him to a vascular surgeon. After a consultation and preliminary investigations, the patient was offered bilateral femoral revascularisation procedures to improve blood flow to his lower limbs. The patient’s spouse and family were not involved in the decision to proceed with surgery. Mr K was admitted to a private hospital and on day 1 in the surgical ward decided to have a unilateral procedure only as he observed the prolonged recovery period of other patients in the ward who had had bilateral procedures. On day 2 he was prepared for theatre but was not operated on as the surgeon was apparently busy with other more urgent cases. On day 3 the patient was again prepared for theatre but was only operated on at nine o’clock that night. He was brought out of theatre at 02:30 on day 4. On day 5 he had what appeared to be an acute coronary event in the ICU and was resuscitated, after which a cardiologist was brought in. The cardiologist was curious as to why he had not been consulted as part of the preoperative work-up of the patient. He was also surprised that neither an ECG nor an echocardiogram had been performed on the patient. He noted significant blood loss during the surgery with resultant hypovolaemia, which could have contributed to the coronary event. Despite this serious postoperative complication, the patient made a remarkable recovery and was transferred to a general surgical ward. A few days later he developed a haematoma at the wound site and was taken back to theatre. He was subsequently discharged from hospital two weeks later with a vacuum drain. Unfortunately, the wound site became severely infected, and he was readmitted to have it debrided in theatre. A week later he was discharged and had nursing care at home. Almost three weeks postoperatively, he was walking with help and appeared to be recovering. Quite unexpectedly, Mr K developed a major bleed from the wound site during the night and demised. A post-mortem revealed a pseudoaneurysm at the site of surgery. As the cause of death was a direct result of the surgery, inquest proceedings were initiated and a full investigation followed. COMMENTARY Given his age and comorbidities, it is clear that Mr K was a high-risk patient from day 1. This scenario triggers a number of critical questions: 1. Was he regarded as a high-risk patient and, if so, did he have a thorough preoperative assessment? 2. Were his cardiologist and pulmonologist consulted preoperatively? 3. He spent three days in hospital – why was he taken to theatre for an elective procedure at nine o’clock at night for a five-hour operation? 4. What was the surgeon’s level of competence at that time of night, and for how many hours had he worked that day? 5. Did surgeon fatigue impact on the quality of care given to the patient? 6. Did surgeon fatigue impact on the proficiency with which the surgery was performed resulting in complications, and ultimately death? 7. Severe wound infection after vascular surgery is a harbinger for pseudoaneurysm formation. Was this predicted and investigated? 61

A combination of individual and system errors led to an adverse outcome. Poor decision making on the part of the surgeon compromised the care he was able to provide and resulted in harm to the patient and his family. The family trauma of a patient dying at home as a result of exsanguination is emotionally devastating – a clear example of collective harm. The concept of a Surgeon’s Scorecard holds relevance in this case. How many deaths has this surgeon had in his career? What has his complication rate been, and what is his success rate? From a systems perspective, how is it possible to access an operating theatre at nine o’clock at night for elective surgery? What about infection control in the hospital? Why did this patient develop such a severe wound infection? Clearly there are multiple factors under scrutiny here. Safety and quality of care were compromised, and harm came to the patient and his family. Case study 7.4 Mrs N is 38 years old, P3G3. She visits Dr OG at a government clinic in the Eastern Cape to find out why the doctors took so long to make a diagnosis of her illness. Mrs N had visited the clinic five times since 2006 and was seen by four doctors and one clinical nurse practitioner (CNP): •

Visit 1: 2006 – Mrs N wanted to have a Pap smear due to her strong family history of cervical cancer. The doctors were extremely busy that day so she was referred to a CNP who took a Pap smear and gave her a follow-up appointment. Mrs N did not return to the clinic.

•

Visit 2: 2008 – On this visit Mrs N complained of heavy irregular vaginal bleeding, dysmenorrhoea and abdominal discomfort. She had been on Nur-Isterate for the past year. She was advised to change her contraception and was treated with Provera tablets, ibuprofen, folic acid and ferrous sulphate.

•

Visit 3: 2008 – Four months later – this time Mrs N had a foul-smelling vaginal discharge and vulval itchiness. She was treated for vaginal candidiasis.

•

Visit 4: 2009 – Mrs N had pain during intercourse and postcoital bleeding. Her sister had recently been diagnosed with cervical cancer and her aunt was receiving radiotherapy for the same condition. Her mother had died of cervical cancer. Mrs N mentioned the previous Pap smear done in 2006. She was fully examined and was found to have cervical excitation tenderness on vaginal examination. Speculum examination revealed a hyperaemic external os. Another Pap smear was done and she was asked to return in four days.

•

Visit 5: 2009 – This time Mrs N arrived on time for her visit. The Pap smear showed carcinoma in situ (CIN III). The doctor made an appointment for her to see a gynaecologist. Mrs N was hysterical and blamed the clinic for not diagnosing this earlier as she had been to the clinic many times and nobody had detected her problem. She threatened legal action.

COMMENTARY This case illustrates a combination of individual and system errors. The underlying system error is the screening policy of government clinics in South Africa – routine Pap smears are usually offered to patients at ten-yearly intervals. Frequently, specimens are lost or inadequate. Results are often misplaced and may 62

never be followed up. The first visit was problematic largely due to latent or system errors. Firstly, the clinic was under resourced and overworked, making it impossible for a doctor to see this patient. The CNP did a Pap smear but appears not to have taken the family history of malignancy too seriously. There was no system in the clinic to trace the patient after the results had been obtained. While it was irresponsible of the patient not to return for almost two years after that first visit, there should have been a system in place to send a reminder to her telephonically or by post or via the district nurse doing home visits. Visits 2 to 4 reflect mainly individual error. Three doctors saw the patient and did not trace the original Pap smear result or repeat the Pap smear until visit 5. One wonders if a physical examination, specifically a gynaecological examination, was done on visits 2, 3 and 4.

7.4 RESOLVING MEDICAL ERROR AND MINIMISING HARM We can’t solve problems by using the same kind of thinking we used when we created them. - Albert Einstein

7.4.1 Disclosure of medical error When a mistake is made in clinical medicine, the question usually posed is whether the error should be disclosed to the patient concerned. The three main theories of ethics discussed in Chapter 4 – consequentialism, deontology and virtue ethics – are relevant to the disclosure of medical mistakes to patients. Consequentialism Here we consider the outcomes of disclosure to patients. A consequentialist argument relating to disclosure would therefore examine the risks and benefits of disclosure to both patients and doctors. The risks and benefits to patients would carry more weight in this setting. On average, patients are less likely to pursue legal action if there has been open and honest discussion about adverse outcomes in treatment. Deontology Deontologists would argue for disclosure based on the doctor’s duty to disclose based on the fiduciary nature of the doctor-patient relationship, i.e. the fact that the relationship is based on trust. If, for example, a swab was left in a patient after surgery, duty would require the doctor to inform the patient, and obtain consent to remove it to prevent infection. Virtue ethics

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A good or virtuous doctor is expected to be honest and have integrity. Thus, an argument based on virtues would support disclosure of mistakes to patients. Taking all three theories into account, on balance it would be most appropriate to disclose errors to patients as and when they occur. When disclosure is controversial, it is important to get a second opinion from a colleague, ethicist, lawyer or ethics committee. Disclosure of mistakes is never easy, so once the decision has been made to disclose, how should we do so?

7.4.2 Practical tips on the disclosure of mistakes 1. Timing of disclosure: Disclosure should be done when a patient is physically and emotionally stable. However, it is important to do so promptly and openly. 2. Who should make the disclosure: It is the treating doctor’s responsibility to speak to his or her patient. If the mistake has been made by a doctor in training, then both that person and the supervisor should make the disclosure jointly. Sometimes it might be necessary to include a hospital administrator, risk manager or quality assurance representative. 3. What to say: Disclosure of mistakes usually involves “breaking bad news” to the patient. Special skills are required here and are usually taught in communication modules at most medical schools in South Africa (Blitz-Lindeque 2006). The American College of Physicians ethics manual advises the following: Information should be given in terms the patient can understand. The physician should be sensitive to the patient’s responses in setting the pace of disclosure … Disclosure should never be a mechanical or perfunctory process. Patients may become upset or angry – this must be accepted as a normal response, and doctors should not react defensively: •

The doctor should simply start by telling the patient that he or she made a mistake.

•

Discuss the decisions that were made.

•

The course of events should then be described in detail using simple language – the nature of the mistake, the outcome and corrective action taken.

•

The doctor should express personal regret and apologise: “I am sorry that this has happened”.

•

Finally, the doctor should invite questions.

•

When the mistake has resulted in major complications, an offer should be made to cancel costs generated by the complications (Wu et al. 1997).

Consider the following case Case study 7.5 Dr Z prescribed a sulphonamide to Mrs S who was known to be allergic to sulpha drugs. She developed an anaphylactoid reaction. He set aside some time to speak to Mrs S and this is what he said: 64

“Mrs S, I have found out the cause of your illness. I am sorry to tell you that I made a mistake. Before prescribing the tablets for your infection I failed to check if you were allergic to any antibiotics. I now know that you have an allergy to sulpha drugs. The itchy rash, joint pains and fever you now have are due to your allergy. I am giving you brufen and diphenhydramine to help you feel better, and I expect that you will get better over the next few days. I feel very badly that my mistake has caused you to have this reaction. I am sorry. Of course, there will be no charge for the new antibiotic and the other medication that I am giving you now to correct my mistake. Do you have any questions for me?” Source: Adapted from Wu et al. 1997 The incompetent patient: It might be difficult for some incompetent patients to understand an apology. In such cases the apology must be made to a family member or other responsible decision maker.

7.4.3 Disclosure of mistakes made by other doctors A doctor who hears of or witnesses a mistake made by another doctor has the following options: •

Wait for the other doctor to disclose the mistake.

•

Advise the other doctor to disclose the mistake.

•

Arrange a joint meeting to discuss the error.

•

Tell the patient himself or herself.

It is advisable to allow the doctor who made a mistake to disclose it personally. As a last resort it may be necessary for the second doctor to inform the patient.

7.5 CONCLUDING REMARKS The previous chapter discussed beneficence and this chapter explored non-maleficence. This is an artificial separation of the principles for the purposes of teaching. In clinical medicine it is important to understand that these two principles are closely related and require balancing at all times. Much of the ethical debate related to the principle of non-maleficence revolves around the concept of harm. The risk-benefit ratio of any treatment or intervention needs to be carefully considered at all times to maintain the delicate balance between beneficence and non-maleficence. Acknowledging our vulnerability as humans who work as healthcare professionals is important. This is sensitively captured in the words of Clare Bowen after the tragic death of her daughter, Beth: Allow yourself to be found at fault because that is the only way that people can improve (Dawson 2014).

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CHAPTER 8: Justice (Author: Keymanthri Moodley, Rafique Moosa & Sharon Kling) By the end of this chapter you should be able to: • • • • •

describe the three forms of justice describe the theories of justice understand how ethics, law and human rights are related in the principle of justice understand the concept of distributive justice in a resource-depleted setting engage in debates around rationing, priority setting and triage.

8.1 INTRODUCTION Justice as a principle refers to fairness. In healthcare, justice refers to the fair treatment of patients. The obligations of justice may be divided as follows: ▪

Respect for morally acceptable laws – legal justice

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Respect for people’s rights – rights-based justice

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Fair distribution of limited resources – distributive justice

8.2 LEGAL JUSTICE Fairness to patients from a legal perspective is an obligation of the principle of justice. It is therefore important to have a good working knowledge of the laws that impact on healthcare. When patients are harmed in the course of receiving healthcare, a sense of injustice is created. They may feel that they have been treated unfairly, especially after they have paid for services. In an attempt to restore a sense of justice they may seek redress or compensation. Initially their request for redress may be discussed directly with a member of the healthcare team. Failure to resolve the problem may result in litigation. While the law is an important contributory factor in the solution of an ethical dilemma, it is beyond the scope of this book to cover all the relevant health-related legal statutes and rules. Chapter 10 describes important concepts in medical law in more detail. Where possible and appropriate, we have alluded to the legal implications of major healthcare issues in other chapters. Knowledge of and respect for morally acceptable laws is an ethical requirement in terms of upholding the principle of justice.

8.3 RIGHTS JUSTICE A right may be regarded as an entitlement to something that is considered valuable. As such a claim to a right requires no justification (Schwartz, Preece & Hendry 2002). Examples of rights include the right to healthcare, the right to be seen on time as per appointment, and the right to a high standard of healthcare. These rights are reflected in the Patients’ Rights Charter, which is based on Chapter 2 of the Constitution – the Bill of Rights. The link between rights and obligations is important. While one person might be entitled to enjoy a specific right, another person might be obligated to ensure that the first person does enjoy the particular right. At the same time, the person enjoying the 66

privileges of the particular right also has an obligation linked to that right. For example, in the context of the doctor-patient relationship, the patient has certain rights like competent and confidential treatment from the doctor. The doctor has the obligation to treat the patient appropriately. However, the patient has an obligation to follow the doctor’s advice in terms of complying with the prescribed treatment. The Patients’ Rights and Responsibilities Charter, developed by the South African Department of Health, is a good example of rights and obligations, which are discussed in more detail in Chapter 9.

8.4 DISTRIBUTIVE JUSTICE The concept of justice as applied to the distribution of scarce resources is best defined in terms of fairness and desert (what one deserves, giving to each his or her due). Distributive justice is defined by Beauchamp and Childress (2013: 250) as “[f]air, equitable and appropriate distribution of benefits and burdens determined by norms that structure the terms of social co-operation”. While all categories of justice are important, distributive justice is particularly relevant in South Africa and other developing countries where, especially in the public health sector, limited resources exist.

8.4.1 Theories of distributive justice Several theories have been developed to determine how to distribute social burdens, goods and services (Beauchamp & Childress 2013: 253): 1. Utilitarianism. Utilitarians argue that the standard of justice depends on the principle of utility. As such we need to maximise overall good – the greatest good for the greatest number. Public healthcare for as many people as possible is supported by this theory. 2. Libertarianism. This theory of distributive justice is based on the ability of individuals to pay for their healthcare – those who can pay are entitled to it. This theory supports private healthcare. 3. Communitarianism. Principles of justice are regarded as pluralistic. Communities decide what their healthcare needs are and how resources will be distributed. The healthcare needs of a community will be prioritised over those of individuals. 4. Egalitarianism. This theory holds that all people should receive an equal distribution of healthcare irrespective of their ability to pay. In the 21st century, two new theories of justice have been proposed: 1. Capabilities theories These theories have been pioneered by Amartya Sen and developed further by Martha Nussbaum. They argue that the quality of people’s lives depends on what they are able to achieve. Consequently “a life well lived is one in which individuals sustain and exercise a group of core capabilities”: life, bodily health, bodily integrity, senses, imagination and thought, emotions, practical reason, affiliation, living with other species, the ability to play, and having control over their environment (Beauchamp & Childress 2013: 259). 2. Wellbeing theories Unlike the capabilities theories, Madison Powers and Ruth Faden argue, justice requires a sufficient level of wellbeing in six core domains: health, personal security, reasoning, respect, attachment and self67

determination. “Being healthy, being secure and being respected are desirable states of being, not merely capabilities or functionings” (Beauchamp & Childress 2013: 261). The basic premise here is that “social justice is concerned with human well-being” (Beauchamp & Childress 2013: 260). Exercise: Read more about the four traditional theories of justice and the two recent theories in Beauchamp and Childress (2013) (7th ed.), pages 253–262. Try to apply these theories in the case studies that follow. In South Africa we face resource limitations in public and private hospital settings on a daily basis. When resources are limited, how can they be distributed fairly among those who need them? No consensus exists as to which principles should govern the allocation of resources within the healthcare budget. Knowledge of the outcome and effectiveness of treatment is essential if we are to determine how resources should be allocated. Clinical auditing may help in this process. Setting priorities through guidelines of good clinical practice has attracted much interest and increasing emphasis has been placed on evidence-based guidelines. In South Africa, medical need is a factor that carries much weight in the priority setting that occurs at primary and secondary levels of care. Consider the following cases: Case study 8.1: The tragic story of Unabantu Mali In March 2009 17-month-old Unabantu Mali became very ill with gastroenteritis. His grandmother Ntombizodwa Mali carried him on her back to seek medical treatment in Nyanga, Cape Town. She said she went to the Nyanga clinic first, then to the Gugulethu Maternal Obstetrics Unit and finally to the Guguletu Community Health Centre. At all three clinics she said she was turned away as they were full. She then started the two-hour walk home because she could not afford the taxi fare. Unabantu died on her back on the way home. Source: Maposa 2009 COMMENTARY The story of Unabantu is a tragic reality of healthcare in a resource-depleted setting. On a daily basis, primary healthcare clinics in South Africa implement a triage system to separate patients into urgent, semiurgent and non-urgent cases. While urgent and semi-urgent cases are admitted for care, non-urgent cases are given an appointment according to need. Occasionally, a very sick child is missed, as occurred in the case of Unabantu. This case illustrates a complex violation of justice in both the right of access to healthcare and entitlement to health. The egalitarian theory of justice and the wellbeing theory apply. Based on the utilitarian theory of justice, the greatest number have been helped. Unabantu was in the minority, hence in terms of this theory, his death is almost justified. Priority setting and resource allocation is a challenge at tertiary-care centres as well. Case study 8.2 Baby B is in cardiac failure from a ventricular septal defect (VSD). He is admitted to the intensive care unit with pneumonia and requires surgery as it is difficult to wean him off the ventilator. The problem is that he also has Down syndrome and is HIV-positive. Difficult choices have to be made: should he be operated on ahead of other children with a better prognosis? If he does not undergo an operation, he continues to occupy an ICU bed that could be used for a child with a better prognosis. This also raises questions of a more general nature: Should HIV-

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positive children be admitted to the ICU? Should children with Down syndrome and heart defects be operated on if they are never going to earn a living and pay tax? How does one make such difficult decisions? COMMENTARY Acute life-saving treatment has traditionally received the highest priority, but sometimes one has to consider the costs in terms of the overall healthcare budget. In South Africa, resources allocated to trauma and emergency care utilise a substantial proportion of the budget. It is, however, extremely difficult to impose restrictions under these circumstances. Needs-based A common way of prioritising patients is in terms of their need for treatment, with the implication that the greater the capacity to benefit from treatment, the greater the need. This argument postulates that the greater the number of years of good-quality life (QALYs = quality-adjusted life years, explained further on) that can be gained from treatment, the greater the need. But can the degree of need for healthcare be equated to the capacity to benefit from it as measured in terms of quality and quantity of life? The degree of need for healthcare comprises the following: 1. The urgency, intensity or importance of the need 2. The amount of what is needed 3. The capacity to benefit from what the individual needs According to Harris (1981), we need to decide which dimensions of need indicate greater necessity for treatment, or have a more compelling claim on the resources available for healthcare. We could ask what the patient stands to lose if he or she is not treated. But in the case of loss of life, is the loss greater if more years of life are lost? Obviously this is mere speculation as no one knows how long a patient would have lived had he or she not died at that particular moment. A greater loss does not equate with longer life expectancy, nor must the number of life years gained, quality adjusted or not, be equated with the measure of health gain. The use of a QALY approach to microallocation tends to bias the healthcare system in favour of the young and against the old, and tends to favour patients with conditions that are cheaper to treat. The latter would result in discrimination against persons with certain conditions, such as AIDS or cancer. This approach also discriminates against people with disabilities. Economic evaluation Decisions to allocate funds to healthcare rather than to other priorities may reflect cost-benefit analysis, i.e. weighing gains in health against other methods of increasing welfare. Cost-benefit analysis refers to prioritisation among health-related benefits. The highest priority is then assigned to healthcare interventions that involve the lowest cost per unit of health-related quality of life. QALY and DALY The most widely used general unit of measure of medical benefit is the quality-adjusted life year (QALY), which is a measure of disease burden that includes both quantity and quality of life. In other words, it is 69

a year of life adjusted for its value. This discounts life years compromised by symptoms and functional limitations. The disability-adjusted life year (DALY) relies on experts’ estimates of the impact of particular symptoms and functional limitations on the quality of a person’s life. The DALY is a measure of overall disease burden. One DALY is one year of healthy life lost. These measures can be used to measure the benefits of healthcare interventions and their cost-effectiveness. The problem with these types of measure is how one values the benefits of longevity and quality of life. In this view a 75-yearold has less value than a 35-year-old, and someone in a wheelchair has less value than an able-bodied person. Regarding measuring the quality of life, a healthy person would be unable to imagine what a chronic condition would be like and can thus not be relied upon to make a judgement that could be used as the basis for health measurements. If we are only concerned about the highest total number of health benefits rather than about their distribution among individuals, then a person with a lifethreatening but treatable condition would be allowed to die so that others could enjoy relief from mild discomfort. However, moral intuition tells us that this obviously is not right. Lifestyle Some people feel that one’s degree of responsibility for one’s own state of health should be a factor in deciding how healthcare resources should be allocated. In this view, people who fail to take the necessary steps to remain healthy forfeit some of their right to healthcare. Examples of this would be smoking, obesity or excessive alcohol intake. This has not really been used to influence the allocation of resources in practice, as it is uncertain whether these lifestyle changes are really within the power of the individual in question. One of the examples, however, is the refusal to do a liver transplant in alcoholics, although this may be on a cost-benefit basis rather than that the patient has not earned the care. Australia has a programme whereby people with hypercholesterolaemia have to earn expensive lipidlowering drug therapy by proving that they have altered their lifestyle in terms of diet and exercise. Value Sometimes the value of someone’s life is used as an argument to justify treating one person rather than another. This includes value to the community, value to others near to the person (e.g. family) and value to oneself. This may also be extended to include someone whose past contribution to society has been great, or service to the healthcare system. In this view a community leader may be valued above a gangster. Age and life expectancy Some people evoke the argument of a “fair innings” in determining entitlement to healthcare. This suggests that people are entitled to live a fair lifespan (60 or 70 years?) but that after that their healthcare needs are given a much lower priority. On this argument, Nelson Mandela’s right to lifesustaining treatment was exhausted before his release from prison! The only sensible alternative is to count each life for one and none for more than one, irrespective of age and other quality considerations. Prognosis Those who equate need with capacity to benefit will argue that someone with the best chance of successful treatment should be given priority. We could use this argument in the case posed earlier in this chapter (Case study 8.2) to argue against baby B being offered surgical correction of his heart

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defect. Consider, however, whether the murderer with pneumonia should be treated in preference to the church minister with lung cancer! Moral character and fault Should the prisoner be given the same treatment as a law-abiding citizen? Should the drunk driver or his victim be given the higher priority? Accountability for reasonableness (A4R) A critical point of departure to consider in the development of a rationing or priority-setting process is that such a process reflects a sense of fairness. Norman Daniels (Daniels 1985) and others have described the elements of a fair decision-making process in terms of rationing as follows: 1. Relevance. Decisions should be made based on evidence/principles/values that are relevant to meeting healthcare needs. A renal unit, for example, will have a list of criteria that must be met before a patient qualifies for dialysis. 2. Transparency. Decisions and rationales should be made publicly accessible. The policy of the hospital with respect to, for example, dialysis should be displayed in the unit so that patients are able to read and understand it. 3. Revision and appeals. There should be opportunities for dispute resolution and revision of decisions. If a patient feels that he or she has been unfairly discriminated against or that certain treatment such as dialysis has been granted to a patient who does not qualify, the complainant should be able to discuss this and ask for an explanation. 4. Enforcement. There should be regulations to ensure that 1–3 above are met. The clinic should have a standard operating procedure that refers to the fair distribution of, for example, dialysis, taking points 1–3 above into consideration. In tertiary-care hospitals, resources such as dialysis, assisted reproduction and theatre slates are severely limited, and it is essential that patients are fairly allocated to these resources. Renal dialysis for the treatment of patients with end-stage kidney failure (ESKF) is one of the truly amazing therapeutic discoveries of modern medicine whose success has undoubtedly surpassed the wildest expectations of its early protagonists. Dialysis is capable of keeping patients, otherwise doomed to die, alive and well for many years (even decades). Such patients often return to their communities to lead very productive lives. The success of dialysis has led to unprecedented demand for treatment. Treatment is, however, very expensive and the question often raised is whether the use of enormous resources for the benefit of a relatively small number of ESKF patients in the face of other pressing health demands is the best way to use scarce health resources. Worldwide, the need for dialysis is escalating (Moeller, Gioberge & Brown 2002) and the discrepancy between the demand for renal services and its actual delivery is increasing despite the annual 7 per cent increase in the maintenance population (Lysaght 2002). As a result, it has become necessary to develop evidence-based policies to fairly distribute dialysis services to patients. An example of a prioritisation policy:

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All patients in whom the diagnosis of end-stage or advanced chronic kidney disease is made will undergo formal assessment. This process will stream patients into three groups: Category 1: Patients with this priority rating must be accommodated on the dialysis and transplant programme. Resources will always be found to treat these patients. Patients in this category are considered to potentially have the best possible outcome and would derive maximum benefit with the lowest risk of treatment failure. In addition to meeting the relevant requirements of category 2 (and not having been excluded by any category 3 factor), a patient in this category must be assessed against and meet the following constellation of factors: •

Age ≤ 50 years

•

BMI less than 30 kg/m2

•

HIV-negative

•

Hepatitis B surface antigen (HBsAg) negative

These factors, taken together and considering the patient’s overall medical condition, will guide the decision on selecting patients for category 1. Category 2: Patients with this priority rating will be accommodated on the programme only if resources allow, with priority being given to the category 2 patients who have waited the longest and who have the best chance of good outcomes. Of overriding importance is that patients in categories 1 and 2 must be suitable for kidney transplantation. Patients in this category may be eligible for treatment provided resources allow. The following factors improve a patient’s chances of being offered treatment: Social factors • • •

The patient has good home circumstances (including access to storage space, running water, sanitation and electricity) needed to succeed with dialysis and transplantation. The patient is well motivated and has access to a good social support system required to do well on dialysis and transplantation. The patient has proximity to and/or evidence of financial means or other capability to regularly arrange transport to a renal unit as frequently as this may be needed (the unit is unable to pay for or provide such transport).

The following factors, taken together, reduce the chances of being offered treatment: Medical factors • • •

Above age 50 BMI 30–35 kg/m2 (Gore et al. 2006) Hypertension with severe left ventricular dysfunction or other severe target organ damage

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• • • •

• • •

HBsAg/HCV positive with no cirrhosis (Gane & Pilmore 2002; Harnett et al. 1987; Mathurin et al. 1999) Smoking (Cosio et al. 1999; Sung et al. 2001) Diabetes mellitus (Nampoory et al. 2002) HIV-positive patients whose CD4 count ≥ 200/ml, have an undetectable viral load and, if on antiretroviral (ARV) treatment, have demonstrated good adherence and clinical response within six months (Roland & Stock 2006) First presentation with ESKF requiring urgent dialysis (Cass, Cunningham, Snelling & Ayanian 2003; Kessler, Frima, Panescu & Briançon 2003) Comorbid disease, for example stable ischaemic heart disease (Anavekar et al. 2004; Foley, Parfrey & Sarnak 1998; Herzog, Ma & Collins 1998) Previous kidney transplant

These factors, taken together and considering the patient’s overall medical condition, will guide the decision on offering treatment but no single factor will automatically exclude patients from treatment. Patients who resemble category 1 patients have a greater likelihood of being accepted; conversely, the greater the number of unfavourable factors, the lower the chances of acceptance. Kidneys are a very scarce resource and should be allocated to patients who will derive the most benefit from the transplant. Any condition or circumstance that compromises the medium- to long-term survival of a patient or the graft will exclude the patient from transplantation and selection for category 2 or category 1. Category 3: Patients in category 3 will be offered optimal conservative treatment, are not eligible for category 1 or 2, and will not be offered renal replacement therapy. Any one of the following factors excludes patients: • • • • • • • • • •

Renal transplantation is contraindicated or carries unacceptable risks AIDS or HIV infection other than HIV-positive patients with the medical characteristics described in category 2 Age ≥ 60 years (Moosa 2003; Saudan et al. 2001) Active substance abuse or dependency (Rodrigue et al. 2007) Morbid obesity (BMI > 35 kg/m2) (Aalten et al. 2006; Gore et al. 2006; Kramer & Luke 2007) HBeAg positive or cirrhosis (Gane & Pilmore 2002) Diabetes mellitus and aged >50 years (Cosio et al. 1999) Active, uncontrollable malignancy with short life expectancy Habitual non-adherence (Patients with habitual non-adherence to any medical treatment) Advanced, irreversible progressive disease of vital organs such as the following: - Cardiac, cerebrovascular or peripheral vascular disease - Liver disease - Lung disease 73

•

- Unresponsive infections Psychological exclusion criteria: Any form of serious mental illness or incapacity which, as shown by psychiatric and medical examination, would preclude the patient and/or family or available support group from successfully managing the patient, considering his or her impairment, through dialysis, a transplant, and extended follow-up care

Using the prioritisation policy described above, consider the following cases: Case study 8.3 Mr TS, a 46-year-old man, was admitted to internal medicine with advanced and irreversible kidney failure. He tested positive for HIV and his CD4 cell count was 43 cells/ml. Further examination revealed generalised lymphadenopathy which on biopsy showed Kaposi’s sarcoma. The patient was married and had four children ranging in age from 12 to 21 years. He worked as a contractor in Mmthata where he was seen and treated but was not satisfied with his treatment. He took himself to a Cape Town healthcare facility for medical care. He was seen by the renal team and assessed for the renal replacement programme. COMMENTARY The assessment team used the guidelines developed using the A4R process to make a decision. This patient was a category 3 patient because of the diagnosis of AIDS. This precludes patients from the programme because of the poor overall prognosis. The guiding principle underlying the development of the guidelines was the principle of utilitarianism. In order to avoid filling all dialysis places, patients who are not suitable for transplantation are not accepted (see Chapter 19 on the ethics of transplantation). In South Africa the number of patients with HIV who have chronic kidney failure is increasing and it has been shown that they may do well after kidney transplantation provided that they do not have AIDS and adhere to ARV treatment. It has therefore been accepted that patients living with HIV may be accepted for renal replacement treatment provided they fulfil certain criteria. FOR FURTHER DISCUSSION The patient refuses to accept the decision of the renal team and calls his brother who is a member of parliament. The latter insists that his brother be treated because he (the patient) used to be a freedom fighter and argues that he has a constitutional right to treatment. How would you address this issue? Case study 8.4 Ms JZ, a 27-year-old mother of two from Paarl, is referred by her doctor for assessment for renal replacement treatment. Her diagnosis is end-stage kidney failure. She had been seen as a child for kidney disease and has been regularly followed up by her doctor. She trained as a radiographer but is now a housewife, having ceased working to take care of her young family. Her HIV and hepatitis B virus tests are both negative. She has no other comorbid disease. On learning of her illness, several members of her family offered to donate a kidney, including her life partner. Her kidney function is only 14 per cent of normal but she does not require immediate treatment for kidney failure. COMMENTARY

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The assessment team had no hesitation in accepting her for the renal replacement programme. She had none of the factors that would exclude her from the programme and she was assessed as being a category 1 patient. She was a compliant patient who presented well before the actual need for dialysis. She also was free of comorbid disease that could adversely affect long-term survival following transplantation. Perhaps the most important factor considered by the team was the family’s support and willingness to donate a kidney. Ideally, this patient should be transplanted pre-emptively – this form of transplantation before the need arises for dialysis is seldom achieved because the majority of patients present when the kidney disease is very far advanced. FOR FURTHER DISCUSSION Both her 18-year-old single sister and her partner are found to be suitable donors, with the former having a slightly better match than her partner. Which would you choose and why? Case study 8.5 Mrs RK, a 45-year-old hypertensive diabetic, presented at the hospital in extremis, with a serum creatinine of 1823 μmol/l. She was in florid pulmonary oedema and required urgent dialysis. Following the treatment, she improved dramatically and admitted she had not been taking her antihypertensive medication or her antidiabetic treatment as regularly as she should have because she often had no money to get to the community health centre. She drank over weekends and smoked five to ten cigarettes per day. She was unemployed but took care of her daughter’s three-year-old child while the daughter was at work. She lived in a shack in a squatter camp with eight other family members. Running water was available from a tap several hundred metres from her dwelling. Both her HIV and hepatitis B virus tests were negative. On examination, her blood pressure was very elevated and her heart was enlarged. Fundoscopy revealed florid diabetic retinopathy. Her body mass index was 33 kg/m2. A subsequent renal biopsy confirmed end-stage kidney disease. The patient was then assessed by the team for suitability for treatment. COMMENTARY The team felt disinclined to accept her for the renal replacement programme because of the multitude of medical and social problems. Of special concern was the diabetes as these patients generally fare poorly on renal replacement treatment. Poor domestic circumstances limited the patient’s treatment options. The late presentation, alcoholism and lack of family support were also cause for concern as was the poor adherence. It was decided to request a scan of the heart, which showed that the patient had poor cardiac function. On the grounds of all these factors it was decided that the patient was not suitable and treatment was withdrawn. The patient was placed in category 2. FOR FURTHER DISCUSSION What are the challenges facing the team when it comes to withdrawing dialysis treatment in this patient? How would you prepare the patient and her family for that event?

8.5 CONCLUDING REMARKS South African healthcare is often challenged by resource constraints. Distributive justice is an integral part of medical practice. This chapter has examined the principle of justice in detail, paying special attention to distributive justice. The next two chapters will discuss rights justice and legal justice in more detail. 75

CHAPTER 9: Human Rights: The Relevance for South African Health Professionals (Author: Leslie London) By the end of this chapter you should be able to: • • • • • • •

understand what human rights are and why they are important see how human rights are relevant to health professional practice understand what constitutes the right to health, both in South African law and in the international context understand how the right to health is operationalised in South Africa appreciate the circumstances under which rights may be limited in the interest of the public good recognise when threats to the independence of a health professional undermine patients’ human rights apply your understanding to identifying when the human rights of a person in your care are under threat of violation and what to do about it.

9.1 INTRODUCTION Apartheid was a process of dehumanisation. It reduced the majority of our people to objects or physical entities. Imperceptibly, medicine also became dehumanised. The focus was on the disease and not the person, their family and community. South Africa is politically free; however, our people need to be healed spiritually, mentally and physically if we are to create the type of society and country that we all desire. Doctors, medical schools and their teaching staff, and medical students can become important instruments for this change. The most important step in this process is to re-humanise medicine … In short, change is not merely desirable, it is essential. The narrow outlook of the past can no longer be justified (Testimony of Prof. Maharaj at the TRC hearings 1997). It is almost intuitive to think that human rights are entitlements we should all enjoy, but it was not always the case that society thought that every person should enjoy equal entitlements to dignity and respect. Historically, we have had societies that treated people very differently according to whether they were of a certain gender, caste, religion or age. Even well into the 20th century, forms of slavery and abuse persisted as state policy. The apartheid government’s policy of treating black people in South Africa as inferior is still a legacy with which we are grappling, and discrimination on the grounds of race remains a huge challenge in health, both in South Africa, as confirmed at the health sector hearings of the Truth and Reconciliation Commission in 1997. For example, the provinces in South Africa with predominantly black, rural populations are the poorest in the country with the weakest health systems. As a result, it is poor black patients who suffer the denial of care when drugs run out, equipment is absent, transport systems fail and posts are not filled – well documented, for example, in the reports of the Eastern Cape Health Crisis Coalition Committee and section 27 (Eastern Cape Health Crisis Action Coalition, 2014). Even though ideas about social equality and non-discrimination began to emerge through the 19th and 20th centuries, it was only after World War II following the revelations of atrocities perpetrated by the Nazis in their death camps that human rights acquired formal recognition in international human rights 76

law, first in the adoption of the Universal Declaration of Human Rights (UDHR) in 1948, and subsequently in the adoption of a range of other international conventions covering different aspects of human rights. The UDHR was an aspirational document that expressed hope for a better future, and arose as a direct response to revulsion at the way the value of human lives was negated by Nazi policies that treated Jews, communists, homosexuals, gypsies and other groups as less than human. The UDHR framed health in terms of a right for everyone “to a standard of living adequate for the health and well-being of himself and of his family” and specifically singled out “motherhood and childhood” as being “entitled to special care and assistance” (UN General Assembly 1948). Subsequent human rights conventions adopted have been more than aspirational – they place direct obligations on governments to meet the human rights of their people.

9.2 WHAT ARE HUMAN RIGHTS? Human rights are entitlements people can claim relating to their basic needs because they are human. Fundamental to all human rights is respect for human dignity. Under apartheid laws in the past in South Africa, there were many ways in which human rights were violated. Consider the following cases: Case study 9.1: The death of Mr Steven Bantu Biko – Medical complicity in torture The following is a quote from the inquest into the death of Steve Biko, cited in Baldwin-Ragaven, De Gruchy and London (1999: 93): o

Q: In terms of the Hippocratic Oath, are not the interests of your patients paramount?

o

Dr L: Yes.

o

Q: But in this instance they were subordinated to the interests of the security police?

o

Dr L: Yes.

On 12 September 1977, Mr Bantu Steven Biko died while in police custody following torture and assault by his security police captors. This quote is taken verbatim from the inquest into his death, which took place some two months after he died and reflects the attitude of the doctor who treated Mr Biko in the days before his death. Steve Biko was a prominent political activist who was detained under security legislation for his political activities, one of many such political leaders who were viewed by the then apartheid government as a threat to national security. He was held incommunicado in police cells in Port Elizabeth for a period of 24 days, during which time he was subjected to multiple assaults and other forms of abuse during his interrogation. As a result of one of these assaults, he sustained a subdural haematoma (a form of brain haemorrhage). Because the security police were aware that Mr Biko appeared unwell, they called in two district surgeons (medical practitioners who were responsible for the medical care of prisoners under apartheid). Despite finding clinical signs of assault (Mr Biko had bruises on his body and abrasions on his forehead), they declined to ask about the source of injuries. Instead, one of the doctors signed a certificate indicating Mr Biko had “no pathology” on examination. As Mr Biko’s physical condition continued to deteriorate, the doctors noted serious signs of brain injury, including an extensor plantar reflex and blood in the cerebrospinal fluid, but declined to hospitalise Mr Biko 77

for the kind of care appropriate for a patient with a suspected head injury. Instead, they allowed the security police to transfer Mr Biko in the back of a police van, semiconscious and virtually naked, without any treatment, medical records or accompanying medical staff, to a police cell in Pretoria more than 1 000 km away. Mr Biko arrived in Pretoria late on the night of 11 September 1977, was perfunctorily assessed by the attendant doctor who, with no referral notes, put up a drip on the unconscious patient. Mr Biko died the next morning as a result of a combination of medical negligence and security force abuse. Rather than have his torture exposed through admission to a public hospital in Port Elizabeth, the police moved Mr Biko by police vehicle so that he would die in a military hospital out of the public limelight. Sadly, the doctors responsible for his care allowed the police to take charge of their patient’s medical needs. Rather than making the care of a vulnerable patient their professional responsibility, the doctors allowed their clinical judgement to be directed by the security police. QUESTIONS Think about this case. It is trite to say that Mr Biko’s human rights were violated, but reflect on the case carefully to answer the following questions: 1. What rights were violated in this case and how were they violated? 2. For each right you have identified, who was responsible for protecting the right? 3. If you were a patient of Dr L’s, what kind of care would you expect from a health professional? Compare this to the care that Mr Biko received. In what way was this standard of care compromised? 4. What sort of measures should be put in place to prevent such a case ever happening again? South Africa was not alone in allowing the torture of political detainees. Many of the dictatorships in South America in the 1960s and 1970s used torture routinely against political dissidents and made use of medical and psychological professionals to assist their torture methods. So bad was the problem that the World Medical Association had to adopt an international guideline for its member medical associations explicitly prohibiting any medical complicity in torture (see the Declaration of Tokyo at http://www.wma.net/en/30publications/10policies/c18/): 1. The Declaration forbids doctors from participating in torture. Does this only apply to statesponsored torture? For example, if a person suspected of abducting a missing child has been beaten to extract information as to the whereabouts of the child and the suspect is brought to you to treat his injuries so that he is fit to give more information, would you be precluded from treating him if it were a community committee meting out this form of justice? Or would it only apply if the perpetrators were police? 2. The Declaration offers a definition of torture. You are a psychologist and are called to see a detainee who is due for interrogation. The detainee is suspected of being a terrorist planning to plant a large bomb in a public place with maximum loss of life. It transpires that the interrogator plans to break down the resistance of the suspect by threatening to kill his wife and children if he does not cooperate. Would you be countenancing or condoning torture if you allowed the interrogation to go ahead with this form of threat? 3. Reflect back on the case of Mr Steve Biko. Did the doctors exercise “complete clinical independence in deciding upon the care” of Mr Biko? What actions would have been consistent with “complete clinical independence”? 78

Thankfully today these kinds of egregious abuse involving torture and medical complicity in torture are no longer with us to the extent to which they were routinely done in the past, although there are some notable exceptions (see the following box). It has been the growing international recognition and respect for human rights that have played a very important role in getting rid of torture and medical participation in torture both in South Africa and worldwide. Case study 9.2: US medical personnel participation in torture – recent evidence Writing in the New England Medical Journal in July 2004, Robert Lifton, author of the seminal text The Nazi Doctors, described evidence of ongoing abuse of detainees by US security personnel in detention centres at Abu Ghraib and Guantánamo Bay, and the complicity of medical personnel in it. He points to three ways in which medical personnel have become complicit in the torture of detainees: a) by failing to report to higher authorities wounds clearly caused by torture; b) by declining to take action to interrupt this torture; and c) by releasing prisoners’ medical records to non-medical security personnel for use in interrogation. He suggests that doctors become socialised to atrocity-producing situations and because they have medical status, help to sustain the environment in which abuses continue to take place. He warns that professionals should “recognize what doctors are capable of when placed in atrocity-producing situations”. He ends by calling on doctors who were involved in interrogations to speak up about what they saw as a step “toward reclaiming their role as healers” Source: Lifton 2004 So human rights are very important forms of protection against state abuse, but human rights can also include social or material claims, such as those to housing, water and access to healthcare. The former are usually referred to as civil and political rights (e.g. freedom to vote; freedom of speech, movement and political affiliation; freedom from torture, etc.), while the latter represent socioeconomic rights to resources we require to meet our fundamental needs. As they were originally framed, human rights were conceived to prevent abuse by limiting state power over individuals – hence the idea that these were “first-generation” rights. However, in the 20th century, it was increasingly recognised that socalled first-generation rights are interdependent with social and economic rights (so-called secondgeneration rights). For example, the right to vote depends on people having received access to sufficient education so that they can read the ballot paper. For that reason, we regard all categories of rights as equally important and indivisible. Exercise: Think about the right to health There are many factors required in order to be healthy, not only health services. What other types of rights (besides access to healthcare) might you need to be met in order to realise your right to health? How does this illustrate the indivisibility of human rights? Although different cultures will express respect for human dignity in different ways, international convergence in adopting human rights conventions means that rights are increasingly recognised as universal. What is fundamental to human dignity in East Asia will be the same set of values as in North America and Africa, although local cultural norms expressing these values may differ. This means that human rights are regarded as universal.

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9.3 WHO IS RESPONSIBLE FOR HUMAN RIGHTS? It is no good having a right unless someone has a reciprocal duty, otherwise a right is meaningless. Usually it is the state that is responsible for meeting a right. The state must meet its rights and obligations in four ways: a) Firstly, it must respect rights, which means the state must make sure its actions do not violate people’s rights. For example, it should not pass laws that, for example, discriminate against certain categories of vulnerable persons. The obligation placed on the state is a negative one – to refrain from actions that would violate rights. b) Secondly, it must protect rights, which means it must take action that prevents your rights being violated by a third party. For example, the South African government passed legislation in 1998 that prevented employers from discriminating against HIV-positive persons. c) Thirdly, it must fulfil rights by taking active steps, including budgeting, planning and providing services and infrastructure to meet its obligations. d) Lastly, it is of little help if rights exist only on paper. For that reason, the South African Constitution (Constitution of the Republic of South Africa Act 108 of 1996) imposes a fourth obligation on the state to promote rights, which means the state has to take measures to enable its population to access their rights – such as providing human rights education and awareness raising, or structures to promote a human rights culture in society. For this reason, the South African Constitution provides for institutions whose mandates are to support constitutional democracy and human rights.

Chapter 9 of the Constitution provides for institutions whose mandate is to support constitutional democracy. These include the Public Protector; the South African Human Rights Commission; the Commission for Gender Equality; the Commission for the Promotion and Protection of the Rights of Cultural, Religious and Linguistic Communities; the Auditor-General; and the Independent Electoral Commission. From the point of view of intervening to address threats to human rights, it is the first four institutions that are most important. You may find you have a need to make use of them in your professional practice – to report a complaint, to seek advice, to help a client or patient whose rights have been violated, or to refer them for further action: A. The Public Protector can investigate any conduct suspected or alleged to be improper by any arm of government and can take appropriate remedial action. Thus, any person who feels aggrieved by any actions taken by public servants or public representatives can lodge a complaint with the Public Protector. In this way, improper conduct that results in violations of human rights can be taken up by the Public Protector. For example, in 2001 a legal advocacy NGO, the AIDS Law Project (ALP), laid a complaint against the Health Professions Council of South Africa (HPCSA) with the Public Protector. The complaint detailed the failure of the HPCSA to hold doctors registered with them accountable for testing HIV-positive patients without their consent. In practice, the HPCSA either did not pursue action against the doctors, or took so long to begin exploring 80

disciplinary action that the affected parties died of HIV-related complications before the case could be heard. Despite repeated efforts by the ALP to get the HPCSA to take the matter seriously, no progress was made in expediting such complaints. The Public Protector investigated the complaint and recommended six interventions aimed at addressing the long delays in processing complaints. Some of these interventions have been implemented and, for example, an expedited process of dealing with complaints against doctors is now in place with the HPCSA, though its efficiency is still a matter of concern. Source: Bateman 2005: 629–630 B. The South African Human Rights Commission (HRC) is responsible for promoting a culture of human rights in South Africa, promoting the protection, development and attainment of human rights, and monitoring the observance of human rights in the Republic. It has powers to investigate, mediate, educate and conduct research relating to human rights matters, both in response to complaints and proactively. It also has a responsibility to oversee reports from all organs of state on measures taken towards the realisation of the rights in the Bill of Rights concerning housing, healthcare, food, water, social security, education and the environment. These reports are available on its website: http://www.sahrc.org.za/home/index.html/. It has established a complaints mechanism to which one can turn if one feels one’s rights have been violated (http://www.sahrc.org.za/home/indexab35.html?ipkContentID=23/) , and regularly holds public hearings into aspects of socioeconomic rights. For example, in May 2007 the HRC convened public hearings on the right of access to healthcare in response to the large number of complaints they were receiving from the public about violations of health rights. The hearings received submissions from 59 stakeholders including health professionals, training and regulatory institutions, public and private health service management and government departments, community members, and persons representing interest groups (e.g. children, women, the disabled, domestic workers, refugees, gays, lesbians, older persons, people with mental illness, HIV and AIDS). Combined with research conducted in preparation for the hearings by the HRC itself, a picture of the lack of access to healthcare was captured in the report and a set of recommendations made for improving healthcare, both to public and private systems. Source: South African Human Rights Commission http://www.sahrc.org.za/home/21/files/Health%20Report.pdf C. The Commission for the Promotion and Protection of the Rights of Cultural, Religious and Linguistic Communities is responsible for promoting respect for the rights of cultural, religious and linguistic communities, and developing peace, friendship, humanity, tolerance and national unity among cultural, religious and linguistic communities, on the basis of equality, non-discrimination and freedom of association. This commission is the youngest of the Chapter 9 institutions and to date has not taken up a human rights issue. D. The Commission for Gender Equality has the responsibility to promote respect for gender equality and the protection, development and attainment of gender equality through monitoring, investigation, research, education, lobbying, provision of advice and reporting on issues concerning gender equality. It also has a complaints mechanism for those who feel they are victims of gender-based discrimination. Source: Commission for Gender Equality http://www.cge.org.za/index.php?option=com_content&view=article&id=75&Itemid=80

Although the norm is to think about human rights applying to states, it is increasingly recognised that in the modern globalised world, states are sometimes powerless to act in the face of the power of big 81

multinational corporations. For that reason, scholars are beginning to explore how parties other than states who are very powerful (called non-state actors), such as multinational corporations whose turnover is often larger than the entire GNP of small countries, should be held accountable for their actions when they lead to violations of human rights. These activities are leading to the development of norms and standards for multinational corporations because they are important to protect the rights of vulnerable groups. Consider the following case Case study 9.2: South Africa v Pharma In 1997, the South African parliament amended the existing Medicines and Related Substances Control Act No. 101 of 1965 to introduce measures aimed at making medicines more affordable. Among these measures were provisions that would have enabled the government to import or produce cheaper versions of patented brandname drugs, including antiretroviral medication. The pharmaceutical industry lobbied strongly against the bill and, when they were unable to delay or block its adoption, they took the government to the Constitutional Court the following year, claiming that the Act violated their intellectual property rights. The case continued for three years, partly delayed by an attempt to seek a settlement when the new cabinet took office after elections in 1999. Initially, the 40 or so pharmaceutical companies that sided against government were confident they would be able to roll back the legislation as unconstitutional. However, it soon emerged that the companies were more concerned about profits than about the impacts of high drug prices on the lives of people dependent on publicsector drug procurement for survival. In particular, patients with HIV desperately in need of antiretrovirals were being denied access to treatment because of the prohibitively high costs of patented drugs. An unprecedented international campaign ensued, highlighting how the industry was putting profits before people. A global network of NGOs, scientists, advocacy groups, and even consumers of medicines and shareholders in the companies, joined hands to protest against the companies’ behaviour. The case was portrayed by campaigners as a David-and-Goliath contest, pitting public health against the corporate wealth of billion-dollar drug companies. The companies had no real answer to accusations that they were denying people their rights by seeking to reverse the legislation. In the end, public outrage at the actions of the industry forced them to withdraw the court action, which they did in 2001. It was a humiliating climbdown for the industry and illustrated that non-state actors can and should be held accountable for actions that impact adversely on human rights. International conventions are important because when a country ratifies a convention, it commits itself to ensuring that its legislation and programmes meet the rights contained in the international convention. For example, a country that has ratified the Convention Against Torture (CAT) must commit to making sure its laws give expression to this prohibition on torture. For most conventions, countries are expected to report periodically to the UN committee responsible for the convention on their progress in implementing the rights contained in the convention. For example, South Africa ratified the Covenant on Economic, Social and Cultural Rights in 2015 and will need to submit its first report to the relevant UN Committee before 2017. South Africa’s last report on its performance in terms of the Convention on the Rights of the Child, submitted in 2013, shows substantive progress in legislative protections for children (restricting child labour, passing new legislation in terms of the Child Justice Act and the Children’s Act in rendering primary healthcare for children under six free and expanding the 82

child-care grant progressively over time). If you are interested in knowing more about what conventions relevant to health the South African government has signed, take a look at http://www.hsprj.com/health-maintanance/realizing-the-right-to-health-in-the-whoafrican-regionissues-challenges-andthe-way-forward.pdf.

9.4 HEALTH AS A RIGHT Besides our professional obligation as healthcare providers to respect and protect the human rights of our patients and clients, it is also the case that health itself is a right. There are many different ways to think about this. For example, the Constitution of the World Health Organization, adopted in 1946, states (in its second paragraph, immediately after the more famous definition of health as being more than just the absence of disease) that the “enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition”. This formulation is echoed in the International Covenant on Economic, Social and Cultural Rights (ICESCR), adopted in 1966, which restates the notion of the “highest attainable standard” but specifically notes that it applies to both physical and mental health. What is meant by the “highest attainable standard” is elaborated on in more detail in General Comment 14 issued by the Committee on Economic, Social and Cultural Rights in 2000. The committee identified core obligations on governments to realise the right to health and affirmed the importance of social determinants of health, not just healthcare, being essential to the right to health (see Table 9.1). Table 9.1 Core obligations of the state to realise the right to health •

Functioning public health and healthcare facilities, with programmes available in sufficient quantity

•

Health facilities and services that are accessible (physically, economically and information-wise) without discrimination

•

Services that are respectful of medical ethics and culture

•

Services that are scientifically appropriate and of good quality

•

Services that recognise the special needs of vulnerable groups

Sources: UN 2000; Chapman & Russell 2002; Backman, Hunt, Khosla, Jaramilla-Strauss, Fikre et al. 2008 It is important to realise that the right to health does not mean the right to be healthy, since people have different genetic potentials and cannot all expect to be equally healthy. Nor does it imply that governments must put in place services and facilities which it cannot afford. Rather, as articulated by Mary Robinson, former head of the UN High Commission on Human Rights, “it does require governments and public health authorities to put in place policies and action plans which will lead to available and accessible health care for all in the shortest possible time” (WHO 2002). However, now that South Africa has ratified the ICESCR, it must try to make sure it meets the standards set by the ICESCR for the highest attainable standards of health through its legislation, planning, budgets and programmes. Many of the ICESCR rights are already present in our South African Constitution in the Bill of Rights. Table 9.2 Categories of health rights in the South African Constitution: 83

9.5 THE SOUTH AFRICAN CONSTITUTION AND THE BILL OF RIGHTS Precisely to protect the rights of all people in our country and to affirm the values of human dignity, equality and freedom, the South African Constitution includes a Bill of Rights that outlines numerous provisions related to the right to health (Table 9.2). The right to health includes not only access to healthcare services, but to many of the social determinants of health, such as adequate water, social security, housing and education as well as to foundational rights such as dignity, equality and life. These are illustrated in the cases that follow. For each case, there is a set of questions to guide you through the different aspects of the right to health and what the role of a health professional should be in advancing health rights. Consider the following cases: Case study 9.3: Arbitrary withdrawal of a disability grant by the Eastern Cape government Between March 1996 and September 2000, the Eastern Cape provincial government embarked on a process to weed out bogus claimants who were said to be costing the province R65 million per month. The process involved stopping the grants of all beneficiaries (thought to number about 100 000) who then had to re-apply for their existing benefits, during which time their particulars would be verified and updated. However, for poor grant recipients, many of whom were totally dependent on the grants, the way in which this policy was applied brought tremendous hardship. Disability grant (DG) holders had their grants cancelled without notice and without proper explanation. Even when recipients were finally given the reasons for the cancellation, the provincial government services were unable to process the required applications, leading to multiple delays, despite endless efforts by public interest organisations and health and welfare professionals to seek redress for their clients. As a result, many DG recipients faced destitution. 84

Three grant recipients in this predicament then enlisted the Legal Resources Centre to challenge the Eastern Cape government’s action as arbitrary and unfair. The Supreme Court of Appeal ruled in the plaintiffs’ favour, calling the manner in which the authorities chose to deal with the problem of bogus grant recipients “extreme, and the consequences for large numbers of needy people savage”. Judge Edwin Cameron, speaking on behalf of the five judges, commented: All this speaks of a contempt for people and process that does not befit an organ of government under our constitutional dispensation. It is not the function of the courts to criticise government’s decisions in the area of social policy. But when an organ of government invokes legal processes to impede the rightful claims of its citizens, it not only defies the Constitution, which commands all organs of state to be loyal to the Constitution, and requires that public administration be conducted on the basis that “people’s needs must be responded to”, it also misuses the mechanisms of the law, which it is the responsibility of the courts to safeguard.

The fact that the most vulnerable were affected by poor and arbitrary administrative action was seen as an aggravating circumstance, precisely because the constitutional imperatives require preferencing of the most vulnerable and disadvantaged. The grants were restored to the applicants. One of the applicants, Mrs Meltafa, recounted how, in the course of the case, she was labelled a troublemaker by welfare officials. She responded by saying to the officials, “You have been sleeping, I have woken you up!” Source: https://www.youtube.com/watch?v=l3d0WlBiHCM/ QUESTIONS 1. 2. 3. 4.

What rights were violated in this case? How were they violated? How could these violations be prevented? What do you think Mrs Meltafa’s comment about “waking up” the officials implies for human rights? 5. If you were Mrs Meltafa’s doctor and she came to you telling you that her disability grant had been discontinued, what could/should you do to ensure her rights are not violated? Case study 9.4: Antiretroviral treatment access The Treatment Action Campaign (TAC) was started in December 1998 to campaign for and popularise a right of access to treatment for people with HIV/AIDS. Its initial focus was to secure treatment for all HIV-positive pregnant women to prevent mother-to-child transmission (PMTCT). Initially, it had good cooperative relations with government. For example, it supported the government as an amicus curae (a friend of the court) in the court action brought by the pharmaceutical industry against state pharmaceutical legislation intended to reduce the cost of medicines in 1998 (see Case study 9.2). However, in 2001, the TAC was forced to go to the Constitutional Court to force the Department of Health to roll out a PMTCT programme across the country. The department had refused to commit to a treatment programme, citing high costs and toxicity of medicines as reasons. Underlying the refusal to implement the programme was the denialism of the then President Mbeki who found an enthusiastic supporter in the then Minister of Health.

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In 2002, the Constitutional Court ruled in favour of the TAC, using the criterion of reasonableness to conclude that the Department of Health was being patently unreasonable to withhold roll-out of PMTCT that would save the lives of thousands of babies and reduce healthcare costs of caring for infected children. While our Bill of Rights does recognise that if resources are limited, the state is not expected to go beyond its “available resources” to deliver on its rights obligations. However, the Constitution simultaneously provides for progressive realisation of socioeconomic rights such as the right of access to healthcare – meaning that, even if the state could not afford to provide ARVs to everyone immediately, it had to increase access to ARV treatment over time and show how it planned to do so. In parallel to the court action, the TAC mobilised a popular movement that had wide support from health professionals, researchers, churches, trade unions and, most of all, from people living with HIV/AIDS. Many health workers joined the TAC marches and spoke out against the state’s position. The Constitutional Court ruling showed that it was possible to hold the South African government accountable to its rights obligations Subsequent pressure from the TAC helped to accelerate the adoption of a national ARV treatment programme in 2007, which is the largest ARV programme globally and which has probably saved half a million lives to date. QUESTIONS 1. What were the rights violated by the state’s refusal to implement PMTCT? 2. What do you think motivated health professionals to support the TAC in its case against the Minister of Health around her refusal to provide PMTCT? Case study 9.5: Facing moral choices – Dr Wendy Orr Wendy Orr graduated from the medical school of the University of Cape Town in 1983 at a time when, as she puts it, the undergraduate medical curriculum ignored human rights and sometimes actively colluded in human rights violations prevalent under apartheid. Because she had a student loan to pay off, she went to work as a district surgeon in Port Elizabeth, a job that required both medico-legal work (e.g. treating assault and rape victims) and responsibility for the healthcare of prisoners in the local area. The work proved emotionally draining. For example, a medical doctor was expected to be present when lashes were given to prisoners as a form of punishment, supposedly to ensure that injuries caused were not excessive. However, the lashings, administered with a thick rubber whip to the naked buttocks of a prisoner strapped spread eagled to a frame, were by nature excessive. Dr Orr objected to being part of such barbaric activities. Although told by her superior that she should not “expect any special treatment in this department, just because you’re a woman”, she was then spared future involvement in such canings. However, after a state of emergency was implemented in July 1985, the number of persons detained in the local prison at St Alban’s who she was expected to see for medical assessments and care escalated dramatically. Amidst the large numbers of detainees she would see, the majority would have injuries at the time of their admission resulting from police assault, and those who returned from security police interrogation exhibited a range of injuries, which they reported were the result of torture sustained during interrogation. She sought advice from her immediate superior, the chief district surgeon, who was the same doctor who treated Steve Biko in detention some seven years earlier (see Case study 9.1). He advised her to do nothing but document the injuries and her treatment, as her only responsibility was to treat the injuries. Similar complaints to the prison authorities met with little effect, since the prison officials blamed the police for the assaults. Dr Orr commented: 86

Looking back, I realize how frighteningly easy it would have been for me to stop there. I had tried, I had spoken to those in positions of authority, what else could I do? Nothing I had been taught had prepared me for this. Surely no one could have condemned me for going no further? If action really was required, why had no other district surgeons, anywhere in South Africa, done anything?

Indeed, the pressure to acquiesce and to identify with the prison and police authorities was immense, as was the suspicion in which she was held by the prisoners, who distrusted her as part of the “system”. However, Dr Orr did reflect on her choices – either to be the “good” doctor, recording and treating injuries but doing nothing to prevent them, or to apply to the Supreme Court for an urgent interdict to prevent police from assaulting and torturing detainees. She chose the latter course and when the interdict was successful, assaults and torture declined dramatically, with a visible change of atmosphere in the prison, where her actions led to an outburst of spontaneous celebration among the prisoners recognising her actions to protect them. In contrast, her supervisor said nothing about the case but moved her to prevent her from participating in any work that could be interpreted as political. She eventually resigned, and moved to Johannesburg where she received support from other doctors working in the anti-apartheid health movement. Her contribution was later recognised in her appointment as a Truth and Reconciliation commissioner in 1995, and she organised the special hearings on the health sector for the Truth and Reconciliation Commission in 1997. Source: Adapted from Orr 2002 QUESTIONS 1. In St Alban’s prison, what rights of the prisoners and detainees were violated? 2. How were they violated? 3. How could these violations be prevented? 4. Does a doctor seeing prisoners (or any other vulnerable group) have particular obligations to this group? If so, what are they? 5. Why do you think Dr Orr chose to go to court to seek an interdict against the police? Is that kind of action part of your professionalism? 6. Dr Orr lamented many times about the failure of other district surgeons, who were almost certainly seeing similar abuses among prisoners and detainees, to speak out about torture. Why do you think they failed to do so? What can you learn from this case about what is needed to address this problem? Case study 9.6: Participation in chemical and biological warfare Dr Wouter Basson was a cardiologist and a special forces operative in the South African Defence Force (SADF) under apartheid. He was appointed to head the SADF’s top secret chemical and biological warfare (CBW) programme called Project Coast in 1981. The programme recruited about 200 scientists from around the world to help develop both defensive and offensive capacity for the SADF. Material presented in the TRC investigation of Project Coast in 1997 found evidence suggesting the production of assassination weapons involving anthrax and organophosphate pesticides, and the stockpiling of large quantities of cholera and other bacteria. Also planned (though never remotely realised) at Project Coast’s laboratories at Roodeplaat was a project to develop a vaccine to render black people specifically infertile. All this secret activity related to CBW had been conducted in flagrant disregard for the Biological Weapons Convention, which South Africa had ratified more than a decade earlier in 1975.

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Basson never applied to the TRC for amnesty, maintaining that his involvement in the project was entirely legal and bona fide. However, the state charged him in 1999 on 67 counts, including drug possession, drug trafficking, fraud and embezzlement, murder, conspiracy to murder and theft. After a marathon trial lasting 30 months, and reportedly the most expensive prosecution in South African history, the charges were thrown out by the judge, partly because the judge agreed that charges related to murder and possible involvement in 200 deaths in Namibia could not be prosecuted in South Africa. (See Gould & Folb 2002, and Gould & Burger 2003 for further information.) Basson is currently registered as a cardiologist. In December 2013, 12 years after the first complaint was lodged against him, the HPCSA disciplinary committee found him guilty of unprofessional conduct. His sentence is still pending and he continues to practise. For each of the nine arguments presented by Basson in his defence (listed below), the HPCSA disciplinary committee provided a refutation and systematically rejected each one, with clear reasons (Annas 2015).

1. The circumstances of war justified extreme measures.

2. The respondent was under military orders.

3. Dr Basson was acting as a soldier and not a doctor.

4. Military ethics are different.

5. There was no doctor-patient relationship, so no ethical restraints were needed.

The HPCSA reminded Basson that medical ethics in times of war are the same as in peacetime, citing World Medical Association (WMA) declarations and evidence from a leading bioethics expert. As they put it, “medical ethics are identical during war and peace”. The council rejected “the notion that regulations have to be interpreted in light of the prevailing circumstances. The WMA regulations are unambiguous in this respect”. The committee disagreed that this could justify departure from accepted medical ethics. Rather, the committee’s view is that “a medical doctor is responsible as an individual for his or her actions. Medical ethics require the independence of thinking of each medical doctor. A doctor cannot simply rely on a military order …” The committee pointed out that his role could not have been done by someone who was not a doctor; he was specifically recruited because he was a medical professional. If Basson was really simply acting as a soldier, he should have deregistered as a doctor with the council. Furthermore, it is a problem to “switch roles between being a doctor and being a soldier, while using the knowledge, skills and privileges of a doctor.” Basson’s witnesses quoted an Israeli ethicist (who is not a doctor), who argued that normal principles for medical reasoning are absent, and that doctors do not have autonomy.Council rejected this argument, pointing to numerous international guidelines stating that there cannot be two standards. Firstly, the council pointed out that some international guidelines do not restrict themselves to 88

6. Dr Basson was then a young and inexperienced doctor so cannot be held responsible.

7. Dr Basson was not aware of international codes and guidelines

8. Ethical standards have changed and were not the same in the 1980s as they are now.

9. Chemical substances developed were designed to be non-fatal.

patients, but speak of “victims” in, for example, the Tokyo Declaration. Secondly, where doctors’ actions impact on people, they must take responsibility for their decisions and behaviour, even when there is no explicit doctor-patient relationship. Council rejected this argument. In Basson’s case, he was not inexperienced when taking on the role as head of the CBW programme; in fact, he was not a young follower but a mature leader, and thus has to take responsibility for his actions. Council rejected this argument – ignorance cannot be bliss. No professional recruited to a job within a CBW programme would not think they needed to check ethical and legal legitimacy when accepting the position. While the council acknowledged that ethical emphasis changes over time, there was enough ethical guidance in the 1980s to have conveyed very clear concern about this practice. Council found that Basson used his medical skills for the purpose of abetting military operations, and that this was not compatible with professional standards, nor was supplying military operatives with suicide tablets.

QUESTIONS 1. Consider each argument and consider the HPCSA response. Do you agree or disagree? What principles inform your decision? 2. Do you think the production of chemical or biological weapons is or could be compatible with a human rights framework? Consider the following case Case study 9.7: Access to health care In March 2009, a 17-month-old baby boy, Unabantu Mali, died after repeated efforts by his grandmother to have him seen at primary care clinics in Cape Town were unsuccessful. The child had earlier in the month been admitted to Red Cross Children’s Hospital for vomiting and diarrhoea but had been sent home after appearing to improve. However, his condition must have deteriorated, causing his grandmother to take him for further medical attention. She sought care for the child at three different facilities, walking between them. At the third facility, the Gugulethu Community Health Centre, a nurse initially told her the child would be seen but she was then sent home and told by staff to come back the next day. By the end of the day, the child had died while still wrapped in a blanket on his grandmother’s back as she trudged home, having failed to find a health worker to assess him. A subsequent investigation by an independent panel did not identify anyone negligent or liable for his death. QUESTIONS 89

1. 2. 3. 4.

What rights were violated in this case? How were they violated? How could these violations be prevented? Do you think the fact that no one was identified as negligent means that there could not have been any violations of Unabantu’s rights? What is the relationship between individual health worker accountability and a human rights violation? 5. Is there any particular international human rights convention which South Africa has ratified which could shed light on what the government’s obligations are in regard to the prevention of Unabantu’s death? 6. To whom could Unabantu’s family turn for assistance if they felt a right had been violated? Briefly explain. The South African government has developed a charter of patients’ rights. Along with the rights go a set of responsibilities, in that citizens who are entitled to claim health rights from the state are also expected to respect the rights of others and behave in ways that make it easier for the state to meet its rights obligations. Take a look at the Patients’ Rights Charter. Do you think it would have helped Unabantu’s grandmother if she could have had access to the charter when negotiating care for her sick grandchild?

