SHS/EEP/Bio-core/2007/01

ETHICS EDUCATION PROGRAMME

Bioethics Core Curriculum Proposal

Division of Ethics of Science and Technology Social and Human Sciences Sector UNESCO

Version 1.0 (DRAFT) Last Modified: 1 March 2007

TABLE OF CONTENT
Core Curriculum Content Course Learning Objectives UNIT 1: What is ethics? UNIT 2: What is bioethics? UNIT 3: Human Dignity and Human Rights (Article 3) UNIT 4: Benefit and Harm (Article 4) UNIT 5: Autonomy and Individual Responsibility (Article 5) UNIT 6: Consent (Article 6) UNIT 7: Persons without the capacity to consent (Article 7) UNIT 8: Respect for Human Vulnerability and Personal Integrity (Article 8) UNIT 9: Privacy and Confidentiality (Article 9) UNIT 10: Equality, Justice and Equity (Article 10) UNIT 11: Non-Discrimination and Non-Stigmatization (Article 11) UNIT 12: Respect for Cultural Diversity and Pluralism (Article 12) UNIT 13: Solidarity and Cooperation (Article 13) UNIT 14: Social Responsibility and Health (Article 14) UNIT 15: Sharing of Benefits (Article 15) UNIT 16: Protecting Future Generations (Article 16) UNIT 17: Protection of the Environment, the Biosphere and Biodiversity (Article 17) 3 4 7 14 21 24 31 35 42 48 52 58 62 67 72 76 83 99

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CORE CURRICULUM CONTENT

Units 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Title What is ethics?* What is bioethics?* Human Dignity and Human Rights (Article 3) Benefit and Harm (Article 4) Autonomy and Individual Responsibility (Article 5)** Consent (Article 6)** Persons without the capacity to consent (Article 7)** Respect for Human Vulnerability and Personal Integrity (Article 8) Privacy and Confidentiality (Article 9) Equality, Justice and Equity (Article 10) Non-Discrimination and Non-Stigmatization (Article 11) Respect for Cultural Diversity and Pluralism (Article 12) Solidarity and Cooperation (Article 13)*** Social Responsibility and Health (Article 14)*** Sharing of Benefits (Article 15)*** Protecting Future Generations (Article 16)**** Protection of the Environment, the Biosphere and Biodiversity (Article 17)**** TOTAL HOURS Hours (60 mins) 2 2 2 2 1 2 2 1 2 2 2 2 2 2 2 1 1 30

Content Note

* Units 1 and 2 are tied together. ** Units 5, 6, and 7 are tied together. *** Units 13, 14, and 15 are tied together. **** Units 16 and 17 are tied together.

COURSE LEARNING OBJECTIVES

General Objective: Students should be able to apply the principles of the Universal Declaration on Bioethics and Human Rights Specific Objectives: 1. Students should be able to recognize and distinguish an ethical issue from other issues 2. Students should be able to reason about ethical issues 3. Students should be able to explain the difference between medical ethics and bioethics 4. Students should be able to differentiate bioethics, law, culture, and religion 5. Students should be able to explain the principles of bioethics and how to balance these principles in practice 6. Students should be able to explain the concepts of human dignity and human rights 7. Students should be able to understand the relevancy of these concepts in the context of bioethics 8. Students should be able to identify harms and benefits in health care settings 9. Students should be able to evaluate claims of harm and benefit in health care settings 10. Students should be able to make treatment decisions taking harms and benefits into account 11. Students should be able to explain the concepts of autonomy and individual responsibility and to understand their significance for the healthcare provider patient relationship 12. Students should be able to understand how to determine a patients ability to make autonomous and responsible decisions 13. Students should be able to explain what is 'consent', what is 'informed', and what is 'informed consent'; they should be able to define the principle of 'informed consent' 14. Students should be able to explain what the process of consent requires 15. Students should be able to explain how the principle of consent is applied in different interventions, research, and teaching 16. Students should be able to explain how exceptions to the principle can be justified 17. Students should be able to explain what is competence to consent 18. Students should be able to explain the criteria of competence to consent 19. Students should be able to explain how the criteria for consent are applied in different circumstances of treatment and research 20. Students should be able to describe the limits to the exercise of autonomy 21. Students should be able to explain the principle of respect for human vulnerability 22. Students should be able to analyse the interrelationship between present-day scientific medicine and human vulnerability and to illustrate the difficulties in this relationship with examples 23. Students should be able to specify the connections of the principle of respect for human vulnerability with the notion of personal integrity and with care ethics 24. Students should be able to explain why patient privacy and confidentiality should be respected 25. Students should be able to recognise legitimate exceptions to confidentiality 5

26. Students should be able to identify and deal with the ethical issues involved in allocating scarce health care resources 27. Students should be able to recognize conflicts between the health care professionals obligations to patients and to society and identify the reasons for the conflicts 28. Students should be able to explain the concepts of discrimination and stigmatization in the context of bioethics 29. Students should be able to identify different contexts and bases of discrimination and stigmatization and their implications 30. Students should be able to identify and deal with situations where exceptions to the principle can be justified 31. Students should be able to explain the meaning of culture and why it is important to respect cultural diversity 32. Students should be able to explain the meaning of pluralism and why it is important in the field of bioethics 33. Students should be able to explain what are the limits to the consideration of cultural specificities and how to deal with cultural diversity with respect to the fundamental principles of bioethics and human rights 34. Students should be able to explain the development of the notion of solidarity in different societies 35. Students should be able to describe the difference between solidarity as an instrumental and a moral value 36. Students should be able to give examples of solidarity in the context of health care and research 37. Students should become acquainted with the shared responsibilities of the state and various sectors of society in regard to health and social development 38. Students should understand the requirements of global justice and the notion of the highest attainable standard of healthcare as a right 39. Students should be able to explain that health status is a function of social and living conditions and that the attainment of the highest attainable standard of healthcare depends upon the attainment of minimum levels of social and living conditions 40. Students should be able to appreciate the urgent need to ensure that progress in science and technology facilitates access to quality health care and essential medicines as well as the improvement of living conditions and the environment, especially for marginalized segments of the population 41. Students should be able to analyze potentially exploitative social practices or arrangements affecting public health and recommend possible solutions 42. Students should be able to understand the need for ensuring that scientific knowledge contributes to a more equitable, prosperous and sustainable world 43. Students should be able to explain that scientific knowledge has become a crucial factor in the production of wealth, but at the same time has perpetuated its inequitable distribution 44. Students should be able to explain the reality that most of the benefits of science are unevenly distributed among countries, regions and social groups, and between the sexes 45. Students should be able to analyse efforts that have been undertaken at various levels to promote the sharing of the benefits of scientific knowledge and research and to explore novel 6

initiatives that may be undertaken 46. Students should be able to identify and assess potentially undue or improper inducements in different research settings/situations 47. Students should be able to explain the principle of protecting future generations 48. Students should be able to evaluate the possibilities and difficulties in the application of the principle in practical settings 49. Students are able to explain how bioethics is related to environmental issues 50. Students are able to analyse environmental issues from enthropocentric, biocentric and ecocentric ethical perspectives 51. Students should be able to describe what is sustainable development

UNIT 1

Title What is ethics?

Unit Learning Objectives 1. Students should be able to recognize and distinguish an ethical issue from other issues 2. Students should be able to reason about ethical issues Outline of the Syllabus 1. What is specific about ethics: The moral point of view a. The universal experience of duty b. Moral experience is universal, but moral contents are in many cases different throughout time and space c. Universality and variability of human morality d. The goal of ethics e. Moral statements 2. Facts, values, and duties a. Three types of judgements. i. Descriptive statements or fact judgements ii. Evaluative statements or value judgements iii. Moral judgements or prescriptive statements b. Different, but not independent 3. An ethical method of reasoning a. First step: Fact deliberation i. The case. ii. Deliberation about the facts b. Second step: Value deliberation i. Identification of the moral problems ii. Choice of the main problem iii. The values at stake c. Third step: Duty deliberation i. Extreme courses of action ii. Intermediate courses of action iii. Best course of action d. Fourth step: Tests of consistency i. Test of legality ii. Test of publicity iii. Test of time e. Fifth step: Final decision

Teacher Manual 1. What is specific for ethics: The moral point of view a. The universal experience of duty We all consider that some things ought to be done and others avoided. In other words, we have a duty (obligation) to act in certain ways rather than others. The experience of duty is one of the most universal characteristics of human beings. There is no human language without the so-called duty-verbs, such as must, ought, shall, and also without imperative tenses, in order to express commands, like: do no harm!, fulfil your promises!, do not steal!, do not lie!. Similarly, there is no human society without some rules of conduct, either prohibitions or obligations. b. Moral experience is universal, but moral contents are in many cases different throughout time and space For instance, morality has been changing all over human history. Ten centuries ago, people had different moral values and behaviours than we have nowadays, and moral values are different today, depending on the place in which one is living, the language he or she speaks, the culture, the religions practised. Ask the students to provide examples. c. Universality and variability of human morality It follows from the previous statements that there are some universal and unchangeable elements in human morality, but others are historically conditioned and particular. Structurally, morality is always the same, but the contents are, at least to some extent, variable. In fact, human beings are changing continuously their moral contents. But at the same time, some moral duties remain unchanged throughout our life, because we think that some contents are quite universal. For instance, do not harm others, or tell the truth. d. The goal of ethics Ethics is a discipline, its goal being the analysis of moral experience. Ethics does not create morality or moral experience. The goal of ethics is much more modest: the intellectual analysis of this human experience, giving reasons for the universality of this phenomenon, and explaining at the same time the extent of moral variability. e. Moral statements Human beings express, communicate, and exchange human experiences through language. Statements are judgements, propositions or assertions that attribute some predicates to subjects. For instance, Peter is tall is a statement, This picture is nice is a second, and Do no harm to others is also a statement. But the statements are different. 2. Facts, values, and duties a. Three types of judgements From the previous examples, only the last one is a moral statement. i. The first one, Peter is tall is generally called a descriptive statement or fact judgement, because it is the description of a trait or fact, which everyone can perceive and verify: Peter is a person of more than the average height. ii. The second example, on the contrary, is not descriptive. Its predicate, nice, cannot be perceived by our senses, as the height or the colour of things. In fact, 9

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perceiving the same picture, people can estimate, appreciate or value this picture in very different ways, as nice or ugly, beautiful or awful. Therefore, these judgements are called evaluative statements or value judgements. iii. Finally, the third example, Do no harm to others is neither descriptive, nor evaluative. This judgement is imperative, and expresses a command, a duty or an obligation. It is a typical moral judgement or prescriptive statement, because it is stating that some things ought to be done, and some others must be avoided. Ethics, of course, deals with this third type of statements, the socalled moral judgements. b. Different, but not independent These three levels have important differences. But they are not independent. They are articulated as three links or rings of a chain, or better, as three steps or levels of a stairs. At the lowest level are facts, defined as perception data. Values are supported by facts: for instance, if we do not see a picture, we cannot say if it is beautiful or not. Values are always supported by facts. Values are attributes of things, and things are always perception data. Finally, the third level, duties, is supported by the second, by values. Our duty is always the same: to promote the realization of some values, and to avoid the implementation of others. And because values are also dependent on facts, it follows that our moral duties are the fulfilment of values, which at the same time are dependent on facts. Therefore, in order to define a duty, it is necessary to proceed by analyzing first of all the facts of the case; second the values at stake, in order to establish in the third place the actual duties in this particular case. This is, therefore, the way of analyzing an ethical conflict. An ethical method of reasoning Decision-making and ethics Ethics is a practical discipline. This is another difference with the other two previous types of judgements. This is the reason why verbs in the other types of statements are generally in indicative tense, while prescriptive statements use frequently the imperative one. The goal of ethics is to take right decisions, and in order to do that, it is necessary to go step by step, analyzing, first, the facts of the case, second, the values at stake, and third, the duties. a. First step: Fact deliberation i. The case The deliberation process begins always in the same way, with the presentation of a problem or a case, which is difficult from the moral point of view. This difficulty is perceived as a conflict, generally called moral conflict. Conflicts appear when a decision should be taken, and it is difficult to identify the best course of action, because in all possible actions important values are at stake, and selecting one implies the infringement of other compelling values. The goal of the ethical method of reasoning is always the same, to help people in order to solve these kinds of problems, taking wise or prudent decisions. ii. Deliberation about the facts In order to solve a moral conflict, the first thing we must do is to make a careful analysis of the facts of the case, lowering the uncertainty in this field as much as possible. This is not an easy task, and it takes usually a lot of time. But at this point, the careful analysis of facts is basic if we try to do things well. For instance, a careful analysis of medical facts is essential in medicine in 10

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order to know the situation of the patient, the diagnosis, prognosis, and treatment. This is a very difficult task, with incertitude that we must reduce as much as possible, through the process of individual or collective deliberation. Nobody knows all possible facts involved in a situation. Our perception of facts is influenced by our education, cultural background, personal expertise and experience. We have been trained to perceive some facts, for instance, the medical ones, but we do not have the same sensitivity to perceive others, which other people, with other training, perceive easily and better. Therefore, we should analyze facts carefully, taking advice of other people when things are difficult. For instance, in medicine so-called clinical rounds often take place, in which physicians discuss the facts of a clinical case, in order to reduce their uncertainty about its diagnosis, prognosis, and treatment. Such deliberation can be organized in an ethics committee. Second step: Value deliberation i. Identification of the moral problems The analysis of a case starts when somebody thinks that he or she has a problem and thinks it is a moral problem. But if we analyse carefully any case, no matter what its content, we realize that many moral problems are present there. People ask about a problem, but this does not mean that this is the only problem the case presents. It is necessary, therefore, to identify and describe the different moral problems we are able to find in the case. At least we should know at any moment the problem we are discussing. If not, everyone will discuss a different problem, and deliberation will be impossible. ii. Choice of the main problem After the identification of all ethical problems at stake in the case, we must choose one among them, which is to be discussed in the next steps of the analysis. Problems should be discussed one by one. Only after the discussion of one can we begin the debate about another, and so on. If we mix different problems, reaching a conclusion will be impossible. In any case, we consider that the problem to be discussed first is, of course, that conveyed by the person who presented the case in step 1. This is the main problem, at least for him or her, and our duty now is to help him or her to reach a wise decision. iii. The values at stake We have been talking until now of problems, and moral problems. We have not given a precise definition of this expression. A moral problem is what is perceived as such by somebody, because, at least for him or her, it is a moral problem. Problems are always concrete, specific. They are not abstract. When someone has a moral problem, it is because he or she does not know how to take a right decision. We say that the person has a conflict. A problem is like a conflict. And if we analyse the kind of conflict, we will see that it is always a conflict of values. Therefore, the specific language of moral problems can be translated into the abstract and universal language of values and conflict of values. Values are special qualities. For instance, beauty is a value, life is another, as well as health, wealth, justice, truthfulness. Values are qualities that human beings think important. If they disappeared from the face of the earth, we would consider this a big loss. If we think of a world without life, or without justice, or truthfulness, or beauty, we can realize that these are important or positive values. There are, of course, opposite 11

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d.

values to them, as death, injustice, lies, ugliness. Our duty is always and necessarily to implement positive values, promoting them in our world. And conflicts, moral conflicts appear when the attempt to carry out a specific value infringes the fulfilment of another. In order to solve this conflict, the first thing to do is to identify the different values at stake; that is, to translate moral problems in the language of values and conflict of values. Third step: Duty deliberation A conflict of values can be solved in different ways, and our duty is to identify and choose the best one, that is, that which promotes best the fulfilment of positive values, or that infringes least upon the values at stake. Therefore, we must identify now the different possible courses of action of the case. And the easiest way of doing that is identifying first the extreme courses of action. i. Extreme courses of action In case of a conflict between two opposite values, which is the most frequent situation, the extreme courses of action will be the choice of one of these two values, with the total loss of the other. Naming the first value A and the second B, one extreme course of action will be to choose A losing completely B, and the other extreme course of action will be the opposite. In general, extreme courses of action are not the best, because they are very expensive in terms of values, losing completely one of them. ii. Intermediate courses of action Intermediate courses are all between both extremes. After the identification of the extreme courses of action, it is easier to find the intermediate. In any case, identifying the intermediate courses of action is not an easy task, as it requires a lot of time. The human mind is capable of identifying the extreme courses quickly, but it is less effective in finding the intermediate. Ethical views from many cultures point out that virtue is in the middle, which means that the best course of action is generally one of the intermediates. iii. Best course of action The goal of ethics is not merely to avoid what is bad, but to do the best. This is one of the differences between ethics and law. Law is trying to define limits to human conduct; on the contrary, ethics is looking always for the best. The goal of our analysis is, therefore, to find the best course of action, that which promotes best the fulfillment of values, or that infringes upon them less. Fourth step: Tests of consistency At the end of the analysis we have chosen one course of action as the best one, because in our view it promotes best or diminishes less the fulfilment of the values at stake. But in order to test the consistency of our choice, some additional tests are useful. i. Test of legality The first is the comparison of our choice with relevant law. Decisions can be at the same time moral and illegal, or legal and immoral, but generally moral decisions are legal. When they are illegal, we must know that implementing this decision can be penalized by law. ii. Test of publicity All of us are prone to take some secret decisions, which we would have not taken if we were sure they could be known by others, or could be made 12

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public. When a decision cannot withstand the test of publicity, we consider that it is not ethical. iii. Test of time Emotions appear suddenly in cases of conflict. They are sudden reactions of rejection or acceptance. They appear very often in case of moral conflicts. And because they are often profoundly unconscious and irrational, decisions taken in these situations have the risk to be unwise. Due to the fact that emotions often decrease their intensity quickly, the test of time makes us think for a moment if we would take the same decision if we had the possibility of waiting some hours or some days, that is, avoiding the emotional pressure of the present situation. If the answer is negative, the course of action we have chosen is likely unwise. Fifth step: Final decision The goal of this procedure is to take wise decisions. Practical wisdom is the moral virtue par excellence. Practical wisdom is the art of taking well-thought decisions. Well-thought decisions do not mean equal decisions. Two people can take two different decisions, or what is more, two opposite decisions, both being wise. And the opposite, two people can take the same decision, both being unwise. The goal of these procedures is not to reach universal consensus about the right solutions to the moral problems, but to promote wisdom, also in the case of diverse solutions.

Study Materials Case 1: Ethics and law A 17-year old young woman is brought to the emergency room with a septic abortion. She is living separately from her parents, from whom she is estranged and who live in a distant town. Local law requires parental consent if there is an abortion in a minor. Cases The patient is septic, blood pressure is stable, and antibiotics are started. The patient does not want her parents informed, but the practitioner is concerned about legal consequences if the patient is treated without parental consent. Readings Movie: 12 Angry Men 12 Angry Men (1957) is the gripping, penetrating, and engrossing examination of a diverse group of twelve jurors (all male, mostly middleaged, white, and generally of middle-class status) who are uncomfortably brought together to deliberate after hearing the 'facts' in a seemingly openand-shut murder trial case. They retire to a jury room to do their civic duty and serve up a just verdict for the indigent minority defendant (with a criminal record) whose life is in the balance. Video/Movie The jury of twelve 'angry men,' entrusted with the power to send an uneducated, teenaged Puerto Rican, tenement-dwelling boy to the electric chair for killing his father with a switchblade knife, are literally locked into a small, claustrophobic rectangular room on a stifling hot summer day until they come up with a unanimous decision - either guilty or not guilty. The compelling, provocative film examines the twelve men's deep-seated personal prejudices, perceptual biases and weaknesses, indifference, anger, personalities, unreliable judgments, cultural differences, ignorance and fears, that threaten to taint their decision-making abilities, cause them to ignore the 13

real issues in the case, and potentially lead them to a miscarriage of justice. Fortunately, one brave dissenting juror votes 'not guilty' at the start of the deliberations because of his reasonable doubt. Persistently and persuasively, he forces the other men to slowly reconsider and review the shaky case (and eyewitness testimony) against the endangered defendant. He also chastises the system for giving the unfortunate defendant an inept 'court-appointed' public defense lawyer who "resented being appointed" - a case with "no money, no glory, not even much chance of winning" - and who inadequately crossexamined the witnesses. Heated discussions, the formation of alliances, the frequent re-evaluation and changing of opinions, votes and certainties, and the revelation of personal experiences, insults and outbursts fill the jury room. Discussion After watching the video, a general discussion of its content will take place. The teacher should organize and conduct the debate. The goal of the discussion will be to see this movie as a process of deliberation, in order to take a wise decision about the case. One important point to be stressed is the difficulty of deliberating correctly, due to many constraints and biases, some psychological, other educational, characterological, etc. The first question to be asked for is why these twelve men are so angry. And the answer is because they have anguish. Anguish is the general reaction against psychological aggression. And we consider, in general, that everyone who argues against our opinions is assaulting us. This is the most important difficulty in the deliberation process: to assume that the own point of view is not absolute, that our reasons about something cant exhaust the matter and that the others, giving different or, also, opposite reasons, are not necessarily wrong, and can help us to progress in the analysis of problems. In order to take part in a true process of deliberation, it is necessary to have some intellectual modesty or humility, that is, the Socratic wisdom of knowing not to know. This is the only way to be capable of listening to the others and progress all together in searching the truth. Deliberation is a rational process of interaction, in order to take wise decisions. And it works well when the final decision is wiser than that we were prone to take at the beginning of the process. In the movie the change of opinion of quite all the participants is evident; the last opinion is also wiser than the first. This is the true test of consistency of a deliberation process.

Role play Group discussion Other

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UNIT 2

Title What is bioethics?

Unit Learning Objectives 1. Students should be able to explain the difference between medical ethics and bioethics 2. Students should be able to differentiate bioethics, law, culture, and religion 3. Students should be able to explain the principles of bioethics and how to balance these principles in practice Outline of the Syllabus 1. The birth of bioethics a. The coining of the word bioethics b. Bioethics as bridge between facts and values c. Bioethics versus medical ethics d. The idea of Potter e. Bioethics as global ethics 2. Health and disease as values a. Health and disease are facts as well as values b. The interrelation between facts and values c. Health identified with wellbeing 3. Principles of bioethics a. Health care decisions include facts and values b. The principles of the Universal Declaration on Bioethics and Human Rights c. Many principles have not been respected throughout history d. Paternalism and informed consent e. Conflicts between bioethical principles. Limits to the autonomy of patients f. Limits of justice and resource allocation g. Limits to paternalism 4. Ethics committees a. Previously, moral conflicts were scarce b. Nowadays, many principles need to be respected and they are often in conflict c. The occurrence of conflicts is not negative d. The main goal of bioethics is to manage moral conflicts e. To accomplish this goal, bioethics uses deliberation f. Bioethics committees are platforms for deliberation g. Different types of committees h. Ethics committees are not legal tribunals 5. Medical professionalism a. Professional ethics b. Changes in medical ethics c. The unchanging goal of professional ethics d. Professionals strive for excellence 15

Teacher Manual 1. The birth of bioethics a. The word bioethics appeared for the first time in 1970. It was coined by Van Rensselaer Potter, an American biochemist and professor of oncology at the McArdle Laboratory for Cancer Research at the University of Wisconsin-Madison (U.S.A.) for more than 50 years. b. Potter conceived this new discipline, bioethics, as a bridge between facts and values. During the second half of the twentieth century, he said that biological sciences had been increasing their knowledge and technical power continuously, but reflection about the values at stake has not progressed in the same proportion. Potter said that he coined the word bioethics using two Greek words, bos, life, representing the facts of life and life sciences, and thos, morals, referring to values and duties. c. The only profession dealing with life during centuries and millennia, especially with human life, has been medicine. But today there are many sciences and professions working in this field. Therefore, bioethics should not be confused with medical ethics, which is only one of its branches. The field of bioethics is as wide as the facts of life, and its study is divided in many branches, each one with its specificity: Ecological or environmental bioethics, Medical bioethics, Clinical bioethics. d. The idea of Potter, and in general of bioethics, is that not all what is technically possible is morally right, and that some control of our intervention on nature and environment, on animals and on human beings, is needed. The future of life and of mankind is at stake. e. Bioethics is the first attempt of thinking globally in ethics. In fact, one of the books written by Potter is titled Global Bioethics. All over its history, ethics have not had a global dimension. The widest criterion introduced in ethics was the Kantian principle of universality: Act only according to that maxim whereby you can at the same time will that it should become a universal law. But the German philosopher Immanuel Kant (1724-1804) probably understood universal in a very narrow way, as comprising only all the actual human beings. On the contrary, the idea of globalization includes not only all actual human beings, but also future generations (called virtual human beings), all other living organisms, and also nature, the environment. f. Global bioethics includes, therefore: i. All actual human beings See Units 5-15 ii. Future human beings See Unit 16 iii. All living organisms and the environment See Unit 17 2. Health and disease as values a. Health and disease, the same as life and death, are not pure facts, but also values. Usually, health and life are called values, and disease and death, disvalues. Many physicians, especially in the West, think that health and disease can only be defined as pure facts. Diseases, they say, are due to the alteration of some tissues or parts of the human body, which can be determined scientifically. Therefore, disease is a scientific fact, the same as the usual facts in physics or in chemistry. b. But talking about pure facts is always an oversimplification. There are no pure 16

