USUNESCO: NEGOTIATIONS ON BIOETHICS DECLARATION

UNCLAS SECTION 01 OF 03 PARIS 005195

SIPDIS

FROM USMISSION UNESCO PARIS

STATE PASS HHS - BILL STEIGER
STATE PASS OSTP - GENE WHITNEY

E.O. 12958: N/A
TAGS: TBIO UNESCO KSCI HHS
SUBJECT: USUNESCO: NEGOTIATIONS ON BIOETHICS DECLARATION


1. SUMMARY. The second and final session of the
Intergovernmental Meeting of Experts met June 20-24 at
UNESCO and reached consensus on a draft "Universal
Declaration on Bioethics and Human Rights." The US was
successful in adding to the draft Declaration a statement
that one of the aims of the Declaration is ensuring respect
for the life of human beings and in deflecting efforts to
have the document include "right to health," "special
responsibility of human beings for the protection of the
environment," and various other social agendas as bioethical
principles. The United States received appreciation for its
proposal concerning the "social responsibility" article, and
this was instrumental in helping the US successfully oppose
objectionable provisions. The draft declaration will be
sent forward to the UNESCO General Conference in October
2005 for consideration and likely adoption. The negotiations
were challenging but were generally conducted with respect.
However, the process was deficient in several respects,
resulting, inter alia, in insufficient time for governments
to review and comment on the final revised text and meeting
report. END OF SUMMARY

BACKGROUND


2. The first session of the Intergovernmental Meeting of
Experts Aimed at Finalizing a Draft Declaration on Universal
Norms on Bioethics was held April 4-6, 2005. It considered
the Preliminary Draft Declaration prepared by the
independent International Bioethics Committee (IBC). The
April session demonstrated widespread dissatisfaction by
member countries with the IBC draft, but no consensus on the
major issues, including the scope of the Declaration.
Following this meeting, an informal discussion was convened
by Ambassador Pablo Sader (from Uruguay),Chairman of the
Meeting. Sader attempted to find compromise on the basis of
that discussion and other consultations.

RESPECT FOR HUMAN LIFE


3. The Second Session of the Intergovernmental Meeting was
held at UNESCO headquarters, June 20-24, 2005. At that
meeting, the U.S. was successful in adding to the article on
Aims (Article 2(iii) of the draft Declaration) a provision
on respect for the life of human beings. Any reference to
respect for the life of human beings had been vigorously
opposed by a number of states in the previous meeting. The
draft Declaration now states that one of its aims is "to
promote respect for human dignity and protect human rights,
by ensuring respect for the life of human beings.." The
Declaration recognizes human life (or respect for it) as a
part of human rights and thus incorporates it into the
various provisions of the Declaration in which the term
"human rights" is used. The ability to obtain consensus for
this provision was facilitated by inclusion at the urging of
the U.S. of language in the preamble that the Declaration is
to be understood consistent with domestic and international
law (see paragraph 6).

SCOPE


4. The U.S. delegation was successful in limiting the
explicit scope of the draft Declaration to medicine and the
life sciences; the definition of bioethics in the IBC draft
that had included the social sciences and relationship to
the biosphere was deleted. In addition, the U.S. was
successful in limiting the explicit application of the draft
Declaration to States to guide them in the formulation of
their legislation, policies, or other instruments in the
field of bioethics, with a reference to its also providing
guidance to decisions or practices of private actors.
(However, some of the actual provisions appear to be
relevant only to private actors.)

DOMESTIC LAW


5. The U.S. insisted on a provision (in the Preamble, and
accepted with revisions in a similar provision in Article
27) that the draft Declaration is to be understood in a
manner consistent with domestic and international law; some
articles also contain a provision referring to domestic law.
(The French delegation attempted to delete the preambular
provision at the last moment, even though, as the Chairman
stated, the consensus that had been reached on other items
was made possible by the understanding that the preamble
would contain this provision.) The U.S. successfully
opposed inclusion of an explicit savings clause, pursuant to
our policy for negotiating declarations.