9.6 LIMITING RIGHTS IN THE PUBLIC INTEREST It is sometimes the case that human rights need balancing, since different people’s rights might conflict. Alternatively, a state’s action might violate someone’s rights in the interest of meeting the state’s obligation to protect, promote or fulfil other rights. How these difficult trade-offs are made is dependent on a number of factors. Table 9.3 summarises the international consensus on what conditions should be met for a limitation on someone’s rights to be justified by a public good. This tradeoff is illustrated in the following two cases (Case studies 9.8 and 9.9). Consider the following case Case study 9.8: Drug-resistant TB and forced confinement In October 2007, the Western Cape Department of Health applied for a court order to compel three patients with extensive drug-resistant (XDR) TB to return to Brooklyn Chest Hospital. The patients had absconded from the hospital repeatedly in preceding months and were not taking their medication. They all had a history of retreatment for previous TB infections. The department argued that they were a risk because of the possible spread of a virtually untreatable form of TB to other people in the community and at home, so had to be subjected to confinement. In response, the four patients identified the substandard conditions at Brooklyn Chest Hospital as a form of discrimination and the enforced isolation a violation of their rights. The two judges considered the merits and concluded in July 2008 that the confinement could be justified on the basis of the public interest. QUESTION 90

Take a look at Table 9.3, which outlines the conditions under which it is considered justified to limit rights in the public interest. The Western Cape Department of Health was willing to limit the patients’ rights because of an obligation to promote the public’s health. Do you think the Western Cape Department of Health was justified in limiting the patients’ rights in this way? Case study 9.9: Rationing and the case of Mr Soobramoney Mr Soobramoney was a diabetic patient in chronic renal failure who had concomitant ischaemic heart disease and vascular disease as complications. In 1997 he was receiving renal dialysis in the private sector, but ran out of private medical insurance so he approached a state hospital for it. However, in the public sector, because of limited resources, access to dialysis is usually dictated by the patient’s suitability for renal transplant, since the only route off dialysis is to receive a kidney transplant. Without a transplant, patients will remain permanently on dialysis. Because of the high cost and limited numbers of dialysis machines, accepting a patient who is not a candidate for transplant onto the dialysis programme means that another patient is deprived of a place. Public-sector dialysis is therefore reserved for patients who have a prospect of exiting the dialysis programme through transplant. Because of Mr Soobramoney’s comorbidity, he was not a candidate for transplant and was therefore refused dialysis. Mr Soobramoney sought a court interdict to compel the KwaZulu-Natal Department of Health to provide him with dialysis. He argued this on the basis of his right to life and his right to emergency medical treatment. Although Mr Soobramoney won his initial application for an interdict, the Department of Health appealed the decision to the Constitutional Court, which overruled the first decision. The rationale for the Constitutional Court’s decision was that both grounds argued by Mr Soobramoney were incorrect. The court interpreted the right to life to mean a right not to have one’s life arbitrarily taken away, rather than a right to have one’s life indefinitely extended. Further, the court defined an emergency as contained in the right to emergency medical treatment to imply a condition which is sudden or unexpected, for which treatment may be expected to restore a patient to health or at least a better health status, rather than treatment of a condition which had already existed for many years. Moreover, the court recognised that for access to healthcare, which is subject to resource limitations, the need to ration resources is inevitable. Decisions made by the Department of Health with regard to how best to prioritise healthcare availability would not be questioned as long as the department was able to demonstrate that the decisions were not discriminatory and were based on relevant evidence, and that it was transparent on how decisions were to be made. Mr Soobramoney died shortly after the court’s decision. QUESTIONS 1. Other than the two rights Mr Soobramoney included in his court interdict as being violated, what other rights might he have considered to be violated? 2. What is the state’s obligation in this setting? To whom does the state owe obligations for the realisation of health rights? Take another look at Table 9.3, which outlines the conditions under which it is considered justified to limit rights in the public interest. The KwaZulu-Natal Department of Health was willing to limit Mr Soobramoney’s rights of access to dialysis because of an obligation to promote the public’s health. Do 91

you think the KwaZulu-Natal Department of Health was justified in limiting Mr Soobramoney’s rights in this way?

In summary, rights can be limited to serve a public interest, but only in very specific circumstances. This will mean that all five conditions in Table 9.3 must be met. For example, the purpose of the limitation is to enable the health department to meet an important public health need; the limitation is necessary to achieve that objective; there is a judicial or formal process where the limitation is captured and carried out in terms of the law; there is no alternative that is less invasive of rights; and, lastly, in the implementation of the policy, these are not actions that are arbitrary, unreasonable or discriminatory, and there are opportunities to review the limitation.

9.7 DUAL LOYALTY AND THE HEALTH PROFESSIONAL There are many situations where health professionals may find themselves in a situation of dual loyalty. On the one hand, loyalty to a patient should come first. But the health professional may have simultaneously a legitimate obligation to a third party. For example, state doctors may also have obligations to their employer to report cases of infectious disease, which would violate their patient’s right to privacy. However, most of these everyday conflicts of interest do not have major repercussions for patients, but where the interests of the patient and the third party do not coincide, there is a potential for the rights of the patient to be violated. This poses a large challenge to health professionals. For example, when Wendy Orr found herself seeing detainees complaining of assault and torture, her supervisor and the head of prisons were more interested in covering up the abuse (see Case study 9.5). She had to choose a course of action to protect her vulnerable patients. It is often very difficult to choose this kind of action because doctors may be intimidated and threatened, or may fear losing their jobs, their income, or their prestige if they act against their employer’s interests. For that reason, it is 92

critical that organisations of the profession take collective responsibility to support health professionals who are vulnerable to dual loyalty pressure and to protect their independence even under pressure. An international working group developed guidelines on dual loyalty, which are available at http://physiciansforhumanrights.org/library/report-dualloyalty-2006.html. Consider the following case Case study 9.10: Dual loyalty and patients’ rights Dr M is a medical doctor who ran a regional hospital in the capital of Mpumalanga, a province in South Africa. Although medically trained, he was an administrator with no direct clinical duties but was responsible for the overall management of the facility. A local NGO providing support for rape survivors had negotiated with the hospital staff and with Dr M to provide counselling to rape survivors and access to antiretroviral (ARV) medication. The NGO provided the counsellors and funding for the ARVs, while the hospital medical staff provided the prescriptions for patients to take to a pharmacy to obtain the medication. The system was working well until it was brought to the notice of the provincial MEC for Health in 2000. During this period, the government was under pressure to provide ARVs to pregnant women from organisations in civil society, which national government was strongly resisting. Statements issued by the national Minister of Health and the then President Mbeki implied that ARVs were toxic as part of a justification for government’s refusal to provide ARVs to various categories of patients (HIV-positive pregnant women, rape survivors, AIDS patients, etc.). No explicit written policy existed whereby government could be held to account – only public speeches by the Minister and the President provided an indication of what national policy on the matter was. Privately, public servants in the Ministry of Health did not share these views about the toxicity of ARVs and were working towards their introduction as an essential component of the country’s HIV control programme but were not willing to declare their position publicly. The provincial MEC for Health in Mpumalanga, the province where Dr M’s hospital was located, began to repeat the Minister’s statements about the toxicity of ARVs. She called in Dr M to severely censure him for allowing the NGO to operate in the hospital. He refused to eject them from the hospital. Dr M was then called to a disciplinary hearing under the authority of the provincial head of health. The charges were not directly related to his support for the NGO providing ARVs. Instead he was charged in terms of public-sector regulations for not obtaining permission to accept a donation of paint and furniture to refurbish the room used by the NGO to conduct its counselling! Found guilty by the disciplinary hearing, he was dismissed from his post in November 2001. Protests from NGOs and an appeal to the Human Rights Commission and the Medical Association to intercede on his behalf were unsuccessful. He turned to the labour courts to challenge his unfair dismissal in terms of existing labour law. After a long delay, he finally won his case with costs and his reinstatement was ordered by the courts, which he declined. By the time Dr M won his case, a national protocol for treating rape survivors which included access to ARVs had been adopted by the Department of Health, and all HIV-positive pregnant women had gained access to Nevirapine treatment to prevent mother-to-child HIV transmission in South Africa, thanks to another NGO’s Constitutional Court challenge. The provincial MEC for Health was never sanctioned for her role in Dr M’s victimisation. After being implicated in misappropriation of departmental funds intended for HIV programmes, she was shifted sideways to another portfolio in the provincial cabinet in the province (Sports and Environment). She remains an active member of the ANC, having held various senior positions at provincial and national leadership within the ANC. She is a nurse by training. 93

QUESTIONS 1. What ethical obligations did Dr M have? To whom did he owe these obligations? 2. What conflicting obligations did Dr M also have that ran contrary to his obligations to the rape survivor patients? 3. In what way were different pressures exerted on Dr M? 4. What would have been the consequences for human rights depending on how Dr M decided to act? 5. Do you think the MEC for Health has ethical obligations to rape survivors? If so, what are they? 6. Do you think the MEC for Health in Mpumalanga has human rights obligations towards rape survivors? If so, what are they? 7. How could the violations related to dual loyalty be prevented in future?

9.8 CONCLUDING REMARKS Healthcare providers have many opportunities to facilitate the realisation of the right to health. Whether in terms of documenting and, if necessary, providing testimony for those whose rights have been violated or improving the quality and accessibility of healthcare services, health workers can support the attainment of the full range of health rights. By becoming aware of provisions in the South African Constitution, in international human rights legislation as well as in ethical codes of conduct, health professionals can begin to redress the legacy of human rights violations and ensure positive conditions for people’s health.

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CHAPTER 10: Law and the Health Professional in South Africa (Author: Jerome Amir Singh) By the end of this chapter you should be able to • • • • •

describe the different sources of South African law and know their respective implications for health professionals appreciate the legal dimensions of the doctor-patient relationship understand the legal dimensions of informed consent discuss the legal dimensions of confidentiality understand the legal implications of professional malpractice.

10.1 INTRODUCTION TO GOVERNANCE AND LAW IN SOUTH AFRICA Health provision and service delivery by health professionals in South Africa is regulated by law and the legal system. Accordingly, an understanding of law and the legal system is fundamental to the provision of competent and safe patient care. Such an understanding will enable health professionals to engage in informed decision making about health provision and service delivery.

10.1.1 Governance in South Africa Before outlining the nature of South Africa’s legal system, it may be helpful to briefly review how the country is governed. South Africa has three primary state organs: (1) the legislature (also referred to as parliament); (2) the executive (also referred to as cabinet or the government); and (3) the judiciary (also referred to as the courts). The legislature in South Africa sits in Cape Town and comprises two houses of parliament: a) The 400-seat National Assembly (NA), elected every five years through a proportional representation system. For example, if political party X wins 60 per cent of the votes in national elections, it is awarded 60 per cent of the seats in the NA. In South Africa, every 0,25 per cent of the national vote secures a political party a seat in the NA. The function of the NA is to represent the people of South Africa in the making, amending and repealing of laws. b) The 90-seat National Council of Provinces (NCOP). Election to the NCOP is indirect. Citizens vote for provincial legislatures, and each of these then nominates a delegation of ten members to the NCOP. The delegation, which includes the province’s premier, must reflect the proportion of each political party in the provincial legislature. Thus, each of South Africa’s nine provinces has equal representation in the NCOP regardless of population. A delegation from the South African Local Government Association (SALGA) may also attend sittings of the NCOP but may not vote. Laws created by parliament are referred to as statutes or Acts (see below for more details on how laws are created). An Act has to be approved by the NCOP before it can be sent to the president for assenting (signature). The signed copy of the Act is then published in the Government Gazette, which stipulates the date that the Act (or sections thereof) becomes operational.

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The executive is headed by the president, who serves as the country’s head of state. The president is elected by members of parliament. He or she has the prerogative of appointing cabinet ministers and their deputies, although, in practice, these appointments are usually a collective decision of senior officials of the party that wins the majority of votes in the country’s general election. The function of the executive is to govern the country, and to draft or amend state policy. Most statutes also confer the right on relevant cabinet ministers to make regulations in connection therewith. Regulations are sometimes referred to as subordinate legislation and are equally as legally binding as the principal legislation under which they are passed. The executive is based in Pretoria. South Africa has an independent judiciary, subject only to the Constitution and the law. The judiciary comprises the Supreme Court of Appeal (based in Bloemfontein; except in respect of certain labour and competition matters, the Supreme Court of Appeal is the second highest court of appeal for nonconstitutional matters); the Constitutional Court (based in Johannesburg; the Constitutional Court was established post-apartheid and is the highest court in South Africa); high courts; magistrates’ courts, and other courts (such as labour courts and small claims courts) established or recognised in terms of an Act of Parliament.

10.1.2 Law in South Africa Broadly speaking, law in South Africa may be divided into civil law and criminal law. Civil law involves private legal action between parties. Here, each party has to secure, at their own expense, legal services to represent their interests in court. In such matters, each party will have to prove the merits of their respective arguments on a balance of probability (i.e. they will have to convince the judge or magistrate hearing the case that their respective version of events is, on probability, more credible than that of their opponent). Criminal law, on the other hand, involves the state prosecuting an alleged perpetrator of crime on behalf of society. Here, the victim of crime is deemed to be a member of society, and does not have to hire legal services to prosecute the alleged perpetrator. Instead, a state prosecutor performs this duty. Alleged perpetrators (the accused), though, usually have to hire legal representation at their own expense, unless they can prove they cannot afford to do so. In such instances, they may qualify for legal representation at state expense. In criminal cases, the onus is on the state to prove guilt beyond a reasonable doubt. This is a far higher burden of proof than in civil cases, given the gravity of the consequences for the accused (a criminal record if found guilty). A single matter may give rise to both a criminal and a civil case, both of which may run concurrently. The court’s finding in each case does not necessarily influence the outcome of the other. Consider the following case Case study 10.1: Civil vs criminal case X undergoes an operation at a hospital. Before surgery can commence, the doctor performs a non-consensual blood draw on the patient while she is under anaesthetic to ascertain her HIV status. X later learns that she was subjected to an HIV test without her consent. X will have the right to bring a civil action against the doctor and the hospital for invasion of privacy for the non-consensual blood draw performed on her. X may also elect to lay a charge of assault (which constitutes a criminal action) against the doctor for performing the blood test on her without consent. If the state elects to prosecute the doctor, both cases would run independently of each other. 96

A finding of liability on a balance of probability in the civil case is unlikely to influence a finding of guilt beyond a reasonable doubt in the criminal case, and vice versa.

10.1.3 Sources of South African law South African law has three primary sources: common law, statute law and customary law. Some argue that the Constitution is a fourth source of South African law as it is the supreme law of the country. For the purpose of this chapter, the Constitution will be regarded as a fourth source of South African law. 1. Common law South African common law comprises Roman-Dutch law (which was imported into the country’s legal system when South Africa was a Dutch colony) and English common law (which was imported into the country’s legal system when parts of South Africa were colonised by the British). Common law is sometimes referred to as “judge-made law” given that it comprises rules and principles developed over hundreds of years by jurists, magistrates and judges. Common law is widely prevalent in the South African legal system, forming the backbone of the country’s criminal justice system (for instance, the crimes of murder and assault are common-law crimes) and its civil justice system (for instance, defamation and invasion of privacy are common-law civil actions). Common law evolves over time with courts occasionally modifying common-law principles. 2. Customary law Post-apartheid, customary law has enjoyed a renaissance. Customary law has varied sources. Examples of customary law in South Africa include African customary law and Islamic customary law. Customary law is not considered a source of law of “general application”. In other words, it is deemed to apply only to those who choose to be bound by it. Customary practices, such as male circumcision, should not be confused with customary law. 3. Statutory law Statute law refers to law created by parliament. A statute is referred to as an Act. Each Act is accorded a sequential number and reflects the parliamentary year it was passed by the National Assembly. A draft Act is referred to as a bill. An Act must be passed by both houses of parliament (the National Assembly and the National Council of Provinces) and assented to (signed) by the president. It becomes operational (binding) on the date stipulated in the edition of the Government Gazette in which it is published. 4. Constitutional law South Africa’s post-apartheid Constitution is generally regarded as the most liberal and progressive national constitution in the world. Although the Constitution is technically statutory law given that it is a statute created by parliament, it is generally regarded as a separate source of law in South Africa as it is the supreme law of the country. Put differently, all other sources of law may be struck down and declared unconstitutional by a higher court if they are deemed to be incompatible with any of the provisions outlined in the Constitution. For example, the courts have deemed the common-law definition of marriage (previously a union between a man and woman) to be unconstitutional on the basis that it violates the equality rights of gays and lesbians in terms of section 9 (the right to equality) in the Constitution. The Supreme Court of Appeal accordingly modified the common-law definition of marriage to “the union of two persons to the exclusion of all others for life”. 97

10.1.4 Medical law vs health law Broadly speaking, medical law relates to the legal aspects of medical practice. More specifically, medical law has been described as the body of rules of law relating to: (a) the medical profession; (b) the relationship between the doctor or hospital on the one hand and the patient on the other; (c) the relationship between the medical profession and other healthcare workers; and (d) the relationship between the doctor and healthcare legislation. Health law, on the other hand, is broader in scope. It encompasses medical law and also all other health-related policy and law matters that go beyond being applicable to just doctors. In terms of applicability, health law pertains to all those involved in health research and health service delivery. This chapter will focus on selected medical and health law themes of particular relevance to medical doctors. Key South African statutes that focus on health law 1. 2. 3. 4. 5. 6. 7.

Medicines and Related Substances Control Act No. 101 of 1965 Choice on Termination of Pregnancy Act No. 92 of 1996 Sterilisation Act No. 44 of 1998 Medical Schemes Act No. 101 of 1998 Mental Health Act No. 17 of 2002 National Health Act No. 61 of 2003 Children’s Act No. 38 of 2005 (particularly sections 13, 129–130, 134)

10.2 THE DOCTOR-PATIENT RELATIONSHIP 10.2.1 Parties to the treatment contract A patient who consults a doctor in private practice enters into a contractual relationship with that individual. In return, the doctor owes the patient a duty of care. The patient who presents at a hospital enters into a contractual relationship with the provincial or private hospital authority, as applicable. Hospitals may be liable for the negligent conduct of their staff through the legal notion of vicarious liability (the master is held responsible for the acts of his or her servant), although staff may also be held liable in their personal capacities. Nature of the doctor-patient contract A doctor-patient contract usually takes the form of an implied agreement that the doctor will diagnose and treat the patient according to generally accepted medical procedures. An examination of a patient by a doctor does not necessarily amount to an undertaking to treat that patient for his or her condition. For example, the patient may need to be referred to a specialist. If a doctor departs from the patient’s express instructions, or fails to treat a patient without good reason, or fails to satisfy a guarantee given to a patient, the doctor may be sued for breach of contract and may be denied the right to claim remuneration for services rendered. If remuneration has already been paid, the doctor may be required to reimburse the patient. The duty to treat Except in instances of medical emergencies, private practitioners may refuse to treat a patient and there is no duty incumbent on them to treat individuals who are not already their patients. This is because in law there is no liability for an omission (a failure to act) unless there is a duty to act, or the 98

circumstances are such that society would regard the failure to act as unlawful. However, a doctor’s unreasonable refusal to treat a patient in a non-emergency context – for example, on the basis of that patient’s race – could be deemed unethical conduct. A doctor may, however, refuse to treat a patient on the basis of a conscientious objection – for example, where the patient presents for a termination of pregnancy and the doctor does not want to perform the procedure on the basis of his or her constitutional right to conscience, religion, thought, belief and opinion (section 15 of the Constitution). State-employed doctors, on the other hand, may not refuse to treat patients whom they are obliged to treat in terms of their contracts of employment. In emergency contexts, health professionals in the private and public sectors are under a legal and ethical obligation to render medical assistance. Section 27(3) of South Africa’s Constitution states: “No one may be refused emergency medical treatment.” This is reinforced in section 5 of the National Health Act No. 61 of 2003, which states: “A health care provider, health worker, or health establishment may not refuse a person emergency medical treatment.” South Africa’s Constitutional Court has defined an “emergency” as a “dramatic, sudden situation or event which is of passing nature in terms of time and not a chronic terminal illness …” [Soobramoney v Minister of Health, KwaZulu-Natal 1998 (1) SA 765 (CC)]. This case is discussed in Chapter 9 (Case study 9.9). Duty to complete treatment once commenced Although there is no obligation on doctors to take on a case, once they do so, they must carry it through except under the following circumstances: a) b) c) d)

The doctor transfers management of that patient to another competent health professional. The doctor issues sufficient instructions for further treatment. The patient is cured or requires no further treatment. The patient refuses further treatment or insists on being discharged from hospital and is mentally competent. e) The doctor gives the patient reasonable notice that he or she is intending to discontinue practising, in which case the doctor should ensure other facilities are available and issue full instructions to the new doctor to ensure continuity of that patient’s management. Refusal to treat When determining whether or not the failure to treat by the doctor is unreasonable, the court may consider the following factors: (a) The doctor’s knowledge of the patient’s condition (b) The severity of the patient’s condition (c) The professional ability of the doctor to treat the patient (d) The physical state of the doctor (e.g. an intoxicated or exhausted doctor should not treat a patient) (e) The availability of other doctors to assume responsibility for managing the patient (f) The interests of other patients the doctor may be attending to, if applicable (g) A consideration of professional ethics (e.g. if the refusal is based on the patient’s race) In terms of section 20(4) of the National Health Act No. 61 of 2003, “healthcare provider[s] may refuse to treat a patient who is physically or verbally abusive or who sexually harasses [them]”. 99

Scenario A man collapses outside the gates of a hospital. When healthcare workers attend to him, they discover he is a homeless person. Upon discovering this, the health workers abandon him and return to the hospital. Five minutes later, the man dies. What are the legal implications of the health workers’ conduct? Rights and duties of patients RIGHTS OF PATIENTS The rights of patients are outlined in the National Patients’ Rights Charter, published by the Department of Health (see http://www.doh.gov.za/search/index.html and Chapter 9 and the appendices to this book). The Charter is subject to the provisions of any law operating within the Republic of South Africa and to the financial means of the country. In addition, a number of provisions in the Constitution of South Africa also pertain to patients. These include the right to be treated equally and not to be subjected to unfair discrimination (section 9), to have their dignity respected and protected (section 10), and the right to bodily and psychological integrity, which includes the right (a) to make decisions concerning reproduction; (b) to security in and control over their body; and (c) not to be subjected to medical or scientific experiments without their informed consent (section 12). In terms of section 18(1) of the National Health Act No. 61 of 2003, “any person may lay a complaint about the manner in which he or she was treated at a health establishment and have the complaint investigated”. DUTIES OF PATIENTS In terms of common law, contractually patients should make themselves available for treatment. However, if they fail to do so, they cannot be forced by a doctor to submit to treatment. A patient who fails to keep a scheduled appointment with a health professional may be held liable for the loss of that revenue by that doctor. This is done by calculating how much the doctor would have earned had he or she attended to the patient, and subtracting from that total how much the doctor actually did earn during that time (e.g. by attending to another patient who was on standby for an appointment). Patients are entitled to cancel appointments but must do so in a timely manner. It is generally recommended that patients provide two hours’ notice before cancelling appointments with general practitioners, and 24 hours’ notice before cancelling appointments with specialists. However, each case should be treated on its merits. From a statutory perspective, in terms of section 19 of the National Health Act No. 61 of 2003, a user must (a) adhere to the rules of the health establishment when receiving treatment or using health services at the health establishment; (b) provide the healthcare provider with accurate information pertaining to his or her health status and cooperate with healthcare providers when using health services (c) treat healthcare providers and health workers with dignity and respect

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(d) sign a discharge certificate or release of liability if he or she refuses to accept [the] recommended treatment. Rights of healthcare personnel Section 20 of the National Health Act No. 61 of 2003 outlines the rights of healthcare personnel. It stipulates that “[they] may not be discriminated against on the basis of their health status” (although conditions on their service may be imposed on them as a result of their health status, based on guidelines determined by the health minister). Moreover, it stipulates that health establishments must implement measures to minimise (a) injury or damages to the person and property of healthcare personnel; and (b) disease transmission. As mentioned earlier, section 20(4) also entitles healthcare providers to refuse to treat a patient “who is physically or verbally abusive or who sexually harasses [them]”. As noted earlier (see Section 10.2.1), in certain non-emergency contexts, healthcare personnel also have a right to refuse to perform medical procedures based on their right to conscience, religion, thought, belief and opinion.

10.3 INFORMED CONSENT A patient can consent expressly to treatment, either verbally or in writing, or tacitly (unspoken) by way of conduct (e.g. by nodding). In instances where a patient requests surgery, consent in writing is required. Both written and oral consent are legally binding, although written consent constitutes better evidence that the patient consented to the procedure in question. It is the primary duty of the doctor to ensure that consent is obtained from a patient before an examination, treatment or surgery can commence. This duty should not be delegated to a medical student, a clerk or another health worker, such as a nurse or intern.

10.3.1 The duty to inform Section 6(1) of the National Health Act (NHA) states: Every health care provider must inform a user (patient) of – (a) the user’s health status except in circumstances where there is substantial evidence that the disclosure of the user’s health status would be contrary to the best interests of the user; (b) the range of diagnostic procedures and treatment options generally available to the user; (c) the benefits, risks and consequences generally associated with each option; and (d) the user’s right to refuse health services and explain the implications, risks and obligations of such refusal. Section 6(2) of the NHA states that the healthcare provider concerned must, where possible, “inform a user in a language that he or she understands and in a manner which takes into account the patient’s level of literacy”.

10.3.2 Legal requirements of informed consent The National Health Act No. 61 of 2003 clearly outlines the legal requirements for consent. Section 8 of the NHA stipulates that a “user has the right to participate in any decision affecting his or her personal health and treatment”. If informed consent is given by a person other than the user, such person must, 101

if possible, consult with the user before giving the required consent. Users who are capable of understanding must be informed, as contemplated in section 6, even if they lack the legal capacity to give their informed consent as required by section 7. Consider the following case Case study 10.2: Castell v De Greef 1994 (4) SA 408(C) In 1982 Mrs C had surgery for removal of lumps in her breast. In 1989 she developed more lumps. As Mrs C had a family history of breast cancer, her gynaecologist recommended a mastectomy as prophylaxis, and referred her to Dr D. Mrs C, her husband and Dr D discussed the proposed operation and decided that as much breast tissue as possible would be removed with simultaneous reconstruction of the breast using silicone implants. The operation was performed two months later. Such an operation usually carries a high risk of complications, especially necrosis of the skin and underlying tissue, including the areolae and nipples. Mrs C did develop complications – discolouration of the skin and Staphylococcus aureus infection. She required medical treatment for quite a while thereafter, and further surgery which resulted in medical costs, psychological trauma and pain. She filed a lawsuit against Dr D, claiming that the doctor failed to advise her of the 50 per cent risk of complications and that an alternative surgical procedure existed that could have reduced the risk of infection and necrosis. The court held that the doctor had not quantified the degree of risk of complications but that this was not a material non-disclosure. He was, however, negligent in not taking a pus swab when the patient developed an infection. As a result he treated her with an antibiotic to which the organism causing the infection was resistant. Mrs C was compensated for 12 days of pain, suffering, illness, discomfort and anxiety. COMMENTARY In terms of South African common law, as outlined in the case of Castell v De Greef, for informed consent to have been properly solicited, a patient must 1. have knowledge of the nature or extent of the harm or risk about to be entered into 2. appreciate and understand the nature of the harm or risk about to be entered into 3. consent to the harm or assume the risk. In addition, the consent must be comprehensive and extend to the entire transaction, inclusive of consequences (e.g. the side effects of the medication to be prescribed, the length of time the patient is expected to remain on the medication, etc.). Many of these elements have been codified in the NHA. THE DUTY TO INFORM ABOUT MATERIAL RISKS AND REMOTE RISKS The doctor is obliged to warn the patient about any “material risks” inherent in the proposed treatment. A risk is regarded as “material” if (a) a reasonable person in the position of the patient would, when warned of the risk, attach significance to it; and (b) a medical practitioner is reasonably aware that the patient, if warned of the risk, would attach significance to it. There is no duty to warn a patient about all conceivable complications that may arise in a procedure. However, the doctor should, at a minimum, inform the patient about the more serious risks involved. A doctor need not inform a patient of all remote risks, but should, at minimum, mention the probable and possible risks of harm, particularly where they are serious. 102

TREATMENT WITHOUT CONSENT In terms of section 7(1) of the NHA, a health service may not be provided to a user without the user’s informed consent, unless – a) the user is unable to give informed consent and such consent is given by a person: -

mandated by the user in writing to grant consent on his or her behalf; or

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authorised to give such consent in terms of any law or court order;

b) the user is unable to give informed consent and no person is mandated or authorised to give such consent, and the consent is given by the spouse or partner of the user or, in the absence of such spouse or partner, a parent, grandparent, an adult child or a brother or a sister of the user, in the specific order as listed; c) the provision of a health service without informed consent is authorised in terms of any law or order of the court; d) failure to treat the user, or group of people which includes the user, will result in a serious risk to public health; or e) any delay in the provision of the health service to the user might result in his/her death or irreversible damage to his or her health and the user has not expressly, impliedly or by conduct refused that service. Section 7(1) of the NHA states that “a health care provider must take all reasonable steps to obtain the user’s informed consent”. Informed consent, public health, human rights and ethics Patient R has been diagnosed with extensively drug-resistant tuberculosis (XDRTB). He refuses to take any medication for his condition as he is afraid of the associated side effects. Does R’s doctor require R’s informed consent to administer treatment, or can the doctor administer his treatment involuntarily? What are the ethical and human rights implications of involuntary treatment? With regard to the provision of a health service without consent, the NHA indicates that when a patient is admitted to a healthcare facility without his or her consent, the healthcare facility needs to inform the head of the provincial department in the province of the patient’s admission within 48 hours after this event and must submit other such information as may be prescribed. Consider the following cases Case study 10.3: Palmer v Palmer 1955 (3) SA 56 (O) The court held that it could not compel a wife to undergo a medical examination, at the behest of her husband, against her will. Esterhuizen v Administrator, Transvaal 1957 (3) SA 710 (T) The court found a hospital and its doctors liable after they commenced deep radiation therapy on a child without her mother’s consent (which led to the girl losing her right hand, two fingers on her left hand, and both her legs). 103

THERAPEUTIC PRIVILEGE AND INFORMED CONSENT Therapeutic privilege (also known as therapeutic exception) is an exception to the general rule of informed consent and applies in the uncommon instance where a health professional may be excused from revealing information to a patient when disclosing it would pose a serious psychological threat, so serious a threat as to be medically contraindicated. Section 6(1) of the National Health Act (NHA) recognises this exception and states: Every health care provider must inform a user (patient) of – (a) the user’s health status except in circumstances where there is substantial evidence that the disclosure of the user’s health status would be contrary to the best interests of the user. Section 8(3) of the NHA states: If a user is unable to participate in a decision affecting his or her personal health and treatment, he or she must be informed … after the provision of the health service in question unless the disclosure of such information would be contrary to the user’s best interest. FACTORS THAT IMPACT ON THE PATIENT’S ABILITY TO UNDERSTAND Among other factors, a patient’s age, mental status and state of intoxication can affect his or her ability to give informed consent for a procedure. Health professionals should be mindful of these factors before soliciting informed consent from patients. INFORMED CONSENT AND PUBLIC POLICY A patient cannot consent to something that is against public policy or contra bonos mores (e.g. a patient cannot consent to being tortured by a health professional even if that patient is a mentally competent adult). DEPARTURE FROM CONSENT OF PATIENT Consider the following case Case study 10.4: Stoffberg v Elliot 1923 CPD 148 During a surgical procedure for which informed consent had been obtained, the surgeon discovered previously undiagnosed cancer of the penis. Knowing that the patient would then have a life expectancy of only two years, the doctor amputated the penis to prevent the cancer from spreading. The patient sued the doctor for damages. The court held that the patient was entitled to damages for assault as the surgical procedure was performed without specific consent. In general, a health professional is not entitled to depart materially from the treatment agreed upon, especially where the treatment is more radical than that consented to by the patient. In circumstances where it would have been impossible to make a diagnosis beforehand, the health professional may be justified in extending the operation, provided that (a) (b) (c) (d)

the extension is in accordance with good medical practice; the extension takes place in good faith in order to alleviate the patient’s complaint; the risk to the patient is not materially increased; it would be against the patient’s medical interests to first allow the person to recover from the anaesthetic in order to give consent to the operation being extended. 104

In cases of emergency, an extension of an operation without the consent of the patient or his or her surrogate decision maker may be justified on the basis of “necessity”.

10.3.3 Informed consent and criminal law The Criminal Procedure Act No. 51 of 1977 governs the ascertainment of bodily features of accused persons. This includes the taking of blood samples. Section 37(2) states: a) Any medical officer of any prison or any district surgeon or, if requested thereto by any police official, any registered medical practitioner or registered nurse may take such steps, including the taking of a blood sample, as may be deemed necessary in order to ascertain whether the body of any person … has any mark, characteristic or distinguishing feature or shows any condition or appearance. b) If any registered medical practitioner attached to any hospital is on reasonable grounds of the opinion that the contents of the blood of any person admitted to such hospital for medical attention or treatment may be relevant at any later criminal proceedings, such medical practitioner may take a blood sample of such person or cause such sample to be taken. The Sexual Offences Amendment Act No. 37 of 2002 provides for the compulsory HIV testing of persons accused of sexual assault. Upon a magistrate issuing an order for an HIV test at the request of an alleged victim or interested party, section 33(1) stipulates that as soon as the order has been handed to an investigating officer – a) the investigating officer must request any medical practitioner or nurse to take two prescribed body specimens from the alleged offender, and the investigating officer must make the alleged offender available or cause such person to be made available for that purpose; b) the medical practitioner or nurse concerned must take two prescribed body specimens from the alleged offender. In respect of both the above Acts, it is conceivable that the accused may not be prepared to give voluntary informed consent for the taking of such samples. In such instances, the sample(s) may have to be obtained involuntarily. What are the human rights and ethical implications of medical practitioners and nurses involuntarily taking biological samples from accused persons?

10.3.4 Informed consent and mental healthcare patients The Mental Health Care Act No. 17 of 2002 governs consent in relation to the mentally ill. Section 9(1) of the Act states: A health care provider or a health establishment may provide care, treatment and rehabilitation services to or admit a mental health care user only if: •

the user has consented to the care, treatment and rehabilitation services or to admission;

•

authorised by a court order or a Review Board; or

•

due to mental illness, any delay in providing care, treatment and rehabilitation services or admission may result in the: 105

i. ii. iii.

death or irreversible harm to the health of the user; user inflicting serious harm to himself or herself or others; or user causing serious damage to or loss of property belonging to him or her or others.

10.3.5 Informed consent and children Protective legal measures apply in respect of children and are outlined in the Children’s Act No. 38 of 2005. In terms of the Children’s Act, a child is defined as a person under the age of 18. The Children’s Act empowers parents, guardians and caregivers to give consent on behalf of children in prescribed circumstances. Caregivers have been afforded this level of responsibility in recognition of social reality as family members (including minor siblings), friends and neighbours often care for children in the absence of their parents or guardians, who may have died or work away from home. The Act defines a caregiver as follows: Any person other than a parent or guardian, who factually cares for a child and includes – foster parent; a person who cares for a child with the implied or express consent of a parent or guardian of the child; a person who cares for a child whilst the child is in temporary safe care; the person at the head of a child and youth care centre where a child has been placed; the person at the head of a shelter; a child and youth care worker who cares for a child who is without appropriate family care in the community; and … the child at the head of a child-headed household. The child head of a household must be at least 16 years of age and the household in question must have been officially recognised as a child-headed household by the provincial head of social development. The Children’s Act outlines the rights of children. Section 13 states: 1. Every child has the right to – a. have access to information on health promotion and the prevention and treatment of ill-health and disease, sexuality and reproduction; b. have access to information regarding his or her health status; c. have access to information regarding the causes and treatment of his or her health status. 2. Information provided to children in terms of this subsection must be relevant and must be in a format accessible to children, giving due consideration to the needs of disabled children. Treatment Section 129(2) of the Children’s Act states that a child may consent to his or her own medical treatment or to the medical treatment of his or her child if – (a) the child is over the age of 12 years; and (b) the child is of sufficient maturity and has the mental capacity to understand the benefits, risks, social and other implications of the treatment. Surgery Section 129(3) of the Children’s Act No. 38 of 2005 states that a child may consent to the performance of a surgical operation on himself or herself or on his or her child if: 106

(a) the child is over the age of 12 years; and (b) the child is of sufficient maturity and has the mental capacity to understand the benefits, risks, social and other implications of the surgical operation; and (c) the child is duly assisted by his or her parent or guardian. Section 129(4) states that the parent, guardian or caregiver of a child may “consent to the medical treatment of the child if the child is – (a) under the age of 12 years; or (b) over that age but is of insufficient maturity or is unable to understand the benefits, risks and social implications of the treatment”. Section 129(5) states that the parent or guardian of a child may consent to a surgical operation on the child if the child is – (a) under the age of 12 years; or (b) over that age but is of insufficient maturity or is unable to understand the benefits, risks and social implications of the operation. The rights of biological fathers While the right to decision making with regard to a child has traditionally rested with that child’s mother, the position of biological fathers was less clear in certain instances. This created dilemmas for health professionals in instances where the parents of a child disagreed about their child’s treatment or surgery. The Children’s Act has now explicitly clarified the rights of fathers. In respect of married fathers, section 20 of the Children’s Act states: (1) The biological father of a child has full parental responsibilities and rights in respect of the child – a) if he is married to the child’s mother; or b) if he was married to the child’s mother at – i. ii. iii.

the time of the child’s conception; the time of the child’s birth; or (any time between the child’s conception and birth.

If the father is not married to the mother, section 21 of the Act must be considered. It states: (1) The biological father of a child who does not have parental responsibilities and rights in respect of the child in terms of section 20, acquires full parental responsibilities and rights in respect of the child – a) if at the time of the child’s birth he is living with the mother in a permanent life-partnership; or b) if he, regardless of whether he has lived or is living with the mother – i. ii. iii.

consents to be identified or successfully applies in terms of section 26 to be identified as the child’s father or pays damages in terms of customary law; contributes or has attempted in good faith to contribute to the child’s upbringing for a reasonable period; and contributes or has attempted in good faith to contribute towards expenses in connection with the maintenance of the child for a reasonable period.

If the two parents dispute whether these conditions exist, they have to go for mediation to a family advocate or social worker before they can approach the court.

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Rights and responsibilities of parties in relation to artificial insemination The rights and responsibilities of parties in relation to a child conceived by artificial insemination are outlined in section 40 of the Children’s Act No. 38 of 2005. Scenario Gugu, a 13-year-old, gives birth to baby boy, Sipho. Is Gugu or one of her parents authorised to give consent for Sipho’s treatment? Sipho’s father, Mandla, is a 14-year-old who does not live with Gugu. What rights does he have in relation to Sipho’s treatment? Parental, guardian or caregiver refusal to consent The Children’s Act gives consideration to instances where parents, guardians or caregivers may refuse to consent to medical procedures being performed on a child on religious grounds. In this respect, section 129(10) states that “no parent, guardian or caregiver of a child may refuse to assist a child or withhold consent by reason only of religious or other beliefs, unless that parent or guardian can show that there is a medically accepted alternative choice to the medical treatment or surgical operation concerned” (see Hay v B discussed in Chapter 6, Case study 6.1). Section 129(9) stipulates that a high court or children’s court may consent to the medical treatment of or a surgical operation on a child in all instances where another person that may give consent in terms of section 129 of the Children’s Act refuses or is unable to give such consent. Consent by other parties CARE OF CHILD BY PERSON NOT HOLDING PARENTAL RESPONSIBILITIES AND RIGHTS In terms of section 32(1) of the Children’s Act No. 38 of 2005, a person who has no parental responsibilities and rights in respect of a child but who voluntarily cares for the child either indefinitely, temporarily or partially, including a care-giver who otherwise has no parental responsibilities and rights in respect of a child, must, whilst the child is in that person’s care – (a) safeguard the child’s health, wellbeing and development; and (b) protect the child from maltreatment, abuse, neglect, degradation, discrimination, exploitation, and any other physical, emotional or mental harm or hazards. Furthermore, subject to section 129, section 32(2) stipulates that the person referred to in subsection (1) “may exercise any parental responsibilities and rights reasonably necessary to comply with subsection (l), including the right to consent to any medical examination or treatment of the child if such consent cannot reasonably be obtained from the parent or guardian of the child”. SUPERINTENDENT OF A HOSPITAL Section 129(6) provides that “the superintendent of a hospital or the person in charge of the hospital in the absence of the superintendent may consent to the medical treatment of or a surgical operation on a child if: (a) the treatment or operation is necessary to preserve the life of the child or to save the child from serious or lasting physical injury or disability; and (b) the need for the treatment or operation is so urgent that it cannot be deferred for the purpose of obtaining consent that would otherwise have been required. MINISTER 108

Section 129(7) authorises the minister responsible for social development, or where the context – such as health – indicates another minister, to “consent to the medical treatment of or surgical operation on a child if the parent or guardian of the child: (a) unreasonably refuses to give consent or to assist the child in giving consent; (b) is incapable of giving consent or of assisting the child in giving consent; (c) cannot readily be traced; or (d) is deceased. Section 129 (8) also authorises the minister to “consent to the medical treatment of or surgical operation on a child if the child unreasonably refuses to give consent”. Scenario John and Susan are devout Jehovah’s Witnesses. Their 10-year-old son, Richard, has been involved in a serious car accident and urgently requires a blood transfusion. Because of their faith (which prohibits blood transfusions), John and Susan refuse to give consent for this. What should the hospital do in such an instance? HIV testing of children HIV testing of children is governed by the Children’s Act. Section 130(1) states that no child may be tested for HIV except when – (a) it is in the best interests of the child and consent has been given in terms of subsection (2); or (b) the test is necessary in order to establish whether – (i) a health worker may have contracted HIV due to contact in the course of a medical procedure involving contact with any substance from the child’s body that may transmit HIV; or (ii) any other person may have contracted HIV due to contact with any substance from the child’s body that may transmit HIV, provided the test has been authorised by a court. Section 130(2) states that consent for an HIV test on a child may be given by – a. the child, if the child is – (i) 12 years of age or older; or (ii) under the age of 12 years and is of sufficient maturity to understand the benefits, risks and social implications of such a test; b. the parent or care-giver, if the child is under the age of 12 years and is not of sufficient maturity to understand the benefits, risks and social implications of such a test; c. the provincial head of social development, if the child is under the age of 12 years and is not of sufficient maturity to understand the benefits, risks and social implications of such a test; d. a designated child protection organisation arranging the placement of the child, if the child is under the age of 12 years and is not of sufficient maturity e. the superintendent or person in charge of a hospital, if – o

the child is under the age of 12 years and is not of sufficient maturity to understand the benefits, risks and social implications of such a test; and

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o f.

the child has no parent or care-giver and there is no designated child protection organisation arranging the placement of the child; or

a children’s court, if – (i) consent in terms of paragraph (a), (b), (c) or (d) is unreasonably withheld; or (ii) the child or the parent or care-giver of the child is incapable of giving consent.

In terms of the Children’s Act No. 38 of 2005, children to be tested for HIV must be provided with proper pre- and post-test counselling by an appropriately trained person. This means that during pre-test counselling the benefits, risks and social implications of an HIV test must be explained to the child, while during post-test counselling the implications of the results must be explained. In both cases, counselling must be given to children who are of sufficient maturity to understand what is being explained and to the child’s parent or caregiver if either of them have knowledge of the test. Other ages of consent SEXUAL INTERCOURSE In terms of the Sexual Offences Act No. 23 of 1957, the age of consent for sexual intercourse in South Africa is 16 years of age; although sexual acts between two children, where both are between 12 and 16 years of age or where one is under 16 years of age and the other is less than two years older, are not criminal. TERMINATION OF PREGNANCY In terms of the Termination of Pregnancy Act No. 92 of 1996, there is no minimum age of consent for termination of pregnancy. A female of any age may request a termination of her pregnancy. MARRIAGE In terms of the Marriages Act No. 25 of 1961, and regulations passed in accordance therewith, a minor is defined as “a person under the age of 18 and who has not previously been married or if married, whose marriage was dissolved by either death or divorce”. In order to marry, girls under the age of 15 and boys under the age of 18 require consent from their parents as well as from the Minister of Home Affairs. In addition, an application has to be made for the consent of a commissioner of child welfare for the purpose of a minor’s marriage. STERILISATION In terms of the Sterilisation Act No. 44 of 1998, no person under the age of 18 may autonomously consent to a sterilisation being performed on him or her. SOCIAL, CULTURAL AND RELIGIOUS PRACTICES Section 12 of the Children’s Act governs social, cultural and religious practices in relation to children. It states: 1. Every child has the right not to be subjected to social, cultural and religious practices which are detrimental to his or her well-being. 2. A child – 110

a. below the minimum age set by law for a valid marriage may not be given out in marriage or engagement; and b. above that minimum age may not be given out in marriage or engagement without his or her consent. 3. Genital mutilation or the circumcision of female children is prohibited. 4. Virginity testing of children under the age of 16 is prohibited. 5. Virginity testing of children older than 16 may only be performed – a. if the child has given consent to the testing in the prescribed manner; b. after proper counselling of the child; and c. in the manner prescribed. 6. The results of a virginity test may not be disclosed without the consent of the child. 7. The body of a child who has undergone virginity testing may not be marked. 8. Circumcision of male children under the age of 16 is prohibited, except when – a. circumcision is performed for religious purposes in accordance with the practices of the religion concerned and in the manner prescribed; or b. circumcision is performed for medical reasons on the recommendation of a medical practitioner. 9. Circumcision of male children older than 16 may only be performed: a. if the child has given consent to the circumcision in the prescribed manner; b. after proper counselling of the child; and c. in the manner prescribed. 10. Taking into consideration the child’s age, maturity and stage of development, every male child has the right to refuse circumcision. ACCESS TO CONTRACEPTION In terms of section 134 of the Children’s Act No. 38 of 2005: No person may refuse to sell condoms to a child over the age of 12 years; or provide a child over the age of 12 years with condoms on request where condoms are provided or distributed free of charge. Contraceptives other than condoms may be provided to a child on request by the child and without the consent of the parent or caregiver of the child if: a. the child is at least 12 years of age; b. proper medical advice is given to the child; and 111

c. a medical examination is carried out on the child to determine whether there are any medical reasons why a specific contraceptive should not be provided to the child. SUPPLY OF MEDICATION In terms of sections 22A(4)(b) and 22A(6)(b) of the Medicines and Related Substances Control Act No. 101 of 1965, Schedule 1 and Schedule 2 substances respectively may not be supplied to any person apparently under the age of 14 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist’s assistant or by a veterinarian or a person who is the holder of a licence … or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of 14 years. RESEARCH Research on children is governed by section 71 of the National Health Act No. 61 of 2003. In terms of this provision, therapeutic research on children may not commence without the consent of the parent or guardian of a child and the consent of the child. In the case of non-therapeutic research, in addition to obtaining the consent of the parent or guardian of the child and the child, researchers are also required to secure the consent of the Minister of Health before commencing the research. Accompanying regulations (No. R719, published in the Government Gazette 38000 on 19 September 2014) define key terminology associated with section 71. “Non-therapeutic research” means research that does not hold out the prospect of direct benefit to the participant but holds out the prospect of generalisable knowledge. “Therapeutic research” means research that holds out the prospect of direct benefit to the participant. The minister has delegated authority to provide ministerial consent for “nontherapeutic” health research with minors to research ethics committees that have achieved full registration with the National Health Research Ethics Council (NHREC) and who have been found to be compliant with an NHREC audit. The regulations also stipulate that research with minors should only take place when a. adults are not appropriate participants for the research; b. the research poses no more than a minimal risk to the minor; or c. the research poses more than a minimal risk, but holds out the prospect of direct benefit to the minor; or d. the research poses a minor increase over minimal risk, and holds out no prospect of direct benefit to the minor, but is anticipated to yield generalisable knowledge about the condition under study. The regulations define “minimal risk” as meaning “the probability and magnitude of harm or discomfort anticipated in the research is not greater than that ordinarily encountered in daily life in a stable society or in routine medical, dental, educational or psychological tests or examinations”. ACCESS TO HEALTH RECORDS In relation to requests for access to health records in terms of section 30 of the Promotion of Access to Information Act No. 2 of 2002, persons above the age of 16 have the right to nominate a health 112

practitioner of their choice whose duty would be to determine if the disclosure of their health records to the relevant requesting person would be likely to cause serious harm to their physical or mental health, or wellbeing.

10.3.6 Remedies for violating a patient’s right to informed consent If a procedure, treatment or surgery is performed on an individual without his or her informed consent being prospectively solicited, that individual may 1. lay a charge of assault against the practitioner concerned 2. bring a civil action for invasion of privacy against the practitioner and/or his or her employer (a) lay a complaint with that practitioner’s employer, if applicable, so that disciplinary measures against that practitioner may be instituted (b) lay a complaint against the practitioner with his or her professional governing body, e.g. in the case of doctors, the Health Professions Council of South Africa (HPCSA). Consider the following case Case study 10.5: C v Minister of Correctional Services 1996 (4) SA 292 (T) Prisoner C stood in a row of prisoners in a hospital passage. They were informed that a blood sample would be taken from them to be tested for HIV and other sexually transmitted diseases. They had the right to refuse to be tested. The court held that since pre- and post-test counselling was not done, blood was drawn from C without his informed consent. He successfully sued the head of prisons, the Minister of Correctional Services, and was awarded damages for the violation of his right to privacy.

10.4 CONFIDENTIALITY The patient’s right to confidentiality finds its genesis in the age-old Hippocratic Oath. It has since become a cornerstone of medical practice. The right to confidentiality is seen as central to the health professional-patient relationship as without being assured of their right to confidentiality, patients could withhold vital information pertinent to their condition, and this could detrimentally affect their diagnosis and prognosis. The patient’s right to confidentiality continues even after the patient ceases being a patient of the health professional or dies. The terms “confidentiality” and “privacy” are often used interchangeably but are distinct from a legal perspective.

10.4.1 Confidentiality and privacy distinguished Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission, in ways that are inconsistent with the understanding of the original disclosure. For example, an individual may disclose personal information to an attorney, physician, therapist or other individual with the expectation that the information cannot be divulged to third parties without the expressed consent of that individual. On the other hand, privacy has been described as the freedom from intrusion into one’s personal matters and personal information. Furthermore, privacy refers to the control over the extent, timing and circumstances of sharing oneself (physically, behaviourally or intellectually) with other parties.

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10.4.2 Confidentiality, disclosure and the common law In terms of the common law, every person has a right to privacy. However, common law also recognises a health professional’s right to disclose confidential patient information in the following instances: 1. 2. 3. 4.

The patient consents to the information being disclosed to a third party. A court of law orders the disclosure of that information. An Act of Parliament obliges the disclosure of that information. The disclosure of that information is necessary for the defence of the health professional in a civil, criminal or disciplinary inquiry. 5. The disclosure of that information is necessary for the medical management of the patient. 6. There is a moral or legal duty to share that information with pertinent parties.

10.4.3 Confidentiality and privacy: constitutional and statutory provisions An individual’s right to privacy is enshrined in the South African Constitution. In this regard, section 14(4) of the Constitution states: “Everyone has the right to privacy, which includes the right not to have … the privacy of their communications infringed.” In the health context, the patient’s common law right to confidentiality has been codified and is explicitly recognised in section 14 of the National Health Act No. 61 of 2003, which states: 1. All information concerning a user, including information relating to his or her health status, treatment or stay in a health establishment, is confidential. 2. Subject to section 15, no person may disclose any information contemplated in subsection (1) unless – a. the user consents to that disclosure in writing; b. a court order or any law requires that disclosure; or c. non-disclosure of the information represents a serious threat to public health. The Protection of Personal Information Act No. 4 of 2013 (hereinafter POPI) governs the protection of personal information by public and private bodies. POPI outlines eight conditions for the lawful processing of personal information: (a) Accountability (section 8) (b) Processing limitation (sections 9–12) (c) Purpose specification (sections 13 and 14) (d) Further processing limitation (section 15) (e) Information quality (section 16) (f) Openness (sections 17 and 18) (g) Security safeguards (sections 19–22) (h) Data subject participation (sections 23–25)

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In terms of POPI, “personal information” broadly means any information relating to an identifiable, living, natural or juristic person (e.g. companies). “Processing” broadly means anything done with the personal information, including collection, usage, storage, dissemination, modification or destruction. POPI promotes transparency with regard to what information is collected and how it is to be processed. POPI compliance involves, among other things, identifying personal information and taking reasonable measures to protect the data, capturing the minimum required data, ensuring accuracy, and removing data that are no longer required. Once POPI is made operational, a year’s grace period (extendable to a maximum of three years) will be allowed for compliance. Scenario X, a preschool teacher, is diagnosed with drug-resistant TB. Before she leaves the health facility, she notifies the health professionals who diagnosed her that she does not want anyone to be informed of her diagnosis and wants to continue working. Can X’s employer be informed of her health status? The Children’s Act No. 38 of 2005 makes it clear that children also enjoy the right to confidentiality. Section 13(1)(d) of the Act states: “Every child has the right to … confidentiality regarding his or her health status and the health status of a parent, care-giver or family member, except when maintaining such confidentiality is not in the best interests of the child.” Section 134(3) stipulates that “a child who obtains condoms, contraceptives or contraceptive advice in terms of this Act is entitled to confidentiality in that respect subject to section 105” (in respect of child protection services, section 105(5)(c) provides for the “carrying out of investigations and the making of assessments, in cases of suspected abuse, neglect or abandonment of children”). As noted above, section 12(6) of the Children’s Act states that “the results of a virginity test may not be disclosed without the consent of the child”. Mental healthcare patients also enjoy the right to privacy. Section 8(1) of the Mental Health Act No. 17 of 2002 states: “The person, human dignity and privacy of every mental health care user must be respected.” In relation to the notification and keeping of records pertaining to termination of pregnancy, section 7(1) of the Choice on Termination of Pregnancy Act No. 92 of 1996 states: “The identity of a woman who has requested or obtained a termination of pregnancy shall remain confidential at all times unless she herself chooses to disclose that information.” Consider the following case Case study 10.6: Jansen van Vuuren and Another. NNO v Kruger 1993 (4) SA 842 (A) In this case, a doctor disclosed the HIV test results of his patient to a dentist colleague while they were playing golf together. The court found that the doctor’s conduct was wrongful as he had no legal duty to disclose the information, and his colleague had no right to receive that information. (This case is discussed in more detail in Chapter 16, Case study 16.4.)

10.4.4 Confidentiality and privilege A privileged communication is a statement made in a private context that must be kept in confidence by the recipient for the benefit of the communicator. The health professional-patient relationship is recognised as a privileged relationship. This means that health professionals have a special duty to maintain the confidence of their patients. However, unlike the confidence implicit in a lawyer-client 115

relationship, the health professional-patient relationship is not recognised as an absolute privilege, but as a relative privilege. This means that the health professional cannot refuse to divulge confidential information when being ordered to do so by a court, unlike a lawyer who could rely on the absolute privilege of the lawyer-client relationship. Psychiatrists and other therapists are also regarded as having a relationship based on relative privilege with their patients and no special protection applies to them in court.

10.4.5 Confidentiality and disclosure: statutory obligations In some instances, a patient’s right to confidentiality may be subject to mandatory statutory obligations. Examples of statutes that compel disclosure of patient information that would ordinarily be regarded as confidential are the following: The Children’s Act No. 38 of 2005 Section 110 of the Children’s Act governs the reporting of abused or neglected children and children in need of care and protection. It states: 1. Any correctional official, dentist, homeopath, immigration official, labour inspector, legal practitioner, medical practitioner, midwife, minister of religion, nurse, occupational therapist, physiotherapist, psychologist, religious leader, social service professional, social worker, speech therapist, teacher, traditional health practitioner, traditional leader or member of staff or volunteer worker at a partial care facility, drop-in centre or child and youth care centre who on reasonable grounds concludes that a child has been abused in a manner causing physical injury, sexually abused or deliberately neglected, must report that conclusion in the prescribed form to a designated child protection organisation, the provincial department of social development or a police official. 2. Any person who on reasonable grounds believes that a child is in need of care and protection may report that belief to the provincial department of social development, a designated child protection organisation or a police official. 3. A person referred to in subsection (1) or (2) – a. must substantiate that conclusion or belief to the provincial department of social development, a designated child protection organisation or police official; and b. who makes a report in good faith is not liable to civil action on the basis of the report. The Prevention of Family Violence Act No. 133 of 1993 Section 4 of the Prevention of Family Violence Act outlines the obligation to report ill-treatment of children. It stipulates: Any person who examines, treats, attends to, advises, instructs or cares for any child in circumstances which ought to give rise to the reasonable suspicion that such child has been ill-treated, or suffers from any injury the probable cause of which was deliberate, shall immediately report such circumstances – a. to a police official; or b. to a commissioner of child welfare or a social worker. 116

The Sexual Offences Amendment Act No. 32 of 2007 Section 54 of the Sexual Offences Amendment Act of 2007 obliges any person who has knowledge of a sexual crime against a child or a mentally disabled person to report the matter to relevant authorities. The Older Persons Act No. 13 of 2006 In terms of the Older Persons Act, an “older person” means “a person who, in the case of a male, is 65 years of age or older and, in the case of a female, is 60 years of age or older”. In respect of notification of abuse of older persons, section 26 of the Older Persons Act states: 1. Any person who suspects that an older person has been abused or suffers from an abuserelated injury must immediately notify the Director-General or a police official of his or her suspicion. 2. A person is not liable in respect of any notification given in good faith in terms of subsection (1). 3. A person who fails to comply with subsection (1) is guilty of an offence. In terms of section 30(3) of the Older Persons Act, “abuse” includes physical, sexual, psychological and economic abuse, and – (a) “physical abuse” means any act or threat of physical violence towards an older person; (b) “sexual abuse” means any conduct that violates the sexual integrity of an older person; (c) “psychological abuse” means any pattern of degrading or humiliating conduct towards an older person, including: i. ii. iii.

repeated insults, ridicule or name calling; repeated threats to cause emotional pain; and repeated invasion of an older person’s privacy, liberty, integrity or security;

(d) “economic abuse” means: i. ii. iii.

the deprivation of economic and financial resources to which an older person is entitled under any law; the unreasonable deprivation of economic and financial resources which the older person requires out of necessity; the disposal of household effects or other property that belongs to the older person without the older person’s consent.

Mental Health Act No. 17 of 2002 Section 13 of the Mental Health Act governs disclosure of information in relation to mental healthcare patients. It states: 1. A person or health establishment may not disclose any information which a mental health care user is entitled to keep confidential in terms of any other law.

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2. … the head of the national department, a head of provincial department or the head of a health establishment concerned may disclose such information if failure to do so would seriously prejudice the health of the mental health care user or of other people.

10.4.6 Confidentiality, disclosure and professional codes of conduct Health professionals are required to abide by their applicable governing professional codes of conduct. The ethical rules of the HPCSA bind professionals registered with all its boards. Booklet 1 of the HPCSA is entitled General ethical guidelines for the health care professions. Paragraph 5.4 of this document stipulates that health care practitioners should: 5.4.1 Recognise the right of patients to expect that health care practitioners will not disclose any personal and confidential information they acquire in the course of their professional duties, unless they agree to such disclosure, or unless health care practitioners have good and overriding reason for doing so (for example, if disclosure is not made, there is the likelihood of serious harm to an identifiable third party, or there is a public health emergency, or any overriding and ethically justified legal requirement). 5.4.2 Not breach confidentiality without sound reason and without the knowledge of their patients. 5.4.3 When claiming from medical schemes explain to patients the significance of ICD-10 coding and get the permission of patients to breach confidentiality when making a medical scheme claim.

Rule 13 of the HPCSA’s Ethical and Professional Rules of the Health Professions Council of South Africa as promulgated in the Government Gazette R717/2006 states that a practitioner may divulge information regarding a patient only if this is done 1. 2. 3. 4. 5. 6.

in terms of a statutory provision at the instruction of a court in the public interest with the express consent of the patient with the written consent of a parent or guardian of a minor under the age of 12 years in the case of a deceased patient, with the written consent of the next of kin or the executor of the deceased’s estate.

The HPCSA has also published guidance on good clinical practice specifically pertaining to confidentiality entitled: Confidentiality: protecting and providing information. (See http://www.hpcsa.co.za/downloads/conduct_ethics/rules/confidentiality_protecting_providing_info.pd f.)

10.4.7 Disclosures in court As health professionals are bound by their professional codes of conduct, they should not voluntarily disclose information in court. Instead, they should wait for the presiding officer to order them to disclose confidential information before doing so. Failure to do so could mean that a doctor has violated the HPCSA code of conduct. Accordingly, the doctor could face disciplinary action by the HPCSA. It is important to note that while lawyers and spouses cannot be forced to reveal confidential information about their clients and spouses, respectively (this is termed “absolute privilege”), the health professional’s relationship with his or her patient is a “relative privilege” (i.e. in applicable circumstances, they are obliged to answer questions put to them in court pertaining to their patient’s confidential medical information and may face contempt of court charges should they fail to answer 118

such questions). The relationship between a psychotherapist (such as a psychiatrist, psychologist and social worker) and his or her patient/client is also a relative privilege. Consider the following case Case study 10.7: Parks v Parks 1916 CPD 702 In this case, a woman who had contracted a sexually transmitted infection during her marriage filed for divorce from her husband on the grounds that he had transmitted the infection to her, and accordingly was unfaithful to her during the marriage. Her husband’s doctor was asked to verify that her husband had been treated for the STI in question. The doctor claimed privilege but was ordered by the court to answer the questions put to him.

10.4.8 Moral, social and legal duty to disclose In terms of the common law, a health practitioner has a moral, social and legal duty to disclose certain information to an endangered third party that could save that person’s life, or possibly prevent irreversible damage to his or her health. Consider the following case Case study 10.8: Tarasoff v Regents of the University of California The US case of Tarasoff v Regents of the University of California, highlights the moral and legal duty to disclose pertinent information to endangered third parties. In this case a male student disclosed to a university counsellor that he wanted to kill a female student who had been rejecting his advances. The counsellor informed the university security services but did not inform the student who was the subject of the threat. The male student carried out his threat and killed her. The girl’s family sued the University of California, arguing that its counsellor ought to have disclosed the threat to the girl so she could have taken steps to protect herself from harm. The court found in favour of the girl’s parents, holding that the university had a duty to inform the party at risk. The court stated: “The confidential character of patient-psychotherapist communications must yield to the extent that disclosure is essential to avert danger to others. The protective privilege ends where the public peril begins.” Although this judgment is not binding outside of California, it has become highly influential worldwide in relation to the health professional’s duty to warn identified parties at risk. HIV and the health professional’s duty to disclose to endangered third parties In 2015, South Africa’s Department of Health published a guidance document entitled National HIV Counselling and Testing Policy Guidelines. Paragraph 11 of the guidelines states: All clients must be assured of the confidentiality of their test records, of the system of record keeping and of their test results. Note that: •

The results of the client should be documented in the client’s file and may be communicated to other members of the health-care team involved in the management of the client, with the client’s consent.

•

Disclosure to sexual partners should be encouraged; however, the decision to disclose should be taken by the person undergoing the test. (DOH 2015)

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Notwithstanding the provisions in the above guidelines, if a health professional diagnoses a patient as HIV-infected and that patient unreasonably refuses to inform his or her sexual partner of that HIV status despite being counselled to do so and being given a reasonable period to make voluntary disclosure to that partner, it could be argued that the health professional has a moral and legal duty to make the disclosure to that partner if his or her identity is known, even if doing so is against the wishes of the patient. In this regard, the HPCSA and the South African Council for Social Service Professions (SACSSP) have imposed a positive obligation on their members to make disclosure to endangered sexual partners in instances where their HIV-positive patients refuse to make voluntary disclosure despite being counselled to do so. Section 2.3.8 of the HPCSA’s General Ethical Guidelines for Healthcare Professions states that healthcare practitioners should treat personal or private information as confidential in professional relationships with patients – unless overriding reasons confer a moral or legal right to disclosure. Furthermore, section 5.4.1 of the guidelines states that healthcare practitioners should recognise the right of patients to expect that health care practitioners will not disclose any personal and confidential information they acquire in the course of their professional duties, unless they agree to such disclosure, or unless health care practitioners have good and overriding reason for doing so (for example, if disclosure is not made, there is the likelihood of serious harm to an identifiable third party, or there is a public health emergency, or any overriding and ethically justified legal requirement). (See http://www.hpcsa.co.za/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_1_guidelines_ good_prac.pdf.) Section 9.2.3 of the HPCSA’s ethical guidelines for good practice with regard to HIV states: If the patient still refuses to disclose his or her HIV status or refuses to consider other measures to prevent infection, counsel the patient on the health care practitioner’s ethical obligation to disclose such information. (See http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/rules/generic_ethical_rul es/booklet_11_hiv.pdf.) Accordingly, professionals registered with the HPCSA, the SACSSP and the Pharmacy Council face the risk of disciplinary action if they fail to make disclosure to an identifiable party at risk. Such professionals could also face civil action by the party at risk for failing to inform them of the risk they faced. It could be argued in law that had the sexual partner been made aware of the risk, he or she could have taken steps to guard against the harm (e.g. by abstaining from sex or having only protected sex with the infected party). Even if sexual partners are already knowingly or unknowingly infected with HIV, it could be argued that were they to be informed of the risk they face by having unprotected sex with an HIVinfected person, they could take steps to prevent their ongoing re-infection (each incident of unprotected sex with an HIV-infected person could raise another HIV-infected person’s viral load and, accordingly, worsen their condition). Notwithstanding the health practitioner’s duty to disclose information to identifiable parties at risk, it could be argued that health practitioners do not have to disclose such information if doing so puts their life or that of their patient at risk. In such instances, disclosure should be deferred until such time as it is

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safe to do so (e.g. the individual at threat obtains a protection order in terms of the Domestic Violence Act No. 116 of 1998, and/or social welfare authorities have intervened in the matter). Legal implications of breaching confidentiality An aggrieved patient whose right to confidentiality was breached by a healthcare worker or professional has the following legal remedies: 1. The patient may bring a civil action against the healthcare worker for breach of privacy or defamation. 2. The patient may lay a complaint with the relevant professional body that governs the professional. 3. The patient may lay a complaint with the employer of the health professional, if applicable, for appropriate disciplinary action to be taken against that professional. In addition, failure to observe and comply with the provisions of POPI can lead to a variety of implications for healthcare practitioners. These include the following: •

A complaint could be lodged with the information regulator.

•

There could be a civil claim for payment of any damages.

•

Criminal prosecution may occur, and if conviction follows, there could be a fine up to R10 million or a prison sentence up to ten years, or even both.

10.4.9 Access to health records, confidentiality and disclosure Access to health records is governed by section 15 of the National Health Act No. 61 of 2003. It stipulates that a health worker or any health care provider that has access to the health records of a user may disclose such personal information to any other person, health care provider or health establishment as is necessary for any legitimate purpose within the ordinary course and scope of his or her duties where such access or disclosure is in the interests of the user. Section 16(1) of the National Health Act states that a health care provider may examine a user’s health records for the purposes [of] (a) treatment with the authorisation of the user; and (b) study, teaching or research with the authorisation of the user, head of the health establishment concerned and the relevant health research ethics committee. However, section 16(2) stipulates that if the study, teaching or research contemplated in subsection (1)(b) reflects or obtains no information as to the identity of the user concerned, it is not necessary to obtain the authorisations contemplated in that subsection. In terms of section 5 of POPI, a data subject has the right to have his, her or its personal information processed in accordance with the conditions for the lawful processing of personal information as outlined in the Act, including the right – (a) to be notified that – i.

personal information about him, her or it is being collected; or

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ii.

his, her or its personal information has been accessed or acquired by an unauthorised person.

Access to health or other records is also governed by sections 29 and 30 of the Promotion of Access to Information Act No. 2 of 2000. Section 30(1) entitles relevant persons access to health records unless the designated information officer in charge of such requests “is of the opinion that the disclosure of the record to the relevant person might cause serious harm to his or her physical or mental health or wellbeing”. In this case, the information officer may, before giving access to the information, consult with a health practitioner who has been nominated by the relevant person. In terms of section 30(2), if the relevant person is – (a) under the age of 16 years, a person having parental responsibilities for the relevant person must make the nomination contemplated in subsection (1); or (b) incapable of managing his or her affairs, a person appointed by the court to manage those affairs must make that nomination. In terms of section 30(3)(a), if, after being given access to the record concerned, the health practitioner consulted in terms of subsection (1) is of the opinion that the disclosure of the record to the relevant person would be likely to cause serious harm to his or her physical or mental health, or wellbeing, the information officer may only give access to the record if the requester proves to the satisfaction of the information officer that adequate provision is made for such counselling or arrangements as are reasonably practicable before, during or after the disclosure of the record to limit, alleviate or avoid such harm to the relevant person. In terms of section 30(3)(b), “before access to the record is so given to the requester, the person responsible for such counselling or arrangements must be given access to the record”. In terms of section 13(3) of the Mental Health Act No. 17 of 2002, a mental healthcare provider may temporarily deny mental healthcare users access to information contained in their health records, if disclosure of that information is likely to – (a) seriously prejudice the user; or (b) cause the user to conduct himself or herself in a manner that may seriously prejudice him or her or the health of other people. Access to biographical and medical information concerning genetic parents by a child born of artificial insemination or surrogacy, or the guardian of such child, as well as related disclosures made in respect of such requests for access, are governed by section 41 of the Children’s Act No. 38 of 2005. In terms of section 33(1)(e) of the Sexual Offences Amendment Act No. 32 of 2007, once a medical practitioner or nurse has conducted an HIV test on an alleged sexual offender, the investigating officer must hand over to the victim or to the interested person who requested the test, as the case may be, and to the alleged offender, the sealed record of the test results and a notice containing prescribed information on the confidentiality of, and how to deal with, the HIV test result.

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In terms of section 36 of the Sexual Offences Amendment Act, the outcome of the application for the HIV test is confidential and may only be communicated to (a) the victim or the interested person referred to in section 30; (b) the alleged offender; and (c) the investigating officer and, where applicable, to – (i) a prosecutor … or (ii) any other person who needs to know the test results for purposes of any civil proceedings or an order of a court. In terms of section 37 of the Act, the HIV test result of the alleged offender is confidential and may be disclosed only to the above parties.