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facts. Facts are always supporting values. We cannot perceive a fact without valuing it. Nothing is value-free. All is value-laden, also the scientific knowledge. The idea that the only real things are facts is a mistake inherited from the positivistic era. c. Health and disease are not only facts but also values. We think of health as a positive value, and disease as a negative one. These values can change without changing the facts that support them. Today it is usual to identify health with wellbeing. This is the core idea of the definition of health stated by the World Health Organization. People think today that they are ill when they feel some lack of wellbeing, even without any biological alteration. Because of this new conception of health values are important in the concepts of health and disease. Principles of bioethics a. Physicians and other health care professionals have always taken health care decisions, mixing facts and values, clinical facts with personal values. b. Our duties are always the promotion and implementation of values. The duty of promoting values is the origin of norms. When these norms are wide and general, they are called principles. The UNESCO Universal Declaration on Bioethics and Human Rights identifies fifteen bioethical principles: i. Human dignity and human rights ii. Benefit and harm iii. Autonomy and individual responsibility iv. Consent v. Persons without the capacity to consent vi. Respect for human vulnerability and personal integrity vii. Privacy and confidentiality viii. Equality, justice and equity ix. Non-discrimination and non-stigmatization x. Respect for cultural diversity and pluralism xi. Solidarity and cooperation xii. Social responsibility and health xiii. Sharing of benefits xiv. Protecting future generations xv. Protection of the environment, the biosphere and biodiversity c. Many of these values and principles have not been respected through history. For instance, physicians took into account traditionally their own values, but not the values of their patients. Patients are weak -they thought-, and therefore they are in need of direction. In fact, they are like children, in need of fathers or tutors in charge of conducting them and looking for their best interest or benefit. This has been the traditional value introduced by physicians in their decision making process. Today, this is considered inadequate, and called paternalism. d. Paternalism is a normal behavior that can be taken as morally right, when societies are very homogeneous from the point of view of values. This was the case in old times, and it is also today in many parts of the world. People in traditional societies shared the same values. When physicians, therefore, made medical decisions taking 17

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into account only their own values, they could suppose they were respecting also the values of their patients. But this situation has changed drastically during the last centuries. One of the reasons for this change has been the continuous mobility of people and the mix of different values, beliefs, and traditions in modern societies. There are many societies where physicians can assume that patients share their values. They, therefore, must ask patients for their values. This is the origin of the doctrine of the informed consent, opposite to the traditional paternalism of the medical profession. The moral principles here involved are the following of the previous list: i, iii, iv, vi, vii, and x. e. Professionals must respect prima facie the values of patients. But in some cases the preferred values of patients can not be obeyed by physicians, because they are in conflict with other bioethical principles. One very important duty of health care professionals is expressed by the traditional saying: do no harm. Medical interventions are risky, with important side effects, and many times they hurt people. The balance between benefits and risks is essential in order to determine when medical procedures are maleficent or not. A limit to the autonomy of patients is set by the moral principles listed with the numbers ii, ix, and xv. f. Another limit to the values preferred by patients is fairness in the access to health care and the distribution of resources. The growing technological development of medicine is increasing the price of health care to such an extent that individuals are incapable of paying their own bills. This has opened another set of moral problems, all of them related to justice, the right to have health care, and the fair distribution of scarce resources. The moral principles to deal with these problems are the following: viii, ix, x, xi, xii, xiv and xv. g. Our moral duty is not only not to harm others, but to help and benefit them. This is especially important for health care professionals since their goal is to do the best for people in need. This has always been the main principle of medical ethics. But there is an important difference between the understanding of this duty and the new one. Today, what is beneficial for patients and what is not cannot be determined only by health care professionals; it is also, and primarily, determined by patients. Ignoring this situation leads to paternalism. To act in the best possible way without paternalism: this is the new definition of the moral principles listed with the numbers ii, v, and xiii. Ethics committees a. The situation of present day health care is much more conflictual than any other before. Traditional medical ethics used to work with the moral principle of beneficence, understood in a paternalistic way. The only decision maker was the professional, and the only moral principle to be taken into account was beneficence. Therefore, the possibility of moral conflict was very remote. b. On the contrary, there are different moral principles and values to be respected in each specific situation. Often, these principles conflict among each other. There are potentially conflicts between all of them. c. The number of conflicts is not related to the high or low morality of a society, or of a profession. In fact, conflicts arise when people are entitled to decide and take part in decision-making processes. When only one person has the power to decide and the unique moral duty of all others is obedience, conflicts are quite impossible. Conflicts are part of human life, and they are as frequent as respect for human 18

5.

freedom and moral diversity increases. d. The problem is not the existence of conflicts; the problem is to ignore how they should be solved. This is the main goal of bioethics, to train people in the management of moral conflicts, in order to take wise decisions and, in this way, increase the quality of health care. e. In order to reach this goal, bioethics uses deliberation as the way of approaching and thinking about moral conflicts. People can work individually with this procedure, especially when problems are not very complex. But when conflicts are difficult, or when they involve many people, deliberation should be done collectively. f. This is the origin of the so-called bioethics committees. They are platforms for deliberations in order to take wise decisions and to make policy recommendations. There are different types of ethics committees, as described in the UNESCO Guides Establishing Bioethics Committees and Bioethics Committees at Work: Procedures and Policies: i. Policy-Making and Advisory Committees (PMAs) ii. Health-Professional Association (HPA) Bioethics Committees iii. Health Care Ethics Committees (HECs) iv. Research Ethics Committees (RECs) g. Each of these committees has its own characteristics, as described in the UNESCO documents. For instance, HEC committees do important work in clinical bioethics. They consist of physicians, nurses, social workers, and lay members, both men and women. Different backgrounds, expertise and experiences allow a better understanding of cases, enriching all the individual perspectives and facilitating decision-making. h. HEC committees are not judicial bodies with the responsibility of sanctioning wrong conduct and imposing disciplinary measures. This is one of the biggest differences between ethics committees and legal tribunals. The goal of ethics is not to compete with law, but to promote wise decisions among people and professional excellence. Bioethics does not look for what is legally right but for what is humanly best. The goal of bioethics is to promote excellence. Medical professionalism a. Professionalism refers to the skills or qualities needed to be a good professional. It is, therefore, directly related with ethics. The coding of professionalism is called professional ethics. b. Throughout the history of medicine, many changes have occurred in medical ethics. The influence of paternalism has decreased, to the same extent as respect for autonomy has increased. There have also been important changes related to access to health care services and the distribution of scarce resources. c. But there is one thing that has remained unchanged in professional ethics all over its history, which is the moral duty of professionals not only not to do harm but to do the best for their patients. This is a primary goal of professional codes of conduct which each professional is obliged to observe. d. Professionals must strive for excellence. They have in their hands the most valued things people have: life and health, and their duty is to do the best for them. 19

At the beginning of the Nicomachean Ethics Aristotle wrote: There is some end of the things we pursue in our actions which we wish for because of itself, and because of which we wish for the other things; [] clearly this end will be the good, i.e. the best. Then surely knowledge of this good is also of great importance for the conduct of our lives, and if, like archers, we have a target to aim at, we are more likely to hit the right mark. (Nicomachean Ethics I 1: 1094 a 18-26) Study Materials Case 1: Medical professionalism Dr. D.L. is the only doctor serving a small suburban community. Dr. D.L. is treating J.T., the 22-year old son of the T family, for active venereal infection, which J.T. says he probably contracted in his relationship with an exotic dancer who works in a nightclub in the nearby town. On testing J.T., Dr. D.L. has found no evidence that he has contracted HIV infection. When Dr. D.L.'s patient, Mr. M.A., is in the doctor's office for treatment, he informs Dr. D.L. that his daughter, aged 17, is to marry J.T. in two months' time, and asks Dr. D.L. whether there is any health information about J.T., who M.A. knows is a patient of Dr. D.L.'s, of which his daughter should know. Case 2: Double loyalty of the psychiatrist A child psychiatrist agrees to provide an expert opinion with regard to allegations of sexual abuse made by a six-year-old child. She submits her report to the judge after 3 months. During this work she notices that the child is the victim of great physical suffering, and so agrees to continue seeing the child, at the mother's request, for psychotherapy sessions. Six months later, she is summoned to court to give testimony regarding the affair for which she provided an expert opinion. She then realizes that she is, at that point, both expert witness and consulting doctor. Case 3: Conflict of interests A seventy-six year old very wealthy woman is affected with mild dementia. Her children call on her doctor complaining of her spending habits of giving liberally to members of a church cult, whom they think, are scheming to alight her of her wealth. They are worried about their rights to her inheritance and request from the doctor to declare her incompetent to manage her own affairs. The doctor dutifully advises his patient about the visit from her children and told her that he did not think that a psychiatric consultation was in order. The doctor himself was a member of the same church cult. Case 4: Conflict of interests A fifty year old psychiatrist hires a patient to clean her apartment. At the same time she is treating the patient for phobias with hypnosis after returning home in the evenings. The arrangement for her cleaning work was intended to provide a kind of payment for the treatment she could not afford otherwise.

Cases

Readings

References to codes of ethics and other policies of the World Medical Association and national medical associations and to recent statements on medical professionalism: http://www.wma.net/e/ethicsunit/professionalism.htm UNESCO, Establishing Bioethics Committees, Paris, Unesco, 2005 (http://portal.unesco.org/shs/en/ev.php20

URL_ID=1372&URL_DO=DO_TOPIC&URL_SECTION=-465.html) UNESCO, Bioethics Committees at Work: Procedures and Policies, Paris, Unesco, 2005 (http://portal.unesco.org/shs/en/ev.phpURL_ID=1372&URL_DO=DO_TOPIC&URL_SECTION=-465.html) WMA Medical Ethics Manual: http://www.wma.net/e/ethicsunit/resources.htm Check the materials enlisted in: http://endeavor.med.nyu.edu/lit-med/lit-meddb/filmtitles.html To conduct a session of a Hospital Ethics Committee Discussion about the description of the field of bioethics in Article 1 Paragraph 1 of the Universal Declaration on Bioethics and Human Rights: Ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions. Discussion about the definition of health stated by the World Health Organization (WHO). It states "health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" (WHO, 1946). Discussion about the duties of a father and of a boss, as described by Aristotle: There is no difficulty in distinguishing the various kinds of authority; they have been often defined already in discussions outside the school. The rule of a master, although the slave by nature and the master by nature have in reality the same interests, is nevertheless exercised primarily with a view to the interest of the master, but accidentally considers the slave, since, if the slave perishes, the rule of the master perishes with him. On the other hand, the government of a wife and children and of a household, which we have called household management, is exercised in the first instance for the good of the governed or for the common good of both parties, but essentially for the good of the governed, as we see to be the case in medicine, gymnastic, and the arts in general, which are only accidentally concerned with the good of the artists themselves. (Aristotle, Politics III 6: 1278 b 33- 1279 a 2)

Video/Movie Role play

Group discussion

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UNIT 3

Title Human dignity and human rights (Article 3)

Unit Learning Objectives 1. Students should be able to explain the concepts of human dignity and human rights 2. Students should be able to understand the relevancy of these concepts in the context of bioethics Outline of the Syllabus 1. Concepts of dignity in the history of ideas: a. Classical antiquity. b. World religions traditions. c. Modern philosophy (Pico della Mirandola, Thomas Hobbes, Immanuel Kant). d. Contemporary humanitarian law. i. The Universal Declaration of Human Rights. ii. The European Convention on Human Rights and Biomedicine. 2. Human dignity as an intrinsic value of the person as an agent capable (at least potentially or as a member of natural kind) of reflection, sensitivity, verbal communication, free choice, self-determination in conduct and creativity. a. Human dignity is an end in itself. b. Equality in dignity of all human beings. c. Respect and care. d. The interests and welfare of the individual are prior to the sole interest of society. 3. The diverse understandings of human dignity in different cultural moral codes (Buddhist, Confucian, Judaic-Christian, Muslim, communitarian, liberal) and different types of societies. 4. A persons dignity and rights entail others obligation to treat a person respectfully. 5. Ethical aspects of healthcare provider patient relations in regard to human dignity and human rights. a. The problem of paternalism. b. In treatment of children, elderly persons, and mentally handicapped individuals. c. In palliative treatment of terminal patients and patients in vegetative state. d. In treatment of embryos and fetuses. Teacher Manual 1. There is a number of concepts of dignity in the history of ideas: a. Classical antiquity. Common understanding of dignity as deserving of honour and esteem according to personal merit, inherited or achieved. In Ancient Greek philosophy, particularly of Aristotle and the Stoics, dignity was associated with human abilities of deliberation, self-awareness, and free decision-making. b. In many world religions human dignity is considered to be predetermined by the creation of human beings in the image of God; those who are weak in body and soul have dignity equal to those who are robust and sturdy. c. Modern philosophy: 22

2.

3.

4.

i. Giovanni Pico della Mirandola (1463-1494) : human dignity as an aspect of personal freedom; ii. Thomas Hobbes (1588-1679): human dignity as an embodiment of ones public worth; iii. Immanuel Kant (1724-1804): human dignity is a universal virtue, "unconditional and incomparable worth" determined by ones autonomy rather than origin, wealth, or social status. The basic principle of ethics is treating any other person always at the same time as an end, never merely as a means. This latter was considered by Kant as the actual basis for human rights. e. In contemporary international law, national constitutions, and other normative documents, human dignity is strongly connected with human rights. i. According to Art. 1 of the Universal Declaration of Human Rights (1948) all human beings are born free and equal in dignity and rights. The Declaration establishes human rights (like freedom from repression, freedom of expression and association) on the inherent dignity of every human being. ii. The European Convention on Human Rights and Biomedicine in Art. 1 declares protection of the dignity and identity of all human beings and guarantees everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine as its main purpose. The notion of human dignity expresses the intrinsic value of the person as an agent capable (at least potentially or as a member of natural kind) of reflection, sensitivity, verbal communication, free choice, self-determination in conduct, and creativity. a. Unlike material values, or financial prices, human dignity has no external equivalent; it is an end in itself. Unlike merit as an embodiment of publicly recognized personal achievements, a person is dignified as a human being as such. b. All human beings are equal in dignity irrespective of gender, age, social status or ethnicity. c. Recognition of a persons dignity presupposes active respect and carefulness for her self-worth and self-understanding. d. A society or a community should respect each of its members as a person or a moral agent on the basis of the notion of human dignity. This notion also requires that the interests and welfare of the individual are considered as prior to the sole interest of society, community, or any particular kind of publicly wholesome activity. The emphasis on the sole interest of science or society is important. It implies that because of his human dignity, the individual should never be sacrificed for the sake of science (as has happened in medical experiments during the Second World War) or for the sake of society (as has happened in totalitarian regimes). But sole also implies that there might be exceptional circumstances in which the interest of others or the community as a whole are so important that infringing upon the interests of individuals is unavoidable in order to save others or the community. An example is the threat of a deadly pandemic. In a comparative cultural view, human dignity is diverse in different moral traditions (for example, Confucian, Judaic-Christian, Muslim) and respected in various ways in different types of societies (traditional, modern, totalitarian, democratic). From the point of view of ethics, the persons dignity and rights are proved by others 23

obligation to treat a person respectfully, that is to cause no harm, not to abuse, to be fair, not to impose unwelcome models of personal good and happiness, not to treat her merely as a means, and not to consider the interests and welfare of the individual as subordinate to others interests and welfare, to the sole interest of science and society. 5. Healthcare provider patient relations are just one kind of human relations, presupposing all ethical requirements. a. However, historically these relations used to be considered as unequal. A physician was associated with an active role of decision-maker, providing medical care, taking responsibility. Hence, he or she was higher in status. A patient was associated with a passive role of recipient, being in need, not responsible for his or condition and, hence, lower in status. In this paternalistic model of healthcare provider and patient relationship the patient used to be in a dependent position. b. Actual inequality in the status of the healthcare provider and the patient may be aggravated in special cases when patients are children, handicapped individuals, elderly persons. Particularly risky are cases of patients who are mentally handicapped. c. Special attention in regard to human dignity and human rights is required in palliative treatment of terminal patients and patients in vegetative state. d. Though there is no consensus either in public or in the expert community concerning the ethical and legal status of embryos and fetuses, the latter should be treated with respect and care. The principles manifested in articles 4-15 of the Universal Declaration on Bioethics and Human Rights give a proper framework to respect patients dignity and rights and clarify the specific context of human rights in bioethics. Study Materials Cases Universal Declaration of Human Rights, General Assembly resolution 217 A (III) of 10 December 1948, http://www.un.org/Overview/rights.html. Convention on Human Rights and Biomedicine, Council of Europe: European Treaties. ETS No. 164, 04.IV.1997, http://www.iatp.am/hr/rus/europe/164e.htm. Human Dignity, The President's Council on Bioethics, Readings http://www.bioethics.gov/topics/human_dignity.html. A Guide to Patient Rights, http://pdcweb.mc.duke.edu/PatientRights/patientrights.html. Bioethics and Human Rights Links, http://www1.umn.edu/humanrts/links/bioethics.html. JME Online, http://jme.bmjjournals.com/contents-by-date.0.shtml. Video/Movie Role play

Group discussion Other

Is human dignity a useful or useless concept in bioethics and medicine?. Discussion on an article by Ruth Macklin, Dignity is a useless concept (British Medical Journal. 2003, No. 327 (20 December), pp. 1419-1420, http://bmj.bmjjournals.com/cgi/content/full/327/7429/1419.) Novel: The Death of Ivan Ilyich, by Leo Tolstoy 24

UNIT 4

Title Benefit and harm (Article 4)

Unit Learning Objectives 1. Students should be able to identify harms and benefits in health care settings 2. Students should be able to evaluate claims of harm and benefit in health care settings 3. Students should be able to make treatment decisions taking harms and benefits into account Outline of the Syllabus 1. What is a health benefit? a. Problems in determining what is a health benefit; this is not always related to disease states b. The WHO definition of health as a possible solution of these problems 2. What is harm? a. Similar problems of identifying what is harm b. Hippocratic injunction above all do no harm c. Distinction between positive and negative harm 3. How do we evaluate benefits and harms in practice? a. Dimensions of comparing harms and benefits in individual patients b. Significance of these dimensions for making treatment choices Teacher Manual 1. Begin by analyzing the various interpretations of health benefit proposed by the students. Various possibilities can be mentioned: a. relief of suffering b. care c. prevention of disease, illness, disability d. health e. enhancement f. psychological benefit 2. At first glance it does not seem to be problematic to identify health needs. We are all only too familiar with the common reasons we have for going to see our doctor. Perhaps we have an unexplained pain or we are short of breath or we simply feel dreadful and find we have no energy to do anything. We expect the doctor to diagnose some kind of problem associated with disease, either trivial or serious. We are told that we have an infection, or that our condition demands further investigations which will involve sophisticated detective work to determine whether we are developing a malignant tumour, or rheumatic joints or a stomach ulcer or whatever. There is an orthodox nosology to which doctors refer when conducting these investigations. It is tempting therefore to conclude that to be healthy is to be free from any of the diseases detailed in that list and being unhealthy is to suffer from one or more of them. Once we have determined the disease state of a person then, it seems, we have also identified their health needs. Absence of disease means no health needs and therefore no possibility of health benefits; disease means there is a need for treatment and the possibility of treatment leading to either a cure or the palliation of the effects of the disease, each of which counts as a health benefit. 25

3.

4.

A narrow concept of health Attractive though the above story is, it is only part of the truth. A cursory glance at the practice of medicine will show that health benefits are available to people who do not presently suffer from any disease. These are provided by prophylactic treatments or disease prevention programmes such as vaccination against whooping cough. To be protected from the onset of a disease clearly constitutes a health benefit. Indeed it has been argued by health economists that these are the cheapest forms of health benefits to achieve. Most people would also prefer that their health practitioners enable them to avoid suffering diseases rather than have to treat those diseases when they occur. However, conceding this point does not move us far from the disease model of health in that the range of health benefits is still exhausted by either the treatment or the avoidance of disease. If we look more closely at health care delivery we will see that non-disease conditions are also part of the remit of medicine and surgery. The most obvious treatments which go beyond the disease related conditions are bodily dysfunctions arising from traumas, such as broken legs and brain injuries. Restoring proper physical functioning by treating the results of non-disease events are clearly part of the remit of health care provision. But the practice of health care professionals might go far beyond restoring normal bodily functions in the face of such events. When such restoration is impossible, health care professionals might still have a role in providing health benefits to those who suffer impairments of function. For example, the provision of prostheses to people who have suffered the loss of arms or legs in accidents is doing nothing to restore normal bodily functioning nor to treat or ameliorate the affects of disease. It is to treat a social dysfunction insofar as the new limb enables its wearer to engage in a wider range of social activity and the affairs of life than would otherwise be possible. No-one would hold that this was not to provide a health benefit. Such an extension of the definition of health benefits demonstrates that simply widening the disease model of health to one related to physiological function is also inadequate. Here the social context of a physical condition becomes significant. Further reflection will soon bring us to a consideration of mental health problems. Only a very few people would assert that such problems always originate from or are explicable in terms of physiological functioning. Even though there has been vigorous debate amongst psychiatrists and philosophers about the application of terms like illness to mental conditions, it is generally accepted that many behaviours and psychological phenomena fall under the umbrella of health. Indeed mental health is a major segment of health care delivery. Whilst there are some advocates for physiological explanations of mental problems, including genetic determinists, most practitioners disagree. Indeed, to take an extreme example, even personality disorders which figure in the Diagnostic and Statistical Manual of Mental Disorders (DSM IV), are not so explained. If, for example, an apparent psychopathy can be explained by the existence of a brain lesion, a physiological explanation, then it is described as a pseudo-psychopathy. Discuss the WHO definition of health: a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity a. examples of a wider range of proper clinical activities can be used to demonstrate the narrowness of any disease oriented definition of health benefits b. the example of infertility constituting a health need can be employed to explore the evolution of the character of health intervention c. at the same time, the WHO definition is often criticized for being too wide; it is encompassing many situations that are not disease related and that can expand the area 26

5. 6.