CONSENT


6. The meeting had difficulty drafting the provisions on
informed consent (now Articles 6 and 7). A large informal
working group presented language to the plenary meeting for
discussion. The Chairman gaveled it as agreed to after only
brief discussion. Several countries objected strongly to
the approval without meaningful discussion. Canada in
particular objected to the fact that there was only minimal
discussion and expressed formal reservations on the
articles. The U.S. supported the Canadian objection.
Article 6 contains a new paragraph (c),which had not
previously been tabled, providing that in addition to
obtaining the consent of individuals for research,
researchers "may" obtain the "additional agreement of the
legal representatives of the group or community concerned."
(Comment: It is uncertain whether this has the potential to
create additional expense and delay for research without
benefit for the patient. End Comment)

SOCIAL RESPONSIBILITY AND HEALTH


7. Brazil proposed an amendment to the already problematic
Article 13 in the IBC Preliminary Draft (now Article 14 in
the Draft Declaration). Its amendment received broad
support in the meeting (particularly from Andean countries).
Its amendment made promotion of health and social
development a "duty" of governments. It also drew from the
WHO Constitution and referred to the enjoyment of the
highest attainable standard of health as one of the
fundamental rights of every human being. The U.S. countered
with language referring to health and social development
"for their people" as a "central purpose" of governments and
restored the language from the WHO constitution left out of
the Brazilian amendment (highest attainable standard of
health is a fundamental right "without distinction of race,
religion, political belief, economic or social condition").
The U.S. language also deleted the reference to
"reproductive health." The U.S. compromise was adopted, and
the U.S. was thanked for its constructive contribution and
its cooperation. This increased support for the U.S.
position on other items of concern to the U.S.

ENVIRONMENT


8. The U.S. was successful in changing a provision that
would have made it a principle of bioethics that any
decision or practice should take due regard of its effect on
all forms of life and that there was a "special
responsibility" of human beings for the protection of the
environment. The agreed language (Article 17) deletes the
reference to "special responsibility" and says that "due
regard" is to be given to the interconnection between humans
and other forms of life, to the importance of appropriate
access and utilization of biological and genetic resources,
to the respect for traditional knowledge and to the "role"
of human beings in the protection of the environment. The
U.S. was also successful in opposing addition (in Article
21) of references to "biopiracy" proposed by Brazil and
supported by the Andean states.

PRECAUTIONARY PRINCIPLE


9. The Preliminary Draft contained a muddled and
potentially troublesome version of the precautionary
principle. The U.S. was successful in substituting for it a
provision (Article 20) saying that "appropriate assessment
and adequate management of risk" should be promoted.

DECLARATION NOT CONVENTION


10. The U.S. was successful in changing the tone and words
of the Declaration in several ways to make it consistent
with the fact it is a declaration, not a binding instrument:
the word "shall" was replaced in each instance by "is (are)
to be" or "should"; the concept of "implementation" was
removed; the provision for reports to UNESCO by states was
deleted; the roles envisaged for the IBC and IGBC (the
Intergovernmental Bioethics Committee) were reduced
considerably, and UNESCO was directed to promote cooperation
between them; and the reference to future instruments was
deleted.

PROCESS


11. UNESCO seemed to be focused more on having a product for
the General Conference than on the quality of that product.
The overall process for developing the Declaration was not
satisfactory. The amount of de facto control given to the
IBC (a group of independent "experts") was particularly
troublesome. The IBC was directed to prepare a recommended
draft. It met 6 times over an 18-month period. Member
states had only limited input through the IGBC, and the
suggestions made by the IGBC were not reflected in the IBC's
Preliminary Draft. The IBC asked for more time to develop a
draft but was pressured into finalizing its draft. This was
presented to Member States as a consensus draft when in fact
there were major disagreements among the members of the IBC
itself and there was no consensus among Member States. The
IBC prided itself on expanding the notion of bioethics to
include protection of the environment and social
responsibility and its "independence" from governments.
The resulting Preliminary Draft presented by the IBC was not
acceptable to Member States. They were presented with an
unacceptable text that they had to fix, and to do it in only
two sessions of the intergovernmental meeting, in which 90
states participated.


12. In addition, pressure from the Secretariat to have the
document ready for this fall's General Conference meant
there was not time for full consideration and good drafting.
And there was little opportunity for any reflection or
consultation with capitals about the language being drafted.
The draft Declaration in fact was adopted after midnight as
the translators were leaving without a chance for full
consideration; there was no debate on the consent article.
In addition, there was no opportunity to read or consider
the report accompanying the draft. It was an uphill battle
against a draft prepared in secret, by a small,
nonrepresentative, and supposedly expert group who had been
given no guidance by the Member States. The process was
essentially upside down.

COMMENT


13. The U.S. was successful in blunting some of the most
troublesome aspects of the Preliminary Draft presented by
the IBC and of amendments that member states sought to make
in the Intergovernmental Meeting. It succeeded in obtaining
a reference to respect for human life. The result was
better than could have been expected, particularly
considering the poor process. There will be more
discussions about the terms of the Declaration, and we will
monitor efforts to change it. At the same time we await
reactions as to whether there are provisions that would
prevent the U.S. from joining consensus. We also will be
vigilant to any efforts to turn the Declaration into a
Convention and make clear our opposition to any such effort.

OLIVER