1. Summary: The 13th session of the International Bioethics
Committee (IBC) examined the preliminary reports of its working
groups on social responsibility and health and on consent. During
the debate on social responsibility and health, IBC members
reiterated their independence from UNESCO itself and member states.
The debate on consent focused on patient autonomy, the different
types of consent, and regulation of the flow of information related
to a patient's right to know. A UNESCO official urged that the
reports and subsequent debate adhere to the principles and language
contained within the Declaration itself. End Summary.



2. Following the adoption of the Universal Declaration on Bioethics
and Human Rights in 2005, the International Bioethics Committee
(IBC), at its 12th session in Tokyo in December 2005, decided to set
up two commissions in order to prepare reports concerning two
principles stated in the Declaration: one on consent (Articles 6 and
7) and one on social responsibility and health (Article 14). This
session of the IBC sought to assess and debate the preliminary
reports of the two working groups.



3. At the opening, Henk ten Have, Director of the Division of the
Ethics of Science and Technology, gave a detailed account of
activities undertaken by UNESCO for the dissemination, the
promotion, the application, and the elaboration of the principles of
the Universal Declaration on Bioethics and Human Rights.

Social Responsibility and Health


--------------------------





4. Director-General Matsuura stressed that the IBC should adopt a
different approach than other international forums such as the World
Health Organization. Nouzha Guessous-Idrissi (from Morocco) recalled
that the IBC's role is not to replicate work already done by other
organizations, but to refocus and redefine the debate from the point
of view of bioethics. She stressed the importance of Article 14 of
the Declaration as it acts as a synthesis of the Declaration itself,
as well as parts of other existing declarations, for example Article
27 of the Universal Declaration on Human Rights. An invited expert,
William Schabas from the Irish Centre for Human Rights, linked the
debate on Social Responsibility to Article 27 of the Universal
Declaration on Human Rights. He stated that if there is a right to
benefit, then people who have that right also have a right to
determine the direction of research. While holding up a photo of
Eleanor Roosevelt, he made a gratuitous remark against the United
States by saying that the U.S. was "at one time" a leader in the
development of human rights. Gabriel d'Empaire (from Venezuela),
Vice-Chairperson of the IBC, called for specific levels of
responsibility, a precise definition of the concept of "highest
attainable standard of health" with criteria for the realization of
this goal, and rational selection of necessary medicine.



5. Numerous IBC members complained that the developing world has not
received the benefits of health care technology. Donald Evans (from
New Zealand) stated that the world needs international
responsibility, declaring that developed countries exploit
developing countries. Gamal Ibrahim Abou Serour (from Egypt) claimed
that governments in developing countries are complicit in the brain
drain. Claude Huriet (from France) said that improving health in
developing countries does not come from innovation and technology.
He insisted that basic needs can and shall be satisfied without
access to the latest technology. Prakash Narain Tandon (from India)
asserted that the objective of the IBC is to reduce gaps between the
rich and poor countries and within countries.



6. Jeanine-Anne Stiennon (from Belgium) said that governments cannot
provide health care for their entire populations. For example, in
Europe, citizens over the age of 70 do not receive the cancer
medications and other forms of health care promised their
government. Prakash Narain Tandon asserted that inequities exist in
the United States: 35 million people go hungry and 30 million people
have to pay for their health care. He said that it would be a
disaster if health care became part of the world economy as the
World Bank has suggested. Kwang-ho Meng (from South Korea) insisted
that bad lifestyles are responsible for fifty percent of today's
health problems. He said that fighting against malnutrition is one
of the best ways to improve world health.



7. Some IBC members linked the debate on bioethics to the debate on
intellectual property rights. Toivo Maimets (from Estonia) argued
that the world needs public financing for the development of
important drugs with no patent protection. Jean Martin (from
Switzerland) argued against intellectual property rights and also
suggested creating a convention against smoking. William Schabas
argued that the inability to obtain access to needed medicine
constitutes a human rights violation.