10.4.10 Involuntary disclosure of confidential genetic information to related third parties In genetics, the “true patient” may be a family with a shared genetic heritage. When an individual has a hereditary genetic condition, family members may want to know the probability of themselves and future generations developing the condition. It has been argued that it is the individual’s moral obligation to tell relatives at risk about a diagnosis and/or results of genetic tests so that these relatives can choose whether to be tested themselves. This becomes challenging when the patient diagnosed with the condition refuses to disclose this information voluntarily to relevant related family members. Section 17 of the HPCSA’s guidelines entitled Seeking patient’s informed consent: the ethical considerations – which governs consent to genetic screening and testing – states that in order for there to be an informed decision, a healthcare practitioner must explain “any significant medical, social or financial implications of screening or testing for the particular condition or predisposition”. “Social implications” could be interpreted as including the need to consider the implications of the test for related third parties. In a report entitled Review of ethical issues in medical genetics, the World Health Organization outlined the stance of the US President’s Commission – a multidisciplinary body of ethicists, clinicians and legal experts – on the issue. The genetics professional may, unless it is prohibited by law, override individual confidentiality if the following four conditions are met: • • • •

All efforts to persuade the individual to disclose the information voluntarily have failed. There is a high probability of harm to the relatives (including future children) if the information is not disclosed, and there is evidence that the information could be used to prevent harm. The harm averted would be serious. Only genetic information directly relevant to the relatives’ own medical status would be revealed. Information relevant to the individual must remain confidential.

10.5 MEDICAL MALPRACTICE A medical practitioner is expected to exercise the degree of care and skill of a reasonable practitioner in his or her field. In deciding reasonableness the court will have regard to, but is not bound by, the general level of skill and diligence possessed and exercised by members of the branch of the profession to which the practitioner belongs. A greater degree of skill is expected of a specialist than of a general practitioner. Greater care and skill are required where more complicated procedures are involved. Accordingly, general practitioners would be deemed negligent if they undertook work that required special skills which they did not possess. Professionals who represent themselves as possessing greater skills than they actually possess will be

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held to the higher standard. Professionals who give guarantees regarding the care or treatment they administer may be civilly liable if that guarantee is not met.

10.5.1 Standard of care The test for the standard of care expected of a medical practitioner is: How would a reasonable practitioner in that branch of health/speciality have acted in a similar situation? It must be established that the reasonable practitioner would have foreseen the likelihood of harm and taken steps to guard against its occurrence. In such instances, the court will rely upon the testimony of experts. However, the court is not obliged to believe the testimony of an expert witness. Unusual complications: There may be no liability where a highly unusual complication occurs in the treatment of the patient (e.g. due to the patient’s peculiar hypersensitivity), unless the condition could have been tested beforehand. A greater degree of skill and care will be required in the handling of dangerous substances, or where the practitioner has special knowledge of circumstances that increased the risk.

10.5.2 Vicarious liability As a general rule, an employer may be held vicariously liable for the wrongful acts of a person it employed where such an act occurred in the course and scope of that person’s work. This includes those instances where the employee has intentionally engaged in wrongdoing, and where the employer has warned its employees against using certain procedures, provided these acts were committed within the general scope of their employment. South African courts have recognised that a standard of excellence cannot be expected that is beyond the financial resources of a hospital authority. Whether a doctor is liable for the acts of his or her assistants depends on whether they are “servants” under the doctor’s control (in which case the doctor would be liable), or have “independent duties to discharge” (such as a theatre nurse, in which case the doctor would not be liable). However, even if an assistant is executing an independent task, a doctor who is in a position to prevent harm but fails to do so may also be liable for negligence. Notwithstanding the notion of vicarious liability, a patient will have the right to bring a civil action against a hospital authority and the practitioner in question (i.e. both can be sued). Generally, a surgeon is not liable for the negligence of an anaesthetist.

10.6 CONSUMER LAW AND HEALTHCARE The Consumer Protection Act (CPA) No. 68 of 2008 and its Regulations became operational on 31 March 2011 and 1 April 2011 respectively. The CPA has potentially far-reaching implications for health practitioners. In terms of the CPA, patients could be regarded as consumers, and medical practitioners as suppliers or service providers. In terms of the CPA, “service” refers to work performed by a person for the direct or indirect benefit of another, including the provision of information, advice or consultation. A “supplier” is a person who markets goods or services, including individuals, corporate entities and organs of state. “Market” in this context means to supply or promote goods or services, whereas “supply” means to sell services, or to perform them or cause them to be performed or provided. In relation to goods, “supply” means to sell, rent, exchange or hire goods in exchange for money. “Goods” are broadly defined and include “anything marketed for human consumption”, which could include medicines, devices and medication. Seen in this light, virtually all interactions between patients, healthcare providers and even medical schemes will fall within the ambit of a CPA transaction.

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In terms of the CPA, consumers have the right to demand quality service. This requires, among other factors, that (1) services must be performed timeously; (2) consumers must be given timely notice of a delay in the performance of the services; (3) services must be performed in a manner and quality that could generally be expected. If these standards are not met, the consumer may opt to: (a) accept performance; (b) reject performance; and (c) cancel the agreement without penalty. The CPA stipulates that consumers have a general right to expect that goods are, among other things, (a) in good working order; (b) free from defects; and (c) usable and durable for a reasonable period of time. Whereas traditional medical claims rest on fault (intention or negligence) on the part of the practitioner being proven, the CPA is based on “no-fault liability”. This means that the consumer does not have to prove fault in the matter. The entire supply chain could thus incur joint and several liability, irrespective of whether or not they were negligent and harm resulted, either wholly or partly, as a consequence of (a) supplying any unsafe goods; (b) product failure, defect or hazard in any goods; (c) inadequate instructions or warnings provided to the consumer pertaining to any hazard arising from, or associated with, the use of the goods. The supply chain consists of the producer, importer, distributor or retailer of any goods, and sometimes even a supplier of services, who, in conjunction with the supply of services, gives the consumer access to certain goods. Liability in terms of the CPA extends to death, injury, illness, loss, damage to property and economic loss.

10.7 CONCLUDING REMARKS An understanding of South African law and the country’s legal system is critical for competent patient care and service delivery. Health professionals should always strive to familiarise themselves with current and proposed health law. Moreover, they should involve themselves in legislative reform by providing input on existing and proposed health laws, where necessary. Such knowledge and involvement will ensure a just and appropriate health regulatory environment for patients and health professionals alike.

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CHAPTER 11: Professionalism (Author: Keymanthri Moodley) By the end of this chapter you should be able to • • • •

understand the features that define a profession understand obligations to patients created by being a professional acquaint yourself with the rules of the Health Professions Council of South Africa (HPCSA) develop an approach to dealing with impaired colleagues.

11.1 INTRODUCTION A profession refers to a publicly declared “dedication, promise or commitment” (Pellegrino 2000). Medicine is regarded as a “moral enterprise”. Healthcare workers are obligated to act primarily in their patients’ best interests. This requires them to fully and honestly inform patients, enable them to make their own treatment choices and provide competent, continually improving care. Being a good doctor requires a lifelong commitment to good professional and ethical practices and a dedication to one’s patients and to the public. This chapter will examine briefly some of the main attributes of professionalism as well as the professional body – the Health Professions Council of South Africa (HPCSA) – that oversees the health sciences. Common findings of disciplinary committees will be illustrated, and impairment of students and doctors will be explored.

11.2 WHAT IS REGARDED AS UNPROFESSIONAL CONDUCT? The HPCSA lists the following as examples of unprofessional conduct. This list is, however, not exhaustive: •

Unauthorised advertising

•

Overservicing of patients

•

Practising with a criminal conviction

•

Improper relationships with patients

•

Improper conduct of practitioners

•

Performing operational procedures without patients’ permission or consent

•

Disclosure of patients’ information without their permission

•

Incompetence regarding the treatment of patients

•

Charging excessive fees/overcharging

•

Insufficient care of patients

•

Racial discrimination

•

Rude behaviour towards patients

•

Giving prescriptions to already addicted patients

•

Perverse incentives and kickbacks

Consider the following case 126

Case study 11.1 Mr Q contacted Dr P telephonically to request a prescription for Aldara. Mr Q sent his girlfriend, Miss Q, to collect the prescription, expecting it to be in a sealed envelope, but the receptionist just handed her the prescription. She read it and on her arrival at home, did a Google search on the medication, where she discovered that the medication prescribed was for genital warts. She confronted her boyfriend, Mr Q. He was very upset with Dr P for not preserving his privacy, and lodged a complaint against him with the HPCSA for unprofessional conduct. The following questions arise: 1. Should a doctor issue a prescription after a telephonic consult with a patient he has not examined? 2. How should confidentiality be preserved in a medical practice? 3. Should receptionists have access to prescriptions in this manner?

11.3 FEATURES TYPICAL OF PROFESSIONS The following are features of professions (adapted from Hope, Savulescu & Hendrick 2003): •

A commitment to serving the public good and providing an important public service

•

Significant knowledge and training to practise the profession

•

Standards in conducting professional work set by the profession, as well as self-regulation

•

A certification or licensing procedure that determines who can be part of the specific profession

•

The existence of a professional body such as the HPCSA that sets professional standards, oversees disciplinary mechanisms, determines training content and carries out a certification or licensing procedure.

The following HPCSA professional conduct cases illustrate the importance of professionalism: Knowledge and training – postoperative management Case study 11.2 Dr AB, a plastic surgeon, booked Mrs X for breast reduction surgery in August 2006. The operation was done at a clinic, and she was discharged the next day. Mrs X was unhappy that Dr AB did not come to see her the next day. Instead, all instructions were conveyed to her via a nurse. At home she had considerable pain, and subsequently developed wound site infection. She then sent a letter of complaint to the HPCSA. HPCSA FINDINGS Dr AB postoperatively mismanaged the patient by: 1. failing and/or neglecting to take such steps as were necessary to prevent the patient using unsterile garments immediately postoperatively 2. prematurely admitting the patient to an inappropriate clinic 127

3. inappropriately and/or prematurely discharging her to recover at home 4. failing and/or neglecting to provide appropriate and adequate postoperative care 5. inappropriately giving an instruction and/or failing to take such steps as were necessary to prevent early removal of the sutures 6. inappropriately delegating and/or failing to take all such steps as were necessary to prevent postoperative management and/or decision making to a lesser-qualified nursing sister. Dr AB was found guilty on counts 1 and 2. The penalty imposed was the following: a) He was suspended from practising for one year, which was wholly suspended for a period of three years on condition that he worked in a state hospital or clinic under supervision for a period of six months. b) Thereafter a reputable plastic and reconstructive surgeon was to report to the health committee of the HPCSA as to whether he was competent to practise independently and privately. c) A further condition was that he was not convicted of unprofessional conduct during the period of suspension. Case study 11.3 Dr XZ was a general practitioner working in an urban area, who operated on a patient without good reason in December 2011. After the patient presented with lower abdominal pain, Dr XZ performed an unnecessary appendectomy and perforated the patient’s bowel in the process. HPCSA FINDINGS The HPCSA found Dr XZ guilty as he •

had practised outside the scope of his profession

•

was negligent in the treatment of his patient

•

had performed a procedure he was not trained to do

•

had performed surgery when conservative management was indicated.

He paid an admission of guilt fine of R70 000 in 2013. The patient then proceeded with a civil case against him. Commitment to serving the public good and providing an important public health service Case study 11.4 On 14 February 2008, Dr CD issued a medical certificate to a patient dated 1 February 2008. The certificate stated that the patient had backache and was unfit for work. The employer lodged a complaint with the HPCSA. Source: Adapted from http://www.hpcsa.co.za HPCSA FINDINGS 128

•

The HPCSA found Dr CD guilty of unprofessional conduct or conduct which, with regard to his profession, is unprofessional. This conclusion was reached because he issued a medical certificate on 14 February 2008 to his patient, the contents of which were false or not correct in all respects.

•

He did not see or examine his patient on 1 February 2008.

•

A fine of R10 000 was imposed on Dr CD for issuing a false medical certificate.

Case study 11.5 A specialist on call for a private hospital was called out by the casualty department at 22:00 to see a patient with acute chest pain. The medical officer diagnosed acute coronary syndrome. Dr JS refused to see the patient and subsequently refused to conduct a cardiac revascularistion procedure on the patient. This seriously delayed treatment of the patient and violated the National Health Act requirement for all patients to be seen in emergencies. HPCSA FINDINGS In 2013 Dr JS was found guilty of •

refusing to treat a patient in an emergency

•

refusing to perform a procedure on a patient.

Dr JS paid an admission of guilt fine of R25 000 in 2013. Certification or licensing procedure that determines who can be part of the specific profession Case study 11.6 Dr K is a successful GP and takes frequent holidays. In 2003, 2004, 2005 and May 2006 he employed Dr J to work as a locum. Several patients were unhappy with the services rendered by the locum. Three complaints were lodged with the HPCSA. HPCSA FINDINGS The HPCSA found that Dr K •

failed and/or neglected to ensure that Dr J was registered with the HPCSA while working at his practice; and/or • claimed on behalf of Dr J for services rendered by him from the medical aid and/or from the patient(s) concerned while Dr J was unregistered with the HPCSA. Case study 11.7 Dr N employed Dr M as a locum. Dr M was busy with his internship at the time, and would frequently work at Dr N’s practice on his free weekends. On one of these weekends, Dr M saw a patient with asthma. The nebuliser in the practice was faulty, so he referred the patient to a private hospital where the patient arrived in his own car in a very unstable state. The receiving doctor lodged a complaint with the HPCSA. 129

HPCSA FINDINGS Dr N and/or his locum Dr M • • •

failed and/or neglected to stabilise a seriously ill patient; and/or failed and/or neglected to keep and/or maintain adequate equipment at the practice; and/or allowed a person registered as an intern to act as a locum GP at the practice.

Case study 11.8 Between 2008 and 2013, Dr OA failed to pay his professional fees to the HPCSA, which was in contravention of section 19(1)(d) of the Health Professions Act No. 56 of 1974. Although his name was removed from the register as a result of this, he continued to practise. This was a contravention of the provisions of section 17 of the Act, and the HPCSA fined him R30 000. He had to pay R20 000, and the remaining R10 000 was suspended on condition that he was not convicted of a similar offence during the period of suspension. Standards in conducting professional work set by the profession, as well as self-regulation Case study 11.9 Dr G managed a pregnant patient with severe pre-eclampsia in a manner that was incompetent and/or negligent. Dr G was called to see the patient but only examined her an hour after he was called. He failed to document the standard of care and blood results of his patient in his notes. He advised her husband to drive her to the hospital in his car. HPCSA FINDINGS Dr G acted in a manner that was not in accordance with “norms and standards” of his profession in that he: • failed to act timeously when he was called upon • failed and/or neglected to ensure that the patient was transported by ambulance to the hospital • failed and/or neglected to administer treatment to the patient. Case study 11.10 Dr GQ, a surgeon, operated on a patient in June-July 2010, who subsequently died. HPCSA FINDINGS The HPCSA found him guilty of unprofessional conduct as he • • • • •

did not explain the risks and complications to the patient or family prior to surgery failed to provide evidence of consent certified that the patient died of natural causes when this was not the case failed to complete the death certificate legally failed to report the death to the state pathologist as it was an unnatural death directly related to the surgical procedure. The case was finalised in 2013 (three years later), and the surgeon paid an admission of guilt fine of R10 000. 130

11.4 THE HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA (HPCSA) The HPCSA is a statutory body established in terms of the Health Professions Act No. 56 of 1974. There are 12 professional boards and a council. The boards that fall under its auspices are: Dental Therapy and Oral Hygiene; Dietetics; Emergency Care; Environmental Health; Medical and Dental; Medical Technology; Occupational Therapy, Medical Orthotics/Prosthetics and Arts Therapy; Optometry and Dispensing Opticians; Physiotherapy, Podiatry and Biokinetics; Psychology; Radiography and Clinical Technology; and Speech, Language and Hearing Professions. The professional board of interest in medicine is the Medical and Dental Board, where all dentists, doctors and dental and medical students are registered. The HPCSA promotes the provision of the highest quality of healthcare to the public. As such it is integrally involved in monitoring and evaluating medical and dental training. When high standards in healthcare are not maintained, disgruntled patients may lodge a complaint with the HPCSA. The number of complaints against medical professionals is increasing. In 2014 and 2015 there were 2597 complaints.

11.4.1 A typical complaints procedure The following illustrates a typical complaints procedure: Mrs X consulted a general practitioner, Dr Y, complaining of backache. Dr Y examined Mrs X, diagnosed mechanical backache and prescribed analgesia. Mrs X went back to Dr Y after a few days as the pain had worsened. Dr Y changed his diagnosis to sciatica and prescribed stronger analgesics. His notes were as follows: “looks well; walked into surgery”. She recalled that he did not examine her on the second visit. Mrs X deteriorated over the next three days and developed bladder symptoms and altered sensation in her limbs. She consulted Dr Y telephonically and he advised her to increase her fluid intake but did not ask her to come in for an assessment. A few days later she went to Dr Z, who did a thorough examination, diagnosed cauda equina syndrome and referred her to an orthopaedic surgeon. She then had an emergency laminectomy and excision of the prolapsed L5/S1 disc. Postoperatively she experienced significant pain and discomfort and sexual dysfunction, and had to self-catheterise several times a day. She felt she had received substandard care and held Dr Y responsible for the delay in diagnosis and the complications that ensued. Mrs X was very dissatisfied as she had exceeded her medical aid benefits. She wrote a letter of complaint to the HPCSA. The registrar of the HPCSA received the letter and corresponded with Dr Y within seven days, asking for an explanation within 40 days. Dr Y consulted with the Medical Protection Society (MPS) and, with their assistance, wrote a letter of explanation to the HPCSA. Both letters were submitted to the Committee of Preliminary Enquiry. This committee then forwarded the complaint to the Professional Conduct Committee, and a hearing was scheduled during which the doctor, Dr Y, and the patient, Mrs X, gave oral evidence. Expert independent witnesses were consulted and Dr Y was found guilty of professional misconduct for failing to fully examine Mrs X on the second visit, for giving her telephonic advice without examining her and for delaying referral to a specialist. This delay in diagnosis and in referral compromised Mrs X’s health. OUTCOME 131

The Professional Conduct Committee resolved that Dr Y be suspended from practising his profession for three months but that the implementation thereof be suspended for a year on condition that he was not found guilty of any offence during this period. His name was also published on the HPCSA website. Armed with this conviction from the HPCSA, Mrs X then pursued legal action against Dr Y in a civil case. The Professional Conduct Committee may impose one of the following penalties: • • • • • •

A caution/reprimand, or both A fine Suspension from practising the profession for a specified period of time Being struck off the roll A compulsory period of professional service Payment of the costs of the proceedings or restitution

11.5 OVERSERVICING The provision of unnecessary, inappropriate, excessive or fraudulent treatment falls squarely within the ambit of overservicing or overtreatment. Such practices are regarded as both unethical and unprofessional. According to the HPCSA guidelines, “overservicing” means the supply, provision, administration, use or prescription of any treatment or care (including diagnostic and other testing, medicines and medical devices) which is medically and clinically not indicated, unnecessary or inappropriate under the circumstances or which is not in accordance with the recognised treatment protocols and procedures, without due regard to both the financial and health interests of the patient. Several services provided on a regular basis by doctors may be regarded as overservicing: •

X-rays taken routinely without clinical justification

•

Unnecessary follow-up visits

•

Unnecessary blood investigations

Consider the following finalised conduct inquiries, which were published on the HPCSA website for 2008 (adapted from http://www.hpcsa.co.za). Consider the following cases Case study 11.11 Dr A was found guilty of unprofessional conduct or conduct which, when regard is had to his profession, is unprofessional because on 16 January 2008 he performed a cholecystectomy on his patient. Preoperatively he failed to examine the patient properly, or at all, in order to arrive at a clinical diagnosis. His decision to operate on the patient was hurried and/or the operation performed on the patient was not indicated or necessary and/or he failed to discuss or inform the patient of his intention to charge fees in excess of the medical aid rates. The HPCSA penalty was a R10 000 fine. In addition there is the potential for civil action by the patient. Case study 11.12 132

In 2007, Dr B submitted fraudulent claims to the Spectramed Medical Aid Scheme in which he claimed for medicines which he did not dispense to a patient in March 2007, and as a result thereof caused actual and/or potential financial prejudice to the patient and/or Spectramed Medical Aid Scheme, and brought his profession into disrepute. Ethically, a doctor who chooses to overservice a patient is caught in a position of conflict between self-interest and the best interests of his or her patient. Self-interest may be fuelled by greed and the financial gain that flows from medical funders. Alternatively, overservicing may be motivated by perverse incentives (see section 11.6.1) offered to doctors by pharmaceutical companies or specialist colleagues based on referrals. Case study 11.13 In July 2010, Dr NS conducted a functional reconstruction of a nasal septum on a patient, and performed an endoscopic turbinectomy (laser procedure). He subsequently charged the patient for six follow-up consultations. Five years later, in 2015, the case was finalised and he paid an admission of guilt fine of R30 000.

11.5.1 Important questions to ask before embarking on a treatment plan The following questions are adapted from Hartshorne and Hasegawa (2003): 1. 2. 3. 4. 5. 6.

Is the chosen treatment necessary? Is the treatment based on good evidence? Will the treatment benefit the patient? Will the treatment cause the patient any harm if not done? Am I treating the patient or my pocket? Has the patient given informed consent?

11.6 IMPAIRED STUDENTS AND COLLEAGUES Impairment is defined in the Health Professions Act No. 56 of 1974 as “a mental or physical condition, or the abuse of or dependence on chemical substances, which affects the competence, attitude, judgment or performance of a student or person registered in terms of this Act”. Rule 26 of the Council’s Ethical and Professional Rules imposes a duty on health professionals to report impairment in fellow students, interns, practitioners or themselves to the appropriate board. As at 13 June 2013, there were 314 impaired practitioners reported to the HPCSA, 238 of whom are medical practitioners. Consider: You are a 4th-year student working in a group in the paediatric ward. You notice that your fellow student has a tremor and cannot take blood from a patient assigned to her. This happens on a regular basis – even in the adult wards. You are aware that she is abusing drugs. What should you do? OPTIONS •

Do nothing.

•

Discuss your observations with the student.

•

Report the matter to your supervisor.

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•

Report the matter to the HPCSA.

COMMENTARY As a point of departure, it is important to discuss the matter with the student concerned. It is important to advise the student regarding rehabilitation due to the risks posed to patient safety. All medical students are registered as students with the HPCSA. As such, HPCSA regulations apply to medical students. The rules on impairment specifically include students. As such, all medical schools in South Africa should have a policy relating to impaired students. This policy should be widely distributed to all students upon registration. The policy should outline the reporting mechanism within the institution. If the institution fails to assist the student in terms of rehabilitation the matter will then need to be reported to the HPCSA. The guidelines for the management of impaired students were published in November 2014 and can be accessed at: http://www.hpcsa.co.za/uploads/editor/UserFiles/2014%20Guidelines%20for%20the%20management%2 0of%20impaired%20students.pdf Consider the following case Case study 11.14 Dr I and Dr K are both general practitioners who work 50 metres away from each other. Mr J had an incision and drainage (I&D) of a buttock abscess by Dr K. One week after the I&D he was still in pain. He returned to Dr K but was told that he was “on leave”. He then consulted Dr I for the first time and complained of the persistent pain. While examining Mr J, Dr I noticed that there was still a large amount of pus in the abscess. Clearly the cavity had not been drained adequately. Dr I advised Mr J that he needed to drain the abscess again. Mr J then started to wonder why Dr K did not remove all the pus in the first place. Dr I is acutely aware that he has seen several patients in the past three months who have consulted him after being treated by Dr K. It has become apparent that Dr K is frequently “not available” in his practice, especially on Monday mornings and after long weekends. Dr K’s practice nurse has told Dr I’s receptionist that Dr K reeks of alcohol when he does come to work and she can no longer work with him. Dr I’s receptionist has shared this information with him. Dr I is concerned about the rising number of Dr K’s patients that he is seeing with substandard treatment. PERPLEXING QUESTIONS What should Dr I do? 1. 2. 3. 4. 5. 6.

Do nothing and continue treating Dr K’s ex-patients. Contact Dr K and discuss the matter with him. Discuss the matter with another colleague. Advise the patient to consult a lawyer. Advise the patient to contact the HPCSA. Write a letter to the HPCSA himself.

COMMENTARY

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It is possible that Dr K’s pattern of behaviour is consistent with substance abuse. It is clear that this is impacting on the standard of care he is delivering to his patients. Dr I is aware of his legal obligation in terms of rule 26 of the Health Professions Act to report Dr K to the HPCSA. He is, however, still contemplating his obligation to report from an ethical perspective. He feels duty bound to protect the health of unsuspecting patients, to end the poor quality of care that patients are receiving, and to uphold the integrity of the medical profession. Although Dr K will be angry and embarrassed if he is reported to the HPCSA, in the long term he will benefit if he is able to be rehabilitated. Furthermore, several patients will be protected. Dr I decides to make an appointment to see Dr K. He discusses his concerns and shows him records of the patients who have been to see him. Dr K is furious with Dr I and asks him to leave his rooms. Dr K then lodges a formal complaint with the HPCSA. This complaint may be lodged on an anonymous basis in writing. The matter is investigated by the Health Committee who reports to the Executive Committee of the Council. The Health Committee adopts a nonpunitive approach, aiming to provide support to such practitioners in managing their impairment rather than penalising them. In some cases, practitioners may be restricted to supervised practice while undergoing rehabilitation. In more severe cases, temporary suspension may be implemented until rehabilitation is complete. Similarly, impaired students must also be reported to the HPCSA. Most tertiary institutions have a dedicated staff member who handles the inquiry at an institutional level before the matter is taken to the HPCSA.

11.6.1 Perverse incentives Case study 11.15 Dr F is a general practitioner. She is a very good friend of Dr Z, a plastic surgeon. Dr Z offers Dr F a “referral fee” of R100 per patient for each patient she refers for cosmetic procedures. Soon Dr Z will be busy with a clinical trial on a new antibiotic for postoperative sepsis for a pharmaceutical company, and he would like Dr F to refer patients to be screened for eligibility for the trial. For every patient that Dr Z enrols in the trial he is willing to pay Dr F a referral fee of R300. PERPLEXING QUESTIONS What should Dr F do? 1. Refuse the monetary offer and avoid referral of patients. 2. Accept the monetary offer and refer all patients requesting cosmetic surgery. COMMENTARY According to the HPCSA, improper financial gain is regarded as a perverse incentive for work done. “Improper financial gain or other valuable consideration” means “money”, or any other form of compensation, payment, reward or benefit which is not legally due or which is given on the understanding, whether express, implied or tacit, that the recipient will engage or refrain from engaging in certain behaviour in a manner which is either

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(i)

illegal; and/or

(ii)

contrary to ethical or professional rules; and/or

(iii)

which, in the opinion of the HPCSA, may adversely affect the interests of a patient or group of patients in order to procure some direct or indirect advantage, benefit, reward or payment for the person offering or giving the said money, compensation, payment, reward or benefit.” The term “perverse incentive” is taken to have the same meaning as “improper financial gain”.

Referral of patients is required, when appropriate, in the course of clinical care of patients. This usually occurs in the best interests of the patient concerned. As such, the HPCSA has the following rule regarding referral: Healthcare practitioners shall not pay commission or render any financial gain or other valuable consideration to any person for recommending patients. This rule applies in the research setting as well: Health care practitioners shall not charge a fee or receive any financial gain or other valuable consideration for referring patients for participation in drug trials or other research trials of a similar nature. Clearly, Dr F has only one option: refuse the referral fee and refer only those patients with postoperative sepsis who have a good clinical indication for participation in the trial. Dr F is also free to refer her patients to a plastic surgeon who is chosen in consultation with the patient.

Case study 11.16 Between January 1999 and December 2000, a radiology firm belonging to Dr I and partners was involved in -

overbilling of patients

-

inaccurate billing of patients and medical aids

-

overservicing patients

-

paying kickbacks to doctors for referring patients to their practice.

The Radiological Society of South Africa (RSSA) laid the initial complaint of misconduct against the radiologists in 1999. The referring doctors were paid 4,5 to 5 per cent of the monetary value of their referrals less VAT and bad debts. One doctor was paid R765 133 in kickbacks and another accepted R156 792. All the radiologists were suspended from the HPCSA for variable periods of time and paid fines ranging from R50 000 to R150 000. Source: Bateman 2004 A similar rule applies to the purchase and sale of supplies, equipment, medication or devices: Health care practitioners shall not accept commission or any financial gain or other valuable consideration from any person or body or service in return for the purchase, sale or supply of any goods, substances or materials used by the health care professional in his or her practice.

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Similarly, all rental agreements for consulting rooms may not be linked to turnover or referral of patients to a particular specialist or hospital. Finally, doctors may not charge a fee for seeing medical representatives. Table 11.1 HPCSA penalties

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11.7 CONCLUDING REMARKS Professionalism drives medical practitioners to deliver high standards of care and in so doing maintains the relationship of trust that exists between patients and the healthcare team. Excellence in healthcare provision cannot be driven by a professional body alone via guidelines, standards and rules. Selfregulation, where individual doctors develop and internalise their own guiding principles and values, is essential. All doctors have an ethical duty to stay abreast of new developments in healthcare, hence continuing professional development (CPD) for doctors is essential, as is an ethical obligation to ensure good patient care. True self-regulation occurs at a personal level where doctors take responsibility for their own performance and that of their colleagues.

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CHAPTER 12: Resolving ethical dilemmas – An Approach to decision making (Author: Keymanthri Moodley) At the end of this chapter you should be able to: • •

understand the five-step approach to resolving ethical dilemmas apply this approach to solve your own ethical dilemmas.

12.1 INTRODUCTION In the course of medical practice one is bound to encounter several clinical situations that pose ethical dilemmas. The nature of such dilemmas will vary from mundane to highly complex. Part 1 of this book has so far explored the body of general theoretical knowledge in the field of ethics, law and human rights. This chapter looks at the application of theory to a clinical/ethical dilemma using a structured stepwise approach. The framework is intended to serve as a guide to assist you in your attempts at resolving your own ethical dilemmas. Consider the following case Case study 12.1 Ms P is 14 years old. She was admitted to a tertiary government hospital and was transferred to the high-care unit of the obstetric ward. Two days prior to the admission she delivered a baby girl at a secondary hospital. She had a traumatic vaginal delivery and sustained cervical and vaginal lacerations. As a result she had a massive postpartum haemorrhage. The lacerations were sutured in theatre and she was transferred to the tertiary hospital where she arrived in grade 3 shock. Resuscitation commenced with Voluven® and Ringer’s lactate. Ms P had a haemoglobin count of 3.3 g/dl and was stable. The obstetricians were of the opinion that a blood transfusion was indicated. Her mother refused the transfusion as the family subscribes to the Jehovah’s Witness (JW) faith. Ms P, however, had not yet been baptised into this faith. As the treating doctor, what would you do?

12.2 STEP 1: IDENTIFY AND ARTICULATE THE MORAL DILEMMA As a starting point, it is important to understand what a moral dilemma is. Beauchamp and Childress (2013) describe moral dilemmas as “circumstances in which moral obligations demand or appear to demand that a person adopt each of two or more alternative actions” without being able to perform all the required alternatives. In this case the alternative actions are either to administer a life-saving blood transfusion or to choose a risky option of alternative fluid replacement that might not work and would then result in the death of a young patient. The choice is between saving a young life on the one hand and respecting a religious belief on the other that might result in a young patient dying. Respect for autonomy conflicts with beneficence and non-maleficence. If the refusal of a blood transfusion is respected, will the treating doctors cause more harm than good, especially if the 14-year-old mother Ms P dies?

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12.3 STEP 2: ESTABLISH ALL THE NECESSARY INFORMATION Prior to embarking on an ethico-legal analysis of this case, it is important to establish all the necessary scientific and medical information related to it.

12.3.1 Scientific and medical information General questions to pose: 1. Is this a medical emergency and is the blood transfusion indicated? 2. What are the alternatives to blood transfusion and is there evidence to support use of these alternatives? 3. Why did Ms P have such a traumatic delivery at the secondary hospital? A vaginal delivery may be assisted with an episiotomy and forceps or vacuum extraction. Specific questions: 1. If Ms P went into cardiac failure during the night, would a transfusion be indicated? 2. Is she entitled to expensive alternatives with respect to blood replacement such as Hemopure® (bovine haemoglobin)? 3. If the patient has refused a blood transfusion, should she occupy a high-care bed? 4. Is the baby healthy? 5. Would an independent opinion contribute to resolving the clinical dilemma?

12.3.2 Legal questions What laws will influence your decision? In this case we have to take cognisance of the Children’s Act No. 38 of 2005 and the age of consent. Ms P is 14 years old and hence in a position to accept or decline medical treatment. Is a blood transfusion regarded as medical treatment? If, however, Ms P develops cardiac failure, the blood transfusion will be regarded as life-saving medical treatment. Can the parents deprive their child of this treatment based on religious grounds? According to the South African Constitution, the child’s right to life is of paramount importance. The high court has already ruled in favour of transfusing children against parental religious wishes in two cases – one involved a baby and the other a 12-year-old girl (see chapters 6 and 10 for more details). The Children’s Act No. 38 of 2005 defines a child as being less than 18 years old. According to the new Children’s Act, section 129(10) reads as follows: No parent, guardian or caregiver of a child may refuse to assist a child in terms of subsection (3) or withhold consent in terms of subsections (4) and (5) by reason only of religious or other beliefs, unless that parent or guardian can show that there is a medically accepted alternative choice to the medical treatment or surgical operation concerned. This part of the Children’s Act (section 129) has been signed into law. •

How old is the father of the baby? This could be a case of statutory rape in terms of the Sexual Offences Act. The doctor then has obligations to report the matter in terms of the Act. Does the father of the baby have any rights to his child in this case? (See Chapter 10.) 140

•

Have any HPCSA rules been violated?

•

From a legal perspective, are there grounds for civil action against the hospital if the girl is transfused?

12.3.3 Ethical questions What is the ethical standpoint? How do the four principles interact? Here we consider autonomy versus non-maleficence/beneficence. Is the patient (Ms P) making an autonomous decision or is she under the influence of her mother? It could be argued that her competence to consent is impaired by the emotional stress of her traumatic delivery and the coercive influence of her mother. Is her refusal truly informed given that the consequences of her refusal could include death and permanent separation from her baby? Beneficence will override autonomy if an argument can be made that the young girl cannot make an autonomous decision to refuse the blood transfusion. The relevant principles must be balanced against each other. How do the theories impact on this case? We ask whether a universal ethical theory such as consequentialism can influence a decision to treat, especially when the consequence could include death. Were the outcomes considered at the outset and was the greatest good for the greatest number achieved? The consequences of transfusion are as follows: Positive consequences •

Ms P’s life will be preserved.

•

She will make a quicker recovery.

•

Her baby will have a mother.

•

The bonding process will be enhanced.

•

Breastfeeding can be established.

Negative consequences •

Her parents may be treated as outcasts in the JW community.

•

The doctor may face legal sanction.

The consequences of not transfusing her could be as follows: Positive consequences: •

The parents will be embraced by the JW community.

Negative consequences: •

Cardiac failure and death of a teenager

•

Depriving the baby of its mother (if the mother dies) 141

•

Prolonged hospital stay with risk of nosocomial infections (if the mother survives)

•

Delayed bonding with the baby

•

Higher costs of alternative iron replacement such as Hemopure®

Using a deontological approach, the treating doctors could argue that it is their duty to preserve life and this creates an obligation to transfuse the patient irrespective of the outcome. All doctors set out with a duty to do good and provide the best level of care possible. What about virtue ethics? What would a good doctor do? A good doctor would act with honesty and integrity. This would preclude administering the blood at night, for example, and deceiving the parents. Casuistry or case-based reasoning is a useful theory as we have two cases that have set legal precedent in South Africa – Hay v B – discussed in Chapter 6 and the leukaemia case discussed in Chapter 14. In Hay v B the baby was a newborn, and the leukaemia case involved a 12-year-old girl. In both cases the children were in life-threatening situations. In this case Ms P is 14 years old, not herself a baptised JW and she is not as yet in a life-threatening situation. •

What are the patient’s preferences? Ms P is 14 years old and not yet baptised into the JW faith. She has articulated her preference not to have a blood transfusion. However, she is also very uncertain and traumatised after the delivery. She is also under the influence of her mother, who sleeps in the ward and watches over her and the medical staff day and night.

•

What does your personal value system dictate? Usually, this will influence the final decision significantly. In South Africa, these value systems may be influenced by medical education, parental influence, political affiliations, religious beliefs and personal experiences.

•

What are the sociopolitical norms of the day? Are they acceptable? How will they influence medical decision making? In South Africa we have a firmly entrenched human rights culture that emphasises autonomy.

In step 2, the four-quadrant approach may also be useful. Exercise You can use the four-quadrant approach to construct a simple diagram with four blocks. Label each block accordingly – clinical indications, patient’s preferences, quality of life and contextual features. Consider the important factors in each quadrant. This is a useful tool to apply at the bedside when you encounter a clinical dilemma. You can incorporate this diagram into your patient notes. •

Quadrant 1 – Clinical indications

In this quadrant, the medical indications are very important: here we consider the harms and benefits of the proposed intervention, treatment goals and the extent to which these are attainable, the prognosis and alternative treatment plans. •

Quadrant 2 – Patient’s preferences

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Here we assess whether the patient is competent to take part in her medical decision making or not. If the patient is competent to consent, we need to establish what her understanding of the situation is and what her opinion is. If the patient lacks capacity to consent, prior preferences, including advance directives, must be considered. Surrogate decision making must also be explored. •

Quadrant 3 – Quality of life

This quadrant looks at the effect of the proposed intervention on the patient’s quality of life. How will further treatment affect mental, physical and social wellbeing? What decision is in the best interests of the patient? If an intervention will preserve life or prolong life, what is the value of prolonging or preserving life for the patient? •

Quadrant 4 – Contextual features

In this quadrant the feelings and wishes of the parents will be considered. Various religious and cultural factors will be explored. The doctor’s personal value system will be taken into account. Resource allocation is an important factor to consider. Professional guidelines and legal issues are included here (Sokol 2010).

12.4 STEP 3: ANALYSE THE INFORMATION Considering all the information gathered in step 2, you will go through a balancing process in which the various components are assigned different weights. It is important to confer different weights to the principles. Respecting patient autonomy does not mean that doctors must do exactly what patients request all the time. The obligation of informed consent created by the principle of respect for autonomy requires a thorough consent process to occur between doctor and patient. An inadequate consent process invalidates the weight carried by the principle of autonomy and tips the balance in favour of beneficence, i.e. acting in the best interests of the patient. In addition, you may use different approaches to the core problem and examine different outcomes. This process will culminate in the development of moral arguments to justify your position. Wellconstructed premises using logic and rationality will lead you to rational conclusions.

12.5 STEP 4: FORMULATE SOLUTIONS, MAKE RECOMMENDATIONS, THEN ACT In this step you consider possible solutions, make recommendations, and then act on the decision. Possible solutions include the following: 1. A treatment protocol for JW patients who decline blood transfusions may be developed. Such a protocol will include procedures that must be followed in emergency situations as well as nonemergency elective procedures. 2. For emergencies, accessing urgent legal guidance may be required, especially where the clinician decides to override patient autonomy. This is of special importance where minors are concerned.

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3. In elective, non-emergency situations, the establishment of a counselling team to consult with the patient before a final decision is taken is important. Consulting with colleagues is usually helpful. Involvement of the hospital JW representative regarding use of alternative forms of fluid replacement may be necessary. 4. A comprehensive consent document for competent adult patients to read before declining lifesaving treatment may be developed. 5. An educational video may be sourced or made to provide patients with information on the surgical process to be followed and the use of alternative forms of fluid replacement.

12.6 STEP 5: IMPLEMENT POLICY Policy may have to be implemented, created or amended in a medical institution such as a hospital as well as in a private medical practice. Any policy development will be based on how the case was handled in the end. Guidelines may have to be drawn up so that the management of a similar problem in the future is much clearer. These guidelines can be incorporated into the standard operating procedures of the clinic or practice. Table 12.1 An approach to ethical decision making Step 1: Identify the moral dilemma – what are the conflicting values? Step 2: Establish all the necessary information – medical, legal, ethical, sociopolitical norms; patient preferences; practitioner’s personal value system. Step 3: Analyse the information obtained. Step 4: Formulate possible solutions and make recommendations or take action. Step 5: Implement the necessary policies in institutions/private practice. Source: Adapted from the curriculum in medical ethics, courtesy of Dr Eugene Bereza, family physician/clinical ethicist, Department of Family Medicine, McGill University, Canada

12.7 THE OUTCOME OF THE CASE Ms P and her mother were counselled, but they continued to refuse the blood transfusion. The ethics consultant was of the opinion that Ms P’s competence to consent was questionable due to her emotional distress. The teenage pregnancy could have disempowered her in terms of her ability to negotiate her treatment preferences with her mother. If Ms P went into cardiac failure, it would be necessary to override the parental decision and transfuse. Until such time, the use of Hemopure® could continue as there was a donated supply of six units on the hospital premises. Haematinics and fluids continued for two weeks. On day 14 postdelivery, Ms P’s haemoglobin count was 8.9 g/dl, and she and her baby were discharged. Fortunately, in this case an alternate expensive intervention was available at a state hospital. If this had not been so, it may have been the parents’ responsibility to pay for the alternate treatment or remove their daughter to private care. It was also fortuitous that the patient did not go into cardiac failure. If she had, it may have been necessary to obtain a court order and transfuse her against the wishes of her parents.

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Consider the following case Case study 12.2 A 50-year-old man, Mr AB, was admitted to the surgical intensive care unit (ICU) following a motor vehicle accident in which he sustained a head injury and laceration of an arm. The arm laceration caused arterial rupture, blood loss, prolonged hypovolaemia and prolonged hypotension, necessitating intensive resuscitation, intubation and ventilation. He was unconscious on admission, and a CT scan of his brain revealed cerebral oedema, haemorrhagic contusions, punctate haemorrhages and a left-side base of skull fracture. He required mechanical ventilation and inotropic support. He became oliguric with severe renal failure (urea 36.0 mmol/l, reference range 2.1–7.1 mmol/l; creatinine 615 μmol/l, reference range 64–104 mmol/l) and required renal dialysis. After two weeks his renal function improved, both in terms of urine output and the level of urea and creatinine, and dialysis could be stopped. His neurological status, however, did not improve and he could not be weaned off ventilation. His abnormal neurological status was attributed to a combination of posttraumatic head injury, hypovolaemic shock from his arterial laceration and uraemia. A tracheostomy was performed to facilitate ventilation. After 40 days in the ICU, Mr AB improved and was weaned off the ventilator, but the tracheostomy tube was not removed. The plan was to transfer him to a general ward for supportive care. Neurologically he could open his eyes, but he remained obtunded and unable to communicate. The family setup was complicated. Mr AB was divorced with two adult children, and was in a long-term, stable relationship with Ms CD. His mother and sister were also involved in making decisions regarding Mr AB’s care. A conference was held regarding his further management with the family, as Mr AB was unable to comprehend his situation or communicate any preferences. The day after the family conference, a lawyer called the doctor in charge of the ICU, Dr YZ, to inform her that the family wanted him to get a court order to prevent transfer to the general ward. In the interim, the patient deteriorated with left lower lobe collapse, klebsiella pneumoniae septicaemia and deteriorating renal function. He required ventilatory and inotropic support again, and the question was posed as to how much longer Mr AB should receive life-supportive treatment. The case of Mr AB raises a number of ethical, legal and clinical questions. We will now examine it in more detail in an attempt to resolve this complex dilemma.

STEP 1: IDENTIFY AND ARTICULATE THE MORAL DILEMMA As a starting point, it is important to understand what a moral dilemma is. Beauchamp and Childress (2013: 11) describe moral dilemmas as “circumstances in which moral obligations demand or appear to demand that a person adopt each of two or more alternative actions” without being able to perform all the competing alternatives. In this case, the alternative actions are either to respect the wishes of the family and continue with ventilation, or respect the right of access of other patients to the ventilator and ICU bed. In this case, respect for autonomy and beneficence (acting in the patient’s best interest) conflict with distributive justice. 145

STEP 2: ESTABLISH ALL THE NECESSARY INFORMATION Prior to embarking on an ethico-legal analysis of this case, it is important to establish all the necessary medical and scientific information related to it. •

SCIENTIFIC AND MEDICAL INFORMATION 1. What is Mr AB’s neurological prognosis and what is potentially reversible? What role is the renal failure playing in his depressed neurological status? 2. Do we have expert opinions from the various clinical disciplines involved in the case? 3. Are there protocols in place in the ICU regarding prognostic indicators and length of ventilation? 4. Would an independent clinical opinion contribute to the clinical dilemma?

•

LEGAL MATTERS Which laws will influence your decision? Are there any HPCSA regulations that apply?

We do not have specific laws that deal with end-of-life issues in South Africa but there are HPCSA regulations on withdrawing and withholding treatment. The first question that we need to pose is: does the patient have a living will or advance directive? In this case, Mr AB did not have any form of advance directive. As a result, we need to explore the concept of surrogate consent. Who is the surrogate decision maker in this case – the partner or Mr AB’s mother? Clearly the ex-wife and sister are out of the picture as Chapter 2 of the National Health Act lists spouse/partner, parents, grandparents, adult child and sibling, in that order, as surrogate decision makers when patients are unable to make decisions for themselves. The “partner” should be seen as the primary decision maker in this case. If there is a major difference of opinion between mother and partner, hospital management would have to contact the state attorney’s office, and ultimately it may become necessary to approach the high court for a decision on who the surrogate decision maker should be in this case. The second legal issue to consider is liability for the hospital bill. This patient was classified as a “paying patient” in a state hospital. The partner would not be liable for the hospital bill unless she signed the admission agreement to pay. If the family is liable for paying the account, does this give them increased legal rights than if the patient were a state patient? Do we have any idea of what the hospital bill would be after 40 days of ventilation? Is the family aware of the hospital bill? If the family insists that the patient is kept on the ventilator, can the state hospital make arrangements to transfer him to a private hospital? •

ETHICAL ISSUES

What is the ethical standpoint? How do the four principles interact? Here we consider autonomy versus non-maleficence/beneficence, taking distributive and legal justice into account. The relevant principles 146

must be balanced against each other. What are the patient’s preferences? This is usually made known by a competent conscious patient. In cases of incompetence, advance directives or surrogate decision makers will indicate the patient’s preferences. Mr AB is unconscious and therefore unable to make autonomous decisions, so how should decisions be made for him? A substituted judgement standard could be used where the surrogate decision maker makes a choice that he or she thinks the patient would have made if he had been competent. Alternatively, the best interests standard (beneficence) could be used where the surrogate decision maker considers all the options and the risks and benefits associated with each one, then chooses the option with the greatest net benefit for the patient.

Non-maleficence: are we harming the patient by continuing therapy that will not translate into a good outcome? There is a degree of suffering and pain being experienced by the patient (recurrent arterial and venous punctures, ventilation, dialysis). Distributive justice: he has already been in ICU for 40 days. This means utilising a scarce resource for a patient with a guarded prognosis to the potential detriment of other patients. Whether the patient or a medical aid is paying, the same applies: limited resources that are not utilised responsibly.

How do the theories impact on this case? We ask whether a universal ethical theory such as consequentialism can influence patient management, especially when the consequence could include death. Were the outcomes considered at the outset and was the greatest good for the greatest number achieved? The consequences of continuing ventilation are as follows: Positive consequences •

Mr AB’s life will be preserved for longer.

•

His family will have more time to visit him.

•

There is a small chance of recovery.

Negative consequences •

His neurological status may not improve or may even deteriorate.

•

The family will witness his suffering and loss of dignity.

•

State resources are being used in a case with a poor prognosis.

•

Another possibly younger patient with a better prognosis is being deprived of an ICU bed.

The consequences of withdrawing ventilation are as follows: Positive consequences •

A patient with a poor prognosis will be allowed to die with dignity. 147

•

Morbidity will be reduced.

•

The family will be able to achieve psychological closure.

•

The financial strain on the family and the state will be reduced.

•

The bed could be made available to another patient with a better prognosis.

Negative consequences •

The potential for legal action by the family

•

Family conflict

•

The death of Mr AB

Using a deontological approach, the treating doctors could argue that it is their duty to preserve life, and this creates an obligation to ventilate the patient irrespective of the outcome. All doctors set out with a duty to do good and provide the best level of care possible. Alternately, a doctor might feel that it is his or her duty to minimise or remove harm and suffering. In a case of futility, the doctor might opt to withdraw ventilation. This approach would be used without taking consequences into consideration. What about virtue ethics? What would a good doctor do? A good doctor would act with compassion, honesty and integrity. It would be important to establish the clinical prognosis of this patient with a team of clinicians, nurses and a counsellor/social worker/clinical psychologist, and then to share this information with the family in a caring and compassionate manner. A good doctor also needs to know how to use his or her discretion in terms of withdrawing treatment in cases of futility. Casuistry or case-based reasoning is a useful theory that incorporates the precedent set by previous cases of a similar nature. We could consider other cases where it was necessary under similar circumstances to withdraw ventilation. What does the doctor’s personal value system dictate? Usually this will influence the final decision to a certain extent. In South Africa, these value systems may be influenced by medical education, parental influence, political affiliations, religious beliefs and personal experiences. If a doctor has a conscientious objection to withdrawing life support, then treatment of the patient must be handed over to another doctor. This raises the important question of whether a doctor who is unable to withdraw treatment when indicated should be employed in an ICU where these decisions need to be made on a regular basis. What are the sociopolitical norms of the day? Are they acceptable? How will they influence medical decision making? In South Africa we have a firmly entrenched human rights culture that emphasises individual autonomy. However, we also have a communitarian ethic in traditional African culture where communal rights may trump individual rights. At the same time, we also live with severe resource constraints in healthcare in South Africa, and patient autonomy and distributive justice must be balanced very carefully.

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STEP 3: ANALYSE THE INFORMATION Considering all the information gathered in step 2 will mean going through a balancing process in which the various components are assigned different weights. It is important to confer different weighting to the principles. Respecting patient autonomy does not mean that doctors must do exactly what patients or their families request all the time. The obligation of informed consent created by the principle of respect for autonomy requires a thorough consent process to occur between doctor and patient. When the patient lacks capacity to consent, the weight carried by the principle of autonomy is invalidated and the balance is tipped in favour of beneficence – that is, acting in the best interest of the patient. In addition, doctors may use different approaches to the core problem, and examine different outcomes. This process will culminate in the development of moral arguments to justify their position. Well-constructed premises using logic and rationality will lead to rational conclusions.

STEP 4: FORMULATE SOLUTIONS, MAKE RECOMMENDATIONS, THEN ACT In this step possible solutions are considered, recommendations are made, and the decision is acted upon. Possible solutions could include the following: •

Seeking an independent second clinical opinion

•

Discussing the prognosis of the patient with the partner, and then arranging a family conference as indicated

•

Consulting with the hospital’s clinical ethics committee

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Contacting the Medical Protection Society (MPS) for advice

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Withdrawing artificial ventilation after all necessary consultations

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Transferring the patient to a private hospital

RECOMMENDATIONS • • • •

The development of a standard operating procedure in the ICU for ventilation The development of a standard operating procedure to guide when a second clinical opinion is indicated and when the clinical ethics committee should be consulted Developing hospital policy to encourage patients to draw up advance directives or living wills Sourcing of or making a video to provide patients with information on ventilation and the need to withdraw it

STEP 5: IMPLEMENT POLICY Policy may have to be implemented, created or amended in a medical institution such as a hospital as well as in a private medical practice. Any policy development will be based on how the case was handled in the end. Guidelines may have to be drawn up so that the management of a similar problem in the

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future is much clearer. These guidelines can be incorporated into the standard operating procedures of the clinic or practice. OUTCOME OF THE CASE A week later the patient deteriorated and died. His prognosis was poor and the futility of further treatment was confirmed by his death.

12.8 CONCLUDING REMARKS Ethical decision making can be challenging at the best of times. The approach outlined above is intended as a guide to the decision-making process, and may need to be modified on a case-by-case basis.

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CHAPTER 13: Ethics in the Consulting rooms (Author: Keymanthri Moodley) By the end of this chapter you should be able to: • • • •

understand the importance of maintaining ethical standards in a practice appreciate the importance of training staff with respect to ethics understand the relationship between good clinical governance and ethics manage sexual harassment if it arises in a practice.

13.1 ETHICAL STANDARDS AND NORMS OF A MEDICAL PRACTICE Over and above the legal provisions set out by the Health Professions Council of South Africa (HPCSA) relating to the establishment and operation of a private medical practice, every medical practitioner also has ethical obligations to his or her patients. These ethical obligations are reflected in various ways in a practice. The ethical issues that arise in the consulting room and during the consultation itself are referred to as micro-ethical issues. They impact on the reception staff and all members of the medical team as they interact with patients in a practice. The case studies that follow illustrate some of these micro-ethical issues.

13.1.1 Advertising services Medicine is a well-established profession. As such, advertising of medical services has always been tightly regulated. In particular, canvassing of and touting for patients are strictly forbidden by the HPCSA. Advertising may vary from subtle attempts in the form of practice plaques, professional stationery and fridge magnets to more blatant attempts in the media where the intention is to capture the attention of potential patients. Consider the following case Case study 13.1 Dr A is a general practitioner who practises in an industrial area. The brass plaque outside the practice next to the front door has the following information: ‘Dr AA. A MBChB General practitioner Hypnotherapist Alternative homeopathic practitioner Medico-legal advisor.’ The claim to being a hypnotherapist is based on completion of a short course in “medical hypnosis”. Dr A has no documentary proof of attendance of an approved homeopathy course. His medical degree is valid and he has completed a diploma in medico-legal medicine. QUESTIONS 1. What do you think about his credentials? 2. If the plaque meets the legal requirements in terms of size and location, what do you think about the content? Are there ethical and/or legal violations regarding the content on the plaque?

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When we discussed the principle of beneficence in Chapter 6, we discovered that acquiring the knowledge and skills we claim to possess and providing these to the patient is an obligation of beneficence. This principle is clearly breached if a doctor claims to be able to provide homeopathic care in addition to Western allopathic medical care if he or she lacks the knowledge and skills to do so. Respect for patient autonomy requires one to tell the truth. Deceiving patients about what one is able to offer them shows lack of respect for their autonomy. In deceiving one’s patients, one is violating their rights. If a sense of fairness does not prevail in the treatment of patients, the principle of justice is violated. Finally, by advertising services that one is not trained to provide, the risk-benefit ratio is tilted in the direction of high risk and low benefit. As such, the concept of harm to the patient becomes an important issue and the principle of non-maleficence (do no harm) becomes significant. Using the principle-based approach to ethics, Dr A’s plaque illustrates how all four principles can be violated. One is also inclined to make a value judgement on the virtues and personal value system of Dr A. In addition, legal violations abound in this case scenario. In terms of the Health Professions Act No. 56 of 1974, a practitioner shall be allowed to advertise his or her services “… provided that the advertisement is not unprofessional, untruthful, deceptive or misleading” (HPCSA Booklet 2). If you were a patient, what would you prefer – a doctor skilled in general medicine who offers the care he or she is qualified to offer, or a doctor who masquerades as being able to offer a great deal more without the necessary training – and who might thus place your health, and even your life, at great risk?

13.1.2 Privacy in the reception area Respecting the privacy of patients is important from the time they enter the practice until they leave. Even though the reception area is a public area inhabited by reception staff and other patients, every effort must be made to ensure that the privacy of individual patients is maintained. Consider the following case Case study 13.2 Dr B has a general practice in a suburban area. When new patients come into the practice, their demographic and administrative details are entered into their patient records by the receptionist whose desk is in the open-plan reception area/waiting room. Mrs X is a new patient. She is questioned by the receptionist, who speaks rather loudly. Very personal information like her age, address, marital status and medical aid details are requested and provided to the receptionist, and other patients waiting in the reception area can hear the entire conversation. This makes Mrs X feel exposed, embarrassed and uncomfortable. PERPLEXING QUESTIONS 1. Of the four principles discussed in Chapters 4–7, which is violated the most? 2. Can patient details be obtained and recorded confidentially? 3. How can Dr B make changes in the practice to ensure this?

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COMMENTARY Like confidentiality, privacy is a requirement of the principle of respect for autonomy. Confidentiality usually refers to the importance of protecting patient information. Privacy refers to the importance of respecting the personal space of patients and is a prerequisite to maintaining confidentiality and hence respecting patients. It is extremely important that a sense of trust and comfort in the doctor-patient relationship is fostered from the moment a patient enters the practice. What options are available to preserve patient privacy? 1. The patient could be asked to fill in his or her own details, and this information can be entered into the folder by the receptionist later – in her own handwriting so that all records look uniformly neat. Alternatively, the information could be typed in. 2. In South Africa, many patients have been educationally disadvantaged and thus may be illiterate. For such patients, a private cubicle or area should be available where the receptionist can ask for and record their demographic and administrative information. This area should be out of earshot of other patients in the waiting area. 3. It is the responsibility of Dr B to ensure that his staff are thoroughly trained in ensuring the privacy of patients when completing patient records. QUESTION Do you have any other suggestions?

13.1.3 Privacy in the consulting rooms The doctor-patient relationship is based on trust. On entering the consultation room, patients cherish the expectation of privacy and confidentiality within the confines of a safe space. Privacy during the consultation is relevant during both history taking and examination. Consider the following case Case study 13.3 Dr C has a busy practice in a commercial area bordered by low socioeconomic housing schemes. The practice is arranged with a single reception area, but has a series of consulting rooms – five in total. There is a passage, which is common to all five consulting rooms, so that Dr C can move from one patient to the next with ease. There is almost always a patient in each of the five consulting rooms to save time for Dr C. Because individual consulting rooms are not sealed off, but rather interleading, the patient in the next consulting room is within earshot of the entire consultation from the room next door. One of his patients, Mrs M, presents with a vaginal discharge. PERPLEXING QUESTIONS 1. What level of privacy is offered to each patient? 2. Is adequate time spent on each consultation when a “conveyor-belt system” is used? 3. Is it possible to maintain confidentiality during each consultation? COMMENTARY 153

In the case above, it is evident that the consulting style constitutes a serious breach of privacy and confidentiality. Consulting patients using a “conveyor belt system” is most probably cost-effective and time-saving. To a utilitarian, it would represent a means of seeing the largest volume of patients as quickly as possible, with rapid financial gain. To the individual patient, however, it represents a loss of dignity. This consulting style shows blatant disrespect of one’s patients. In the outpatient clinics of state hospitals in South Africa, it is not uncommon for several doctors to share a large consulting room or for individual consulting rooms to have a common corridor. Under these circumstances, and given the sensitive nature of questions that must be posed, privacy may easily be breached. Doctors must elicit information about personal matters like bowel habits, bladder function, domestic violence, marital discord, vaginal discharges, sexual function, menstruation and contraception – all extremely sensitive questions that produce incredible discomfort at the best of times. The magnitude of this problem is exacerbated when there is a language barrier between doctor and patient, and the consultation is conducted using an interpreter. Private medical practices, on the other hand, often have individual consulting rooms, but may face different challenges. Here the privacy of the patient may be invaded by overbearing partners, spouses or family members who accompany the patient and assist with the provision of the history. In such circumstances, especially if the patient appears to be uncomfortable, it may be preferable to interview the patient alone initially and privately, and to invite family members or partners in later, but only if the patient is comfortable to do so. This may occur to a lesser extent in state health facilities as well. However, it may sometimes be culturally acceptable for several family members to accompany the patient on a medical visit in families where the concept of personhood differs from that in Western cultures and where the patient is quite comfortable and in fact prefers family members to be present during the consultation. This request should be respected. In all consultations it is imperative that the patient is granted privacy to undress and is provided with an examination gown. It is also essential that patients are not overexposed during the examination. This is crucial when patients are required to have intimate examinations, such as vaginal or rectal examinations and Pap smears.

13.1.4 Non-payment of consulting fees South Africa is home to a wide spectrum of patient populations from various socioeconomic groups. Inequities in healthcare abound between private and public healthcare services. While patients with medical aid attend private medical practices, those without any form of medical insurance must, of necessity, use public health clinics. Occasionally, uninsured patients present at private practices for care, either with a full cash payment or with a partial payment for the consultation fee. Consider the following case Case study 13.4 Dr D has a medical practice in a low socioeconomic area. Some of her patients belong to a medical aid, but most pay cash for services rendered. Ms Y is attending the practice for the first time. The receptionist ignores her for about five minutes while she is engaged in a personal telephone conversation. When she has finished, she attends to Ms Y. On discovering that Ms Y does not belong to a medical aid, her first concern is whether she has money to pay the doctor. She then turns the patient away when she realises that Ms Y is only able to pay half the consultation fee. Dr D is not consulted on this issue. 154

QUESTIONS 1. Is it ethical to turn away a patient who does not have enough money without the doctor establishing why the patient is there in the first place? 2. What training has the receptionist received from Dr D in respect of quality of service to be offered to patients? 3. Does the practice have a standard operating procedure (SOP) to deal with payments? COMMENTARY This case scenario highlights the crucial role played by the reception staff, either in a private medical practice or in a state health clinic. The receptionist forms an interface between the doctor and the public. As such, he or she is an important member of the healthcare team. If he or she is unprofessional, this represents a weak link in the healthcare team and creates a poor impression of the practice. As a practice manager it is the doctor’s responsibility to ensure that all reception staff employed have the necessary training and skills to function competently and professionally within the scope of the job description. It is often better to hire a suitably trained person for the job at a higher salary than someone who is inexperienced, untrained and, ultimately, financially exploited. The money saved in such a receptionist’s salary is often lost in dissatisfied patients and a bad reputation for the practice. In state health facilities, where patients endure many hardships along the way – from arriving at the health clinic very early in the morning to administrative delays and long waiting periods – having to deal with unfriendly or difficult reception staff results in an irate, angry, unhappy patient arriving in the doctor’s consulting room. This situation, if not managed diplomatically, could easily erode the doctorpatient relationship. It is evident that the receptionist contributes significantly to the ultimate reputation and success of the practice. It is therefore necessary that apart from the training in reception skills, the ethical nature of medical care is stressed to him or her. Often this will be the responsibility of the employer – and the need for respectful and fair treatment of patients must be encouraged. In addition, the importance of maintaining confidentiality at all times will have to be emphasised. In keeping with the theory of virtue ethics, the personal characteristics or virtues of reception staff and nurses are as important as the virtues of the doctor. The context or specific circumstances of a patient is important to bear in mind in cases of this nature. The issue of non-paying patients is a thorny one that is not easily solved. Each practice will manage this problem in its own way; however, it is important that a policy is established and that it is applied fairly and professionally to all patients. It is important also that individual cases are discussed privately with the doctor, who makes the final decision. A patient who is turned away by a receptionist without the knowledge of the doctor and who is later found to have had an emergency such as a myocardial infarct can pose serious medico-legal problems. From an ethical perspective, provision of emergency care is based on the principles of beneficence and non-maleficence (do good and do no harm). From a legal perspective, all healthcare practitioners (in both the private and the public sectors) are obliged to provide emergency medical care to all patients irrespective of their ability to pay for services (Chapter 2 of the National Health Act). Ultimately, it becomes the doctor’s responsibility if he or she has not given the receptionist specific directives on the importance of assessing patients before referring them to state health facilities. 155

THE OPTIONS WHEN PATIENTS ARRIVE FOR TREATMENT WITHOUT ANY MONEY 1. All such patients could be examined and given treatment irrespective of whether they will return to settle the account or not. 2. All such patients could be assessed briefly by the doctor and given a referral letter to the local day hospital, free of charge. 3. Provided it is not an emergency, the doctor may decide that all such patients will not be treated in the practice. 4. Only those patients in dire financial need will be seen and treated – at the doctor’s discretion. This will form part of the corporate social responsibility of the practice. 5. All such patients will be treated but future consultations will be permitted only if the account for the initial visit has been settled. Each medical practice can decide on the policy it wishes to adopt. Such a policy might be influenced by utilitarian principles, Kantianism (a sense of duty/obligation), liberal individualism (the rights of the doctor), communitarian theory (the good of the community) or virtue ethics (based on the personal traits of the doctor – compassion, integrity, altruism, and so on). What is important is that a policy exists and that staff members are aware of it and have guidelines to follow for such incidents. It is also important that such a policy is implemented in a non-discriminatory manner.

13.1.5 Employees and vicarious liability Medical practices vary from solo practices to large multidisciplinary group practices. While most solo practices comprise a doctor, a receptionist/nurse and a cleaner, large group practices function with a team comprising one or more receptionists, nurses and nursing assistants, and one or more doctors. From time to time, locum doctors may be employed by an individual doctor or by a practice. Doctors may not share premises with individuals who are not registered with the HPCSA; for example, a doctor may not share premises with a pharmacist or other commercial business partner. In large private group practices the receptionists, nurses and doctors are employees of the principal doctor. There may also be health professionals at the practice who function as independent contractors. A complex web of relationships may therefore exist in the medical team, especially from a medico-legal perspective. Consider the following case Case study 13.5 Dr E had employed a nurse, a receptionist and a cleaner to work in his consulting rooms. When the cleaner was done with her cleaning duties she was responsible for packing tablets and capsules into smaller containers and packets that could make up a course of treatment – for example 15 antibiotic capsules in a packet for a patient with pharyngitis. The cleaner would then pack 20 antibiotic packets into a box. After Dr E had examined patients and prescribed treatment, the nurse would dispense the prepacked medicines to them.

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Mrs Y had been known to the practice for several years. She had a penicillin allergy and so Dr E prescribed erythromycin for her bronchitis. The nurse handed her the antibiotics from a box labelled “erythromycin”. Later that day Mrs Y was taken to hospital after developing an anaphylactic reaction to the antibiotics. After resuscitating Mrs Y, the hospital doctors contacted Dr E to inform him that her medication pack labelled “erythromycin” actually contained penicillin tablets. Dr E discovered that the cleaner had made this error. Mrs Y took legal action against Dr E. PERPLEXING QUESTIONS 1. 2. 3. 4.

Is it acceptable for a cleaner to prepack medication in a general practice? Did the nurse have a dispensing licence? Did the doctor check the medication? From a legal perspective, who would be liable – the doctor, the nurse or the cleaner?

COMMENTARY All staff in a medical practice must receive adequate training for the roles they play in the medical team. All doctors who dispense medication to patients are required to have a dispensing licence in terms of the 1997 and 2002 amendments to the Medicines and Related Substances Control Act No. 101 of 1965. Registered professional nurses may complete a dispensing course and hold a dispensing licence. However, a cleaner may not prepack medication. Dispensing practitioners are required by law to dispense medication themselves to patients on an individual basis. That is, doctors must ensure that they check the bulk supply of antibiotics, for example, and count and pack the correct doses into a container or packet. The container/packet must be carefully labelled and handed over to the patient with instructions on how to use the medication. Any warnings associated with use of any medication must also be given to the patient by the doctor. The nurse could be responsible for dispensing provided she has a dispensing licence and has been trained by the doctor. The nurse in Dr E’s practice did not hold a dispensing licence. From a legal perspective, establishing responsibility for negligence is important. Vicarious or indirect liability refers to liability for the wrongful act of another. In the course of employment, if an employee does not act with the required amount of skill and care, harm will be caused to others. In order to decide if an employer is vicariously liable for the actions of his or her employee there must be an employer-employee relationship. In the legal claim launched by Mrs Y, Dr E would be vicariously liable for the harm caused by his employees. If Dr E had employed a locum, he would be vicariously liable for the actions of the locum. If, however, Dr E had another doctor in the practice who was functioning as an independent contractor and not as an employee of Dr E, and he was directly involved in an error with patient care he would be held liable for his own actions if they caused harm to a patient. It is important that these matters are clearly defined in all contracts of employment (Strauss 2005). Public hospitals can be held vicariously liable for the negligent conduct of their employees. In addition, employees can also be held individually liable. In terms of the Public Finance Management Act No. 1 of 1999, section 12(2), a public hospital may not accept liability for the negligent actions of an employee if the employee • • • •

intentionally exceeded his or her powers made use of alcohol or drugs did not act in the course and scope of employment acted recklessly or intentionally 157

•

made an admission that was detrimental to the state without prior consultation with the state attorney or failed to comply with or ignored long-standing instructions which led to damage/reason for the claim.

In the context of labour legislation in South Africa, every doctor who employs other staff must be familiar with the Labour Relations Act No. 66 of 1995 and the Basic Conditions of Employment Act No. 75 of 1997. It is advisable to conclude a contract with locum doctors before they start to work in the practice. This is particularly important when employing long-term locums. In such cases it is important to include a restraint of trade agreement in the contract so that locums are unable to open up their own practice within a specific distance from the original practice that employed them for a reasonable time period.

