UNESCO Draft Declaration: Towards a Declaration on Universal Norms on Bioethics

Below, you will find the entire UNESCO Universal Draft Declaration on Bioethics and Human Rights (24 June 2005)which is currently being made public. The initial text is the description of the history and background for the Declaration. I wanted to make this text promptly available to all who are interested (and really I think all citizens of the world should be interested wherever they are and under whatever conditions they live). I hope to bring up for discussion here elements of this Declaration in the future. ..Maurice.



Towards a Declaration on Universal Norms on Bioethics

Since the 1970s, the field of bioethics has grown considerably. While it
is true that bioethics today includes medical ethics issues, its
originality lies in the fact that it goes much further than the various
professional codes of ethics concerned. It entails reflection on
societal changes and even on global balances brought about by scientific
and technological developments. To the already difficult question posed
by life sciences - How far can we go? - other queries must be added
concerning the relationship between ethics, science and freedom.

The background

A growing number of scientific practices have extended beyond national
borders and the necessity of setting universal ethical guidelines
covering all issues raised in the field of bioethics and the need to
promote the emergence of shared values have increasingly been a feature
of the international debate. The need for standard-setting action in the
field of bioethics is felt throughout the world, often expressed by
scientists and practitioners themselves and by lawmakers and citizens.

States have a special responsibility not only with respect to bioethical
reflection but also in the drafting of any legislation that may follow.
In the field of bioethics, whilst many States have framed laws and
regulations aimed at protecting human dignity and human rights and
freedoms, many other countries wish to establish benchmarks and
sometimes lack the means to do so.

At its 31st session in 2001, the General Conference invited the
Director-General to submit "the technical and legal studies undertaken
regarding the possibility of elaborating universal norms on bioethics".

At the request of the Director-General, the International Bioethics
Committee (IBC) therefore drafted the Report of the IBC on the Report of
the IBC on the Possibility of Elaborating a Universal Instrument on
Bioethics finalized on 13 June 2003. The Report examines some issues in
bioethics that could be addressed in an international instrument and
illustrates how the elaboration of such an instrument could contribute
to and support international efforts being made to provide ethical
guidelines in matters related to recent scientific developments. The
Report explores the likely form and scope of an instrument as well as
its value in terms of education, information dissemination,
awareness-raising and public debate.

The mandate

At its 32nd session in October 2003, the General Conference considered
that it was "opportune and desirable to set universal standards in the
field of bioethics with due regard for human dignity and human rights
and freedoms, in the spirit of cultural pluralism inherent in bioethics"
(32 C/Res. 24).

The General Conference also invited "the Director-General to continue
preparatory work on a declaration on universal norms on bioethics, by
holding consultation with Member States, the other international
organizations concerned and relevant national bodies, and to submit a
draft declaration to it at its 33rd session" (32 C/Res. 24).


Which instrument?

As to the form of the instrument, IBC - supported by Member States
during the General Conference - came out clearly in favour of an
instrument of a declaratory nature, at least initially, which would be
best suited to a constantly changing context and would enable the
broadest possible consensus to be reached among Member States.

The form of the instrument does not prevent its content from
contributing to a code of universally recognized general principles of
bioethics (such as human dignity, solidarity, freedom of research,
respect for privacy, confidentiality, non-discrimination, informed
consent, integrity of research and intellectual honesty) insofar as
these principles pertain to bioethics. Lastly, an instrument on
bioethics must call strong attention to the importance of
awareness-raising, information, education, consultation and public
debate.


Why UNESCO?

Over the years UNESCO has confirmed its standard-setting role in
bioethics. UNESCO has already contributed to the formulation of basic
principles in bioethics through in particular the Universal Declaration
on the Human Genome and Human Rights, adopted unanimously and by
acclamation by the General Conference in 1997 and endorsed by the United
Nations General Assembly in 1998, and the International Declaration on
Human Genetic Data, adopted unanimously and by acclamation by the
General Conference on 16 October 2003.

Apart from the fact that ethical issues related to the advances in life
sciences and their applications are highly topical, the depth and extent
of their roots in the cultural, philosophical and religious bedrocks of
various human communities are reason enough for UNESCO, the only
organization whose fields of competence include the social and human
sciences, true to its ethical vocation, to take the lead in this
initiative.


Which procedure?

UNESCO will obviously not be able to embark alone on such an
undertaking. If the first steps of the elaboration of the declaration
are entrusted to IBC, in close consultation with the Intergovernmental
Bioethics Committee (IGBC), only the participation of all the actors
concerned could ensure that all the different perceptions of ethical and
legal issues are taken into account.