7.

of work of medical doctors Given the apparently limitless extension of the boundaries of health and consequently of needs and benefits indicated above, can we find some kind of general description which would secure a manageable range of benefits for which health care should aim? The WHO, fully aware of the dangers of imposing narrow limits on the notion of health, has provided a definition which has been influential for many years. This definition certainly takes account of the extensions of health beyond the boundaries imposed by disease related and physiological dysfunction related conceptions. It takes the psychological and social dimensions of peoples conditions seriously. Insofar as this is the case the definition is valuable. However it is limited in its usefulness by the sheer immensity of the range of circumstances and conditions for which, by implication, health authorities should be regarded as responsible. These would include the benefits of the provision of adequate defence capabilities to provide for the security of the population of a country and for the benefits of the provision of education to a population. A later amendment includes the ability to lead a socially and economically productive life. However the amended definition remains open to the same criticism. In addition the amended definition might tempt us to consider that there are universal objective measures of health and consequently of health benefits. This would oversimplify the task of identifying and measuring health benefits. So how do we proceed when we want to identify a health benefit? General definitions of health tend to be either too wide or too narrow to fit all cases to be of much assistance. It might therefore be helpful to look at the arguments that have been made for and against the identification of a particular condition as a candidate for being a health need and for the identification of the relevant concomitant health benefits attaching to the treatment of that condition. Review the distinction between direct and indirect benefits (for example, the indirect benefit of participating in clinical trials) It will not be surprising to learn that the task of identifying harms in health care delivery suffers from the same difficulties as the identification of benefits. It is not necessary to labour this point and one example of this relationship should be sufficient. Let us imagine that a surgical procedure to remove an ovarian cyst is carried out successfully on a patient. In the course of the procedure one of her fallopian tubes is inadvertently damaged and scarred. This damage results in infertility. Has a harm been visited upon that patient? The answer to this question is that it all depends on the patient. If the patient considers that she has completed her family and that she will not want any further children, then the inability to conceive will not constitute a harm for her. Of course it might turn out that she will change her mind about this, given the possible circumstances which could develop in her life. In such an event she would come to consider that the surgical error did harm her. In other words we are obliged to consider the context of the surgical mistake in the life of the patient before we can determine whether it was harmful or not. The harm that is established in relevant cases, however, cannot be divorced from the kind of benefit which the provision or protection of fertility would constitute for the woman concerned. Proceed with analyzing the various interpretations of harm; ask the students to identify what can be harm in the health care setting, for example: a. physical harm b. psychological harm 27

c. moral harm (harm to interests, harm as unfairness, harm as disrespect d. social/economic harm (consequences for social role, stigmatization) 8. But there remain some interesting issues to consider around the question of identifying and avoiding harms in health care. If the Hippocratic oath which asserts the primum non nocere (above all do no harm) principle is to be adhered to in practice, how can any surgical procedure be attempted, or indeed any medication be prescribed, when we can never know with certainty what the effects in total of that intervention will be in a given patient? In another context the wound inflicted by the surgeon in an abdominal operation would constitute a grievous bodily harm. Similarly the administration of cytotoxic drugs in other situations than in treatments of malignant disease would constitute poisoning. What justifies them in surgery and chemotherapy is the net balance of benefit over the harm which the treatments inevitably involve. Indeed any clinical intervention has to be undertaken only after the completion of a risk of harm/likelihood of benefit calculation. If a patient does not stand the chance of benefiting overall from an intervention, then that intervention is not indicated for him/her. That is, where the risk of harm outweighs possible benefit, then the treatment is not indicated. These calculations are often very difficult to make for not only will the variety of perceptions of harm and benefit mentioned earlier come into play, but the empirical and conceptual uncertainties of the possible outcomes will confound the procedure. With respect to the former uncertainty it has been said that every administration of a drug is an experiment. How one patient will react will not always be a reliable guide to how another will react. One patient with the same disease as another might respond well to a drug whereas the other will remain unhelped. Or one might suffer unpleasant adverse events whereas the other will tolerate the medication well. Whilst there is hope that the new technology of pharmacogenomics will increase our levels of confidence in matching medicines to patients and remove much of the trial and error element of prescribing, it will never eliminate uncertainty. With respect to conceptual uncertainty we might consider the difficulties of making risk of harm/likelihood of benefit calculations in withdrawing or continuing intensive care treatments. In such circumstances is it the same to ask whether it can be of benefit to a patient to withdraw life prolonging treatment as to ask whether it can be harmful to continue life support where it precludes the possibility of a dignified death? We might well find that we cannot easily determine what can count as a harm or benefit in such cases. 9. In the ethics of Hippocrates, an important moral principle is above all do no harm; discuss this principle and answer the following questions: a. Can a physician avoid harm? b. What is the distinction between expected and unexpected harm? c. What is positive and negative harm? d. Who determines what counts as harm? 10. In health care practice it is important to evaluate benefits and harms a. explore the difficulties of measuring harms and benefits in individual patients, involving i. the assessment of degrees of harm and benefit ii. the incommensurability of harms and benefits iii. the social context of physical and mental suffering

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iv. the subjective nature of suffering b. treatment choices also have to be made among patients; here an assessment has to be made between harms and benefits for different patients. This will be particularly important for resource allocation; when time or material resources are scarce, different priorities can be selected; focusing on patients who are most in need because of the harm they are suffering or on patients for whom treatment will produce the greatest benefit. Study Materials Case No. 1: Treatment without consent Mrs.E.D. is a 69 -year -old retired bank manager. She has been suffering from poorly controlled diabetes for the last 18 years. For the last 6 months she has needed hemodialysis twice a week for end-stage renal disease. Three days ago, she was hospitalized because of an infected non-healing wound at the amputated stump of her left leg. Two days later gangrene set in. Following a meeting of her diabetologist, infectious disease specialist, surgeon and family it was decided to amputate. Her eldest son, a physician, agreed to the amputation but announced that no one should tell her about it. She would only be told that the wound would be "surgically cleaned". Last year when the foot was to be amputated, Mrs. E.D. refused to give her consent. They did it without her consent and after her initial anger for a few days, she appeared to understand the need and no longer blamed them. Her son anticipates the same reaction and feels informing her will only add more stress. Her husband and other children agree to the plan. Cases Other cases to be considered:

Amputee: better dead with 2 legs than alive with one Ovarian tube ligation during abdominal surgery without consent (future pregnancy dangerous for patient) Living organ donation (harm for one person, benefit for another) Enhancement Morphine treatment of pain (double effect) Clinical research: use of placebo for psychiatric treatment; phase I trials in cancer patients The duty not to kill Patient safety, medical mishaps/mistakes Whistle-blowing Experiments to inflict pain: video fragments about Milgram experiments

Readings Video/Movie Role play Group discussion

Discuss the case of infertility Formulate an answer to the following questions: a. Is infertility a health need? b. Are the benefits afforded by such treatment health benefits? 29

c. Should scarce health funds be used for providing treatments for infertility? Background For centuries the inability of couples to produce their own children was blamed on the female partner who was described as barren. We now know that in at least half of the cases of infertility the problem lies with the male partner rather than the female, and is usually connected to an inadequate production of sperm. This knowledge has come as a great relief to many women who suffered irrational guilt, anxiety and social disapproval for not being able to become mothers. But such a relief is a small comfort to them when nothing can be done to address the issue of their childlessness except artificial insemination. In limited numbers of cases women with disease conditions which caused their infertility could be treated for those diseases, or the results of them, and their fertility could be restored. Tubal surgery is still performed for this purpose. Such treatments enjoy limited success. But they also leave unhelped couples whose infertility is not explained and those whose infertility is due to their male partners problems. The technological breakthrough of in vitro fertilisation (IVF) in the late 1970s afforded clinical hope for these couples. Professor Robert Edwards (United Kingdom) has reported that by the year 2002 more than a million children had been born as a result of the use of this technology and that by 2012 he estimates that ten million people will be alive who were born by these means. But the provision of these services has been the subject of continued dispute amongst health care providers in numerous parts of the world. The problems can be seen to arise from the difficulties presented by the temptation to assume that health is fundamentally constituted by the absence of disease. This is clearly demonstrated in a comparison of the behaviour of a number of health providing authorities in the United Kingdom (in 1993). Half of them refused to purchase IVF treatments whilst the other half did purchase them. The reasons for their choices are illuminating. The predominant reason given by the non-purchasers of IVF services was that couples with unexplained infertility were not ill and that their infertility was not a disease. Even some of the purchasers gave reasons which also embodied the assumption of the need to relate the treatment to disease in that they purchased the services as a prophylactic designed to ward off the onset of stress and mental illnesses which often arise from infertility. Others paid lip service to the importance of social aspects of the condition but in such a way as to bar it from treatment. The view was that the condition of childlessness was a social rather than a health need. It is the case that the use of IVF does not really constitute a treatment of infertility as such but rather that of childlessness. This is because the treatment leaves the couple as infertile as they were before that condition was circumvented to achieve a pregnancy. But to disengage such physiological conditions from the context in which they occur, as these non-purchasers did, is a sure way to misidentify health needs and benefits. It is not difficult to make a case for regarding infertility as a health need in certain 30

circumstances and, hence, to regard its clinical circumvention as a health benefit. It is acknowledged by all that the condition is a source of much unhappiness and stress causing suffering for many couples. It is also clear that it constitutes a physiological dysfunction. The function of procreation is a fundamental physiological function at the species level. But it also an extremely important function at the personal level for the vast majority of people for whom living in and rearing families is a major constituent of emotional wellbeing. For the infertile couple who long for a child the dysfunction is socially debilitating. We have already noted that other dysfunctions such as the loss of limbs are standardly treated by health care professionals because of their socially significant consequences. So why not infertility or, rather, childlessness? Until the advent of IVF and the subsequent research on the early stages of human development and reproduction there was little that could be done to address the condition for most couples. Thus they could not then be said to have any need for clinical treatment. But now that we do have clinical means to circumvent their infertility and enable them to achieve a pregnancy in many cases they can be said to have a clinical need. This is tantamount to saying that they have a health need and that the successful bringing to birth of a child constitutes a health gain. It now begins to look as though the amended WHO definition of health does, after all, serve the purpose of identifying what shall count as a health benefit if we add the rider that where a clinical intervention can achieve the possibility of a socially productive life then it achieves a health benefit. Nevertheless this is not quite so. One might be tempted to read it as suggesting that wherever infertility is found then it represents a physiological dysfunction which calls for treatment. But this would be a mistake. It is possible to argue that no physiological condition in itself constitutes a health need. That is, until the condition is cast in the context of the life of the person or persons concerned we cannot know whether it is a health need or not. This is easily demonstrated in the case of infertility or childlessness. It is ironic that in many areas where IVF services are not accessible to patients contraceptive and sterilisation services are available. Of course in some cases sterilisation, for example, is thought to be an important clinical treatment to avoid the possibility of diseases unrelated to reproduction. But in most cases it is offered in order to produce a desirable biological dysfunction for the patient concerned. This is because for those patients their fertility is seen as constituting a health need and the state of childlessness, whether temporary or permanent, is seen to be a desirable condition. Thus in the process of identifying possible health benefits it is important to consider the particular circumstances of each patient in question in order to see whether the apparently general rule in fact applies. Other

31

UNIT 5

Title Autonomy and individual responsibility (Article 5)

Unit Learning Objectives 1. Students should be able to explain the concepts of autonomy and individual responsibility and to understand their significance for the healthcare provider patient relationship 2. Students should be able to understand how to determine a patients ability to make autonomous and responsible decisions Outline of the Syllabus 1. The concepts of autonomy and responsibility. a. Autonomy: i. Different levels (and notions) of autonomy. ii. Kantian and utilitarian approaches to autonomy. b. Responsibility: its different aspects and dual nature. c. Mutual correlation of autonomy and responsibility in ethics. 2. Collaborative character of decision making in medicine. a. Autonomy and patients right to self-determination in treatment. i. Autonomy and paternalism. ii. Autonomy as a right and an obligation. b. The patients right to refuse a healthcare providers recommendation. c. Special measures for protecting the rights and interests of socially and mentally disabled patients. 3. Patient autonomy and responsibilities in healthcare. The range of patient responsibilities. a. Evaluation of patients abilities to self-motivation and self-control. Teacher Manual 1. The concepts of autonomy and responsibility. a. Autonomy - as individual capacity for self-determination, independent decisions and actions. i. Different levels (and notions) of autonomy: 1. freedom from paternalistic interference, all the more so, from authoritarian dictates from any agent, specifically from the state; ones capability to self-determination; 2. capability to act on the basis of rational principles and rules accepted as adequate to ones understanding of good, personal dignity, and happiness; 3. capability to reflect upon these principles and rules, to influence their formation and transformation through public discourse. ii. In the Kantian approach, autonomy is an ability of deliberated self legislation; in the utilitarian approach, autonomy is decisional privacy. b. Responsibility is ones awareness of ones obligation to make decisions and to act appropriately on the basis of certain commitments (for example, towards an external authority, oneself, ones status, engagements, or agreements, respected others, accepted principles and rules). 32

2.

3.

4.

i. Different aspects of responsibility: 1. spontaneously obtained status or commitments (for example, responsibility of parents); 2. consciously accepted status or commitments (responsibility of an officer, professional, self-committed person); 3. legal responsibility. ii. Dual nature of responsibility: 1. responsibility as accountability, 2. responsibility as personal and universalizable duty. c. In ethics, the notions of autonomy and responsibility are mutually related. Responsibility manifests autonomy; there is no autonomy beyond responsibility; without responsibility autonomy turns into self-will. Collaborative character of decision making in medicine. a. In medical practice the principle of autonomy underlies the patients right to selfdetermination. As such the principle of autonomy has been recognized in opposition to paternalism, which has been essential for a traditional type of healthcare provider patient relationship. As a condition for the patients final decision, autonomy is not merely a right but also an obligation. The person is autonomous to make responsible decisions. b. A healthcare provider is an expert in medicine; a patient is an expert in her/his preferences, beliefs, and values. A patient may refuse a healthcare providers recommendation, but she/he cannot demand treatment beyond the present medical standards. In other words, patients have a right to refuse treatment but they cannot claim all treatments. Demanding or claiming treatment would violate the autonomy of the health care provider. c. Special measures are needed for protecting the rights and interests of persons who are not capable of exercising autonomy and making responsible decisions concerning medical care and treatment. Patient autonomy and responsibilities in healthcare. Patient responsibility has the following range: d. Responsibility for consequences of freely taken decisions. If individuals are really autonomous and if they decide in all freedom, they have to take responsibility for the consequences of these decisions. An example is engagement in risky behaviours. e. Responsibility to avoid infringement of another persons autonomy. A limit to the autonomy of an individual is the autonomy of other individuals. We cannot argue that as autonomous persons we have the right to limit the autonomy of other persons. If we want our free choices, and thus our values, to be respected, we are obliged to give the same respect to the free choices, and thus values, of others. An example is the debate on smoking; we are free to decide to smoke and endanger our own health, but we cannot endanger the health of others. In cases when a patients ability to autonomous and responsible decision-making is not clear, special steps should be taken to evaluate her/his abilities to self-motivation and selfcontrol, to keep commitments and loyalties, to make decisions while taking into account the given situation, the goals, and the remote results, to choose on the basis of reflective preferences and principles. 33

Study Materials Case 1: Informed consent A 25 year old man goes to see a psychiatrist for the first time. He is accompanied by his father, who says that his son has been acting strangely for the last three weeks. He is seen on his own by the psychiatrist, and the young man describes the aural hallucinations that he has been having for three weeks. His discourse reveals an intense, invasive mystical delusion, with no signs of being dangerous. The psychiatrist diagnoses an acute psychotic episode and fears that it marks the beginning of schizophrenia. He wants to start neuroleptic treatment as soon as possible and tells the patient so. He explains the benefit of swift treatment and the possible side effects of the medicine. The patient refuses the treatment, fearing that his intellectual capacities will be harmed. The psychiatrist then sees the patient again in the presence of his father, to explain the situation. At this point, the patient agrees to the treatment as he thinks that his father is the "emissary of God" and he must obey him. Case 2: Informed Consent A 42 year old Aboriginal woman with a diagnosis of residual schizophrenia is functioning well and is symptom free for many years. She was admitted with suicidal ideation in the context of an unplanned and unwanted pregnancy. She has two adult children, both of whom were removed from her care at an early age. She considered termination of pregnancy, although with overwhelming feelings of guilt: the thought of a new baby was reprehensible for her. Pregnancy was the result of a casual encounter with her cousin who is regarded as an elder in the Aboriginal community. The father of the unborn baby was unaware of pregnancy. She continued to think about termination and time became critical. The patient's mental health deteriorated, initially with depression, then psychosis. Her capacity to give informed consent became impaired as her mental state deteriorated. Pharmacotherapy was required, but the issue of safety in pregnancy prevailed. She is pressured by elders to give the baby to a childless, schizophrenic, younger sister (age 32). As she had an idealized transference towards her consultant, she refused to speak with nursing staff or with registrar. She wanted the consultant to make the decision for her: "I will do whatever you say". Case 3: Forced treatment Victor is a 78 year old retired man who has a history of schizophrenia that went untreated for many years. His compliance with medication has been erratic. There are concerns about whether he also suffers from dementia (Alzheimers). He has several medical problems, especially arthritic pain. He does not have a regular family doctor, but attends to several doctors in different parts of the city. One doctor placed him on multiple testosterone injections and he was using dangerous quantities of other medications. This led to an acute urinary obstruction that required emergency prostate surgery, the seriousness of which was not understood by the patient or his family. He was then transferred to the psycho-geriatric unit. Victor lives at home with his wife and adult son. Two other children live independently. His relationship with his wife is strained on account of his abusive verbal behaviour towards her and his accusations that she is a prostitute and that she has liaisons with other men. He has become violent. Recently he put paint thinner in her denture cup and placed steel 34

Cases

wool in her food. He also pulled a kitchen knife on his son and has, on numerous occasions, left the gas stove on after cooking. More recently, he left the emergency room of a hospital when advised that he needed surgery for acute urinary retention. His wife is scared of him and she feels that she can no longer look after him at home. She believes that he is unsafe and dangerous and in need of placement. His son supports her, but other members of the family are opposed and believe that she and the son have their own reasons so family members are pressuring his son to protest against any intervention from the psycho-geriatric team. The team considers that Victor is unable to take care of himself due to declining cognition, especially executive decision-making. Victor feels that he has been unduly incarcerated against his will. He constantly contacts his immediate and wider family to help "rescue" him. On the other hand, other than his wife and his son, the rest of the family does not think that he is at risk. They do not seem to understand the severity of his illness and his impaired capacity to make rational decisions. The team's decision is that Victor needs placement and they have successfully applied for a guardian. Readings Video/Movie Role play Discuss the following questions a. What is good about paternalism? b. What is bad about autonomy? Materials for discussion: http://jme.bmjjournals.com/cgi/search?andorexactfulltext=and&resourcetype=1 &disp_type=&sortspec=relevance&author1=&fulltext=paternalism&volume=& firstpage= http://jme.bmjjournals.com/cgi/search?andorexactfulltext=and&resourcetype=1 &disp_type=&sortspec=relevance&author1=&fulltext=autonomy&volume=& firstpage= Discuss the following statement and provide arguments for a positive as well as negative reply to the question. Every competent adult has the right to refuse unwanted medical treatment for her/his illness. Is this right valid in a case of a pregnant woman? Resource material: http://wwwhsc.usc.edu/~mbernste/ethics.refusaloftreatment.html. Other

WMA Declaration of Lisbon on the Rights of the Patient http://www.wma.net/e/policy/14.htm

Group discussion

35

UNIT 6

Title Consent (Article 6)

Unit Learning Objective(s) 1. Students should be able to explain what is 'consent', what is 'informed', and what is 'informed consent'; they should be able to define the principle of 'informed consent' 2. Students should be able to explain what the process of consent requires 3. Students should be able to explain how the principle of consent is applied in different interventions, research, and teaching 4. Students should be able to explain how exceptions to the principle can be justified Outline of the Syllabus 1. Interconnection of principles a. The principle of consent is based on the principle of human dignity and human rights b. The principle of consent is a practical specification of the principle of autonomy and individual responsibility c. If the principle of consent cannot be applied, the provisions of Article 7 (Persons without the capacity to consent) are applicable. 2. What is the purpose of the principle of consent? a. The principle of consent principle aims to achieve several objectives: i. it asserts the patient's autonomy; ii. it protects his/her status as a human being; iii. it prevents coercion and deception; iv. it encourages the doctor's self-criticism; v. it supports the process of rational decision-making; vi. it educates the public at large. 3. Interrelation between consent and autonomy 4. Explanation of the principle a. Medical intervention includes diagnosis, treatment, prevention, rehabilitation and palliation b. What is prior, free and informed consent? c. What is adequate information? d. What is express consent? e. Withdrawal of consent f. Compare the provisions for consent in scientific research with those for medical interventions g. Consent by individual, group and community 5. Exceptional circumstances for the application of the principle of consent a. Emergency situations b. Minors c. Mental patients d. Jehovahs Witnesses 36

e. Euthanasia f. HIV patients Teacher Manual 1. Introduction: explain how the principle of consent is connected to other principles of the Declaration a. Article 3: A person's basic rights are established on recognition of his/her human status, the inviolability of his/her life, and the fact that he/she was born and will always be free. Because human dignity and human rights are to be respected, the person concerned needs to give consent for medical interventions and for participation in scientific research. b. Article 5: Since the autonomy of every person is accepted as an important value, participation in decisions concerning one's own body or health must be recognised as a right. c. A decision to treat should be determined by co-operation between the person who treats and the person who is treated, both parties being linked together by mutual trust and reciprocity d. Article 6 of the Declaration states that any medical intervention is only to be carried out with the prior free and informed consent of the person concerned based on adequate information. The Article also applies to scientific research. e. If the provisions of Article 6 cannot be applied (because consent is not possible), Article 7 applies with special provisions for persons not able to consent (see Unit 7). 2. The principle of consent has several objectives. a. The purpose of the informed consent principle is to achieve several objectives. It asserts the patient's autonomy; it protects his status as a human being; it prevents coercion and deception; it encourages the doctor's self-criticism; it supports the process of rational decision-making; it educates the public at large. b. The principle of consent is also important, even if it has no purpose at all. Article 1 of the Universal Declaration or Human Rights 1948 holds that all human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood. Consent therefore expresses respect for the dignity and rights of each human beings 3. Explain the relation between autonomy and consent a. Autonomy may be defined as self rule and refers to the right of persons to make authentic choices about what they should do and what shall be done to them (see Unit 5). b. Autonomous persons can only make decisions and take responsibility for these decisions if they consent to interventions that affect their lives. 4. The provisions of Article 6 are subsequently explained a. The article applies to all medical interventions. Medical intervention includes diagnosis, treatment, prevention, rehabilitation and palliation b. Being informed implies cognition, understanding, willingness, intention, and consideration c. Consenting implies freedom (no coercion) d. Consent requires adequate information. What is the requested information content? 37

e. Diagnosis, prognosis, treatment, alternative treatment, risks, benefits, according to relevant circumstances f. Information process: by whom; when (in advance); how (oral, writing, expressed); and to whom (patients, relatives, guardians, others)? g. The patient's rights: a) to refuse, b) not to know h. Consent of subjects of medical research (Sections 2 and 3 of Article 6) i. Consent by the individual and by the community 5. Exceptional circumstances a. There are some circumstances in which the application of the principle is difficult or even impossible. b. For difficult circumstances special care needs to be given to the application of the principle, but it still does apply, even if difficult c. If consent is impossible for various reasons, the provisions of Article 7 do apply (see Unit 7) d. Examples of exceptional circumstances: i. Emergency situations ii. Minors iii. Mental patients iv. Jehovahs Witnesses v. Euthanasia vi. HIV patients Study Materials Case 1: Explanation needed A 72 year old male farmer with three children has been suffering from colon cancer. He described his illness as a "mass in the intestine" but he did not know what kind of a treatment modality would be needed. The day after the surgery, the assistant surgeon on duty visited the patient for routine inspection and treatment of the surgical wound. The patient, expecting to see a closed wound, was scared when he saw the opening of his colostomy. He asked the surgeon about "the hole in his abdomen". The surgeon, in a serious manner, replied: "The end of the intestine that was operated on was sutured to your abdomen. You are now to defecate through this hole and into the bag I will place at the end of it." Surprised and angered by the response, the patient asked: "Whom did you ask before opening that hole?" The surgeon told the patient Cases that they had informed his son about the procedure. The patient shouted in anger: "Who was to be operated on and have a hole in his abdomen? Is it me or my son? How dare you perform that without asking me? I will sue all of you!" The surgeon, unprepared for such a reaction, slowly started to explain the reason why colostomy had been performed and referred to the patient's disease as a "bad" one. After the explanation, the patient said: "If you had told me this earlier, I would not have shouted at you. I am not that illiterate, you know! I could understand." Case 2: Treatment without consent Mrs. E.D. is a 69 year old retired bank manager. She has been suffering from poorly controlled diabetes for the last 18 years. For the last 6 months she has needed hemodialysis twice a week for end-stage renal disease. Three days ago, she was 38

hospitalized because of an infected non-healing wound at the amputated stump of her left leg. Two days later gangrene set in. Following a meeting of her diabetologist, infectious disease specialist, surgeon, and family it was decided to amputate. Her eldest son, a physician, agreed to the amputation but announced that no one should tell her about it. She would only be told that the wound would be "surgically cleaned". Last year when the foot was to be amputated, Mrs. E.D. refused to give her consent. They did it without her consent and after her initial anger for a few days she appeared to understand the need and no longer blamed them. Her son anticipates the same reaction and feels informing her will only add more stress. Her husband and other children agree to the plan. Case 3: Informing the patient Mr. S.R. is a 28 year old former graduate academic scholar at a prestigious Catholic university who left school to work full time with the poorest of the poor. He engaged in carrying heavy sacks of rice for some time in his new task. Eventually he developed moderate to severe low back pains which could not be relieved by resting and medications. He consulted an orthopedic surgeon who investigated him and discovered a protruding disc and suggested surgical correction but he informed S.R. that the operation carried a risk of permanent disability. S.R. was unhappy, apprehensive and decided to forgo the procedure and confined himself to chiropractic treatment. There was no benefit. S.R. consulted a second orthopedic surgeon who told him that under a skilled surgeon's hands the risk of surgery would be minimal. The second surgeon urged Mr. S.R. to ask him all the questions he wanted. But S.R. did not ask anything about the risk of permanent disability. As S.R. was an obviously anxious patient, the second surgeon held back information about this possibility; he did not go any further into the description of the risks. Case 4: The right not to know Mr. D.A. is a 55 year old salesman, married, with 3 children. He has been a heavy smoker for the last 30 years. He has a chronic productive cough, with moderate exercise dyspnea, both of which led to medical tests that resulted in a diagnosis of COPD 5 years ago. He has no other known medical disorders and does not take any regular treatment. During the last month, he has been suffering from hemoptysis. After some hesitation, he told this to his family, and they persuaded him to inform his family physician, who knew him well. Upon meeting with his family physician, he agreed to be referred to a pulmonologist and to undergo tests, such as a chest roentgenogram, but he requested that if a severe disorder was found, such as lung cancer, he should not be informed. He explained this request as due to his preference to be spared the heartbreak involved in such bad news, and he was not willing to discuss related treatment, such as surgery, radiation therapy or chemotherapy. The family physician explained to him the variability of prognosis of different types of lung cancer and the importance of the patient's knowing the diagnosis, as he can then decide in an informed and perhaps more rational manner on treatment, but Mr. A. persisted in his request to waive the breaking of bad news. Case 5: Refusal of treatment A couple attended a fertility clinic wishing to conceive a child, and needed IVF treatment. In the female history, the woman reported that her father had Huntington's 39

chorea, an autosomal dominant condition which presents in the fourth decade of life, and leads to dementia and an early death. The woman was in her early 30's. She had chosen not to be tested for the condition (she has a 50 % chance of having it), as to find out that she has the condition would be psychologically too much to bear, and has implications for insurance purposes. Case 6: Refusal of treatment A 46 year old engineer with acute relapse of paranoid schizophrenia calls at the emergency room of the local psychiatric hospital kindly requesting admission to the closed ward. He is reporting vivid delusions of persecution (e.g. being attacked by cosmic rays sent from satellites driven by the extramundane creatures which bring him to the state of "mental and physical paralysis") and hallucinations (e.g. hearing the warning voices of those creatures, feeling the painful penetration of his body with the rays). After entering the ward the patient rejects the proposition of psychopharmacology stating he feels safe and comfortable staying in the closed ward, behind the grated windows and without handles, as his persecutors are not able to get at him there. Case 7: Refusal of treatment A 24 year old woman with three children following four pregnancies is seen in the emergency room with heavy vaginal bleeding that is only partially slowed by vaginal packing. She is found to have a Stage LLB cervical cancer and is eight weeks pregnant. The recommended next steps are either to embolize the uterine artery or try high dose fractions of radiation to stop the bleeding - both of which will cause termination of the pregnancy. The patient speaks only a foreign language, but both the interpreter and her husband confirm that she refuses treatment because she will lose the pregnancy. She continues to haemorrhage, loses consciousness, and her health and perhaps her life may be endangered if she continues to bleed. The husband asks that the health team please move forward with any procedure needed to save his wife. Case 8: Incompetent patients A woman, 28 years of age, attends an occupational therapy day program at a local psychiatric hospital. She has mild mental retardation (IQ 65) and for the past month has been diagnosed with AIDS. According to her psychiatrist, she was able to give informed consent for HIV testing after proper counselling had taken place. She has proven herself to be very promiscuous and in spite of ongoing psycho-education about her illness, the availability of condoms and her promises to practise safe sex, she just cannot act according to her knowledge. At the day program it is possible to 'shadow' her, but according to her mother her promiscuous behaviour poses a threat to herself and others in the community. Efforts to curb her sexual behaviour by means of an SSRI (Serotonin Reuptake Inhibitor) have failed. She is verbally quite strong, commutes to the hospital on her own by train, has many friends and lives with her mother and siblings within the community. The mother contacts her therapist and asks whether her daughter should not be institutionalized for the sake of her own safety and the safety of others. Case 9: Minors 40