13.1.6 Sexual harassment in the practice Boundary issues within the context of the consultation have been described between male doctors and female patients. With the growing number of female doctors, problems are arising with male patients. In the context of the male doctor-female patient setting, traditional advice is that a female chaperone is present during the consultation, particularly for intimate examinations in general practice or gynaecology. Although the use of chaperones may protect both doctor and patient, it represents an invasion of privacy and patients may or may not agree to the presence of a chaperone. Ten best-practice points for the use of chaperones have been advocated by the Medical Protection Society (MPS) (2006): 1. Chaperones should be offered for intimate examinations. The doctor should consider what is “intimate” and judge this from the patient’s perspective. 2. If the doctor is the same gender as the patient it cannot be assumed that a chaperone is not necessary. 3. Religious beliefs may influence the patient’s decision regarding the use of a chaperone. Hence, doctors must be aware of and respect cultural decisions. 4. The most appropriate person to act as a chaperone would be a member of the clinical team. 5. The patient should be introduced to the chaperone before the examination proceeds. 6. The name and status of the chaperone must be recorded in the patient’s notes. 7. If the offer of a chaperone is declined by the patient, this must be documented in the patient’s notes. 8. If the doctor does not wish to proceed in the absence of a chaperone, this should be explained to the patient with reasons. The patient may then reconsider or agree to see a different doctor on another occasion. 9. A chaperone should never be forced on an unwilling patient. 10. Using a chaperone each time a patient is examined may be impractical – the doctor should use his or her discretion to decide when a chaperone is appropriate. Seeking consent from a patient for the use of a chaperone is a reflection of respect for patient autonomy. Where a female doctor and male patient are concerned, who should the chaperone be – a male nurse, a female nurse, a female receptionist or a male receptionist? Consider the following case Case study 13.6 158

Dr F is a young female family practitioner in private practice. Mr Z, a 30-year-old male patient, presents with vague complaints relating to his genitalia. After taking an adequate history, she examines him. No obvious pathology is found. She reassures him and asks him to return if his symptoms become more specific or change in any way. On exiting the consulting room, Dr F hears Mr Z tell his friend in the consulting room that “she made me take off my pants”. On his way out, Mr Z leaves a note with the female receptionist with all his contact numbers together with a cryptic message. He asks her to give this note to Dr F. PERPLEXING QUESTIONS 1. 2. 3. 4.

Can this be regarded as sexual harassment? If so, can this situation be prevented? What effect does it have on the doctor-patient relationship? Does the female doctor have individual rights?

COMMENTARY Sexual harassment refers to behaviour typically experienced as offensive, by means of which sexual approaches are made within the context of a relationship of equal/unequal power or authority. Sexual harassment is a form of discrimination on the grounds of gender. It is unwanted and may be experienced as an expression of power, authority and control of a sexual nature. It creates a hostile environment that impedes the individual’s capacity to learn and/or work (Stellenbosch University: Sexual Harassment Policy). Very few guidelines exist where matters of sexual harassment are concerned. At best, each case should be handled on its merits depending on the circumstances. If a female doctor is attracted to a patient and would like to explore a personal relationship with him, she needs to terminate the professional relationship and refer him to another doctor. If she is uncomfortable with the behaviour of a patient, and it is in keeping with the definition of sexual harassment, she also needs to terminate her professional relationship with him. If it is clear that no emergency treatment is required, she is not obligated to treat him further and is at liberty to refer him elsewhere for medical treatment. The National Health Act supports such a decision. If necessary and in cases of persistent harassment, a report may need to be lodged with the police. The same holds true for a male doctor being harassed by a female patient. If a member of the medical team, for example a nurse, is harassed by a patient in a private practice, it is the responsibility of the employer to investigate, warn the patient accordingly and ensure that the employee does not have to treat that patient in future in non-emergency situations. It is also possible that harassment can occur in the opposite direction, i.e. doctors may sexually harass patients. Doctors have been found guilty of sexual misconduct or of violating patient-practitioner boundaries for the following reasons: vulnerability due to personal or professional stress; psychiatric disorders, especially affective disorders; personality disorders; or substance abuse. Because such behaviour violates the trust essential in the doctor-patient relationship, it is important that preventive measures are taken to avoid misunderstanding on the part of patients and to ensure appropriate behaviour on the part of doctors.

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13.1.7 Access to medical records Medical records are an important medico-legal component of the consultation and the medical practice. While records are housed in the practice, clinic or hospital, individual patients may request access to their records at various points in time. Consider the following case. Case study 13.7 Mrs M was a patient in Dr G’s medical practice for five years. She was last seen two years ago. While Dr G is out to lunch she visits the practice and requests her patient folder and X-rays. The receptionist looks for her folder but is unable to find it. Mrs M insists that she is entitled access to her records. The receptionist then informs Mrs M that her records might have been destroyed a year ago as she had not been to the practice for a very long time. Mrs M becomes very angry and threatens legal action. QUESTIONS 1. 2. 3. 4. 5. 6.

As a private patient does Mrs M have the right of access to her records and X-rays? How long should medical records be kept before they are destroyed? If this were a public hospital, how would the rules differ? Should the receptionist have consulted Dr G first? Should there be a standard operating procedure (SOP) outlining record management? Should the receptionist be aware of this SOP?

COMMENTARY Keeping medical records is compulsory. This is both a professional and a legal requirement (HPCSA; National Archives of SA Act No. 43 of 1996; Promotion of Access to Information Act No. 2 of 2000; National Health Act No. 43 of 2003). At a minimum the following information must be contained in medical records in South Africa (adapted from HPCSA guidelines on keeping of patient records): 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

Personal identifying information about the patient The bio-psychosocial patient history including allergies and idiosyncrasies Time, date and place of each consultation Assessment of patient’s condition Proposed clinical management and treatment given Medication and dosage prescribed Details of referrals to specialists, if any Patient’s reaction to treatment, including adverse events Test and imaging results Times patient was booked off work and reasons Written proof of informed consent where applicable

All patient notes must be signed off: Any student, intern or practitioner who, in the execution of his or her professional duties, signs official documents relating to patient care such as prescriptions, certificates, patient records, hospital or other reports, shall do so by signing such document next to his or her initials and surname in block letters (HPCSA Rule 14). 160

Furthermore, it is important that notes are kept in indelible ink and that erasure fluid is not used. Information should never be removed from a medical record. An error should be deleted in black ink and corrected. The date on which the correction was made must be entered and signed off in full. An explanation should be entered in the patient records. Handwriting must always be legible to allow other members of the medical team to continue with medical care in the absence of the original doctor. Notes should be updated as treatment progresses. New dates and times must be added when new notes are added. All patient records must be stored in a safe place. Electronic records must be password protected. According to the National Health Act: The person in charge of a health establishment in possession of a user’s health records must set up control measures to prevent unauthorized access to those records and to the storage facility in which, or system by which, records are kept. Keeping family records is a common practice, but should be avoided as this can sometimes lead to breaches of confidentiality or confusion of medical information, with the diagnosis of one family member being mistakenly attributed to another. Records must be stored for a minimum of six years from the date they became dormant. In the case of children this period may be longer, and discretion must be used in the length of retention of records. Consider the following case Case study 13.8 Mr Y presents to the consulting room of Dr O on a Wednesday morning requesting a medical certificate. The receptionist informs him that he must be seen by the doctor before a medical certificate can be issued. Mr Y informs Dr O that he has not been to work on Monday and Tuesday due to a headache. Dr O examines Mr Y and is unable to find anything physically wrong with him. He issues a medical certificate indicating that Mr Y has been ill from Monday to Thursday inclusive. The employer calls the practice to query the certificate. COMMENTARY It is important for every medical practice to have a clear policy around the issuing of medical certificates. The HPCSA has a number of rules relating to medical certificates. The receptionist was correct in advising the patient that he would need to be examined by the doctor first in terms of rules 16(1)(e) to 16(1)(g) that stipulate that a medical certificate should be issued only on the basis of a proper medical examination and diagnosis of a patient, and not on the mere observation of a patient. Dr O, however, was not very clear on the provisions of rule 16(1), which specifies that a medical certificate should contain the following information: a. b. c. d. e.

f.

The name, address and qualification of the healthcare practitioner The name of the patient The employment number of the patient (if applicable) The date and time of the examination Whether the certificate is being issued as a result of personal observations by such practitioner during an examination, or as a result of information which has been received from the patient and which is based on acceptable medical grounds A description of the illness, disorder or malady in layman’s terminology with the informed consent of the patient, provided that if such patient is not prepared to give such consent, the practitioner 161

shall merely specify that, in his or her opinion based on an examination of such patient, such patient is unfit to work g. Whether the patient is totally indisposed for duty or whether the patient is able to perform less strenuous duties in the work situation h. The exact period of recommended sick leave i. The date of issue of the certificate j. The initials and surname in block letters and the registration number of the practitioner who issued the certificate In the event that a patient requests leave retrospective to the date of the consultation, it is necessary for the medical practitioner to indicate that he or she was informed by the patient that he or she was unfit to work on those days. The date of examination of the patient must be clear. In terms of rule 16(2), read with rule 15, medical certificates are official documents and must be personally and originally signed by a medical practitioner next to his or her initials and surname, which must be printed or written in block letters. The signature must be legible. While it is not necessary to write a diagnosis on a medical certificate without the patient’s consent and while the employer does not have the right to know the diagnosis, he or she can query the date on which the patient presented to the practice and whether the patient was unfit for work. Finally, it is the doctor’s responsibility to ensure that his or her certificate book is stored safely at all times. There are a number of cases where medical certificates are removed from a consulting room and fraudulently issued in communities by individuals who are not authorised to do so.

13.2 CONCLUDING REMARKS This chapter has provided insight into the ethical, legal and professional rules that govern consultation and practice management. The case scenarios described highlight some of the ethical problems one may encounter in one’s consulting rooms. The list is indeed endless! The HPCSA website has several booklets relating to practice management issues for further reading. It is the responsibility of practitioners to familiarise themselves with the relevant rules and guidelines. The Consumer Protection Act No. 68 of 2008, which was enforced in April 2011, adds a legal dimension to many of the issues discussed in this chapter. Please refer to Chapter 10 for more information on the Consumer Protection Act.

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CHAPTER 14: Paediatric Ethics (Author: Sharon Kling and Mariana Kruger) At the end of this chapter you should be able to: • • • • • •

understand that children have rights and that healthcare professionals must respect those rights and advocate for the child know which paediatric healthcare-related rights are entrenched in the South African Constitution understand that decisions for children are usually made using the “best interests” principle, and what that means know the legally defined ages at which children may consent to healthcare-related tests, treatment and research understand how to involve children in decision making regarding their own healthcare and participation in research understand the framework for withholding and withdrawing life-sustaining therapy (LST) from critically ill children.

14.1 INTRODUCTION The involvement of children in healthcare decision making is a relatively recent development. Customarily, children were regarded as being unable to make decisions, and their parents were entrusted with this responsibility. Two main reasons are responsible for this change. Firstly, there is the increased emphasis on human rights and the recognition that children also have rights. Secondly, it has been recognised that children have the capacity to be involved in healthcare-related decision making according to their age, development and experience. Doctors are frequently confronted by difficult decisions regarding consent, confidentiality and refusal of treatment by children and young people. Sometimes children and parents disagree regarding treatment. In this chapter we hope to provide some guidance to healthcare professionals about decision making in children, with explication of the ethical and legal issues.

14.2 CHILDREN’S RIGHTS AND HEALTHCARE The Convention on the Rights of the Child (CRC) was adopted by the General Assembly of the United Nations in 1989, and has subsequently been ratified by 192 countries, including South Africa, which did so in 1995 (Unicef 1989). It was endorsed rapidly and by more governments than any other human rights instrument, with only the US and Somalia not having ratified it as yet. The CRC was born out of the recognition that children are deserving of special care, help and protection. A child is defined as any person younger than 18 years. The Convention specifies compulsory obligations on all governments to protect and promote the rights of children that are necessary to fulfil their needs, and makes provision for monitoring of these governments. It guarantees children the three Ps: protection from maltreatment, neglect, exploitation; provision of food, healthcare, education, social security; and participation in all matters concerning them (Reynolds 1999). Adults are comfortable with the first two Ps, but not that comfortable with the last one. Four of the most important underlying principles of the CRC are tabulated below: 163

Underlying principles in the Convention on the Rights of the Child •

Article 2. All the rights in the Convention apply to all children without discrimination on any grounds.

•

Article 3. In all actions affecting children their best interests must be a primary consideration.

•

Article 6. All children have the right to life and optimal survival and development.

•

Article 12. All children capable of expressing a view have the right to express that view freely and to have it taken seriously in accordance with their age and maturity.

The implications of the CRC for health professionals are the recognition that children have rights and that these rights impose certain duties on adults. Health professionals are required to respect children’s rights and act as advocates for children to promote their health and survival. What are the rights of child patients in hospital, and how should healthcare professionals and students approach the examination of sick children? Consent to examine children should be taken from their parents and from the older children themselves. A children’s rights charter should include the right to privacy and to be asked before anyone touches them. It is important for healthcare professionals or students to explain their role and why they want to examine the child. The explanation should include the fact that the clinical examination is important for the child’s health, but can also be an educational exercise and that the child may refuse to be examined, in which case the refusal will be respected, but that permission to examine the child will be appreciated. If the child becomes agitated or distressed, the examination should stop (Hope, Frith, Craze & Mussai 2005; Craze & Hope 2006).

14.2.1 Children’s rights in South Africa Children’s rights are specified in section 28 of the Bill of Rights (Chapter 2 of the South African Constitution 1996). Section 28(1)(c) states: “Every child has the right to basic nutrition, shelter, basic health care services and social services.” The problem is that nowhere is the concept of “basic health care services” explained in more detail. Does it mean that the government has to supply only a fixed package of these services for all children, or does this also include healthcare for children with special needs that may be rare or expensive to treat, but that they need in order to continue to exist, grow and develop? Usually, healthcare budgets are based on the burden of disease and preventive medicine such as national immunisation programmes. Basic healthcare services will therefore be country specific, and healthcare professionals should actively advocate for what they deem is essential in “basic health care services” for children. Children with disabilities and special needs also have the right to appropriate healthcare.

14.3 HOW ARE DECISIONS MADE FOR PATIENTS? Autonomous persons are capable of making decisions for themselves provided that they are given all the information required to make such decisions (see Chapter 4). If they are unable to make decisions for themselves, someone else, a surrogate decision maker, is tasked with this. The surrogate decision maker may make a decision on treatment based on what he or she thinks the incompetent person would have decided if that person were competent – this is termed the “substituted judgement standard”. Children are evolving in their cognitive ability and therefore have evolving capacity to 164

develop autonomy. In the case of children who are not yet competent to decide for themselves, the “best interests standard” is applied (Beauchamp & Childress 2013; Kopelman 1997, 2007).

14.3.1 The concept of “best interests” The guiding principle in dealing with children is the “best interests” principle, which is the standard used to assist persons lacking in autonomy. Depending on the child’s capacity for understanding, he or she may not be autonomous and able to make a truly informed decision. In this case, the parents, legal guardian or caregiver will have to decide for the child. On what basis should this decision be made and what does “best interests” mean? The best interests standard is employed in South African law: section 28(2) of the Bill of Rights states: “A child’s best interests are of paramount importance in every matter concerning the child” (also in Children’s Act No. 38 of 2005, Chapter 2, section 9). With regard to healthcare, section 28(1) (c) states that every child has a right “to basic nutrition, shelter, basic health care services and social services”. In healthcare, “best interests” usually refers to the best treatment available in a given healthcare context and does not literally mean the best treatment, as it may not be affordable in countries with limited resources. Healthcare policymakers also use best interests to determine healthcare priorities for children, for example the universal immunisation policy. The physician should therefore assess what resources are available and what potential benefit is expected. The best interests standard is also used in custody issues (parental divorce, child abuse) to determine the best environment for the child to live in. The difficulty with the best interests standard is that it is not always obvious in any given situation what the best interests of the child are. “Best interests” is usually interpreted to mean the “highest net benefit among the available options that apply to any situation in which a decision has to be made regarding the health of the child” (Beauchamp & Childress 2013). It applies to decisions that affect individual children, such as the decision to treat, the nature of the treatment and how that treatment is administered. In cases where medical treatment carries low risk and offers substantial benefit to the patient, it is generally thought to be in that person’s interests. According to Beauchamp and Childress (2013), “[t]he best interests standard protects another’s well-being by assessing risks and benefits of various treatments and alternatives to treatment, by considering pain and suffering, and by evaluating restoration or loss of functioning”. It is thus a quality-of-life criterion. Other factors also need to be taken into consideration, however, such as the child’s ability to participate in any decision making, the views of the parents and family, implications of treating or not treating, effectiveness and side effects of the treatment, and risks from delayed treatment or not treating. Any assessment of “best interests” must take into account the physical, emotional, social, cultural and psychological needs of the person. Criticisms of the “best interests” standard are that it is unrealistic, too narrow and too focused on the incompetent or incapacitated person’s interests or does not respect the family (Salter 2012). However, Kopelman (1997, 2007) argues that it does not require what is ideal but what is reasonable, given the available options. In other words, it should also take into account the needs and rights of others. This would apply in a resource-limited setting where it may be in one child’s interests to be admitted to an intensive care unit (ICU), but these have to be weighed against the needs and interests of other children (who may in fact have a better prognosis and therefore a stronger claim to the ICU bed).

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Consider the following case Case study 14.1 Ashley X was born in 1997 in Seattle, Washington, in the US. She was diagnosed with static encephalopathy, which meant that she had developmental and cognitive impairment. She remained at a developmental level of three months – unable to walk, talk, eat, sit or roll over. In 2004, Ashley’s parents and doctors at Seattle Children’s Hospital devised the “Ashley treatment” which consisted of high-dose oestrogen therapy to stunt her growth, a hysterectomy to “prevent menstrual discomfort”, and removal of her breast buds to limit breast growth. The parents contended that this therapy was to “improve our daughter’s quality of life and not to convenience her caregivers”. The story was published in the Los Angeles Times of 3 January 2007, when Ashley was nine years old. Her parents said that keeping Ashley small would make it easier to carry her around and care for her, and they termed her their “pillow angel”. Source: Liao, Savulescu & Sheehan 2007 COMMENTARY We can ask whether we believe that these treatments were in Ashley’s best interests. Did they truly improve her quality of life or were they designed to make things easier for her family? Was she treated with dignity and respect? We believe that performing a hysterectomy on Ashley may have been justifiable for her comfort, but the other “therapies” are much more difficult to defend. According to Liao et al. (2007), this brings up concerns about the ethics of “body modification”. The concept of “best interests” does not apply only to individual children. It should also be applied to children’s best interests within the health service as a whole, and should be taken into account when considering allocation of budgets, research involving children, waiting lists for medical or surgical treatment, and access to treatment. Children do not have access to policy-making bodies; they do not have the vote and frequently are unable to advocate for themselves. It therefore happens all too often that children’s rights and interests are ignored in favour of those with more power.

14.3.2 The “harm principle” Sometimes the best interests standard provides insufficient guidance when making decisions for children. In particular, if there is a difference of opinion between parents and healthcare professionals as to what is in a child’s best interests, the standard may be difficult to apply. One alternative that has been suggested is to use the “harm principle”. This derives from the government’s permitted power to intervene in the area of health and safety if the aim is to prevent harm to other people (Diekema 2004). If we apply this to decision making for children, the harm principle could serve as a minimum threshold to determine the limits of parental authority. It aims at protecting the child, rather than respecting the child’s interests (Hester 2012). An example of this would be if parents who belong to the Jehovah’s Witness faith refuse consent for a blood transfusion in their young child whose life is threatened by acute blood loss. However, what if parents refuse to have their child immunised because they believe the immunisation may cause autism in the child? We could argue that it is both in the child’s best interests to be immunised, and that the child would be at risk of serious harm if he or she is not immunised. In this case, however, it is much more difficult to invoke the harm principle to override the parents’ decision (Diekema 2004).

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14.4 CHILD ABUSE AND NEGLECT Children are among the most vulnerable members of our society, and for this reason they need special protection. In section 28(1)(d) of the Bill of Rights, it is stated that: “Every child has the right to be protected from maltreatment, neglect, abuse or degradation.” The Children’s Amendment Act No. 41 of 2007 increases the range of the group of professionals that are legally obliged to report abuse of children under section 110(1) to include medical and dental professionals; midwives; physio-, speech and occupational therapists; psychologists; homeopaths; traditional health practitioners; traditional leaders; and staff at child and youth care centres. The areas that are covered by this mandatory reporting are sexual abuse, psychological abuse, physical abuse causing injury, and deliberate neglect. Some of the indicators of deliberate neglect specified in the legislation include underweight and signs of protein energy malnutrition. The report must be made to a child protection organisation (e.g. Child Welfare), the provincial department of social development, or a police official. Generally speaking, child abuse “refers to actions (or failures to act) by a parent or caregiver that result in serious physical or emotional harm, sexual abuse or exploitation, or imminent risk of serious harm” (Levi 2008). The National Department of Social Development (2004) defines abuse as all forms of physical and/or emotional ill-treatment, sexual abuse, neglect or negligent treatment, or commercial or other exploitation resulting in actual harm to the child’s health, survival, development or dignity in the context of a relationship of responsibility, trust or power. In South Africa, the incidence of both physical and sexual abuse of children is extremely high. This is linked to poor socioeconomic circumstances, overcrowded homes, the patriarchal society prevalent in many areas, and high unemployment levels (Richter & Dawes 2008). The role of the healthcare professional is to recognise abuse as well as potential abuse, and then to act appropriately. However, value conflicts may arise when faced with children from different traditions and cultures, and from poor circumstances (Webb & Moynihan 2010). It may be difficult to define maltreatment in the context of the child. When does spanking a child cross the line and become a physical beating? When is suspicion of abuse sufficiently reasonable to justify mandatory reporting (Levi 2008)? The case of a 19-day-old baby presenting with an apparent spontaneous nosebleed while lying in his cot was reported from Leicester in the UK (Walton & Davies 2010). The baby had blood crusting both nostrils but was otherwise well. He was seen by a junior emergency department (ED) doctor and sent home after discussion with a senior doctor who did not see the child. Thirteen days later the baby returned with a skull fracture, intracranial haemorrhages, and various lower limb fractures. The authors recommend that isolated nosebleeds in an infant should raise the suspicion of abuse, and the baby should be admitted for observation and investigation, including social evaluation.

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Consider the following cases Case study 14.2 Dr B, a mental health professional, is phoned by a woman who asks her to help her as she thinks her husband is sexually abusing her four-year-old daughter. Her GP, Dr C, has referred her to Dr B. Dr B offers to see her the next day, but the caller asks, “You won’t report this, will you?” When Dr B explains that under South African law she is mandated to report it, the caller puts down the telephone. Dr B realises that she does not know the caller’s name, and phones Dr C, who refuses to disclose the name, saying that he does not want to get involved in the case. Source: Adapted from Bourne, Newberger & White 1991 COMMENTARY Dr B is correct in telling the mother that she has to report the case. What should she do now that Dr C refuses to get involved? She should point out to him that he is obliged to provide her with the information regarding the caller, and then she should follow it up by reporting the telephone call to social welfare for further investigation. The reluctance of medical professionals to become involved in reporting and testifying has been compounded by rulings against prominent paediatricians in the UK (Jenny 2007; Mathews, Payne, Bonnet & Chadwick 2009). Professor Sir Roy Meadow, an eminent British paediatrician, testified in a number of child abuse cases. His testimony in the Sally Clark case resulted in her being wrongly convicted in 1999 of murdering her two baby sons, who died 13 months apart, at the ages of 11 and eight weeks respectively. Sir Roy testified that two deaths in one family were highly unlikely to be due to sudden infant death syndrome (SIDS) and that he did not believe that either child died as a result of SIDS. Clark was found guilty of murder. She was imprisoned for three years and released in 2003. She died in 2007 of acute alcohol poisoning, having never recovered from her ordeal. The General Medical Council (the British equivalent of the Medical and Dental Board of the HPCSA) withdrew Sir Roy’s licence to practise medicine in 2005. He was reinstated in 2006 after an appeal, but other paediatricians have been intimidated by the press and parents, resulting in a reluctance to become involved in child abuse cases. According to Levi (2008), the difficulty is precisely that the laws designed to protect children may endanger the child’s safety, and the healthcare professional may believe that refraining from reporting may in fact be in the child’s best interests. This course of action is potentially dangerous, both for the child and for the healthcare professional, who may face legal sanction.

Case study 14.3 A four-year-old girl is brought to the emergency department by her mother, with a short history of cough, runny nose and fever. The doctor notices a swelling on the side of her head and a number of bruises on her body. The mother says that the child fell off the top bed of a double bunk, and the child does not contradict her story. At this stage the mother starts to become agitated and tells the doctor that the child’s father will be wondering why they have been away from home for such a long time.

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COMMENTARY On further questioning, it becomes apparent that the “father” is not the child’s biological father, but the mother’s current boyfriend. He abuses alcohol on occasion. There is no record of previous physical injury in the child’s hospital or clinic record. Physical examination of this child reveals an upper respiratory infection, but no evidence of any serious injuries. A fall from the upper bunk is a plausible explanation for this child’s bruises, but there are some worrying features in this case. Unless the doctor is convinced that this child is not at risk for further injury, the safe decision would be to admit the child and report this as suspected physical abuse. In the hospital environment, the hospital social worker would be the appropriate official to manage the case further. In this way, the child’s circumstances can be investigated, and her security protected.

14.5 CHILDREN AND CONSENT: ETHICS ”Bioethics is still dominated, though, by outdated Piagetian age-stage theories of child development that tend to emphasize children’s ignorance, inexperience, and inability to make truly informed autonomous decisions, as if the mind and conscience grow as slowly as the body.” (Alderson, Sutcliffe & Curtis 2006). Article 12 of the CRC states: “Children have the right to express their view freely and to have it taken seriously in accordance with their age and maturity.” Currently we recognise that children should be involved in decision making when any treatment is considered. Children as young as seven to eight years old may demonstrate decisional ability, and the capacity for abstract thought is achieved at about 14–16 years of age. Weithorn and Campbell (1982) showed in their studies that children aged 14 years and older have decision-making capacity regarding their own medical treatment, but often defer decision making to their parents. This finding was not statistically significant. Younger children of nine years of age also have decision-making capacity, but will defer decision making to their parents – a statistically significant finding (Weithorn & Campbell 1982). Article 12, however, carries broader implications: it imposes an obligation on adults to respect the rights of children who are able to express their views and to take these views seriously when decisions affecting them are made. This does not mean that their wishes must always be acceded to, but it does mean that their views must be taken into consideration when making decisions that affect them. In order for children to be able to participate in the decision-making process, they must be given full information in a format that makes it understandable for them. Research has shown that children want to be informed, even if the information is distressing or painful. “The central message is that the child is a subject of rights, not merely a beneficiary of adult good will and as such must be included as an actor in the decision making process” (Lansdown 2000). The prerequisites for informed decision making in children are the same as for adults, and are detailed in Chapter 5. Any child who possesses a stable value system, and has the ability to understand the information relevant to the decision(s), to deliberate the consequences of the options, and to make decisions that reflect his or her own value system has the capacity for decision making (Ackerman 2001). It is important to consider the child in the context of the family while at the same time respecting the child’s ability to make decisions. 169

There are three levels of decision-making capacity in children from infancy to the teenage years: 1. Lacking decisional capacity 2. Developing decisional capacity 3. Developed decisional capacity Some problems with children’s roles in decision making include the difficulty of judging the child’s capacity to make a decision, the lack of standards for judging competency, and how much weight should be attached to the refusal of medical therapy (Kenny, Downie & Harrison 2008). The development of decisional capacity is detailed in the following list. Development of decisional capacity in children: (Source: Kenny et al. 2008) a. Children with no communication (newborns, young children) b. Children with some communication but no decisional maturity (younger school-aged children) c. Children with some communication and developing decisional authority (older schoolaged children) d. Children with decisional maturity (equivalent to adult capacity and mature and emancipated minors) The factors to be taken into account in assessing children’s capacity to consent are listed below (King & Cross 1989): 1. Reasoning: i.

Age

ii.

IQ

iii.

Cognitive functioning

iv.

Emotional functioning

2. Understanding i.

Experiential factors (what the child has experienced previously)

ii.

Knowledge of the problem

3. Voluntariness i.

Uncoerced patient decision (valid consent requires freedom of choice)

4. The nature of the decision to be made i.

Gravity (e.g. having an intravenous line put up as compared with major surgery)

ii.

Urgency of the decision (emergency treatment)

iii.

Risk-benefit balance 170

Appropriate involvement of children in decision making includes the following: •

Infants – unable to participate or understand any information, thus comfort is essential

•

Young children who have no decisional capacity but good understanding of language – the treatment should be explained (i.e. information sharing)

•

Mature minors – should be given full information with the moral authority to make a decision (Kenny et al. 2008).

In young children incapable of giving consent but able to understand the tests and treatment that they will undergo, the term “assent” has been used as a bridge between no patient participation and full decision making. This is seldom used in acute clinical care, but is used for children with chronic illness who understand their disease and treatment, as well as in paediatric research from the age of seven years onwards. Consider the following case Case study 14.4 Hannah Jones aged 13 years, from Herefordshire in the UK, has had a cardiomyopathy following treatment for leukaemia since the age of four years. Her only chance of survival is a heart transplant, but she says she has had enough of hospitals, and wants to spend the rest of her life at home, not in hospital, and refuses surgery: “I have been in hospital too much – I’ve had too much trauma. I don’t want this, and it’s my choice not to have it.” Her parents support her decision, although they are heartbroken at the thought of losing her. Source: BBC News QUESTIONS 1. Do you think that Hannah’s decision to refuse further treatment should be respected, or should she be forced to undergo a heart transplant? 2. What factors should be considered in your deliberations? 3. In Hannah’s case, the hospital obtained a court order to force her to have a heart transplant. Do you think that this was appropriate? COMMENTARY Hannah is 13 years old, but has lived through nine years of chemotherapy and repeated hospital admissions for her cardiomyopathy. Because of these experiences her refusal of further treatment, especially an operation as major as a heart transplant, should be respected, provided she has been counselled and fully understands the implications of her refusal. In other words, her autonomy should be respected. In this case, the fact that her parents support her lends weight to her decision. It would be inappropriate to try to force her to have a heart transplant. Hannah subsequently convinced the court not to force her to undergo the surgery. Interestingly enough, Hannah went into kidney failure a few months later and changed her mind, deciding to undergo the heart transplant. She has subsequently done extremely well and is currently back at school. This case illustrates how difficult it can be to respect decisions to refuse treatment when they have such grave implications. The tension here lies between respecting the autonomy of the child and beneficence –

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what is in the child’s best interests? The next case is slightly different – the consequences may not be as grave, but they do hold significant implications for the patient and the doctor-patient relationship.

Case study 14.5 Mary, aged 14 years, has been Dr X’s patient for many years. She consults him because she is sexually active and wants him to prescribe contraceptives for her, but she asks him not to tell her mother. What are Dr X’s options? What should Dr X do? Source: Adapted from Melnick 2007 COMMENTARY Dr X’s options are the following: • • • • •

Call Mary’s parents. Tell Mary that what she is doing is wrong and refuse to prescribe contraceptives. Refer Mary to the family planning clinic. Prescribe the contraceptives but tell Mary she has to inform her parents. Prescribe the contraceptives, counsel Mary, and advise her to confide in her parents.

The first two options would destroy the doctor-patient relationship between Dr X and Mary, and would do her a disservice. She has already made the decision to become sexually active, and not prescribing contraceptives would not be in her best interests as she may become pregnant. Calling her parents would betray patient confidentiality and would probably not result in altered behaviour. Referring Mary to the family planning clinic would allow her access to contraceptives, but would be deferring the responsibility to someone else. This is, however, a viable option if Dr X is not comfortable with prescribing contraceptives. Options 4 and 5 acknowledge Mary’s autonomy, respect her confidentiality, and also try to foster a good relationship with her parents. At the same time Dr X is helping her to understand the possible risks of her sexual activity. The authors believe this is what the “good doctor” would do. He could even offer his assistance to help Mary inform her parents. In terms of South African legislation, the doctor is permitted to prescribe contraceptives to children over 12 years of age. So, what would he do if Mary was 11 instead of 14 years old? Some doctors would refuse to prescribe contraceptives, using the law to justify their actions. Is the higher moral option not option 5, even for the younger girl?

14.6 CHILDREN AND CONSENT: THE LAW The guiding principles of the Children’s Act No. 38 of 2005 regarding the participation of the child in decision making are stated in Chapter 2, section 10: “Every child that is of such an age, maturity and stage of development as to be able to participate in any matter concerning that child has the right to participate in an appropriate way and views expressed by the child must be given due consideration.” Section 129 of the Children’s Act addresses children and consent. Regarding consent, the Act states that children older than 12 years may consent to medical treatment on themselves and their own children provided they are of sufficient maturity to do so. Children over 12 years of age may give consent to surgical treatment provided they are of sufficient maturity to do so and are assisted by the parent or 172

guardian. In children under 12 years of age, the parents, legal guardian or caregiver may give consent for medical procedures, while parental or guardian consent is required for surgical procedures. The legislation does not specify how maturity should be assessed, but guidelines are available as to which factors should be taken into account (King & Cross 1989). The concept of maturity clearly refers to the child’s developmental level and experts may be asked to assess this. Healthcare professionals will have to be able to assess the child’s cognitive development and maturity in order to comply with the legislation. We can debate whether a 12-year-old child is truly capable of informed consent, but the spirit of the legislation is to involve children in decision making regarding their own healthcare. An interesting change in the legislation is that the obligation is placed on the parent, guardian or caregiver to obtain a court order to prevent treatment that the medical team believes is in the child’s best interests. The law states (Children’s Act 38 of 2005 section 129): “No parent, guardian or caregiver may refuse to assist a child or withhold consent because of religious or other beliefs, unless they can show that there is a medically accepted alternative choice to the medical treatment or surgical operation concerned.” Section 130(2) refers to children and HIV testing. Children 12 years of age and over may give consent to HIV testing, while children under 12 years of age may give consent if they are sufficiently mature to understand the benefits, risks and social implications of the test. If the child is not sufficiently mature and it is in his or her best interests to have the test, consent may be given by a parent or caregiver, the provincial head of social development, or a designated child protection organisation. If consent is unreasonably withheld and it is in the child’s best interests to be tested, application may be made to the children’s court to perform the HIV test. These laws appear to be rather drastic, but they are designed to address situations where parents may try to prevent their children from being tested, which would not be in the children’s best interests. They would also apply to circumstances where a child lives on the streets or is in a child-headed household.

14.7 CONSENT IN THE AFRICAN CONTEXT The above description reflects a Westernised approach to consent. In the African context, individual autonomy is less important, and elders and extended family are often involved in the consent process. The important concept in African philosophy is Ubuntu. The meaning of Ubuntu is “humanness”; when used in the phrase umuntu ngumuntu ngabantu it means that “it is through others that one attains selfhood”. One cannot exist as a human being in isolation. We are linked to others and what we do influences others as well. Mkhize (2006) argues that, although it would seem that involving the family or community in consent for treatment for an individual violates the principle of autonomy, in fact it shows a higher level of respect because one is showing respect for the traditions and culture of the patient’s community. It is important for healthcare professionals to be aware of the cultural value systems of their patients, and refrain from paternalism in their communications with patients and their families. However, we should also acknowledge that all societies are dynamic and therefore these value systems are not necessarily fixed.

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14.8 WHEN PARENTS AND CHILDREN REFUSE TREATMENT Problems may occur when children’s views differ from those of their parents or doctors. There are three situations in which treatment refusal may arise in the medical management of children:. SCENARIO 1: PARENT REFUSES THE DOCTOR’S MANAGEMENT PLAN The resolution in scenario 1 depends on the circumstances. If the doctor is convinced that the management is indicated, he or she may override the parents in the child’s best interests. It is important that a higher authority assesses whether an intervention is truly in the best interests of the child. An example of this would be transfusing a Jehovah’s Witness child who is bleeding to death. This measure is justified only because it is necessary to save the life of the child – see Hay v B (2003) in Chapter 6. Subsequently there have been other cases where the high court in South Africa has granted doctors permission to give life-saving blood transfusions, the most recent case being that of a 12-year-old Jehovah’s Witness girl with leukaemia at Chris Hani-Baragwanath Hospital in February 2009 (Foss 2009). SCENARIO 2: CHILD AND DOCTOR AGREE, PARENT DISAGREES In the early 1980s, the Department of Health and Social Security (DHSS) in the UK advised doctors that they would not be acting illegally if they prescribed contraceptives for girls younger than 16 years of age, provided that the intention was to prevent harmful effects from sexual activity, and that they should try to persuade such girls to confide in their parents. Mrs Victoria Gillick challenged this legal provision and demanded the assurance that none of her daughters would receive contraceptives without her knowledge and consent if they were younger than 16. The case went to the highest court in the UK, and the final decision was in favour of the DHSS, by three votes to two. This has subsequently become a landmark case in British medical ethics and law. The Gillick principle recognises that children may be mature enough to request certain forms of treatment and empowers the doctor to assess that maturity and act accordingly, and children who are deemed capable of such decisions are termed “Gillick competent” (Hope 2004). SCENARIO 3: PARENT AND DOCTOR AGREE, CHILD REFUSES If the doctor and parent believe the intervention is truly in the child’s best interests, they could override the child’s wishes. However, depending on the child’s age, maturity and understanding, he or she has the right to have his or her view respected. As an example, if a six-year-old child refuses an injection because it is painful, his or her view could be disregarded. However, if a 12-year-old with terminal cancer refuses further treatment after the position has been carefully explained to him or her, it would constitute a very serious step to override his or her decision and wishes. In these scenarios, where there is a difference of opinion, it is best to call on a third party uninvolved in the case to assess what is in the best interests of the child. As illustrated by the case studies, very often these cases are referred to the high court. However, it is important to establish clinical or hospital ethics committees in healthcare settings that can assist healthcare professionals, parents and children in these decisions where there is no agreement on the necessary action.

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14.9 NEONATAL CIRCUMCISION FOR THE PREVENTION OF HIV AND URINARY TRACT INFECTIONS Neonatal circumcision is most commonly done for religious or cultural reasons. Following the publication of three studies from Africa demonstrating a protective effect of circumcision against heterosexual HIV acquisition in adult males (Auvert et al. 2005; Bailey et al. 2007; Gray et al. 2007), some experts have recommended that mandatory neonatal circumcision should be performed in subSaharan Africa (Clark, Eisenman & Szapor 2007; Kalichman 2010). There are also advocates of routine neonatal circumcision to prevent urinary tract infections in young babies. However, the results of the adult studies cannot be used to recommend routine infant circumcision. The argument that “newborns are extremely resilient and are programmed for stress” to support the neonatal timing of circumcision (Schoen 2007) does not take into account the ethical issues surrounding the removal “of healthy tissue from patients who are unable to consent to the procedure” (Andres 2007).

14.10 END-OF-LIFE ISSUES AND CHILDREN Modern medicine has made tremendous strides over the past 25 years, and patients and their families expect that everything will be done to keep them alive. Unfortunately, many conditions can be treated but their progression may not necessarily be reversed. The benefits and burdens of critical care must be assessed in such cases, often resulting in decisions to withhold or withdraw life-sustaining therapy (LST). With withdrawal of life support we allow the natural course of the disease to continue, resulting in death.

14.10.1 Withholding and withdrawing life-sustaining therapy (LST) Consensus in ethics and law holds that there is no ethical or moral difference between not starting (withholding) LST and stopping (withdrawing) such therapy. However, most medical and nursing professionals feel that withholding therapy is preferable to withdrawing. Emotionally it is “easier” for the healthcare practitioner to withhold than withdraw – the latter requires an action, whereas withholding is passive. However, ethicists believe that withdrawing life support is preferable to withholding for two reasons. The first is that the patient has been offered a chance and there has been time to assess the prognosis and the likelihood of a successful outcome. The second is that inappropriate withholding of support from patients who may have a good outcome is less likely to occur. The Royal College of Paediatrics and Child Health (RCPCH) (2004) describes a framework for considering withholding or withdrawing LST in children, based on the fact that it is not in their best interests to continue treatment (Larcher et al. 2015). Three sets of situations may apply: 1. When life is limited in quantity: If treatment will not or may not prolong life significantly, it may not be in the child’s best interests to provide it: a. Brain stem death has occurred. b. Imminent death – there is deterioration despite treatment. c. Inevitable death – death is not immediately imminent, but it will occur and LST confers no overall benefit on the child. 2. When life is limited in quality: Treatment may be able to prolong life significantly but it will not lessen the burdens associated with the illness or the treatment: 175

a. The treatment burdens outweigh the potential or actual benefits by causing pain and suffering. b. The burdens of the child’s underlying condition or disease cause such severe pain and distress that they negate any benefits of LST. c. The ability to benefit from continued life is absent. 3. Informed competent refusal of treatment: This situation may apply to an older child, especially one who has experience of illness, and who is considered competent to refuse treatment or who repeatedly consents to the withdrawal or withholding of LST. If in addition the child is supported by the parents and the clinical team, there is no ethical obligation to provide LST. However, if there is uncertainty about the child’s prognosis or the likely outcome of the illness or treatment, treatment should be continued until there is improved accuracy regarding the degree of certainty. In terms of the Children’s Act No. 38 of 2005 and its subsequent amendments, children older than 12 years are legally empowered to be involved in making decisions regarding their own healthcare, and are able to refuse LST. However, the treating team needs to be certain that the child fully understands the implications of his or her decision, and that the parents are in agreement. In cases of uncertainty, a period of negotiation should be initiated. We have found the RCPCH criteria to be a very useful framework to guide endof-life decision making in the clinical situation. Many young doctors are faced with difficult decisions with regard to management of critically ill children during their internship and community service years. If doubt exists as to whether the treatment is in the patient’s best interests, rather resuscitate and stabilise the patient and then discuss further management of the child with the referral hospital. The following would be a difficult case scenario: Case study 14.6 Baby D was born by normal vertex delivery at 35 weeks’ gestation (his mother had a urinary tract infection) at a private hospital. He was weak and hypotonic from birth, and initially his condition was thought to be due to perinatal asphyxia and hypoxic ischaemic encephalopathy. He did not require ventilation but was on continuous positive airway pressure (CPAP) through nasal prongs for a few weeks. Eventually the diagnosis of a muscle problem was suspected. A muscle biopsy was performed, and a diagnosis of X-linked myotubular myopathy was made. Baby D had the following problems: he was unable to swallow and had gastro-oesophageal reflux, thus requiring naso-duodenal tube feeding; he was oxygen dependent through nasal prongs (not CPAP); and he was unable to swallow and needed regular suctioning. The treating team felt that he should have a tracheostomy done (for suctioning) and a gastrostomy tube inserted for feeding. At the same time he would need an antireflux procedure, which constitutes reasonably major surgery. The child was managed in the neonatal intensive care unit (NICU) of the private hospital. The parents were repeatedly counselled, but they refused to let baby D undergo any surgical procedure, said they did not want to take him home, and asked the doctor to switch off the oxygen so that baby D could be allowed to die. Subsequently the medical funds also ran out. COMMENTARY 176

The baby’s doctor, Dr R, was not certain what he should do. He was reluctant to turn baby D’s oxygen off as he believed that it was keeping him comfortable. The treating team would not stop his feeds as they believed that that would cause baby D to suffer unnecessarily, and of course by now he was five months old and the staff was very attached to him. What would you do in a similar situation? If we use the ethical framework described in Chapter 12 to approach this problem, we may define the ethical dilemma in terms of what is in baby D’s best interests (i.e. beneficence) and non-maleficence (i.e. not wanting to cause him harm) versus parental autonomy. In addition, issues of distributive justice may be important. He may be preventing other babies from being admitted to the NICU, and is also utilising funds that may better be spent elsewhere. The next step is to identify all the important issues that may impact the decision-making process. In this regard, X-linked myotubular myopathy presents with severe muscle weakness; such patients are unable to swallow, are rarely able to sit, and will never walk. They are cognitively normal. Children usually die from respiratory failure or pneumonia, usually surviving up to approximately one year of age. Would it be justifiable to withhold LST from him, and would it be ethically acceptable to withdraw his oxygen therapy? Using the RCPCH framework, we could argue that LST for baby D could be withheld on grounds of the “life is limited in quality” situation. He has a severe neurological disease, and LST would only prolong his dying. The parents may also feel that baby D’s life will be unbearable. When the goals of care change from saving the life of the child and curing the disease to providing the best possible death for the child, symptom relief for the patient and emotional support of the parents and family become extremely important. A clear care plan should be available, detailing the level of intervention as well as management of pain and other symptoms.

14.11 TRUTH TELLING It is very important to share medical information with patients. However, parents may refuse to allow their child to be informed of a serious condition such as cancer. Such refusal is often linked to the underlying cultural value system of the parents. It is important for healthcare professionals to assist parents in a disclosure strategy to child patients, as they have the right to their healthcare information and to have their questions answered honestly. It is important to assist parents in the process and to obtain their agreement to the sharing of such information.

14.12 CONFIDENTIALITY Trust is essential for the doctor-patient relationship and to ensure this, it is necessary for the doctor to treat the patient’s information as confidential. This is as essential for the child patient as for adults. Only when it is in the child’s best interests should information be shared with other healthcare professionals after obtaining the assent of the child if the child is in possession of the necessary understanding and maturity. It is especially important to ensure that confidentiality is maintained in the hospital setting and not discussed in open and public spaces.

14.13 THE CHILD AND RESEARCH Children often receive drugs that are either not licensed for use in children or that are prescribed outside the licensing terms for that specific drug – off-label drug use (Kimland & Odlind 2012). The 177

licensing terms include the age, the indication, the dose, the frequency and the route of administration, as well as the formulation of the drug. This is due to the lack of the necessary randomised clinical trials (RCTs) in paediatrics, which are deemed to be the gold standard in adult medicine. Nearly 70 per cent of drugs used in neonates and infants have either not been tested or were inadequately tested for safety and efficacy in children (Kimland 2012). Both the US and the European Union (EU) have addressed the lack of paediatric clinical trials by introducing legislation and incentives to ensure that these trials are conducted by experienced paediatric researchers (Hoppu et al. 2012). There is no current similar legislation in South Africa. The reason for the lack of clinical trials in children is due to their vulnerability regarding their own lack of autonomy (as discussed above), as well as the risks posed by research. For this reason they need additional protection in the research process, which is reflected in current research guidelines. The same principles involved in consent/assent for children in healthcare decisions are applicable in research. The child’s refusal to participate in research is, however, very important and again the standard of best interests must prove beyond doubt that participation is truly in the best interests of the child. The National Health Act No. 61 of 2003 classifies paediatric research into the problematic categories of therapeutic and non-therapeutic research, whereby clinical trials are defined as therapeutic research and where it is essential to obtain parental consent and the child’s assent if the child is able to understand the research. For non-therapeutic research, the law requires ministerial consent, which may actually hamper essential non-therapeutic research involving children, such as a new vaccine (Strode & Slack 2015). The National Health Act No. 61 of 2003 of South Africa does not discuss what level of risk is allowed for paediatric research, while a risk-benefit assessment is of equal importance to ensure that there is potential benefit to the child or the class of children with a particular healthcare problem and to avoid any exploitation. A good guiding document for risk assessment for research involving children is the Code of Federal Regulation 45 subpart D of the Office for Human Research Protection (OHRP). According to this guideline, risks are divided into four categories: (1) no more than minimal risk; (2) more than minimal risk but with direct benefit; (3) more than minimal risk with no direct benefit, but benefit/generalisable knowledge for the class of patients; and (4) all other research. Consent for the first three categories involves the consent of parents and the child if of the necessary cognitive and social development to participate in the decision-making process. The last category should have the approval of experts in the field and the ethics review committee. Finally, it is our ethical responsibility to undertake research involving children where the medicines or interventions will benefit them. Research, however, should only be undertaken if the same research in adults will not generate the necessary results that will benefit the child.

14.14 CONCLUDING REMARKS This chapter has addressed some of the ethical issues that the medical student and doctor may encounter while managing paediatric patients. The paediatric relationship is a three-pronged one: the child patient, the decision maker (parent/caregiver) and the doctor. It is important that the doctor is aware of the ethical issues and moral dilemmas influencing this relationship, and that the child’s best interests remain paramount in any decision making regarding him or her.

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CHAPTER 15: Ethics in Mental Healthcare (Author: Willem Pienaar) By the end of this chapter you should be able to: • • •

understand the unique ethical challenges that must be addressed in mental healthcare assess the capacity of your patient to consent ensure that the rights of vulnerable patients are respected.

15.1 INTRODUCTION In true Socratic tradition, we will begin by asking a question: Why should bioethical issues in the discipline of psychiatry be different from those in other disciplines in the health sciences? Since a psychiatric disorder can be an illness of the brain, just like other illnesses affecting various organs and physiological systems of the human body, ethics in psychiatry has much in common with ethics in other disciplines. However, the brain is unique due to its exceptional function and enables the individual to think, feel, act, decide, contemplate, wish, remember, fantasise and finally self-determine. As a result, special moral and bioethical deliberation becomes necessary when diseases of the brain are involved.

15.2 PSYCHIATRIC PRACTICE VS GENERAL MEDICAL PRACTICE Psychiatric practice is different from general medical practice in a number of ways: 1. Patients with psychiatric illnesses are vulnerable. Because of their illness, their cognitive, emotional and behavioural functions are adversely affected, resulting in poor judgement and insight. The competence of patients with psychiatric disorders to make safe, reasonable decisions on their own behalf is compromised and leaves them vulnerable to all kinds of exploitation. The psychiatrist should be a person of character who always puts the patient first, always acts as an advocate for patient rights, upholds good values and respects patient selfdetermination as far as possible. 2. Psychiatrists are confronted with unique clinician-patient relationships as, their patients may share very personal information with them. Confidentiality and privacy are of the utmost importance, especially in the management of personal information. On the other hand, it is also important that psychiatrists do not seek unnecessary personal information if it is not clinically important. Using one’s discretion about invading the privacy of patients is an important skill to develop. 3. Psychiatrists are often confronted with dependent, aggressive, manipulative, histrionic or severely seductive behaviours of patients. Again it is the character, professionalism and personal “fibre” of the clinician that should guide good clinical conduct. 4. Psychiatrists are at times confronted with information from the patient that may harm or affect individuals and members of the broader community. For example: “Next time my boyfriend cheats on me, I will make him pay dearly.” Again, this poses a value decision between respect for confidentiality and responsibilities to third parties at risk of harm. In psychiatry this kind of complex and unique clinician-patient relationship necessitates that the character (virtue) of the clinician is strong, non-paternalistic and caring. 179

However, general practitioners also encounter patients with psychiatric disease. For example: 1. During routine follow-up of a patient with hypertension, a general practitioner becomes aware that the patient is severely depressed. The patient has not requested help for this problem. 2. A patient, because of his or her drinking problem and consequent threatened job loss, asks for a sickness certificate. Other than a heavy hangover, a physical examination cannot confirm a physical illness that warrants a sickness certificate. Loss of his or her job would be detrimental to him or her and the family. 3. Despite acute liver cell damage resulting from alcohol abuse, family violence during bouts of intoxication and repeated episodes of driving under the influence, a patient refuses any form of treatment. 4. A hard-working corporate executive asks for a repeat prescription of his sleeping tablets because “they work so well during these difficult times”. 5. A very conscientious, overworked, high-achieving university professor refuses to change his lifestyle despite his clinician’s advice. Mostly patients ask for help. Clinicians want to care, and should offer care if it is needed. Can it be as simple as demand and supply? Some individuals may ask for “care” yet they do not need any form of care as we understand the need for care. The care that is requested may be inappropriate for our profession, or might not be in accordance with good clinical practice or our professional norms and standards. Some individuals may, according to our perceptions, be in dire need of care but do not ask for it, and yet others may need care but refuse it when offered. What constitutes a healthy supply-anddemand doctor-patient interaction or relationship? Sometimes it is clear that the clinician may refuse care if that care would be inappropriate in terms of the norms and standards of our profession, evidence-based medicine or good clinical practice, or if it is clearly an inappropriate request by the patient. Thus the demand or request for care by patients may not always govern good clinical practice. Care should always result in a net benefit to the patient. Benefit to the patient, as judged by whom? The answer is: as judged by the competent patient, good clinical practice, and the norms and standards of our profession, and as judged by the decisions that most “reasonable” persons would make. Consider the following case Case study 15.1 A severely depressed patient with end-stage carcinoma asks his clinician to assist him to end his suffering. COMMENTARY This request may appear to be “reasonable” in that situation, but contemporary legislation and our current norms and standards of practice do not allow any kind of assisted euthanasia. First, the depression and pain could be treated successfully; second, end-of-life care could be maximised not by curative care but good palliative care; and third, the moral debate on euthanasia has not been adequately settled and should continue. Worldwide physician-assisted suicide (PAS) is becoming more readily available for the competent few who choose to end their suffering in the face of futile treatment. This moral debate should be encouraged. The patient-clinician interaction is therefore not always straightforward, and it becomes clear that the decision to care for a person (best moral action) can often not escape a judgement call. The clinician has to 180

“value” or weigh the need for care in every case. The “contract” between patient and clinician may be seen to have the same “ingredients” or complexities as our everyday social contract (the interaction between people in our everyday life). The three elements of value in the clinician-patient contract are firstly, the need of the patient as experienced by the patient; secondly, the knowledge and skills of the clinician within the norms and standards of the medical profession; and lastly, the consensus expectations that the community at large would place on the clinician. One of the problems within our social contract, and even more so with a doctor-patient contract, is that not all people can be considered “equal” in their capacity to decide what is in their best interests. The level of understanding, competence or capacity may differ from one patient to the next. Those afflicted by mental disorders may not have the capacity for self-determination and may not be able to act in their own best interests. Consider these scenarios: • • •

Small children cannot decide whether immunisation against TB is good for or harmful to them. An elderly demented patient does not have the capacity to decide on the best treatment options. During the acute psychotic phase of his or her illness, the psychiatric patient may not have the competence to make important treatment decisions and may refuse treatment.

Children because of their age, and some patients because of their illness, thus become “unequal” in the task of deciding on the need for care or the type of care required, and decision making becomes compromised. In such cases, the compromised person would be more reliant on the clinician to act in his or her best interests. Even in the case of fully competent patients, unhampered by their young age or by illness, the clinicianpatient relationship may in many cases be seen as being “unequal”. Patients, because of the burden of their suffering or illness, frequently entrust themselves to clinicians because they believe that clinicians “know best”. Clinicians, who desire to help and have been trained to provide such help, are regarded as “experts” when it comes to important decisions made on behalf of their patients. This relationship leads to or encourages paternalism. It is important for all clinicians to make a conscious decision to actively avoid paternalistic practices by always respecting the self-determination of competent patients and as far as possible of those patients whose ability (competence) to make informed decisions is compromised. Autonomy and competent patients A fully competent patient who recently experienced a violent hijacking is emotionally traumatised, but refuses all psychological help and wants to go home in the care of his family. In this case the clinician should offer future help and may decide to accept the current “wrong” decision of the person! Autonomy and incompetent patients An elderly lady narrowly escapes a flood that swept away the old-age home. Immediately after the event she repeatedly tries to walk back into the raging river to, in her words, “fetch my Bible”. Surely the rescue team may grant most of her wishes, but not the wish to walk back into the river.

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15.3 SUMMARY OF GOOD CLINICAL CARE Good clinical care should carefully consider the following elements: 1. A competent patient may ask for help. 2. The autonomy of a competent patient is generally to be respected. 3. The request for help is evaluated by the patient and community as being appropriate and as providing net benefit. 4. The clinician can help by virtue of his or her knowledge and skills. 5. The illness or disorder is treatable. (The net benefit outweighs the burden of treatment.) 6. The patient gives informed consent to treatment and takes part in the treatment programme. 7. If the patient is incompetent or partially incompetent, the autonomy of the patient should be respected to the extent possible. A surrogate decision maker should be sought in the case of an incompetent patient. Good clinical practice should prevail in order to serve the best interests (net benefit) of the patient in order to restore patient competency if possible.

15.4 THE TOOLS OF BIOETHICAL DELIBERATION Moral dilemmas and difficult bioethical decisions are our everyday companions in medicine, especially in the field of psychiatry. These include the following: • • • •

An end-stage alcohol-dependent person refusing help A patient in a psychotic state due to drug intoxication refusing hospital admission A depressed patient expressing suicidal ideation Family members asking the doctor questions about loved ones that would compromise patient confidentiality

In order to be able to solve these daily moral dilemmas and difficult bioethical questions, the clinician has to develop an inquiring mind, an attitude of compassion, discernment, trustworthiness and integrity, and be acquainted with the contemporary moral theories as described in Chapter 3. Doctors can only strive for what is morally good. Aristotle (488–432 bc) suggested that we should spend our lives in search of the good (moral) life. He said it is more about who we are than what we do. In psychiatry, we serve people who are vulnerable by virtue of their having mental disorders. Our moral deliberation in the discipline of psychiatry thus focuses on patient competence, respect for autonomy (confidentiality, privacy and self-determination), human rights or liberal individualism, standard of care, patient advocacy, beneficence, non-maleficence, and what is fair and good towards both the patient and the community. Consider the following case Case study 15.2 A 21-year-old recently qualified physiotherapist is brought to the doctor by her mother with an eight-month history of altered behaviour, hearing voices of command, and believing that her actions influence the universe, and that there are certain unnamed people in the community who should be “eliminated”. At times she becomes very restless, agitated and aggressive because of the “voices”. During the past month she has been neglecting herself. After being interviewed by the doctor it becomes clear that she has a diagnosis of first-episode 182

schizophrenia. On physical examination she is healthy. Palpation of the abdomen reveals a uterus consistent with a 16-week pregnancy. The doctor asks for a few special investigations to rule out important physical illnesses and substance abuse. These reveal that she is HIV-positive and her urine tests positive for cannabis and mandrax. Ultrasound confirms the pregnancy. The doctor wants to admit her to the local psychiatric hospital but the patient refuses and wants to go home in the care of her mother, who is a single parent with a night-time job. DIAGNOSIS • • • •

Paranoid schizophrenia – first episode Personality – premorbid paranoid traits, no personality disorder HIV-positive Normal singleton pregnancy of 16 weeks gestation

CASE DISCUSSION The practical debate: • • •

What would the good clinician do? What would good clinical guidelines of our profession allow us to do? What would the Constitution and the Mental Health Care Act No. 17 of 2002 (MHCA) allow the clinician to do?

PRACTICAL ISSUES • •

What immediate action would be appropriate? Admit and treat the patient appropriately. What immediate action would current legislation and our good clinical practice guidelines allow us to do? Our Constitution promises the right to freedom and personal choices, but also the right to appropriate, available and effective treatment. The MHCA would allow us the choice of voluntary admission, assisted admission and involuntary admission.

The moral debate: • • •

What are the moral issues and conflicts at hand? What would make the clinician’s action good? Weigh and balance all arguments and values and motivate your action by using the contemporary moral theories.

Moral issues and conflicts: • •

•

•

The right to choose freely and respect for autonomy (self-determination) versus the right to treatment, appropriate care and the benefit of treatment The best interests and health of the unborn versus the possible harm of the proposed treatment to the unborn and the potentially negative effects of the pregnancy on the psychotic mother The compromised ability of the mother to give informed consent for special investigations and the management of her psychiatric illness, HIV status and continued pregnancy (competency) Respect for her confidentiality (HIV and psychiatric diagnosis) versus what would be fair to tell her closest family in this situation 183

• •

Her right to freedom versus her own safety and the safety of the community if not admitted The right action would be that action which would secure or promise the best: 1. Results for the patient and the community 2. Rational action of good intent – to treat the person as an end in herself 3. Virtuous action – the ongoing striving (personal need) of the clinician to be in search of what is good, for no other reason than that the action taken is good, even in the face of difficulties, opposition and great effort 4. Fulfilling our social contract with the community 5. Respect for human rights 6. The common good of the community 7. Caring act 8. Consideration of all facts and drawing from experience 9. Balance between respect for autonomy (as far as possible), taking the course of action that would benefit and not harm the patient and doing what most reasonable people would consider fair

Before we embark on the journey of moral deliberation, we need to know and understand the moral theories and be able to use them in the value arguments in this case. Secondly, clinicians have to consult with others in difficult cases and not become isolated in difficult decision making. Thirdly, clinicians must finally make judgement calls. Judgement calls are not mere fixed opinions of an individual, but the careful and thorough deliberation of value arguments by that person as stated above. Armed with the tools of moral theory discussed in Chapters 3 to 9, we return to our case study. The clinician should firstly identify and prioritise the important moral or bioethical issues at hand. •

•

Is this an emergency situation? If so, and if the emergency situation is caused by a psychiatric illness so serious that it leaves the patient incompetent to decide for herself, she may pose an immediate danger to herself and others, and no further time should be wasted before acting on her behalf. Time is of the essence, and harm may come if the clinician does not act immediately. How would one define “emergency”? Imminent, serious danger may result if the clinician does not act immediately. Management clearly belongs to the field of medicine. The patient clearly has “patient” status and the clinician would be the appropriate professional to respond. Can this patient give informed consent? To what degree does the brain disease (schizophrenia) make her incompetent to fend for herself or to decide in her best interests? Clearly her contact with reality is compromised. If she is incompetent to make informed decisions and she clearly suffers from a psychiatric illness that can be successfully treated, and if the benefit exceeds the burden of available treatment, she should be able to receive that appropriate effective treatment. She should thus enjoy the option of treatment even if she refuses such treatment and has to be admitted to hospital as an involuntary patient. In this case the moral debate weighs heavily in favour of treatment: it would secure the best result for the patient, it is the action of good intent, the person is treated as an end in herself, it would be the morally good thing to do, she has the right to effective treatment, the community wants clinicians to care, and taking all clinical information and evidence-based experience into consideration, she could only benefit from the treatment. Conflict arises if it is argued that her autonomy should be respected 184

because her capacity to decide is compromised. Similarly, the right to refuse outweighs the right to be treated. This is the judgement call that has to be made. This is the weighing and balancing of value arguments. After careful consideration of this case, most doctors and individuals in the community would agree that treatment of the patient, even without her consent, would be the good moral action to take.

15.5 COMPETENCE IN MENTAL HEALTHCARE How does one judge patient competence in the presence of mental illness? Patient competence refers to the cognitive and emotional capacity to make an informed best-interest decision. Patients may demonstrate various degrees of competence/incompetence. Beauchamp and Childress (2009) suggest seven “levels” of competence. Briefly, these are the following: 1. The patient can communicate a choice or preference (understanding, insight and judgement not evaluated). 2. The patient can communicate and understand the situation and consequences of a decision. 3. The patient can also understand relevant facts and information about the illness and its treatment. 4. The patient can give a reason for the decision. 5. The patient can give a rational reason for the decision (which can be tested and contested). 6. The patient can give risk-benefit-related reasons for the decision. 7. The patient can reach a reasonable decision (based on the reasonable person standard). Who then would be competent to make a treatment decision? If the patient should be required to decide on minor insignificant issues like her preference for what colour to wear that day, she surely requires only a level 1 standard of competence. If the decision is serious and expected to have a major impact on the wellbeing of the person, the patient’s level of competence should at least be at level 5 or 6. Thus it is not only the level of competence, but also the weight of the decisions and the gravity of the outcome of the decisions that determine whether a patient has the capacity to make an informed decision in her best interests. By gravity of the decision one should consider the burden of illness and the burden of treatment, the treatability of the illness, the expected outcome/success of treatment, the benefit of treatment, and the impact of the illness on the patient’s family and the community. As far as possible, the therapist should respect the patient’s human right to choose. If the patient is deemed incompetent, the disorder is reversible by treatment, and the treatment is humane (accepted good clinical practice), the patient should have the right to such care. Again, especially in the field of mental disorders, the doctor cannot escape the judgement call on the best moral action. In psychiatric practice, therapists are often confronted with severely disordered patients who cannot make informed decisions and cannot act in their best interests because of their illness. It is advisable to temporarily treat the patient by obtaining consent from surrogate decision makers (closest family members) or to provide involuntary treatment for the sole purpose of restoring competence and good health, if possible, especially if the burden of illness is severe and the illness reversible. Weigh and balance all clinically significant factors and do what is ultimately the best for the patient. Involuntary treatment should always be as short as possible.

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In summary, if the patient, like most patients with a psychiatric disorder, can provide informed consent, he or she should be managed as a voluntary patient and his or her autonomy respected. If the patient is incompetent to make an informed decision, but does not refuse treatment, a surrogate decision maker (closest family member, guardian or curator) should assist in the treatment management by taking the responsibility for the decision on “best treatment” together with the clinician, and the patient can be admitted as an assisted mental healthcare user. (See Mental Health Care Act No. 17 of 2002 (MHCA).) The MHCA also makes provision for a patient to be admitted as an involuntary patient. Should the patient be incompetent to make an informed decision and refuse treatment, the surrogate decision makers, together with the clinicians, should apply for the patient to be admitted as an involuntary patient until such time as the patient can become a voluntary patient.

15.6 HIV TESTING IN THE INCOMPETENT PATIENT If the clinician has to rule out HIV as a cause or complicating factor in the treatment process of the patient, can the patient give informed consent to such a test? If the patient, because of his or her mental illness, does not have the competence to make an informed decision, surely pre- and posttest counselling for HIV becomes obsolete? But what would a good clinician do if knowledge of the patient’s HIV status is necessary for his or her management? HIV is a chronic disease and, like many other chronic diseases, treatable. If so, it may be seen as bad practice not to test, especially if the HIV illness could be a cause of the psychiatric disorder or complicate its treatment. Without disregarding the ongoing stigma of this disease for the patient, clinicians should be advocates for testing and, if clinically relevant, offer it to all patients. The fact that the stigma of being HIV-positive is a reality does not make testing for HIV good or bad. An ethical dilemma could arise when an HIV test result of a psychotic patient who has not received pretest counselling because his or her understanding was judged to be impaired is found to be positive. When is the clinician going to tell the patient about the positive test? When should family members or the sexual partner be told? A judgement call has to be made. The doctor should weigh and balance the benefit and clinical need for testing as well as the consequences of testing without proper consent (understanding) against the maleficence and poor practice resulting both for the patient (who is unaware of his or her HIV status) and for the doctor (who is ignorant of it). The following clinical guidelines should be noted: • •

•

Always get informed consent from competent patients. If the patient is judged to be incompetent to give consent for HIV testing, and if testing is not clinically urgent, the test could be postponed until the patient is well (competent to give consent). If it is clinically urgent that the patient’s HIV status be known (to rule out opportunistic infections or early dementia), then do the test and once the patient is competent, perform counselling, informing the patient that the test has been done and that he or she may know or refuse to be informed of the result.

HIV testing might also be important in order to start ARV treatment, as HIV-associated dementia cannot be appropriately managed without ARVs. This brings up a whole new debate: Can/should the

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incompetent patient be started on ARVs? Contemporary research has shown that the benefits of treatment clearly outweigh the potential harm that may be caused to the mother and baby.

15.7 PREGNANCY IN THE INCOMPETENT PATIENT On physical examination of the patient in Case study 15.2 above, a gravid uterus compatible with a gestational age of 16 weeks was discovered by palpation. A pregnancy test confirmed the pregnancy and routine sonar reported a 16-week-old normal foetus. Making a moral decision in this case may be difficult, since it is influenced by the patient’s choice in the matter, the provisions of the Choice on Termination of Pregnancy Act No. 92 of 1996, the future potential of the foetus and the actions the treating doctor is prepared or obliged to perform. There may be conflict between what the mother needs in terms of her own care and respect for early life. There could also be conflict between what the Act would allow or instruct the doctor to do and the doctor’s personal value system. Does the fact that the Act allows the clinician to perform a certain action make it good? Certainly not! Similarly, does the fact that the Act prohibits an action make non-action good? Certainly not. Clinicians should know that personally held beliefs, professional guidelines of good clinical practice, the law and what constitutes a good moral action are more often than not in dire conflict with one another. What are the facts? A young acutely psychotic patient is pregnant. What does the literature say about pregnancy and patients with first-episode schizophrenia? Does the illness in any way negatively affect the foetus, or vice versa? Can the best treatment options available (antipsychotics) harm the baby now or in the future? If the literature suggests that the mother’s schizophrenia and its treatment are unlikely to negatively affect the foetus, and that the continuation of the pregnancy will not negatively affect the mother’s illness and treatment, why embark on a moral debate on a non-issue? Also note that moral debates should be based on real moral issues, and one should not use them to strengthen personally held concepts, opinions or beliefs. It is of vital importance to consult with colleagues and experts in the field.

15.8 SUBSTANCE ABUSE AND MENTAL ILLNESS The patient’s urine tested positive for mandrax and cannabis. So what? It is scientifically plausible that the psychotic illness was triggered by the patient’s substance abuse. This would imply that management should also focus on substance abuse treatment regimens, because the outcomes of illness or “prognosis” for the patient may be better if the patient were to abstain from drug abuse. Should the therapist allow himself or herself to have less empathy for this patient because this illness can be seen as self-induced? Again, should/can clinicians allow themselves to become opinionated and judgemental? Do all clinicians accept current clear scientific evidence that a substantial percentage of substancedependent patients started off with a genetic predisposition and a “vulnerable” brain? Should the good clinician not always unconditionally accept his or her patients, although this is difficult in practice? Should patients, even if they are vulnerable, not take responsibility for their lives? The clinician should make every effort to develop the difficult skill of accepting the person (unconditionally) but not necessarily his or her, at times, self-defeating (or drugging) behaviour. Both the clinician and the patient should know that “it is real to be limited, and to be limited is to be real”, and that all human beings make mistakes. The skill of giving the patient back the ownership of his or her 187

illness is a professional motivational exercise that is difficult to master. Unconditional acceptance is an acquired moral art of our profession. This case study aimed to demonstrate the moral reasoning, insight and wisdom required when balancing the conflicting demands of respect for autonomy and beneficence, as well as beneficence and nonmaleficence.