As explicitly requested by Member States, wide-ranging consultations and
hearings will therefore be held from the very beginning of the
elaboration of the declaration in order to involve in particular States,
the United Nations and the other specialized agencies of the United
Nations system, other intergovernmental and non-governmental
organizations and appropriate national bodies and specialists.


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Universal Draft Declaration on Bioethics and Human Rights





The General Conference,

Conscious of the unique capacity of human beings to reflect upon their
own existence and on their environment; to perceive injustice; to avoid
danger; to assume responsibility; to seek cooperation and to exhibit the
moral sense that gives expression to ethical principles,

Reflecting on the rapid developments in science and technology, which
increasingly affect our understanding of life and life itself, resulting
in a strong demand for a global response to the ethical implications of
such developments,

Recognizing that ethical issues raised by the rapid advances in science
and their technological applications should be examined with due respect
to the dignity of the human person and universal respect for, and
observance of, human rights and fundamental freedoms,

Resolving that it is necessary and timely for the international
community to state universal principles that will provide a foundation
for humanity's response to the ever-increasing dilemmas and
controversies that science and technology present for humankind and for
the environment,

Recalling the Universal Declaration of Human Rights of 10 December 1948,
the Universal Declaration on the Human Genome and Human Rights adopted
by the General Conference of UNESCO on 11 November 1997 and the
International Declaration on Human Genetic Data adopted by the General
Conference of UNESCO on 16 October 2003,

Noting the two United Nations International Covenants on Economic,
Social and Cultural Rights and on Civil and Political Rights of 16
December 1966, the United Nations International Convention on the
Elimination of All Forms of Racial Discrimination of 21 December 1965,
the United Nations Convention on the Elimination of All Forms of
Discrimination against Women of 18 December 1979, the United Nations
Convention on the Rights of the Child of 20 November 1989, the United
Nations Convention on Biological Diversity of 5 June 1992, the Standard
Rules on the Equalization of Opportunities for Persons with Disabilities
adopted by the United Nations General Assembly in 1993, the ILO
Convention 169 concerning Indigenous and Tribal Peoples in Independent
Countries of 27 June 1989, the International Treaty on Plant Genetic
Resources for Food and Agriculture adopted by the FAO Conference on 3
November 2001 and entered into force on 29 June 2004, the Recommendation
of UNESCO on the Status of Scientific Researchers of 20 November 1974,
the UNESCO Declaration on Race and Racial Prejudice of 27 November 1978,
the UNESCO Declaration on the Responsibilities of the Present
Generations Towards Future Generations of 12 November 1997, the UNESCO
Universal Declaration on Cultural Diversity of 2 November 2001, the
Trade Related Aspects of Intellectual Property Rights Agrements (TRIPS)
annexed to the Marrakech Agreement establishing the World Trade
Organization, which entered into force on 1 January 1995, the Doha
Declaration on the TRIPS Agreement and Public Health of 14 November 2001
and other relevant international instruments adopted by the United
Nations and the specialized agencies of the United Nations system, in
particular the Food and Agriculture Organization of the United Nations
(FAO) and the World Health Organization (WHO),

Also noting international and regional instruments in the field of
bioethics, including the Convention for the Protection of Human Rights
and Dignity of the Human Being with regard to the Application of Biology
and Medicine: Convention on Human Rights and Biomedicine of the Council
of Europe, adopted in 1997 and entered into force in 1999, together with
its additional protocols, as well as national legislation and
regulations in the field of bioethics and the international and regional
codes of conduct and guidelines and other texts in the field of
bioethics, such as the Declaration of Helsinki of the World Medical
Association on Ethical Principles for Medical Research Involving Human
Subjects, adopted in 1964 and amended in 1975, 1989, 1993, 1996, 2000
and 2002 and the International Ethical Guidelines for Biomedical
Research Involving Human Subjects of the Council for International
Organizations of Medical Sciences adopted in 1982 and amended in 1993
and 2002,

Recognizing that this Declaration is to be understood in a manner
consistent with domestic and international law in conformity with human
rights law,

Recalling the Constitution of UNESCO adopted on 16 November 1945,

Considering UNESCO's role in identifying universal principles based on
shared ethical values to guide scientific and technological development
and social transformation, in order to identify emerging challenges in
science and technology taking into account the responsibility of the
present generation towards future generations, and that questions of
bioethics, which necessarily have an international dimension, should be
treated as a whole, drawing on the principles already stated in the
Universal Declaration on the Human Genome and Human Rights and the
International Declaration on Human Genetic Data, and taking account not
only of the current scientific context but also of future developments,

Aware that human beings are an integral part of the biosphere, with an
important role in protecting one another and other forms of life, in
particular animals,