J.B., a 5 year old girl, is brought to hospital by her parents with symptoms of fever and weakness. Upon further examination acute lymphocytic leukemia (ALL) is suspected, but a bone biopsy is required to confirm the diagnosis. The parents are informed of the procedure for the "bone marrow pin-prick" and give their consent. When a diagnosis of ALL is confirmed, the standard chemotherapy treatment is explained to the parents as well as the probable prolongation of life for a few years. On realizing the cost involved in this treatment and that "success" is not guaranteed, the parents are distraught and feel it is not worth continuing treatment. Case 10: Euthanasia A 34 year old man is hospitalized in the ward for the final phase of a testicular tumor with numerous metastases (seminal cancer). Palliative care is recommended. He was submitted in the previous months to numerous treatments that failed (castration, ganglion resection, chemotherapy). On his admittance, his clinical status is precarious. There is severe deterioration because of the general metastases. His wife (who benefited from an artificial insemination before chemotherapy) and his parents are there and look after him. After somatic treatment and psychological support, a morphine protocol has started with a strong dose that seems insufficient to relieve the patient from his pain; nevertheless, this treatment seems enough to create some impairment of consciousness. The nurse informs the physician about the formal wish of the patient and of his family to put an end to his sufferings by increasing the morphine. The physician is already close to lethal doses. He comes back to the ward to see his patient and meet his relatives. Case 11: HIV patients Mrs.W.L., a 29 year old married woman, and her husband are patients at the clinic. W.L. visits the clinic looking very sad. She lost her two children in the last three years, all before the age of three years, due to diarrhoea and severe febrile illnesses. During the illness of her last baby, the doctor attending her baby counselled that the baby and she undergo HIV tests. Both tests came out positive and were confirmed on further testing. She believes that her husband infected her. She has heard rumours that he was a womanizer, but he denied this when she confronted him. Now, the husband, a prosperous businessman, is continuously insisting that she conceive again so that he may gain recognition among his friends and the child born can inherit his wealth. He further warns that if this does not happen within a year, he will divorce her and marry a younger woman. He is not aware of her HIV status nor does he know his. The wife is afraid of revealing her HIV status for fear of a divorce. Case 12: HIV patients Mrs. B.G., aged 16, has been found HIV-positive at Dr. K.D.'s charity-maintained clinic. She explains that she is the third wife of a husband entitled in their culture to have several wives, and has had sexual intercourse only with him. Dr. K.D. is aware of the husband's polygamous marriages, and has treated his other two wives, but does not know their HIV status. B.G. says that her husband is unaware that she has come to Dr. K.D.'s clinic, and would angrily disapprove because she did not seek his prior consent. She therefore asks Dr. K.D. not to let him know. International Bioethics Committee; Report on Consent. UNESCO 2007. Carmi A. (Ed.): Informed Consent (UNESCO Chair in Bioethics, 2003) 41

Readings

Video/Movie Role play Group discussion Other

Dickens B., Cook R., Kismodi E. (Eds.): Reproductive Health: Case Studies with Ethical Commentary (UNESCO Chair in Bioethics, 2006) Carmi A., Moussaoui D., Arboleda-Florez J. (Eds.): Teaching Ethics in Psychiatry: Case-Vignettes (UNESCO Chair in Bioethics, 2005) WMA, Declaration of Helsinki (http://www.wma.net/e/policy/b3.htm) BBC video on the Code of Silence How to inform patients/subjects?

42

UNIT 7

Title Persons without the capacity to consent (Article 7)

Unit Learning Objective(s) 1. Students should be able to explain what is competence to consent 2. Students should be able to explain the criteria of competence to consent 3. Students should be able to explain how the criteria for consent are applied in different circumstances of treatment and research 4. Students should be able to describe the limits to the exercise of autonomy Outline of the Syllabus 1. Criteria for competence to consent a. Definition of incompetence b. Criteria to determine competence to consent c. Article 7 preface: special protection is to be given to persons who do not have the capacity to consent d. Give examples of persons who cannot satisfy the criteria; distinguish different categories of persons not able to consent 2. Categories of persons without the capacity to consent a. Different distinctions can be made b. Examples of persons who cannot satisfy the criteria c. Illustrative case of mental patients 3. Legal provisions concerning consent and capacity to consent a. The role of domestic legal provisions b. The role of international human rights law 4. Procedures: a. Explain Article 7.a. b. How to obtain consent in health care practice? c. Special procedures in ethics to construct consent i. Determination of appropriate substitute decision-makers ii. Best interest criterion 5. The context of research involving human subjects a. Explain Article 7.b. b. Should research been done with persons not able to consent? c. Research for direct health benefit d. Research without potential direct health benefit Teacher Manual 1. Define incompetence and the criteria for competence to consent a. Incompetence can be defined as lacking the freedom to make authentic decisions because of an inability to make such decisions even when given the opportunity. Various groups of people have been traditionally labelled in this way. They include people with learning difficulties, the mentally ill, children, confused elderly and unconscious people. A more systematic distinction between categories will be made 43

2.

later in this unit. b. Define the criteria for competence to consent i. The ability to understand given information ii. The ability to appreciate the nature of the situation iii. The ability to assess the relevant facts iv. The ability to exercise choice v. The ability to use understood information for realistic and reasonable decision vi. The ability to appreciate the consequences of giving or refusing consent c. Why is it important to make special arrangements for persons without the capacity to consent, as stated in the first sentence of Article 7? d. Give examples of persons who cannot satisfy the criteria; distinguish different categories of persons not able to consent Categories of persons not able to consent a. Different distinctions Competency to consent can be compromised due to various circumstances. Distinctions should be made between: i. categories of practices 1. clinical treatment and research 2. epidemiological research (e.g. use of previously collected data) 3. public health (e.g. vaccination) 4. emergency conditions (e.g. resuscitation) ii. categories of subjects 1. persons not yet able to make their own decisions (e.g. minors) 2. persons no longer able to make their own decisions (e.g. demented persons) 3. persons temporarily unable to make their own decisions (e.g. unconscious persons) 4. person permanently unable to make their own decisions (e.g. severely intellectually impaired persons) iii. categories of contexts 1. disadvantaged economical conditions 2. illiteracy 3. socio-cultural circumstances 4. captive audiences (e.g. prisoners, laboratory assistants) b. Examples i. Neonates 1. Neonates cannot think like adults. It is therefore impossible for them to be able to make decisions, to understand information, to process information rationally or to desire reasonable outcomes. As decisions have to be made about them, the best candidates for this role are the parents, on the assumption that above all people they will have the best interests of their child at heart. However, in some cases parents do not 44

ii.

iii.

iv.

v.

vi.

make decisions in the best interests of their children. In those cases it is possible for the state to step in and remove the decision making role from them. This is done by making the child a ward of the court. Children 1. It might appear that children cannot think like adults. Whilst this is certainly true of very young children, as children develop they show marked differences from each other. The United Nations Convention on the Rights of the Child (UNROC) asserts that children have the right to say what they think should happen when adults make decisions that affect them and to have their opinions taken into account (Article 12), have the right to get and share information (Article 13), have the right to think and believe what they want and practice their religion as long as they do not stop other people enjoying their rights (Article 14), and have the right to privacy (Article 16).Research activities involving children are carried out to learn more about the nature of paediatric development, disease and potential treatments. An important safeguard required to minimize loss of respect for autonomy is the general rule that where the research can be carried out by employing adults then children should not be used. Confused elderly patients 1. Various forms of neurological deterioration including Alzheimer's disease rob people of the powers to make decisions. Relatives or true friends who knew them when well should be asked to help to build a picture of the patient's life, the preferences, the values and the wishes in which one can locate the decision that should be made. A hypothetical consent is a consent which would likely be in accord with the feelings of the patient when well. Patients with learning difficulties 1. It is important not to confuse intellectual impairment with mental illness. Patients with learning difficulties represent a wide range of intellectual ability and no simple standard of competence can be assumed between them. In each case an assessment according to the criteria outlined above is called for in combination with an awareness of the nature of the decision to be made. Only in extremely serious cases will a person with this problem be unable to make a decision about anything. In those cases where either the impairment is so severe that the decision is too onerous or complex to be grasped by the person, a best interest judgment on their behalf should be made. Mentally ill patients 1. As with intellectual impairment so with mental illness, one cannot assume that all persons are equally competent or otherwise. On the one extreme people in a psychotic state cannot make authentic choices. On the other hand when not in florid state a person with schizophrenia might be quite clear about how he feels about matters of life and how he would wish to address them. Unconscious patients 45

1. Such documents as Advance Directives or Living Wills might be valuable guides but have inherent weaknesses that should be taken into account. They might be old and out of date, they express hypothetical wishes, and there is always the need to know under what circumstances the documents were produced. c. Illustrative case of mental patient: A person who is termed incompetent is one whose insanity or mental deficiency deprives him/her of the ability to control his/her own interests. 3. Explain in this case how the criteria for competence apply 4. Discuss what will be good medical practice for such a patient 5. Legal provisions concerning consent and capacity to consent a. The role of domestic legal provisions b. The role of international human rights law 6. Procedures: a. Explain Article 7.a. b. Obtaining consent in health care practice c. Special procedures in ethics to construct consent i. Determination of appropriate substitute decision-makers ii. Best interest criterion 7. The context of research with persons a. Explain Article 7.b. b. Should research been done with persons not able to consent? c. Research for direct health benefit d. Research without potential direct health benefit Study Materials Case 1: Forced treatment Ruth, an 80 year old holocaust survivor living alone in her home, was born in Poland and was in a concentration camp until the age of 22. She lost her entire family during the war. She moved to Australia with her husband and was happily married, but had no children and only a few friends. Her only relative is an 84 year old sister who suffers from dementia and lives in a nursing home. Ruth became depressed after the death of her husband from a stroke two years previously. She is also experiencing significant anxiety and difficulty in coping on her own. She has no previous mental history, but suffers from hypertension. While on treatment at home, she experienced Cases severe nausea and vomiting from the antidepressants making it necessary to admit her, involuntarily, to a psycho-geriatric unit. A case manager was appointed with a view to organizing support at home. The patient was considered to be seriously depressed with persistent low mood, lack of energy and motivation, poor selfesteem, obsessive rumination, but no suicidal thoughts or psychotic symptoms were elicited. Minimental state was assessed at 27/30. The organic work-up was unremarkable. The neuro-psychology report showed a borderline to low-average range for executive function and memory. Although she reacted better to new medications and responded well to the support in the clinic, even participating in group activities, she continued to experience significant anxiety and suffered a 46

relapse with deterioration of her mental state when advised that a guardian had been appointed. Although she accepted this decision, she objected to being placed in a nursing home, wishing to return home on her own and, yet, acknowledging that she would not be able to manage. Worsening depressive symptoms, severe agitation, expression of suicidal thoughts and deterioration in self-care occurred despite the current treatment with medications. On consultation, two psychiatrists recommended electroshock therapy (ECT), or adding another anti-depressant medication. She reluctantly accepted to take the new medication, but refused consent for ECT. Her guardian agreed that her doctor should go ahead and treat her with ECT. Case 2: Forced treatment Arnold is a 24 year old unemployed man, who used to live independently in a home adjacent to his parents' large property. He associated largely with "alternative" and "greenie" groups. He was referred to psychiatric services by the community outreach workers who had concerns about his physical and mental state. He had been eating minimal amounts and appeared malnourished and emaciated. He could barely walk and had collapsed several times. He had been subsisting on a skimpy vegetarian diet. At 184 cm and a weight of 44kg, his body mass index was only 13. His mother reported that he began to lose weight approximately four years before when he became interested in alternative medicine and dieting. He had read alternative nutrition materials and was convinced that fruitarians were happier people. He believed that non-organic foods were toxic to the vital organs and manufactured as part of food and drug "conspiracies". He claimed that dairy products were "mucous forming" around the throat, which interfered with absorption. He also believed that eating root vegetables meant "killing" the vegetable and that his fasting would make him live longer. Three years earlier he had moved into a van and isolated himself, was disheveled, and walked around town with only a blanket on, becoming verbally aggressive when confronted. Eventually he began to suffer from urinary incontinence. On admission, despite his life threatening physiological changes, he insisted that his weight was adequate and maintained that if he had survived on his diet thus far, his food intake must have been adequate. He felt that people come in different shapes and sizes and commented that people who are obese are not locked up. He did not accept the abnormal results of his X-rays, blood tests, electrocardiogram, etc. He had no interest in contact with psychiatric services and he was generally mistrusting of doctors. Arnold proved a difficult diagnostic and management problem. He required urgent nasogastric re-nutrition against his will as an involuntary patient. In undergoing such treatment, he felt that doctors were "fascist" and that, as a free citizen, he had the right to eat what he wanted and not have to adhere to conventional westernized ideals. He did not view himself as a mental patient, and accused the system of being intolerant to alternative lifestyles and beliefs. Case 3: Minors A child aged 8 was referred to a mental health hospital by the social worker for family affairs who reported behaviour disorders. The child and his brother are caught in the midst of severe divorce disputes between their parents, and are in temporary custody of their father. In the first diagnostic session this boy's behaviour could be described as hostile; he was furious and his answers were laconic. The moment the 47

Readings

meeting was over, the father entered the room, and in front of his son demanded to see what I wrote in his file. He said, "According to the Patients' Rights Law I'm entitled to see the notes you write in my son's file". He added that he deserved to know what his son thought about his mother and about him. It seems that the father perceived this son as being more attached to the mother, and as betraying him by loving his mother too. This child was probably aware of his father's intrusiveness and therefore he refused to cooperate in the psychiatric examination. Also, it was clear that the child was afraid to cooperate and reveal his feelings and thoughts, as his experience taught him that his father's anger could be very dangerous. International Bioethics Committee: Report on Consent. UNESCO, 2007. Carmi A. (Ed.): Informed Consent (UNESO Chair in Bioethics, 2003) Dickens B., Cook R., Kismodi E. (Eds.): Reproductive Health: Case Studies with Ethical Commentary (UNESCO Chair in Bioethics, 2006) Carmi A., Moussaoui D., Arboleda-Florez J. (Eds.): Teaching Ethics in Psychiatry: Case-Vignettes (UNESCO Chair in Bioethics, 2005) United Nations: Convention of the Rights of the Child, 1989 Council of Europe: Convention on Human Rights and Biomedicine, 1997 World Medical Association: Declaration of Helsinki, 2004.

Video/Movie Role play Group discussion Other

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UNIT 8

Title

Respect for human vulnerability and personal integrity (Article 8)

Unit Learning Objective(s) 1. Students should be able to explain the principle of respect for human vulnerability 2. Students should be able to analyse the interrelationship between present-day scientific medicine and human vulnerability and to illustrate the difficulties in this relationship with examples 3. Students should be able to specify the connections of the principle of respect for human vulnerability with the notion of personal integrity and with care ethics Outline of the Syllabus 1. The notion of human vulnerability a. Respect for human vulnerability b. Different aspects of vulnerability i. biological ii. social iii. cultural c. Implications of the principle: care 2. The powers of medicine: a. The fight against vulnerability b. Successes and failures c. Problems with the basic assumption that vulnerability should be eliminated d. Towards sustainable medicine 3. The dilemmas of vulnerability 4. Care ethics a. New approaches in bioethics b. Solidarity c. The duty to care 5. The notion of personal integrity: a. Relation between vulnerability and personal integrity b. Personal integrity does not refer here to a virtue c. Personal integrity refers to respect for the patients understanding of his or her own life and illness, but also for his/her interests and free will Teacher Manual/Resources 1. Explain the notion of vulnerability a. The principle of respect for human vulnerability expresses a concern for the fragility of an intact but destructible totality. The principle is related to the principle of personal integrity b. Several aspects of vulnerability need to be distinguished: i. biological or corporeal vulnerability; this concerns the fragility of the human organism originating from: 49

1. natural threats are coming from our biology: aging, susceptibility to illness and disease, and death 2. environmental and other natural threats: famine, earthquake, hurricanes, pollution and environmental disasters ii. social vulnerability; this concerns the fragility of the human capacity for creating coherence in ones life and for sharing goods and services. 1. social threats stemming from war and crime, prejudice and discrimination, cruelty and indifference 2. persons also become vulnerable due to hospitalization and institutionalization 3. social circumstances and conditions iii. cultural vulnerability; this concerns the fragility of particular traditions and conceptions of values that are typical for a community or local cultures c. In ethics, the notion of vulnerability is not just a neutral description of the human condition but instead a normative prescription to take care of the vulnerability that is characteristic for human beings. Ethics is more than respecting individual choices and decisions; it aims at care for the other. For example, the human face shows the vulnerability of the human person and at the same time appeals for help and assistance 2. The powers of medicine a. The fight against vulnerability. The common idea is that the vulnerability of the human condition should be eliminated or reduced. Science and technological innovations should be used to overcome the natural threats. Medical research should be focused on eliminating the biological threats to the human body. The basic assumption behind this fight is that any vulnerability of the human condition is in the end contingent, not inherent. b. This fight has been successful but at the same time has failures. Life expectancy and health have improved, poverty and starvation reduced, but at the same time many people die from common diseases, life expectancy is decreasing in many countries, and poverty is still widespread. c. The basic assumption that vulnerability should be eliminated has in itself created problems: i. if vulnerability is regarded as an evil to be eradicated, it cannot be given any positive meaning; we cannot understand human vulnerability and thus human suffering ii. religion, alternative medicine and traditional knowledge present different ways of knowing and valuing; because they are open to different perspectives, they can give meaning to vulnerability, but their views are generally not accepted by mainstream science or bioethics iii. economic problems; the success of science and technology has created financial difficulties in almost all countries in achieving decent levels of health care for the population. Because of its continuous fight against vulnerability, medicine often is not sustainable medicine iv. medical progress itself has created new forms of vulnerability, i.e. chronic illness. This presents continuing vulnerability for a growing population. d. An unrestrained fight against human vulnerability generates its own problems. Not the 50

struggle against human vulnerability is a mistake but the struggle to rid the human condition of all vulnerability. For a sustainable medicine it is necessary to accept some vulnerability as a permanent part of the human condition. 3. The dilemmas of vulnerability a. Taking into account human vulnerability, as stated in Article 8, requires a balance between eliminating and accepting human vulnerability. This balance is manifest is some dilemmas: i. disability; disability is viewed as abnormal and the disabled therefore are by definition vulnerable; at the same time the disabled should not be stigmatized by being treated as abnormal. ii. death; in medicine the place of death in human life is ambivalent; in palliative care, death is understood as being part of life; in some other sectors of medicine death is still treated as the enemy. iii. depression; Prozac is widely used as anti-depressant drug, when there are clear clinical symptoms of depression; at the same time it is regarded as medication for unhappiness and sadness. b. Human suffering and misery express human vulnerability. They also pose a challenge. We must at the same time struggle to keep suffering to a minimum and also accept it as part of life. Human vulnerability cannot be merely regarded as an enemy to be eliminated. Too much emphasis on eradication has led to evils in the name of some supposed good: the eugenics movement, Nazism to eliminate the socially and ethnically unfit, and totalitarian regimes to eliminate social injustice. 4. Care ethics a. The challenge of human vulnerability is that it can never be entirely eliminated from human life. Instead, it should inspire new approaches in bioethics b. The human condition requires solidarity; human beings all share common vulnerabilities c. Human vulnerability also leads to an ethics of care. Because it is a shared characteristic, it is also a source of concern for others as well as awareness that we rely on others. It is the basis for the duty to care for those threatened by biological, social and cultural threats as well as by the power of medicine itself. 5. The notion of personal integrity: a. The principle of respect for human vulnerability is related to the notion of personal integrity; this is mentioned in the last part of Article 8. b. Integrity concerns the wholeness of an individual. In ethical discourse, integrity is often considered as a virtue, related to the honesty of somebodys character for example. But respect for personal integrity in this Article does not refer to somebodys moral character or his/her good behaviour. It refers to fundamental aspects of a human life that should be respected. c. Personal integrity refers here to respect for the patients understanding of his or her own life and illness, but also for his/her interests and free will. Each persons life has a coherence, a narrative whole based on important events in his/her life and by his/her interpretations and values. What is most valuable to a person is grounded in this narrative whole. It is this personal integrity of human beings that must be protected.

51

Study Materials Cases

Readings

Zentrum fr Medizinische Ethik: Barcelona Declaration, 1998 http://www.ruhr-uni-bochum.de/zme/Barcelona.htm Mary C. Ruof: Vulnerability, vulnerable populations and policy. Scope Note 44, National Reference Center for Bioethics Literature, Georgetown University http://www.georgetown.edu/research/nrcbl/publications/scopenotes/sn44.pdf UNEP: Africa Environmental Outlook: Chapter 3: Human vulnerability to environmental change http://www.grida.no/aeo/234.htm (English) http://www.grida.no/aeo/french/index.htm (French) Vulnerability and Health Alliance: A framework for conceptualising and reviewing vulnerability to malaria, TB and HIV. Policy Briefing Paper, Liverpool School of Tropical Medicine, June 2003 http://www.liv.ac.uk/lstm/vha/16vhapb.pdf

Video/Movie Role play

Group discussion

Discuss the Policy Briefing Paper (June 2003) of the Vulnerability and Health Alliance. The paper discusses vulnerability to infectious diseases. It provides a definition of vulnerability and proposes a framework for understanding vulnerability. Analyse the paper and focus on the following questions: o What notion of vulnerability is used in the paper? Which aspects of vulnerability are discussed? o What are the ethical implications of the framework proposed? o What should be the first priority for health care policy in the area of infectious diseases according to the principle of respect for human vulnerability?