15.9 SPECIFIC ISSUES IN THE FIELD OF PSYCHIATRY 15.9.1 Children with psychiatric disorders Consider the following case Case study 15.3 You are the doctor on duty in a district hospital. It is Friday evening and you have to admit a 13-year-old Grade 8 girl after she has taken an overdose of paracetamol. On admission she is very groggy and cannot give a full history. You manage her medically for the overdose. The next morning when she is awake you conduct a proper interview and the following emerges: Her 18-year-old boyfriend left her when he heard that she was pregnant. She felt desperate and did not want to live any longer. During the interview it emerges that she has an adjustment disorder and still has suicidal thoughts. She asks for an abortion. She has had 16 weeks of amenorrhea. She has a very poor support system and lives with her mother and three siblings in a shack in the backyard of some friends. She does not want her mother or family to know about the pregnancy as her mother would “kick her out of the house”. What would a good doctor do? COMMENTARY In your thinking, focus on your patient and consider the following in your management of the case: 1. 2. 3. 4. 5. 6. 7. 8. 9.

What should you do first? Prioritisation and the use of the element of time The patient’s age, competence and consent The patient’s autonomy – self-determination, privacy and confidentiality Beneficence and non-maleficence The right of parents or guardians to know The Choice on Termination of Pregnancy Act No. 92 of 1996 The rights of the unborn child The difference between personal morality, professional and legal duties, and finally moral good that most clinicians would agree to

Can children decide for themselves? The Children’s Act advocates for involvement of the child in decision making. The Act has reduced the age of consent to 12 years. Again, the weight of the decisions to be made, the ability of the child to understand and participate in decision making, and the child’s limited experience of life should all be taken into account. Adults should remember that in making “adult” decisions we have a lifetime of experience behind us. Children lack past experience and have to make first-time decisions. The therapist should give the child clear and simple information and always ask the child for consent. If the child cannot give consent by virtue of his or her age, then at least ask the child for assent before treatment is commenced. 188

In the child-parent relationship two further issues should be taken into account. The child’s “dependence” (for clothes, food, money, healthcare, nurture, love and care) and his or her inability or immaturity (too young to grasp the long-term importance of current decisions) do not give the parents the right to dominate child decision making. Parents and doctors should allow children to become coowners of decision making by giving them as much autonomy and freedom to choose as possible. Here again the issue of having to make a judgement call comes into play. On the other hand, the parents have an obligation or duty to care for their child. Again, this duty and the desire to care should not disallow the child from participating in or becoming a partner in decision making. UNRAVELLING THE CASE STUDY 1. Build a therapeutic relationship and trust. 2. The patient can take ownership of her dilemma only after she is again in control of her cognitive, emotional and behavioural functions. It is therefore imperative to first stabilise the patient and deal with the physical effects of the overdose. Thereafter, when she has, by means of therapy, regained her premorbid function, she may start to rechallenge her problems at hand. 3. At age 13 she can be helped to work through the realities of her failed relationship with her boyfriend – her grief reaction. 4. Next step – a process of proper psychoeducation should be undertaken and the following questions should be considered. Is the pregnancy unwanted or untimely? What are the realities, pros and cons of continuing or ending the pregnancy? What is her future development potential? If the decision to perform an abortion, which is well within her right, is made, what are the practicalities, the realities about hospitalisation, not being at school, the pain of deciding and doing this on her own and the benefit of having her negative support system on board? What are the other possibilities? This process of psychoeducation is indeed a therapeutic process of giving the patient all the information to help her make a “reasonable” person’s decision, even at this young age. It is important to respect self-determination and the right of personal choices, even at age 13, as far as possible. By doing so, trust and respect will prevail. 5. During this therapeutic process the doctor can form a clearer understanding of the competence of the young girl to take autonomous decisions. He will consider her best interests at this time. The doctor can most probably get her consent to involve the parents at some stage of the process. Consider the possible harm if the doctor did not allow this process to develop. Consider the following statement: “A 13-year-old girl can never decide in a case like this. The parents must be notified.” What if the real biological father was a close family member, or maybe the father of your patient? The Choice on Termination of Pregnancy Act compels the clinician to respect the confidentiality of the young girl in a case like this, as the biological father could be in her home. 6. A 13-year-old girl cannot give consent to sex. The age of consent to sex is 16 years as stipulated by the Sexual Offences Act No. 23 of 1957. An amendment to the Sexual Offences Act was made in July 2015 to ensure that children of ages older than 12 but under 16 are not held criminally liable for engaging in consensual acts with each other if the age difference between the two consensual partners is not more than two years. Under the age of 12 years, the child can never give consent to sex. In our case scenario the difference of age is five years. Even if consensual, the act should be reported as rape. 7. The rights of the biological father will not be relevant if he wants to have nothing to do with the pregnancy. 189

15.9.2 Demented and intellectually disabled (ID) patients Consider the following case Case study 15.4 Mary is 28 years old and intellectually mildly disabled with an IQ of 65. She has been living in a home with her peers for the past 14 years since her parents died. She is well adapted to her living conditions and enjoys life. She is healthy, takes no medication and has a normal menstrual cycle. Mary has befriended a 30-year-old male peer. The nursing staff of the home are worried that the couple may become sexually active and request the following: either the two should be separated or, if this relationship is allowed, Mary should be surgically sterilised. You are the visiting doctor. What would your action be? UNRAVELLING THE CASE STUDY 1. She should be able to enjoy a relationship. 2. She should be able to enjoy a sexual relationship should it come to that. In this case the doctor has the perfect opportunity to evaluate her (their) insight into a relationship and sex. 3. This case provides the ideal opportunity to do simple psycho education on relationships, sex and the responsibilities of parenthood, provide the least intrusive form of birth control and get the couple’s consent and cooperation so as to maximise the end result. 4. This is most probably not a “moral” exercise but a clinical human one. Clinicians should not “moralise” clinical situations if no moral conflict is present. 5. Read the Sterilisation Amendment Bill No. 3 of 2005. Demented and intellectually disabled (ID) patients are often clearly compromised in their ability to make autonomous decisions. Again, depending on the degree of competence/incompetence, the clinician and family should try to respect or allow certain decisions to be made by the patient (weighing the magnitude of the decision and its potential benefits and risks), thus respecting autonomy as far as possible. Demented and ID patients can often not fight for or claim their rights. It is for the clinician and community to bestow rights on them. The young clinician should also be able to internalise the difference between quality and quantity of life. Maslow (1908--1970) taught us the importance of selfactualisation and the hierarchical organisation of human needs that is present in everyone (Sadock, Sadock & Ruiz 2015: 181). If these needs are fulfilled one may experience quality of life. Quality can be summarised as the person being warm, safe and well fed, and enjoying basic healthcare, experiencing a sense of belonging and being loved and nurtured, i.e. those things that bring happiness to the person or, in the words of Aristotle, eudaimonia. Quantity of life refers to those things that can be quantified – personal assets, jobs, careers, money, and the number of years of life, but these cannot guarantee happiness. Demented and ID individuals have the right to quality of life and it is our purpose and privilege to be able to give this to those in need. Such individuals are no less our fellow men or women.

15.9.3 Anxiety-, mood-, stress-related and other non-psychotic disorders Case study 15.5 A 42-year-old single mother of three children lives in a shack and struggles to provide for the family. On occasion she performs domestic work but she has no permanent income. About a month ago on her way from work she was brutally raped. She has now been admitted to a psychiatric hospital, severely depressed and suicidal. In her 190

second week of admission, and still very depressed, she admits to her therapist that her oldest son, who is 21 years of age, has been abusing “tik” for the past six months and makes their lives at home impossible. At times he is extremely aggressive, and assaults her and his brother and sister, and threatens to kill them. He steals from the house and has sold most of their possessions to buy drugs. The mother now admits that she secretly tried to poison him once, but without success. She has gone to the police and local social services but no help was forthcoming. Before admission to hospital she eventually succeeded in getting an interdict served on him, preventing him from making any form of contact with the family or coming near their place of residence. QUESTIONS What is your ethical dilemma(s) and how would you go about managing the situation? Consider the following: 1. What is your duty as a citizen in such a case? 2. What is your duty as a therapist is this case? 3. The relevant facts of this case: • Her illness – and what it does to her current thinking and possible subsequent behaviour • The facts and realities surrounding her oldest son and his siblings • The interdict served on him • The potential danger she poses to others (son) • The time factor • Confidentiality (patient-therapist contract and trust) • Fairness towards her oldest son • His rights – her rights • What needs to be done first QUESTIONS 1. Do citizens and therapists have a duty to inform the potential victim (son) and do we have to report this potentially serious crime to the police? 2. People who are severely depressed may have extremely negative thoughts – this would question her current competence and raise the concern that she may again act on her morbid thinking. Can this illness (depression) be treated? What is the time factor involved? 3. Should we consider, at least for now while in hospital, that her son is safe (the mother’s previous attempt to poison him failed). The time factor comes into play again. 4. Can one say without a doubt that it is confidentiality (not informing the police) above fairness (warning the son)? (Value decision.) 5. Is it absolutely necessary to make an immediate decision on the above? The following input is given in deliberating about this case. •

•

Yes, we do have a duty to inform the victim and police of criminal activity such as attempted murder. Can this duty be in conflict with our duty to also protect the mother from the aggression of her son who is “tik” dependent? Do we have to inform him and the police immediately? The depression can be treated successfully. If the patient informed the therapist in confidence about the poisoning of her son, it would be important to get all the information 191

•

on her current thinking on the matter and her thinking on the matter when she is well again. The morbid thoughts may now have disappeared and the whole scenario could be dealt with in psychotherapy. Everything should be well documented. Efforts should be made to get the son into therapy while his mother is an inpatient. At the end of her illness, while she is still in therapy, the past events should be thoroughly talked through and the way forward should be discussed. By now the mother may of her own accord have informed the son of what happened in the past. If not, the therapist should do a risk assessment again, discuss the bioethical and legal issues with his or her supervisor, make good notes and decide on what appropriate action would be in this case. At this stage it might be in the best interests of all to call a meeting between the mother, the therapist and a police officer to discuss past events and future follow-up management.

15.9.4 Substance-induced disorders Case study 15.6 A 28-year-old well-qualified intensive care nursing sister is admitted to a psychiatric hospital as a voluntary patient with the following diagnosis – post-traumatic stress disorder and opioid dependency. Two years previously she suffered severe physical trauma and lost her husband and child in a motor vehicle accident. Since then she has experienced severe anxiety symptoms, flashbacks, insomnia, depression, and a kind of “dead” feeling. After the accident she became opioid dependent. Before admission she did not function in her profession, made several suicide attempts and had serious drug-seeking behaviour. After three weeks of therapy it is clear that her mood has lifted, she has no suicidal ideation, and she functions well in the ward, but she does have ongoing self-defeating drug-seeking behaviour. It was discovered that visitors had been smuggling in drugs to feed her drugging behaviour and these visits have been stopped. She has now been drug free for two days. She refuses to stay in hospital and demands to be discharged. She even promises to go for rehab, but there are no firm plans on the table. During her drug-seeking behaviour she has indulged in unprotected sex and theft in order to pay for drugs. Should she be made an involuntary patient? COMMENTARY Consider the following: 1. Her right to freedom 2. Respect for autonomy (self-determination) 3. Her competence as an opioid-dependent patient As stated, substance abuse and eventual dependency may be triggered by genetic predisposition, many social factors and a chosen lifestyle, but the final stage of dependency was by no means the patient’s original intention. Clinicians have to understand why individuals become addicted to substances, what sustains addiction and the long, difficult road of patient motivation. Clinicians have to internalise the fact that addiction is a brain disease and a chronic relapsing disorder. It is also known that a few patients in the end stage of addiction may be so “trapped” in their illness that they can no longer make a lifesaving decision. One may argue that these patients are, on the basis of their illness, incompetent to make an autonomous decision. Clinicians should guard against being opinionated or making moral judgements regarding the actions or lack of action by the addict. 192

UNRAVELLING THE CASE STUDY 1. A patient can be admitted to a psychiatric hospital as a voluntary, assisted or involuntary patient. As a voluntary patient, the patient is competent to such a degree that he or she understands the need to be admitted, the pros and cons of admission, and the burdens and benefits of illness and treatment, and is willing to be admitted. A patient who is an assisted admission is not competent as above, but does not refuse treatment or admission and must be “signed in” by a close relative (e.g. a patient with dementia). In order for a patient to be admitted as an involuntary patient, he or she has to have a serious psychiatric illness, pose an imminent danger to self or others, and refuse treatment and/or admission, and the illness must be treatable. 2. Does this young woman satisfy the above criteria for involuntary admission? 3. Should the clinician not argue that she has the right to the best chance of survival and the right to good treatment, and that it would be the most virtuous action to admit her? It would be to her benefit, an action of good intent and the caring thing to do. 4. Alternatively, should the clinician argue that she has the right to choose, even if she is opioid dependent? 5. If the clinician decides to make her an involuntary admission, it should be for the shortest time possible.

15.9.5 Personality disorders Why are we all so different? Do children “take after” their parents, and if so, why? Our personality is the sum of our traits as we experience ourselves and as others perceive us: optimistic/pessimistic, introvert/extrovert, worrying/relaxed, shy/outgoing, orderly/disorderly, anxious/calm, responsible/blaming, serious/relaxed, social/loner, leader/follower, warm/cold, and many, many others. Where do these traits come from? In short, traits are genetically inherited and shaped by all the experiences throughout our lives (learnt behaviour), and are determined by our personal choices, wants and future idealisation, summarised as: “I am, I became and I want to be.” Mostly, the sum of our traits are such that most individuals feel good about themselves or cope with their own complexities, talents and weaknesses, and interact with others in such a way that, as a whole, they accept that what they are is good (a self-perception that is true and ego syntonic – “I am OK”). At times, however, the dominant traits make it difficult for the person to deal with everyday life and interactions with others. Traits become inflexible and generally remain permanent after the age of, say, 25 years. If traits are inflexible, persistent, causing personal distress and resulting in erratic and poor interpersonal relationships with others and the community at large, they may be recognised as a personality disorder. Examples include the antisocial, the dependent and the histrionic personality disorders. One last word on the development of personality: one may say that temperament is inherited and character is built. (Further reading on the work of Robert Cloniger on personality development is encouraged.) MORAL DELIBERATION ON PERSONALITY DISORDERS 1. If temperament and character (personality) are inherited and may be caused by personal experience (abuse, neglect, etc.), can the person be held responsible for his or her actions?

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2. How much of the action taken by the person with a personality disorder is predetermined by genetic inheritance and how much by family/social experiences and hardships? Or should/could that individual have decided differently (e.g. not to have stolen because he or she was hungry, or not to have sexually abused someone while intoxicated)? 3. Can the individual be deemed “incompetent” by virtue of having a personality disorder? Should that person be held responsible for his or her action? What would the end result be if individuals with personality disorders were not held responsible for their chosen deeds even if these were motivated by their ingrained and fixed personality? 4. If the personality disorder were reversible by treatment, it would be reasonable to say that the person with such a personality disorder was temporarily “incompetent” to take responsibility for a certain action against another or the community. However, we also have ethical principles such as those governing social contracts, the common good, rational rules of good intent, the rights of others to be safe and protected against harm, and justice or “fairness”. These would compel society to insist that a person diagnosed with a personality disorder, but no current comorbid psychiatric illness, take responsibility for his or her actions. Every person, in the end, should take responsibility for his or her talents and weaknesses, or else chaos would result. Having said that, it is worth adding that it is vitally important for the clinician to at least offer long-term psychotherapy to people with personality disorders so that they may eventually become more comfortable with who they are and with others.

15.10 CONCLUDING REMARKS Within our community there are many people who still regard mental illness as “madness” or human weakness, and sufferers are stigmatised and even ridiculed. Mental illness is generally not considered an illness like any other physical illness. Therapists at times come across such patients who are being marginalised, pushed out of jobs and homes, neglected, punished, isolated and abused. Therefore, therapists have the obligation to be advocates for their patients. To be an advocate for his or her patient, the therapist should ensure a therapist-patient relationship that respects the four pillars of principles-based ethics: autonomy, beneficence, non-maleficence and justice. Secondly, the therapist should interact with the patient’s family, friends, significant others, healthcare agencies and healthcare policy makers only as far as it benefits the patient. A virtuous therapist will always make the patient a full partner in therapy. Therapy must be negotiated and always embarked on with informed consent. Equal partnership encourages treatment adherence and treatment response. Therapists should know that science alone cannot heal the sick. In contemporary, everyday healthrelated dilemmas we are forced to make extremely difficult clinical and moral decisions. Yet in our patient-therapist relationship the final moral good action often eludes us. This situation should lead us to a lifelong search for what is truly good. The only clue in our search would be our wish to treat others as we would like others to treat us. We have to do this with integrity and compassion so that we can be trusted by our patients to act in their best interests – to serve and treat our patients as ends in themselves and never as a means to an end.

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CHAPTER 16: HIV/AIDS in South Africa: An Exploration of the Ethical Options (Author: Theresa Rossouw & Keymanthri Moodley) By the end of this chapter you should be able to: • • • •

describe a moral framework to consider the ethical issues of HIV/AIDS understand the concepts of informed decision making and confidentiality in the context of HIV/AIDS be familiar with the ethical guidelines on HIV/AIDS issued by the South African Medical Association (SAMA) and the Health Professions Council of South Africa (HPCSA) apply your understanding of the ethical issues to the clinical management of your patients with HIV/AIDS.

16.1 INTRODUCTION “…HIV is not just a virus. It is also a disease of society and human relationships. It brings out both the best and the worst in how people treat each other. Tragically up to now, it has been more of the latter than the former. HIV has become an epidemic of stigma, unfair discrimination and even extreme violence against people known or suspected to have HIV. Our history is becoming full of untold stories of people who have had to face the cruelty of others simply because of the fact that they live with the virus that is now treatable and manageable…” (Heywood 2009)

The evolution of HIV/AIDS in a clinical, socio-political and cultural context has been unlike any other disease in the history of mankind. Ever since the first patients were diagnosed in 1981 with this strange new and then inevitably fatal disease, occurring in minority populations like men who have sex with men (MSM) and injection drug users (IDUs) in the US, people infected with this virus have been severely stigmatised and discriminated against. The disease is transmitted sexually, from mother to child, or through blood products, is incurable (except for the possible cure of Timothy Brown (Lisziewicz, Rosenberg, Lieberman, Jessen, Lopalco, Siliciano et al. 1999) and was in 1981 still untreatable, leading to extreme fear and condemnation of infected populations from all sectors of society. Now, 35 years later, despite a changing demographic distribution and the availability of treatment, stigma and discrimination still characterise this disease complex. HIV/AIDS has posed a wide spectrum of ethical challenges to the healthcare profession. These ethical dilemmas range from controversy over the origins of HIV infection to issues such as disclosure to children and family members; access to antiretroviral therapy; mandatory HIV testing; screening out HIV-positive blood donors in South Africa; and the ethics of research on treatment, prevention and “cure”.

16.2 ORIGINS OF HIV INFECTION Most scientists agree that the HI virus responsible for AIDS in humans arose from the simian immunodeficiency virus (SIV) that was transferred from monkeys to humans in Africa. This has been postulated to have occurred in a number of different ways: hunting, eating undercooked monkey meat and bites from monkeys. In the late 1980s Louis Pascal raised much controversy when he proposed that the transfer of SIVs to humans could have occurred accidentally through polio vaccines given to thousands of people in Central Africa during 1957–1960 in the world’s first mass polio vaccination campaign. These polio vaccines were cultured on monkey kidneys, hence the possibility of

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contamination with SIVs. Pascal’s theory was met with much concern and alarm. Most medical journals declined publication of the theory and many scientists rejected it. The concern was twofold: 1. Attention should be focused on the diagnosis and treatment of the disease rather than its origins. 2. The theory would derail vaccination programmes by causing alarm regarding all forms of vaccination among members of the public. The manufacturers of the vaccine eventually filed a lawsuit against another scientific magazine for publishing information alluding to this theory. This debate certainly opened a can of worms relating to the validity of scientific information, and the ethics of publication and of unorthodox theories (Martin 2003).

16.3 ETHICAL ISSUES RELATING TO HIV/AIDS IN THE CLINICAL CONTEXT Thus far, HIV/AIDS has been managed with great sensitivity to the ethical issues pertaining to informed consent and confidentiality. In South Africa at present HIV testing and notification are not compulsory. A significant ethical dilemma arises in the context of HIV/AIDS when the interests of individual patients come into conflict with those of the public at large. This has been borne out in a controversy over the South African Blood Transfusion Service and screening of potential donors using race as an exclusion factor. It is also an important factor in the availability of antiretroviral treatment compared with treatment for other chronic diseases. In South Africa, fewer than half the patients who were eligible for treatment were on antiretrovirals at the time of writing (UNAIDS 2016). AIDS epitomises an illness that demands a holistic approach – medical treatment, counselling, support and significant attempts at behaviour and lifestyle modification. In addition, all this must be situated within an ethical framework. The autonomy of the patient has thus far been emphasised – the patient’s right to confidentiality, obtaining informed consent to or refusal of testing for HIV as is illustrated by the detailed pretest counselling protocol (Miller 1987). In the past ten years, great efforts have, however, been made to “normalise” HIV infection and to make testing part of the routine laboratory tests offered to patients. On the other hand, unlike other sexually transmitted diseases, HIV/AIDS is life threatening and hence obligations to third parties arise in terms of protecting those at risk – sexual partners; medical personnel, especially surgeons, obstetricians, dentists and nursing staff; caregivers in the home; undertakers; pathologists and district surgeons. In other words, this is an ideal example of a situation where confidentiality is of the utmost importance due to the nature of the disease but where genuine conditions for breach of confidentiality also exist in terms of third-party risk. The ethical tension inherent in the duties and obligations of the medical practitioner to his or her patient with HIV/AIDS, as opposed to obligations to the profession and public health remains an important challenge in South Africa. In assessing the options available to address the ethical dimension of the management of HIV/AIDS a traditional principle of medical ethics, namely patient advocacy, may be considered. The limits of the doctor’s obligation to his or her patients need to be examined (Ackerman & Strong 1989). The options are as follows: 196

1. The strict advocacy view – if one supports this view, duties to the individual patient should always take precedence. Confidentiality should be strictly maintained, and informed consent should always be obtained. This view is supported by the theory of liberal individualism. 2. The no advocacy view – here duties to the patient would be marginalised and public interest is primary. No attempts are made to protect the privacy of the patient. Proponents of a no advocacy view would condone • • • •

compulsory notification of HIV/AIDS criminalisation of transmission of the disease compulsory HIV testing for all absolute transparency without regard for confidentiality.

3. The moderate advocacy view – this is where duties to patients would usually take priority, but in some circumstances could be overridden.

16.4 HIV/AIDS CARE AND ETHICS A wide range of ethical dilemmas have arisen in the context of HIV/AIDS care: 1. 2. 3. 4. 5. 6. 7.

Informed consent and HIV testing Confidentiality vs disclosure of HIV status Treatment access Treatment adherence Children and HIV Reproductive rights of HIV-positive couples Stigma and the punishment theory of disease

16.4.1 Informed consent and HIV testing Despite monumental therapeutic advances, the diagnosis of HIV/AIDS is still surrounded by thoughts of sexual promiscuity, aberration and infidelity. Even though the disease is no longer necessarily characterised by fatality, its treatment requires strict adherence to daily and lifelong treatment, which may have disfiguring side effects. It is therefore important to explore the ethical dimensions around HIV testing and gain an understanding of the expanding debates around appropriate and relevant testing strategies. The HIV antibody test became widely available in developed countries in 1985. The availability of the test created enormous anxiety. Almost immediately, a debate arose about the ethics of mandatory as opposed to voluntary testing. VOLUNTARY COUNSELLING AND TESTING (VCT) HIV counselling and testing must be ethical, based on human rights, and conducted within a supportive environment. Health and human rights are inextricably intertwined. Safeguarding human rights is an essential part of effectively responding to the HIV epidemic. South African Department of Health (2015) In 1987, the World Health Organization (WHO) supported voluntary testing with pre- and post-test counselling and respect for confidentiality. The HIV test could not be considered “just another test”. The 197

importance of “voluntarism” was stressed (Bayer & Edington 2009). Pretest counselling is given to an individual before an HIV test to ensure that he or she has sufficient information to make an informed decision. Full details of the pretest counselling session can be found in Appendix F. Post-test counselling is provided when an individual receives his or her HIV test results. This involves one or more sessions (ideally at least two) and should include discussions on feedback and understanding of results. In particular, the consequences of negative and positive results must be explored (see Appendix F for posttest counselling outline). Although this approach has been criticised by healthcare workers as creating “HIV exceptionalism” and is very expensive in terms of staffing requirements and time, it has become entrenched in South African medical practice because of many important considerations, primarily the issue of stigma. Despite the availability of VCT, only a fraction of people in the world know their HIV status. UNAIDS (2014) reported in 2013 that 19 million of the 35 million people living with HIV globally do not know their HIV status. This is not only a problem of the developing world: it has been estimated that one in three HIV-infected people in Europe and one in eight (12,8%) of the general population and as many as one in four of certain high-risk groups in the US were unaware of their status in 2013 (CDC 2015; HIV Europe). In 2010, approximately half of newly diagnosed individuals across Europe presented late for care (i.e. with a CD4 count below 350 cells/μL) (HIV Europe). In 2006 it was estimated that approximately four in five South Africans who were infected with HIV did not know their status (South African National Department of Health 2007). The country therefore initiated a very active testing initiative in 2011 called the National HIV Counselling and Testing Campaign, which saw more than 20 million South Africans tested for HIV over the course of 20 months (South African National AIDS Council 2013). It is estimated that by 2015, 66,5% of South Africans were aware of their HIV status. This has not, however, translated into more people on treatment, prompting the Department of Health to release new HIV counselling and testing (HCT) guidelines in 2015. The guidelines, while still retaining the core elements of VCT such as confidentiality, counselling and consent, correct test results and linkage to care, specifically aim to reduce the number of missed opportunities by means of strategies such as provider-initiated counselling and testing, couple counselling and testing, home-to-home HCT, and infant and children HCT (South African Department of Health 2015). The stringent counselling component of VCT introduced at the start of the HIV epidemic is viewed by some healthcare workers and some patients as being extremely time consuming. Many healthcare workers therefore attempt to rely on proxy testing for HIV, for instance by performing a total white cell count (WCC) or CD4 count. This approach has become popular in some settings since these tests ostensibly have no counselling requirement before they can be performed. It is, however, unacceptable and should not be used as it can lead to both over- and underdiagnosis of HIV. In addition, according to the National Health Act No. 61 of 2003, Chapter 2, every healthcare provider must inform a patient of “the range of diagnostic procedures and treatment options generally available” and the “benefits, risks, costs and consequences generally associated with each option”. In other words, informed consent must be obtained for all tests, including HIV. ROUTINE OFFER OF TESTING The need to increase uptake of HIV testing and simplify the process of counselling sparked new proposals regarding different approaches to HIV testing. Internationally, there has been a steady move 198

from VCT to routine or opt-out testing. In 2001 the WHO reviewed its earlier policy of VCT and introduced the concept of provider-initiated testing and counselling in health facilities for all persons with symptoms or medical conditions that could indicate HIV infection (WHO 2007). Since many HIVpositive patients are missed this way, the WHO policy changed in 2004 to advise the routine offer of testing and counselling in all healthcare settings. This “routine offer of testing” or opt-out testing requires that each patient be offered an HIV test regardless of what condition he or she presents with. HIV testing is done after notifying the patient that the test will be done, and consent is inferred unless the patient declines. The Centres of Disease Control and Prevention (CDC) in the US changed their recommendations regarding VCT in 2006 and now advise the following: • • • • • • •

Routine, voluntary HIV screening for all persons 13–64 years in healthcare settings, not based on risk or prevalence Opt-out HIV testing with the opportunity to ask questions and the option to decline The inclusion of HIV consent with general consent for care (separate signed informed consent is not required) No requirement of prevention counselling in conjunction with HIV screening in healthcare settings Communication of test results in the same manner as other diagnostic/screening tests Provision of clinical HIV care or the establishment of reliable referral to qualified providers Repeat of HIV screening of persons with known risk at least annually

South Africa expanded its VCT policy in 2010 to include client-initiated counselling and testing, and provider-initiated counselling and testing (PICT) with the latter mandated to be implemented in all public health facilities. Accordingly, PICT should be offered to all persons attending clinical services in both the public and the private sector, regardless of whether they show signs or symptoms of HIV infection. PICT does, however, still have as its core principles voluntariness and confidentiality, as demonstrated below. Core principles of HIV counselling and testing in South Africa (South African Department of Health 2015): •

HCT clients(s) and patient(s) must be provided with sufficient information about HIV counselling and testing so that they can give their explicit and voluntary informed consent to receive services.

•

HCT services shall be confidential, meaning that anything discussed between the client(s) or patient(s) and the HCT provider may not be shared with other persons; except in cases where the client’s results are shared for the client’s medical benefit or when ordered by the court or law. Even in such instances, the clients should be informed that their HIV results will be shared.

•

HCT services must include accurate and sufficient client-centred counselling that addresses the needs and risks of the HCT clients(s) or patient(s) and the setting in which the services are being rendered.

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•

HCT services must adhere to national quality assurance guidelines for testing to ensure the provision of accurate and correct test results.

•

It is the responsibility of HCT programmes and providers to ensure that HCT clients and patients are linked to care. This includes prevention, care and treatment and other clinical services.

The current testing strategy does not provide for mandatory HIV testing. All testing is voluntary with informed consent, even when HCT is initiated by the provider, with the exception of cases of alleged sexual offenders (Criminal Law (Sexual Offences & Related Matters) Amendment Act No. 32 of 2007). The opt-out approach has mostly been evaluated in the context of PMTCT (prevention of mother-tochild transmission of HIV) where it has been shown to sustainably increase prenatal HIV testing and has been the recommended practice in this setting in the US and in Canada. African studies in Kenya, Botswana and Zimbabwe confirmed a high acceptance rate of this strategy (Kiarie, Nduati, Koigi, Musia & John 2000; CDC 2004; Perez, Zvandaziva, Engelsmann & Dabis 2006). Even though this approach to HIV testing is provider initiated, all patients should still receive essential information about HIV testing and be informed of their right to refuse. There also still remains a need for effective post-test counselling (De Cock 2005). Despite these safeguards, possible negative impacts in the implementation of this strategy should not be neglected and might include issues such as stigma, spousal violence and lower uptake of prenatal care, affecting the ethical principles of non-maleficence and autonomy. Ethically, routine testing might satisfy the demands of utilitarianism in that more people will have access to their HIV results, thus enabling them to access life-saving treatment timeously. The costs involved in this strategy stand to yield substantial gains for the health of individuals and the population at large. The possible concerns regarding autonomy and non-maleficence, however, require further study and there clearly still exists a need to evaluate this strategy further for actual impact before introducing it on a large scale. Consent and HIV testing in South Africa Consider the following case Case study 16.1: VRM v The Health Professions Council of South Africa (HPCSA), 1999 A patient known as VRM was under the care of Dr L during her pregnancy in 1999. When she was six months pregnant he tested her for HIV, apparently without her consent. VRM received an account for R160 from a group of pathologists in private practice. VRM’s husband asked Dr L to explain the account to him. In particular he wanted to know what an “HIV Elisa” was and if it had anything to do with AIDS. The full details of Dr L’s response are in dispute. He claimed that he had “informed” VRM that routine blood tests would include a test for HIV. According to him, counselling was not done as there were no facilities for this at the hospital. He did not tell her that she was HIV-positive. He apparently decided not to communicate the positive result to her as he felt it would burden her unnecessarily. On 1 April 1999, VRM went into labour and was admitted to hospital. On 3 April 1999 she had a Caesarean section and her baby was stillborn. The next day the doctor explained to her that her baby had probably died as a

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result of her HIV infection. Dr L issued a death certificate for the baby in which he described the cause of death as “stillborn/HIV-positive”. According to the doctor, he did not test the baby for HIV. Her case was taken to the HPCSA by the AIDS Law Project at the University of Witwatersrand. The HPCSA held a preliminary inquiry into the case, heard only the doctor’s evidence and decided not to investigate the case further. The case was then taken to the Pretoria High Court. The court did not make a judgment but compelled the HPCSA to conduct a full hearing. Sources: Adapted from Sidley 2003: 949; Veriava 2004: 309–320 COMMENTARY Informed consent is highly questionable in this case. As discussed above, in 1999 the best-practice standard for HIV testing was VCT. This means that Dr L had to counsel VRM before testing, provide her with her results if she had agreed to testing and counsel her again after informing her of her results. None of this occurred. In fact, Dr L appears to have included HIV testing as part of routine testing. He therefore adopted the opt-out form of mandatory testing in 1999. This testing policy has not been adopted in South Africa to date. HIV testing without consent is not permissible in South Africa. The 2006 SAMA guideline on HIV/AIDS suggests that informed consent must always be obtained prior to HIV testing except if the patient is unconscious and alternative consent cannot be obtained, and if it is in the patient’s interest to check his or her HIV status. A special scenario that evokes considerable debate arises when a healthcare worker sustains a needle-stick injury. It is advised that consent for HIV testing must be sought from the patient even if there is an existing blood sample. If the patient declines consent, the 2006 SAMA guidelines caution against testing an existing sample without consent. This word of caution is based on the National Health Act, Chapter 2, which states that one may only waive consent for medical testing where a law or court order authorises the waiver. For HIV testing no such law or court order exists. HIV testing in the case of needle-stick injuries without the patient’s consent may, however, be justified on the basis that testing will avoid unnecessary use of post-exposure prophylaxis (PEP) and increased resistance to PEP by healthcare workers. Furthermore, according to the HPCSA guidelines, a needle-stick injury may be regarded as an emergency situation to justify testing of the patient’s blood without consent. If an existing specimen is tested without patient consent in keeping with the two arguments described above, the result should only be given to the patient with his or her informed consent. Where a specimen does not exist, forcefully drawing blood from a patient may result in assault charges against the healthcare worker and is not recommended.

16.4.2 Confidentiality vs disclosure with regard to HIV status Disclosure of a person’s HIV status can take place in three ways (Open Society Foundation for South Africa 2009): 1. An individual finds out about his or her HIV status and decides whether or not to disclose (case scenario 1). 2. A health worker finds out about someone’s HIV status and decides to disclose it (case scenario 2). 3. A third party (a public or private institution such as employers and schools) finds out someone’s HIV status and decides to disclose such status (case scenario 3). 201

Consider the following cases: Case study 16.2: The case of Stephen Kelly, February 2001 Stephen Kelly was a 33-year-old intravenous drug user (IDU) who became HIV-infected while in prison. He received harm-reduction counselling from a nurse while in prison. After his release he became involved with Anne Craig, with whom he had a sexual relationship but did not disclose his HIV status. Furthermore, he told her that using condoms was unnecessary. Anne subsequently tested HIV-positive. The case was taken to the high court in Glasgow in February 2001. Stephen Kelly was convicted of recklessly causing injury to another and was sentenced to five years imprisonment. Source: Adapted from Chalmers 2002 COMMENTARY Three important questions arise from this case: 1. Did Stephen have a moral duty to inform Anne of his HIV status? 2. Did Stephen’s healthcare provider have a duty to inform Anne of his HIV status? 3. Should this moral duty be reinforced by criminal law? Case study 16.3: R v Parenzee, 2008 SASC 245 Parenzee had had unprotected intercourse with three women in Australia on numerous occasions. One of the women seroconverted. He then claimed that HIV did not exist and gained notoriety in the media for this claim. This appeal was dismissed. He later appealed on the issue of whether unprotected sex created a risk of serious harm. The court of appeal found that it did. Parenzee was convicted of an act which endangered life or created a risk of serious harm under section 29 of the Criminal Law Consolidation Act 1935 (South Australia). Source: Adapted from Stewart 2009 COMMENTARY In South Africa, we do not have specific laws to deal with deliberate HIV transmission at present. Since 2001, there have, however, been a number of international court cases like the two scenarios above where wilful transmission of HIV has been criminalised, and HIV-positive people have been found guilty of charges such as “causing reckless injury”, “first-degree assault” and “grievous bodily harm” after such transmission (Terrence Higgins Trust 2010; Avert 2010). Healthcare workers have similarly been found guilty of negligence for failing to disclose to a third party at risk (Avert 2010). Case study 16.4: Jansen van Vuuren and Another NNO v Kruger 1993 (4) SA 842 SAA M had lived in a homosexual relationship with V in the Transvaal town of B. They were fairly well-known residents and the nature of their relationship was either generally known or surmised. During 1990 they began a business venture and moved to another Transvaal town, retaining some links with town B. M applied for life insurance and had to submit to the usual medical examination, including a test for HIV. M nominated Dr K to prepare the medical report. A blood sample was taken and the laboratory informed the doctor that the test was positive for HIV. Dr K arranged for an appointment with M in order to consult with him on the outcome of the test. M was extremely upset and distressed. He was also concerned about a possible leak and raised the issue with Dr K, who promised to respect his wish to keep his status confidential.

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The following day, in the course of a game of golf with Dr X, also a general practitioner, and a dentist Dr Y, Dr K disclosed M’s condition to them. M and these three doctors were part of the same social circle in the town of B. M was engaged in a business venture with Dr X’s wife. M had in the past been a patient of Dr Y the dentist. Dr K’s ex-wife and her parents were on friendly terms with V. The news spread and M became aware of this fact. M was annoyed and took steps to establish the source of the breach of confidence. In due course Dr K was sued for R250 000 damages. Source: Adapted from Strauss, Mare & Coetzee 2005 COMMENTARY This is the only South African case to date that has specifically tested the issue of disclosure of a patient’s HIV status by a healthcare practitioner without the patient’s consent. The Appellate Division of the Supreme Court (now the Supreme Court of Appeal) decided that a doctor may not disclose the HIV status of a patient to other doctors without the consent of the patient unless there is a clear legal duty to do this. The case established the norm of confidentiality of HIV results, especially because the healthcare professionals to whom the primary doctor had disclosed were either not treating the patient at the time (one was the patient’s former dentist) or had no interest in or relationship with him. An example of one’s right to privacy in the context of HIV/AIDS disclosures is the following Constitutional Court case: Consider the following case Case study 16.5: NM and Others v Smith and Others (Freedom of Expression Institute as amicus curiae) 2005 The names of three HIV-positive women were disclosed without their consent in the biography of Patricia de Lille. Because of the disclosure of their status, the applicants testified that their circumstances changed for the worse: the first applicant had her shack burned down by her boyfriend, who had since left her and broken off that relationship; the second applicant had withdrawn from society for fear of being ostracised by her family; and the third applicant had not told members of her family about her condition, which depressed her. COMMENTARY The court made the following findings: •

Private and confidential medical information contains highly sensitive and personal information about individuals. The personal and intimate nature of an individual’s health information, unlike other forms of documentation, reflects delicate decisions and choices relating to issues pertaining to bodily and psychological integrity and personal autonomy.

•

The court stated that individuals value the privacy of confidential medical information because of the vast number of people who could have access to the information and the potential harmful effects that may result from disclosure.

•

The lack of respect for private medical information and its subsequent disclosure may result in fear, thus jeopardising an individual’s right to make certain fundamental choices that he or she has a right to make. There is therefore a strong privacy interest in maintaining confidentiality.

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•

The court rejected the idea that once someone discloses their HIV and AIDS status, others can freely disclose such status without the discloser’s consent. In other words, the court’s view is that an individual does not automatically consent to or expect the release of information to others outside the administration of healthcare.

APPROACHES TO DISCLOSURE Two approaches may be entertained where HIV disclosure is concerned: a human rights approach and a public health approach. The human rights approach was adopted in response to the stigma, discrimination and prejudice that has characterised HIV diagnosis since the beginning of the epidemic. The rationale of the human rights approach is that individuals will be more likely to access testing, treatment and care, and will be more amenable to prevention messages when they know that their rights are protected. Some have lauded this approach and feel that the focus on the standards around patient rights – dignity, privacy, confidentiality, autonomy and informed consent – have been a necessary corrective in medical practice, and have reminded doctors about the oaths they have taken to care for their patients to the best of their ability (Voluntary HIV-1 Counselling and Testing Efficacy Study Group 2000). Others have, however, criticised this approach for creating and maintaining “AIDS exceptionalism”, since no other disease – even other life-threatening and stigmatised diseases like cancer – is treated in the same manner. These critics feel that the human rights approach is adding to the stigma around HIV and is undermining public health goals of promoting health and preventing disease. Advocates of the public health approach argue that it is essential to safeguard the health professional’s right to reveal the HIV status of a patient to another professional, a sexual partner, a family member or caregiver in order for them to take action that could contribute to lessening the spread of HIV, or at least empower others to take the necessary precautions. It is, however, still unclear what approach will ultimately have the best outcome for both the individual and society. The next section aims to explore the current ethical thinking and guidelines that are available in South Africa. “Disclosure is a process, not an event.” - Marks, Crepaz, Senterfitt & Janssen 2005 It can be very difficult for HIV-positive individuals to make a decision regarding disclosure of their status to their partners, family, friends and employers, since disclosure and non-disclosure can have major and life-changing consequences (Education and Training Unit 1999).

Non-disclosure can also potentially have negative consequences, such as the following (Marks et al. 2005): •

• • •

The risk of infection for others, particularly sexual partners, and an increase in the risk of re-infection for the patient Inability to access appropriate medical care, counselling or support groups Loss of a job due to frequent sick leave Internalised stigma d 204

DISCLOSURE AND SOUTH AFRICAN GUIDELINES (VOLUNTARY HIV-1 COUNSELLING AND TESTING EFFICACY STUDY GROUP 2000) There are legal, policy and guideline frameworks in place around disclosure in South Africa. They have unfortunately not been fully clarified in medical practice, leaving the distinction between the healthcare worker’s right and the duty to disclose ill-defined. Healthcare workers are then often placed in a position of having to make difficult ethical decisions using their own judgement. The Medical Protection Society (MPS 2016) advises that the status of HIV-infected patients should always be treated as highly confidential and that health practitioners should ensure that their medical record system includes a means of protecting highly sensitive information that can be accessed only by specified individuals. LAWS RELEVANT TO DISCLOSURE 1. The Bill of Rights of the South African Constitution (1996) section 14 states that everyone has the right to privacy. This means that no one has the right to disclose personal information without prior consent. This law does not, however, protect the confidentiality of deceased persons. 2. The Promotion of Equality and Prevention of Unfair Discrimination Act No. 4 of 2000 is particularly relevant where disclosure by a medical practitioner has led to other disclosures in the community. 3. The Births and Deaths Registration Act No. 51 of 1992 requires medical practitioners to complete a death certificate form. The first page is for the registration of the death by the Department of Home Affairs and the issuing of a burial order. The second page contains demographic details about the deceased and the medical cause of death, required for medicolegal and statistical purposes. This page must be sealed and attached to the first for transmission to the Department of Home Affairs. In practice, officials and undertakers review the second page to check if the details conform to those on the first. As things currently stand, doctors are obliged to state the true cause of death – even if it is HIV – and to complete these forms accurately. 4. The National Health Act No. 61 of 2003 addresses the issue of medical confidentiality without expressly mentioning HIV and AIDS. It allows for disclosure of medical information only when: a. the person gives written permission to do so b. a court order or a law requires the disclosure, or c. non-disclosure of the information represents a serious threat to public health (section 14(2)). 5. The Medical Schemes Act No. 131 of 1998 is designed to ensure compliance with the constitutional obligations which include confidentiality of a person’s medical records and other related matters. OTHER GUIDING DOCUMENTS 1. The National Patients’ Rights Charter section 7 addresses issues around confidentiality and privacy: “Information concerning one’s health, including information concerning treatment, may 205

only be disclosed with informed consent, except when required in terms of any law or an order of court” (SAMA 2009). 2. Health Professions Council of South Africa (HPCSA) guidelines a. Disclosure to other healthcare workers The healthcare worker may disclose the HIV status to another healthcare worker who is also involved in the management of the patient only with prior consent of the patient. This is also the case for disclosure of test results, reports of results by a laboratory, or records of diagnostic information. b. Disclosure to sexual partners i.

Healthcare workers should encourage their patients to disclose their status to their sexual partners so as to encourage them to undergo VCT and access treatment if necessary. If the patient refuses to consent, healthcare workers may, after carefully weighing up all the factors, use their discretion when deciding whether to divulge the information to the patient’s sexual partner. Disclosure by the healthcare worker without the patient’s consent must still involve the patient and the patient must be counselled on the healthcare worker’s ethical obligation to disclose such information. After disclosure, the healthcare worker must follow up with the patient and the patient’s partner to see if disclosure has resulted in adverse consequences or violence for the patient and, if so, intervene to assist the patient appropriately.

ii.

The guidelines are not clear on whether healthcare workers have an ethical duty to inform at-risk sexual partners about a deceased person’s HIV status even if the patient did not consent to this, on the grounds of “public interest”. It is unclear whether failure to inform could result in legal action by the dependants of the deceased.

iii.

The healthcare worker must respect the wishes of the patient with regard to sickness certificates. The patient can ask that confidential information be omitted from the certificate, and it is acceptable and legal for the doctor to respect this wish.

3. Guidelines of the South African Medical Association (SAMA) a. These guidelines recommend that a patient’s medical information should be kept confidential. b. However, if disclosure to a sexual partner is considered, the following conditions must be met: • •

The sexual partner should be known and identified. The sexual partner should be at real risk of being infected – the patient has refused to disclose or take precautions and the doctor must have substantial information on this. There should be no other way to protect the partner.

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• • •

The patient must be warned of the intended disclosure and given a specified period of time to disclose on his or her own accord. After the above steps, the doctor may disclose. If the patient firmly believes that his or her disclosure to a partner will place his or her life at risk, the doctor’s duty is to protect the life of the patient and act in his or her best interests.

Consider the following cases that involve HIV disclosures to spouses and partners: Case study 16.6 A 30-year-old salesman Mr Z presented with chronic diarrhoea and weight loss. His HIV test was done after VCT and was found to be positive. He was advised to inform his wife. A week later he returned for his CD4 result, which was 464. He had not informed his wife but had started using condoms. The doctor again advised him to inform his wife. Ten days later Mrs Z came to see the doctor demanding to know her husband’s HIV results. What should the doctor do? Case study 16.7 Mrs AB is a 30-year-old housewife who is married with three children. Her husband is a bank manager. He was treated at the local hospital for a genital ulcer a few months ago but declined HIV testing on that visit and did not return to the hospital. On visiting the hospital, Mrs AB brings a medication bottle with her and asks the doctor what the pills would be used for. The label indicates that it is a herbal immune booster, which the doctor is aware is used for various ailments including HIV. On further enquiry it emerges that Mrs AB suspects that her husband is HIV-positive. Her suspicions are based on two occurrences – firstly, her husband has been hiding the medication from her and, secondly, she is convinced that he was having an affair with a woman who died of AIDS four months previously. Rumours have been circulating in the community and people suspect that Mrs AB is HIVpositive. Some of the neighbours and some of her friends have been avoiding her recently. What should the doctor tell her about the medication and how should he manage her further? Case study 16.8 Ms X is a fourth-year medical student. She has just clerked a new patient, Mr NN. During the consultation with him it emerges that he is HIV-positive. Later that afternoon she presents her patient on an academic ward round with her consultant and six fellow students. This time Mrs NN is sitting with her husband but the student does not notice her. At the end of the presentation she informs her consultant that Mr NN is HIV-positive. Mrs NN starts to scream hysterically – this is the first time that she has heard of her husband’s positive status. Ms X is terrified and starts crying. How should the consultant handle the wife and the student? The summary that follows will guide you on disclosure to spouses and partners. NOTIFICATION OF HIV/AIDS? In keeping with the legal and ethical perspectives on confidentiality in South Africa, AIDS is currently not a notifiable medical condition but is so in many African countries (such as Angola and Kenya) as well as in other countries such as Sweden, Israel and certain states in Canada and Australia. In September 1997, the then Minister of Health, Dr N. Zuma, indicated her intention to make AIDS notifiable (Cherry 1999). Subsequently, draft regulations to that effect appeared in the Government Gazette, inviting comment from the public. The draft regulations required that AIDS and not HIV status be notified. Such 207

notification was to be anonymous to preserve confidentiality – however, immediate family members and caregivers of persons with AIDS had to be notified. The purpose of this was to create openness and debate around HIV/AIDS to remove stigmatisation. Thus far the main criticisms against notification have revolved around the breach of confidentiality and the problem of underreporting. Francois Venter (2014), former president of the Southern African HIV Clinician Society, and colleagues also recently added to this criticism. They argue that “proponents of notification overstate the need for accurate statistics and the range of practical interventions available to act on successful HIV notification, underplay the possible harm of forced disclosure in communities, and are too cavalier about violating confidentiality” (Venter 2014: 608). In addition, notification of sex partners is unenforceable and even unnecessary, given the existing guidelines on managing patients unwilling to disclose their status to sex partners. They further stress the disadvantages, such as increased bureaucracy and cost, unintentional disclosure of HIV status in communities where this may carry risk for the individual, and the possibility of “driving the disease underground” and hence increasing stigma and undermining autonomy. Ultimately, the argument against the notification of AIDS is that such notification will not provide the information that health authorities really need. Furthermore, it will be a costly and contentious issue in a country where limited resources exist for healthcare. The prospect of “shared confidentiality” as an alternative to full notification has been explored by the ministry of health. Shared confidentiality is a form of limited notification where the patient identifies the person/s to be informed.

16.4.3 Treatment access The right of access to medical treatment is enshrined in the Constitution. However, where HIV/AIDS is concerned, this right was denied to many HIV-infected patients for many years. Prior to the antiretroviral (ARV) roll-out programme in 2004, involvement in HIV clinical trials was the only way of accessing treatment. The efforts of non-governmental organisations (NGOs) like the Treatment Action Campaign (TAC) and Médecins Sans Frontières (MSF) contributed significantly to ensuring access via the national ARV roll-out programme. In keeping with the budgetary constraints of a Third World country, access to ARV clinics is governed by the principle of distributive justice – the fair distribution of limited resources. Accordingly, from mid-2004, only patients with end-stage disease (CD4 < 200 and/or WHO stage 4 disease) were able to access treatment. In 2009, treatment access was extended to patients with a CD4 count of 350 and lower if they had active tuberculosis or if they were pregnant; and in 2013 to all patients with CD4 < 350 regardless of clinical staging. The guidelines changed again in 2015 and now advise treatment for all adults with CD4 < 500 or WHO stage 3 or 4, all pregnant women, and children under five years of age, regardless of CD4 count or staging. However, the goalposts keep shifting and the release of data from the strategic timing of antiretroviral therapy (START) and TEMPRANO ANRS 12136 trials early in 2015 prompted most international bodies, including WHO (WHO 2015) and SAHIVCS (Meintjes, Black, Conradie et al.), to release new guidelines advocating ART for all HIV-infected persons. Treatment for all is now evidence-based, and in line with a human rights approach to healthcare. It does, however, raise serious questions about distributive justice and the claims people have to the best available therapy in the context of limited resources. This is especially true in patients who have failed first- and second-line treatment due to poor adherence and are now in need of very expensive third-line therapy. (Distributive justice is discussed in more detail in Chapter 8.) 208

There have been great strides in terms of the development of new treatment modalities and most countries, including South Africa, now have access to a fixed-dose combination tablet for first-line therapy. South African patients failing first-line have access to second-line treatment, but the public sector still has limited and restricted access to third-line treatment and management aids such as genotypic drug-resistance testing. Newer drug classes needed for the long-term management of patients remain prohibitively expensive in the developing-world context. The first apparent cure for HIV, in the form of a bone marrow transplant from a donor with a homologous CCR5 D32 deletion, the Timothy Brown case, will be impossible to emulate in a resourceconstrained environment. Thirty years down the line, a simple and affordable method of prevention like a vaccine remains elusive. The international community has donated millions of dollars for treatment, and many African countries are almost exclusively dependent on PEPFAR (US President’s Emergency Plan for AIDS Relief) for their HIV treatment programmes. The chasm between the rich global north and the poor south is, however, continually widening, and questions remain about the moral responsibility of the rich towards the poor and the sustainability of donations in the context of a global economic crisis.

16.4.4 Treatment adherence While many of the ethical dilemmas relating to HIV/AIDS at the onset of the epidemic related to disclosure and testing subsequent to the introduction of ARV treatment programmes, the dilemmas now being experienced relate to exclusion criteria used at the clinics as well as to adherence problems. Consider the following cases Case study 16.9 Mrs NH is 45 years old. She presented in March 2004 with symptoms of depression. She had been diagnosed as HIV-positive in 2001 and was divorced soon thereafter. Since the divorce she has been using alcohol on a daily basis. Her initial CD4 count was 161. She was keen to start ARVs but her doctor preferred that she stopped drinking first. She was commenced on cotrimoxazole prophylaxis and multivitamins. By October 2004 her CD4 count had dropped to 114. She was still drinking so treatment was deferred once again. By March 2005 her CD4 had fallen to 81 and her doctor decided to start her on combivir (AZT, 3TC) and efavirenz in spite of the alcohol use. On two occasions she was late to collect her treatment. COMMENTARY The principle of distributive justice is pivotal in this case – due to resource constraints and to ensure the fair distribution of these limited resources, eligibility criteria have been set to ensure that those who will benefit the most from treatment with ARVs are admitted to the programme. Clearly, patients with substance abuse are less likely to be compliant and this could result in the development of resistance to ARVs, endangering the care of all other HIV-positive people in the community. On the other hand, Mrs NH’s CD4 count is dropping fast and she is now in dire need of ARVs. Her ultimate outcome on ARVs will be compromised the longer they are deferred. It is clear that the doctor has to also consider the rights of this individual patient compared with the rights of the community as a whole. Case study 16.10

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Andisiwe has been known to Dr X since she was one year old. Her mother, Bongeka, is 21 years old and single. When Bongeka disclosed her HIV status to her family, she was rejected and ended up living alone in an informal settlement. Andisiwe and her mother were admitted to a local children’s home as the baby needed supervised nutrition and commencement of ARVs. During this stay, Bongeka often disappeared for days at a time. Her CD4 count was less than 100. The doctor wished to start the mother on treatment first and then the baby. Bongeka attended all the counselling sessions and was started on triple therapy. The baby had a CD4 percentage of nine and was eligible to start ARVs. However, on the scheduled monthly visits, Bongeka either missed the appointment or came a week late. When she did come on the right day, she would come several hours late. Her adherence to her ARVs was questionable. The doctor’s concern was that if the mother was not showing appropriate commitment, she would not administer the baby’s treatment responsibly. COMMENTARY This scenario raises a number of ethical questions: 1. 2. 3. 4.

Should treatment be withheld from the baby based on the mother’s failure to adhere? Does this mother require further counselling? Are her reasons for non-adherence reversible? Is this a case of child abuse or neglect, and should it be referred to the social worker?

Society operates on the assumption that parents always act in the best interests of their children. However, this is not always the case. If the doctor is concerned that the best interests of the child are not being prioritised, he or she may have to implement measures to ensure that the child receives the appropriate care required. Andisiwe may have to be admitted for therapy and her therapy may have to be supervised by a carer at the children’s home. Treatment cannot be withheld from the child on the basis of the mother’s poor compliance. Involving a social worker in the care of Andisiwe would be crucial.

16.4.5 Children and HIV In 2014, 2,6 million children under the age of 15 were living with HIV – 2,28 million in sub-Saharan Africa. Ninety per cent of the more than five million children who have been infected since the start of the epidemic were born in Africa. Children under 15 years of age account for one in seven (14%) AIDSrelated deaths worldwide and one in nine (11%) new HIV infections (UNAIDS 2015). The vast majority of paediatric infections occur through mother-to-child transmission which can be prevented with timely and proper intervention. In South Africa there are currently an estimated 340 000 children living with HIV (UNAIDS 2015). Some 15 million children under the age of 18 have lost one or both parents to AIDS, and countless children become responsible for the care of their siblings and other family members when parents are debilitated by poor health. By 2014, there were approximately 2,3 million orphans in South Africa (WHO 2008). These facts in South Africa pose enormous ethical challenges as the number of childheaded households increases. The ethical issues pertaining to children and AIDS exist both in clinical practice and in research. Consider the following case Case study 16.11 Nolunthando is an 11-year-old girl who lives with her maternal grandmother and aunts in Guguletu in Cape Town. Nolunthando’s mother died of an AIDS-related illness two years ago. Nolunthando is also HIV-infected but 210

her aunts have told her she has TB. Nolunthando does not believe them and suspects she might have the same sickness as her mother. She often hears them whispering in the kitchen when they think she is asleep. The aunts also told the grandmother that Nolunthando’s mother died of TB. The aunts did this because they wanted to honour their eldest sister and mother, and not bring dishonour to the family. Nolunthando has not seen or heard from her father for about five years. In fact, no one in the family knows where he lives. Although Nolunthando has been quite well, lately she has started to cough a lot and gets tired very easily. She is also missing a lot of school. This worries her because she is a bright child who enjoys going to school and being with her friends. She confides in her aunts that she wishes she were well like other children at school. The aunts feel very sad, and worry that Nolunthando might get worse and even die like her mother. They know there is no cure for AIDS, but one day they read in the newspaper that a doctor at Groote Schuur Hospital (GSH) is running a special clinic that gives free antiretrovirals to HIV-positive children. The aunts persuade Nolunthando’s doctor at the day hospital to give them a referral letter to GSH. They, however, face many hurdles … Enrolment in the programme, which is part of a drug trial, requires that Nolunthando and her immediate family (aunts and grandmother) know the diagnosis, and informed consent is needed from a legal guardian. Nolunthando looks confused and the aunts ask her to wait in the passage. Alone with the doctor, the aunts beg him to let one of them sign consent. They explain that on their sister’s deathbed they promised to raise Nolunthando as their own daughter, in keeping with their culture. They also point out that they have been taking her to the day hospital for medical treatment for the last two years anyway, so why are things suddenly different? QUESTIONS 1. Should Nolunthando be told her diagnosis? 2. May the aunts sign consent for her participation in the research study? 3. As the doctor in the HIV clinic, what are you going to do? COMMENTARY Disclosure of a diagnosis of HIV infection to a child is an area of care that is fraught with ethical concerns. On the one hand, one wishes to respect the autonomy of the child – the right of the child to know what is wrong with him or her. On the other hand, there is the concern with non-maleficence (protecting the child from the harm of stigmatisation that could result from disclosure). The autonomy of the child is also controversial, especially in cultures where personhood is communal rather than individualised. If the fear exists that both child and family will be stigmatised based on disclosure of the child’s HIV status, the parent may decide not to disclose to the child for the greater good of the family. We have also experienced in the ART clinic that parents often do not disclose a child’s status to his or her family as this implies that one or both parents are also HIV-infected. In the African context, children are often cared for by their grandparents or aunts, and care will be compromised if the extended family is not aware of the child’s diagnosis. Often, when parents die of HIV-related complications, their children default on ART since no one else is aware of their diagnosis. Intensive counselling is often necessary to assist the family with the disclosure process both to the child and to other relatives as may be necessary. Consent for treatment and research may become very difficult with AIDS orphans. Often there is no legally appointed guardian and this may prove to be challenging in several research settings. The Childrens Act No. 38 of 2005 uses the term “caregiver” as opposed to “guardian” and this may facilitate the process of 211

consent in a research setting. A “caregiver” is a person who factually cares for a child (section 1 Children’s Act No. 38 of 2005); a caregiver is obliged (in terms of section 32(1)) to safeguard the child’s health, wellbeing and development; and to protect the child from abuse and other harms. Further, a caregiver may exercise the parental right to consent to medical examination or treatment of the child (in terms of section 32(2)). See Chapter 10 for the legal definition of caregiver. Case study 16.12 A very ill nine-month-old HIV-positive baby was admitted to the paediatric ward for an illness that was diagnosed as terminal four weeks later. He was first seen with his unmarried Xhosa-speaking mother, who was well herself, had good insight and was working as a waitress. She told the ward staff that her mother, who was the child’s primary caregiver, would be with the child while she was at work. It soon became apparent to the ward staff that the grandmother did not know what was wrong with the child. As the child’s condition deteriorated the grandmother got increasingly distressed that not enough was being done to save the baby. She said she wanted to remove the child so that he could be seen by someone in the family who had “healed” the baby’s mother when she was “sick with the same illness” at the same age. The doctors could not inform the grandmother of the diagnosis because the mother had not disclosed it. One evening the grandmother tried to remove the child, who was by now oxygen dependent, by force. The staff contacted the mother, who was at work. She remained adamant that the grandmother should not be told that the child had AIDS and was terminally ill, and that he should not be removed from hospital. Eventually the grandmother had to be restrained and the police were called. QUESTIONS 1. Does the grandmother have a right to know the child’s diagnosis? 2. Should the mother’s request be respected? 3. What criterion should be used to make a decision in this case? COMMENTARY As the primary caregiver the grandmother should be told the diagnosis of the child. Once again, the best interests of the child must be considered. Under the circumstances, disclosure of the child’s diagnosis to the grandmother would facilitate appropriate treatment of the child.

16.4.6 Reproductive rights of HIV-positive couples As HIV can be treated successfully with ARVs, it is increasingly being viewed as a chronic disease. This makes it possible for HIV-infected individuals to consider starting a family. In HIV-discordant couples where the woman is uninfected and the man infected, sperm-washing techniques are available to allow artificial insemination. Where the man is uninfected and the woman is infected, this is more complex. The woman would need to be on antiretroviral therapy and preferably conceive using artificial or selfinsemination. The risk of transmitting HIV to an uninfected partner when the plasma viral load is undetectable is, however, extremely low and the use of artificial insemination may not be necessary under these conditions (Rodger, Bruun, Cambino, et al. 2014; Letchumanan, Wu, Bondy et al. 2013). The use of ARVs very early in pregnancy is thought to be safe, but long-term studies and pregnancy registries are needed to verify this (AIDSinfo 2015). Where both partners are HIV-infected, conception would have to follow treatment of both partners and treatment would have to be continued during pregnancy.

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From an ethical perspective the issues are as follows: •

According to the South African Bill of Rights, “Everyone has the right to have access to health care services, including reproductive health care” (South African Constitution 1996). Does this right extend to reproductive technology?

•

Do resources exist for such sophisticated fertility methods?

•

Will the principle of justice be violated in terms of the unborn child?

•

What will the life expectancy of the parents be and will this be adequate to provide the child with parenting?

16.4.7 HIV, stigma and the punishment theory of disease The punishment theory of disease This theory applies generally to all forms of serious disease, including cancer. We have all heard people with serious illness ask, “What did I do to deserve this?” From the earliest awareness of HIV/AIDS, people, including patients, have viewed this disease as “punishment for sin”. Since 1986, claims have been made that “AIDS was sent by God to show displeasure that homosexuality was growing in social acceptance”. According to Kopelman (2002), this theory would imply that “being bad or doing bad things can directly cause disease and when it does, blame should be placed on those who get sick”. She goes on to explain that a “punishment theory of disease does not employ a causal concept of disease but rather a moral concept of blame or moral responsibility”. Such a theory can be explained both from a religious and a secular perspective. The religious slant is that “God or a transcendental being(s) inflicts punishment on the culpable person”. This is supported by certain African traditional belief systems, where the ancestors or God are believed primarily to determine an individual’s health, disease and death. People accordingly become ill because they have angered their ancestors or God or have been the victims of witchcraft. The secular slant holds that “people bring diseases on themselves by their bad lifestyles”. These beliefs seem to be becoming more widespread as people are disillusioned with the biomedical model that remains unable to cure HIV or explain why a particular person becomes infected while another in similar circumstances does not (Voluntary HIV-1 Counselling and Testing Efficacy Study Group 2000). There are arguments both for and against such belief systems. However, what is important to remember is that holding a view of moral blame for disease can be dangerous for the following reasons: (a) (b) (c) (d)

It is irrational. It divides people into “innocent” and “guilty”. It creates a divide between “us” and “them”. The sick are viewed as the “other”, resulting in stigmatisation, prejudice, disconnection and abandonment. This process of blaming the victim leads to various forms of discrimination and lack of concerted efforts to provide care and treatment to disenfranchised groups (Farmer & Castro 2005). Many people predicted that the stigma would disappear as more people were living with HIV and disclosing their status, as high levels of death occurred in a community and society, and as testing and treatment became more readily available. This has, however, not happened (Voluntary HIV-1 Counselling and 213

Testing Efficacy Study Group 2000), and HIV care is still surrounded by blame, judgement and discrimination. Stigma Stigma is a very complex and dynamic social, cultural and political phenomenon. Stigma usually occurs because of the recognition and labelling of differences between individuals – for instance differences of skin colour, gender and sexual preferences – and the transformation of these differences into inequality (Eba & Crew 2007). Stigmatisation usually follows a series of processes: distinguishing and labelling of individuals; association of difference with negative attributes; separation of “them” from “us”; and loss of status with resulting discrimination (Link & Phelan 2001). Stigma has surrounded HIV/AIDS since it was discovered in the early 1980s. The origin of this stigma can be traced back to society and culture, specifically the oversimplified conceptualisation of human sexuality and behaviour; variable understanding of death and dying; and entrenched patterns of belief and superstition (Farmer & Castro 2005). In HIV it seems as if the advent of AIDS amplified existing stigma and discrimination towards certain groups who were seen to follow objectionable lifestyles voluntarily, for instance men who have sex with men (MSM) and injection drug users. It was easy to ostracise these groups based on their perceived voluntary risky and immoral behaviour, since they were perceived to be responsible for their disease, and hence collective names such as “gay plague” or “gayrelated immune disorder” were commonly used at the start of the epidemic. Such depictions of HIV can be a direct barrier to testing. Many people refusing testing seem to do so not because they believe that the test is not important, but rather because of social barriers such as stigma (Kamb et al. 1998). Stigma can further decrease testing since it affects people’s perception of their risk of infection, and studies have shown that even people at high risk of infection may fail to identify themselves as such since they believe that only the promiscuous can become infected (Voluntary HIV-1 Counselling and Testing Efficacy Study Group 2000). In the developed world, attempts have been made to address stigma through public health laws against discrimination, protection of human rights and the confidentiality of a patient’s status, and social marketing campaigns raising awareness about HIV/AIDS (Burris 1999). Similar attempts have been started in South Africa by means of mass media campaigns and public demonstrations, and the second People Living with HIV Stigma Index does show a decline in external stigma, though internal stigma still affects more than 40 per cent of people living with HIV. Overall, the country still has a moderate level of stigma affecting about one-third of HIV-infected people who took part in the study and there is clearly still a long way to go. (http://www.sanac.org.za/resources/publications/reports/doc_download/157the-people-living-with-hiv-stigma-index-south-africa-2014-summary-report)

16.5 CONCLUDING REMARKS South Africa is in the midst of one of the worst pandemics ever. However, this is not just a biomedical disease but rather one to which much stigmatisation and hidden meaning is attached. Hence, policies must be developed with great sensitivity and great urgency as well. There is a need to balance individual rights by respecting confidentiality and promoting public good through encouraging dialogue, disclosure and acceptance. Finding solutions to the challenging dilemmas posed by HIV/AIDS requires wisdom, imagination, compassion and the ability to use one’s discretion. 214

CHAPTER 17: Reproductive Ethics (Author: Keymanthri Moodley) By the end of this chapter you should be able to: • • • • • •

discuss your viewpoint on the moral status of the foetus understand how religion and spirituality influence decisions on human reproduction critically discuss the Choice on Termination of Pregnancy (TOP) Act describe the rights of the mother, father, foetus and doctor in TOP debate foetal-maternal conflicts discuss the ethics of assisted reproduction and surrogacy.

17.1 INTRODUCTION Reproductive ethics includes a wide range of ethical concerns around fertility, ranging from measures to control fertility on the one hand (contraception and termination of pregnancy) to new technological advances to enhance or assist infertility on the other. This chapter will explore ethical concerns at both ends of this spectrum, beginning with contraception and ending with requests for assisted reproduction that may sometimes even occur in end-of-life settings. In addition, the sensitive nature of the pelvic examination raises concerns regarding privacy, use of chaperones and medical student training in acquiring the skill.

17.2 REPRODUCTIVE CHOICE Recent scientific advances and technology have enhanced the reproductive choices available to women. Consider the following options: 1. Women can choose from a wide range of contraceptive methods, including surgical ones that can be reversed if their reproductive needs change later in life. 2. Women and their partners who are faced with infertility have a wide range of options available to assist reproduction, including the use of a surrogate mother. 3. Advanced sperm-washing techniques and antiretroviral treatment allow HIV-serodiscordant couples as well as HIV-seroconcordant couples to choose to conceive a child with a high probability of it being born HIV-negative. 4. Parents who have a child with leukaemia or Fanconi’s anaemia may conceive a child as a genetic match for the ill sibling as a potential bone marrow donor, using preimplantation genetic diagnosis (PGD). 5. Women who are at risk of transmitting genetic disorders to their children due to mitochondrial DNA abnormalities may use mitochondrial DNA from a donor to create a three-genome baby free of the disease. 6. Women may decide to terminate pregnancy for a range of reasons, including socioeconomic ones (Moodley 2007).