8. Arguing that inequalities in health care are immoral and
unethical, Jean Martin insisted that the IBC take advantage of its
independence to display courage in the drafting of its documents and
recommendations, even if it is sometimes politically and
diplomatically incorrect. Marwan Hamade (from Lebanon) argued that
the IBC should limit its objectives specifically to what is in
Article 14 and that the role of the working group report should be
to give new rules of engagement on social responsibility. All
members agreed that the report should convince stakeholders at all
levels, to adopt socially responsible behavior. Jeanine-Anne
Stiennon suggested that the word 'should' be changed to read 'shall'
in Article 14 of the Declaration.

Consent


--------------------------





9. IBC Members discussed autonomy and consent and the problem posed
for uninformed patients.



10. Members discussed the problem of paternalism as it affects the
doctor-patient relationship. Members said that paternalism should be
avoided; however, Ole Johannes Hartling (from Denmark) noted that in
some situations, i.e. for unconscious patients, paternalism is
occasionally necessary. In paragraph 26 of the report, it is stated
that the relationship between the doctor and the patient "cannot be
equal to equal." Gabriel d'Empaire commented on this point, saying
that this should not be presented as fact rather that the
relationship depends on circumstances.



11. Ching-li Hu (from China) argued that cultural differences should
be taken into account. He explained that in China, medical decisions
are often made by the family as a whole. Sissel Rogne (from Norway)
objected to this idea of putting emphasis on the family decision
making model due to the fact that this touches upon gender issues
related to patient autonomy. Mr. ten Have countered that cultural
differences do exist, but that this cannot be used to say that
principles of consent do not apply. He insisted that in any
discussion of an exception to informed consent, the exception must
be made in relation to principles found elsewhere in the
Declaration.



12. Many IBC members brought up the difference between consent at
the clinical treatment level and at the research level. Members
repeatedly asked for greater elaboration on what consent is in each
scenario. Mr. ten Have argued that this question must be clarified
by referring to the terms used within the Declaration itself.



13. Concerning secondary usage of biological samples for scientific
research, paragraph 79 of the draft report states that it is "not
acceptable" to obtain "overall prior consent." Ephrat Levy-Lahad
(from Israel) expressed concern about this language as many biobanks
currently obtain this kind of consent when dealing with the
secondary usage of biological samples in scientific research. A
Canadian observer intervened on this point to comment that in Canada
and the U.S., the use of samples for secondary research is subject
to ethics committee reviews and that secondary consent can be
waived.



14. Debating on patients' right to know/not to know, Claude Huriet
(from France) and a Tunisian observer commented on the need for the
report to address the role of the media. Both delegates said that
much of the information available online is not accurate. The two
delegates stressed the adverse effects that incorrect information
can have on informed consent and the doctor-patient relationship.



15. In paragraph 31 of the draft report, the "right not to know" is
mentioned. Several IBC members requested a more in-depth exploration
of this topic within the report. However, ten Have reminded members
that "the right not to know" is not mentioned within the Declaration
itself. He maintained that there must be a correlation between the
report and the Declaration.



16. Observers from the Ivory Coast and Tunisia requested that the
report make a distinction between a legitimate representative and a
legal representative in situations where a patient may be unable to
give consent. Fawaz Saleh (from Syria) remarked that the question of
legitimate and legal representatives is something that originates in
domestic law of a state. In addition, he argued that a legal
representative is always a legitimate representative, but a
legitimate representative is not always a legal representative.



17. COMMENT: IBC members (36) are appointed by the DG as
"independent experts" to make recommendations and give advice.
(Edmund Pellegrino, Chairman of the President's Council on
Bioethics, is a member of the IBC but was not able to attend this
meeting.) It is one of several such bodies (COMEST is another,
particularly problematic one). Pronouncements of IBC may sound to
the outside world as if they represent UNESCO views. In addition,
it can be used to start momentum for and influence the direction of
normative instruments. In 2005, the IBC presented a draft Bioethics
Declaration to Member States that was largely unsatisfactory to
Member States (for different reasons), and had to be rewritten; but
because the IBC draft was the starting point, the process was
difficult and constrained. The existence of these bodies of
"independent experts" raises serious governance questions; the USG
may want to consider whether to challenge the creation and
continuation of these bodies. END COMMENT.
OLIVER