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UNIT 9

Title Privacy and confidentiality (Article 9)

Unit Learning Objective(s) 1. Students should be able to explain why patient privacy and confidentiality should be respected 2. Students should be able to recognise legitimate exceptions to confidentiality Outline of the Syllabus 1. Definitions of privacy and confidentiality 2. Reasons for respecting privacy and confidentiality 3. Duty of healthcare providers to protect the privacy of patients 4. Duty of healthcare providers to maintain confidentiality (also known as professional secrecy) 5. Confidentiality extends to all personal health information, including genetic data 6. Justified breaches of confidentiality include: a. Sharing information for patient care b. Using interpreters c. Teaching medical students d. Mandatory reporting e. Serious danger to others f. Genetic information g. With patient or guardian consent 7. Special circumstances of research Teacher Manual 1. Begin by defining privacy (related to autonomy it is the right of an individual or a group to be free from intrusion from others, and includes the right to determine which information about them should be disclosed to others) and confidentiality (an attribute of personal information requiring that it not be disclosed to others without sufficient reason) 2. Reasons for respecting privacy and confidentiality: a. Individuals own their information: it is essential to their personal integrity. b. Respect for others requires protecting their privacy and the confidentiality of information about them. c. Patients are less likely to trust health care providers and confide in them if they think that the health care providers will not keep the information confidential. 3. Health care providers should protect the privacy of patients to the greatest extent possible in the circumstances. For example, they should ask the patients permission to examine him or her unclothed and should ensure that an unclothed patient cannot be viewed by passers-by. 4. The duty of maintaining confidentiality (also known as professional secrecy) has been part of Western medical ethics since Hippocrates and preceded the notion that privacy is a right; ethics courses in non-Western countries should discuss the source of medical confidentiality in their cultures. 5. Confidentiality extends to all personal health information, including genetic data (UNESCO International Declaration on Human Genetic Data: all medical data, including genetic 53

data and proteomic data, regardless of their apparent information content, should be treated with the same high standards of confidentiality. 6. Justified breaches of confidentiality include: a. Sharing information for patient care: in the hospital setting, many individuals need access to the patients chart in order to provide care; however, each of these individuals is bound to maintain confidentiality to the greatest extent possible; outside the hospital setting, family members may need patient information in order to provide care and/or to protect themselves; b. Using interpreters: where the health care provider does not speak the patients language, an interpreter will be needed who will then have access to information about the patient; interpreters should be bound to observe confidentiality; c. Teaching medical students; observation and discussion of patients is a necessary part of medical education; students should be informed of their obligation to maintain confidentiality; d. Mandatory reporting; health care providers should be familiar with the laws about mandatory reporting of infectious diseases, suspected child abuse and other conditions in the country where they practise; normally patients should be informed that their information has to be reported to the appropriate authorities; e. Serious danger to others: for example, in exceptional circumstances and generally as a last resort, health care providers may need to inform other persons that the patient has threatened to harm them, whether by violence or by sexual contact when the patient has an transmissible disease such as HIV; f. Genetic information: there is controversy regarding whether other individuals with the same genetic makeup (usually close family members) have a right to a patients genetic information; g. With patient or guardian consent: this should generally be obtained for all breaches of confidentiality and renders the breach acceptable ethically. 7. Special circumstances of research a. Disclosure of personal health information obtained in the course of a research study requires the prior consent of the research subject; b. There is a great controversy regarding whether anonymized patient information requires consent for disclosure; c. Scientific publication should respect confidentiality to the greatest extent possible. Study Materials Case 1: Informing the wife? Mr. S. is married and the father of two school children. He is treated in your clinic for a rare form of pneumonia that is often associated with AIDS. His blood test results show that he is indeed HIV-positive. Mr. S. says that he wants to decide himself if and when he will tell his wife about the infection. You indicate that it Cases could be life-saving for his wife to protect herself from infection. Besides, it would be important for her to have an HIV test herself. In case of a positive test result she would then have the opportunity to take drugs to slow down the outbreak of the disease and thereby prolong her life. Six weeks later, Mr. S. comes into your clinic for a control investigation. Answering your question he says that he hasn't informed his wife yet. He doesn't want her to know about his homosexual contacts because he 54

fears that she would end their relationship and the family would shatter. But to protect her he has had only "safer sex" with her. As the treating physician, you wonder whether you should inform Mrs. S of the HIV status of her husband against his will so that she would have the opportunity to start treatment if needed. Case 2: Prison events As part of your medical duties you spend one day every two weeks seeing inmates in a nearby prison. Yesterday you treated a prisoner with multiple abrasions on his face and trunk. When you asked what caused the injuries, the patient replied that he had been attacked by prison staff during interrogation when he refused to answer their questions. Although this is the first such case you have experienced, you have heard of similar cases from your colleagues. You are convinced that you should do something about the problem but the patient refuses to authorize you to disclose information about himself for fear of retaliation from the prison authorities. Furthermore, you are not certain that the prisoner has told you the truth; the guard who brought him to you said that he had been in a fight with another prisoner. You have a good relationship with the prison staff and do not want to harm it by making unsubstantiated accusations of mistreatment of prisoners. What should you do? Case 3: Warning the friend? A 45 year old rich, handsome, sociable and elegant man, a member of the jetset society, had an amorous relationship with an equally elegant and beautiful 35-year old woman. Due to some bouts of jealousy on the part of the man (possibly of morbid dimensions), the young woman decided to put an end to the relationship. Following this, the man visited a psychiatrist, whom he had been seeing for some time, informed him that he was carrying a gun and that his next visit would be to his ex-girl-friend because he intended to kill her. He added that this information was confidential from patient to doctor and that any breach in confidentiality would not remain unnoticed. The psychiatrist decided that a breach of confidentiality was necessary in this case and informed the lady and the police. When asked by the police, the man denied that he had bad intentions. A heated discussion among professionals followed, which was re-fuelled by the fact that this man eventually managed to kill his ex-friend with the very gun he carried when he visited the psychiatrist's office. Case 4: The politician A sixty-eight year old powerful politician was affected with Lou Gehrigs Disease (Amyotrophic Lateral Sclerosis) and given no more than one year of life. She prohibited her doctor to ever mention her condition even to her husband or her family because of the sensitive political situation that such a revelation might entail or to seek further consultations. As her condition worsened, pressures mount on her doctor to refer her to another physician or to hospitalize her. Following the expressed directions of his patient he refused, but her family insists on consultation and possible hospitalization. Case 5: The bus driver A 46 year old man, married and father of three children, is a bus driver on an interurban line on difficult roads across the mountains. In a consultation with a doctor, his 55

main complaint is that he has started to experience episodes of acute tachycardia during the past five months, following the death of his mother. It happened first when he was in the street, where he thought that he was taking leave of his senses and was about to die. In the emergency room of the hospital to which he was rushed he was diagnosed as having a heart that was in good shape, but owing to his stress, he was advised to take a holiday. Upon return from his vacation he began to suffer the same episodes especially when he was driving across the mountains. He also began to believe that his driving might become careless and cause him to drop into the ravine. He insisted that this was exclusively a heart disease, refusing to consider that he was suffering from any kind of panic disorder which might be complicated by agoraphobia. Refusing to accept any psychotropic medication or psychotherapy, he demanded treatment by a cardiologist. He asserted that he would refuse to take "the same kind of medication as his mother", who had been treated for years as a person with schizophrenia. At the same time he continued working on his arduous bus route, since he had contracted debts which he had to repay. Case 6: Publishing a case Dr. X. published a paper based on two dreams from psychotherapeutic treatments (without any identifying clues), making detailed diagnostic and prognostic comments. A brief version was published in a magazine dedicated to Human Sciences Updating. As Dr. X. was a prestigious colleague, I used to include his name in my list of professional references. When my hospital workmate asked me for a therapist, I gave her three names, including Dr. X. She categorically rejected him because she considered that he badly harmed her sister, when she was his patient. The problem originated from the above mentioned paper. The patient had bought the Human Sciences magazine at a newspaper and magazine stand, precisely because she saw her therapist's name as an author. She was deeply upset when she recognized her own dream printed in the magazine, and when she realized (even if nobody else could recognize her as the patient), that the theoretical comments were about her personality and her psychological conflicts. She discontinued her treatment and rejected any meeting with her former therapist.

Readings

World Medical Association Medical Ethics Manual, Chapter 2 http://www.wma.net/e/ethicsunit/pdf/manual/chap_2.pdf British Medical Association, Confidentiality as Part of a Bigger Picture http://www.bma.org.uk/ap.nsf/Content/ConfidentialityBiggerPicture%7Emod el?OpenDocument&Highlight=2,privacy ETHOX Centre, Confidentiality http://www.ethox.org.uk/education/teach/confidentiality/confidentiality8.htm European Guidance for Healthcare Professionals on Confidentiality and Privacy in Healthcare http://www.eurosocap.org/Downloads/European-Guidance-for-HealthcareProfessionals-on-Confidentiality-and-Privacy-in-Healthcare.doc UNESCO International Declaration on Human Genetic Data, Article 14 http://portal.unesco.org/en/ev.phpURL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html

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Role play

Group discussion

The personal physician 1. Consider the following real events. a. President Francois Mitterand of France died on 8 January 1996, at the age of 79. Dr Claude Gubler, the general practitioner who treated him from 1969 to 1994, published a book, The Great Secret, jointly written with a journalist, immediately after the death of the president. The book went on sale on 17 January having been featured, with excerpts and unofficial photographs of the president lying in state, the previous day by the popular weekly magazine Paris-Match. The book stated that the president was diagnosed with cancer of the prostate and bone metastases as early as 1981 but that the diagnosis was kept as a "state secret" despite President Mitterand's promise of transparency regarding his health. The cancer was revealed to the public only late in 1992, and Dr Gubler asserted that "In November 1994, I considered Francois Mitterand no longer capable of carrying out his duties." (French officials denied that he had been incapacitated, and even the prime minister, Alain Juppe, who served as foreign minister under the Socialist president, said: "I never found him in a state of impairment.") . Dr Gubler said that he started his book in August 1995 because he wanted to reveal the truth behind the incomplete medical bulletins issued in his name over several years. He said that he and Dr Adolphe Steg, a urologist, had regularly given President Mitterand radiation and chemotherapy since 1982, when the already advanced stage of cancer led to the pessimistic prognosis of a survival time of about three years. In November 1994, wrote Dr Gubler, the president came to work at about 9.30 or 10 a.m. and spent most of his days in bed. "He was not working because nothing interested him except his disease." At the end of 1994, after voicing doubts about the president's capabilities, Dr Gubler was dismissed, and President Mitterand was treated by a doctor specialising in homoeopathy and by Dr Jean-Pierre Tarot, a pain specialist, who became his personal physician and stayed with him until his death. b. The book was an instant success; the first day of its publication about 40.000 copies have been sold. 2. Make 4 sub-groups and discuss separately in each group whether any actions are appropriate. The four groups are all meeting in the afternoon of January 17. a. The family of the deceased president b. The Medical Association c. Paris judges d. Journalists 3. Exchange the views of the 4 groups and discuss what will be the best strategy to respond to this event. 1. Discuss the question: Are privacy and confidentiality specifically Western concepts or are they universal? 2. Identify the most influential Medical Code of Ethics in your country analyse the statements in the Code in regard to privacy and confidentiality 57

identify for which situations the provisions in the Code for privacy and confidentiality apply review when breaches of confidentiality are justified according to the Code

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UNIT 10

Title Equality, justice and equity (Article 10)

Unit Learning Objective(s) 1. Students should be able to identify and deal with the ethical issues involved in allocating scarce health care resources 2. Students should be able to recognize conflicts between the health care professionals obligations to patients and to society and identify the reasons for the conflicts Outline of the Syllabus 1. Definitions of equality, justice and equity 2. The different types of justice: a. Distributive b. Procedural c. Retributive d. Restorative e. Social 3. The different concepts of distributive justice (the most important types for health care): a. Authoritarian b. Libertarian c. Utilitarian d. Egalitarian e. Restorative 4. How these different concepts of justice are reflected in the different health care systems found around the world 5. The right to health care 6. Disparities in health status a. Local b. National c. Global 7. Roles of health care professionals in establishing health care priorities and allocating scarce health care resources a. As government policy makers and officials b. As hospital authorities c. As direct health care providers. Teacher Manual 1. Describe or ask the students to identify several issues in allocating health care resources and accessing health care in your area. 2. Discuss definitions of equality (sameness in some respect such as human dignity), justice (different types, but generally fairness), equity (application of fairness, which may require unequal treatment). 3. Describe the different types of justice: a. Distributive (ensuring that each person receives a fair share of public resources) 59

Procedural (ensuring a fair process for making decisions and settling disputes) Retributive (ensures punishment of wrongdoers) Restorative (attempts to repair harm done in the past) Social (combination of the previous types as applied to a society in which individuals and groups receive fair treatment and a just share of the benefits of society). 4. Describe the different concepts of distributive justice (the most important type for health care): a. Authoritarian (what the King or other highest authority decrees is just) b. Libertarian (what an individual decides to do with his or her own property is just) c. Utilitarian (what most contributes to the greatest good of the greatest number is just) d. Egalitarian (justice is achieved when everybody has equal access to the societal resources that they need) e. Restorative (justice requires favouring previously disadvantaged individuals or groups) 5. These different concepts of justice are reflected in the different health care systems found around the world. The Libertarian one is strong in the U.S.A. The Egalitarian one is predominant in many European countries where the value of social solidarity is recognized. South Africa is attempting to implement a restorative approach. Most economists lean towards the Utilitarian approach. Which predominates in your country? 6. The Constitution of the World Health Organization states that the "enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being." International statements on human rights, such as the International Covenant on Economic, Social and Cultural Rights and the Convention on the Rights of the Child, support the right to health and require signatory nations to secure its observance. What does this right to health mean in practice? 7. Health care professionals are faced with many disparities in health status, generally associated with disparities in wealth/income a. Local b. National c. Global What can/should they do about these disparities? 8. Health care professionals play several roles in establishing health care priorities and allocating scarce health care resources a. As government policy makers and officials b. As hospital authorities c. As direct health care providers. What concept of distributive justice is most appropriate for each of these roles? How should health care professionals deal with conflicts between roles (e.g., between providing expensive curative measures for individual patients in need and vaccination programs for the population)? Study Materials Case 1: Shopping patients Cases Dr. S is becoming increasingly frustrated with patients who come to her either before or after consulting another health practitioner for the same ailment. She considers 60

b. c. d. e.

this to be a waste of health resources as well as counter-productive for the health of the patients. She decides to tell these patients that she will no longer treat them if they continue to see other practitioners for the same ailment. She intends to approach her national medical association to lobby the government to prevent this form of misallocation of health care resources. Case 2: Sex selection An infertility clinic is considering whether or not it wants to include sex selection in its offerings. A long debate has been going on between the staff members on the issues of selection of embryos based on genetic characteristics that do not influence the health of the child. One side maintains that all such selection is discrimination and usually against females. The other side maintains that there should be no discrimination if selection is offered only for a second or later child when couples are seeking the sex different from that of the first child or previous children. The other fertility centre in town has been offering sex selection without regard to whether there is a first child or "family balancing".

Readings

World Medical Association Medical Ethics Manual, Chapter 3 http://www.wma.net/e/ethicsunit/pdf/manual/chap_3.pdf U.K. Clinical Ethics Network, Resource allocation in health care http://www.ethics-network.org.uk/Ethics/eresource.htm UNHCHR: The Right to the Highest Attainable Standard of Health http://www.unhchr.ch/tbs/doc.nsf/(symbol)/E.C.12.2000.4.En?OpenDocument International Society for Equity in Health http://www.iseqh.org/ International Society on Priorities in Health Care http://www.healthcarepriorities.org/society/default.html Global Forum for Health Research: A Practical Framework for Setting Priorities in Health Research http://www.globalforumhealth.org/filesupld/1090_report_99/109099CHPT8. PDF WHO/UNAIDS: Guidance on Ethics and Equitable Access to HIV Treatment and Care http://www.who.int/ethics/en/ethics_equity_HIV_e.pdf

Video/Movie Choosing core health services Suppose that your government invites you to be a member of a State Committee that should make recommendations concerning a new system of healthcare services, distinguishing core services and other services. The Committee should make a proposal for these essential (core) services that should be included in the basic healthcare package, open to all citizens. You are specifically invited to study the following list of services, and identify those that should be regarded as essential services: in vitro fertilisation contraceptive medicines 61

Role play

organ transplantation alternative medicine relaxation therapy (Spa treatment) esthetic surgery physio-therapy screening for breast cancer screening for hypertension home nursing care medical-technical devices (prosthesis, wheelchair) dental care opticians prescriptions

Group discussion Other

Is there a right to health care in your country? What does it mean in practice?

62

UNIT 11

Title Non-discrimination and non-stigmatization (Article 11)

Unit Learning Objective(s) 1. Students should be able to explain the concepts of discrimination and stigmatization in the context of bioethics 2. Students should be able to identify different contexts and bases of discrimination and stigmatization and their implications 3. Students should be able to identify and deal with situations where exceptions to the principle can be justified Outline of the Syllabus 1. What is discrimination and stigmatization? a. The notion discrimination b. The notion stigmatization 2. What is positive or reverse discrimination? 3. Grounds of discrimination a. Advances in medical technology may create disproportionate disadvantages for some social groups b. The unfair use of genetic testing c. Genetic discrimination 4. Legal context a. Explanation of Article 11 b. Background for the Article 5. Limitations of the principle: a. Each principle of the Declaration relates to the other principles (Article 26) b. Limiting the application of the principles is regulated in Article 27 c. The protection of public health can be a limiting factor Teacher Manual 1. Definition of the notions discrimination and stigmatization a. The word discrimination comes from the Latin "discriminare", which means to "distinguish between". Thus, to discriminate socially is to make a distinction between people on the basis of class or category without regard to individual merit, which is an infringement of the ethical theory of egalitarianism based on social equality (see Unit 10). Distinctions between people which are based just on individual merit (such as personal achievement, skill or ability) are generally not considered socially discriminatory, contrary to distinctions based on race, religion, sex, sexual orientation, disability, ethnicity, height, and age. b. According to the Encyclopedia Britannica stigmatization is a discrediting process which strikes an individual who is considered as "abnormal" or "deviant". He or she is reduced to this single characteristic in other peoples eyes or opinions for whom this label justifies a range of social discriminations and even exclusion. The social impact of stigmatization shows a number of negative behaviours toward stigmatized people that can end in real discrimination as regards, for example, access to social services such as healthcare and education, employment and professional advancement, income level and domestic life. 2. Positive or reverse discrimination 63

a. Discriminatory policies or acts that benefit a historically and socio-politically non dominant group (typically women and minorities), at the expense of a historically and socio-politically dominant group (typically men and majority races) are called "positive or reverse discrimination" or affirmative action policies. b. However, whether a given example of discrimination is positive or negative is often a subjective judgment. c. In the field of healthcare and bioethics, some groups need more protection such as infants and elderly people, AIDS patients, psychiatric patients and depressed patients. 3. Grounds of discrimination a. Advances in medical technology have the potential to create disproportionate disadvantages for some social groups, either by being applied in ways that harm members of these groups directly or by encouraging the adoption of social policies that discriminate unfairly against them with significant individual, social and legal consequences. For instance, reproductive medicine has developed techniques that enable parents to choose the sex of their child which raises the concern of discrimination against girls and women in societies where male children are valued more highly than female children. Similar concerns have been raised about the increasing use of abortion as a method of birth control in overpopulated countries where there is considerable social and legal pressure to limit family size and where the vast majority of the parents who use it choose to have a boy rather than a girl. b. In the field of genetics, the use of relatively simple tests for determining a patient's susceptibility to certain genetically transmitted diseases has led to concerns that the results of such tests, if not properly safeguarded, could be used in unfair ways by health-insurance companies, employers, and government agencies. In addition, through genetic counselling prospective parents can be informed about the chances that their offspring will inherit a certain genetic disease or disorder; this will enable them to make more informed decisions about reproduction. This is viewed by some bioethicists and some NGOs as contributing to a social atmosphere considerably less tolerant of disability than it ought to be. The same criticism has been levelled against the practice of diagnosing, and in some cases treating, congenital defects in unborn children. c. Research on the genetic bases of behaviour, though still in its infancy, is controversial, because of its potential to encourage the adoption of crude models of genetic determinism in the development of social policies, especially in the areas of education and crime prevention. Such policies, it is claimed, could result in unfair discrimination against large numbers of people judged to be genetically disposed to undesirable forms of behaviour, such as aggression or violence. 4. Legal context a. Explanation of Article 11, as a theoretical and practical continuation of Articles 3 and 10, and continued in discussion of Articles 13, 14, and 15 b. Background for the Article: i. Articles 1 and 2 of the Universal Declaration of Human Rights ii. Article 7 of the International Declaration of Human Genetic Data 5. Limitations of the principle: a. Article 26 of the Declaration states that the principles should be understood as complementary and interrelated; the Declaration is to be understood as a whole. This implies that if a bioethical issue or problem emerges, it is usually the case that several principles are relevant to the issue or problem and need to be balanced in order to 64

reach a justified conclusion about what to do. b. Article 27 specifies the limitations on the application of the principles. It mentions several conditions in which application may be limited: i. by law 1. laws in the interests of public safety 2. laws for the investigation, detection and prosecution of criminal offences 3. laws for the protection of public health 4. laws for the protection of the rights and freedoms of others ii. such law need to be consistent with international human rights law c. When therefore public health is at risk, exceptions or restrictions to the non discrimination principle can be necessary either by affirmative actions in favour of some key persons or groups, or by negative actions that may infringe upon individual rights. These exceptions must be publicly discussed and applied with transparency and according to the national law. They also must be subject to revision according to developments of the situation and scientific knowledge. Study Materials Case 1: Stigmatization? Y.L., aged 18, has come to Dr. N.G. for contraceptive care and testing of her status for sexually transmitted infections, explaining that her father's friend has been sexually abusing her, including by non-consensual intercourse. She further explains that, when she complained to her parents, they angrily denied the possibility, and accused Y.L. of flirting and being sexually provocative. The family lives in a small community and has few means, so she is not able to leave home and be selfsupporting. The community is also religiously devout, so any sexual scandal involving police or other authorities would be very stigmatizing. Y.L. asks that her parents not be informed that she is receiving contraceptive care, because this would Cases confirm their suspicions of her immorality. Case 2: Non-discrimination E.F., aged 16, was married six months ago to a man aged 27 she knew only very little, by an arrangement made between her parents and his family. Her husband has brought her to Dr. G.H., a family physician, for a routine health examination. Dr. G.H. finds E.F. quite petite, malnourished and with an underdeveloped pelvis. E.F. informs Dr. G.H. that she wants to delay childbearing until she is aged 20, although her husband and his family are anxious that she should bear a child as soon as possible. She asks Dr. G.H. for a contraceptive method.

Readings

Universal Declaration of Human Rights, 1948 http://www.un.org/Overview/rights.html Universal Declaration on the Human Genome and Human Rights, 1997 http://portal.unesco.org/shs/en/ev.phpURL_ID=1881&URL_DO=DO_TOPIC&URL_SECTION=201.html UNESCO International Declaration on Human Genetic Data, 2003 http://portal.unesco.org/shs/en/ev.phpURL_ID=1882&URL_DO=DO_TOPIC&URL_SECTION=201.html Convention on the Elimination of All Forms of Discrimination against 65

Women (CEDAW), adopted in 1979 by the UN General Assembly http://www.un.org/womenwatch/daw/cedaw/cedaw.htm Movie: The Elephant Man (1980) Based on the true story of Joseph Merrick, a 19th-century Englishman afflicted with a disfiguring congenital disease. With the help of kindly Dr. Frederick Treves, Merrick attempts to regain the dignity he lost after years spent as a sideshow freak. Movie: Miss Evers Boys (1997) In 1932 Macon County, Alabama, the federal government launched into a medical study called The Tuskegee Study of Untreated Blacks With Syphilis. The study selected 412 men infected with the disease and faked long term treatment, while really only giving them placebos and liniments. The premise of the action was to determine if blacks reacted similar to whites to the overall effects of the disease. The experiment was only discontinued 40 years later when a Senate investigation was initiated. At that time, only 127 of the original study group were left alive. The story is told from the point of view of Nurse Eunice Evers, who was well aware of the lack of treatment being offered, but felt her role was to console the involved men, many of whom were her direct friends. In fact the movie's name comes from the fact that a performing dancer and three musicians named their act for her - "Miss Evers' Boys". All had the disease. A romance with one goes unrequited even after he joins the army during World War II and is treated and cured by penicillin. As the result of the Senate investigation, the medical experimentation on humans has been curbed. The survivors of the study did receive treatment and financial compensation after the Senate Investigation.

Video/Movie

Role play Case discussion Discuss the following cases and determine whether or not exceptions to the principle can be justified: o Affirmative action: situations in medical practice, e.g. priority of access to scarce medical resources in case of pandemics and natural catastrophes to: Young vs. aged people Health professionals, politicianss and security key persons. o Negative action situations where the public interest impose restrictions of the non discrimination principle Cases of violent patients in the hospital: can they be refused future access to the hospital? Quarantining of infected patients due to public health risks (e.g. SARS ) If an exception to the principle is justified, what are the arguments? Which principles are overriding the principle of non-discrimination? 66

Group discussion

Other

67

UNIT 12

Title Respect for cultural diversity and pluralism (Article 12)

Unit Learning Objective(s) 1. Students should be able to explain the meaning of culture and why it is important to respect cultural diversity 2. Students should be able to explain the meaning of pluralism and why it is important in the field of bioethics 3. Students should be able to explain what are the limits to the consideration of cultural specificities and how to deal with cultural diversity with respect to the fundamental principles of bioethics and human rights Outline of the Syllabus 1. Background a. Definition of culture and cultural diversity b. Value of respect for cultural diversity c. Value of pluralism 2. Explanation of Article 12: a. As a theoretical and practical continuation of other articles b. The principle will raise questions concerning: i. Discrimination ii. Infringement of the autonomy principle iii. Infringement of national laws 3. Limits to the consideration for cultural specificities a. Human dignity, human rights and fundamental freedoms b. Domestic law, national regulations and international human rights laws c. Principles set out in the Declaration Teacher Manual 1. Definitions and background a. Definition of culture and cultural diversity i. According to the UNESCO Universal Declaration on Cultural Diversity: Culture should be regarded as the set of distinctive spiritual, material, intellectual and emotional features of society or a social group, and that it encompasses, in addition to art and literature, lifestyles, ways of living together, value systems, traditions and beliefs ii. As stated in Article 1 of the above Declaration: Culture takes diverse forms across time and space. This diversity is embodied in the uniqueness and plurality of the identities of the groups and societies making up humankind. b. Value of respect for cultural diversity i. UNESCO considers cultural diversity as the common heritage of humanity and therefore it should be recognized and safeguarded for the benefit of present and future generations. ii. As a source of exchange, innovation and creativity, cultural diversity is as 68

2.