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17.3 CONTRACEPTION Birth control may be voluntary or involuntary. China’s 40-year policy of one child per couple is an example of the role the state may play to limit reproductive choices (Gillon 1998). Over the past 40 years there have been many reported cases of enforced sterilisation and abortions as well as sanctions for having a second child. At an individual level this may be criticised as it limits people’s freedom and ability to reproduce as they choose. At a community level, it may be argued that such a limitation on reproductive liberty is essential to prevent overpopulation and outstripping of natural resources. However, the one-child policy has resulted in a huge gender imbalance (with approximately 30 million more males than females in the country), partially as a result of female infanticide and abortion of female foetuses. The country has an expanding geriatric population and a substantially reduced workforce of young people. Consequently, in January 2016, the controversial one-child policy was relaxed in China (Evans 2016). There is almost universal acceptance that all humans have the right to make reproductive choices for themselves. Most voluntary birth control is exercised by individuals who wish to control the timing of reproduction and family size. Section 12 of the Bill of Rights of the South African Constitution refers to the right of “everyone” to “make decisions concerning reproduction”. In our healthcare settings, the ethical challenge with respect to contraception has revolved around the age at which doctors may provide contraception to young girls. Consider the following case Case study 17.1 Kathy is 12 years old. She had seen Dr L in the gynaecology outpatients department for premenstrual tension six months earlier when she was accompanied by her mother, Mrs M. This time Kathy presents alone. On discovering that Kathy is sexually active, Dr L enquires about contraception and learns that Kathy is having unprotected sex but is desperate to start using an oral contraceptive pill. She requests that Dr L does not discuss this with her mother at all. The doctor is very concerned that a child as young as Kathy is sexually active. What should Dr L do? COMMENTARY Dr L is faced with the ethical dilemma of exercising her duty to prevent the harmful negative consequences of an unwanted teenage pregnancy while respecting the autonomy of her young patient. While oral contraception will most likely protect her from pregnancy, it will not protect her from sexually transmitted diseases and other psychological issues related to early sexual activity. Prescribing contraception without the permission of Kathy’s parents has the potential to compromise the relationship Dr L has with her mother. Legally, the Children’s Act No. 38 of 2005 allows a person aged 12 years and older to access contraceptives without parental consent. Dr L decides to counsel and examine the young girl to exclude contraindications to the use of contraceptives before providing her with contraception. She also counsels her with respect to sexually transmitted diseases, including HIV and the importance of condom usage in preventing both. Dr L explains what statutory rape means as Kathy is under the age of 16 years and requests a follow-up appointment to discuss this further. Finally, she encourages Kathy to discuss her use of contraception with her mother.

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17.4 PREGNANCY Pregnancy raises fundamental ethical questions about fetomaternal interests. On the one hand one may view mother and foetus as separate entities and in recent times the “foetus as patient” is a popular concept to consider. However, the anatomical and physiological interdependence of foetus and mother makes it difficult to conceptually separate one’s moral obligations and treating the pregnancy as a state of intertwined fetomaternal interests is often necessary (Lo 2009). During the various stages of pregnancy, the value of foetal versus maternal interests may vary. Early in pregnancy, maternal interests take precedence. However, once the foetus reaches viability, foetal concerns become more prominent. There are, however, exceptions to this rule, and examples will be discussed later. While it is assumed that mothers will always act in the best interests of the foetus, this is not always the case and the doctor or obstetrician may be required to act as an advocate for foetal interests. This becomes especially relevant when a pregnant mother abuses drugs, alcohol or tobacco. Refusal of an HIV test during pregnancy raises questions about a mother’s obligations to protect her foetus. Poor adherence to antenatal care programmes may also be regarded as ethically questionable. In some cases, disregard for the wellbeing of the foetus may fall into the realm of child neglect or abuse. Later in pregnancy, questions of foetal best interests may be raised when a mother requests a Caesarean section based on convenience or when she declines one that is clinically indicated based on foetal distress. If the decision for an early delivery via Caesarean section will not adversely affect the health of the foetus, this request may be respected. However, when an early Caesarean section will compromise the baby due to prematurity, this must be discouraged in the best interests of the baby. Likewise, refusal of a Caesarean section when medically indicated may necessitate overriding the mother’s refusal and if consent cannot be obtained from the father of the child, emergency consent via the hospital superintendent may be necessary to save the life of the baby. In cases of severe eclampsia, it may be necessary to terminate the pregnancy to save the life of the otherwise healthy mother. In such cases, maternal interests predominate.

17.5 ABORTION The abortion debate has been strongly contested for decades. There are powerful arguments both for and against abortion. These range from the extreme position of abortion being equated to murder, to the liberal view that women are autonomous and have the right to exercise control over their bodies and their reproductive ability. Many of these arguments revolve around an understanding of when life actually begins: at conception; when the foetus can feel pain (10–12 weeks); when the foetus resembles a human form; when it is viable (22–24 weeks); or at birth. Is the foetus a person or only a potential person?

17.5.1 Moral status of the foetus vs the moral status of the newborn The ethical debate surrounding abortion stems from an understanding of the moral status of the foetus. Closely linked to this is the moral status of the newborn (Gross 1999). The moral status of the foetus is related to theories alluding to a definition of the beginning of life – and these definitions range from life existing at conception to life beginning at birth. Such definitions vary across cultures, religions and philosophies, as well as geographically. Biologically, the foetus is accorded medical significance at 217

viability – the point in the gestational cycle at which independent extra-uterine survival is possible. Viability is currently defined at 24 weeks of gestation in most parts of the world (Gross 1999). Before 24 weeks, the foetus is generally not accorded moral status. The mother may choose to confer moral status prior to viability. Globally, most countries confer moral status upon the foetus after 24 weeks. In the medical environment, the “foetus as patient” (Savulescu 2001) becomes relevant after 24 weeks except in those countries, such as Israel, where moral status is conferred only after birth (Gross 2002). The legal status of the foetus varies globally ranging from post-viability in the US to post-delivery in Israel and South Africa (Child Care Act No. 74 of 1983). The moral status of the newborn, on the other hand, is very clearly established. There is universal consensus that newborns have both moral and legal status. However, policies on how absolute such status is differ globally (Gross 2002). For example, where moral and legal status of the newborn is regarded as absolute (as is the case in Israel) parents lack the choice of withholding or withdrawing treatment after birth of an abnormal child. Such countries tend to have more lenient policies on TOP and feticide after viability. Parents must therefore make their decisions early. As a result, Israel has one of the highest TOP and feticide rates in the world (Gross 1999). The US, on the other hand, has a strict policy of TOP after viability but allows parents to decide to withhold or withdraw treatment of neonates in the event of severe congenital abnormality. In the case of less severe abnormalities, however, parents may not withdraw treatment based on quality-of-life arguments (Gross 1999; 2002). Neonatal moral status therefore exerts a significant influence on policy making around TOP and feticide. Pro-life and pro-choice supporters represent extreme positions on the spectrum of abortion debates. Pro-life supporters emphasise the preservation of human life from conception at any cost, to the extent that the life of the foetus is given priority over that of the mother. Pro-choice supporters argue that a woman should be able to have control over her body to the extent that her reproductive choice overrides the development of a new human being. There are three moral positions – liberal, conservative and moderate – on the subject of abortion. Central to these positions is the concept of personhood. Historically, a number of different philosophers have held different positions in the moral debate based on the concept of personhood. Criteria for personhood 1. Consciousness of objects and events external and internal to the being – in particular, the capacity to feel pain 2. Reasoning – the capacity to solve new and relatively complex problems 3. Self-motivated activity 4. A capacity to communicate 5. The presence of self-concept and self-awareness (Feinberg 1984) • Liberal position. This view is held by philosophers like Mary Anne Warren. Using the above criteria, she argues that a foetus does not sufficiently resemble a person to be able to claim a right to life. Until birth, a foetus has no moral status and lacks a serious right to life.

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Conservative position. This view is supported by the American law professor John Noonan, who rejects the argument of foetal development in stages, because the stages may be arbitrary. He believes that the line can be drawn only at conception. Here one may argue that the foetus has full moral status from conception and hence a serious right to life. Moderate position. This view was held by the late philosopher Jane English. Her argument centres on the extent to which a foetus resembles a person. In the early stages of pregnancy, when the foetus hardly resembles a baby at all, abortion may be permissible when it is in the interests of the pregnant woman or her family. In the later stages of pregnancy, when the foetus closely resembles a person, abortion may not be justified.

In general, those who support abortion on demand may advance the following arguments: 1. Reproductive freedom. A woman has a right to make decisions regarding her body and her health. Ethically, this is based on the principle of autonomy and legally, it is enshrined in the Bill of Rights of the South African Constitution and supported by the Choice on Termination of Pregnancy Act No. 92 of 1996. 2. Prevention of illegal abortions. Many developing countries, including South Africa, have a history of high rates of backstreet abortions that pose a danger to the lives and health of women. These abortions decrease in the face of legal abortion on demand. 3. A foetus is not a person. This is according to the criteria for personhood as described. As such a foetus does not have a claim to rights. 4. Child abuse. Unwanted pregnancies may result in child abuse. Arguments against abortion on demand include the following: 1. A foetus is a person – because life begins at conception. 2. Doctors are not in a position to kill – based on the principle of non-maleficence (do no harm). 3. The slippery slope argument states that if the abortion of foetuses is permitted, killing of other humans (those with genetic disease or mental retardation) may occur and set in motion the creation of a eugenic society. 4. Alternatives to abortion exist, for example adoption.

17.5.2 Abortion and the law Globally, abortion is not legal in many countries. The recent outbreak of Zika virus infections in Brazil has brought into sharp focus restrictive policies, even where an epidemic affects pregnant women to the extent that their babies are being born with microcephaly. Despite the epidemic in the region and WHO guidance released in May 2016 stating that affected women should be afforded the right to a safe termination of pregnancy in such cases, this is not allowed. South Africa is one of very few countries globally with a liberal abortion law – the Choice on Termination of Pregnancy Act No. 92 of 1996 – that has been strongly contested since its inception. Some of the arguments above were used and the definition of foetus was contested in the case law in Case study 17.2. Consider the following case Case study 17.2: Christian Lawyers Association of SA and Others v Minister of Health and Others 1998 (4) SA 1113(T) 219

The plaintiffs alleged that the Act was in conflict with section 11 of the Bill of Rights which states that: “Everyone has the right to life.” They argued that life begins at conception, and abortion ends the life of a human being. The court found that the status of the foetus under common law with respect to whether it is a legal persona is uncertain. Section 28 of the Constitution protects the rights of the child and not the foetus. A child, according to South African law, has rights upon birth. So “everyone” does not include a foetus. As such, the Choice on TOP Act has been in force since 1997. According to gestational age, the Act permits TOP as follows: The first 12 weeks During this period a pregnancy may be terminated on request by “any female person of any age”. The TOP may be performed by a medical practitioner, registered midwife or registered nurse with specific training (according to the amendment to the Act). Consider the following case Case study 17.3 A 20-year-old woman was admitted to a hospital with a psychotic disorder. She also had a moderate intellectual disability. It later emerged that she had missed her period for two months. Ultrasound revealed a pregnancy of ten weeks’ gestation. Her mother requested a TOP as she felt that her daughter would not be able to take responsibility for parenting the child. The psychiatrist was of the opinion that the patient lacked capacity to consent, given the psychosis. Source: Adapted courtesy of the Tygerberg Hospital Clinical Ethics Committee COMMENTARY According to the Act, TOP is permissible on request at any age without parental or partner consent during the first 12 weeks. In this case, however, the complicating factor is the psychotic disorder which makes it impossible for the patient to request or consent to a TOP. According to the Act, where a woman is “severely mentally disabled to such an extent that she is completely incapable of understanding and appreciating the nature and consequences of a termination of pregnancy”, her natural guardian, spouse or legal guardian may give consent. In this case, the patient’s mother consented and a TOP was performed. From 13 to 20 weeks There are seven different indications for a TOP during this period: 1. 2. 3. 4. 5. 6. 7.

The continued pregnancy will pose a risk to the woman’s physical health. The continued pregnancy will pose a risk to the woman’s mental health. There is a substantial risk that the foetus will suffer from a severe physical abnormality. There is a substantial risk that the foetus will suffer from a severe mental abnormality. The pregnancy has resulted from rape. The pregnancy has resulted from incest. The pregnancy will significantly affect the social or economic circumstances of the woman.

A medical practitioner, after consultation with the woman, must be certain that at least one of these indications is present. Only a medical practitioner may conduct a TOP for one of these indications at this

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gestational age. “Rape” includes statutory rape (sexual intercourse with a girl under the age of 16 years or with a female imbecile). Case study 17.4 Miss A is a 15-year-old girl. She has been involved in a relationship with Mr B, a 27-year-old man, for seven months, and they have been living together for the past six months. Mr B has just found out that he is HIVpositive. Miss A is 16 weeks pregnant and requests a TOP for socioeconomic reasons. Mr B is unaware of her intent to have a TOP. Dr X is a gynaecology registrar at the local hospital and is opposed to TOP on religious grounds. He refuses to perform the TOP or to refer Miss A to a colleague. The nurse working in the clinic with Dr X overrides his decision and refers Miss A for HIV testing and a TOP. COMMENTARY The conflicting values in this case are respect for patient autonomy (patient request for TOP) versus nonmaleficence (do no harm/do not kill). In terms of the Act, Miss A satisfies one of the indications for a TOP at this gestation. The crucial issue here is the refusal of the doctor to refer the patient for a TOP. According to the TOP Act, section 10 states that any person who “prevents the lawful termination of pregnancy or obstructs access to a facility for the termination of a pregnancy shall be guilty of an offence and liable on conviction to a fine or to imprisonment for a period not exceeding 10 years”. The Constitution supports the right to “freedom of conscience, religion, thought, belief and opinion” (section 15.1). The doctor may therefore refuse to perform the TOP but must refer the patient to a colleague who is willing to take over the case. A disjunction exists between the willingness of doctors to accept TOP and their corresponding willingness to actually perform these procedures. Savulescu (2006) argues that doctors may claim a right to conscientious objection and refuse to conduct TOP provided that other doctors are available to perform these procedures. In more remote areas where fewer doctors are available, he argues that it is unethical for doctors to refuse to conduct a TOP (Savulescu 2006). In this case the nurse acted correctly, both ethically and legally. She demonstrated courage and integrity in overriding the doctor’s decision in the best interests of the patient. According to the Child Care Act, this is a case of statutory rape and the doctor is obliged to report it. In terms of the TOP Act, the father’s consent is not required for a termination. It has been argued that the rights of the father or potential father are not taken into consideration in the Act. After the 20th week There are three different indications for TOP during this period: 1. The continued pregnancy would endanger the woman’s life. 2. The continued pregnancy would result in severe malformation of the foetus. 3. The continued pregnancy would pose a risk of injury to the foetus. A medical practitioner must find one of these indications after consultation with another doctor or midwife. Only a doctor may perform a TOP at this gestational age. Case study 17.5 A 34-year-old primigravida was admitted to a rural hospital with recurrent seizures that she was experiencing for the first time. She was at 26 weeks’ gestation with a blood pressure of 220/140 and had proteinuria. She was 221

drifting in and out of consciousness in between the seizures. Ultrasound revealed a live foetus. A diagnosis of eclampsia was made. Treatment was commenced with magnesium sulphate, oxygen and antihypertensives. However, the seizures continued. Definitive management required that the pregnancy be terminated. The husband declined consent for termination as his wife had tried to fall pregnant for five years and they had spent a fortune on fertility treatment. He requested that the doctors manage his wife conservatively. The medical team knew that there was no way the baby could be saved at 26 weeks as there was no neonatal unit at the hospital and the nearest referral centre was 200 km away. What should the doctor do? COMMENTARY Continued pregnancy in this case would endanger the woman’s life. She has therefore met the indication for a late TOP. Prior to viability of the foetus, maternal interests take precedence. Post-viability, foetal interests predominate in most countries except where the life of the mother is threatened or where the foetus has a severe life-threatening abnormality. Usually a foetus of 26 weeks’ gestation would be regarded as viable and might survive outside the uterus in an institution with a good neonatal unit. However, in a rural setting this may not be possible and the rights of the mother would outweigh the rights of the foetus to life. As such it would be ethically and legally permissible to override the father’s request to manage the woman conservatively. A medical termination of pregnancy is indicated in this case as it would be in the best interests of the mother.

17.5.3 Feticide Technological advances in medical science have both enhanced and expanded antenatal healthcare. In foetal medicine, three- and four-dimensional ultrasound, magnetic resonance imaging (MRI), intrauterine foetal therapy and genetic testing have led to the detection of foetal abnormalities at all gestational ages, including the period of viability and beyond (Wesley 2003; Noble & Rodeck 2008). While the preference is for abnormalities to be detected early, there are several instances in which abnormalities may only be detected late in pregnancy. These include late bookings at antenatal clinics especially in resource-depleted settings, missed early abnormalities and those abnormalities that are only detectable as pregnancy advances. While such scientific progress is exciting and innovative, it is inescapably accompanied by ethical and legal complexity. New moral dilemmas have emerged and have served to advance the ethical debate on termination of pregnancy (TOP) and feticide. Abnormal ultrasonographic findings after 24 weeks of gestation create ethical dilemmas for parents and the treating obstetrician alike. Upon diagnosis of a foetal anomaly, parents may decide to continue with the pregnancy or to request foetal therapy if indicated (Noble & Rodeck 2008). On the other hand, they may decide to consider the option of late TOP (after 20 weeks of gestation) or feticide. In the case of multiple pregnancy, selective reduction (Lipitz et al. 1996) is also an option. Procedurally, feticide and late TOP differ – feticide involves methods aimed at directly and deliberately killing the foetus so that the mother delivers a dead baby (Senat, Fischer, Bernard & Ville 2003), while a late TOP involves methods to prematurely end the pregnancy. The result might include the delivery of a viable or live baby which may then be left to die. Conceptually, the outcome is the same – the premature and artificial death of a foetus. Case study 17.6

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A patient was admitted to a hospital at 28 weeks’ gestation. Ultrasound revealed several severe abnormalities – absent bones in the fingers and forearms, severe scoliosis, and cardiac and renal defects. The findings and treatment options were discussed with the mother. The mother requested that the foetus be killed as she preferred that it should not be born alive to suffer. She was referred to the foetal unit for specialised management. COMMENTARY The burden carried by a mother who knows that her foetus is seriously malformed or will have a short postdelivery survival accompanied by suffering and/or prolonged hospitalisation or repeated surgery is significant (Gevers 1999). Her autonomous choice may thus be to terminate the pregnancy on the basis of compassion for her child, self-determination or self-interest. The obstetrician faces the dilemma of respecting the autonomy of the mother and harming or killing the foetus. The notion of the ability of the foetus to feel pain especially from 23–26 weeks exacerbates the concept of harm in feticide (Anand 2007). Pregnant women may request a late TOP or feticide for a spectrum of different reasons (Savulescu 2001; 2006). Severe life-threatening congenital abnormality early in pregnancy does not create ethical conflict. In general the reproductive choice of women to terminate pregnancy or request feticide in instances of severe life-threatening congenital abnormality must be respected. However, when the request arises due to a potential disability that is not life threatening such as Down syndrome or cleft lip/palate, this becomes more ethically questionable. At the extreme end of the spectrum, late TOP requests may also arise in the absence of foetal abnormality – where a pregnancy is inconvenient in economic terms or where career choices of the mother are prioritised. Slippery slope arguments will therefore apply where indications for feticide or late TOP may include less serious disability or even a normal foetus. The ethical conflict at this level relates to the degree of abnormality that can be considered sufficient to warrant a late termination or feticide. Finally, late TOP and feticide may be regarded as a form of eugenics especially when the indications include abnormalities that are not life threatening. Passive eugenics is intended to remove any degree of abnormality from society and is inherently discriminatory towards the disabled (Savulescu 2001). An ultimate aim of modern medical science is the creation of a genetically pure human race. Severe criticism was levelled against Hitler, his dream of a eugenic society and the “law for the prevention of genetically diseased descendants” implemented in 1933 (Popenoe 1934). How far are we from creating a similar “Utopia” – based on perfectionistic and hedonistic utilitarianism (Savulescu 2001)? Only 20 per cent of all pregnancies end in abortion. An even smaller proportion results in a late termination or feticide. However, when the request is made, it is fraught with ethical concerns. It is hence imperative that all obstetricians and obstetric units – in public and private practices – have evidence-based protocols and policies in place. Such policies must consider the important concepts of foetal and neonatal moral status. Ultimately, a universal policy on foetal and neonatal moral status will ensure a universal right to life or death for all foetuses irrespective of where in the world they exist (Moodley 2008).

17.6 ASSISTED REPRODUCTION Case study 17.7 A 42-year-old woman, Ms E, presents to the gynaecology department at a state hospital with a problem of infertility. She has two children from a previous marriage, but has been involved in a relationship with a 36-yearold man, Mr F, for the past five years. They are not legally married. He has never had any children and would like 223

to have a baby with her. They have been having unprotected sex for the past five years. She has been having regular menses. She requests help to fall pregnant. COMMENTARY Based on the principle of distributive justice, state health policy may have specific criteria for treatment of infertility. The policy might indicate, for example, that only couples without children may be investigated and treated for infertility. As Ms E already has two children, she might be ineligible for care under state health but may be offered further care at a private infertility clinic at the same hospital or in the private sector. Ms E agrees to pay for her fertility investigation and treatment. During investigation of the couple, it is discovered that Mr F is HIV-positive. How will the management change? COMMENTARY Assisted reproduction for HIV-discordant couples is an ethically challenging situation that may nevertheless arise frequently in South Africa where HIV prevalence is very high. Ethical conflict arises because such couples have a right to procreation based on the principle of autonomy. This right is supported legally by the South African Constitution. On the other hand, one needs to consider the ethics of deliberately transmitting a chronic disease to a child who may lose one or both parents prematurely due to their own disease. Availability of antiretroviral treatment and advanced sperm-washing techniques make assisted reproduction a possibility for such couples in developed countries. In South Africa, limited resources and hence the principle of distributive justice may not allow for advanced sperm-washing procedures in the state health sector. Case study 17.8 At 42, Miss C is found to have a uterus with multiple fibroids, giving her a poor chance of conception. She and her partner decide to opt for in vitro fertilisation (IVF) using HIV-negative donor sperm and Miss C’s ova. Her friend, Mrs G, who is aged 35, agrees to act as the surrogate mother for the couple. Is this permissible? COMMENTARY At the best of times, surrogacy arrangements are complicated and controversial. From an ethical perspective it is argued that the use of surrogate mothers has the potential to commercialise reproduction and commodify the child that is born. Surrogate mothers may subject themselves to risks, both known and unknown, to gain financially from such arrangements. In order to obliterate the financial incentive that may arise in such situations, surrogacy laws in most countries permit compensation of medical expenses and loss of income only. In South Africa, surrogacy contracts are legal but not enforceable because they are regarded as contra bonos mores (against public interest). In legal terms, a surrogacy contract represents an agreement to hire a womb. Legal issues surrounding surrogacy are dealt with in the Children’s Act No. 38 of 2005. However, the potential for emotional conflict may still arise if the surrogate mother is unable to honour the contract and give up the child. In order to minimise such conflictual situations, gynaecologists involved in surrogacy work usually follow clinical, ethical and legal guidelines very carefully, with intensive counselling and preparation of the biological couple and the surrogate mother. In so doing, a positive outcome is often achieved for all concerned.

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17.7 POSTHUMOUS REPRODUCTION Case study 17.9 A healthy 36-year-old woman slept for seven hours on an international flight. On awakening, she needed the bathroom, but collapsed on her way there. A doctor on the flight found that she had no pulse and commenced cardiopulmonary resuscitation (CPR). Despite the CPR she arrived in Boston (US) with anoxic brain injury. She had collapsed due to multiple pulmonary emboli that had originated from a deep vein thrombosis. The woman had been on an oral contraceptive for several years. Over the next few days her neurological function deteriorated and she developed raised intracranial pressure. Owing to the poor prognosis, the family agreed that she be extubated. A few hours later the family reversed their decision and her husband requested that maximal medical treatment be resumed to permit oocyte retrieval from the patient. Source: Adapted from Greer et al. (2010) COMMENTARY A request for oocyte retrieval for the purposes of future assisted reproduction in an end-of-life situation is uncommon. However, several ethical, legal and clinical questions are raised by this case. From an ethical perspective, would the patient have consented to becoming a parent after her death? The husband confirmed that the patient was taking an oral contraceptive for the purpose of preventing pregnancy. Neither he nor his wife had a desire for children prior to her collapse. She did intend to have children in the future and had mentioned this to him but he had not voiced such a desire to her. They had intended to discuss this later. Her regular gynaecologist was contacted to ascertain whether she had made any decisions about future pregnancy. Although it was a standard practice of this gynaecologist to ask about and document pregnancy wishes, this patient had not discussed any with her. It was hence clear that the patient had not documented (verbally or in writing) a desire to have children after her death. If she had expressed a desire to have children after her death, would she have consented to oocyte retrieval, IVF and a surrogate mother and how would the surrogate mother have been chosen? If this case had occurred in South Africa, we would have to look at Chapter 8 of the National Health Act No. 61 of 2003, where it is stated that removal of gametes from the body of a living person can occur only with written consent from that person. The patient in this case is not brain dead, so technically she is regarded as a living person. This patient did not have a living will or advance directive referring to gamete donation nor was there any verbal discussion with her husband regarding gamete donation at any stage of her life. Chapter 8 of the National Health Act also states the purposes for which gametes can be removed from a living person with their consent, and artificial fertilisation of another person is included. Whether this other person would include her husband is unclear and legal advice would have to be sought in the absence of case law in South Africa. From a medical perspective long-term use of oral contraceptives could result in minimal oocyte yield. Ovarian hyperstimulation could take seven to ten days of gonadotrophin stimulation and supporting the patient for this length of time may be problematic. Furthermore, keeping the patient in the lithotomy position for this period of time would result in a further increase in intracranial pressure leading to brain herniation and death. In this particular case the medical team denied the request of the patient’s husband on medical, ethical and legal grounds. The husband accepted their decision and the patient was extubated and died shortly thereafter (Greer et al. 2010).

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17.8 PREIMPLANTATION GENETIC DIAGNOSIS (PGD) Case study 17.10 In Colorado in the US, a six-year-old girl was found to have Fanconi’s anaemia. Both her parents were carriers. The condition is recessive. The afflicted child may have fused hips and wrists, missing thumbs, an incomplete gut and, in the next two years, may develop leukaemia. The parents planned to have another child, so they opted for IVF and pregenetic diagnosis, and froze the cord blood of the perfectly matched child for use in the sibling. COMMENTARY Advanced technology has made it possible to create a foetus using IVF, test for genetic disease and human leucocyte antigen (HLA) compatibility, and implant only the most suitable foetus for further development. At birth, cord blood is harvested to use as a source of bone marrow for a sibling with a serious disease. Ethically, this amounts to deliberate procreation – the creation of a child for stem cells or “spare parts”. In this way the created child is used as a means to an end – hence the argument relating to commodification of the child. As a result of the ethical controversy surrounding such cases, the Human Fertilisation and Embryology Authority (HFEA) in Britain has specified criteria for use of PGD: 1. 2. 3. 4. 5. 6. 7.

The affected child must have a serious or life-threatening disease. The embryos must also be at risk of developing the same disease. All other treatments must be explored. The recipient must not be the parent. Only cord blood may be used. There must be thorough counselling of the parents. Parents must participate in follow-up studies, and clinics must report treatment cycles and outcomes. 8. Embryos may not be genetically modified to produce a tissue match. These regulations are challenged on a regular basis as new cases emerge. PGD, while controversial, offers hope to seriously ill children, and support for the procedure under regulated conditions is growing, provided that the newly created child is nurtured and cared for in the same manner as the other siblings.

17.9 ETHICS OF THE PELVIC EXAMINATION Medical students are obliged to develop their skills in conducting pelvic examinations and performing Pap smears. This is an ethical requirement in terms of their training and subsequent competence as clinicians. However, unlike taking a history or conducting a general physical examination where considerations of privacy are important, the pelvic examination raises more serious concerns about patient privacy and consent. Patients seeking care at academic hospitals are aware that they will encounter medical students during the course of their care. However, in addition to this, specific consent must be sought from patients for pelvic examinations. Medical students should be considerate in terms of maintaining privacy and respecting the dignity of patients during pelvic examinations. It is 226

also important that too many students do not burden the same patient in terms of requests to conduct a pelvic examination. In fact at some academic hospitals internationally patients are paid to allow students to examine them (Lo 2009). Initial practise in performing pelvic examinations, speculum examinations and Pap smears should be obtained in a skills laboratory on a suitable synthetic model. Practising pelvic examinations in theatre on anaesthetised patients should be done with the prior consent of the patient. Such permission could be included in the consent form related to the surgery or could be documented on a separate consent form related to student teaching.

17.10 CONCLUDING REMARKS Ethics in reproductive health is both complex and challenging. The Choice of Termination of Pregnancy Act No. 92 of 1996 in South Africa strongly supports reproductive choice and has introduced clarity in terms of permissible TOPs. However, the Act remains problematic as it refers to “non-mandatory” counselling and does not set a limit on the number of TOPs one may have. As such TOP is sometimes used as a form of contraception. The indication of socioeconomic reasons for mid-trimester abortions is also controversial and prone to abuse. Irrespective of whether one is pro-choice or pro-life, termination of pregnancy will always remain a difficult and emotionally charged topic and as such the ethical debate will continue.

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CHAPTER 18: Ethics at the End of Life (Author: Keymanthri Moodley) By the end of this chapter you should be able to: • • •

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define and describe passive and active euthanasia, and understand the differences between voluntary and non-voluntary euthanasia and physician-assisted dying provide moral arguments for and against euthanasia grapple with the ethical tension between non-provision of life-prolonging treatment and the duty of care: killing and letting die, the doctrine of double effect, ordinary and extraordinary means, assisted dying versus suicide understand the importance of advance directives discuss the Draft Bill of the SA Law Commission on End-of-Life Issues.

18.1 HISTORICAL PERSPECTIVE The word “euthanasia” literally means a “good death” and as such has remained one of the most contentious ethical dilemmas in current-day medical practice around the world. Much of the controversy relates to the medical profession’s role in preserving and saving life as opposed to ending life. The degree of controversy parallels the various types of euthanasia that are requested or practised. While passive euthanasia involving withholding or withdrawal of treatment is widely practised and accepted to a certain degree, active euthanasia attracts far more controversy. Voluntary active euthanasia involves the doctor administering a drug at the request of a patient, resulting in death. Physician-assisted dying usually involves the doctor providing a prescription for a lethal drug to a patient at the patient’s request. The patient takes responsibility for the final act that leads to death. Many regard euthanasia as antithetical to the goals of medicine. Different countries around the world vary in their policies on end-of-life issues. One of the earliest policies on euthanasia originated in Germany where, in 1895, Adolf Jost published a book called The right to death. This book promoted direct medical killing and advocated that control over the death of an individual must belong to the state. Subsequent texts spoke of destruction of lives unworthy to be lived. An “unworthy life” included that of the incurably ill and also the mentally ill, the feebleminded, the retarded and deformed children. In 1929, Adolf Hitler publicly discussed the killing of German infants with physical defects. It was therefore not surprising that Germany’s euthanasia programme started with the destruction of children born with birth defects, mental retardation and genetic disease. A precedent was set in 1938 when a father appealed directly to Hitler to grant a mercy death to his child who was born blind and retarded, and with one arm and one leg. Hitler subsequently established an advisory committee to prepare for the killing of deformed or retarded children. The committee informed midwives and doctors delivering children with congenital deformities to register the child with the local authorities. This information was then examined by a group of “experts” who sorted the children into two groups – those who were to be exterminated and those who were allowed to live. Those destined for extermination were transported to one of 28 institutions with extermination facilities. Initially, children up to the age of three years with birth defects were exterminated. By 1941 the children’s euthanasia programme was extended to 17 years of age and by 1943 the inclusion criteria extended to healthy Jewish children and healthy children of other “unwanted” races. 228

It was only a matter of time before the killings – usually by shooting or the use of carbon monoxide – extended to adult Jews, gypsies, mental patients and Russians, as well as prisoners in the concentration camps (Garver & Garver 1991). This is an excellent illustration of the slippery slope argument frequently used in the euthanasia debate, and we shall discuss this further later in the chapter. The Netherlands has had established policies on end-of-life issues for a few decades but, unlike the old German ones, Dutch euthanasia policies have been carefully regulated and limited to incurable medical illness aimed primarily at ending suffering. These policies date back to the 1980s when voluntary active euthanasia and physician-assisted dying were openly practised and then legalised by the courts and the Royal Dutch Medical Association. An exception in the criminal code enacted in 2002 means that doctors who perform euthanasia or provide assistance in suicide commit no offence if they follow the guidelines for “due care” (Battin et al. 2007). The guidelines are as follows: • • • • • •

The patient must make a voluntary, informed and well-considered request. The patient must be facing unbearable and hopeless suffering either currently or in the immediate future and with no outlook for improvement. The doctor must agree with the patient that no reasonable alternative treatment is available. The doctor must consult with another independent doctor. The action must be performed with due care. The action must be reported to the appropriate authorities.

Oregon was the first state in the US to legalise physician-assisted dying. The Oregon Death with Dignity Act was passed in 1997. It allows terminally ill residents in the state of Oregon to receive a prescription for self-administered lethal drugs from their doctor. It does not permit a doctor or other person to administer a medication directly to a patient to end his or her life (Battin et al. 2007; Chin, Hedberg, Higginson & Fleming 1999). The criteria that must be met are as follows: • • • • •

• •

The patient must be an adult resident of Oregon (i.e. 18 years or older). The patient must be able to make and communicate healthcare decisions. The patient must have an illness that will lead to death within six months. The patient must make one written and two oral requests to the doctor. The oral requests must be at least 15 days apart. A primary doctor and a consultant must: - confirm the diagnosis of the terminal condition and its prognosis - confirm that the patient is competent - refer the patient for counselling if they believe the patient’s judgement is questionable. The primary doctor must inform the patient about alternatives such as hospice care and palliative treatment. All written prescriptions must be reported to the Oregon Health Division.

The second state in the US to legalise assisted dying was Washington in 2008. Linda Fleming, a 66-year-old woman with stage 4 cancer of the pancreas, was the first person to take a lethal drug cocktail prescribed by her doctor under the new law. She was in excruciating pain (Ertelt 2009).

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The Dignitas Clinic in Zurich was founded by Ludwig Minelli, a Swiss lawyer, in 1998. In Switzerland, assisted dying is not illegal according to the 1918 penal code, provided that assistance to die is given without any motives of self-interest. Assisted dying does not conflict with a doctor’s or relative’s obligation to save life (Bosshard et al. 2008) because the patient is regarded as primarily responsible for ending his or her own life. Voluntary active euthanasia, where the doctor is the proximate cause of death, is, however, illegal. Dignitas acts as a neutral party – it charges a fee for assisted dying (10 000 Swiss francs), but apparently has nothing to gain from the death of people who come to the clinic to die. Unlike other countries where assisted dying has been legalised, Dignitas allows foreigners to come to Switzerland to seek to end their lives, and a form of “suicide tourism” has developed. In January 2008, a French couple, Genevieve Gall Peninou (81) and her 86-year-old husband, went to Dignitas to die. She had Alzheimer’s disease and had suffered for several years. Her husband was healthy but did not want to live without her (Ball & Mengewein 2010). Recent concern about the lack of regulation of “suicide tourism” resulted in the Swiss cabinet proposing two new laws – one to tighten regulations and the other to ban suicide altogether. Tighter regulations would require patients to get the opinions of two doctors that their illness was incurable and imminently fatal. It would also be necessary to get assurances that the person seeking assisted dying is of sound mental capacity and has repeatedly expressed a desire to die (for assisted-dying laws in the US and abroad, see http://www.pbs.org/wgbh/pages/frontline/suicidetourist/etc/links.html). In addition to the countries already listed, several others do not regard physician-assisted dying as unlawful. These are Albania, Belgium, Canada, Colombia, Luxembourg and Mexico. It has also been legalised in two more states in the US: Montana and Vermont. The case of Carter versus Canada has significantly advanced global debates on physician-assisted dying. Kay Carter had been suffering from degenerative spinal stenosis. Physician-assisted dying was illegal in Canada in 2010, so her daughter, Lee Carter, took her to Switzerland to end her life. Other patients with terminal illnesses also found themselves in this predicament and the legal system was challenged. The prohibition of physician-assisted dying was contrary to the Canadian Charter on Rights and Liberties. After a four-year-long legal battle, on 6 February 2015 the Canadian courts granted those patients who are mentally competent and suffering intolerably the right to be assisted by a doctor to end their suffering. While the legal system in Canada is adjusting its laws to permit physician-assisted dying, doctors will not be compelled to participate. Source: https://www.youtube.com/watch?v=HBQtHDsncEU

18.2 END-OF-LIFE ISSUES – A CLINICAL PERSPECTIVE Active euthanasia has always been and remains illegal in South Africa. Historically, active euthanasia has resulted in legal prosecution of doctors. Some of these legal cases will be discussed below. The draft bill of the South African Law Commission (SALC) is a legislative proposal about all aspects of end-of-life decision making, including palliative care, advance directives, withholding and withdrawal of life-sustaining treatment, physician-assisted suicide (PAS) and voluntary active euthanasia (VAE). To begin with, we will examine the various ways in which a doctor may assist a patient in dying: 1. Withholding or withdrawing treatment/passive euthanasia 230

2. Voluntary or non-voluntary euthanasia 3. Physician-assisted dying

18.2.1 Passive euthanasia Withholding or withdrawing treatment Withholding (not starting) treatment falls into the realm of an omission, which some may argue is more ethically permissible than a commission such as withdrawing (stopping) treatment. Others argue that an omission and a commission carry equal moral worth, and that a distinction is unnecessary and both forms of euthanasia are therefore challenging. The decision to withhold or withdraw treatment is often context dependent and guided by the wishes of patients and their families as well as the medical team. An important point of departure in the debate on withholding and withdrawing treatment involves a definition of the term “treatment”. Various classifications and definitions exist with respect to treatment. The literature has referred to extraordinary and ordinary treatment as well as sustenance technologies versus medical treatment. Treatments that are regarded as technologically advanced, complicated, unusual or expensive may be regarded as extraordinary. Examples include mechanical ventilation and renal dialysis. Antibiotics, intravenous fluids and tube feeding may be regarded as “ordinary” treatments (Lo 2009). Traditionally, extraordinary treatments may be legitimately foregone while ordinary treatments may not be legitimately foregone. Refusal of ordinary means of treatment was long considered to be a form of suicide. Some ethicists see the distinction between ordinary and extraordinary treatment as outdated and unhelpful, and hence morally misleading (Beauchamp & Childress 2013). It is more important to consider the benefits and burdens of interventions in specific cases and to consider patient preferences (Lo 2009). Another distinction can be drawn between medical treatment and sustenance treatments. Traditionally, medical treatment refers to life-saving drugs and artificial ventilation. However, hydration and nutrition are regarded as sustenance forms of treatment. The distinctions between these definitions of treatment were established in landmark cases in the US like the Karen Ann Quinlan case where for the first time tube feeding, hydration and antibiotics were classified as forms of treatment. If these forms of treatment were withdrawn, death would occur. Consider the following case Case study 18.1: The Karen Ann Quinlan case, 1975–1985 In 1975, Karen Ann Quinlan was 21 years old. She was at a party where she had been drinking alcohol and also took Valium. She suffered cardiac arrest and required support with a ventilator. Her parents believed that the ventilator was causing her pain and had it removed. When artificial ventilation was discontinued she lived for another ten years as a result of antibiotics, nutrition and hydration via a nasogastric tube. She was unable to communicate and lay in a foetal position with respiratory problems, bed sores and weight loss (her weight dropped from about 55 kg to 35 kg). The Roman Catholic theologians advising her parents believed that it was not morally necessary to continue with nutrition, hydration and antibiotics. Her parents, however, felt that the nasogastric tube was not causing her pain and continued to feed her. During the ten years another case arose – that of Nancy Cruzan – and the New Jersey court ruled that the provision of nutrition and hydration through nasogastric tubes and other medical means is not always legally required. Source: Adapted from Beauchamp & Childress 2013 231

Read more: Court and the end of life – the right to privacy: Karen Ann Quinlan http://www.libraryindex.com/pages/582/Court-End-Life-RIGHT-PRIVACY-KARENANNQUINLAN.htmlixzz0oxVz7aO9 Case study 18.2: The Nancy Cruzan case, 1983–1990 Nancy was 25 years old when she sustained a head injury and progressed into a persistent vegetative state. In 1987 her parents requested removal of her gastrostomy tube. In 1988 a court ruling allowed the family’s request. However, the Attorney General then appealed and the Missouri Supreme Court reversed its decision, offering to pay $130 000 per year for her medical costs. The family appealed to the US Supreme Court in 1989 and by December 1990 the Missouri State Court ruled that the tube could be removed. Nancy Cruzan died 12 days later. Source: http://journalofethics.ama-assn.org/2001/07/imhl1-0107.html COMMENTARY The Quinlan case and the Cruzan case set important legal precedents with respect to patients’ right to die and for the withdrawal of treatment. Both cases demonstrated that life-support measures (such as ventilators) and forms of sustenance treatment, including hydration, nutrition and antibiotics, may be withheld or withdrawn, thereby allowing a patient to die. This may be at the patient’s request (while competent or via a living will when a previously competent patient becomes incompetent) or based on a judgement in the patient’s best interests. For example, it may be in the best interests of a terminally ill patient that cardiopulmonary resuscitation (CPR) is withheld if the patient were to go into cardiac arrest. In such cases a “do not resuscitate” (DNR) order is issued and noted in the patient’s folder in sufficient detail to guide members of the medical team in terms of further care. Such a decision is usually made in consultation with the patient if he or she is able to understand, or the family/surrogate decision maker if the patient lacks decision-making capacity. In cases where neither patient nor family is able to be involved in decision making, the medical team may reach such a decision in the best interests of the patient and in the setting of treatment futility. The medical record of the patient must reflect the reason for the DNR order, the agreement of the patient or family and the plans for further care. Verbal DNR orders may be given in an emergency but must be followed up with a written order in the medical records as soon as possible. Withholding or withdrawing treatment may be viewed as “passive” euthanasia. The legality of this issue is unresolved in South Africa. It is included in the Draft Bill of the South African Law Commission. Generally, however, a consensus has emerged that it is indeed permissible and even mandatory to withhold or withdraw life-sustaining treatment under certain circumstances. Case study 18.3: Clarke v Hurst NO and Others 1992 (4) SA 630 (D) Dr Clarke was a well-known medical practitioner and politician in Durban, Kwa-Zulu-Natal. In his lifetime he had been the MEC responsible for hospital services in Natal for five years. He was a member of the SA Voluntary Euthanasia Society and had signed a living will before his illness. In July 1988, when he was 63 years old, he was having treatment under epidural anaesthesia and his blood pressure dropped. He went into cardiac arrest and was resuscitated. His heartbeat was restored but he was left brain damaged due to cerebral anoxia. Dr Clarke became deeply comatose and went into a persistent vegetative state for several years. About three years after he

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went into this state, his wife approached the court and requested that she be appointed curatrix with the power to withhold further medical treatment and to discontinue the nasogastric feeds. A long legal debate ensued in which the judge reminded Mrs Clarke that a curator personae is at all times under a duty to act in the best interests of the patient and not necessarily in accordance with the wishes of the patient. A person who assists another to commit suicide will be guilty of murder or culpable homicide according to South African law. Societal norms regarding withdrawing treatment were also discussed. The court eventually ruled that discontinuing medical treatment would not be unlawful. Judgment was handed down on 30 July 1992. Mrs Clarke was appointed as curatrix to her husband with the power to withhold treatment and to authorise discontinuance of any treatment. Dr Clarke was taken home from the hospital and died on 14 August 1992. COMMENTARY The Clarke case was judged in 1992. Now consider the following case which occurred in 2009, and compare and contrast the two cases in terms of how the living will was viewed. Case study 18.4 Mr Y was a 63-year-old accountant who had retired two years previously. He developed carcinoma of the duodenum (CA duodenum) and had a Whipples resection. Unfortunately, the surgery was complicated by a leak, and a pancreatic abscess developed. This necessitated a laparotomy and drainage. Postoperatively Mr Y developed atelectasis and required admission to an intensive care unit (ICU). He required mechanical ventilation and low-dose inotropic support. His renal function was poor with a urea level of 40 mg/dl and a creatinine level of 209 mg/dl. A CT scan of his brain was normal. His prognosis with respect to the CA duodenum: survival for about two to three years. However, his organ failure postoperatively would leave him with significant morbidity. He would need to be tube fed for the next two months. Repeated surgery would be required to reconstruct his gastrointestinal tract. His wife became very concerned as she knew that Mr Y was very uncomfortable with extraordinary treatment at this stage of his disease and life. She met with his surgeon and presented his living will, drawn up three months previously after he had been diagnosed with CA duodenum. The living will read as follows: Should I no longer be capable of making decisions for my own future and should my physical and/or mental condition deteriorate to such an extent that there is no reasonable prospect of my recovery from physical illness or impairment which is expected to cause me severe distress or to render me incapable of rational existence, I request that • • •

I be allowed to die. I further request that no systems be used in order to keep me alive in circumstances where, but for the use of such systems, I would have died I be given whatever quantity of drugs which may be required to keep me free from pain or distress even if the moment of death is hastened Any decision to turn off any systems that may be keeping me alive as per my wish shall be made by my wife (failing which, my daughter and son) in consultation with the doctors. 233

Exemption It is my express wish that my doctors or members of my family who carry out my aforegoing requests be fully exonerated and exempt from all blame or liability arising from their use or their failure to use or their decision to terminate the use of any systems. (Anonymous) PERPLEXING QUESTIONS The surgeon was plagued by the following questions: 1. 2. 3. 4.

Is the living will a legal document? Should patient autonomy be respected above all else? Is it permissible to withdraw treatment? What will the legal consequences be to the doctor and the hospital if the living will is followed?

COMMENTARY This is an excellent illustration of the various questions raised at the end of life when a patient has expressed clear wishes regarding his preferences with respect to medical care. The legality of a living will has been uncertain for a long time in South Africa. However, the National Health Act No. 61 of 2003 section 7(1)(e) indicates that a health service may not be provided to a patient without informed consent unless “any delay in the provision of the health service to the user might result in his or her death or irreversible damage to his or her health and the user has not expressly, impliedly, or by conduct refused that service”. Indirectly, this implies that a living will in which healthcare was declined must be taken into account and a doctor cannot provide treatment without the patient’s consent in such a case. The major uncertainty created by the living will in this case was whether Mr Y was referring to his terminal cancer illness or any illness that made him dependent on systems – in this case the ventilator. His advance directive stated: “I further request that no systems be used in order to keep me alive in circumstances where, but for the use of such systems, I would have died”. It was the use of the ventilator during his postoperative illness that reminded his wife of his directive and she requested that the ventilation be discontinued. After wide ethics and legal consultation and a family conference, the doctors decided to discontinue ventilation. Mr Y died two days later. In the Mr Y case, like the Clarke case, decision making was facilitated as the family’s request was consistent with that of the patient. Ethical challenges are exacerbated when there is discordance between the wishes of the family and those of the patient or when there is conflict among family members, as occurred in the following American case: Case study 18.5: The Terri Schiavo case, 1990–2005 Terri was 24 years old when she collapsed as a result of what was thought to be a potassium imbalance. She sustained cerebral anoxia and became comatose, then went into a persistent vegetative state. She had no higher cortical function, but she had brainstem activity and her respiration and circulatory system were intact. Her husband Michael was appointed as her curator. Terri did not have a living will but Michael maintained that they had had discussions about end-of-life issues and she had voiced her preference not to be kept alive by artificial means. He therefore made several attempts via the courts to have her feeding tube removed. Her parents disagreed with Michael and appealed his court applications to remove her feeding tube. They wanted their

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daughter to be kept alive in the hope of a recovery. After 15 years of family conflict and legal battles, Terri’s feeding tube was eventually removed in March 2005 and she died 13 days later. Source: NNDB 2016 COMMENTARY In the absence of an advance directive such as a living will or durable power of attorney, a surrogate decision maker must be appointed. Who this person should be is determined by law. The National Health Act has a priority list of surrogate decision makers for incompetent patients – the spouse or partner becomes the primary decision maker and if there is no spouse/partner, then the parents, grandparents, adult child or siblings, in that order, may take over decision making for the patient. In the US, the surrogate decision maker must make a decision for the patient based on what the patient would have wanted. In South Africa, from the Clarke case it became evident that the curatrix must make a decision that is in the patient’s best interests – not necessarily what he or she would have wished. However, the National Health Act takes into account the prior wishes of the patient. THE DOCTRINE OF DOUBLE EFFECT Case study 18.6 Mr V was 52 years old and was generally well until he started to experience pleuritic chest pain and dyspnoea on exertion. He visited the local state hospital in Johannesburg where a chest X-ray and subsequent pleural biopsy revealed a diagnosis of mesothelioma. Mr V was a non-smoker and could not understand how he had developed a form of lung cancer. The doctor enquired about previous exposure to asbestos. Mr V recalled that he had worked as a school teacher in Johannesburg for 25 years and the roof of the school building was made of asbestos. Six months later, Mr V deteriorated and a left pneumonectomy was performed. Postoperatively he was intubated and ventilated. It soon became evident that he had bone metastases. Mr V was ill but awake and alert. He understood that his prognosis was poor and requested that he be weaned off the ventilator and transferred to a general medical ward. Dr U was a medical registrar working in the medical ward. She had regular family conferences with Mrs V and her three children. They were particularly concerned that Mr V was in severe pain. On several occasions the family requested pain relief for Mr V. Dr U treated the pain with morphine. As the pain worsened it became necessary to increase the dose of morphine. An intern working on the ward was concerned about the episodes of apnoea that followed the dose of morphine. Finally the pain became so severe that Dr U had to increase the dose of morphine again. This time Mr V slipped into a coma. He died an hour later. The family was relieved that Mr V’s suffering had ended. The intern working in the ward was a devout Catholic and lodged a complaint about Dr U initially with the consultant and subsequently with the HPCSA. A preliminary inquiry hearing followed. COMMENTARY The doctrine of double effect incorporates a distinction between intended effects (such as pain relief) and foreseen effects (such as respiratory depression). Clearly a single act (administering morphine) can have two effects, one good and one harmful. The act is morally permissible if the following conditions are met (Beauchamp & Childress 2013): 1. The nature of the act must be good or morally neutral. 2. The agent’s intention must be good. The bad effect can be foreseen but must not be intended. 3. The bad effect must not be a means to the good effect. 235

4. The good effect must outweigh the bad effect. In the case of Dr U, her primary intention was relief of pain and suffering. Respiratory depression was not intended but occurred as a result of her intention to relieve pain. The HPCSA committee therefore ruled in her favour.

18.2.2 Active euthanasia Voluntary and non-voluntary euthanasia Voluntary euthanasia refers to intentionally bringing about a competent patient’s death where death is reasonably believed to be in that patient’s interests at the informed request of the patient. The doctor’s act is the proximate cause of death. This is also referred to as voluntary active euthanasia (VAE). An incompetent but previously competent patient who has requested euthanasia by advance directive is included here. Non-voluntary euthanasia involves incompetent individuals who have never been competent (e.g. an anencephalic infant) or who were formerly competent but gave no advance directive (e.g. someone in a permanently vegetative state). The following cases are examples of active euthanasia. Case study 18.7: S v De Bellocq 1975 (3) SA 538 (T) A young married woman had her first child. After birth it emerged that the child had toxoplasmosis and that her brain would be irreversibly damaged. The mother was a medical student and aware of the implications of the diagnosis. In a state of emotional distress and severe depression, she killed the child by drowning it in a washbasin. She was accused of murder and found guilty but not sentenced. Case study 18.8: S v Hartmann 1975 (3) SA 532 (C) An 87-year-old man had suffered with cancer of the prostate for many years. He developed metastatic disease, was bedridden and emaciated, and then developed a pulmonary embolus. His son was a doctor. While in hospital, a nurse administered a considerable dose of morphine to the old man on the instruction of his son. The doctor (his son) then administered further doses of morphine as well as pentothal. The old man died within minutes of receiving the pentothal. The doctor was found guilty of murder. The judge indicated that the father had not expressed a wish to die. Even if he had, that would not have constituted a defence. There were, however, strong mitigating factors present, and he sentenced the doctor to imprisonment for a year, the entire period of which was suspended until the rising of the court. In other words, the sentence was suspended until the court adjourned that day. COMMENTARY All forms of voluntary active euthanasia are currently not permitted in South Africa and in many parts of the world.

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18.2.3 Physician-assisted dying A doctor may intentionally provide the means for a competent individual to take his or her own life. Here, the patient’s act is the proximate cause of death. As discussed at the beginning of this chapter, physician-assisted dying is legal in some parts of the world such as Oregon in the US and the Dignitas Clinic in Zurich. In South Africa the legal landscape concerning active euthanasia is very different. The draft bill on the Rights of the Terminally Ill compiled by the SA Law Commission refers to physician-assisted dying and VAE jointly as “active euthanasia”. The draft bill clearly outlines the following prerequisites in its suggested legislation relating to active euthanasia: The patient must • • • • • • •

be suffering from a terminal illness be subject to extreme suffering be mentally competent and over the age of 18 years be adequately informed of the nature of the terminal illness, the prognosis, and any available treatment make an informed and well-considered decision regarding euthanasia have the opportunity to re-evaluate his or her request and yet still persist with the request be in such a position that euthanasia is the only way in which he or she can be released from suffering.

Other guidelines are included in the document relating to the doctor’s involvement. The full document is available at: http://wwwserver.law.wits.ac.za/salc/salc.html South Africa is in the process of deciding whether to legalise assistance with dying in the forms of physician-assisted dying and VAE. In August 1999, the draft bill was submitted to the Minister of Justice with three options: 1. Euthanasia could remain illegal in South Africa. 2. Euthanasia could be legalised, with the doctor making the final decision relating to its appropriateness in a particular situation. 3. Euthanasia could be legalised with an ethics committee deciding on the appropriateness of the request. The outcome of this submission is awaited. Meanwhile, the debate relating to euthanasia continues relentlessly. In one of his many articles on euthanasia, Willem Landman (1997) submits arguments both for and against active euthanasia. Arguments in support of active euthanasia: PERSONAL AUTONOMY Competent persons have a moral right to make their own choices and to act upon them. As a result, doctors who are willing to provide assistance in dying should be permitted to do so. PREVENTION OF SUFFERING 237

Life may become a burden due to suffering which can only be relieved by death. As a result, it may be cruel to refuse physician-assisted dying/VAE. THE EQUIVALENT TO “PASSIVE” EUTHANASIA Physician-assisted dying may be regarded as being equivalent to withholding or withdrawing life support – which is widely regarded as ethically acceptable. Withholding treatment is viewed to be an omission while physician-assisted dying and VAE are regarded as acts. However, we are morally and legally responsible for both acts and omissions. Can you think of any counterarguments to those named above? Arguments against active euthanasia: RELIGION Only God, it is argued, has the authority to dispose over life and death. Doctors therefore “play God” when they determine the time and manner of a patient’s death. As a result, physician-assisted dying and VAE are morally wrong because they usurp God’s authority. THE PROFESSIONAL DUTIES AND MORAL OBLIGATIONS OF DOCTORS The medical profession is caring and life preserving, therefore doctors should not be given the role of causing or assisting death. SLIPPERY SLOPE ARGUMENTS If physician-assisted dying/VAE were legalised, there would be undesirable consequences. Doctors would abuse their social standing and power to end the lives of vulnerable patients. The slippery slope would lead to involuntary euthanasia – killing patients against their wishes (Landman 1997). Do you have any arguments to add, either for or against active euthanasia? In 2010, South Africans became aware of the ethical and legal dimensions of assisted dying when Sean Davison, forensic scientist and professor of biotechnology at the University of the Western Cape, was arrested for assisting his mother, Patricia Ferguson, to die in New Zealand in 2006. She was a medical specialist herself and, in 2004 at the age of 83, was diagnosed with colon cancer. By 2006, it had spread to other organs – liver, lungs and brain – and she became terminally ill. She had attempted to starve herself to end her life, but this was unsuccessful. After watching his mother suffer for several weeks, Professor Davison (who is not a medical doctor) eventually assisted his mother to end her life, at her request, by giving her a solution of crushed morphine tablets to drink. Although he was initially charged with culpable homicide, he was finally found guilty of assisted dying and subjected to four months of house arrest in New Zealand. Since then he has returned to South Africa and started an organisation called Dignity SA. In 2015, the debate on assisted dying was reignited when a 65-year-old advocate, Robert James Stransham-Ford, who had been diagnosed with advanced cancer of the prostate in 2013, became terminal. The cancer (Gleason grade 9/10) spread to his lymph nodes, kidneys and lower spine between 2013 and 2015. Robert was an intelligent, rational and well-informed man, and an advocate of the High

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Court. He had three adult children and a 12-year-old daughter. He had been assessed by a psychologist, who found him fully competent to make a request for assisted dying via the legal system, which he did. According to the advocate, his request to end his life was justified as follows: I wish to end my life with dignity, surrounded by my loved ones, while I am able to breathe on my own, speak to my loved ones and see and hear them … I am not scared of dying. I am scared of dying in this terrible way. It is not a dignified manner to end my life. Robert was in severe pain and was experiencing nausea, vomiting, abdominal cramps, loss of appetite, disorientation, weight loss and weakness. He was bedridden. Despite trying a wide range of Western allopathic treatments, Chinese and Ayurvedic treatments, and cannabis, he was in excruciating pain. Judge Fabricius granted his request, but unfortunately the decision was confirmed two hours after he died naturally (Stranshamford case 2015). The Fabricius decision was strongly contested by the Minister of Health, the Minister of Justice, the South African Medical Association (SAMA) and the Health Professions Council of South Africa (HPCSA). Remember that it is often difficult to have definite views on such sensitive issues. Surveys among doctors on beginning- and end-of-life issues sometimes yield significant differences between the number of doctors who support physician-assisted dying or abortion in theory, and the number of doctors who would actually be personally involved in physician-assisted dying or termination of pregnancy. Marcia Angell of The New England Journal of Medicine has the following to say regarding euthanasia and the doctor’s involvement: “If euthanasia were legalised, doctors opposed to it should not, of course, be required to perform it. On the other hand, doctors who believe in the desirability of euthanasia under certain conditions, but who refuse to perform it, raise a different issue. Can they appropriately excuse themselves from a difficult part of what they consider good patient care? Would they favor the creation of a profession especially dedicated to performing euthanasia (a problematic and, I think, unsavory prospect)? … Perhaps, … those who favor legalizing euthanasia but would not perform it should rethink their position (Angell 1988: 1350).”

Do you agree? Senicide THE CASE OF GILL PHAROAH In 2015, a 75-year-old healthy palliative-care nurse from the UK went to Life Circle in Basel, Switzerland to end her life. For years she had discussed her wish to end her life with family and friends. In her work in palliative care, she had seen many elderly patients suffer, and as a nurse herself had experienced a suboptimal public health system to care for the elderly. She said: “I have got so many friends with partners who, plainly, are a liability.” Gill made a voluntary decision to end her life while she was still healthy. In the 21st century, this is an unusual decision relating to the end of life. However, historically, the ending of life of healthy elderly

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people was not uncommon when resources were scarce and had to be preserved for the younger members of society. Senicide is an ancient practice in which the elderly are abandoned to death, encouraged to commit suicide or are killed. In Ancient Rome and Greece, in the context of food shortages on the island of Keos, all those over the age of 60 were forced to kill themselves by drinking hemlock. The Inuit Eskimos were known to leave the elderly out to die on the ice. This was practised until around 1939. In south India, elderly people would be given coconut water to drink to precipitate renal failure (thalaikoothal). Senicide was also practised among the Japanese, where the elderly were taken to the mountains (Obasute-yama or “granny-dump mountain”) and left there to die.

18.3 CONCLUDING REMARKS The debate on euthanasia is far from over. Decisions to withhold or withdraw treatment are made by medical teams around the world and largely involve a balancing of the principles of beneficence and non-maleficence. Patient autonomy is respected to the extent possible via advance directives and existing legislation. Apart from the countries mentioned where physician-assisted dying has been legalised, voluntary active euthanasia remains illegal globally. In South Africa we await further development on the bill proposed by the South African Law Commission.

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CHAPTER 19: Organ Transplant Ethics and Law (Author: Anita Kleinsmidt and Rafique Moosa) By the end of this chapter you should be able to: • • • • •

discuss the conditions under which organ donation may legally take place in South Africa understand the arguments for and against payment for organs understand the arguments for and against a presumed consent system of organ donation know the approach of the Constitutional Court to resource allocation problems appreciate the problem of international organ trafficking.

19.1 INTRODUCTION Transplantation refers to the transfer of organs or tissue from one person to another. The most common solid organ transplants performed in South Africa are those of the kidney and the heart. Less common are liver and pancreas transplants. Although the donor may be alive (related or unrelated) for kidney and liver transplants, in South Africa the most common source of organs is deceased donors, although living donor transplants have overtaken deceased donor transplants in certain centres. Suitable donors are individuals who have suffered irreversible brain damage and have been declared brain dead. These individuals are supported by a ventilator while the circulation is maintained by the beating heart. Removal of organs from a deceased donor takes place soon after the declaration of brain death. Xenotransplantation using organs harvested from animals has failed to live up to expectations despite initial enthusiasm. At this stage, this is still an experimental procedure, although harvested heart valves remain an important source of tissue. The first successful kidney transplant was performed in 1954 in Boston, US, between identical twins. The first heart transplant in the world was performed in South Africa in 1967. With advances in technology, tissue typing and immunosuppressive drugs, the challenge of acute rejection of donor organs has diminished greatly, and patients can survive for many years with a transplanted organ and enjoy a significant improvement in quality of life. The main challenge faced by patients with organ failure is the lack of donor organs and the declining number of transplants performed. This has resulted in an increase in the time to transplantation. There were 4300 people awaiting transplants in South Africa in 2013, with numbers increasing every year. In 2013, 566 transplants were performed, with 573 in 2012, 550 in 2011 and 604 in 2010. Reasons for the reluctance to donate include the following: • • • •

Fear of receiving inferior treatment during an emergency and doctors harvesting organs prematurely A desire to donate but failure to inform one’s next of kin Next of kin refusing to allow organ harvest Discomfort on the part of doctors in approaching recently bereaved families to request organ donation 241

• Religious or cultural beliefs • Lack of appropriate resources in certain locations The desperate need for life-saving organs has led to illegal organ trafficking taking place transnationally. South Africa has instituted special measures to prevent this practice. The National Department of Health appointed a ministerial advisory committee to screen all non-related living donor transplants, which can only occur with ministerial approval. South Africa is also a signatory to the Declaration of Istanbul that bans commerce in organs. Many patients from rich countries had transplants performed in poorer countries – an exploitive practice labelled “transplant tourism”, which has largely been curbed by the Declaration. Many ethical debates in the arena of organ donation centre on the degree of consent required, whether deceased persons can be said to have interests in what happens to their organs, and whether the sale of organs should be allowed. Of course, other body tissue such as hair, ova, sperm and blood can be sold in some countries, but the sale of solid organs is prohibited in most countries except Iran. Consider the following case Case study 19.1: The Iranian model of compensated and regulated living unrelated kidney donation In Iran, a regulated system of payment for kidneys was instituted in 1988, which eliminated the renal transplantation waiting list by 1999. Most donors are living unrelated donors who receive a government donor award of health insurance, $1 200 (in 1988) and postoperative drugs and care. The majority of donors and recipients are from a poor background. There are no agencies or brokers. The government covers the costs of the operation and postoperative care. Recipients offer gifts to and meet with the donors, with charitable organisations providing the gifts if the recipient does not have the means. Foreigners are not allowed to participate in the programme. Source: Ghods 2007 COMMENTARY When considering the matter of payment for organs, it must be remembered that everyone involved in a transplant procedure, except the donor of the organ, receives remuneration for their contributions in the form of normal salaries and payments for services rendered – the surgeon, nurses, hospital, anaesthetists, etc. Unregulated or illegal trafficking in organs inevitably results from a situation where poor people have something to sell, which rich people need to save their lives. This has resulted in a situation where illegal donors are underpaid, exploited by middlemen and not provided with proper postoperative care. The international transplant community was so alarmed at the abusive practices involving the sale of organs in an exploitative manner that an international summit was held culminating in the Declaration of Istanbul, which condemned commerce in organs (The Transplantation Society and International Society of Nephrology 2008). Case study 19.2 An Israeli citizen was arrested in Durban after receiving a kidney transplanted from a Brazilian citizen. A number of doctors and hospital managers were charged after extensive international investigations had exposed the middlemen in an organ-trafficking syndicate from South Africa and Israel. Up to 109 illegal transplants had taken place at St Augustine’s Hospital from 2001 to 2003. Organ brokers were found guilty of contravening the Human Tissue Act No. 65 of 1983 by contracting and paying donors from Brazil, Romania and Israel to enter South Africa illegally to donate kidneys for the illegal transplants. It is known that Brazilian donors received between R40 000 242

and R160 000 each for their kidneys. Fraudulent medical documents purported to show that the donors and recipients were related to each other. The Brazilian donors received prison sentences, and a South African doctor and a Hebrew translator received suspended sentences and paid fines. Netcare in KwaZulu-Natal admitted guilt and paid a fine of R4 million and a confiscation order of R3,8 million. The case against the remaining doctors has been dropped with a permanent stay of prosecution. Source: Medical Chronicle 2013 Israel passed the Organ Transplant Act in 2008, which prohibits giving and receiving compensation for organs both inside and outside of Israel. This was no doubt to counter the reputation of Israelis as leading international organ transplant “tourists”. To deal with the deficit in available organs, an innovative national system of rewards for those willing to register as organ donors has resulted in a significant increase in available organs for transplants. Donors and their families receive priority and extra points should they eventually require organ transplants. (The points system is also related to age, waiting time, compatibility, etc.) (Linde 2014).

19.2 IS IT ETHICAL TO BUY AND SELL BODY PARTS FOR TRANSPLANT? The arguments against selling body parts involve debates about dignity and exploitation of the poor for the benefit of the wealthy. The exploitation argument states that rich, well-resourced people who need organs will buy them from poor people, thus exploiting their indigence. The argument against the poor selling their organs to the rich is based on the view that the sale is not truly autonomous, but arises out of the desperation borne of poverty. The state takes a paternalistic role by prohibiting payment for organs, and restricts what competent people may do with their own body tissue. Paternalism in ethics means the overriding of the wishes of a competent person. State paternalism occurs where the state has decided that the autonomous wishes of some of its citizens should not be allowed for their own wellbeing. An example of state paternalism is the law requiring motorcyclists to wear helmets for their own safety, whether they want to or not. State paternalism is usually exercised in the interests of a societal good. The phenomenon of state paternalism was taken to its ultimate conclusion in China. Formerly, the largest number of organ transplants occurred in China where organs from judicially executed criminals were harvested. The Chinese allowed these organs to be used in foreigners as well (Cameron & Hoffenberg 1999). Owing to many concerns about proper informed consent from families and prisoners, and also concerns about the Chinese justice system, in 2006 the World Medical Association called on China to immediately cease using prisoners as donors. The Chinese government undertook that organs from those in custody would be used only if required by the prisoner’s immediate family (Iltis 2010). Another argument against the sale of organs is that a market in human organs is demeaning and an affront to basic human dignity. A counterargument is that society tolerates many instances of people performing undignified tasks for remuneration. Similarly, society should allow a competent person who needs money and who has an autonomous wish to sell a kidney to do so. The argument has also been made that an organ, like other organic matter, has no inherent dignity and has value only insofar as it can be a vital source of life (Savulescu 2003). Some ethicists disagree with the prohibition on the sale of organs, and propose a well-regulated, staterun ethical system of organ procurement (Harris 2003) (see the Iranian model – Case study 19.1). Savulescu (2003) argues that people should have the right to decide what to do with their body parts. 243

The risk for a living kidney donor is minimal, and the result is an improvement in the quality of life for the recipient. The state allows people to take other risks with their own bodies, for example by smoking or going to war to defend their country. According to Savulescu (2003), a living paid donor is also taking a risk but here the difference is that at least someone – the recipient of the organ in this case – is benefiting. In addition, the donor receives some financial compensation for the beneficial act. Reimbursing the donor or his or her family for expenses incurred or loss of income are issues that have been considered, as has the practice of payment of funeral costs. The debate on some form of compensation for donation of an organ continues, especially in the face of declining deceased-donor numbers.

