Professional Documents
Culture Documents
TABLE OF CONTENT
Core Curriculum Content
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35
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52
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UNIT 12: Respect for Cultural Diversity and Pluralism (Article 12)
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72
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83
99
103
Title
1
2
3
4
5
6
7
8
9
10
11
12
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14
15
16
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
17
Content Note
Hours
(60 mins)
2
2
2
2
1
2
2
1
2
2
2
2
2
2
2
1
1
30
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
UNIT 1
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
3.
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
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b.
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
c.
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
e.
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
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
14
UNIT 2
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
3.
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
4.
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.
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.
Cases
Readings
Video/Movie
Role play
Group
discussion
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)
Other
21
UNIT 3
2.
3.
4.
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
Group
discussion
Other
UNIT 4
3.
4.
5.
6.
7.
28
Readings
Video/Movie
Role play
31
UNIT 5
2.
3.
4.
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.
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
Group
discussion
Other
35
UNIT 6
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
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.
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
2.
ii.
iii.
iv.
v.
vi.
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.
Dickens B., Cook R., Kismodi E. (Eds.): Reproductive Health: Case Studies
with Ethical Commentary (UNESCO Chair in Bioethics, 2006)
Video/Movie
Role play
Group
discussion
Other
48
UNIT 8
Title
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
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?
Other
52
UNIT 9
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
Readings
Video/Movie
56
Role play
Group
discussion
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
Other
58
UNIT 10
b.
c.
d.
e.
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
Readings
Video/Movie
Choosing core health services
Role play
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
Group
discussion
Other
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
Is there a right to health care in your country? What does it mean in practice?
62
UNIT 11
Readings
Video/Movie
Role play
Group
discussion
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 )
Other
67
UNIT 12
2.
3.
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
Video/Movie
Role play
Group
discussion
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 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.
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UNIT 13
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/
Group
discussion
solidarity between the rich and the poor; the rich should contribute to provide
health care for the poor
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
Other
76
UNIT 14
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
Video/Movie
Role play
Group
discussion
Other
83
UNIT 15
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.
88
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
90
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
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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
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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
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97
Readings
Video/Movie
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
Role play
Group
discussion
Other
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UNIT 16
2.
3.
4.
5.
Cases
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
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Readings
Video/Movie
Role play
Group
discussion
Other
103
UNIT 17
Title
2.
3.
Video/Movie
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.
Role play
Group
discussion
Other
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