3.

necessary for humankind as biodiversity is for nature and it is essential to ensure harmonious interaction among people and groups with plural, varied and dynamic cultural identities as well as their willingness to live together. iii. Thus, policies for the inclusion and participation of all cultural groups and citizens are guarantees of vitality, social cohesion and peace. c. Value of pluralism i. Pluralism is, in a general sense, the affirmation and acceptance of diversity. The concept is used in a wide range of issues: politics, science, religion, philosophy and ethics. ii. Value-pluralism in philosophical ethics means that there are several values which may be equally correct and fundamental, and yet in conflict with each other. These various values and ideals have no common character apart from the fact that they are ideals. In addition, value-pluralism postulates that in many cases, when such incompatible values conflict, there is no way of telling which should prevail or even whether they have equal significance since there is no objective ordering of them in terms of importance. Value-pluralism is a theory in metaethics, rather than a theory of normative ethics, or a set of values in itself. Explanation of Article 12: a. As a theoretical and practical continuation of Articles 3 and 10, and to be continued in discussion of Articles 13, 14, and 15 b. The principle will raise questions concerning: i. Discrimination ii. Infringement of the autonomy principle iii. Infringement of national laws Limits to the consideration for cultural specificities a. Human dignity, human rights and fundamental freedoms. i. Respect for cultural diversity can never be invoked when it infringes upon human dignity, human rights and fundamental freedoms. ii. Cultural value pluralism thus cannot be used as a way of justifying discrimination and stigmatization. Value-pluralism is an alternative to moral absolutism and differs also from value-relativism in that pluralism imposes limits to differences, such as when vital human needs or rights are violated. The value of cultural diversity may be in conflict with other human rights values. In this case, it is necessary to analyze and balance wisely the values in conflict. b. Domestic law, national regulations and international human rights laws i. Legal limits: 1. Example: blood transfusion for children in the case of Jehovahs Witnesses ii. Moral and legal limits: 1. Example: sex selection by the use of prenatal and preimplantation genetic diagnosis without any concomitant medical reason but for family balancing in non-egalitarian societies. Usually used to select 69

male embryos or fetuses, this is considered discrimination (see Unit 11) c. Using international declarations/instruments i. Article 4 of the UNESCO Universal Declaration on Cultural Diversity stipulates Human rights as guarantees of cultural diversity: The defense of cultural diversity is an ethical imperative, inseparable from respect for human dignity. It implies a commitment to human rights and fundamental freedoms, in particular the rights of persons belonging to minorities and those of indigenous peoples. No one may invoke cultural diversity to infringe upon human rights guaranteed by international law, nor to limit their scope. ii. Article 4 of the International Declaration on Human Genetic Data: Human genetic data have a special status because: (Paragraph iv) they may have cultural significance for persons or groups. Due consideration should be given to the sensitivity of human genetic data and an appropriate level of protection for these data and biological samples should be established Study Materials Case 1: Treatment without consent Treating Mrs. T.P. for complications late in her pregnancy, Dr. R.R. diagnoses placenta previa and concludes that, by following Mrs. T.P.'s intention of natural delivery, the fetus would not be born alive and the life of Mrs. T.P. herself would be in serious peril. Mrs. T.P. rejects the advice of Dr. R.R. that she deliver by caesarean section, however, stating her religious conviction that, if the diagnosis is correct, the condition will be resolved by divine intervention, and she will safely deliver a healthy baby. Case 2: Traditional circumcision of girls Mrs. B.E. brings her six-year old daughter to Dr. G.H. asking that she be safely "circumcised." Mrs. B.E. explains that she wants the procedure done for fear that the daughter will not be eligible for marriage in the rather isolated community where the family lives if it is not done, and for fear that her daughter will be considered negatively by members of her wider family and by her young peers. The mother further explains that she wants Dr. G.H. to undertake the procedure because such procedures performed on her two older daughters by a traditional birth attendant resulted in their severe bleeding and infection. Mrs. B.E. adds that, unless Dr. G.H. performs the procedure, her mother-in-law, who lives with the family, will insist on undertaking the procedure herself by customary means, or on taking the daughter to a traditional birth attendant. There are no legal prohibitions in the jurisdiction that ban the practice. Case 3: Unnecessary treatment A 26 year old woman contacts a psychiatrist because she is perplexed by a situation which she does not know how to handle. She was born of Turkish immigrant parents, and has been brought up in a Western European country. With respect to norms and values in the sphere of women's behaviour she feels that her personality has been split by two cultures. She has had sexual relations without the knowledge of her parents who are arranging for her marriage to a young man from Turkey. She knows that her prospective bridegroom's parents are traditional and will accept only a virgin as their daughter-in-law. She reluctantly contacts her family doctor for advice with reference to the restoration of her virginity. She is met with a refusal since he cannot 70

Cases

recommend that a tradition be upheld that does not provide a woman with freedom to choose her sexual partner. The young woman is distressed by the fact that the date of the marriage is approaching and she believes that her family will be disgraced and she will become the object of contempt. Case 4: Expert testimony A 29 year old Turkish worker, who had come to Germany four years before, stabbed his wife and wounded her severely. Her life was saved only because he rushed her to the hospital for emergency surgery. In court both claimed that they had a quarrel before the stabbing in their car. She accused him of adultery and told him that she was going to make love to his best friend and that his friend would do a better job than the husband. The defendant remembered that he stabbed once, although the victim was wounded twice, and he had a blurred memory which could be a sign of profound disturbances of consciousness, a reason to mitigate punishment according to German law. The couple had meanwhile been reconciled and wanted to continue their marriage. After the psychiatric examination, which did not reveal any disturbances, the defendant wanted to talk to the psychiatrist under the privilege of confidentiality, which was denied. At that moment the defendant started to tremble, cry, and sweat and almost collapsed. He then claimed that he had been the victim of sexual abuse in Turkey and had seen a doctor at that time but had not told him about his victimization. The only persons who knew about it were his brother who had prevented the defendant from shooting his molester, and now the psychiatrist. If anyone in the Turkish community were to learn about it, he would lose all self respect; and his wife would leave him because he could not be master of his own house. This opinion was supported by an expert on oriental culture. The defendant preferred a harsher sentence over the disclosure of his secret to the court.

Readings

UNESCO Universal Declaration on Cultural Diversity, 2001 http://unesdoc.unesco.org/images/0012/001271/127160m.pdf UNESCO International Declaration on Human Genetic Data, 2003 http://portal.unesco.org/shs/en/ev.phpURL_ID=1882&URL_DO=DO_TOPIC&URL_SECTION=201.html

Video/Movie Role play Discuss the following cases: A woman consults the physician in order to have a prescription for contraceptives. The physician only wants to make a prescription if the husband consents in order, as he argues, to respect the cultural customs of the country A clinical trial has been started in the hospital. In order for adult women to be included a male consent (usually the husband or the father) is requested instead or in addition of the womans consent. In a traditional community researchers have set up a trial to study the incidence of specific diseases. Because individual autonomy is not highly appreciated in this community, they have asked the chief of the community to give permission to include all adult members of his community in the trial 71

Group discussion

In a society in which the family is very important, medical doctors used to communicate the diagnosis of a patients terminal condition to the family instead of to the patient himself or herself In order to respect cultural diversity, a hospital has made the rule that male patients will only be received by male doctors, and female patients only by female doctors. In a particular country long-standing systems of alternative healing and medication are practised and commonly used by the population. An advertisement campaign has started to call on AIDS patients to use these traditional medicines because they are very efficient in our culture. For each case: determine how the principle of respect for cultural diversity can be used Does cultural diversity need to be respected? If not, which other principle of the Declaration does apply? Other

72

UNIT 13

Title Solidarity and cooperation (Article 13)

Unit Learning Objective(s) 1. Students should be able to explain the development of the notion of solidarity in different societies 2. Students should be able to describe the difference between solidarity as an instrumental and a moral value 3. Students should be able to give examples of solidarity in the context of health care and research Outline of the Syllabus 1. The notion of solidarity a. Discuss the notion of solidarity: first associations b. Solidarity in health care c. Opposition to individualism d. Evolution of solidarity in society i. mechanical solidarity ii. organic solidarity iii. organized solidarity e. Ethical perspective i. Solidarity as instrumental value ii. Solidarity as moral value 2. Threats to solidarity in present-day societies 3. Relationship of solidarity, autonomy, and justice a. Solidarity goes beyond justice b. Solidarity does not necessarily restrict autonomy 4. International research a. What do solidarity and cooperation imply? b. Relationship with benefit sharing 5. Health insurance provision of healthcare to the general population as an end, health insurance as a means Teacher Manual 1. The notion of solidarity a. Discuss the notion of solidarity: ask students with what do they associate this notion, for example: i. mutual respect ii. support of the weak and vulnerable iii. commitment to a common cause or the common good iv. belonging together v. mutual understanding vi. shared responsibility b. Solidarity is applicable in the context of health care systems. In Europe for example, everyone is obliged to make a fair financial contribution to a collectively organised insurance system that guarantees equal access to health and social care for all 73

members of society c. Solidarity is often considered to be opposed to individualistic behaviour and contrasted with self-centred individualism, as a personal and social concern for vulnerable groups in modern societies, in particular the chronically ill, the handicapped, political refugees and the homeless. d. Sociological analysis shows that solidarity can have different expressions in the evolution of societies: i. In traditional societies (homogeneous and without much differentiation in social functions) solidarity rests on the social uniformity of beliefs, practices and sentiments (mechanical solidarity, group solidarity or associative solidarity); ii. During the transition from traditional to modern societies, the form and contents of social ties between individuals are transformed and hence the nature of social solidarity. Differentiation and diversification of functions and tasks creates relations of interdependence between individuals. Division of labour and structural interdependence require new rules of cooperation (organic solidarity, contractual solidarity); iii. In post-industrial, globalised societies, solidarity takes the form of organised solidarity. Building new forms of solidarity is an ongoing project. In many cases, common interests, interdependencies and personal relations no longer exist. Still solidarity of strangers is possible. Modern solidarity functions between non-related and impersonal members of a society. e. From an ethical perspective, solidarity is first and foremost a moral value focused on providing support to those who need it. Among members of a community mutual obligations exist. This also implies that a fundamental difference should be made between two forms of solidarity: i. Solidarity as instrumental value: solidarity as self-interest, reciprocal solidarity. The enlightened self-interest of rationally calculating individuals motivates them to cooperate. ii. Solidarity as moral value: group oriented responsibility to care for the weaker and more vulnerable members of the community. Real solidarity implies that we take care of vulnerable persons even if it would not be in our interest or even if there is no specific purpose. Human beings share identity as members of the same collectivity and therefore feel a mutual sense of belonging and responsibility. Solidarity in this sense is humanitarian solidarity; it is the expression of an ethics of commitment, a sense of responsibility towards the most vulnerable in society. Not self-interest but the interest of others motivates cooperation. 2. Threats to solidarity a. Solidarity in present-day societies is under threat due to various factors i. globalisation; more anonymous approach; less connectedness with other human beings; ii. increasing demands for expensive treatments, due to the ageing of populations; the range of options for individuals has enlarged; iii. changing and more demanding attitudes of clients, related to increasing individualisation of societies with increasing stress on the moral significance of individual autonomy; 74

iv. shift towards more private financial responsibility and increasing pressure of market ideology; v. erosion of local communities and extended family networks changing personal and social relationships; b. In present-day societies there is a tension between solidarity, personal autonomy and responsibility. The example of unhealthy lifestyles illustrates this tension. Individuals are free to choose the lifestyles they prefer but if these are notoriously risky for their health, can they still expect the solidarity of citizens if they fall ill? 3. Relationship of solidarity, autonomy, and justice a. Solidarity goes beyond justice Justice is a matter of obligation from one free individual to another; it is based on the shared interest of preserving the requisite amount of freedom for all citizens. Solidarity cannot be a matter of obligation; it is not based on duties and rights. b. Solidarity does not necessarily restrict autonomy 4. International research a. What do solidarity and cooperation imply? b. Relationship with benefit sharing (see Unit 15). 5. Health insurance provision of healthcare to the general population as an end, health insurance as a means Study Materials Cases Towards an ethics of solidarity. Report from the World Social Forum, 2005 http://news.spirithit.com/index/south_america/more/towards_an_ethics_of_so lidarity/ Ethics and SARS: Learning Lessons from the Toronto Experience http://www.yorku.ca/igreene/sars.html Readings Report of the IBC on solidarity and international co-operation between developed and developing countries concerning the human genome, UNESCO, 2001. http://portal.unesco.org/shs/en/file_download.php/559ac31d0288b0aa0d7886 a707826cfcSolidarity_en.pdf Video/Movie Role play Discuss the following statements solidarity between generations: the younger age groups should contribute to the expenditures required to meet the needs of the older generations solidarity between the rich and the poor; the rich should contribute to provide health care for the poor solidarity for disadvantaged persons: for examples homeless people and addicted persons should receive preferential treatment to ameliorate their condition solidarity requires that all citizens contribute to (and pay taxes to allow) healthcare for all other citizens, regardless of their own health status; thus men pay for obstetric care, and everybody pays for psychiatric care, even if 75

Group discussion

they are sure they will never need it themselves solidarity requires that all citizens contribute to provide health care for those in need, for example for postmenopausal women who wish to have children through egg donation Solidarity requires that the system of explicit consent to organ donation should be replaced by a system of presumed consent. Discuss each statement and determine whether or not you agree that solidarity requires what is expressed. Explain the arguments for your agreement or disagreement.

Other

76

UNIT 14

Title Social responsibility and health (Article 14)

Unit Learning Objectives 1. Students should become acquainted with the shared responsibilities of the state and various sectors of society in regard to health and social development 2. Students should understand the requirements of global justice and the notion of the highest attainable standard of healthcare as a right 3. Students should be able to explain that health status is a function of social and living conditions and that the attainment of the highest attainable standard of healthcare depends upon the attainment of minimum levels of social and living conditions 4. Students should be able to appreciate the urgent need to ensure that progress in science and technology facilitates access to quality health care and essential medicines as well as the improvement of living conditions and the environment, especially for marginalized segments of the population 5. Students should be able to analyze potentially exploitative social practices or arrangements affecting public health and recommend possible solutions Outline of the Syllabus 1. Highest attainable standard of health as a fundamental human right a. Universal Declaration on Human Rights b. WHO Constitution 2. Health and the impact of social and overall living conditions. a. the need for health care initiatives to take into account the broad development context b. the ethical significance of public and population health initiatives 3. Duty, obligation and responsibility and how these are acquired by individuals, groups or institutions. 4. Responsibilities for governments and various sectors of society. a. Responsibilities of governments b. Social responsibilities of the health sector and the medical profession c. Social responsibilities of the private sector and industry 5. Health and contemporary challenges to global justice a. Access to essential drugs and health services b. Poverty and the HIV/AIDS pandemic c. Standard of care in international health research d. The protection of vulnerable populations e. Research prioritization f. Providing health care services across national boundaries g. Organ transplantation and medical tourism Teacher Manual 1. Highest attainable standard of health as a fundamental human right. a. Section 1, Article 25 of the Universal Declaration on Human Rights states that everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and 77

necessary social services . . . (1948). b. Moreover, the WHO Constitution provides 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(1946). The recognition of the highest attainable standard of health as a fundamental human right establishes a heavy ethical burden on health care and related sectors, especially because of the broad definition of health as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity (1946). See also Units 2 and 4. 2. Health and the impact of social and overall living conditions. a. Ethically-minded players in the health sector appreciate the need for health care initiatives to take into account the broad development context that includes the reduction of poverty, stewardship of the environment, and assurance of human rights, gender equity and global security. Such ethical initiatives reaffirm the definition of health as expressed in WHOs Constitution, and the recognition of health as both a means to other development goals and as an end in itself. b. This section also highlights the ethical significance of public and population health initiatives, as they constitute a dynamic instrument for achieving social and economic development, justice and security. Whereas health has been conventionally viewed as an end in itself, the discussion examines the synergistic relationship between health and other aspects of development. i. Poverty defined as the undermining of a whole range of key human capabilities, including health. Ill-health disproportionately afflicts poor people, and sudden health problems push people into greater poverty (the medical poverty trap). ii. The need to reduce the burden of excess mortality and morbidity suffered by the poor populations in both poor and rich countries. iii. The sensitivity of health to the social environment and to the social determinants of health. iv. Inequalities between men and women, regions, ethnic groups, rural and urban areas, and in legal status. 3. Duty, obligation and responsibility and how these are acquired by individuals, groups or institutions a. Individuals, groups or institutions may be ascribed duties, responsibilities or obligations in a number of ways. In the case of governments, these may be defined constitutionally, or by the instrument that established the state. These may also be determined by agreements entered into with other governments, international organizations, or other bodies. In the case of individuals, these may be defined by state laws or by rules and regulations governing membership of a particular group (e.g., professional, religious, interest, or advocacy group). The same applies to groups or agencies established within the context of national laws or statutes. b. Responsibility may be acquired also in respect of roles that individuals, groups or institutions assume in a particular social-political-economic context. Moreover, in light of conditions characterized by wide disparities in economic, social and political power, protection of the fundamental right to the highest attainable level of health puts a burden on individuals, groups and institutions to provide assistance that is within 78

their means. This notion of responsibility has been specifically referred to as social responsibility. 4. Responsibilities for governments and various sectors of society. a. This section examines the context within which governments and other stakeholders have to operate when they try to provide health care and other needs to the population. The conditions characterizing that context have implications for the specific responsibilities that may be ascribed to the different stakeholders. Ordinarily, the degree of responsibility increases as ones amount of control over a given situation rises. It is useful to analyze different situations in order to consider the extent to which stakeholders may be adjudged to have a responsibility, and to identify the specific initiatives that may be identified as falling within the sphere of their ethical obligations. i. Responsibilities of governments. The government or the state has the primary duty to uphold and protect the rights of its citizens. It is also charged with the responsibility to provide the environment that could maximize the contributions of other sectors to the promotion of fundamental rights. ii. Social responsibilities of the health sector and the medical profession. The Physicians Oath contained in the Declaration of Geneva (1948, 1968, 1983, 1994, 2006) and the WMA International Code of Medical Ethics (1949, 1968, 1983, 2006) enumerate the duties of medical practitioners. Nurses, dentists, caregivers and other workers in the healthcare community have similar or corresponding responsibilities. This section examines the responsibilities that arise in relation to professional roles as well as to the gaps in health service that cannot be sufficiently filled by referring to such roles. iii. Social responsibilities of the private sector and industry. Regardless of the nature of the products they produce or services they offer, industries have a responsibility to promote the interests of society. The responsibility ought to be shared in accordance with relevant principles of justice and fairness. In many countries, the pharmaceutical industry observes codified regulations that include provisions for social responsibility. A study of the regulations could reveal certain gaps that need to be filled. 5. Health and contemporary challenges to global justice. The wide disparities in the provision of health care experienced globally give rise to questions of equality and global justice. a. Access to essential drugs and health services. More than 33% of the global population has no access to essential drugs and more than half of this deprived population lives in the poorest regions of Africa and Asia. The development of drugs for tropical diseases has progressed very little and even when drugs are available, they are often inaccessible to those who need them the most. The global patent regime is partly responsible for the inequitable situation. Hence, it is very important to re-examine and re-evaluate the WTO-TRIPs Agreement which gave rise to the global patent regime as well as to many existing national drug patent systems. b. Poverty and the HIV/AIDS pandemic. HIV/AIDS spreads more quickly in poor countries and amongst poor people. This highly visible and paradigmatic example illustrates the inevitable connection between poverty and disease in general. Poverty itself is the reason for such an exacerbated effect; thus, the fight against HIV/AIDS (and disease in general) requires progress in the elimination of poverty. c. Standard of care in international health research. Developing countries attract 79

researchers from the affluent parts of the world. Many pharmaceutical companies are testing their drugs in developing countries. While these countries urgently need research to help address the enormous burden of disease they carry, the inequalities in resources pose a real risk of exploitation in the context of externally-sponsored research. It is of great importance to develop local expertise in the provision of healthcare and come up with research hosting protocols. Researchers on the other hand should follow an ethical framework guided by duties to (1) alleviate suffering, (2) show respect for persons, (3) be sensitive to cultural differences, and (4) not exploit the vulnerable (Nuffield Council on Bioethics, 2002) . d. The protection of vulnerable populations. The 2005 World Summit Outcome adopted by the United Nations General Assembly expresses the resolve of UN member states to continue making progress in the advancement of human rights of the worlds indigenous peoples (Sec. 127), to pay special attention to the human rights of women and children and undertake to advance them in every possible way (Sec. 128), and to recognize the need for persons with disabilities to be guaranteed full enjoyment of their rights without discrimination (Sec. 129). Member states also noted that the promotion and protection of the rights of persons belonging to national or ethnic, religious and linguistic minorities contribute to political and social stability and peace and enrich the cultural diversity and heritage of society (Sec. 130). Incompetent persons, prisoners and refugees also deserve special attention as vulnerable populations. These and similar groups ought to receive special consideration for a number of important ethical and historical reasons, specifically those give rise to various forms of exploitation (See also Unit 8). e. Research prioritization. Global health research funding has been heavily tilted in support of the needs of the affluent minority, leaving a mere 10% of research resources to address the needs of the developing world. It is important to promote responsive, fair and equitable initiatives in this area. Research projects carried out in poor countries should be relevant to their needs. Participants should also be considered as major stakeholders in the research projects. This section looks at illustrations and case studies in developing countries. f. Providing health care services across national boundaries. The migration of medical doctors and other health care workers has reached alarming proportions. Developing countries are continuously losing their healthcare workers to developed countries that provide higher remuneration and benefit packages. This section examines the experience from a global perspective and traces responsibility to the various institutions involved, including the highly developed countries that draw valuable health care personnel away from the environments where they are most needed. g. Organ transplantation and medical tourism. The global income disparity is also manifest in the ongoing practice of transplanting organs from the poor to the rich. The medical tourism industry has provided a smokescreen that serves to disguise the injustices associated with transnational exploitation. This section examines the ethical issues involved and some of the measures that have been offered to curb unethical and illegal practices. Study Materials Case 1: Tenofovir trials in Cambodia Cases The proposed study is a double blind placebo-controlled trial. It involves using Tenofovir, an Anti-Retroviral drug, among HIV-negative female sex workers. The 80

objective of the study is to assess if the drug has a protective effect in reducing the risk of HIV infection. One of the reasons for the initiation of the trial is that behavioural measures in the prevention of HIV infection are not adequately effective since the use of highly efficacious and readily available means such as condoms is not always guaranteed for one reason or another. Therefore, chemo-prophylactic means, if proven effective, would provide a wider range of options for people to choose according to their own convenience. The study would recruit up to 960 female sex workers in both arms, and they will take a daily dose of Tenofovir or placebo up to one year with regular follow-ups during which blood testing and counselling will be performed. Before the recruitment of the participants a series of community meetings will be conducted to explain the objective of the study, the procedures, the possible risks and benefits. A test of understanding will be administered to all potential participants; only those who fully understand the procedures and risk of the study will be asked to consent. The participation will be completely voluntary and participants have all the rights to withdraw from the study at any time without giving reasons and with no punishment or penalty. The study has been criticized over several aspects: 1. The use of placebo would subject participants to greater risk of infection than they would have if they are not participating in the study. It has been suggested that participants in the control arm be given best proven substance instead of placebo. The researcher argued that there have not been any best proven chemoprophylactic measures available yet. The only effective preventive measure is the condom; and the participants will be encouraged to use a condom as much as they can during the course of the study. Therefore, this would justify the use of placebo. 2. The question of why Cambodia has been selected as a site for the study is very much debated. There has been fear that a poor country like Cambodia is easily exploited by pharmaceutical companies to test their products that sometimes cannot be done in rich countries where ethical and legal systems are stricter. In response to the concern, the researchers argued that Cambodia is not the only site for the project. It has been done elsewhere including the United States. One of the reasons why Cambodia is included is the burden of HIV/AIDS the country is bearing. The country has a critical need for effective preventive measures to tackle the spread of the disease. 3. The future availability and affordability of the drug to the Cambodian people are also questioned. It is argued that Cambodian people who participate in the study would not benefit from the study as the cost of the drug is not expected to be at an affordable level. Although unable to give specific assurance, the researchers believe that the price of the drug would drop and continue to drop as generic drugs can be produced locally, just like in the case of other ARV drugs which are now produced in many developing countries with the price affordable to a reasonably good number of AIDS patients. 81

What social responsibilities do you think the researchers have to the research subjects? What about the pharmaceutical company that manufactures the drug what responsibilities do they have to the research subjects? Given those social responsibilities, what do you think of the issues raised in #1 to 3 above? Case 2: Unnecessary hospitalization A 58 year old male, diagnosed with paranoid schizophrenia in full remission, is placed in a psychiatric hospital for 8 months, as he has no private place to reside in. The patient has no official guardian. His brother, who sold the patient's home without permission, refuses to take him from the hospital and take care of him. The patient has to stay in the hospital, where he has only the minimal basic needs for existence. Case 3: Unnecessary hospitalization A 47 years old, unemployed female, diagnosed with schizophrenia several times was treated at a psychiatric hospital. She had lived with her husband and all contacts with other relatives were lost. During remissions she used to do laundering at a country house. For the last few years, she lived alone, as her husband left her. For two years she heard voices which issued commands to her. Under their influence she destroyed her own house by fire and was arrested by police and hospitalized. After a few years her mental status was stabilized; she now sincerely regrets what she had done. At the same time, she has no place to live after discharge. There is no assisted residency in the country, which is why she is still kept at the hospital. She has no prospects of improving her domiciliary status in the foreseeable future.