Recognizing that, based on the freedom of science and research,
scientific and technological developments have been, and can be, of
great benefit to humankind in increasing inter alia life expectancy and
improving quality of life, and emphasizing that such developments should
always seek to promote the welfare of individuals, families, groups or
communities and humankind as a whole in the recognition of the dignity
of the human person and the universal respect for, and observance of,
human rights and fundamental freedoms,

Recognizing that health does not depend solely on scientific and
technological research developments but also on psycho-social and
cultural factors,

Also Recognizing that decisions regarding ethical issues in medicine,
life sciences and associated technologies may have an impact on
individuals, families, groups or communities and humankind as a whole,

Bearing in mind that cultural diversity, as a source of exchange,
innovation and creativity, is necessary for humankind and, in this
sense, is the common heritage of humanity, but emphasizing that it may
not be invoked at the expense of human rights and fundamental freedoms,

Also bearing in mind that a person's identity includes biological,
psychological, social, cultural and spiritual dimensions,

Recognizing that unethical scientific and technological conduct has had
particular impact on indigenous and local communities,

Convinced that moral sensitivity and ethical reflection should be an
integral part of the process of scientific and technological
developments and that bioethics should play a predominant role in the
choices that need to be made concerning issues arising from such
developments,

Considering the desirability of developing new approaches to social
responsibility to ensure that progress in science and technology
contributes to justice, equity and to the interest of humanity,

Recognizing that an important way to evaluate social realities and
achieve equity is to pay attention to the position of women,

Stressing the need to reinforce international cooperation in the field
of bioethics, taking into account in particular the special needs of
developing countries, indigenous communities and vulnerable populations,


Considering that all human beings, without distinction, should benefit
from the same high ethical standards in medicine and life science
research,

Proclaims the principles that follow and adopts the present Declaration.

GENERAL PROVISIONS

Article 1 - Scope

a) The Declaration addresses ethical issues related to medicine,
life sciences and associated technologies as applied to human beings,
taking into account their social, legal and environmental dimensions.

b) The Declaration is addressed to States. As appropriate and
relevant, it also provides guidance to decisions or practices of
individuals, groups, communities, institutions and corporations, public
and private.

Article 2 - Aims

The aims of this Declaration are:

(i) to provide a universal framework of principles and procedures to
guide States in the formulation of their legislation, policies or other
instruments in the field of bioethics;

(ii) to guide the actions of individuals, groups, communities,
institutions and corporations, public and private;

(iii) to promote respect for human dignity and protect human rights,
by ensuring respect for the life of human beings, and fundamental
freedoms, consistent with international human rights law;

(iv) to recognize the importance of freedom of scientific research
and the benefits derived from scientific and technological developments,
while stressing the need that such research and developments occur
within the framework of ethical principles set out in this Declaration
and that they respect human dignity, human rights and fundamental
freedoms;

(v) to foster multidisciplinary and pluralistic dialogue about
bioethical issues between all stakeholders and within society as a
whole;

(vi) to promote equitable access to medical, scientific and
technological developments as well as the greatest possible flow and the
rapid sharing of knowledge concerning those developments and the sharing
of benefits, with particular attention to the needs of developing
countries;

(vii) to safeguard and promote the interests of the present and future
generations; and

(viii) to underline the importance of biodiversity and its conservation
as a common concern of humankind.

PRINCIPLES



Within the scope of this Declaration, in decisions or practices taken or
carried out by those to whom it is addressed, the following principles
are to be respected.

Article 3 - Human Dignity and Human Rights

a) Human dignity, human rights and fundamental freedoms are to be
fully respected.

b) The interests and welfare of the individual should have priority
over the sole interest of science or society.

Article 4 - Benefit and Harm

In applying and advancing scientific knowledge, medical practice and
associated techologies, direct and indirect benefits to patients,
research participants and other affected individuals should be maximized
and any possible harm to such individuals should be minimized.

Article 5 - Autonomy and Individual Responsibility

The autonomy of persons to make decisions, while taking responsibility
for those decisions and respecting the autonomy of others, is to be
respected. For persons who are not capable of exercising autonomy,
special measures are to be taken to protect their rights and interests.