19.3 PRESUMPTIVE CONSENT: THE OPT-OUT SYSTEM In certain countries such as Spain, Austria, Belgium, Argentina, Russia and Sweden, an opt-out system for organ donation is in place (Shepherd, O’Carrol & Ferguson 2014), This system operates on the principle of presumptive rather than informed consent. All citizens of these countries are automatically presumed to have consented to organ donation unless they have registered their refusal (i.e. opted out), thus explicit informed consent is not required for harvesting organs from the deceased. It is sufficient for the hospital administration to satisfy itself that the deceased has not registered an objection to organ donation before proceeding to transplant. The rationale is that many people would like to donate their organs but have never registered as organ donors and would in fact consider it morally correct to save lives by donating what they will never need again. If one argues for respecting the autonomy of the deceased, one should respect the desire to donate. An opt-out system is thus respecting that desire to donate by autonomous agents and the desire of others not to donate. At the time of writing, 27 countries around the world were using the opt-out system, the latest addition being Wales as from 1 December 2015. Most people accept what Savulescu (2003) terms a “weak, moral obligation of beneficence” or “the duty of easy rescue”. This is a duty to assist another when the harm to oneself is minimal or absent, and the value to the other is great. He argues that an opt-out system involves minimal risk to the donor and great benefit to the recipient, while respecting the autonomy of both parties. He argues that a presumed consent system would be respecting the autonomy of the donor and those who do not wish to donate, and at the same time adopting a moderated beneficence-centred approach by using an organ if: • it would be of significant benefit to a patient • there is no good reason to believe that the donor would have objected • using the organ is not against the interests of the donor. Harris (2003) is of the view that if one is to weigh up the competing interests at play, i.e. the interests that a dead person might have in not donating and allowing his or her organs to decay versus the interests of the recipient of the organ, the potential recipient’s interests would always far outweigh those of the dead person insofar as the deceased might have interests in his or her organs. Another argument in favour of a presumed consent approach is that when a patient has died, doctors find it difficult to speak to the bereaved family about removing organs in such an emotionally charged atmosphere. Even when they are approached, the family may object, having just suffered the loss of

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their loved one or not having been informed of the deceased’s wishes in the matter. This difficulty is absent in an opt-out system. In a presumed consent system, those who wish to donate organs do not have to register as their consent is presumed, but those who have objections of any sort register their wish not to donate. In some countries, citizens who opt out of donating will be placed at the bottom of the waiting list of potential recipients should they require an organ. An argument against the presumed consent approach is that people who do not wish to donate may not bother to register this and that their organs will then be donated anyway, without true consent. Etheredge, Turner and Kahn (2014) are of the opinion that the opt-out system would not fulfil the legal requirements in South African law for informed consent and its corollary – informed refusal. The presumed consent approach requires an informed public who are in a position to exercise their rights. It has been argued that it is unlikely that the South African population can be educated sufficiently to allow this system to be implemented fairly and that cultural and language differences would present further barriers. It would also require reliable databases and additional resources which currently are not available. These obstacles could be surmounted by the creation of reliable databases and a massive media campaign. These measures might allay the concerns articulated by Etheredge et al. (2014) above about informed consent.

19.4 ORGAN DONATION AND RELIGION Some religions place restrictions on organ donations, allowing followers to receive but not to donate organs. In Israel, religious scholars are debating the definition of “the moment of death”, the prohibition on mutilation of the body, the requirement to inter the deceased’s body speedily and whether this is overridden by the strong principle of pikuach nefesh, the obligation to save lives. Similarly, Islamic principles emphasise the need to save lives where possible. In 1995, the Sharia Council of the UK issued a fatwa, or decree, that saving the life of another overrules the prohibition on mutilating a dead body, that Muslims may register as organ donors and that the family of a person may give permission for organ harvesting (see http://www.organdonation.nhs.uk). In South Africa, Muslim clergy have failed to reach consensus, with the main obstacle being the debate as to what constitutes death; for them, brain death fails to pass muster as death if the heart is still beating. Other religious considerations generally centre on whether organ donation is a mutilation of the body. Counterarguments to this position are that the body will decay after death anyway and that organ donation would greatly benefit a living person.

19.5 RESOURCE ALLOCATION The criteria for allocation of scarce organs and the process that is followed are generally not known to the lay public or even to medical professionals who are not directly involved in organ transplants. Once an organ becomes available for donation, the decision on who the recipient should be is based on several factors, but for a kidney the most important are the length of time on the waiting list and the degree of tissue matching. The Western Cape has devised a semi-automated system that allocates a kidney to a patient based on previously agreed-upon criteria, with the duration on dialysis and the degree of tissue matching being the main ones. Principles of distributive justice require that the allocation of scarce resources is carried out in a fair and just manner. The ethics of resource allocation is discussed further under distributive justice in Chapter 8 of this book. The requirements for a transparent 245

fair process are discussed by Daniels and Sabin (1997). Their “accountability for reasonableness” approach to a healthcare rationing process is set out below:

Accountability for reasonableness in resource allocation: •

There must be transparency about the grounds for decisions.

•

Opportunities must be given for appealing rationing decisions.

•

Allocations must be contextually relevant to fair-minded people.

•

A process of enforcement must exist for implementing the conditions above.

One must bear in mind that a fair process does not indicate what the ethical principles are that have been applied before the transparent decision making takes place. It is much easier to agree on the process than on the substance of the decision. For example, should a hospital spend a large amount of money to provide one renal patient with dialysis, transplantation and postoperative care or the same amount to provide good palliative care for dozens of patients? (Benatar & Fleischer 2008) If the hospital decides to spend the funds on renal dialysis, what criteria will be used to select the eligible patients: social worth/contribution to society, age, medical outcomes, political connection, number of dependants, financial status, etc.? Most health systems allocate their resources in such a way that the positive long-term medical outcomes are maximised. The Western Cape government has followed an “accountability for reasonableness” approach to develop a policy that guides the choice of which patients with kidney failure would be eligible for renal dialysis and kidney transplantation (Policy H 32 of 2010). This policy is discussed in Chapter 8.

19.6 NON-LIFE-SAVING ORGAN TRANSPLANTS There are certain organ transplants that are not essential or life saving. Two types are discussed below: penile and uterus transplants.

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19.6.1 Penile transplants and ethics Every year, hundreds of young men, mainly of the Xhosa clan, undergo ritual circumcision as a rite of passage. These procedures are performed in non-clinical settings by individuals who are not medically trained. The result is that scores of young men die of septicaemia, and many of those who survive suffer from genital mutilation, resulting in sexual dysfunction and urinary problems, and the associated emotional and psychological issues (Meel 2016). In December 2014, the world’s first successful penile transplant was performed at Tygerberg Hospital in South Africa. The team reported that the ethical considerations were thoroughly considered beforehand. The penis transplant was performed mainly to restore lost urological and sexual function, but there could also be significant benefits to the psychological wellbeing of the recipient. One of the ethical debates centres on the allocation of scarce resources in a developing country: is a penile transplant justified in the setting of other major health priorities? The procedure, a highly complex one involving a multidisciplinary team, is relatively novel but its reported success might be an important proof of concept. The informed consent process with the recipient must be especially rigorous, with care taken to ensure that the subject is treated as a patient rather than as research subject. Other ethical concerns are the psychological wellbeing of the family of the donor: confidentiality of the donor and his family are very important in the case of penile transplant to avoid embarrassment and so as not to deter future donations. Safeguarding the identity of the recipient was especially important in the South African case, where there were concerns of stigmatisation. Zhang, Zhao and Hu (2010) recommend comprehensive psychological screening with strict requirements for the acceptance of patients for this procedure. This recommendation is based on the first penile transplant performed in China in 2006. The procedure subsequently had to be reversed due to psychological difficulties between the recipient and his wife. Of note is that a large number of American soldiers suffered severe genital injuries in the Middle-East conflict, and American surgeons plan to commence a similar programme of penile transplantation (Grady 2015).

19.6.2 Uterus transplants This procedure would be carried out on women who were born without a uterus or for those who have had a hysterectomy because of an illness such as cancer. The first live birth was achieved in Sweden following a uterus transplant in 2013 on a patient with congenital absence of the uterus (Rokitansky syndrome). A successful pregnancy a year after the transplant followed implantation of a cryopreserved embryo (Brännström et al. 2015). A live menopausal donor underwent a 90-day course of oral contraceptives. This carries some risks for the donor, and informed consent of both the donor and the recipient must, of course, be obtained, as with all medical procedures. The recipient must take immunosuppressant drugs throughout the pregnancy and undergo a Caesarean section to deliver the baby. The uterus should be removed after the baby is born (to which the recipient must consent) or she will have to spend the rest of her life on immunosuppressant drugs. There are thus a number of operations attendant on each uterus transplant. In the Swedish case, the recipient developed pre-eclampsia and required preterm delivery and a course of steroids. The neonate did not require intensive care. Until there are more live births, it is unknown whether the pre-eclampsia and preterm delivery were peculiar to this patient or whether they will accompany all births from transplanted uteruses. Explanation of the risks of preterm delivery,

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anaesthesia, steroid treatment and pre-eclampsia would form part of the informed consent process (Farrell & Falcone 2015). The procedure is not life saving, and there are alternative means of procuring and raising children, such as adoption or gestational surrogacy. However, for many women, falling pregnant and bearing a child carries strong psychological and cultural meaning. Whether public health facilities with the technological capability decide to offer this transplantation service to women who have other reproduction options will depend on fiscal and resource allocation policies.

19.7 ORGAN TRANSPLANTS AND THE LAW Organ transplantation is regulated by the National Health Act No. 61 of 2003 and its regulations are contained in Government Notice R180 in the Government Gazette 35099 of 2 March 2012: Regulations Regarding the General Control of Human Bodies, Tissue, Blood, Blood Products and Gametes. The definition of “tissue” in the Act covers “human tissue, and includes flesh, bone, a gland, an organ, skin, bone marrow or body fluid, but excludes blood or a gamete”. “Organ” means “any part of the human body adapted by its structure to perform any particular vital function, including the eye and its accessories, but does not include skin and appendages, flesh, bone, bone marrow, body fluid, blood or a gamete”. Section 58 of the Act deals with institutions which may perform transplants and the authorisations required. The Act states that a person competent to make a will (i.e. 18 years of age) may make provision for organ donation in a will witnessed by two competent witnesses or in another document. An oral statement witnessed by two people is also allowed. Unless a person has stated that he or she does not wish to be an organ donor, after death the spouse, partner, major child, parent, guardian, major brother or major sister may allow the organ donation. In terms of section 63(a) of the Act, if there is no explicit permission to donate or prior refusal to donate and the next of kin cannot be traced, the director-general of the National Department of Health or a person authorised by him or her may consent to the donation. Reasonable steps must be taken to trace the next of kin in this case. In practice, this option is seldom exercised because of uncertainty as to what constitutes “reasonable steps”. If the organ is to be harvested from a minor, the written consent of the parents or guardian is required. The Act stipulates that at least two medical practitioners must certify the death of the donor patient and that they may not be members of the transplant team. In the case of eye tissue, a death certificate will suffice. The dead donor rule has been questioned (but not overruled) in cases where the organ donor has given the required permission, but the process of dying, while inevitable and irreversible, is so prolonged that the organs are no longer viable after death (Truog, Miller & Halpern 2013). Section 60 of the National Health Act states that no one may receive payment for a transplant organ or tissue except what is “required to cover the costs involved in the importation, export, acquisition or supply of the tissue”. Medical professionals involved in the transplant may receive remuneration for professional services. The donor may not receive remuneration, except for reimbursement of reasonable costs. 248

The regulations to the Act state that the identities of organ donors and recipients may not be made known to each other except with the consent of the donor and/or recipient, as the case may be. Consider the following case Case study 19.3: Soobramoney v Minister of Health 1998 (1) 765 CC In this case, the Constitutional Court was called upon to consider the allocation of scarce resources by the Department of Health when it had refused to allow a patient on the renal dialysis programme. Mr Soobramoney was a 41-year-old diabetic suffering from ischaemic heart disease, cerebrovascular disease and irreversible chronic renal failure. His life could be prolonged by means of regular renal dialysis but there was no prospect of a cure. He applied to court for an order compelling the department of Health to provide him with dialysis for his chronic renal failure. The Department had refused him entry to the dialysis programme because of his other serious health problems, which rendered him unfit for renal transplantation. Only patients who are eligible for kidney transplants are also eligible for dialysis in the state health sector because of the high costs involved in dialysis. The kidney transplant removes the need for dialysis and prevents a situation where a patient requires lifelong renal dialysis. The rationale for this approach is to have patients on dialysis awaiting kidney transplantation, after which they no longer require dialysis. Transplantation vacates a place for another patient who requires dialysis treatment. If patients who are not transplantable were to be placed on renal dialysis where there are a limited number of machines, it would mean that more deserving patients would be denied treatment. The Constitutional Court considered the Department of Health’s reasons for refusing to provide dialysis for this patient and agreed with the reasons. The court refused to overrule rational budgeting decisions about the number of renal dialysis machines purchased by the department. The department applied utilitarian principles of maximising the use of dialysis machines, in that patients who would have spent the rest of their lives on dialysis would not be allowed on the programme. By using the available dialysis machines in accordance with the guidelines, more patients benefited. Soobramoney’s application was therefore denied and he died shortly afterwards. (For further discussion on the human rights issues involved in this case, please refer to Chapter 9 of this book.) Labuschagne and Carstens (2014) make a convincing case that the current system of organ donation in South Africa is open to constitutional challenge, and that there is a duty on the state to consider a better method of increasing the availability of organs for donation. This system has demonstrably not met the needs of patients in need of organ transplants and affects their constitutional rights to life, dignity, freedom and security of the person, bodily integrity and access to healthcare.

19.8 CONCLUDING REMARKS The organs and tissues of the living human start to decay upon death. Technological advances mean that certain organs can be used to save or significantly improve the quality of the lives of hundreds of people. South African law requires voluntary informed consent from the donor or family. Paid donation is illegal in most countries of the world. With the Declaration of Istanbul there has been a significant decline in organ trafficking and transplant tourism. In South Africa, the majority of patients with end-stage renal failure are not offered treatment and those who are, have to wait, often for years, for a transplant. Patients with other major organ failure die while waiting for transplant organs because of the lack of donor organs. There is a desperate need to educate the public and consider measures to improve the organ donation rate. 249

CHAPTER 20: Genetics and Ethical complexity (Author: Keymanthri Moodley and Jacquie Greenberg) By the end of this chapter you should be able to: • • • •

understand why genetics raises ethical concerns describe the ethical dilemmas associated with genetics appreciate the responsibilities to patients versus the responsibilities to families in genetic testing discuss legal, clinical and ethical protections for patients who require genetic testing.

22.1 INTRODUCTION The field of genetics is ethically charged because it raises fundamental questions about who we are and potentially also where we come from. Genetics exposes information that is personal yet shared by family members. As such, genetics challenges the theory of liberal individualism where the principle of autonomy is accorded prime moral value. In the medical setting, genetic information raises important ethical questions: Who owns the information, who should decide when and why testing is performed, and who has a right to knowledge of test results? Taking this a step further: Is there a right not to know one’s genetic information? In the past two decades, genetic research has advanced the field of genomics, expanding the number of genetic tests available to diagnose disease and to predict future disease in individuals and their families. Although exciting new contributions are being made to clinical care, genetic medicine challenges the ethical and professional responsibilities of doctors. The following potential ethical dilemmas may arise: 1. 2. 3. 4.

Confidentiality and privacy issues The potential for genetic discrimination Autonomy and informed consent in decision making Just resource allocation

One of the greatest fears associated with genetics is that genetic information will be used in ways that could harm people (Clayton 2003; Ormond 2008). Much of the fear and anxiety associated with genetic testing stems from the history of discrimination that has surrounded people with genetic diseases. In particular, eugenics movements in several countries around the world have created stigma around genetic disease.

22.2 HISTORICAL PERSPECTIVE Eugenics is derived from the Greek word eugenes (eu meaning “well” and genos meaning “born”). The concept of eugenics refers to an improvement of the race by bearing healthy offspring. The word “eugenics” was first used by Sir Francis Galton in 1883 to describe the “science for the biological improvement of the human race”. In the early 1900s Mendel’s laws of inheritance were revisited and applied to human genetics, and inheritance in human beings was once again a focus of attention. This revived the eugenics movement in the US.

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22.2.1 Eugenics in the US Many biologists believed that certain human conditions, such as feeblemindedness, congenital defects and epilepsy, were inherited and could therefore be controlled by negative eugenics (i.e. a systematic effort to minimise the transmission of genes considered to be deleterious). During the 1890s, Dr F. Hoyt Pilcher castrated 44 boys and 14 girls and was then stopped by public disapproval. In 1907, Indiana was the first state in the US to pass a law which required the sterilisation of inmates of state institutions who were insane, idiots, imbeciles, feebleminded, convicted rapists or habitual criminals. The well-known case of Buck v Bell occurred in 1927. Carrie Buck, her mother and her seven-month-old daughter were labelled as “feebleminded” by the court. Justice Oliver Wendell Holmes Jr ruled in favour of mandatory sterilisation of Carrie Buck. In 1931, 30 states had involuntary sterilisation laws. By 1961, 28 states still had eugenic sterilisation laws (Garver & Garver 1991). Prior to the 1970s, several states in the US required mandatory testing for sickle cell disease in African Americans. Carriers were identified and told of the risks of having children with another carrier. African American children were required to have mandatory testing before entering school, and refusal to do so precluded them from entering school (Fulda & Lykens 2006).

22.2.2 Eugenics in Germany Racial hygiene was a prominent pursuit in the late 19th century in Germany. Dr Schallmayer and Dr Ploetz are regarded as the founders of the German eugenics movement. In 1908, the German colony of South West Africa (SWA), now known as Namibia, was also affected by the eugenic philosophies in Germany. All mixed marriages were annulled and forbidden in future, and German citizens involved in such marriages were stripped of their civil rights. The idea of racial hygiene was explored by Hitler in 1923 while he was imprisoned in Landsberg and he subsequently incorporated these ideas into his own book, My Struggle (Mein Kampf). After 1933 when the Nazis were in power in Germany, many young doctors were eager to endorse the eugenic movement and were keen to change their role from doctor to the individual patient to “doctor of the nation”. The rediscovery of Mendel’s work at the beginning of the 20th century was used to formulate eugenic policies. The “Law for the Prevention of Genetically Diseased Descendants” was passed in July 1933 and sterilisation was enforced. Within four years, 400 000 patients with “congenital mental defects, schizophrenia, manic depression, hereditary epilepsy, severe alcoholism, hereditary blindness and Huntington’s chorea” were sterilised (Garver & Garver 1991).

22.2.3 Eugenics in South Africa “Project Coast” was a top-secret chemical and biological weapons programme instituted by the South African government between 1981 and 1995. The project was headed by Wouter Basson, a cardiologist and personal physician to the then prime minister, PW Botha. Basson allegedly created a number of companies that acted as a front for Project Coast. Several scientists and other personnel were recruited. Although the activities of the project were directed towards military activities initially, there was a plan to develop various biotoxins. An enormous amount of information relating to Project Coast was revealed at the Truth and Reconciliation Commission (TRC) hearings by the apartheid-era surgeon-general and Project Coast scientists. One of these scientists, Dr Adriaan Goosen, founded the front company Roodeplaat Research Laboratory (RRL) in 1983. Dr Goosen told the TRC that research was conducted at RRL in the hope of developing “a bacterial agent that would selectively kill black people”. This research was based on the 251

claim of an unknown European scientist in the early 1980s that he had developed a strain of bacteria capable of “only affecting, making sick and killing pigmented people”. There was an intention to acquire this bacterium to kill black people in South Africa. Dr Goosen also indicated during his testimony that Project Coast was involved in the development of an “anti-fertility vaccine that would selectively target the black majority”. According to Goosen, Basson had expressed concern that if the “birth rate were not slowed, the country would run out of water”. Another Project Coast scientist, Dr Schalk van Rensburg, confirmed that “the development of an anti-fertility vaccine” comprised 18 per cent of all projects conducted at RRL. He testified that blacks and whites were “physiologically, biochemically and endocrinologically” identical so it was not possible to develop a vaccine targeted at one race only. However, it might have been possible, according to him, to skew the delivery of the vaccine along racial lines (S

22.3 GENETIC INFORMATION AND TESTING Genetic testing is most often performed on DNA, but other types of test material can also be used. These include RNA, tissue culture cells, amniocytes and small tissue biopsies which may be removed or withdrawn from individuals for testing purposes. In addition, blood cholesterol levels can be used to diagnose familial hypercholesterolaemia, haemoglobin electrophoresis is used to diagnose carriers of beta-thalassaemia, and abdominal ultrasound can detect polycystic kidney disease. When DNA is used as the source for the diagnostic test, it will usually be obtained from cells in blood or a mouthwash sample but, importantly, it can also be extracted from fresh or stored tissue collected during surgery, cultured cells, hair roots, biopsy specimens and other biological sources. Genetic testing should ideally be performed as a clinical service in a clinical setting. Informed consent to testing needs to be obtained, preceded by a counselling process. The information to be provided at the time of obtaining consent needs to be clear and accurate. In practice, the details of the consent process will vary according to the circumstances. For example, consent to perform a simple diagnostic test, such as for factor V Leiden for someone who has just had a venous thrombosis, will be at one end of the spectrum. At the other end will be consent to perform pre-symptomatic testing for a disorder such as Huntington’s disease, a late-onset lethal genetic condition for which there is no prevention or treatment. In addition, a prenatal test may be requested because it is known that the foetus is at an increased risk of having a particular genetic condition. This type of testing is performed during pregnancy to determine if a foetus is affected with a disorder that is known to be in the family or for which the developing foetus is believed to be at risk, such as Down’s syndrome, where the mother is of advanced maternal age. Chorionic villus sampling (CVS), amniocentesis, ultrasound and fetoscopy are examples of procedures used either to obtain a sample for testing or to evaluate foetal anatomy. Occasionally, foetal blood sampling (cordocentesis) is also recommended; however, couples should always be informed that most of these techniques are associated with a small procedure-related risk of miscarriage (see “Prenatal and diagnostic testing” in GeneReviews, available at http://www.genetests.org).

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22.4 GENETIC EXCEPTIONALISM Is genetic testing different from other forms of medical testing? 1. Genetic information is familial so the test results of one person have health implications for other genetically related family members. 2. The risks of genetic testing may not be clear as they may be psychological, social and financial. Psychosocial risks include guilt, anxiety, impaired self-esteem, social stigma, and insurance and employment discrimination. These risks must be discussed during the consent process. 3. Genetic information has limited predictive power – many genes interact with the environment, hence both genetic information and environmental factors could determine whether one will develop a particular disease. The results of genetic tests alone cannot fully or accurately predict disease onset and/or progression. 4. Many genetic diseases are difficult to treat or prevent, hence the value of genetic information may be limited in the overall care of the patient. The combination of points 1–4 makes genetic testing somewhat different from other types of blood tests (American Academy of Paediatrics 2001).

22.4.1 Pedigree sensitivity Taking a family history and compiling a genogram or pedigree is a routine part of a clinical consultation. However, sensitive information about other family members such as adoption, adultery, divorce, paternity issues, miscarriages, substance abuse or psychiatric illness may be revealed in the process by the primary patient (proband). The ethical significance of this is magnified when such pedigrees or family trees are published in case reports or research studies in the medical literature. The crucial and controversial issue around “third-party rights” and the critical question of how rights are to be balanced when one considers that one cannot protect the rights of third parties without, at the same time, restricting the rights of the information giver/proband must be borne in mind. The issue of obtaining information from individuals regarding and related to other people, including compiling a pedigree (or family tree), which results in certain obligations to other individuals who have not been consulted about having their personal and private information recorded, is of concern. It is therefore imperative to define what our ethical obligations are and to consider how to ensure that they are carried out. Essentially, families cannot be considered merely as a collection of people, as each individual has his or her own rights (Kendler 2001). However, in traditional African communities communal rights may take precedence over individual rights.

22.4.2 Ethical concerns raised by genetic testing Confidentiality of information – the right to know and the right not to know Genetic testing is different from other medical tests as the results of these tests often have implications for other family members, raising ethical conflict with respect to obligations to patients as opposed to obligations to third parties. Furthermore, while other routine blood tests tend to carry more benefit than harm in general to the patient, the results of genetic testing, while beneficial to a certain extent, may carry risks that could be substantial. The benefit of genetic testing may empower patients to make health decisions that could ultimately save their lives. On the other hand, the risks of genetic testing include psychological harm, which includes psychological stress and anxiety; depression; survivor guilt; 253

potential discrimination with respect to employment, medical aid and life insurance; and misattributed paternity. We will now examine some of the benefits and risks of genetic testing. Consider the following cases, which illustrate both the right to have access to and to know one’s genetic information, and the right not to have it. Consider the following cases Case study 22.1 A man died of colon cancer in the 1960s. Twenty-five years later his daughter, Ms B, developed the same malignancy. She obtained her father’s old pathology slides and discovered that he had diffuse adenomatous polyposis coli. If she had known this, she could have had regular colonoscopies to detect the onset of polyposis in her colon. If necessary, she could have had a colectomy and prevented the development of colon cancer. She then took legal action against the estate of her father’s surgeon, alleging that he should have warned her about her 50 per cent risk of developing the malignancy. Source: Adapted from Clayton 2003 Case study 22.2 Ms A has requested a blood test to check if she has a predisposition to develop Huntington’s disease (HD). A detailed family history reveals that her paternal grandmother had HD. Her father, who at birth had a 50 per cent risk of developing HD, did not want to have himself tested. The counsellor explained to her that if she were to be tested and if her results were positive, it would predictively diagnose her father as having inherited the HD mutation which would mean that he will develop the condition sometime in the future. The problem being that with this type of genetic testing, there is no knowing when and/or how the onset or progression of the disease would occur The rest of the family was not aware of the HD risk. Ms A’s brother had recently become a father and she did not want to discuss her decision to test with him. Her main concern was that she would dilute the excitement surrounding the new baby. Source: Adapted from Ormond 2008 PERPLEXING QUESTIONS Several interesting questions arise in these cases: • •

Who is the primary patient? Does the doctor have any obligations to the patient’s parents, children or siblings and, if so, when do these obligations override the demands of patient confidentiality? • Can we ever regard genetic information as individual and private? COMMENTARY Knowledge of her father’s diagnosis would have been enormously beneficial to Ms B. She would most probably have survived a disease that killed her father, with minimal personal risks. On the other hand, imagine the psychological burden that must be carried by Ms A if her test result is positive and she is unable to discuss this result with her father or brother. This is why people either choose to know or choose not to know their results. The importance of informed consent and genetic counselling by a genetic counsellor, medical geneticist or other suitably trained professional is underscored in these cases. When then does a doctor override a request by a patient not to disclose genetic results to other family members? Various international guidelines have provided different perspectives. In 1981, the World Medical Association (WMA) proposed that an individual refusal could be overridden to protect the life of 254

a third party. In 1997 the World Health Organization (WHO) felt that disclosure of information is permissible where children and newborns are concerned. In the same year the Council of Europe acknowledged the right not to know genetic results. This was reinforced by UNESCO in 2003 in their International Declaration on Human Genetic Data when they acknowledged the right of relatives not to know. The British Medical Association in 1998 advised that the following factors should be considered before disclosing information to relatives without the consent of the patient (Hope, Savulescu & Hendrick 2003): • The severity of the disorder (e.g. colon cancer) •

The level of predictability of the condition (e.g. a 50 per cent risk)

•

Protective actions that could be taken by the patient (e.g. colectomy) or reproductive decisions that could be altered

•

The levels of harm and benefit of giving or withholding the information (e.g. saving a life)

•

The reason given by the patient for refusing to share the information

Taking these factors into account, it is not surprising that in the case of Ms B and colon cancer, the appellate court in New Jersey ruled that the doctor had a duty to warn the daughter directly (even though she would have been a child at the time of her father’s death), perhaps even over her father’s objections (Clayton 2003). In 2012, the British Medical Association advised that confidentiality should be maintained as far as possible. However, patients should be encouraged to share their results with family members who could potentially be affected. Breaches of confidentiality are sanctioned if there is a legal requirement or if there is an overriding public interest.

22.5 DISCRIMINATION One of the greatest fears related to genetic information is that it will be used to harm people. Consider the following case Case study 22.3: Burlington Northern Santa Fe (BNSF) Railroad case, 2000 Some employees at this company developed carpal tunnel syndrome during the course of their work and sought disability compensation. On the advice of its company doctor, BNSF started taking blood samples for DNA testing of its employees. The DNA tests were supposed to detect a mutation associated with hereditary neuropathy which predisposed people to develop pressure palsies. The employees were apparently not told the purpose of the tests. It was assumed that the motivation for the tests on the part of the company was to deny disability benefits to employees who had the mutation, arguing that it was this and not the job that caused the carpal tunnel syndrome. The US Equal Employment Opportunity Commission filed suit against the company as they had violated the Americans with Disability Act. The case was settled in May 2002 for US$2,2 million. Source: Clayton 2003

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COMMENTARY As demonstrated in this case study, legislation exists in the US to protect people who have genetic testing from discrimination. Both general and genetic-specific legislation exists. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides some restrictions on the use of genetic information with respect to medical insurance. The Genetic Information Non-Discrimination Act of 2008 (GINA) is a federal law that protects consumers from discrimination by health insurers and employers on the basis of genetic information. GINA prohibits a health insurer from using a person’s genetic information to determine eligibility or premiums. It also prohibits a health insurer from requesting genetic testing of people. Employers may not use a person’s genetic information to make employment decisions such as hiring, firing and job assignments, and employers cannot request or purchase genetic information about persons or their family members. The Act, however, does not cover life, disability or long-term care insurance, and it does not apply to members of the military (Hudson, Holohan & Collins 2008). South Africa has no specific legislation at present to protect people from genetic discrimination.

22.6 MISATTRIBUTED PATERNITY Consider the following case Case study 22.4 Mr and Mrs P attend a genetics clinic after their newborn baby is diagnosed with an autosomal recessive condition. The disorder is severe and it is highly likely that the child will die in the first year. Prenatal diagnosis of this condition may be possible in a future pregnancy. The parents consent to testing of themselves and their baby. The tests reveal that Mr P is not the biological father of the child. During genetic counselling, the couple is told that there is a 25 per cent chance of a future child being affected. The carrier frequency of this condition is one in 1000, and the chance that Mr P is a carrier (especially since he is not the biological father of the child) is negligible. Source: Adapted from Hope, Savulescu & Hendrick 2003 COMMENTARY Misattributed paternity can occur when a child is unintentionally identified as being fathered by someone other than the man who believes he is the father. The rate of parental discrepancy (PD) varies between studies from 0,8 per cent to 30 per cent. To date, it has been common practice for inadvertent identification of PD or misattributed paternity to be kept from those to whom it pertains. More recently, however, many links between genetics and individuals’ health have been identified and consequently the case for the child to be informed now outweighs the harm that could be caused by informing him or her of PD. It has therefore been proposed that health and judicial procedures that can identify PD should give guidance concerning when and how such results should be exposed and that such guidelines should be publicly available. This issue in turn relates to the new concept of direct-to-the-consumer (DTC) testing in which individuals can access genetic testing via the Internet without seeing a doctor (Dandara et al. 2013). It is proposed that disclosing PD in a controlled healthcare environment may have substantially fewer health consequences than if it were later uncovered independently through these commercial tests which are becoming more easily available (Bellis, Hughes, K., Hughes, S. & Ashton 2005).

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22.7 CARRIER TESTING AND INFORMED CONSENT Carrier testing is performed on people to determine whether or not they have a mutated gene or chromosome abnormality which will not affect their health, but increases their chance of having children with the disorder in question. The term “carrier” is used with respect to autosomal recessive and sex-linked recessive traits, as well as balanced chromosome rearrangements. Once an individual is confirmed as being a carrier of a mutation that can result in an autosomal recessive condition, this information needs to be carefully explained to that individual. It needs to be understood that if both parents are carriers, then at each pregnancy, a child has a one in four (25%) chance of being affected; a two in four (50%) chance of being an unaffected carrier (like the parents); and a one in four (25%) chance of being unaffected/not a carrier. Knowledge of both parents’ carrier status is thus very important and needs to be understood by all concerned. The consent process must be detailed as the information that must be conveyed is complex. In clinical practice, the recurrence of an autosomal recessive condition is generally only observed within a particular sibship. Many members of the family may be gene carriers and the risk needs to be established for each individual. The chance of a healthy sibling in such a family having affected children is low as long as he or she does not marry into a closed community, as the risk actually also depends on the frequency of the faulty gene in the general population. Another factor to consider in risk calculation, therefore, is cultural tradition, for example intermarriage, as more than one marriage may be arranged between two families. In this instance, if a consanguinous couple have a child affected by an autosomal recessive condition, other family marriages may also be at risk of having affected offspring. The risk may not be considered high enough to counsel against further planned marriages taking place, but if the carrier state can be determined by a specific test, this will help the families to make decisions, and could reassure the relatives who are not carriers of the faulty gene. The concept of genetic risk and carrier testing for autosomal recessive genetic conditions is well illustrated in an article by Shaw and Hurst (2009). The issues of communicating genetic risk information to populations in which consanguinous marriages are favoured and encouraged pose particular challenges, which are addressed in this chapter.

22.8 PREDICTIVE TESTING IN CHILDREN Genetic testing is performed in childhood for disorders that have the onset in childhood or adolescence, but generally only if testing is of clear benefit to the child, for example testing for familial adenomatous polyposis and multiple endocrine neoplasia (type 2A). Also, testing for cystic fibrosis, the screening of newborns for phenylketonuria (PKU), hypothyroidism and early-onset Stargardt disease have been considered as special cases for presymptomatic testing (Sevick, Netivio & McConnell 2005; Downs et al. 2007; Stone, 2007; Greenberg & Roberts 2012). Case study 22.5: Clinical scenario to illustrate the issue of testing children for a late-onset genetic disorder A couple with two children are referred for genetic counselling because their younger son, a 12-year-old boy, has a movement disorder – predominantly an unsteady gait and dysarthria for which testing for juvenile SCA1 is being

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requested by their managing neurologist. The ethical implications and considerations for the family regarding genetic testing need to be addressed. COMMENTARY BACKGROUND Spinocerebellar ataxia type 1 (SCA1) is characterised by ataxia, dysarthria and progressive deterioration of bulbar functions. Onset is typically in the third or fourth decade, but early onset in childhood has been documented (Zoghbi et al. 1988; Bryer et al. 2003; Smith, Greenberg & Bryer 2016). In adult-onset SCA1, the duration of illness from onset to death ranges from ten to 30 years; individuals with juvenile-onset disease (whose symptoms appear before 13 years of age) generally have a more severe disease with rapid progression. Anticipation, which is an increase in the severity and earlier onset of the phenotype in progressive generations, has been observed in SCA1 (Zoghbi et al. 1988; Bryer et al. 2003). The tendency of the CAG repeat in the SCA1 gene to expand as it is transmitted provides a biological explanation for the earlier age of onset in subsequent generations. Expansions are more likely to occur when the mutation is paternally transmitted, whereas contractions in the gene are more typical of maternal transmissions (Jodice et al. 1994; Tang et al. 2006). Juvenile-onset SCA1 is characterised by severe brain stem dysfunction in addition to the cerebellar symptoms. This brain stem dysfunction occurs rapidly, leading to death within four to eight years of symptom onset. SUGGESTED APPROACH It is firstly essential to establish whether there is a family history of SCA1 and if it is at all possible to obtain molecular confirmation of the diagnosis. As SCA1 is an autosomal dominant disease, it must be assumed that one of the parents is carrying the faulty gene that causes the condition and so this needs to be explored with the family. It is possible that the father has the gene mutation but is not yet showing clinical signs of the condition. It is possible that it is on the mother’s side of the family but it is more likely to be on the father’s side due to the known instability of the gene during paternal transmission. There are many ethical issues around the testing of children for late-onset genetic conditions in general. The harm to and possible danger of discrimination towards the child once there is a label attached to a condition that is lethal and debilitating, overlaid with the potential guilt and devastation for the father who is possibly unaware that he is potentially carrying the faulty gene, has to be balanced against the fact that the 12-year-old boy is showing clinical signs of the condition that is to be confirmed as being SCA1. His clinical management and treatment, albeit very limited, would be appropriate for SCA1 and therefore this would be of benefit to him. The autonomy of the child needs to be considered and assent would need to be obtained from him if genetic testing is to be considered. FURTHER INFORMATION On further investigation, it is ascertained that the father’s eldest sister has SCA1. She is severely affected and lives with and is cared for by the family. Molecular genetic testing had been undertaken and a diseaseassociated repeat expansion in the ATXN1 gene was detected and so confirmation of the diagnosis in the family is now available. WHAT HAPPENED THEN?

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When the 12-year-old boy was seen on his own it was clear that he did not fully understand why genetic testing was being considered. He was aware of his aunt’s condition and could see that she was very ill and disabled. He was aware that his mother felt that he might also have the condition but did not believe this himself. He felt unloved and rejected in the home, cried often and slept poorly. He had wondered about whether it would be better not to live but had not had any clear thoughts of suicide. He often ran away to a friend’s house where he felt happier. He felt left out at school as he was physically weak and could not keep up with the other scholars. He therefore usually kept the company of boys three to four years younger than he was. He admitted that he was also struggling at school and knew that he was probably going to be placed at a special school. Clinically he was very unsteady and clumsy, and although his difficulty with school was of concern, the symptoms seemed to be longstanding and not obviously progressive. In this particular case under discussion, the boy’s lack of knowledge and awareness of the consequences of genetic testing of this nature needs to be taken into consideration. The potential benefit of having a confirmed molecular diagnosis and the subsequent management of the condition as it progresses needs to be balanced against the potential harm of a “label” for this unsuspecting child as well as the impact that this will have on the father, who will have to acknowledge and accept that the mutated gene has most probably come from him, and also to assimilate what this means for him, clinically, in the future.

22.9 GENETIC COUNSELLING Consider the following case Case study 22.6 Mr and Mrs Adams are carriers of sickle cell disease. Their first child had a 25 per cent chance of developing the disease and was born with the disorder. The definitive treatment is bone marrow transplantation. Mrs Adams has heard that they can get an ideal donor if they have another child using the technique called pre-implantation genetic diagnosis (PGD) (Brezina & Kutteh 2015). They visit the genetic counsellor to discuss these issues further. COMMENTARY Genetic counselling is a process whereby individuals and their families are assisted in addressing their concerns relating to the presence or risk of a genetic disorder in themselves or a family member. Genetic counsellors provide information about how genetic disorders are inherited and how likely they are to happen in a family. They are professionals who are trained to individualise each client, taking into account the impact of cultural, religious and socioeconomic issues for each family or population (Begleiter 2002; Weil 2003). The principle of beneficence with respect for confidentiality and individual autonomy guides their practice. Individuals are facilitated in decision making as they are given accurate genetic information communicated with respect for individual beliefs. The genetic counsellors themselves are, in turn, acutely aware of their own personal values and do not impose advice on clients (Edwards, Greenberg & Sahhar 2008). This is commonly referred to as non-directive counselling, although direct counselling is nevertheless required in certain situations. The number of genetic counsellors in South Africa is totally inadequate to service the population, taking into account that the WHO recommends at least one medical geneticist and two genetic counsellors per 259

million people to be the minimum requirement for the provision of an efficient and comprehensive genetic service. There is, therefore, a serious need for the education and registration of genetic counsellors in southern Africa (Christianson & Modell 2004; Greenberg 2005; Edwards et al. 2008; Malherbe, Christianson & Aldous 2015). Consider the following case Case study 22.7: The need for directive and non-directive counselling by professional and experienced genetic counsellors A 30-year-old woman and her sister (her caregiver) attend the neurogenetic clinic for a follow-up visit to receive the result of a Huntington’s disease (HD) diagnostic test. They are part of a well-known family with HD and the test was done because the 30-year-old had developed mild clumsiness and tremor. When informed of the positive diagnosis, both sisters are devastated and tearful, and the caregiver seems to struggle to comfort her sister. COMMENTARY BACKGROUND TO THE CONDITION Huntington’s disease is an incurable, progressive and eventually fatal condition. It is an autosomal dominant genetic disease, which means that if a parent is affected, each child is at 50 per cent risk of inheriting the mutated disease-causing gene. The onset of the symptoms, however, is usually in midadulthood, generally after the person has had his or her own children. Often the family will have had experience of living with and/or observing the progression of the disease in other affected family members. It is a devastating diagnosis for the affected person and for his or her caregiver/s as well, who are most likely to be female relatives. Often, affected individuals do not recognise or may even deny the fact that they are experiencing/displaying mild clinical features. PRACTICAL AND ETHICS ISSUES TO BE CONSIDERED One has to be very aware of the fact that both these individuals in the case study are from the same family and so the fact that they have an affected parent means that both sisters have a 50 per cent chance of having inherited the disease-causing expansion in the HD gene. Whatever questions the affected sister asks might also pertain to the other sister, as she has not yet been tested and so might also carry the mutated gene and only manifest symptoms at a later date. Any questions asked by the caregiver sister should be reflected back to her, and the counselling should therefore be non-directive and rather reflective. A follow-up session should be held with the unaffected sister and a more directive counselling approach could then be used in terms of the practical aspects of caregiving on the one hand, and addressing and dealing with her own risk status on the other. In general, genetic counsellors consider issues around counselling families and individual family members where there is a history of HD to be extremely challenging. This relates to the need to use both directive and non-directive counselling in facilitating decision making with regard to predictive testing. Discussing termination of a gene-positive pregnancy is also challenging (Greenberg 1993, 2005; Hines, McCarthy Veach & Leroy 2010; Kromberg & Wessels 2013). Given the importance of counselling in genetics, it is understandable why direct-to-consumer genetic and genomic testing has become controversial. Members of the public are able to access genetic testing and whole genome sequencing via the internet. This will be discussed further in Chapter 23.

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22.10 CONCLUDING REMARKS Genetics and genetic testing are fraught with ethical concerns. The conflict between liberal individualism and the common good are brought into sharp focus in this field because genetic information is a collective phenomenon. Many genetic conditions have implications for other family members and future generations. As such, the principles of mutuality, solidarity and interdependence are prominent. African philosophy, as discussed in Chapter 4, has much value to add to the ethics of genetics. We are reminded of the poignant concept of Ubuntu – I am because we are – and the foundational role of community in society.

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CHAPTER 21: Research ethics and Scientific Integrity (Author: Keymanthri Moodley) By the end of this chapter you should be able to: • • • • •

describe the historical background of research ethics understand the evolution of guidelines and laws in research ethics appreciate the importance of good science and good ethics in research understand the importance of participant protection in research recognise the difference between plagiarism and valid referencing systems.

20.1 INTRODUCTION The National Health Act No. 61 of 2003 defines “health research” as any research which contributes to knowledge of: • • • • • • •

the biological, clinical, psychological or social processes in human beings improved methods for the provision of health services human pathology the causes of disease the effects of the environment on the human body the development or new application of pharmaceuticals, medicines and related substances the development of new applications of health technology.

Such research must be conducted by qualified health science professionals so that medical procedures and treatment are based on rigorous scientific evidence and must be both scientifically valid and ethically sensitive. Acquiring a knowledge of guidelines and legislation related to research ethics is therefore one of the responsibilities of the medical profession. Research ethics involves the systematic analysis of ethical and legal questions to ensure that study participants are protected, and ultimately that clinical research is conducted in a way that serves the needs of such participants and of society as a whole. A central concept in the debate surrounding research ethics is the important distinction between the doctor-patient relationship in the clinical setting and the investigator–participant relationship in research activities. Traditionally, the doctorpatient relationship is based on concern for individual patients where the patient is seen as a means in himself or herself. In research, the study participant may stand to benefit to a certain degree but the benefit to science and society may be significant enough to render the research participant a means to an end. As a result of this precarious relationship, the research participant requires special protection of his or her rights in such settings. During and subsequent to World War II many ethical problems arose either because the distinction between the doctor-patient and the researcher–participant relationship had not been recognised or because special protection was not afforded to participants, resulting in a violation of their rights. This chapter will explore the human rights accords that constitute the foundation on which international and national laws and guidelines for conducting human research are based, and will discuss a wide 262

spectrum of research activities ranging from large-scale randomised control trials to student projects and assignments in which ethical conduct is crucial. It will examine ethical concerns in human experimentation, as well as the ethics involved in scientific writing and publication.

20.2 A HISTORICAL PERSPECTIVE Research ethics has been debated and discussed since World War II. Prior to the war, research was more or less a cottage industry with small-scale research being conducted by individual researchers on individual patients on a trial-and-error basis. From World War II onwards, there was a significant expansion in research activity. Such research was supported by governments that during and subsequent to the war viewed research as a matter of national security to protect both the armed forces and the nation from infectious diseases and other illnesses. As a result, investigators were given considerable autonomy in the performance of research. Adequate funding was also made available. As we move back in time, we will discover many research atrocities that prompted the development of stringent rules and regulations to protect research participants. The story begins in 1932 …

20.2.1 The Tuskegee Syphilis Study The Tuskegee Syphilis Study began in 1932 and ended in 1972. Six hundred poor African-American men from Macon County, Alabama, were recruited into a project that set out to establish the natural history of syphilis. Of these men 400 had syphilis, and 200 were used as controls. Both patients and controls were told that they had “bad blood” and should have regular medical examinations, including lumbar punctures. These men had been promised free transportation to and from hospital, hot lunches, free medical care for any disease other than syphilis and free burial. However, they were not aware that they were subjects in a research study! When the study began, there was no definitive treatment for syphilis. Heavy metals were used. However, when penicillin was discovered in 1945 and was found to be effective against syphilis, this treatment was deliberately withheld from the men in this study as the researchers wanted to see what the natural history of syphilis would be. On 26 July 1972, The New York Times carried a shocking story: For 40 years, the United States Public Health Service has conducted a study in which human beings with Syphilis, who were induced to serve as guinea pigs, have gone without treatment for their disease … (Jonsen 1998) By the time the story was exposed, 74 of the untreated subjects were still living (Jonsen 1998). In 1997 President Clinton issued a formal apology to the study participants and their families on behalf of the US government. As a direct result of the Tuskegee study, the National Research Act was passed in 1974 in the US, and the Belmont Report was published in 1979 (The National Commission for Protection of Human Subjects of Biomedical and Behavioural Research 1979). The Belmont Report This report is based on three major principles: 1. Respect for autonomy – subjects are autonomous agents and should be treated as such. Protection should be provided for subjects with diminished autonomy, such as children and mentally incapacitated adults. 263

2. Beneficence – researchers working with human subjects should maximise benefits and minimise harm to subjects. 3. Justice – there should be a balance in research between benefit and risk and subjects should be treated fairly.

20.2.2 The syphilis study in Guatemala While Tuskegee was still in progress, 696 Guatemalans were deliberately infected with syphilis between 1946 and 1948. The study was conducted to establish whether penicillin could be used “immediately after sex to prevent infection with several sexually transmitted diseases, especially syphilis”. The study participants included female sex workers, soldiers, prison inmates and mental hospital patients. Prostitutes who were known to be infected with syphilis were sent into the prison involved to deliberately infect the inmates with syphilis. None of the participants consented to participate. The story was uncovered in 2010 by Susan Reverby, a medical historian, at Wellesley College in Massachusetts (Tanne 2010). In 2010, President Obama apologised to the Guatemalan president Alvaro Colon on behalf of the US government and the researchers involved.

20.2.3 The Nazi experiments The Nazi experiments actually preceded World War II. In 1933, in keeping with an emphasis on eugenics, the Law for the Prevention of Genetically Diseased Descendants was in existence and sterilisation was enforced. Within four years, 300 000 patients had been sterilised. As can be expected, sterilisation research thrived. In 1939, at the beginning of the war, the T4 Euthanasia Programme was initiated in which adults and children who were deemed futile or terminal were killed and their organs harvested. The Dachau concentration camp experiments included the prolonged submersion of people in subfreezing water to test the limits of bodily endurance. The Mengele twin studies also became notorious at this time. Josef Mengele was interested in the genetics and the study of twins. He allegedly collected twin children from the camps, measured their physical features, performed cross-transfusions, transplanted genitals and other organs, and created artificial Siamese twins. The Nuremberg Code At the end of World War II, the Nuremberg trial was held and 22 doctors were found guilty of research atrocities. In 1947, the Nuremberg Code was developed (Annas & Grodin 1992). This code is based on ten principles, the most striking of which are the importance of research being based on good science and the concept of voluntary consent. Despite the existence of the Nuremburg Code, research continued, sometimes without informed consent. The Nuremberg Code encapsulated the following: 1. Informed consent is essential. 2. The experiment should be for the good of society, and the results must not be obtainable by other means. 3. The experiment should be based upon prior animal studies. 4. Physical and mental suffering and injury should be avoided. 5. There should be no expectation that death or disabling injury will occur from the experiment. 6. Risk must be weighed against benefits. 264

7. 8. 9. 10.

Subjects must be protected against injury, disability or death. Only scientifically qualified individuals should conduct human experimentation. Subjects can terminate their involvement. Investigators can terminate the experiment if injury, disability or death is likely to occur.

Consider the following case Case study 20.1: The story of Henrietta Lacks Henrietta Lacks was a poor African-American tobacco farm worker in the 1950s. She was diagnosed with invasive metastatic cancer of the cervix in 1951. Biopsy specimens taken for diagnostic purposes revealed an “undifferentiated epidermoid carcinoma of the cervix”. Henrietta was admitted for radium treatment. Eight days later when the radium was inserted, a biopsy specimen was taken and sent to the laboratory of Dr George Gey, head of tissue culture research at Johns Hopkins University, for research purposes. He and his wife had been trying to culture a human cell line for years without success. They used a roller tube technique to grow the cells and Henrietta’s cells grew prolifically in his laboratory (Jones 1997). The cells were used for research initially in his laboratory and later in several other laboratories as well. Although Henrietta died six months later, her cells (known as HeLa cells) continued to grow and were mass produced at the Tuskegee Institute. A vial of HeLa cells costs about $260. Although several biotechnology and pharmaceutical companies benefited financially from the use and sale of HeLa cells, Henrietta’s family lived in abject poverty after her death and were completely unaware of the use of her cells for decades after her death. It is uncertain whether Henrietta ever consented to the use of her cells in research. Source: Boerner 2010

20.2.4 The thalidomide disaster In the 1950s, thalidomide was approved as a sedative in Europe. However, it had not been approved in the US by the Food and Drug Administration (FDA). Physicians used “samples” supplied by the manufacturer to study drug safety and efficacy. Many patients were not aware that they were taking an experimental drug, nor had they given their consent. The drug was widely used on pregnant women for sedation and morning sickness, and to prevent abortion or premature delivery. The drug had severe teratogenic side effects – namely phocomelia. This story broke in 1962 (Jonsen 1998).

20.2.5 The Declaration of Helsinki – 1964 As a result of the above-mentioned research atrocities (and many others that occurred as well), the World Medical Association drafted a document that was intended to provide guidelines for the ethical conduct of research. The Declaration of Helsinki is regarded as a watered-down version of the Nuremberg Code. This document drew a distinction between therapeutic and non-therapeutic research. It was amended in 1975, 1983, 1989, 1996, 2000 and most recently in 2008, and currently includes 35 principles. It is not recognised by the FDA in the US; however, in South Africa the guideline is endorsed as the South African Medical Association is a member of the World Medical Association. All research ethics committees (RECs) in South Africa require researchers to adhere to the Declaration of Helsinki 2008 in the conduct of their research. The following issues were addressed:

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1. Research with humans – this should be based on laboratory and animal experimentation 2. Experimental protocol – this should be reviewed by an independent committee (institutional review board (IRB) or research ethics committee) 3. Informed consent 4. Subjects who are minors or those with physical or mental incapacity

5. Researchers – these should be medically/scientifically qualified individuals 6. Risks/benefits 7. Privacy of the subject/confidentiality of the information 8. Publication of research results 9. Conflict of interest 10. Use of placebos 11. Post-trial obligations of researchers

The latest detailed version of the Declaration of Helsinki (October 2013) may be accessed at http://The Journal of the American Medical Association. The Journal of the American Medical Associationnetwork.com/article.aspx?articleid=1760318/. This version of the Declaration highlights the following issues (These two issues are widely debated nationally and internationally): •

Use of placebos:

“The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention, except in the following circumstances:

•

-

The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

-

Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm

-

and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option.”

Post-trial obligations:

In advance of a clinical trial, sponsors, researchers and host-country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

20.3 THE EVOLUTION OF GOOD CLINICAL PRACTICE (GCP) 20.3.1 The United States In 1964, as a result of the Declaration of Helsinki, review of research procedures was emphasised. However, in the 1970s fraud in research was still continuing in the US.

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In the 1970s and early 1980s, the FDA (the equivalent of the Medicines Control Council (MCC) in South Africa) developed regulations on informed consent, Institutional Review Board (IRB) or Ethics Committee review and approval, and investigational new drugs. Collectively, these regulations, along with various guidelines, became known as good clinical practices or GCPs.

20.3.2 Japan and Europe The first GCP guideline was issued in Japan in 1990 and in Europe in 1991. These guidelines were much less extensive and stringent than the FDA requirements. In Japan and Europe, however, they were just guidelines rather than law, and they were not widely accepted. The various GCPs were widely variable and often inconsistent. This inconsistency, together with the globalisation of many pharmaceutical companies, gave rise to the need for development of an international standard, and so the International Conference on Harmonisation (ICH) process was born.

20.3.3 The International Conference on Harmonisation (ICH) Since 1991, the European Union (EU), the US and Japan had been collaborating in the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. In 1996, the ICH Harmonised Tripartite Guideline for Good Clinical Practice was released. This came into effect in the EU, the US and Japan in 1997, and is based on the Declaration of Helsinki. This guideline is currently being updated.

20.3.4 GCP in South Africa In 1998, the Department of Health in South Africa constituted a working group to develop guidelines for the conduct of research in South Africa. In 2000, the first edition of the Guidelines for Good Practice in the Conduct of Clinical Trials in South Africa (SAGCP) was published. This guideline was revised in 2006 and another revision is under way. The SAGCP provides guidance on the minimum standards that are acceptable for conducting clinical trials. The guidelines cover the following areas: • •

• •

Protection of study participants Responsibilities of the principal investigator and participating investigators Responsibilities of the sponsor Quality assurance

• • • •

Data management and statistics Multicentred studies Ethics committees Ethical considerations for HIV/AIDS clinical and epidemiological research

20.4 THE PRINCIPLES OF GCP •

Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with good clinical practice and the applicable regulatory requirement(s).

•

Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefits for the individual trial subjects and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. 267

•

The rights, safety and wellbeing of the trial subjects are the most important considerations and should prevail over the interests of science and society.

•

The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

•

Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

•

A trial should be conducted in compliance with the protocol that has received prior IRB/IEC (Institutional Review Board/Independent Ethics Committee) approval/favourable opinion.

•

The medical care given to and medical decisions made on behalf of subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

•

Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s).

•

Freely given informed consent should be obtained from every subject prior to clinical trial participation.

•

All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification.

•

The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

•

Investigational products should be manufactured, handled and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

•

Systems with procedures that ensure the quality of every aspect of the trial should be implemented.

20.5 WHAT HAPPENS WHEN GCP IS NOT FOLLOWED? Consider the following case Case study 20.2: The Nicole Wan case Nicole Wan was a healthy 19-year-old student at the University of Rochester. She was involved in a trial early in 1996 investigating the function of lung cells. She underwent a bronchoscopy at the University of Rochester Medical Center in New York. The local anaesthetic that facilitated this procedure was topical lignocaine. She required a considerably high dose of lignocaine to decrease the discomfort caused by the passage of the bronchoscope. After the procedure, she complained of chest discomfort but was nevertheless discharged one hour after the procedure. Later that day, she had an epileptic fit. On admission to the emergency unit, she was found to be in cardiac arrest and died two days later. The proximate cause of death was a toxic lignocaine blood level. This study had been ongoing for a number of years. The study protocol of 1981 had indicated a maximum dose of 300 mg of lignocaine. The most recent study protocol did not specify an upper dose limit. There was no record of the dose of lignocaine administered. However, extrapolation of the dose was conducted from her blood lignocaine levels on admission and was estimated at 1200 mg. Source: Doris 1996 268

Investigation findings The study was in progress for several years and all changes or amendments to the original protocol should have been submitted to the Research Ethics Committee (REC). In this study the amendment had not been submitted to the REC as the university’s REC did not require formal approval of minor alterations that did not have safety implications. •

The REC had not performed an “in-depth” or “complete” re-review of the protocol over the protocol’s 14-year lifespan.

•

The consent form did not mention the possibility of death.

•

A number of protocol violations were detected: the lignocaine solution used was a higher concentration than that specified in the protocol, and 28 bronchial brushings were performed when the protocol specified “about ten”.

The following are recommendations from the New York State Department of Health (Day, Chalmers, Williams & Campbell 1998). 1. RECs should pay attention to long-running research programmes with multiple protocols and amendments. 2. There should be more attention focused on minimising risk to participants. 3. All amendments must be submitted to the REC. 4. Investigators should indicate how amendments will impact on risk. Consider the following case Case study 20.3: The Jesse Gelsinger case Jesse Gelsinger suffered from a partial deficiency of ornithine transcarbamylase (OTC) – a key enzyme in the urea cycle. This is a liver disorder in which the body cannot eliminate urea through the ammonia cycle. It affects one in 40 000 newborn children, most of whom become comatose within 72 hours of birth. They sustain severe brain damage and half die within a month of birth. The other half die by the age of five years. Jesse survived until the age of 18 due to the partial deficiency coupled with a low protein diet and medication. On 13 September 1999 Jesse received an infusion of the OTC gene carried by an adenovirus vector – into his hepatic artery. The adenovirus usually causes mild colds. However, within hours of the injection of the virus vector Jesse experienced a severe immune system reaction to the vector and he died of multi-organ failure four days later. Source: http://www.uab.edu/ccts/images/steinbrook_Gelsinger_Oxford_Textbook_08_3.pdf COMMENTARY When Jesse died, the FDA suspended the trial for the following reasons: 1. Failure to train staff adequately 2. Failure to develop basic operating procedures 3. Inadequate informed consent As part of the informed consent process, Jesse was not informed that other patients had experienced serious adverse events or that three monkeys had died of a clotting disorder and severe liver inflammation after being injected (Sibbald 2001). 269

Another major problem with this study was the failure to report adverse events to the Recombinant DNA Advisory Committee (RAC), the federal group that initially recommended approval of the study. During the hearing, investigators admitted that they had not followed adverse event reporting procedures. There was a failure to notify the FDA of serious but transient adverse events in previous patients. Investigators also did not inform the RAC of changes to the study protocol – the change involved injecting the gene directly into the liver rather than intravenously. This was done in an attempt to prevent widespread vector distribution in the body. However, post-mortem findings indicated that the hepatic infusion had led to “significant vector [distribution] outside the liver”, including high amounts in the spleen and bone marrow (Jenks 2000). The reluctance of researchers to report adverse events and share other trial-related information could be a result of fear of loss of future patent rights in the event that a clinical trial produces a marketable product. In gene therapy trials in the US, an adverse event can be considered to be proprietary information (Sibbald 2001). What was interesting about this case was the principal investigator – James Wilson. He is a worldrenowned expert in his field but also president and major shareholder of a private company – Genova Inc. The company held patents for the procedure and provided funding for the research. The University of Pennsylvania and some of its board members owned stock in Genova. Of particular interest was the fact that Genova had granted research funds to Arthur Caplan, an international expert in the ethics of research in children, who had supported the project (Hoey 2003). THE OUTCOME 1. 2. 3. 4.

Jesse Gelsinger died. His family filed a lawsuit against the university, which they settled. Wilson resigned his post at the university. The University of Pennsylvania issued strict guidelines that prohibit faculty members or members of their families from having any material financial interest in a private company whose product they are evaluating. Harvard University followed suit, as did a number of other institutions.

Case study 20.4: The Ellen Roche case Ellen Roche was a 24-year-old technician who worked at the asthma and allergy centre at Johns Hopkins University. She was recruited into a non-therapeutic research study as a healthy volunteer. The study related to asthma and the nerves in the lung that keep the airways open in normal people. The drug being used was hexamethonium – a drug that would block the nerves and cause bronchoconstriction. The study started in April 2001. On 4 May 2001 Ellen was given the investigational drug, hexamethonium, by inhalation. On 5 May, she developed a dry cough. She became progressively worse and was hospitalised on 9 May with fever, hypoxaemia and chest X-ray abnormalities. She became progressively more breathless and was transferred to the ICU on 12 May. On 2 June 2001, she died as a result of progressive hypotension and multi-organ failure. On 19 July 2001, all research was halted at Johns Hopkins and an investigation was instituted. Source: Savulescu & Spriggs 2002 RESULTS OF THE INVESTIGATION 1. The study had a solid scientific basis and was well designed. 270

2. The drug was scientifically sound. 3. The IRB/REC was criticised because: (a) it did not ask for more safety information on a drug that was not approved by the FDA and that was no longer in clinical use (b) the drug was being given via a non-standard route (inhalation). 4. The investigator was criticised for not reporting the symptoms in the first subject promptly, not delaying the exposure of the next subject to hexamethonium until the symptoms in the first subject had resolved, and not searching “more comprehensively” for previous reports that hexamethonium has pulmonary toxicity. 5. The informed consent document was insufficient. It did not list all the side effects of the drug, the risks of the drug were not clearly stated and the lack of the FDA’s approval was not mentioned. COMMENTARY Johns Hopkins University took full responsibility for the death of Ellen Roche and on 11 October 2001 announced a financial settlement with the Roche family (Steinbrook 2002). This is a clear illustration of the disastrous consequences of not following GCP. This case illustrates the importance of the ethical conduct and reporting of research. It also illustrates the impact of unethical research – on the one hand, it can lead to loss of confidence in medical research by colleagues and the public. On the other hand, and more importantly, it can lead to the death of healthy volunteers, hence the maintenance of personal and professional integrity in the conduct of medical research is crucial. Case study 20.5: TGN 1412 trial The TGN 1412 phase 1 study was conducted in 2006 at Northwick Park Hospital in London. The investigational product was a humanised monoclonal superagonist of the CD28 T cell surface receptor. It was hoped that the experimental drug would be beneficial to people with rheumatoid arthritis, chronic lymphoid leukaemia (CLL) and multiple sclerosis (MS). Eight healthy volunteers were randomised to receive the experimental product or placebo. Shortly after the product was administered to the volunteers, participants developed a cytokine storm. The two participants on the placebo arm watched in horror as the other six participants developed physical abnormalities – swelling up of the body and necrosis of fingers. One participant allegedly transformed so drastically that he was described as the “elephant man”. Source: Attarwala 2010 COMMENTARY Several queries have been raised around this trial: • • • • • •

How were the volunteers recruited and motivated? How much information based on full risk analysis do volunteers receive? How much money is too much and when does money cloud the judgement needed to evaluate risks realistically? (Each volunteer was paid £2000). Why was the drug tested on healthy volunteers rather than patients? Why were eight volunteers given the drug at 5–8 minute intervals? What information did the ethical and regulatory bodies have about the trial? 271

• •

How were the reviews performed – were they theoretically flawed? Can the mouse be used as a model for human physiology when the CD28 receptor differs significantly between mice and humans in terms of its amino acid constitution?

Most of the participants recovered (Steinbrook 2006), but two of the men developed serious adverse events – one developed lymphoma and the other necrosis of some of his digits. Both men pursued legal action and reached an out-of-court legal settlement. Case study 20.6: Death on a French trial A first-in-human trial on an experimental drug called BIA 10-2474 recruited 128 healthy volunteers aged 18–55 years in France. Ninety people received different doses of the drug and the rest received a placebo. This drug was being tested for safety and was developed by a Portuguese drug company to treat chronic pain in patients with cancer, and motor disorders and anxiety in Parkinson’s disease. All participants each received $2600. The first patient to develop serious side effects became ill on 10 January 2016 and died on 17 January 2016. Six others developed brain haemorrhages. The participants who became ill had received multiple doses of the drug. Source: Butler & Callaway 2016 COMMENTARY Several questions have been raised about this trial and the investigation is ongoing: • • • • • •

Were there deaths during animal studies? Given that the drug works on the endocannabinoid system of the brain, were central nervous system side effects not predictable? Was the scientific review sufficiently robust? Was the risk-benefit calculus accurate? Were the dosing intervals between participants adhered to? How will participants who died or who sustained severe brain damage be compensated?

20.6 WHAT MAKES CLINICAL RESEARCH ETHICAL? In order to avoid a recurrence of such research atrocities we need to think about what makes clinical research ethical. The following concepts, adapted from Emanuel, Wendler and Grady (2000) have been described as the benchmarks of ethical research: What makes clinical research ethical? • • • •

Relevance, and scientific, clinical and social value Scientific validity Fair subject selection Risk-benefit ratio

• • • •

Independent review Informed consent Respect for participants Action – policy and publication

20.6.1 Relevance and scientific, clinical and social value For any research to have value it must contribute to generalisable scientific knowledge that leads to an improvement in the health and wellbeing of society. Research that lacks social or scientific value is 272

unethical as it results in the wastage of limited resources and exploits human subjects by exposing them to potential harm.

20.6.2 Scientific validity All research must be conducted in a methodologically sound and rigorous manner. This requires a research protocol with the following characteristics: 1. 2. 3. 4. 5.

The aims and objectives must be clear and scientific. The study design must be relevant, and accepted principles must be used. The sample size must have sufficient power to definitively test the objectives. The methods must be valid, reliable and practically feasible. Data analysis must be clear and plausible.

Clinical research that compares therapies must have “an honest null hypothesis” or “clinical equipoise” (Freedman 1987), meaning that there must be controversy within the scientific community about whether the new intervention is better than standard therapy. The ethical justification of scientific validity relies on the same principles that apply to value – limited resources and the avoidance of exploitation.

20.6.3 Fair subject selection of a vulnerable group The decision about recruitment, enrolment and inclusion into and exclusion from the study needs to be made according to the scientific aims and objectives of the study and not according to vulnerability, privilege or other unrelated purposes. It is imperative that participants are selected so as to minimise risks and enhance benefits to them and society as a whole. Furthermore, participating individuals or groups who bear the risks and burdens of the research should be in a position to enjoy its benefits. The following groups of people are regarded as vulnerable research participants: • Children and adolescents • People with mental disabilities • Pregnant women • Substance-use disorders • The elderly • Vulnerable communities • Prisoners UNAIDS has defined vulnerable communities as communities with • • • • •

limited economic development inadequate human rights protection, and discrimination based on health status inadequate understanding of scientific research limited healthcare and treatment options limited ability to provide individual informed consent.

Dependent relationships Researchers are in a position of power with respect to their choice of human research participants. Using individuals or groups who are in a dependent relationship with the researcher is ethically questionable. This includes the researcher’s students, patients, employees or even family members. Academics should avoid using their own students for research. For many years the medical profession has had a history of using medical students as a convenient sample of “volunteers”, such as in anaesthetic and analgesic trials to test methods of pain control. Other convenient samples include 273

research colleagues or laboratory personnel who are “dependent” on the principal investigator for career advancement or their livelihood. It is good ethical practice to declare potential conflicts of interest prospectively if there would be perceived bias in one’s primary duties and in relation to other parties.

20.6.4 Risk-benefit ratio Clinical research involves drugs, devices and procedures about which there is limited knowledge. As such there is inherent uncertainty about the degree of risks and benefits associated with these experimental interventions. In any research endeavour the net expected benefit to patients must outweigh the anticipated risks. Clinical research can be justified only if the • • •

potential risks to the individual participants are minimised potential benefits to the individual participants are enhanced potential benefits to the individual participants and society are proportionate to or outweigh the risks. The ethical principles of non-maleficence and beneficence embody the requirement for a favourable risk-benefit ratio. Non-maleficence requires that one ought not to inflict harm and this justifies the need to reduce risks associated with research. Beneficence refers to acting for the benefit of others and this translates into the need to enhance the potential benefits of research to both the study participants and society as a whole (Emanuel et al. 2000).

20.6.5 Independent review Conflict of interest may be defined as a “set of conditions in which professional judgement concerning primary interest – such as the validity of research – tends to be unduly influenced by a secondary interest – such as financial gain” (Thompson 1993). In clinical research, there are various levels at which conflict of interest is likely to arise, such as in the actions of pharmaceutical industries, their relation to health professionals, participation of universities and research institutes, and research ethics committees and their members. Among investigators, conflicts may be related to the financial gains associated with participation in sponsored pharmaceutical trials, to the expected academic career boost attained with the publication of the results of trials and also to personal interests such as financial support for trips to international conferences. Universities or research institutes themselves also have conflicts of interest, as sponsored projects may help increase their budgets, both directly (taxes) and indirectly (via the improvement of the physical infrastructure of laboratories or outpatient clinics). Independent review by individuals unaffiliated with the clinical research proposed helps minimise the potential of such conflicts of interest and safeguards social accountability. In some instances, it is difficult to say when a risk is justified in view of the possible benefits related to the research. In many countries we cannot depend on participants always being able to fully appreciate the risks associated with scientific research. Participants in many countries tend to agree with whatever health professionals suggest. This implies that the researcher has an obligation to exercise some responsibility over the risks to which participants are allowed to expose themselves. Internationally, research ethics committees (RECs) attempt to encourage ethical research and to ensure participant protection. All clinical trials and other research must be approved by an REC before any work may commence on the project. In addition, if a drug or device is involved, approval from the medicines

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regulatory agency – namely the Medicines Control Council (MCC) – is required in South Africa. In the US, approval from the Food and Drug Administration (FDA) is required.

20.6.6 Informed consent Individuals participating in clinical research must be able to make a voluntary and uncoerced decision regarding participation. Unlike in the clinical situation where informed consent includes information of material relevance to a reasonable person, in the research setting obtaining informed consent is much more comprehensive and includes full disclosure/declaration of all anticipated risks, including death. However, to provide informed consent, individuals must be accurately informed of the purpose, methods, risks, benefits and alternatives to the research and they must understand the information provided. In many developing countries, including South Africa, illnesses are more prevalent among marginalised populations, the poor and the vulnerable. Voluntary informed consent requires special consideration in healthcare research.

20.6.7 Respect for participants Respect for participants does not end when they have signed the consent form and have been enrolled into the study or when they have declined to participate. Respecting potential and enrolled participants includes the following: • • • • •

Respect for privacy by maintaining confidentiality Allowing participants to withdraw from the study without penalty Providing any new information (positive or negative) that becomes available during the course of the study Carefully monitoring the participants throughout the duration of the study Informing them about the outcomes of the research

20.6.8 Action – policy and publication Research that is not published cannot contribute to generalisable knowledge. Science translation for the general public in lay language in printed and electronic media is imperative. Translating research into policy and publication for dissemination is an ethical obligation of all researchers.