Readings

Universal Declaration on Human Rights (1948) UNESCO Universal Declaration on Bioethics and Human Rights (2005) Universal Declaration on the Human Genome and Human Rights (1997) International Declaration on Human Genetic Data (2003) Nuffield Council on Bioethics (2002). The ethics of research related to healthcare in developing countries. http://www.nuffieldbioethics.org/publications/developingcountries/rep00000 00848.asp (accessed 21 August 2006) Nuffield Council on Bioethics (2002). The ethics of patenting DNA. http://www.nuffieldbioethics.org/go/ourwork/patentingdna/publication_310.h tml (accessed 21 August 2006) Constitution of the World Health Organization (1946) Public health, innovation and intellectual property rights. The report of the Commission on Intellectual Property Rights, Innovation and Public Health. (WHO, 2006) United Nations General Assembly Resolution 60/1. 2005 World Summit Outcome. Moran, M. (2005) A Breakthrough in R&D for Neglected Diseases: New Ways to Get the Drugs We Need. PLoS Med 2(9): e302 http://medicine.plosjournals.org/archive/15491676/1/3/pdf/10.1371_journal.pmed.0010056-L.pdf (accessed 2 September 2006) Chokshi, D.A. (2006) Improving Access to Medicines in Poor Countries: The Role of Universities. PLoS Med 3(6): e136 82

Video/Movie Role play

Group discussion Other

http://medicine.plosjournals.org/archive/15491676/3/6/pdf/10.1371_journal.pmed.0030136-L.pdf (accessed 2 September 2006) Meja, A. (2004) Migration of physicians and nurses: a worldwide picture. Bulletin of the World Health Organization 82:559-636 http://www.who.int/entity/bulletin/volumes/82/8/626.pdf (accessed 12 September 2006) Kidneys for Sale (Videos of Television Programs aired in the Philippines), other television documentaries on Organ Trade, Medical Migration, and International Health Research Students are provided with a budget, and asked to prioritise allocation of resources, as well as provide justifications of their decisions Medical Migration and its implications for the provision of health services in developing countries. Organ donation avoiding the exploitation of vulnerable populations International Health Research Standard of Care and the Protection of Vulnerable Subjects

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UNIT 15

Title Sharing of benefits (Article 15)

Unit Learning Objectives 1. Students should be able to understand the need for ensuring that scientific knowledge contributes to a more equitable, prosperous and sustainable world 2. Students should be able to explain that scientific knowledge has become a crucial factor in the production of wealth, but at the same time has perpetuated its inequitable distribution 3. Students should be able to explain the reality that most of the benefits of science are unevenly distributed among countries, regions and social groups, and between the sexes 4. Students should be able to analyse efforts that have been undertaken at various levels to promote the sharing of the benefits of scientific knowledge and research and to explore novel initiatives that may be undertaken 5. Students should be able to identify and assess potentially undue or improper inducements in different research settings/situations Outline of the Syllabus 1. Global justice as basis for sharing the benefits of science and scientific research. 2. International instruments on benefit sharing. a. International Declaration of Human Genetic Data (2003) b. Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (2002) c. Doha Declaration on the TRIPs Agreement and Public Health (2001) d. Human Genome Organization (HUGO) Committee Statement on Benefit Sharing (2000) e. Universal Declaration on the Human Genome and Human Rights (1997) 3. Models of benefit-sharing agreements. a. Fair and equitable options for research subjects. b. Biopiracy and fair sharing of benefits of genetic resources. c. Patents and intellectual property. d. Valid options for promoting fair and equitable access to new diagnostic and therapeutic modalities or to products stemming from them. 4. Integration of capacity-building components to externally funded research and other initiatives. 5. Prohibition of using improper inducements to participate in research. Teacher Manual 1. Global justice as basis for sharing the benefits of science and scientific research. Many benefits of science are unevenly distributed, as a result of structural asymmetries among countries, regions and social groups, and between the sexes. As scientific knowledge has become a crucial factor in the production of wealth, so its distribution has become more inequitable. Principles of global justice should take central place in scientific endeavours. This can be actualized through the long-term commitment of all stakeholders, public and private, through greater investment, the appropriate review of investment priorities, and the sharing of scientific knowledge. 2. International instruments on benefit sharing. International agreements and other documents 84

have been crafted under the auspices of international bodies committed to enhancing opportunities to share the benefits of scientific advances and research. Article 19 of the International Declaration of Human Genetic Data (2003), the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (2002); the Doha Declaration on the TRIPs Agreement and Public Health (2001); the Human Genome Organization (HUGO) Committee Statement on Benefit Sharing (2000); and the Universal Declaration on the Human Genome and Human Rights (1997) are just a few examples. 3. Models of benefit-sharing agreements. This section examines different models for benefit-sharing agreements and the lessons that may be learned from successful and unsuccessful initiatives. Proper assessment should reveal which measures governments could take in order to ensure that the benefits of science and research are made available to the poor. a. Fair and equitable options for research subjects. Agreements for sharing the medical and scientific benefits arising from the involvement of human subjects in health research projects. b. Biopiracy and fair sharing of benefits of genetic resources. The human genome is part of the common heritage of humanity. It is incumbent upon scientists, governments and industry to find ways for the achievements in scientific and technological research to contribute to economic and social progress to developing countries and not only to developed ones. c. Patents and intellectual property. There is a need to create ways of protecting intellectual property rights and at the same time making discoveries and innovations available and accessible to the public, particularly to those populations who need them the most. The Doha Declaration, for example, affirms that the WTO TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all. d. Valid options for promoting fair and equitable access to new diagnostic and therapeutic modalities or to products stemming from them. To ensure the availability of new products and innovations, continuous, time-specified or needs-based supply, local version manufacturing, patent and licensing agreements are just some of the ways that can be explored. 4. Integration of capacity-building components to externally funded research and other initiatives. Apart from access to material results of research, efforts should be dedicated to improving health systems by strengthening local health research capacities. Higher levels of skills and ability to perform research will prove useful in addressing local needs and concerns. 5. Prohibition of using improper inducements to participate in research. While participants should benefit from the research, there is a strong case for the prohibition of inducements that may unduly compromise informed consent or erode autonomy. Study Materials Case 1: The San people and the hoodia plant The forebears of the San people settled in the southern African region some 150,000 Cases years ago. The San currently number about 100,000 and live in the Kalahari region of South Africa, Botswana and Namibia. In apartheid South Africa most of the Khomani San in the Northern Cape region were classified as coloured, did not own 85

land, and worked as farm laborers or domestic help for whites. Their language, culture and hunting practices were dying out by the early 1990s, but after the collapse of apartheid in 1994, the new South African government moved to return ancestral lands to the Khomani San. Land claims were developed based on oral history research and archived information about the traditional lands occupied by the indigenous group, prior to disruption by colonial forces; in recent years the San had not existed as a geographically distinct community. During the 1990s, as they resolved their land claims with the government, the San people also established national and regional councils. In March 1999, a settlement was reached establishing land ownership in the Kalahari region, and the land agreement was formally signed on May 23, 2002. However, to date the communities are poor, in ill-health and lack education and jobs. The Council for Scientific and Industrial Research (CSIR) has a broad mandate in research and development for technology in South Africa. One arm of the CSIR, Foodtek Chemical and Microbial Products, is involved in a number of bioprospecting activities in South Africa and is developing natural products chemistry capacity. While CSIR is a statutory scientific council established by parliament in 1945, its funding from the state has been declining, and as of 1996 only 40% of its funds came from the government, and the remaining 60% was derived from commercial contracts. CSIR has increasingly sought commercial contracts for product development based on compounds identified through natural products research, as it is not equipped to do clinical or toxicological studies. The organization has thus has been under pressure to obtain commercial investments as well as to respond to its mandate from the South African government. The San have used the hoodia plant as an appetite suppressant for many centuries, especially during hunting expeditions where little food was available for many days. In 1963, CSIR became aware of the plants traditional uses, from a 1937 paper by a Dutch ethnobiologist, and from San trackers who had worked for the South African military. In the 1980s, the CSIR revived its interest in the plant and isolated its active ingredient, a compound called P57, which it then patented in 1995. In 1997 the CSIR licensed P57 to a small British biotech company, Phytopharm, which conducted double blind clinical trials of the chemical, confirming its appetite suppressing qualities. In a phase I trial, obese people were given P57 or placebo, and the group receiving the active compound spontaneously reduced their daily food intake by 1000 calories. Phytopharm then sub-licensed the product to Pfizer for $21 million. A lawyer representing the San people in the contemporaneous land negotiations with the South African government found out about the license to Phytopharm of the CSIR P57 patents. The lawyer also became aware that the head of Phytopharm believed that the Khomani San had disappeared. When the Phytopharm CEO was informed of his error, he expressed concern about proper compensation for the San community, I honestly believed that these bushmen had died out and am sorry to hear they feel hard done by. I am delighted that they are still around and have a recognizable community. The ownership of medicinal plants is extremely complex, but I have always believed that this type of knowledge is the most valuable asset of indigenous tribes. Instead of weaving baskets and taking 86

tourists around, royalty payments from medicines could transform their prospects (http://www.thehoodiacactus.com). At CSIR, the head of the P57 project said that he had intended to tell the San about the drug development once a successful product had emerged, so as not to raise false hopes. The attorney representing the San in the land claims communicated the news of the patents to the newly established San political organization, which decided to challenge the lack of compensation for their traditional knowledge. An urgent meeting was called between the Working Group of Indigenous Minorities in Southern Africa (WIMSA), representing San people in several countries in the region, and representatives of CSIR in June 2001. The attorney described the timing of the patent issue as opportune, since the San had recently organized politically to address the land claims and other heritage problems, and so were in a good position to enter negotiations. Under the auspices of WIMSA, a South African San Council was formed in November 2001, which represented the claims regarding traditional knowledge and benefit sharing in negotiations with CSIR. The San did not challenge the patent itself (which could have resulted in loss of profitability as the commercial knowledge then became public) but rather demanded some form of benefit from the commercial development process. In response the CSIR immediately acknowledged that some form of compensation was appropriate and began negotiations with the indigenous peoples representatives. As a result, the San Council and the CSIR entered into a memorandum of understanding in February 2002 recognizing the San contribution in the form of traditional knowledge. WIMSA reports that benefits will be shared not only with the South African San but also with San peoples in other countries in the region: Namibia, Botswana, Angola, Zambia and Zimbabwe. Reaching an agreement took three years of tough negotiations, to quote the San Council chair. Under the terms of the agreement reached between CSIR and the San, announced in March 2003, CSIR will pay 6% of all milestone payments (estimated to be $0.9 to $1.4 million) it receives from Phytopharm, and 8% of all royalties from products developed from P57. Milestone payments are paid upon completion of agreed technical performance targets over a three to four year period. Royalties would be based on sales, which were not anticipated before 2008. Payments are to be made to a trust fund established for the San, the San Hoodia Benefit-Sharing Trust. The Trust includes representatives of CSIR, the regional San Councils, WIMSA, and an observer from the South African Department of Science and Technology. The trust fund can then be used for local development projects in the community. The San plan to use the money for education, jobs, and preservation of their language. As described in a press release, the trust is set up to use income received from the CSIR for general upliftment, development and training of the San Community as approved by the Board of Trustees. The agreement has been hailed as a landmark in more equitable sharing of benefits from traditional knowledge. At a ceremony celebrating the agreement a San participant, said I am happy that others can benefit from our plants. But a San community development facilitator replied: But it would be wrong if fat white people overseas get slim thanks to us while our children go hungry and uneducated. 87

However, as of August 1, 2003, Pfizer discontinued its development program for P57 and returned the sublicense rights to Phytopharm. The Phytopharm Chief Executive commented that considerable clinical and preclinical data have been obtained and that his company is now seeking other partners for commercial development. The drug has been through phase IIa trials and is reported to have clinical promise in the growing market for anti-obesity compounds. The hoodia plant has already made it to the gray market of internet sales of natural products, although the quality of these unrefined and untested supplements is unknown. Discuss the following questions: 1. Is the benefit-sharing agreement reasonable in terms of amount and type of benefit distributed to the San? How can it be determined that distribution of monetary gains through the San Trust fund is reasonable and genuinely beneficial to the San people? 2. In this case, the San were able to negotiate for benefits with CSIR after a patent had already been established. In some cases indigenous groups have been unsuccessful in making claims for benefit sharing. What kind of oversight could be exercised more generally on the part of the government of South Africa or other nations, to provide for benefits to indigenous communities that share traditional knowledge? 3. In this case, indigenous political organizations had already been formed for land claims issues. How can legitimacy of such organizations be determined, especially when the prospect of large financial gain enters the picture? Case 2: Genetic research in Tonga Introduction In 2000, an Australian biotech company, now known as Autogen, secured an agreement with the government of Tonga, an archipelago nation in the South Pacific, to collect blood samples for genetic analysis. The Tongan population seemed well suited to genetic studies of factors relating to diabetes and obesity, since the island community had had relatively little immigration, was genetically isolated, and in recent years has had a high incidence of the diseases in question. The agreement was announced in the Australian press and in stock market reports, but encountered vigorous opposition from Tongan community groups. Ultimately the plans were shelved. Autogen did not collect or analyze samples and instead formed new agreements with Polynesian groups on other islands to gather genetic information. Background Tonga is an archipelago nation in the South Pacific, about 2/3 of the way between Hawaii and New Zealand, consisting of 169 islands, about 36 of which are inhabited. The current population (108,000) of Tonga consists of descendants of Polynesians who colonized the island over 3000 years ago. There is little to no immigration to the islands, and hence little genetic admixture with other groups. The relative genetic homogeneity of the population, along with a high incidence of certain diseases, are seen as an advantage by some researchers looking for specific alleles associated with multifactorial diseases.

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Tonga was united into a kingdom in 1845, and was a British protectorate from 1900 to 1970, when it became independent. The government of Tonga is a monarchy, and includes a prime minister and a cabinet of 12 members, all chosen by the king. There is a legislative assembly of 30 members, of whom 9 are chosen by popular vote. The Tonga Human Rights and Democracy Movement has been pressing for more democratic representation and free press in the country. The church is influential, and approximately 50% of the population belongs to the Church of Jesus Christ of Latter Day Saints (Mormon church) and the majority of the population overall are members of one of several Christian denominations present in the country. Tonga national Council of Churches is a member of the World Council of Churches, which has been involved in supporting human rights movements in various countries around the world. The economy of Tonga is supported by a narrow agricultural base of exports, and some tourism. GDP is approximately $2,200 per capita (2001). Most food is imported ($30 million, 1999), and the country experiences a chronic trade deficit ($96 million in 1999). Australia and New Zealand have both provided economic aid to the country in different forms. There is 13% unemployment. The health profile of the Tongan population is relatively good and literacy is 98.5%; health services are provided free of charge. One of the rising health concerns has been the rate of diabetes and obesity; it is estimated that 15% of the population has diabetes, twice the prevalence reported 25 years ago. Changes in diet and physical activity, including increased consumption of imported fatty foods, overlaid on a probable genetic predisposition for the disease, are believed to account for the rising prevalence of diabetes in this and in other Polynesian populations. The Autogen agreement In November 2000, through negotiations with the government of Tonga, and in particular, the minister of health, Autogen announced an agreement to conduct genetic research for the purpose of discovering disease-related genes in the relatively isolated and homogeneous Tongan population. Newspaper accounts in the Australian press described arrangements for the companys exclusive rights to collect samples, with individual informed consent, for genetic analysis. However, the chief scientific officer of the company stated that the word exclusive appeared nowhere in the Tonga/Autogen agreement. It is important to note that at this stage there was no existing intellectual property, and so the notion of exclusivity could not have related to an IP-based claim to existing property, but rather, apparently, to a perception that the Tonga government had pledged not to make similar agreements with groups other than Autogen. The company planned to target families already identified with diabetes for sampling and genetic analysis. Autogen made a commitment to donate a certain amount of financial support to the ministry of health, including plans for construction of a new research center in the country, and to share some portion of royalties of any commercial products subsequently developed from the Tonga project. The Autogen CEO stated that This major research initiative will benefit Tonga as well as Autogens gene discovery program. The establishment of a research center will create many new job opportunities in scientific research and provide opportunities for Tongan graduates 89

overseas to return to the country and participate in world-class scientific research. We expect the research facility to grow into a major Autogen initiative over the next few years. Autogen had also included an explicit ethics statement in the project agreement; a bioethicist at Boston University, reviewed the agreement and described it as unacceptably vague. Reactions in Tonga The Autogen/Tonga agreement was announced in the Australian stock exchange and in the popular press in November 2000, and was immediately the target of strong criticism from Tongan community groups. The head of the Tonga human rights and democracy movement stated several objections (see: http://planettonga.com/HRDMT), among them a) lack of public discussion of the project in Tonga; b) lack of transparency on the part of the Tongan government about its actions; c) lack of consideration of privacy concerns for families whose members might participate in the project on the basis of individual consent; there was particular concern about stigmatization and discrimination against individuals in the relatively small and insular Tongan society; d) opposition to the notion of patenting DNA and other life forms; e) no guarantees of any benefit for the Tongan people and f) colonial appropriation of resources of the Tongan people. The human rights and democracy leader remarked that the benefits were a drop in the bucket for the Tongan people compared to the material gain that might be realized by the biotech company in attracting new capital and producing successful products. He also pointed out that at the time Tonga or other Pacific Forum countries (Cook Islands, Fiji, Kiribati, Marshall Islands, Federal States of Micronesia, Nauru, Nieu, Papua New Guinea, Solomon Islands, Samoa, Tonga, Tuvalu and Vanuatu) had no existing intellectual property law or regulation of biologic research, and thus limited ability to protect its own IP interests. In March 2001, the Tonga National Council of Churches and the Geneva-based World Council of Churches convened a meeting in Tonga, attended by other Polynesian representatives as well, to discuss the project and the concerns it engendered. The Tonga National Council of Churches published a statement in the Journal of Medical Ethics in 2001, stating opposition to the Autogen project based on religious beliefs, namely, that patenting of life forms was a violation of respect for the sanctity of life and fundamental religious principles. Moreover, this patenting was not in the interest of the Tongans: The conversion of lifeforms, their molecules or parts into corporate property through patent monopolies is counter-productive to the interests of the [people] of the Pacific. The statement also affirmed the Tongans desire to control research conducted in their country: The peoples of the Pacific have the right to manage their own biological resources, to preserve their traditional knowledge and to protect these from expropriation and exploitation by scientific, corporate or governmental interests. Shortly after the protests by Tongan groups, Autogen withdrew its plans for the project and pursued agreements to gather samples elsewhere. Meanwhile the news of the planned project and the controversy had spread and various news accounts were posted on websites and in international media.

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In commentary on this and other genetics projects, Boyes and Senituli remarked that in the context of national debate about genetic research, informed consent thus becomes a question of public consultation and how political will is mobilized, as much as it is about the components familiar to western bioethics of disclosure, comprehension, voluntariness, competence and consent or refusal. They also note that study of decision making in groups may be inherently difficult: Anthropology has well defined methods for the study of collective decision-making, but bioethics is only beginning to articulate the mismatch between individualistic disclosure models of informed consent and population genetic research. Governance and Benefit-Sharing Commercial benefits of genetic research are difficult to predict, especially in the short term. In cases where benefit-sharing agreements are constructed around potential commercial profits, these benefits may not emerge at all in the short- or medium-term. There are also questions about the form and disbursal of benefits to populations, for example as up-front payments or percentage of future royalties that may be dedicated to projects or programs, or as free provision of commercial products of research resulting from the genetic information. Genetic research is often described as holding a promise of increased understanding of multifactoral disease, and better health care for individuals. Some commentators are concerned that these promises are not balanced in relation to more immediate public health concerns for populations that participate in genetic research. In some cases there are expected benefits from the results of genetic research that may be applicable to specific health problems. In the Tongan case, some commentators believed that unraveling the genetic basis of diabetes and obesity would be critical in addressing their increased incidence in Tonga. Experts note that it is a relatively recent phenomenon, and environmental conditions such as Western diet and decreased exercise probably play a key role, as well as genetic background. Some public health experts believe that focusing on genetic research in relation to diabetes and obesity might be inappropriate, in comparison to preventative approaches or use of existing treatment modalities. Some observers are concerned that it is risky to return results of genetics studies to individuals when there is no evidence for making medical decisions based on the new genetic information. This risk might be higher in situations where medical records are linked to genetic analysis. There is also widespread concern about privacy in genetic research, in particular, breaches of privacy that might result in stigma or discrimination, such as denial of employment or insurance. At the same time, there is little documented evidence of harms that have arisen as a result of disclosure of genetic information gathered in research. Some individuals associate genetic research with fears about manipulation of the genome and devaluation of the natural life of human beings. Others claim that some or all of these fears are unwarranted, and that genetic research is inherently no more or less risky than other kinds of non-invasive biomedical research. Discuss the following questions: 1. What ethical concerns arise concerning the ability of national 91

governments to negotiate and decide agreements for genetic research concerning their populations? Can decision-makers be unduly swayed by the potential for commercial profit or valuable collaboration with scientific groups? The islands of Tonga have a history of relationships with colonial powers, including current economic dependence on more industrialized nations. Is this an interesting footnote, or a substantive concern in the negotiation of agreements with foreign companies? 2. Would it have made any difference if the genetic research project were carried out by a non-profit entity, as opposed to a for-profit commercial entity? Non-profits can also acquire patents to DNA sequences or products derived from research on specific genes. Do the overall goals of the research matter? 3. Are risks of research and potential benefits characterized adequately and analyzed as part of the decision-making process at the national level? Was there sufficient public discussion of potential risks or benefits in the two cases? How can benefit-sharing arrangements be evaluated in terms of fairness, transparency, and responsiveness to national needs? How can it be determined that benefits that may accrue to a body or governmental organization in the country can serve the interests of the population? Case 3: the Maya ICBG Introduction In 1996, a project was initiated to collect ethnobotanical information in Chiapas, Mexico, set up as a joint project with four partners: a US university research team, a Mexican teaching and research center, a biotech company, and a non-profit organization set up by the project to represent the interests of the Mayan communities. The multiple aims of the project included preservation of local medicinal plant knowledge and its use to discover new therapies for a range of local and internationally important diseases, as well as the development of local economic and scientific capacity. Controversy erupted as some local and external groups charged that the project was exploitative, while the project partners defended it as mutually beneficial and socially responsible. Collection of plant materials for bioprospecting was never initiated, and the disputes led to withdrawal of the local public research center partner, cessation of funding, and termination of the project. Background on Chiapas The Chiapas region in southern Mexico is a region of extreme poverty, well below national averages for Mexico in important indicators such as child survival, per capita GDP, and educational levels. Approximately one third of the population is Maya speaking, belonging to one of eight language groups. While rich in natural resources, there are few economic opportunities for Chiapas residents, many of whom farm small plots of land. The economic situation for small farmers in the Chiapas region during the 1990s was bad, and it was getting worse, due to changes in prices and trade policies, as well as accelerated degradation of natural resources. Struggles for land reform in the region had been ongoing for many decades, and had led to the formation of many local peasant resistance groups, including, in 1983, the Zapatista Army of National Liberation (EZLN). In 1994, the 92

indigenous peoples of Chiapas gained world attention in an armed uprising of the EZLN, and became international symbol of ethnic resistance to globalization and the struggle for social equality and indigenous rights. In Chiapas, governance was structured at the municipal level; indigenous land ownership had traditionally, and under Mexican law known as the ejido system, been communal. In the early 1990s, government policies protecting communal land ownership in the ejido system was eroding, but in response to the Zapatista uprising, the San Andres accords of 1996 established local indigenous communities as legitimate land owners. The accords were supposed to support indigenous peoples rights in several areas: control of their traditional natural resources; participation in decision-making regarding public expenditures; control of their own judicial and administrative affairs. Subsequently there was disagreement and controversy regarding the implementation of the accords, which were not translated into legislative action or implementation by the Mexican government, creating further bitterness and disillusionment among indigenous communities. Mayan traditions of healing The highland Maya had a long tradition of use of medicinal plants for healing. These herbal traditions were not seen as a distinct class of medicine, but were part of a systemic view of health and healing that involves spiritual healers, prayer, rituals, and herbal preparations, although healers have become aware of the attractiveness of the use of medicinal plants to outside groups. Herbal preparations continue to be an important source of primary health care for the vast majority of Maya residents of Chiapas. The researchers in the ICBG project had studied the degree to which knowledge of herbal remedies was held by community members generally, and planned to study only those herbal preparations used by the community at large. Also, a large proportion of the herbal preparations are based on plants and knowledge that are shared with other communities outside of the region. However, the local healers group was concerned that specialized knowledge was being appropriated by outsiders. Background on bioprospecting Most bioprospecting agreements do not result in economic gain for industrial partners in the short and medium term due to the low chances of developing a successful, marketable drug from plant or microbial sources; long-term benefits may vary, depending on whether products become commercially successful. Some bioprospecting efforts involve use of traditional knowledge in indigenous communities to focus on plants with known medicinal value, while some do not. Companies frequently view other strategies, such as combinatiorial chemistry, as more efficient means of screening compounds with potential activity. However, there is a fairly widespread public perception that multinational drug companies can easily make millions from appropriation of natural resources of countries with rich biodiversity. The Convention on Biological Diversity (CDB) 1992 arose in part, out of concerns about appropriation or exploitation of biological resources in countries without adequate policies or regulations to protect natural resources or their local users. In the Bonn guidelines, which emerged from the CBD, it is recognized that indigenous groups should be able to share in benefits from their traditional 93