Article 6 -Consent

a) Any preventive, diagnostic and therapeutic medical intervention
is only to be carried out with the prior, free and informed consent of
the person concerned, based on adequate information. The consent should,
where appropriate, be express and may be withdrawn by the person
concerned at any time and for any reason without disadvantage or
prejudice.

b) Scientific research should only be carried out with the prior,
free, express and informed consent of the person concerned. The
information should be adequate, provided in a comprehensible form and
should include the modalities for withdrawal of consent. The consent may
be withdrawn by the person concerned at any time and for any reason
without any disadvantage or prejudice. Exceptions to this principle
should be made only in accordance with ethical and legal standards
adopted by States, consistent with the principles and provisions set out
in this Declaration, in particular in Article 27, and international
human rights law.

c) In appropriate cases of research carried out on a group of
persons or a community, additional agreement of the legal
representatives of the group or community concerned may be sought. In
no case should a collective community agreement or the consent of a
community leader or other authority substitute for an individual's
informed consent.

Article 7 - Persons without the capacity to consent

In accordance with domestic law, special protection is to be given to
persons who do not have the capacity to consent:

a) authorization for research and medical practice should be
obtained in accordance with the best interest of the person concerned
and in accordance with domestic law. However, the person concerned
should be involved to the greatest extent possible in the
decision-making process of consent, as well as that of withdrawing
consent;

b) research should only be carried out for his or her direct health
benefit, subject to the authorization and the protective conditions
prescribed by law, and if there is no research alternative of comparable
effectiveness with research participants able to consent. Research
which does not have potential direct health benefit should only be
undertaken by way of exception, with the utmost restraint, exposing the
person only to a minimal risk and minimal burden and, if the research is
expected to contribute to the health benefit of other persons in the
same category, subject to the conditions prescribed by law and
compatible with the protection of the individual's human rights. Refusal
of such persons to take part in research should be respected.

Article 8 - Respect for Human Vulnerability and Personal Integrity

In applying and advancing scientific knowledge, medical practice and
associated technologies, human vulnerability should be taken into
account. Individuals and groups of special vulnerability should be
protected and the personal integrity of such individuals respected.

Article 9 - Privacy and Confidentiality

The privacy of the persons concerned and the confidentiality of their
personal information should be respected. To the greatest extent
possible, such information should not be used or disclosed for purposes
other than those for which it was collected or consented to, consistent
with international law, in particular international human rights law.

Article 10 - Equality, Justice and Equity

The fundamental equality of all human beings in dignity and rights is to
be respected so that they are treated justly and equitably.

Article 11 - Non-Discrimination and Non-Stigmatization

No individual or group should be discriminated against or stigmatized on
any grounds, in violation of human dignity, human rights and fundamental
freedoms.

Article 12 - Respect for Cultural Diversity and Pluralism

The importance of cultural diversity and pluralism should be given due
regard. However, such considerations are not to be invoked to infringe
upon human dignity, human rights and fundamental freedoms, nor upon the
principles set out in this Declaration, nor to limit their scope.

Article 13 - Solidarity and Cooperation

Solidarity among human beings and international cooperation towards that
end are to be encouraged.

Article 14 - Social Responsibility and Health

a) The promotion of health and social development for their people
is a central purpose of governments, that all sectors of society share.

b) Taking into account that the enjoyment of the highest attainable
standard of health is one of the fundamental rights of every human being
without distinction of race, religion, political belief, economic or
social condition, progress in science and technology should advance:

(i) access to quality health care and essential medicines, including
especially for the health of women and children, because health is
essential to life itself and must be considered as a social and human
good;

(ii) access to adequate nutrition and water;

(iii) improvement of living conditions and the environment;

(iv) elimination of the marginalization and the exclusion of persons
on the basis of any grounds; and

(v) reduction of poverty and illiteracy.

Article 15 - Sharing of Benefits

a) Benefits resulting from any scientific research and its
applications should be shared with society as a whole and within the
international community, in particular with developing countries. In
giving effect to this principle, benefits may take any of the following
forms:

(i) special and sustainable assistance to, and acknowledgement of,
the persons and groups that have taken part in the research;

(ii) access to quality health care;

(iii) provision of new diagnostic and therapeutic modalities or
products stemming from research;

(iv) support for health services;

(v) access to scientific and technological knowledge;

(vi) capacity-building facilities for research purposes; and

(vii) other forms of benefit consistent with the principles set out
in this Declaration.

b) Benefits should not constitute improper inducements to
participate in research.

Article 16 - Protecting Future Generations

The impact of life sciences on future generations, including on their
genetic constitution, should be given due regard.

Article 17 - Protection of the Environment, the Biosphere and
Biodiversity

Due regard is to be given to the interconnection between human beings
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 biosphere and biodiversity.