20.7 PUBLICATION ETHICS 20.7.1 Integrity in scientific writing Trust and honesty are among the most important values that must be embraced in the publication of research and in scientific writing. Inaccurate statements may be produced in research due to justifiable mistakes, careless errors or overinterpretation of results. However, inaccuracy is regarded as fraudulent when there is intentional misrepresentation of data. Scientific misconduct matters for the following reasons (National Academy of Sciences 1992): • • •

It is morally wrong. It is a waste of resources. It is potentially harmful.

• •

It erodes public confidence. It endangers the independence of science.

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20.7.2 Research misconduct Various definitions of research misconduct have been advanced. The Office of Science and Technology Policy (OSTP) was implemented in the US in 2005 and defines research misconduct as follows: Fabrication – making up data or results and recording or reporting the “data” Falsification – manipulating research materials, equipment or processes, or changing or omitting data or results such that the data are not accurately reflected in the research records Plagiarism – appropriating another person’s ideas, processes, results or words without giving appropriate credit Fabrication and falsification of data Dr Werner Bezwoda was an oncologist in private practice with a part-time appointment at the University of Witwatersrand in Johannesburg, South Africa. Throughout the 1990s, he conducted research into the treatment of advanced breast cancer and published results from two randomised trials comparing highdose chemotherapy and autologous stem cell transplantation for patients with advanced breast cancer with standard-dose chemotherapy. Both studies suggested a very strong beneficial effect of high-dose chemotherapy. Unusually, his studies were the only research to show such beneficial effects of a very radical form of treatment for this condition and they therefore attracted tremendous interest internationally. For example, Dr Bezwoda was invited to present a plenary session lecture at the annual meeting of the American Society of Clinical Oncology in 1999 to discuss his findings, and one of his published papers describing the benefits of this form of treatment had received over 300 citations by 2001, indicating the extent to which his findings were beginning to influence clinical practice and research around the world. However, in 2000 an investigation into his research showed that his studies were fraudulent – there were discrepancies in the numbers of patients he claimed were in his studies and many did not comply with known eligibility criteria. Questions were also raised as to whether the patients in the studies actually understood that they were in a clinical trial, all the more concerning because many patients were poorly educated black women whose lack of first-language English competency may have prevented them from giving proper informed consent. Dr Bezwoda later admitted that the protocol for one of the studies was only written long after the study was completed. Following a university investigation, Dr Bezwoda admitted to committing “a serious breach of scientific honesty and integrity”. He was dismissed by the University and sanctioned by the HPCSA following a disciplinary hearing (Weiss et al. 2000). A more recent international case involves Dr Andrew Wakefield, a consultant gastroenterologist in the UK. In 1998 Dr Wakefield published a paper in The Lancet describing his research on 12 children in whom he attempted to establish a link between the MMR vaccine and autism. Although the paper conceded that a definite link was not found, Dr Wakefield suggested at a press conference in North London that single vaccines for measles, mumps and rubella might be preferable to the triple vaccine. Parents became hesitant about using the triple vaccine and the uptake of the vaccine dropped. The number of measles cases subsequently increased. Subsequent research has found no link between the MMR vaccine and autism (Dyer 2010).

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Dr Wakefield failed to disclose that his research was funded by the Legal Aid Board through a solicitor who planned to take legal action against the vaccine manufacturers. Dr Wakefield had also filed a patent application for a new vaccine. The Lancet retracted his paper after they discovered that his investigations had not been approved by a research ethics committee. The General Medical Council (GMC) concluded that he had abused his position, subjected children to invasive procedures such as lumbar punctures and colonoscopies, conducted research that breached the conditions of ethics committee approval and brought the medical profession into disrepute. The findings were: dishonesty (four counts); research on developmentally disordered children without approval (11 counts) and contrary to their clinical interests (nine counts); causing a child to undergo a lumbar puncture that was not indicated (three counts); ordering medical tests without appropriate qualifications; and breach of a non-clinical employment contract (three counts) (Deer 2010). The Lancet retracted his 1998 article in February 2010 as elements of the manuscript had been falsified. Dr Wakefield was struck off the medical register in the UK by the GMC in May 2010. Plagiarism In simple terms, plagiarism is regarded as the theft or use of ideas, written material and/or intellectual products that belong to others and that are passed off as one’s own work. Sources of “borrowed” information could be written text (articles, books, dissertations, theses), visual text, graphics, multimedia (websites, videos), music (CDs, lyrics) and spoken text (speeches, audio recordings). Most tertiary educational institutions have a plagiarism policy that outlines the process that will be followed if students are suspected of scientific misconduct. An example of such a process is as follows, where the levels of misconduct may be categorised into three groups (Stellenbosch University Policy on Academic Integrity 2010): Category 1: These are minor offences that can be regarded as resulting from ignorance, negligence or inaccuracy in working with and acknowledging sources, but that can still be regarded as plagiarism. Category 2: These are less serious cases, in which sources/work/material has/have been handled injudiciously, but that by nature still constitute plagiarism. Category 1 and 2 offences are usually dealt with by the department concerned in the case of students. Repeated category 2 offences can be referred to a central disciplinary process in the case of students, and in the case of staff they will be dealt with in terms of the disciplinary code for staff. Category 3: These are blatant cases, i.e. where the work/material of another person has been taken over and used intentionally and deliberately. In the case of students, such cases will normally be referred to a central disciplinary process, and in the case of staff will be dealt with in terms of the disciplinary code for staff. Self-plagiarism is a contentious issue and allegedly involves the use of one’s own material in different publications. In such cases it is important to reference one’s previous article or book chapter. Most tertiary education institutions use software packages to screen assignments, theses and dissertations for evidence of plagiarism. Plagiarism can be avoided by acknowledging sources of information, using inverted commas for direct quotes, and using citations in the text and references at 277

the end of an assignment, thesis, dissertation or article. Cutting and pasting from internet-based sources should be avoided. One’s own words should be used to explain what one has read in original sources.

20.7.3 Scientific papers Authorship & Acknowledgement The International Committee of Medical Journal Editors (ICMJE 2008) has developed guidelines for authorship and acknowledgement. In order to qualify for authorship of an article one must have participated in: 1. the conception and design of the study and/or analysis and data interpretation 2. drafting and/or revising the article 3. final approval of the version to be published. Furthermore, all authors should be able to take public responsibility for the content of the publication. If a person does not qualify for authorship, he or she may be acknowledged for the following: •

Advice, critical review of the study proposal, data collection, participation in a clinical trial

•

Technical help

•

Financial and material support

Consider the following case Case study 20.7: Dr Jon Sudbo and The Lancet publication, October 2005 In October 2005, a study investigating the relationship between long-term use of NSAIDS and oral cancer was published in The Lancet. The study was based on analysis of data allegedly obtained from a population-based database in Oslo, Norway. The study concluded that long-term use of NSAIDS was associated with a reduced incidence of oral carcinoma. On 13 January 2006 The Lancet was informed that the research published was not based on data from Norwegian national databases but rather on fabricated data. The hospital in Norway commenced an investigation and The Lancet published an “Expression of concern” on 19 January 2006. By February 2006, it had been established that data on all 908 “patients” had been fabricated – in fact 250 of these “patients” shared the same date of birth! On 4 February 2006 the article was retracted by The Lancet. The retraction published in the journal read as follows: “We have received confirmation … that the paper published by Jon Sudbo and colleagues in The Lancet contains fabricated data. This article supersedes our earlier expression of concern and we now retract this article in full.” COMMENTARY An investigation into all previous research conducted by Dr Sudbo was immediately commenced. This case illustrates the importance of ethical conduct and reporting of research. The case also illustrates the impact of unethical research – it can lead to loss of confidence in medical research by colleagues and the public. More importantly, it can lead to the death of healthy volunteers.

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20.8 CONCLUDING REMARKS Maintaining the highest standards in the conduct of scientific research is an ethical requirement. Participants often volunteer their time and their bodies in the interest of medical research based on altruism. As medical scientists we need to acknowledge their generosity in contributing to a generalisable body of knowledge, minimise harm and respect their dignity at all times.

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CHAPTER 22: Global Health & Global Health Ethics (Author: Solomon Benatar) By the end of this chapter you should be able to: • • • •

develop an awareness of the impact of global forces on health understand the social and societal determinants of health and disease at a population level acknowledge that our ethical obligations to improve health extend beyond treating individual patients strive to improve health at national and global levels.

21.1 GLOBAL HEALTH: WHERE TO NOW? 21.1.1 Introduction Improvement in human health worldwide is one of the major challenges for the 21st century. Advances in biological knowledge and their application over the past 60 years have surpassed all previous theoretical and technological achievements. As a result, medicine and healthcare have been transformed, with major increments in longevity and health for many (Porter 1997; McCracken & Phillips 2014). Yet despite these advances and the vast expansion of the global economy, we now face new and almost insurmountable health threats that are intimately linked to poverty (Gandy & Zumla 2003, Benatar & Upshur 2010; Benatar & Brock 2011). Hope in the 1970s that infectious diseases had been conquered is now ironically being reversed by the renewed spread of old infectious diseases (e.g. TB and malaria – including multidrug-resistant strains), and the emergence of many new ones (e.g. HIV, severe acute respiratory syndrome (SARS), H1N1 flu and, most recently, Ebola and the Zika virus). The 2003 epidemic of severe acute respiratory syndrome (SARS) (Nelson, Hui, Wu, Chan, Cameron, Joynt et al. 2003) and the recent Ebola epidemic are small-scale examples of the new, acute, rapidly fatal infectious diseases that may, like the 1918–1919 flu epidemic, sweep through the world with accompanying profound social and economic implications for human security (Benatar 2015a, 2015b; Sands, Mundaca-Shah & Dzau 2016). Population growth, severely adverse living conditions and increasingly close contact between humans and other species provide the context for cross-species shifts of organisms and the emergence of new zoonotic diseases. Arguably these are the most serious global threats to the health of humankind in the 21st century (Garrett 1994; Benatar 2001) and will take their greatest toll in developing countries and among disadvantaged groups in privileged societies (Wilkinson & Pickett 2009; McMichael 2014). Chronic diseases of lifestyle are also on the upsurge, affecting both the affluent and lower/middle classes globally.

21.1.2 On the threshold of a new era We are also now on the threshold of a new therapeutic era. Advances in genomics, genome-related biotechnology and nanotechnology give the hope of transforming medicine and healthcare in the next few decades. While the hope is that such advances will improve health globally (Singer & Daar 2001; Sifferlin 2014; Topol 2013), many obstacles will need to be overcome to achieve desired goals, and the risk that such advances will only be available to those with resources should not be underestimated. Inappropriate and unwise use of the new power of genome-related biotechnologies, like other forms of power, may thus be harnessed to benefit only a privileged minority and increase inequities in global 280

health (Benatar 1999, 2000; Benatar, Gill & Bakker 2009). Consider also that we have not yet wisely applied already proven drugs and vaccines, or our accumulated impressive knowledge to improve the health of people across the world. It is necessary to step back from these magnificent medical advances and the optimism we have for progress in treating individual patients, and reflect on the overall state of health in the world today. We need to consider a range of potential scenarios for global health, and examine what could be done to ensure progress towards the best of these possibilities.

21.2 TRENDS IN GLOBAL HEALTH Disparities in wealth and health within and between nations continue to widen inexorably (the world is more inequitable than it was 60 years ago), and billions of people live in degrading poverty, with little if any access to healthcare, and are susceptible to the ravages of malnutrition. In addition, conflict, civil wars, interpersonal human violence, displacement of large populations and refugeeism are all on the increase. At the beginning of the 21st century, life expectancy, patterns of diseases and causes of death differed markedly across the world in both poor and wealthy countries (Townson 1999; Murray & Lopez 1997). Patterns of disease have changed at variable rates across the world. Some infectious diseases have diminishing relevance in many countries, whereas they are of great prominence in others. While life expectancy for all has increased since 1970, the wide range of life expectancy from well over 70 years (and rising) in highly industrialised countries to below 50 years (and falling) in many poor countries reveals the extent of improvement that remains to be achieved (Wung, Dwyer-Lindgreen, Lofgren, Kajaratnam, Marcus et al. 2012). In sub-Saharan Africa, gains in life expectancy achieved during the first half of the 20th century were rapidly reversed by the HIV/AIDS pandemic, until the widespread availability and use of antiretroviral drugs restored the prospect of an almost normal lifespan to many (Johnson, Mossong, Dorrinton et al. 2013), even in Lower- and Middle-Income Countries (LMICs) (Mayosi & Benatar 2014). Reduction in the frequency of infectious diseases is counterbalanced by excessive consumption of salty and high-calorie food and less exercise as a result of improved transportation. This is leading to growing morbidity and early deaths from diabetes, strokes and cardiovascular diseases (Yach, Hawkes, Gould & Hofman 2004; Daar, Singer, Persad, Pramming, Matthews, Beaglehole et al. 2007). These features illustrate the degree to which many of the contradictory aspects of global health are part of a wider syndrome connected to inequality of the structures and values of our societies (Benatar 1998a; Benatar & Brock 2011). The problem of TB illustrates the paradox of how advances in scientific knowledge and the ability to cure individual patients have not been accompanied by public health gains. While in the 1970s there was hope of eradicating TB from the world at a price that was easily affordable, it is now becoming a multidrug-resistant disease that is too expensive to treat (up to 100 times the cost of treating patients with drug-sensitive strains) except in affluent countries. As extensively drug-resistant (XDR) TB spreads in South Africa and elsewhere, the risk of this is even greater today than when this threat first became evident over a decade ago (Benatar & Upshur 2010; Mayosi & Benatar 2014). These developments are not the result of lack of knowledge, but are rather an example of lack of vision and of wisdom in the application of knowledge and failure to appreciate the complex links between social and economic aspects of life, health and disease (Birn 2011; Benatar & Upshur 2011).

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Other examples of the gap between scientific advances and improvement in public health include the increasing antibiotic resistance of many other organisms; the inexorable increasing incidence of lung cancer (one of the few malignancies for which the main cause – smoking – is definitively known and which can be prevented), especially in developing countries that have been targeted by tobacco companies. Understanding why we have failed to improve health at the world population level requires insight into the state of our world at the beginning of the new millennium, and appreciation that improving health globally will require new ways of thinking and innovative action (Benatar 2015c).

21.3 UNDERSTANDING THE WORLD AS AN UNSTABLE, COMPLEX ORGANIC SYSTEM It has been argued in detail elsewhere that the world in the early 21st century is characterised by instability in many domains – economics, society, the ecology and politics (Benatar 2011). In brief, the global economic system is collapsing on itself – massive financial losses through fraud have severely jeopardised the lives and health of billions. Medicine seems to have lost its way as a caring social function as healthcare becomes increasingly focused on those who can pay, and neglected diseases of poverty relentlessly undermine the lives of many. Global security is failing due to an outdated focus on weapons as a means of protection, and neglect of the potential of infectious diseases and spreading social disruption that cause havoc with the security of all. The international response to the recent Ebola epidemic is an example of how such issues receive too little attention too late (Smith & Upshur 2015; Benatar 2015a, 2105b; Sanders, Sengupta & Scott 2015). The quality of our ecological environment is rapidly eroding due to consumption patterns that are unsustainable. Within a few hundred years humankind has moved from being subdued by the forces of nature, through learning to live with and control nature, to an era in which the destruction of our natural environment and animal species seriously threatens future life on our planet (Steffen, Richardson, Rockstrom et al. 2015). Underlying these processes are the rapidity and extent of change in a complex global system and lack of visionary global leadership for a highly challenging new millennium (Gill & Benatar 2016).

21.4 THE GLOBAL POLITICAL ECONOMY AND HEALTH In order to understand the forces influencing health and medical care, we need to appreciate that modern medical practice is pursued within the context of a world increasingly influenced by powerful social and cultural forces. Globalisation, a widely used term meaning different things to different people, is characterised by such generally accepted features as changing perceptions of time and physical space, and diffusion of ideas, culture and values at an escalating pace on a global scale. While economics is the most commonly used framework for debating this as a phenomenon, globalisation is a complex concept that goes beyond economics to include social, cultural and ecological dimensions. It is not a new phenomenon, but the outcome of a long interwoven economic and political history, involving a wide range of actors, with both beneficial and adverse effects on human wellbeing, although critics can argue that, as with population growth, the adverse effects of globalisation are now becoming starkly apparent (Rowden 2009; Mason 2016; Gill & Bakker 2011). Positive manifestations of progress associated with globalisation include advances in science and technology, increased longevity, enhanced economic growth, greater freedom and prosperity for many, 282

improvements in the speed and cost of communications and transport, and popularisation of the concept of human rights. Negative effects include widening economic disparities between rich and poor within and between nations, and increases in both absolute and relative poverty. At the beginning of the 20th century, the wealthiest 20 per cent of the world’s population were nine times richer than the poorest 20 per cent. This ratio has grown progressively to 30 times by 1960, 60 times by 1990, and to well over 100 times by the early 2000s. World debt grew from $0,5 trillion in 1980, to $1,9 trillion in 1994, $2,2 trillion in 1997 and $5,69 trillion in 2006, and to over $230 trillion in 2012 (My Budget 360). The way in which debt is created and sustained, and its relationship to the arms trade, has been a major factor in perpetuating and intensifying poverty, ill health and displacement of millions of people. The number of people forcibly displaced at the end of 2014 had risen to 59,5 million compared to 51,2 million a year earlier, and 37,5 million a decade ago. These increases are likely to worsen still further. In sub-Saharan Africa, many conflicts (including in the Central African Republic, South Sudan, Somalia, Nigeria, the Democratic Republic of Congo, and elsewhere) led to forced displacement – with 3,7 million refugees and 11,4 million internally displaced people (UNCHR 2014). The evolving complex web of material, institutional and ideological forces, and the power of massive multinational corporations in a globalising world, have profound implications for the accumulation of capital and for the way in which resources are controlled. In 1970, 70 per cent of all money that changed hands on a daily basis was payment for work, while speculative financial transactions accounted for only 30 per cent. By 1998, when daily speculative exchanges amounted to $1,5 billion daily, these proportions had changed to 5 per cent and 95 per cent respectively. Such a striking shift in the distribution of money reflected in only minor reductions in poverty (Kocchar 2015) arguably reflects devaluation of the lives and work of most people in the world. The shift in locus of economic power from the nation state to global corporations is altering the balance of power in the world. Boundaries between states and between foreign and domestic policies are being blurred, and in the process undermining small states’ control over their economies and threatening their ability to provide for their citizens. Most countries that were required by The World Bank to pursue structural adjustment programmes are in greater debt than ever before. Third World debt, although accounting for only a small proportion of total world debt, has reached exorbitant levels relative to income in the Third World, and these countries will never be able to repay it (Rudin & Sanders 2011). Economic disparities have become so marked and adverse effects so apparent that significant incompatibility has arisen between neoliberal economic policies and the goals of democracy (Royal Danish Ministry for Foreign Affairs 2000). In addition to progressive widening of the economic divide between nations, and growing external control by money lenders over the economies of small countries through debt, trade and markets that are increasingly global, other powerful forces, for example feminisation of labour, more part-time employment and exploitation of cheap labour in developing countries, are creating new patterns of inclusion and exclusion. The emergence of many new zoonotic diseases such as AIDS, Ebola and Zika, which afflict predominantly those marginalised by poverty (80 per cent of HIV-positive persons live in the poorest countries in the world), has been attributed to the social and environmental niches created by the nature of the global political economy and its ideology. Failure to appreciate such associations will result not only in the inability to control such diseases as HIV/AIDS (as for TB in the past), but more importantly, will probably 283

favour the emergence of new infectious diseases in the future (Garrett 1994; Benatar 2001, 2015). The changes in demography resulting from urbanisation, migration, travel, multiple small-scale wars, ethnic conflict, displacement of people and refugees, and close contact between animals and humans facilitate the emergence and spread of diseases against which no one should feel immune. The devastation resulting from HIV/AIDS in Africa needs to be seen in the context of 300 years of slavery (from 1441–1870), 75 years of colonialism (from 1885–1960), and the Cold War (from the 1960s until 1991) that successively debilitated the continent. Excitement and pride that came with independence in the 1960s turned to despair under the rule of tyrants in the 1970s. By the 1990s, many viewed African countries as “political and economic infernos” (Schwab 2001). The US retreat from Africa after the Cold War, in addition to the continuing extraction of resources, including skilled labour, minerals and oil, perpetuates centuries of exploitation. Sub-Saharan Africa’s debt of $275,6 billion, which can never be repaid, results in annual interest charges that cancel out the $21,2 billion annual aid donation to Africa, cripples health services and stultifies development (The Economist 2014). The fact that Third World debt is a small component of total world debt and that in sub-Saharan Africa four times as much is spent on debt repayment each year than on health and education combined, make insistence on debt repayment the modern equivalent of slavery. We need to acknowledge the extent to which the so-called developed world has been instrumental in contributing to such deprivation (Pogge 2004; Benatar 2005; Rowden 2009). It must be conceded that corruption and bad government in developing countries contribute significantly to their own misery and poor health. Much less openly discussed is the complicity of powerful nations in supporting leaders who are despots and kleptocrats by legitimising their right to sell their countries’ natural resources, spend profligately on themselves and incur national debts that their impoverished citizens must repay. In the middle of the second decade of the 21st century, the world is thus characterised by widening disparities in economic and health status (between countries and even within wealthy countries where the size of the underclass is growing), and by suffering, conflict, civil wars, displacement and forced migrations associated with pervasive social forces. Erosion of the economies of poor countries, under the impact of the neoliberal economic policies driving globalisation, has obstructed the introduction of effective forms of modern medicine and prevented the achievement of widespread access to even basic healthcare for billions of people (Benatar, Daar & Singer 2003; Benatar, Gill & Bakker 2011).

21.4.1 Comparative healthcare expenditure Since the 1960s, major advances in medicine and technology have been associated with escalating expenditure on healthcare – most of this in highly industrialised countries. In the 1990s, 89 per cent of annual world expenditure on healthcare was spent on 16 per cent of the world’s population who bear 7 per cent of the global burden of disease (in disability-adjusted life years or DALYs). Moreover, 90 per cent of medical research expenditure was on health problems, accounting for only 10 per cent of the global burden of disease, although this has improved somewhat in recent decades with contributions from the Global Fund and other philanthropies. The World Health Organization (2008) estimated that in 1995 the annual per capita cost of providing a basic package of public health and essential clinical services in a low-income country was $15. Even though some parasitic diseases (e.g. onchocerciasis, schistosomiasis and lymphatic filariasis) could be controlled by mass treatment campaigns using inexpensive drugs, the infrastructure required to provide such coverage is inadequate. Effective treatment of diseases such as TB, malaria and HIV/AIDS, as well as prevention of HIV transmission, 284

requires more complex infrastructures than can be afforded on current healthcare budgets in poor countries These disparities are examples of global injustice that should be intolerable if there were genuine commitment to universal human rights and human dignity, and to improving health at the level of whole populations. Vaccine development and drug donation programmes for poor countries, admirably promoted and supported by some pharmaceutical companies and major foundations in the industrialised world, are necessary but insufficient responses to such injustices. Massive reductions in the price of antiretrovirals (ARVs) that made it possible to ensure effective treatment, even in LMICs, is an example that should be more extensively emulated. Modest but significant further increments in economic status and improved living conditions, combined with improved access to affordable and effective basic healthcare delivery systems, offer the potential for improving global health.

21.4.2 Military expenditure and foreign aid Of over 140 million war deaths since 1500, 110 million were in the 20th century. Civilian deaths accounted for 80 per cent of more than 20 million war deaths since World War II. Industrialised countries spend on average 5,3 per cent of GNP on the military (global military expenditure in 2007 amounted to US$1,39 trillion) but about 0,3 per cent on economic aid to developing countries (Sivard 1996). Between 1998 and 2007, world military expenditure increased by 45 per cent (Shah 2013). There have been close links between the arms trade and economic aid, with a considerable proportion of foreign development aid repatriated to donor countries through arms sales. This link has contributed significantly to the escalating number of wars, conflict and widespread torture since World War II. In 1980, there were about 22 million refugees worldwide. By the early 1990s, this figure had almost doubled, and in 2015 it was almost 60 million (UNCHR 2014). Such displacement of people and total disruption of social life has profound adverse effects on life and health, and refugee camps are often hotspots for epidemics.

21.4.3 Some other comparative expenditures The cost of providing basic education for all in the world in the late 1990s was estimated at $6 billion, and the cost of providing access to reproductive health services for all women in developing countries was $12 billion. These costs, likely to be larger today, are nevertheless small in comparison with global military spending at $780 billion in the late 1990s (two-thirds of its level in 1985 at the peak of the Cold War, and almost $1 trillion in recent years) and expenditure of $50 billion on cigarettes, $105 billion on alcoholic drinks in Europe, and $500 billion on narcotic drugs in the world in 1990, which has likely increased further since then. In the US, pharmaceutical companies spend more than $11 billion each year promoting and marketing drugs (Shah 2010). The annual budget of the WHO in 1990 was equivalent to 2,5 hours of global military expenditure, and it remains well below what it requires to respond effectively to such emergencies as the recent Ebola epidemic. During the 2008 global financial crisis, up to $17 trillion was raised worldwide to rescue financial institutions from their fraudulent activities that led to the currently evolving global financial disaster, while it was not possible to raise the $750 billion required to achieve the Millennium Development Goals (Gill & Bakker 2011)!

21.4.4 Responsibility for global health The facts and interpretations offered above are not intended to imply that the wealthy, productive and fortunate in the world should bear the whole burden of the blame for the complex series of historical developments that polarise the world. Political realities within developing countries, including 285

corruption, ruthless dictatorships, ostentatious expenditure by elites and underinvestment in education and health, have contributed greatly to the suffering of billions. However, it is vital for privileged people to have insight into the extent to which these deficiencies in many developing countries have been facilitated by the policies of wealthy nations in pursuit of their own interests (characterised by ongoing extraction of natural and human resources). Insight into how favoured lives are sustained by overt and covert exploitation of unseen others could allow those of us who live comfortable lives anywhere in the world to appreciate that we do not have a monopoly of entitlement to the benefits of progress (Rowden 2009; Gill & Benatar 2016).

21.5 PROGNOSIS FOR IMPROVED GLOBAL HEALTH There are three possible scenarios for the future of global health (Benatar, Gill & Bakker 2009). The first and most likely is ongoing wide disparities with improvements in health being achieved predominantly for the wealthy. A second scenario would feature some improvement in health for many more people (through the efforts of the Millennium Development Goals, the Global Fund, and ongoing Sustainable Development Goals 2105) but with wide disparities still affecting several billion, in particular as achievement of even these modest goals has been set back by several decades by the global financial crisis. It is difficult not to conclude that the prognosis for global health is poor given such impediments as our paradigm of thinking, the development myth, the paradox and defects of foreign aid, acquiescence to poverty through definitions of poverty that lack credibility (Benatar 2016) by overblowing minor improvements at the lowest levels (Jamison, Summers, Alleyne et al. 2013) and by ignoring the upstream forces sustaining poverty. A final possible but less likely achievable goal would be considerable improvement in global health for all through a visionary approach to a fairer global economy (Gill & Benatar 2016).

21.6 A VISION FOR THE FUTURE IN A CHANGING WORLD There is a great need to go beyond the simplistic idea that the health of individuals is merely about making more modern medical treatments more widely accessible to more people. When such medicalisation of health is applied to global health, the goal becomes to increase access to whatever medical treatments are available – so, for example, we have the Global Fund focused on making drug therapy available to all who suffer from HIV/AIDS, malaria and TB – with little attention to their living conditions (lack of food, housing, clean water, etc.) that drive the emergence and spread of such diseases (The Global Fund 2007), or to the basic primary healthcare services required for integrated and effective care. In essence, this view of health coming out of the “barrel of technology or pharmaceuticals” is embodied in an Institute of Medicine (IOM) report on the US’s commitment to global health (Institute of Medicine 2008). This report made it clear at the outset that it would not address the profound population health implications of food security, clean water, sanitary measures, gender discrimination or universal access to basic healthcare. The focus was on US foreign aid for HIV/AIDS and other infectious diseases with attention drawn to those aspects of health that can be classified medically and treated with medications. It is regrettable that a report of this nature from a prestigious institution failed to examine the social and societal determinants of health and disease (Birn 2011) at a time when the WHO was just 286

beginning to do so – many decades later than it should have done (WHO 2008)! These failures were highlighted by the delayed and inadequate WHO and other international responses to the recent tragic Ebola epidemic (Smith & Upshur 2015; Benatar 2015a; Sanders, Sengupta & Scott 2015). Regrettably, the example of medical care as a marketable commodity (albeit with considerable state assistance for the poor and the aged) set by the US is being widely followed. Such privatisation of medical care, aided and abetted by structural adjustment programmes promoted by the policies of the International Monetary Fund and The World Bank, have adversely affected health in many poor countries. These examples of the medicalisation of global health, increasingly associated with the monetarisation of medicine, provide insight into how more technology and drugs do not necessarily improve health, but they fail to highlight how the global economy is structured to maintain the wealth and healthcare (often wastefully provided) of those with resources, while extracting human and material resources from poor countries and ensuring that they lead impoverished lives with little healthcare other than that provided by their own poor governments and generous philanthropy. Perpetuation of this medicalised (and monetarised) view of global health while ignoring powerful upstream forces that profoundly shape the health of whole populations (Benatar & Brock 2011) hardly does justice to human intelligence or to the so-called vital interest in, or commitment to, global health. We should admit that we live in a world undergoing entropy. Genuine interest in global health would extend to understanding our relationship with nature and developing a long-term view of human flourishing on a scale that would reflect insight into the need for the new complex goal of “developing sustainability” in place of the worn-out and failing agenda for sustainable development focused only on economic growth (Bensimon & Benatar 2006). In a world in which money is abundant and there is so much knowledge that could be used to improve human flourishing, we need to be as innovative socially as we are scientifically. Many countries consider access to basic healthcare as a basic human right that nation states should be committed to providing for their citizens. Acknowledging the need for universal access to a basic healthcare package could allow new relationships to be forged between physicians, patients and society. The moral power and potential impact on global health of such action if exemplary local leadership is provided (e.g. the Bolsa Familia programme in Brazil) should not be underestimated (Wong 2015), yet it should be noted that equitable healthcare in Canada is not sustainable under current policies (Naylor, Girard, Mintz, Fraser & Power 2015). As the limits of medicine and how political and economic forces shape healthcare are increasingly recognised, it also becomes necessary to question personal and social meanings of illness and what it means to seek help from our communities and those they empower to provide healthcare (Benatar & Fox 2005). In response to such daunting challenges, many ask what individual physicians and professional associations could do to improve the conditions described above (Benatar 2001). Some suggestions made over a decade ago are listed below: 1. We have an obligation to know about and understand the impact on health of the global forces described above. 2. We should become more introspective about our privileged lives. 287

3. We should appreciate that our personal skills, developed on the basis of labour and investment by previous generations, represent social capital and involve social obligations for us. 4. We should become a force in coupling excellent treatment of individual patients to national programmes that improve public health within nations. 5. We need to locate our activities within the global context described above and promote new ways of thinking about local and international activities that have the potential to improve wellbeing and health at the global level.

21.7 THE WAY FORWARD: CHALLENGING BUT POSSIBLE 21.7.1 Global health ethics In 1971 it was proposed that “global ethics” become a discipline representing a link between biology, ecology, medicine and human values as essential for the survival of human beings and other animal species (Potter 1971). However, a more limited perspective on bioethics has evolved, which has largely focused on biomedicine. With the recrudescence of new infectious diseases, a new bioethics discourse emerged in the field of public health. Almost in tandem, concerns about climate change, environmental degradation and global economic crises, all with adverse effects on global health, have led to an even broader discourse on global health ethics (Benatar & Brock 2011). Lowry (2009) has contributed arguments about “political” and “humanitarian” approaches to global health ethics that could enable us to deal rationally with threats to global health as systemic challenges. Serious reflection on ethical concerns about global health, and extension of the discourse on ethics and human rights towards a more comprehensive approach, requires realisation that health, human rights, economic opportunities, good governance, peace and development are all intimately linked within a complex interdependent world (Benatar, Gill & Bakker 2011; Benatar 2011). The challenges we face in the 21st century are to explore these links, to understand the associated power-relationship implications, and to develop political processes that could harness economic growth to human development, narrow global disparities in health and promote peaceful coexistence (Benatar & Brock 2011; Gill & Bakker 2011).

21.7.2 Global political economy and sustainability Another starting point for change is to acknowledge the harm of the current global economic order, and to place greater emphasis on dealing with the social and societal determinants of health and disease in whole populations. To do this effectively will require addressing the upstream causes of the wealth and health disparities, which can only be achieved if the political will can be mustered to “develop sustainability”. Unless we can face up to the reality of the future and what is required to deal with this intelligently, we are doomed to perpetuate old solutions (that do not work) for new problems which we do have the ability to address constructively. It must surely be clear (especially as the global economic crisis deepens) that the solution to global health must lie in reconstructing a fairer and more sustainable global economic system that could allow appropriate social development, improved living conditions and basic healthcare provision globally. As noted previously (Gill & Bakker 2011), there is no shortage of resources to improve health globally – only a lack of political will to organise our lives and healthcare systems to enable more people globally to lead healthy and peaceful lives. The challenge is enormous and it will take considerable scholarly research and political advocacy to advance this complex new global agenda (Gill & Benatar 2016). The 288

work of Anthony Atkinson and his protégés (Atkinson 2015; Piketty 2013; Zucman 2015) as well as a detailed response to The Lancet–University of Oslo Report (Gill & Benatar 2016) provide some insights into the potential for making significant progress through changes in the structure and functions of the global political economy. These are tough calls as they challenge the complacency of those who live privileged lives, and call for moral imagination and courageous leadership (Benatar 2005; Benatar et al. 2009; Gill & Benatar 2016).

21.8 CONCLUDING REMARKS Changing the paradigm within which we live from 20th to 21st century thought and action is the challenge. A framework that combines understanding of global interdependence with enlightened longterm self-interest has the potential to produce a broad spectrum of beneficial outcomes, especially in the area of global health. An extended public debate, promoted by building capacity for this process through a transdisciplinary approach to global health, ethics in education and daily life, together with knowledge and utilisation of the political sites for action, could be the driving forces for such change.

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CHAPTER 23: New and emerging technologies in healthcare in the 21st century (Author: Keymanthri Moodley, Anton van Niekerk, Collet Dandara, Keleabetswe Mpye, Alice Matimba & Jacquie Greenberg) By the end of this chapter you should be able to: • • • • •

describe the recent advances in medical science understand the ethical challenges that accompany such advances critically discuss the role of governments in ensuring responsible implementation of scientific advances in healthcare debate the value and boundaries of such advances in medical science discuss such advances in the context of global equity.

23.1 INTRODUCTION The 21st century has ushered in remarkable developments in medical science – gene editing and DNA manipulation via synthetic biology, creation of three genome babies to avert mitochondrial disease, clustered regularly interspaced short palindromic repeats (CRISPR) babies and synthetic organs, personalised medicine via pharmacogenomics, genome-wide association studies, cloning and biobanking. However, most of these new technologies are fraught with ethical concerns.

23.2 SYNTHETIC BIOLOGY Synthetic biology is an innovative, transdisciplinary, emerging field of study in which new biological systems are being designed and built. This exciting new field has emerged at the intersection of biology, engineering and related disciplines to design chemically synthesised DNA that will give rise to organisms with unique or enhanced characteristics. Such advances have powerful implications for healthcare and the biological sciences in general. The potential for novel genomic research, enhanced drug development and managing diseases resistant to conventional therapy is enormous. In particular, the use of CRISPR-Cas9 and gene editing as a strategy for HIV cure in sub-Saharan Africa holds much promise. However, research in a field with such enormous potential also carries with it weighty ethical and social challenges. While broad ethical issues such as scientists “playing God”, biosafety and biosecurity have dominated global discussions on the ethics of synthetic biology thus far, the African continent has concerns linked to social justice in the context of gross inequities in global health and limited resources. Science translation and community engagement are also critical in a context where basic science is poorly understood and where complex science poses a significant challenge to authentic consent processes. It is now almost universally accepted that respecting the autonomy of research participants and communities requires intense public engagement. The cultural nuances in Africa add a unique dimension to the ethical concerns around synthetic biology, and create obligations to explore what the advances in this field will mean in various cultural contexts.

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Given the complex ethical and social concerns raised by synthetic biology, a multilayered governance approach will be imperative. Both self-regulation from within the scientific community and external regulation by independent boards (RECs) will be necessary.

23.3 NEW GENETIC TECHNOLOGIES The Human Genome Project (HGP) started in 1990 and was completed in 2003. It was an international effort led by the US Department of Energy and the National Institutes of Health (NIH). At the outset, agreement was reached to release all map and sequence data into the public domain. The sequence of three billion base pairs was determined. The largest gene has ten million bases. The function of 50 per cent of identified genes is still unknown. The significance of the HGP was that it provided a road map for all future genetic research. Of the annual budget, 3–5 per cent was set aside to address the ethical, legal and social issues that would arise as a result of this endeavour. This project became known as the ELSI Programme and is to date the world’s largest bioethics project. Research was conducted among the American public to identify ethical issues raised by the HGP. These issues related to privacy and legislation, minorities, race and genetics, genetic anthropology, and ancestry and gene patenting (Clayton 2003; McGuire et al. 2008). Genomics is the study of all human genes and gene products, and the study of human genetic variations.

23.3.1 Pharmacogenomics and precision medicine: the ethical, legal and social challenges of the application of new technologies Pharmacogenomics, a field that focuses on how human genomes influence patient drug response phenotypes, is a relatively new field that has taken human genetics by storm (Rabbani et al. 2016). Therapeutic drug medication has no doubt played an important role in the observed longevity of world populations (Matimba, Dhoro & Dandara 2016). Treatment is premised on the assumption that patients presenting with similar symptoms, or suffering from the same disease, can be managed with a standard dosage of treatment, the so-called one-size-fits-all model. However, despite all the celebrated advances of therapeutic drugs, the efficacy of prescribed drugs is still a challenge, ranging from 20 per cent to just around 60 per cent. What this means is that upwards of 80 per cent of patients receiving some therapeutic drugs are deriving no benefit from them. Unsafe, unwanted and ineffective medicines cost the healthcare systems a lot of money through unnecessary adverse drug reaction-associated hospitalisations (some leading to death), reduction in economic activity by individuals and reduced quality of life for patients. For example, in the US it is estimated that at least 100 000 people die from adverse drug events annually at a cost of nearly $40 billion (Ross et al. 2011). Pharmacogenomic profiling correlates drug-reaction phenotypes with genotypes: Genotype: specific set of genetic markers (SNPs)/ HLA-B 1502 Phenotype: for example slow metabolism of trial drug/Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with carbamazepine use HLA-B 1502 occurs almost exclusively in patients with ancestry in Asia, including India. In many of these countries, the risk of these skin disorders – SJS and TEN – occurring is about ten times higher than in Western Caucasian populations (1–6 per 10 000 new users), therefore screening for HLA B1502 is important in patients with Asian ancestry before treatment with carbamazepine is started. 291

There is an urgent need for new approaches for monitoring each patient’s health and response in treating them for any illnesses in a manner that “tailors” such intervention to that individual. In response to the above, in 2015 the president of the US announced the Precision Medicine Initiative, the aim of which is to change the way diseases are diagnosed and treated (Collins et al. 2016). At the core of this initiative, of course, is pharmacogenomics augmented by advanced genome characterisation technologies – tools to manage, store and analyse such generated data. In order to derive maximum benefit from this genome characterisation explosion, it is important that the public and physicians improve their understanding of genetics and what all these data mean. According to Collins et al. (2016), genetic information and the meaning of most of these variants will need to be well explained on some dedicated and well-curated websites as patients use the internet to research their health concerns. Precision medicine has evolved through the application of pharmacogenetics and pharmacogenomics. Whereas pharmacogenetics refers to effects of a specific gene or a few genes in the pharmacokinetics and pharmacodynamics of a drug, pharmacogenomics utilises analysis of variation in the entire genome on its influence on drug efficacy and toxicity, and this includes inherited and acquired mutations (Masimirembwa, Dandara & Hasler 2014; Kitzmiller, Groen, Phelps & Sadee 2011; Hansen, Brunak & Altman 2009; Relling & Evans 2015). Pharmacogenomics has only been possible recently through advances in genome characterisation, especially next-generation sequencing (NGS) technologies, which have now made it possible for one to read (i) an entire genome (whole genome sequencing; WGS); (ii) the coding genome (whole exome sequencing; WES); and (iii) genetic markers across the genome (genome-wide association studies or GWAS) (Rabbani et al. 2016). Pharmacogenomics has enabled the discovery of genetic markers that were sometimes never thought to play a role in some disease conditions. Unlike pharmacogenetics, which is heavily dependent on researchers’ knowledge of possible affected pathways, pharmacogenomics allows a hypothesis-free inquiry into possible target biomarkers. Whereas there has been limited understanding of mechanisms involved in susceptibility and drug-response dynamics in patients with complex disease conditions, the advent of pharmacogenomics has enabled identification of new targets/biomarkers. For example, in neurological conditions such as epilepsy, the use of pharmacogenomics has led to the discovery of different causes of mutations leading to discovery of new therapies (Striano et al. 2016). Whereas genome characterisation has become easier, phenotype harmonisation/curation is still a challenge. Many healthcare systems do not have electronic patient records, making it difficult to understand the progression of disease or drug responses among patients. However, despite all these challenges, preemptive genotyping of actionable inheritable variants will soon become part of optimising pharmacotherapy in patients using drugs with a high risk of toxicity. For example, pharmacogenetic screening of the human leukocyte antigen genes (HLA) is now recommended in the use of the antiretroviral drug Abacavir (Munger 2010). The US’s Food and Drug Administration (FDA) and other regulatory agencies across the world are continuously updating guidelines for use of genome-based therapies as more information is accumulated. Ethical, legal and social issues: incorporating pharmacogenomics into clinical practice Many people across the world are afflicted by different disease conditions for which the most common armament is therapeutic drugs. In the use of most medications, a proportion of the patients are refractory to treatment. For example, efficacy of treatments covers a wide range – 20 per cent in cancer, 292

70 per cent in epileptic treatment and nearly 30 per cent in psychotic patients – thus one of the ethical questions/challenges encountered in today’s empirical drug treatment is the proportion of patients who receive standard doses of indicated drugs without receiving any benefit from such treatment. In some cases, adverse drug events are a common occurrence (some resulting in hospitalisation) and these patients are billed through their health insurance for treatment of these events. Pharmacogenomics is seen as one of the solutions to the identification of patients not well suited to particular drugs. It should be remembered that inter-patient variability in drug response is due to interplay between genomic and environmental influences (Dandara et al. 2014), thus pharmacogenomics should be aided by other OMICS technologies, such as pharmacometabolomics which looks at metabolite and microbiome profiles. Indeed, drug-response profiles in patients with autoimmune diseases have already been shown to be influenced by the gut microbiome (Katsila et al. 2016). Genome-based prescribing premised around pharmacogenomics, whether aided by other sciences or not, has resulted in ethical issues. There are four main issues in patients that raise ethics-related concerns, and these are (i) genotype; (ii) phenotype; (iii) disease; and (iv) drug(s) (see Figure 23.1), which is supported by Striano et al. (2016). GENOME ISSUES Whereas in pharmacogenetics, genetic characterisation involves looking at a specific position to infer effect, pharmacogenomics involves sequencing an individual’s whole genome, whole exome or millions of targets across the genome. In pharmacogenetics, the tests only give an answer with respect to one or a few positions. However, for pharmacogenomics there is a lot of genomic information that comes with the characterisation (Rabbani et al. 2016). It is possible to look at other positions in the genome even though they are not related to the disease in question. These are called incidental findings. The ethical dilemma associated with incidental findings revolves around whether these should be reported or not. Incidental findings may not be related to the drug/disease combination being studied, but are still important in the disposition of other unrelated drugs. Incidental findings may relate to genetic conditions with no current intervention/management. At the end of the day, one has to consider whether an individual’s right to autonomy is primary and should be the most protected ethical requirement balanced against society’s right to efficient and effective care. In addition to incidental findings, genome characterisation creates issues associated with shared genomes. All individuals share their genomic sequences with members of their families. After genome sequence characterisation, can individuals withhold their findings from family members? Can they be forced to share their genome information? What choice do relatives have in terms of incidental findings? Suppose the incidental findings point to a particular genetic predisposition to diseases. Some family members may choose not to know. What would the effects on health insurance be if insurers come across clients’ genomic information through their genomic relatedness? Would this affect their level or cost of cover? In response to some of these issues, the US has come up with several Acts under the Health Information Technology for Economic and Clinical Health Act (Vogenberg, Barash & Pursel 2010). Debates are advancing on ownership of the genomic sequence information and what this can or cannot be used for. Focusing on the drugs, the ethical issues relate to the cost incurred by patients on drugs that are not effective. Pharmacogenomics and precision medicine allow patients to avoid ineffective and toxic medication, thereby reducing costs for the healthcare system and for patients who will not have to 293

spend funds on unnecessary treatments. However, the cost of precision medicine should not create “orphan” patient populations simply by out-pricing poor individuals. Most of the ethics issues associated with implementation of pharmacogenomics are possible to resolve with enabling statutory regulations as well as improving the public’s knowledge of genomics and participating in genomics research in an informed manner. Pharmacogenomics promises a new future for those refractory patients, and allows physicians to reduce “harm” to patients. It is our hope that more focused studies on pharmacogenomics will attend to the ethical, legal and social issues raised here.

The circle represents the patient as seen from different dimensions – his or her genome (including microbiome), phenotype, demography and drugs he or she is taking at the same time.

23.3.2 Genome-wide screening New genetic technologies are being developed and implemented every day. In this section, direct-toconsumer testing (DCT) as a general concept as well as genome- wide screening based on genome-wide association studies (GWAS) as a research- based option will be briefly addressed. Over the past few years, the establishment and accumulation of DNA banks from India and Brazil have, among other things, made it possible to undertake GWAS. More recently, as part of the Wellcome Trust Case Control Consortium (2007), a GWA study of severe malaria in The Gambia was used to examine the usefulness and utility of GWA methods in Africa. According to Dimitrios Roukos (2008), from 2006–2008 there was an enormous increase in biomedical research endeavours towards the identification of genetic variation-based personalised management of complex diseases. Already, in excess of 100 new chromosomal regions have been identified by GWAS and over 165 novel DNA variants have been 294

identified that influence the risk of common human diseases and their clinical phenotypes (Roukos 2008). Genetic variations, which are merely differences in the coding and non-coding regions of our DNA, are what make each of us unique. Interestingly, such changes in our DNA, no matter how simple, can also contribute to our individual susceptibility to disease. However, despite huge initial optimism, the clinical utility of knowing about these risk variants is still under scrutiny and is often strongly debated (Roukos 2008). Another way that GWAS provide a powerful way of addressing the problem of complex diseases is that they have the potential to identify often very simple genetic changes determining resistance or susceptibility to common but complex conditions. Owing to the enormous cost of this type of research in the past, to date GWAS have mainly focused on the populations of affluent First World countries. Clearly there is now a strong case for greater scientific investment in GWAS relevant to the needs of developing countries (Parker et al. 2009). South Africa is one of the richest and most developed countries in Africa. However, developing countries, like South Africa, experience and share the global disease burden, and a major challenge is to develop better tools and more effective treatment strategies for disease prevention. Vaccines against HIV, TB and in particular malaria on the African continent are sorely needed. However, our limited understanding of the underlying mechanisms of disease, together with our current lack of knowledge about the concept of protective immunity, is a huge obstacle. The financial implications of this type of research have improved in the past few years, and there can be no doubt that the ultimate benefit of developing vaccines and ensuring effective treatment for specific individuals and particular populations far outweighs the initial costs of GWAS. One major area of concern that has emerged with this new research approach is the need to protect the rights of individuals and their communities, as these are the subjects of GWAS. Awareness has been raised regarding the development of appropriate processes for obtaining valid consent. Clearly the process of acquiring consent needs to be improved so that it is linked to and inseparable from the protection of and added benefits for all participants concerned (Reinhard 2007). Another area that has received a great deal of interest relates to the researchers and institutions in these developing countries where samples are acquired and generated from and provide the data for GWAS. Ways and means have been discussed and debated at length to ensure that subjects, when they participate in these new large collaborative networks that are needed to undertake this type of research, are not exploited and/or put at a scientific disadvantage. The role of data sharing is by no means new, and this is eloquently discussed by Parker et al. (2009) in their paper on the topic of ethical data release of this type of research, following GWAS that have been undertaken in developing countries today. Although people are often very interested in knowing their genetic profile in the hope that there is a way of preventing an inherited disease or avoiding the susceptibility to a common condition, the lay public are rarely equipped to understand these frequent but complex conditions. Several genetic companies offer genetic testing via the internet. The offering of unproven or non-validated genetic tests to the public should be considered to be irresponsible and not the way to convey medical information. Genes on the Web (or direct-to-consumer marketing of genetic testing) refers to the new era of personalised medicine, which Hunter, Khoury and Drazen (2008) seriously caution about being potentially misleading and difficult to interpret, and possibly not yet ready for “prime time” (Wolfberg 2006; Hunter et al. 2008). More 295

recently, Katsanis and Hudson (2008) urge that guidelines need to be available to assist clinicians and counsellors on how to advise patients who are considering this type of genetic testing. Dandara et al. (2013) provide recommendations for direct-to-consumer testing among South Africans. Kraft and Hunter (2009) then go on to ask the question: “Are we there yet?” as GWAS continue to lead to further elucidation and clarification of the biological pathways following the completion of the international HapMap Project and the development of new methods for genotyping individuals, including how to interpret and when to act on the results as they become more available. In conclusion, from what has been published to date the general consensus is that GWAS have not yet produced much useful clinical information and that possibly the information that the public receive following direct-to-consumer testing is likely to cause unnecessary alarm, which is potentially more harmful than of any immediate benefit.

23.3.3 Ethical perspectives on cloning and stem cell research Cloning is one of the most controversial new genetic technologies that have emerged over the past few decades. It is essentially a process of asexual reproduction, i.e. reproduction where offspring is produced without the fusion of male and female gametes. Furthermore, it is a kind of reproduction in which the genetic makeup of the clone (i.e. the reproduced organism) is, for all practical purposes, identical to its “original”, i.e. the cell/organism of which it is the clone or from which it was cloned. Cloning has been a long-standing process in agriculture, and is not morally controversial in that context. Every time a new plant is made to grow from the cutting of an original, we in fact encounter a “clone” of the original plant. The moral controversy of cloning is mainly generated by its (possible) applications in two fields of research: stem cell therapies and human reproduction. In both, cloning in the sense of somatic cell nuclear transfer (SCNT) could in principle be used. SCNT is a process used to create organisms that are genetically identical. This process entails the transfer of a nucleus from a donor adult cell (somatic cell) to an egg from which the nucleus has been removed. If the egg begins to divide normally as a result of external stimuli (e.g. electrical impulses), it is transferred into the uterus of the surrogate mother and develops like a normal embryo.1 Although there have been claims to this effect, successful cloning of a human being has not yet occurred. We shall see later that reproductive cloning, as well as research on it, is currently illegal in most countries. However, even if there are currently significant technical impediments to such a process, it is safe to assume that it will soon be possible. Up to the middle of the 1990s, scientists indicated that it would be very difficult ever to clone a mammal because of the smallness of the cells and other problems. Up to that point, only reptiles had been cloned successfully. It was therefore a great surprise when, on 22 February 1997, it was announced that a sheep named Dolly had indeed been successfully cloned by Scottish scientists. It is safe to assume that the technology for cloning humans is quite close at hand. Cloning, however, is much more pertinent to the current-day practice of stem cell research, which represents one of the most exciting prospects for innovative progress in the history of medicine,2 namely the prospect of being able to repair damaged tissues to correct the results of disease by means of “cell implants” which may initiate the regeneration of lost, damaged or diseased cells and tissues. Stem cells are those cells of the body “that can both renew themselves in their undifferentiated state as 296

well as differentiate into descendant cells that have a specific function (such as heart muscle cells, nerve cells, etc.)” (Okarma 2001). They are unique cells, and because they are not yet fully differentiated, they are able to develop into a variety of tissues. This normally occurs in the process of in vivo foetal development, and tissue and organ differentiation, as well as in the normal physiological process of the replacement of blood cells for example. The hope is that this can also occur in vitro. Whereas more conventional medication acts by replacing hormones or enzymes deficiently produced by diseased organs, or alters cell metabolism in a variety of ways, the stem cell therapeutic approach is fundamentally different: it will cause the growth of new healthy cells to replace damaged ones (Okarma 2001). Research has shown that unique characteristics of embryonic stem cells make them the preferred candidates for research and eventual therapeutic purposes; they are pluripotent (able to develop into many types of cells and tissues);3 immortal (able to continue dividing indefinitely without losing their genetic structure); and malleable (able to be manipulated without losing their function); and they express the enzyme telomerase, which allows cells to grow and divide (Holland, Lebacqz & Zoloth 2001: xviii). Because of these unique qualities, stem cell research may lead to a better understanding of foetal developmental abnormalities, tissue differentiation and organ development. The moral controversy about embryonic stem (ES) cells From the outset, stem cell research has been submerged in severe moral controversy. A fundamental moral objection that bioethicists, politicians, policymakers and even some scientists have raised against ES cell research is that their “harvesting” (an unfortunate term) from embryos implies the wilful “killing” of these embryos that have the potential to grow into fully-fledged human beings. This amounts, for many people, to the equivalent of abortion, the morality of which they generally do not accept. If research on human ES cells is therefore immersed in controversy, the first question to arise is why the research has to be on those cells and not on stem cells derived from other sources? There are indeed three potential sources of stem cells: the inner cell mass of in vitro fertilised pre-embryos (these cells are designated ES); the gonadal ridge of the aborted foetus (EG); and many adult bodily tissues, such as the heart, the liver and bone marrow, which is also responsible for the production of blood cells. In fact, most differentiated human tissues contain stem cells. While research on the utilisation of these cells in research and therapy has not been without some promise, there are sound reasons why this does not solve the dilemma, for either the ethicist or the researcher. Firstly, the therapeutic potential of nonembryonic stem cells is significantly inferior to that of ES cells. The levels of pluripotency are, for example, not the same. Secondly, non-embryonic stem cell lines are not “immortal”. Thirdly, nonembryonic (“adult”) stem cells are tissue specific, and usually reproduce only the type of tissue from which they have been harvested, although there is some evidence to the contrary (Holland et al. 2001: xvii). Finally, some adult human tissues such as myocytes (the contractile cells of the heart) contain no stem cells – only ES cells hold therapeutic potential for the regeneration of this type of tissue. Since it is not yet clear that EG cells have the same capacities as ES cells, we will restrict our discussion to the latter. Legislation Legislation explicitly forbidding stem cell research has been enacted in a number of countries, of which Germany and Italy are the most prominent. In countries such as the US and Britain, no such legislation 297

exists and stem cell research proceeds daily. In the US, however, objections to this research caused the Bush administration to prohibit federal funding for research on ES cell lines derived after August 2001 (Sandel 2004), a decision later overturned by President Obama. In South Africa, the National Health Care Act No. 61 of 2003 makes statutory provision for stem cell research. Article 57 of the Act states that: (1) A person may not – (a) manipulate any genetic material, including genetic material of human gametes, zygotes or embryos; or (b) engage in any activity, including nuclear transfer or embryo splitting for the purpose of the reproductive cloning of a human being. (2) The Minister may, under such conditions as may be prescribed, permit therapeutic cloning utilizing adult or umbilical cord stem cells. (3) The Minister may permit research on stem cells and zygotes which are not more than 14 days old on written application if – (a) the applicant undertakes to document the research for record purposes; and (b) prior consent is obtained from the donor of such stem cells or zygotes. Reproductive and therapeutic cloning The distinction between reproductive and therapeutic cloning presupposed by and addressed in this legislation is significant for the moral issue about stem cell research. There are no differences between the techniques that would be applied for either reproductive or therapeutic cloning if and when they ever become prevalent. In both cases, the nucleus of an ovum is replaced by that of a mature body cell in vivo, and the process of cell division is switched on mechanically. The resulting entity is, in principle, an embryo that could develop into a fully-fledged human being. The legislation forbids this technique when the explicit intent of the procedure is to “create” embryos for reproductive purposes. What is called “therapeutic” cloning in the Act is the same procedure, but with a different intent. In therapeutic cloning, an early dividing clump of cells is brought about by essentially the same technique, but with the explicit intent, not of creating an embryo for reproductive purposes, but of providing ES cells that are used for curative purposes, such as bone marrow transplants in cases of leukaemia where the patient’s original bone marrow has been destroyed by chemotherapy. Also, in the case of therapeutic cloning, the mature cell nucleus comes from the affected tissue of the patient to be treated, thereby preventing the possibility of the body’s rejection of the transplanted tissue extracted from or produced by the stem cells, since tissue emanating from stem cells that were harvested from the same body is, in more than 99 per cent of cases, certain to be a perfect genetic match.4 The way that reproductive and therapeutic cloning is thus distinguished in the mentioned legislation is not without conceptual problems, but the distinction does throw significant light on the way in which new reproductive technologies impinge on and affect our understanding of reproduction and the ethics of reproduction.

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It is remarkable that the moral controversy surrounding stem cell research is seemingly receding, due mainly to the latest technologies such as induced pluripotent cells (e.g. cells that can produce insulin) which are obtained without having to make use of embryonic stem cells. A researcher with the name of Yamanaka has, for example, imported genes into cells by means of retroviruses, thereby reprogramming the cells to start acting like embryos, even though they are not embryonic cells (Wikipedia 2016). Stem cells can thus be harvested from these reprogrammed cells without embryos having, at any point, to be involved. Mention can also be made of the work on disease development of Dr Melton of Harvard University (Park 2011). He has been able to change defective pancreas cells that cause diabetes by switching off the genetic memory of that part of the cell that causes the disease. Also in this way, sick cells are “reprogrammed” into healthy ones without requiring stem cells at all. As stated by Dr Melton: “The idea is now that you can view all cells, not just stem cells, as a potential therapeutic opportunity.”5 Arguments for and against stem cell research and cloning In spite of the fact that the moral controversy about stem cell research is receding because of the developments mentioned at the end of the previous section, we ought still to evaluate the most stringent moral concerns that were raised against the practice, also when it involved the use of embryos. In this respect, we have to point out the inconsistency of the arguments that strongly object to the loss of foetuses in stem cell research, but that do not at the same time object to both assisted reproductive technologies (ART) and, indeed, to “normal reproduction” by means of sexual intercourse and “normal” birthing. Let us, for the sake of the argument, accept that stem cell research has an inevitable number of experimental embryonic casualties. Would this be the only area in the field of human reproduction in which such casualties occur? And, if not, would it not consequently be inconsistent to lament or even renounce the loss of embryos in stem cell research, and yet accept it in other areas? The fact of the matter is that all forms of assisted reproduction such as in vitro fertilisation always result in the production of surplus embryos that cannot, for very good medical reasons, all be implanted into a patient’s uterus. There always are “spare” embryos that can either be cryopreserved for later use by the patient or donated to other women, or that have to be destroyed. Why, particularly in cases where destruction is otherwise inevitable, it would be morally acceptable to destroy these embryos rather than use them for research is not at all clear. Surely in this case the principle of beneficence supports research rather than destruction? So-called normal reproduction is essentially also characterised by the production of “spare embryos”. For every successful pregnancy that results in live birth, many embryos, perhaps as many as five, will be lost or “miscarried” (Harris 2004: 164). Anybody who consistently opposes the loss of embryos in research ought also to actively oppose embryo loss in assisted and normal reproduction. However, this hardly ever occurs.6 We shall, in closing, also consider a few arguments7 for and against cloning for purely reproductive purposes. We have seen that such cloning is illegal in South Africa, yet, as was shown in Chapter 1, what is legal does not always coincide with what is moral. Let us therefore consider a few of the best-known arguments on both sides in their own right. The first argument against cloning we shall consider is the one from unwarranted eugenics. The argument in this respect runs that cloning would create the opportunity for fostering the idea of super 299

races – if it does not actually create the opportunity for experimenting with such an idea, as happened in Nazi Germany (although the cloning technique was not available then). Other concerns are the possibility that people might be created for specific tasks,8 that egotists might try to replicate themselves,9 and that people might, as a result, be treated as mere commodities since they are able to be “produced” for purely functional purposes. The frightening scenarios often set up as possible consequences of cloning are indeed troubling and would represent something deeply dehumanising should they ever occur. The problem is that the possibility of these deformations cannot be put on the account of cloning as such, but much rather on the irresponsible uses to which it can be put by irresponsible agents. We must distinguish between something inherently evil and something which, when applied in a certain way, has evil consequences. Racism, black magic, paedophilia and child pornography, it is generally agreed, are inherently evil. Industry, motorcars and sex, however, are not, but they can become the source of much suffering and are therefore evil if applied or practised in ways that endanger, alienate or objectify other people, i.e. irresponsibly. Cloning, in turn, need not be inherently evil, but could, without doubt, be used to serve evil purposes, and that goes for most of the phenomena that characterise our lives in the modern world. In addition, we ought to be aware of the problems related to distinguishing between eugenics, therapy and simple education. Many procedures other than cloning clearly have a eugenic intent. These include prenatal and preimplantation screening, egg donation, sperm donation, surrogacy, abortion and human preference in choice of sexual partner, not to mention ordinary efforts to raise, discipline and educate a child. Note also the following case, discussed by Holtug (1998), illustrating the problems related to distinguishing between eugenics and therapy. Consider the following case Case study 23.1 Jane is infected with HIV. Her immune system is starting to give in and she is about to develop AIDS. Fortunately, there is a new kind of gene therapy available – call it therapy A – that will boost her immune system and bring it to normal so that she will in fact never develop AIDS. By performing the therapy, we are correcting her immune system. Now consider Helen. She has not yet been infected with HIV, but she is a haemophiliac and, since blood reserves at the hospital have not been screened for HIV, we know it is only a matter of time before she is infected unless she receives a new kind of gene therapy – call it therapy B – that will make her immune. (Unfortunately, therapy B only works on haemophiliacs, so it cannot be used on Jane.) By performing the therapy, we are enhancing her (or her immune system), since we are giving her a desirable property people do not normally (or naturally) have (Holtug 1998: 211). COMMENTARY From this example it is clear that the distinction between therapy and eugenics is often highly problematic, so that eugenic intent cannot that easily be defended as a ground for opposition to biomedical and genetic technology. That said, two remarks of caution ought nevertheless to be added:

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Genetic research has been abused in the past, and it is not inconceivable that it might happen again in future. If such a technology is ever used for human reproduction, the greatest caution regarding its control and the prevention of abuse is therefore called for. Genetic research tends mostly to offend the communities of disabled people, since it is often interpreted as a demonstration of intolerance towards them and as the pursuing of an arbitrary ideal/norm of what it means to be a person and lead a meaningful life. We ought to be sensitive to this fact. While the treatment of genetic disease does not necessarily imply intolerance towards the existence of people suffering from it, the interaction with the community of (genetically) disabled people ought to be conducted with sensitivity and with as much information as possible. We have now looked at an often-raised argument against reproductive cloning. Let us now in turn look at a strong argument in favour of it. This is the argument from reproductive or procreative autonomy. The idea of procreative autonomy has been developed by Dworkin in his books Life’s dominion (1993) and Freedom’s law (1996). According to this doctrine, people have a right to control their own role in procreation unless the state has a compelling reason for denying them that control (Dworkin 1993: 148). The argument then runs that this right includes the freedom to clone one’s own genes. Dworkin draws on the implications of different amendments to the US constitution in support of this argument. The practices that result from the exertion of this right might well offend other people, but according to Harris, who supports Dworkin on this point, that is a price “we should be willing to pay in order to protect freedom of choice in matters of procreation” (Harris 1997: 359). The right to procreative autonomy, in other words, is seen as a radical implication of a “genuinely democratic culture”, and must be respected in spite of the costs it sometimes incurs, such as imprudent choices on the part of those who exert it. In this sense it seems to be analogous to the importance of adhering to rights such as habeas corpus, in spite of situations where public interest might well be better served by detaining a suspect without trial for longer than 48 hours. Democracy, in order to flourish and yield its true benefits to society, has a price that we must be willing to pay. Dworkin’s arguments suggest that “human dignity, and indeed democratic constitutions may be compromised by attempts to limit procreative autonomy, at least where greater values cannot be shown to be thereby threatened” (Harris 1997: 359). The most common concern about reproductive cloning, and thus an argument against it, has to do with safety concerns and the concomitant risk of detrimental genetic effects. There are fears of damaging the DNA in the process of cloning, resulting in unforeseen mutations. There is also the very real concern about the possible detrimental effects of the premature ageing of the clone, since the nucleus of an already differentiated body cell is used to initiate the process. Concerns about the safety of this technique therefore stand at the forefront of the National Bioethics Advisory Commission in the US’s report recommending the banning of research on human cloning. The counterquestion in this regard is whether the fact that a procedure is risky also makes it immoral. That does not necessarily seem to follow. The first heart transplant was clearly very risky and the patient died within a few weeks, but few of us will nowadays conclude that that made the act immoral! While one can have full sympathy with the fact that policy makers are rightfully cautious of cloning, the prudent policy adopted towards it at this stage does not clarify the morality of cloning sufficiently. Another pertinent question is how possible detrimental genetic effects of the procedure are ever to be established if the research is not allowed to continue. However, from the perspective of the policy maker, it is understandable that, as long as these concerns are expressed, particularly from within the 301

ranks of the scientific community itself, there will be great hesitation in encouraging this kind of research. Concluding remarks on cloning: In conclusion, judging by the public response to the Dolly cloning, and its possible implications for humans, one gets the distinct impression that most societies in the world currently are simply not ready to accept reproductive cloning as a practice. Those dead against it – for good or for bad/trivial reasons – have been pretty successful in fuelling reasonable and unreasonable fears in the population at large. Those in favour have failed to adequately motivate cloning as a viable reproductive technique. Are the problems with “normal” reproductive techniques so insuperable – particularly given the immense progress lately made in the areas of infertility treatment and IVF – that our current situation really warrants cloning? If the answer to this question is positive, the proponents of the procedure need to realise that a lot of public persuasion still has to be done. That a public debate is required and must be encouraged is something of which we ought to be in favour. If science and technology are generally good for us, as we are often – and rightfully – made to believe by scientists, the burden is on the scientists to convince a sceptical public that cloning does not cross a threshold that would be better left uncrossed for now.

23.4 BIOBANKING Human biological samples including blood and other tissue are central to clinical medicine and health research globally. A biobank is a prospective organised collection of high-quality human biological material and data that can be used by researchers to advance medical science to benefit humanity. Considerable heterogeneity exists in the field, and biobanks may range from small collections of diseasespecific blood and tissue samples to large-scale general population-based collections of blood and other tissue. Biobanks are located at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multidisciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Biobanking has become a core resource for medical research as it has enormous transformative potential. Research on biobank samples will enable the reduction or elimination of disease, reduce healthcare costs and enhance individual choice in the context of personalised medicine. Since the late 1990s, large biobanks have been established in resource-rich environments predominantly in the US and Europe – Iceland, Estonia and the UK in particular. African genetic diversity lies at the core of the controversy that surrounds data and sample mining. Our samples are highly sought after internationally, and the unidirectional flow of samples out of Africa has raised huge concerns about exploitation. Biobanking in Africa presents an unparalleled opportunity for researchers, pathology companies, the pharmaceutical industry and patients. The Human Health and Heredity Africa (H3 Africa) project funded jointly by the National Institutes of Health (NIH) and the Wellcome Trust, seeks to develop scientific capacity in Africa by encouraging African scientists to develop biorepositories in various African countries, including South Africa. Several bioethical, scientific and management challenges lie at the core of biobanking. It has become evident that trust in health researchers is waning globally and this is acutely expressed in resource-poor environments. This crisis in trust has resulted in the erosion of the legitimacy of biobanking and has been fuelled by a history of exploitation in medical research that takes advantage of the vulnerabilities of developing-world communities. Rapid advances in genetic and genomic research require large volumes of biological samples, but also exacerbate vulnerability as they raise concerns about data privacy and discrimination 302

based on genetic risk and susceptibility. The growing trend of commodification of health and commercialisation of new technologies in the absence of benefit sharing is eroding trust. Individual informed consent is time consuming and often impractical. Applying principles of liberal individualism is counterproductive. However, we may need to start here to build trust. Ultimately, in keeping with African philosophical underpinnings, the notions of Ubuntu – reciprocity, solidarity and mutual interdependence – are becoming increasingly important in biobanking.

23.5 CONCLUDING REMARKS In this millennium, several emerging technologies are drastically changing the face of healthcare. In some respects, these technologies will improve the quality of life, but in others they may prolong the quantity but not necessarily the quality of life. Most of all, they will bring with them complex ethical challenges. While we embrace the advances in medical science, we need to tread cautiously in terms of the extent to which medical professionals “play God” in creating new life forms or in manipulating DNA to eliminate disease. Although these technological advances have good intentions, off-target effects are possible and unintended consequences may result in more harm than good. At this point it is important to reiterate the foundational principle of medical ethics – first do no harm.

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