knowledge (2002),and Prior Informed Consent (PIC) should be sought in communities where biological resources or traditional knowledge is utilized in research. Under Mexican law, permits for collecting biological specimens need to be obtained from a national ministry, and in addition, permission from the owner of the land is needed for any collection destined for commercial purposes. However, the law does not address intellectual property or bioprospecting per se. The International Cooperative Biodiversity Program (ICBG), started in 1993 and sponsored by 3 US government agencies aims to promote research programs that incorporate a commitment to conservation and biodiversity, as well as local economic development, in bioprospecting research (http://www.fic.nih.gov/programs/oecdub.html). The intent of ICBG projects is that they be contracted as fair partnerships among organizations including research organizations, industrial partners, and community organizations, and to develop outcomes that benefit not only the partners, but also larger social goods locally and internationally. Story of the Maya ICBG The Maya ICBG project involved collecting and cataloguing botanical species of the Chiapas highlands, including development of ethnobotanical gardens for conserving plants, evaluating traditional remedies, compiling monographs in several languages (including local languages) which would describe botanical and medicinal findings. The project's principal investigators had been investigating ethnobotany in the region for almost 30 years. Through the ICBG and other efforts they had begun to publish handbooks on traditional remedies for diarrhea, respiratory conditions, infectious diseases, and contraception in native languages with translations to Spanish and English. The ICBG project involved four partners: a US university; a local Mexican public research center with a long history of multidisciplinary, sustainable developmentoriented research activities in the region; a small biotech company based in Wales, whose mission was to identify promising new plant-based compounds that could then potentially be developed by larger pharmaceutical companies for clinical applications; and the Mayan communities themselves. The more than 250,000 Maya people potentially involved were not grouped in a single overarching organization, but had formed complex, diverse and dispersed political, religious and productionoriented organizations. Given that there was no overarching organization representing Mayan communities, the ICBG project leaders proposed instead PROMAYA: a trust fund initially promoted and governed by regional and national political figures sympathetic with the concerns of indigenous people; this governance was selected by the non-indigenous partners in the project. The project never reached the stage of collections for research with commercial development potential. However, the participating organizations had begun drafting agreements regarding intellectual property. The draft ICBG-Maya Joint Ownership agreement stipulated that Maya communities would receive of any royalties and 94

co-ownership of any licenses that emerged from the researchthe other shares were divided in equal fourths among the US university, the biotech company, and the Mexican research institution. The Maya share was to be paid to the NGO/Trust fund PROMAYA. Decisions taken regarding use of PROMAYA funds were to be made by representatives from each of the participating communities, however funds could also be used for projects that benefited other local communities that declined to participate in the research. Prior informed consent was sought in local villages using Tzeltal and Tzotzil language theatre, in order to meet the current legal requirements established by the Mexican government to provide collecting permits. The informed consent process emphasized that the chances of substantial financial benefits from the project were slim, and that other non-monetary benefits were more significant, such as conservation of traditional knowledge, creation of ethnobotanical gardens, and use of plant-based pest control agents. A consent form was signed, usually by elected community leaders, in each of the 46 villages that decided to participate (out of the 47 villages approached). Twelve percent of the project budget was allocated to salaries for 24 Maya field assistants, who received training in transcription in their own languages, field botanical survey techniques, computer literacy, lab techniques, plant propagation, marketing and IP issues. From the beginning of negotiations regarding the project, the local indigenous healers group, was not involved; they had been informed of the project informally by the Mexican research partner during the grant-writing stage. They did not join in the planning or grant-writing stages of the project, although they did attend a public workshop about the project after the grant was obtained. In challenges to the informed consent process, a consortium of healers groups, which included the local healers group, and an NGO advocating widely against bioprospecting activities alleged that the consent of the participating villages was insufficient, and that national level policies regarding protection of indigenous right and resources would be necessary before any collection could begin. In 1999 the healers consortium directed a letter to local and federal authorities called for a halt to the project. Denunciations of the ICBG project were published on numerous websites, and gathered increasing media attention, and support from observers unconnected to the case or to the region. In 2001 the Mexican research institution withdrew from the project, citing the difficulties arising from the challenges of the healers consortium and the NGO, the need for a self-organized indigenous partner, and for national level regulation to provide some resolution of the impasse. Without a local research partner, the project was no longer eligible for US government grant support, and in November 2001 the project folded. Views of participants and observers in the ICBG-Maya story Two of the US researchers who had set up the Maya ICBG felt that NGOs had 95

disrupted the research project in a setting where national level regulation was lacking: We argue these [local, national, and international] NGOs, as part of their unjustified equation of legitimate access to biological resources with what they call biopiracy, have usurped the rightful authority of local communities to act on their own behalf concerning the use of their own resources resources that increasingly represent their best entry point into the world economy. The researchers argue that after the local group opposing the project, COMPITCH, contacted RAFI, the latter provided a consultant who attempted to sabotage all possible negotiations between the project and the healers group when the Mexican government took extraordinary measure to arbitrate the dispute in the early 2000. As a result, both the Mexican government representatives and we were forced to conclude that COMPTICH was not negotiating in good faith. The position of the US researchers was that universal consensus among communities with shared knowledge is impossible and could not be a requirement for conducting research, and that knowledge that is widespread among many diverse groups is, by definition, publicly held. Does one person who opposes a project that offers an opportunity for sustainable development, social and economic benefits prevent all others from taking advantage of the opportunity? Does control of intellectual property only apply to veto power of a single individual? Our answer is that it does not. One of the scientists at the company that partnered in the ICBG similarly felt that the NGOs role was out of place: Clear winners in the biopiracy war are the biopiracy lawyers who often have large salaries and a vested interest in making the process of reaching legal agreement of bioprospecting long and complex.clear losers are the indigenous peoples who often have no direct say in the campaigns on their behalf and who might benefit more from patents than protection by action groups of well-heeled activists in cities. The program director at one the US sponsoring agencies, described ways that political tensions can derail projects and make negotiations difficult. Emotionally charged issues related to human rights, land tenure, the ability of poor communities to exploit the patent system and the morality of patenting inventions derived from study of living organisms (patenting life) frequently inject themselves into the debate.The tensions are frequently at play even where culturally well-defined community governance systems 96

exist, and may be overwhelming to a partnership that depends on participation of communities where such governance systems are lacking or poorly integrated with western legal systems. In such situations, global or national politics that might be considered external to local questions of stewardship and collaboration easily inflame the discussion. Another commentator echoed the concern that local governance can be a critical factor in establishing agreements: In many cases, the diversity of political organization among local groups or the lack of strong regional or national Indigenous institutions will make the application of the concepts [of prior informed consent/prior informed approval] very problematic. Communities will likely have conflicts within and between themselves over strategies for disseminating their knowledge and the compensation they desire, and there may be no indigenously controlled mechanisms for sorting out the conflicts. Some local observers expressed reservations about the project. A Mexican physician working in the area and a longstanding member of the local healers group, felt that the project had isolated the use of plant medicines from the whole context of the Mayan approach to medicine, and that this was doing a disservice to the traditions of healing as part of an entire belief systema view shared by some anthropologists working in the Chiapas region. This physician, as well as members of the local Mexican institution, felt that the huge amounts of time and energy spent trying to get the ICBG project moving forward were disproportionate, given the poverty of the region and the needs of the population, such as treatment for local endemic diseases of poverty. Although he insisted that he had nothing against [a US researcher] or his research prior to the ICBG Maya project, [the physician] added that he sometimes thought the whole thing ironic. How could researchers come to Chiapas and listen to people for years, then try to re-package what they learned to those very same people? The issue of the adequacy of local representation was one of areas that led to objections by the local and external groups. The Mexican research partner, after engaging in government-mediated negotiations with the healers group in an effort to resolve the controversy, published a commentary in a major national newspaper, analyzing the pitfalls of ICBG experience, and reaffirming its commitment to developing fair agreements with indigenous communities. While describing the Maya ICBG as a project in evolution, the statement reflected frustration about the impasse between the projects supporters and detractors: Aside from the fact that the non-indigenous advisors of [the healers consortium] have systematically sought, in a variety of forms of mass media, to denigrate [the Mexican research institution] and its objectives of participating in this project, our desire has been to promote dialogue and information exchange, thus avoiding the addition of a new conflict to the already deteriorated social fabric of Chiapas.

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The Mexican research institutions document announced that bioprospecting permits would not be further pursued by the ICBG project until socially accepted legal requirements were put in place by the government, and until a self-organized, representative indigenous organization joined the ICBG Maya project as full partner. The charge of inadequate Mayan representation was also made by outside NGOs. The NGO that challenged the project protested the design of the Maya ICBG on the grounds that many in the Maya community opposed the project, and that outsiders, they alleged, were making decisions for the indigenous people: Neither well-meaning anthropologists nor civil society organizations can make decisions for indigenous peoples; nor can outsiders appoint organizations to determine who will legitimately represent the interests of indigenous communities. The document from this NGO also makes reference to the lack of formal legal protections for indigenous communities: Equity-based bioprospecting is a myth in the absence of regulatory mechanisms that safeguard the rights and interests of farmers, indigenous peoples and local communities (http://www.etcgroup.org/documents/news_ICBGterm_Nov2001.pdf). There seems to be some difficulty in coming to agreement about the best ways to protect the rights and interests of indigenous groups. On the one hand, including indigenous groups in intellectual property benefits is meant to be a fair way to compensate these groups for their contribution to useful knowledge. On the other hand, the involvement of commercial entities and the logic of intellectual property law may arouse suspicions of exploitation or disrespect. Is this due to a fundamental philosophical difference regarding uses of knowledge, or is it a misunderstanding? Mashelkar, while recommending that continued efforts are needed to reach appropriate benefit-sharing models, comments on the challenges of divergent cultural views: The existing IPR systems are oriented around the concept of private ownership and individual innovation. They are at odds with indigenous cultures, which emphasize collective creation and ownership of knowledge. There is a concern that IPR systems encourage the appropriation of traditional knowledge for commercial use, and that too without the fair sharing of benefits of the holders of this knowledge. They violate the indigenous cultural precepts by encouraging the commodification of such knowledge (http://sustsci.harvard.edu/ists/TWAS_0202/mashelkar_undated.pdf). Discuss and determine what particular ethical issues are most critical in this case: 1. Is it primarily about the need to define informed consent at the community level? 2. The potential for exploitation of indigenous knowledge for the benefit of others? 3. The capacity of these endeavours to actually make a difference in community development? 98

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Video/Movie Role play Group discussion Other

4. The need to respect cultural norms in disadvantaged communities? 5. The interference of external private organizations in agreements between researchers and community members? 6. The degree of protection provided under current Mexican National law or under international contract law? UNESCO World Conference on Science (1999) Declaration on Science and the Use of Scientific Knowledge. http://www.unesco.org/bpi/science/content/docum/declare.htm Universal Declaration on Bioethics and Human Rights (2005) Universal Declaration on the Human Genome and Human Rights (1997) International Declaration on Human Genetic Data (2003) Secretariat of the Convention on Biological Diversity (2002). Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization. Montreal: Secretariat of the Convention on Biological Diversity; http://www.biodiv.org/programmes/socio-eco/benefit/bonn.asp WTO Ministerial Conference (2001). Declaration on the TRIPS Agreement and Public Health. Doha: World Trade Organization. Nuffield Council on Bioethics (2002). The ethics of research related to healthcare in developing countries. http://www.nuffieldbioethics.org/publications/developingcountries/rep00000 00848.asp Nuffield Council on Bioethics (2002). The ethics of patenting DNA. http://www.nuffieldbioethics.org/go/ourwork/patentingdna/publication_310.h tml Maurer, S.M., Rai, A. and Sali, A. (2004): Finding Cures for Tropical Diseases: Is Open Source an Answer? PLoS Med 1(3): e56 http://medicine.plosjournals.org/perlserv/?request=getpdf&file=10.1371_journal.pmed.0010056-L.pdf Correa, C. M. (2004): Ownership of Knowledge the role of patents in pharmaceutical R&D. Bulletin of the World Health Organization 82:784-790 http://www.who.int/bulletin/volumes/82/10/en/784.pdf Capron, A.M. and Reis, A. (2005): Designing an Equitable Strategy for Allocating Antiretroviral Treatments. PLoS Med 2(3): e69 http://medicine.plosjournals.org/perlserv/?request=getpdf&file=10.1371_journal.pmed.0020069-L.pdf Video on Responsibilities of Health Researchers in Africa (Harvard School of Public Health, 2003)

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UNIT 16

Title Protecting future generations (Article 16)

Unit Learning Objectives 1. Students should be able to explain the principle of protecting future generations 2. Students should be able to evaluate the possibilities and difficulties in the application of the principle in practical settings Outline of the Syllabus 1. Why care about the future? a. contexts of concern b. contemporary sensibility towards future generations 2. The scope and limits of future related responsibilities a. Intergenerational; distant generations, all unborn generations? b. Human or non-human species? 3. Do we have obligations to the possible people of the future? 4. How to represent the future in present decision-making? 5. Healthcare and future generations a. Prescription of medication without any rationale (e.g. antibiotics, etc.) is a threat to future generations long-term effects of medicine b. Xenotransplantation c. Genetically modified food d. Germ-line genetic interventions 6. Precautionary Principle Teacher Manual 1. Why care about the future a. Start by exploring in what context the concern for future generations has emerged. i. Many countries are rapidly developing. At the same time, economic growth has consequences such as growing inequity or environmental degradation. Economic growth is often based on natural resources (such as oil or wood) that are diminished, destroyed or consumed. If present trends continue, the world will be more crowded, more polluted, less stable ecologically and more vulnerable to disruption. In this context, the notion of sustainable development(see Unit 17) or development without destruction has been introduced. ii. The 1987 Report of the World Commission on Environment and Development (with the title Our Common Future) defines sustainable development as development that meets the needs of the present without compromising the ability of future generations to meet their own needs. The key idea is that the needs of present and future generations must be taken into account. iii. Responsibility for future generations has been endorsed in many international documents. An example is the 1992 Rio Declaration on Environment and Development. iv. The ethical context of the principle is articulated in the Declaration on the Responsibilities of the Present Generations towards Future Generations, adopted by UNESCO in 1997. Article 4 of this Declaration states that The 100

2.

3.

4.

5.

present generations have the responsibility to bequeath to future generations an Earth that will not one day be irreversibly damaged by human activity. b. It is argued (see, for example, Agius, 2006) that three factors are responsible for the contemporary sensibility towards future generations: i. technology has altered the nature of human activity which is now impacting on not only the lives of people living now but of those who will live in the future; ii. present-day reality is interdependent and interrelated; for example, environmental disasters in one region will affect other regions and other generations; iii. the increasing awareness of the finitude and fragility of our existence and our one and only Earth, as the UN Secretary General said in 1998. The concept of moral responsibilities towards future generations is also related to the concept of intergenerational justice. It implies that the activities of present generations are limited by the obligation to take into account and safeguard the development and needs of future generations. Traditionally, justice has been defined as giving to everyone his or her due. By promoting obligations to future generations as a matter of justice, a new discourse of intergenerational justice has been introduced. Arguing that we have responsibilities to posterity or obligations of justice towards future generations is, however, problematic. Does it make sense to claim that we have responsibilities towards persons who do not yet exist? What exactly do we mean if we speak about future generations: our children or grandchildren who have just been born, human beings who are not yet born and who we cannot even consider as individual persons, or all distant generations, human and non-human, who will inherit the earth from us? Two positions are usually defended: a. we only have a moral relationship with generations of the immediate future; our obligations only extend to the succeeding one or two generations. Crucial here is the view that it makes only sense to talk about moral responsibility if there are moral relationships; b. all future generations can claim that we take them into account; we therefore have responsibilities to even far-distant future generations. Central here is the concept of common heritage; that which belongs to all humanity cannot be considered simply as unexplored and unclaimed territories suitable for expropriation and exploitation on a first-come, first-served basis. Earths resources belong to all generations. How do we represent the future in present decision-making? a. Even if we agree that moral concern for future generations is necessary, what kind of obligations do we have to people who do not yet exist or who might even not ever exist? We do not know what will be the needs of future generations since their identity is dependent or contingent on many factors. Future generations can, by definition, not have any claims upon us because they are not present to make them. b. A solution to this last problem is to have others who act on their behalf. Some have proposed the establishment of an office of guardian to represent future generations at national, regional and international levels. It is a matter of justice to give voice to the voiceless. Institutional mechanisms should therefore be created to make our responsibilities towards future generations a reality. Discuss this option. Take the example of the Commission for Future Generations, created in Israel. Discuss whether and how a similar approach could be realised at international level, for example by creating a UN Commission. Analyse the advantages and disadvantages. In healthcare, there are several examples of technological and scientific progress that have 101

serious impact on future generations. Discuss the case of xenotransplantation, genetically modified food or germ-line genetic interventions. 6. One principle that is often used in this context is the precautionary principle. Where a threat to health or the environment is serious and imminent, we cannot afford to wait for a high degree of proof before acting to prevent damage. If we wait too long, especially the interests of future generations will be irreversibly damaged. Examine this principle, its definitions and applications. Study Materials Case 1: Commission of Future Generations The Israeli Commission for Future Generations was created according to the Knesset (Parliament) Law. The idea at the base of the Commission is to create an innerparliamentary entity, which will have a comprehensive sight of the legislative picture. The Commission overviews the legislative process with special regards to long-term issues and attempts to prevent potentially damaging legislation from passing in the Knesset. The Commission is given the authority to initiate bills that advance the interests of the future generations and advises Members of the Knesset and Knesset Committees over the legislative process. Furthermore, the Commissioner has the authority to delay the legislative process in case he or she will find it necessary to seek more time to formulate the position over the matter. In addition, the Commissioner has the authority to retrieve information from all governmental entities, such as ministries, public companies, state institutions, enterprises and more. The purpose of the Commission is to preserve the resources of this country and create sustainable infrastructures for the coming generations. According to the law, the Commissions authority concentrates on the following areas: environment, natural resources, science, development, education, health, state economy, demography, construction, quality of living, technology and law. The Commission is entitled to: 1. Present its position on bills brought before the Parliaments Plenum that are of interest to the future generations. 2. Present its stand on sub-legislations and regulations, brought by the government before the Parliaments different Committees that are of interest to the future generations. 3. Provide the Parliament, from time to time, with recommendations on any matter the Commissioner considers being of importance regarding the future generations. 4. Advise the Members of the Parliament on matters that are of special interest to the future generations. The opinions and the recommendations given by the Commissioner have to carry a scientific character, be detailed and include comparative research. Case 2 : Germline interventions Case 3: Xenotransplantation 102

Cases

Case 4: Genetically modified food Case 5: Climate change

Readings

COMEST: The Precautionary Principle. UNESCO, March 2005. http://unesdoc.unesco.org/images/0013/001395/139578e.pdf UNESCO: Declaration on the Responsibilities of the Present Generations toward Future Generations. Paris, 1997. E.Agius: Environmental ethics: Towards an intergenerational perspective. In: H.ten Have (ed): Environmental ethics and international policy. UNESCO Publishing, Paris, 2006, p.89-115. World Commission on Environment and Development: Our common future. Oxford University Press, Oxford, 1987. A.S. Daar & L.E. Chapman: Xenotransplantation. In: UNESCO: Ethics of Science and Technology. Explorations of the frontiers of science and ethics. Paris, 2006, p. 101-128. http://unesdoc.unesco.org/images/0014/001454/145409e.pdf

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UNIT 17

Title

Protection of the environment, the biosphere and biodiversity (Article 17)

Unit Learning Objectives 1. Students are able to explain how bioethics is related to environmental issues 2. Students are able to analyse environmental issues from enthropocentric, biocentric and ecocentric ethical perspectives 3. Students should be able to describe what is sustainable development Outline of the Syllabus 1. Ethics and the environment: views of nature a. The relation of bioethics and environmental issues b. Background 2. Ethical perspectives a. Anthropocentric environmental ethics: human centred ethics b. Non-anthropocentric environmental ethics i. Biocentric: other living organisms have intrinsic value ii. Ecocentric: ecosystems have intrinsic value as well c. Basic principles of environmental ethics i. environmental justice ii. intergenerational justice iii. respect for nature 3. Notion of sustainability a. A new ethics of conservation and stewardship b. What is sustainable development? 4. Respect for traditional knowledge Teacher Manual/Resources 1. Ethics and the environment: views of nature a. Ethical concerns with the environment i. Characteristics: 1. extends the scope of ethical concerns beyond ones community and nation to include also animals and the whole of nature 2. interdisciplinary 3. plural: different approaches 4. global: the ecological crisis is a global issue 5. revolutionary: it challenges the anthropocentrism of modern ethics b. Background i. ecological crisis first noticed in 1960s and 1970s ii. Report of the Club of Rome (Limits to Growth) in 1972 iii. first United Nations environmental conference in Stockholm in 1972 iv. Birth of environmental ethics in 1970s 104

2.

3.

v. 1992 Rio Earth Summit Conference vi. 2000: UN Millennium Declaration: the core of our environmental concerns has to do with the threat of living on a planet irredeemably spoilt by human activities, and whose resources would no longer be sufficient for the needs of all humanity, and above all, the needs of our children and grandchildren vii. UN Millennium Declaration: clearly indicates the object of environmental concern: current unsustainable patterns of production and consumption Ethical perspectives There are different schools of environmental ethics. They differ as regards (1) the scope human duties towards others, (2) ethical methodologies, and (3) cultural context a. Anthropocentric environmental ethics: human centred ethics i. human beings have moral duties only towards one another ii. human interests prevail over the interests of other species iii. ethical methodologies: utilitarianism and deontology iv. more related to Western culture (in which nature often has an economic value) b. Non-anthropocentric environmental ethics i. Biocentric: other living organisms have intrinsic value 1. all life forms are moral patients, i.e. subjects that are entitled to moral consideration 2. it is therefore an ethical imperative to respect all life forms 3. all organisms have intrinsic value 4. more related to non-western cultural traditions ii. Ecocentric: ecosystems have intrinsic value as well 1. nature as a whole is a moral patient 2. all organisms and entities in the ecosphere, as parts of the interrelated whole, are equal in intrinsic value 3. holistic methodology c. Basic principles of environmental ethics i. environmental justice 1. environmental benefits and burdens should be equally distributed 2. opportunities to participate in decision-making concerning environmental issues should be equally provided ii. intergenerational justice 1. every generation should leave the following generation an equal opportunity to live a happy life, and should therefore bequeath a healthy earth (see Unit 16) iii. respect for nature 1. the prosperity of human beings depends on the prosperity of nature. Human beings are part of nature. They have therefore the duty to conserve and protect the integrity of the ecosystem and its biodiversity Notion of sustainability 105

a. 2002 Johannesburg Declaration on Sustainable Development: a new ethic of conservation and stewardship should be adopted, focussing on: i. measures to curb global climate change (reduction of emissions of greenhouse gases) ii. conservation and management of all types of forests iii. better use of water resources iv. intensified cooperation to reduce the number and effects of natural and manmade disasters v. fundamental change in the lives of the affluent vi. equitable access to resources b. What is sustainable development? i. Original definition given in report of World Commission on Environment and Development (1987): sustainable development is development that meets the needs of present generations without compromising the ability of future generations to meet their needs. ii. Two important qualifications: 1. the needs of the poor are central in sustainable development 2. the only constraint on sustainable development is the state of technology and social organisation in society iii. Different views of sustainable development 1. Weak notion of sustainability: Classic view: integration of economic, socio-political and ecological spheres: three components of sustainable development but interdependent and mutually reinforcing; problem is that they are often viewed as separate spheres with their own logic and values; often also trade-offs between human and social development and ecological concerns; economic growth and social development often have priority. This notion of sustainability is also strongly anthropocentric; human beings and their needs are the point of departure; everything in nature has instrumental value, contributing to achieving human purposes. 2. Strong notion of sustainability In order to prevent a continuing decline of natural resources over time, a drastic change in patterns of production and consumption is necessary; the way we are using natural resources need to be transformed. It is necessary to emphasise the intrinsic value of nature; nature has a value in and of itself, regardless of any benefits for humans. It is therefore more helpful to regard sustainable development as three embedded spheres; the spheres are intertwined from the outset. 4. Respect for traditional knowledge Study Materials Cases H. ten Have (ed.): Environmental Ethics and International Policy. UNESCO Readings Publishing, 2006. World Commission on Environment and Development: Our Common Future, 106

1987 (selected parts) http://www.un-documents.net/wced-ocf.htm World Summit on Sustainable Development: Johannesburg Declaration on Sustainable Development, 2002 http://www.un.org/esa/sustdev/dcouments/WSSD_POI_PD/English/POI_PD. htm United Nations Conference on Environment and Development in Rio de Janeiro, 2000 (principles of sustainable development) http://www.un.org/documents/ga/conf151/aconf15126-1annex1.htm United Nations: Agenda 21. Programme of Action for Sustainable Development, New York, 1994 http://www.un.org/esa/sustdev/documents/agenda21/english/agenda21toc.htm (English) http://www.un.org/esa/sustdev/documents/agenda21/french/action0.htm (French) United Nations Millennium Declaration, 2000 http://www.un.org/millennium/declaration/ares552e.htm

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Movie: An inconvenient truth (2006) Humanity is sitting on a ticking time bomb. If the vast majority of the world's scientists are right, we have just ten years to avert a major catastrophe that could send our entire planet into a tail-spin of epic destruction involving extreme weather, floods, droughts, epidemics and killer heat waves beyond anything we have ever experienced. If that sounds like a recipe for serious gloom and doom -- think again. From director Davis Guggenheim comes the Sundance Film Festival hit, An Inconvenient Truth, which offers a passionate and inspirational look at one man's fervent crusade to halt global warming's deadly progress in its tracks by exposing the myths and misconceptions that surround it. Discuss the 17 Principles of Environmental Justice Analyse the statement of the First National People of Colour Environmental Leadership Summit, issued in 1991: http://gladstone.uoregon.edu/~caer/17principles.html Develop policy recommendations on the basis of the principles of environmental justice o at individual level o at national level o at international level Point out what will be the practical implications of such policies Indicate which implications you yourself currently bring into practice

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