APPLICATION OF THE PRINCIPLES

Article 18 - Decision-Making and Addressing Bioethical Issues

a) Professionalism, honesty, integrity and transparency in
decision-making should be promoted, in particular declarations of all
conflicts of interest and appropriate sharing of knowledge. Every
endeavour should be made to use the best available scientific knowledge
and methodology in addressing and periodically reviewing bioethical
issues.

b) Persons and professionals concerned and society as a whole
should be engaged in dialogue on a regular basis.

c) Opportunities for informed pluralistic public debate, seeking
the expression of all relevant opinions, should be promoted.

Article 19 - Ethics Committees

Independent, multidisciplinary and pluralist ethics committees should be
established, promoted and supported at the appropriate level in order
to:

(i) assess the relevant ethical, legal, scientific and social issues
related to research projects involving human beings;

(ii) provide advice on ethical problems in clinical settings;

(iii) assess scientific and technological developments, formulate
recommendations and contribute to the preparation of guidelines on
issues within the scope of this Declaration; and

(iv) foster debate, education, and public awareness of, and
engagement in, bioethics.

Article 20 - Risk Assessment and Management

Appropriate assessment and adequate management of risk related to
medicine, life sciences and associated technologies should be promoted.

Article 21 - Transnational Practices

a) States, public and private institutions, and professionals
associated with transnational activities should endeavour to ensure that
any activity within the scope of this Declaration, which is undertaken,
funded or otherwise pursued in whole or in part in different States, is
consistent with the principles set out in this Declaration.

b) When research is undertaken or otherwise pursued in one or more
States (the host State(s)) and funded by a source in another State, such
research should be the object of an appropriate level of ethical review
in the host State(s) and the State in which the funder is located. This
review should be based on ethical and legal standards that are
consistent with the principles set out in this Declaration.

c) Transnational health research should be responsive to the needs
of host countries, and the importance of research to contribute to the
alleviation of urgent global health problems should be recognized.

d) When negotiating a research agreement, terms for collaboration
and agreement on benefits of research should be established with equal
participation by those party to the negotiation.

e) States should take appropriate measures, both at the national
and the international level, to combat bioterrorism, illicit traffic in
organs, tissues and samples, genetic resources and genetic-related
materials.

PROMOTION OF THE DECLARATION

Article 22 - Role of States

a) States should take all appropriate measures, whether of a
legislative, administrative or other character, to give effect to the
principles set out in this Declaration in accordance with international
human rights law. Such measures should be supported by action in the
spheres of education, training and public information.

b) States should encourage the establishment of independent,
multidisciplinary and pluralist ethics committees, as set out in Article
19.



Article 23 - Bioethics Education, Training and Information

a) In order to promote the principles set out in this Declaration
and to achieve a better understanding of the ethical implications of
scientific and technological developments, in particular for young
people, States should endeavour to foster bioethics education and
training at all levels as well as to encourage information and knowledge
dissemination programmes about bioethics.

b) States should encourage the participation of international and
regional intergovernmental organizations and international, regional and
national non-governmental organizations in this endeavour.

Article 24 - International Cooperation

a) States should foster international dissemination of scientific
information and encourage the free flow and sharing of scientific and
technological knowledge.

b) Within the framework of international cooperation, States should
promote cultural and scientific cooperation and enter into bilateral and
multilateral agreements enabling developing countries to build up their
capacity to participate in generating and sharing scientific knowledge,
the related know-how and the benefits thereof.

c) States should respect and promote solidarity between and among
States, as well as individuals, families, groups and communities, with
special regard for those rendered vulnerable by disease or disability or
other personal, societal or environmental conditions and those with the
most limited resources.

Article 25 - Follow-up action by UNESCO

a) UNESCO shall promote and disseminate the principles set out in
this Declaration. In doing so, UNESCO should seek the help and
assistance of the Intergovernmental Bioethics Committee (IGBC) and the
International Bioethics Committee (IBC).

b) UNESCO shall reaffirm its commitment to dealing with bioethics
and to promoting collaboration between IGBC and IBC.

FINAL PROVISIONS

Article 26 - Interrelation and Complementarity of the Principles

This Declaration is to be understood as a whole and the principles are
to be understood as complementary and interrelated. Each principle is
to be considered in the context of the other principles, as appropriate
and relevant in the circumstances.

Article 27 -Limitations on the Application of the Principles

If the application of the principles of this Declaration are to be
limited, it should be by law, including laws in the interests of public
safety, for the investigation, detection and prosecution of criminal
offences, for the protection of public health or for the protection of
the rights and freedoms of others. Any such law needs to be consistent
with international human rights law.

Article 28 - Denial of acts contrary to human rights, fundamental
freedoms and human dignity

Nothing in this Declaration may be interpreted as implying for any
State, group or person any claim to engage in any activity or to perform
any act contrary to human rights, fundamental freedoms and human
dignity.