Declaration
on Universal Norms on Bioethics
or
Universal
Declaration on Bioethics
and Humanity [Humankind / Human Beings]
DPI
comments on the provisional text of Elaboration of the Declaration on Universal
Norms on Bioethics : Third Outline of a Text (all comments in the text in red,
italic and bold)
The General Conference,
Recalling 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, and {{Also recalling the documents of the UNESCO World Conference on
Sciences}}
Also recalling the Universal Declaration of Human
Rights of 10 December 1948, the two United Nations International Covenants on
Economic, Social and Cultural Rights and on Civil and Political Rights of 16
December1966, 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 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 Agreements (TRIPs) annexed to
the 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 the other international human rights instruments
adopted by the United Nations and the specialized agencies of the United
Nations system,
Also
recalling 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, as well as the other international and
regional instruments, national legislation and regulations in the field of
bioethics,
Also
recalling the
international and regional codes of conduct and guidelines and other ethical
texts in the field of science and technology,
{{the Standard Rules on the Equalization
of Opportunities for Persons with Disabilities”. Official Records of the General Assembly,
Forty-eighth Session, Supplement No. 49 (A/48/49), vol. 1, chap. VII, General
Assembly resolution 48/96, annex, of 20 December 1993;
the “Declaration on the Rights of Disabled
Persons”. Official Records of the
General Assembly, Thirtieth Session, Supplement No. 34 (A/10034), Proclaimed by
General Assembly resolution 3447 (XXX) of 9 December 1975
the Committee on Economic, Social Rights and
Cultural Rights; General Comment No. 5 - “Persons with disabilities: 09/12/94”
(Eleventh session, 1994). Official
Records of the Economic and Social Council, Supplement No. 3 (E/1995/22) annex
IV
the Committee on the Elimination of
Discrimination against Women; General Recommendation No. 19 - “Disabled women:
04/01/91” (Tenth Session, 1991). Official Records of the General Assembly,
Forty-sixth Session, Supplement No. 38 (A/46/38); Report of the Committee on
the Elimination of Discrimination against Women (Tenth session)
the UN Economic and Social Council
resolution 1997/20 Children with disabilities Official Records of the General
Assembly, Thirtieth Session, Supplement No. 34 (A/10034), Proclaimed by General
Assembly resolution 3447 (XXX) of 9 December 1975 Proclaimed by General
Assembly resolution 2856 (XXVI) of 20 December 1971,
Organization of American States.
“Inter-American Convention on the Elimination of All Forms of Discrimination
against Persons with Disabilities AG/RES.1608” (XXIX-0/99),
and the in the moment
ongoing consultations within the UN of an United Nations Comprehensive and
Integral International Convention to Promote and Protect the Rights and Dignity
of Persons with Disabilities }}
Considering that, by virtue of its
Constitution, it is incumbent upon UNESCO to promote “the democratic principles
of the dignity, equality and mutual respect of men” and to reject any “doctrine
of the inequality of men and races”, ” {{and “of the
inequality of men based on other characteristics”,}} and that this constitutes a sacred duty which all the nations must
fulfil in a spirit of mutual assistance,
Considering
also that it is the
mission of UNESCO to develop universal principles and norms based on shared
values to guide scientific and technological development and social transformation,
in order to meet emerging challenges {{flowing from
scientific advancements }}taking into account the
responsibility of the present {{towards every human being}} towards future generations,
Bearing in mind UNESCO’s activities and programmes
in the field of natural, social and human sciences, aiming at placing
scientific and technological development in a context of ethical {{and societal }} reflection, and {{at
promoting and conservation of human and no human biological diversity and
sustainable use of non human biological diversity}}at promoting the sustainable use and
conservation of biological diversity and the improvement of the relationship
between human beings and their environment,
Aware that human beings are an integral part of the
biosphere and that they have responsibilities and duties towards other forms of
life,
{{Aware that many genetic and biomedical
practices violate the human rights of people with disabilities;
Aware that there is a lack of transparent public
discussion on the themes that presently affect and will affect in the future
the social well being of human life;
Aware that there is a reemerging of eugenic practices
and an increase commodification of human being}}
Recognizing that scientific and technological developments
have been of great benefit to humankind in increasing
inter alia life expectancy and
improving {{social well being}} of some but also recognizing that the governance of science and
technology lead
to the 10/90 health research gap and stigmatization and discrimination of
certain groups of human beings}} and emphasizing
that such developments should always promote the welfare of individuals and
humankind as a whole in the recognition of the inherent dignity of the human
person and the universal respect for, and observance of human rights and
fundamental freedoms,
Bearing in mind that, without
prejudice to the universal respect for, and
observance of human rights and fundamental freedoms, cultural diversity,
as a source of exchange, innovation and creativity, is necessary for humankind
and, in this sense, it is the common heritage of humanity,
Convinced that ethical
reflection {{should
be}} an integral
part of scientific, technological {{and societal}}
development and that bioethics {{should play}} today a
predominant role in the social choices that need to be made,
Stressing the need to reinforce international
cooperation in the field of bioethics, taking into account in particular the
special needs of developing countries {{and disadvantaged
social group}}s,
Considering that questions of bioethics raised
by advances in science and technology, which have been addressed in part by the
Universal Declaration on the Human Genome and Human Rights and the
International Declaration on Human Genetic Data, should be treated as a whole,
drawing on the principles already affirmed in these two international
instruments and taking account not only of the current scientific context but
also of future developments,
Proclaims the principles that follow and adopts the present Declaration.
(Limited to scientific terms)
General
Provisions
Article 1 -
Scope
The principles set out in this Declaration:
(i) apply to human beings, while recognizing
that human beings have
responsibilities and duties towards other forms of life in the biosphere, and
(ii) apply to issues raised by
scientific and technological developments and their applications, as well as
their availability and access.
The aims of this Declaration are:
{{- to provide a universal framework of fundamental
principles and basic procedures designed to form the basis for reflection and
consideration in bioethical matters for the institutions, groups and
individuals concerned; and to guide States in the formulation of their
legislation and their policies in the field of bioethics}}
-
to
ensure the respect for human dignity and the protection of human rights and
fundamental freedoms in [the sphere of] bioethical decision making, in
accordance with human rights law;
-
to promote respect for {{human
and non-human}} biodiversity;
-
to
recognize the great benefit derived from scientific and technological
developments, whilst ensuring that such development occurs within the framework
of ethical principles that respect human dignity and protect human rights and
fundamental freedoms, and to prevent practices contrary to human dignity;
{{- to foster dialogue between society as a whole and scientists, health
professionals, lawyers, philosophers, ethicists, theologians, NGO’s,
intellectual and professional groups concerned and policy makers; }}
-
-
to
promote the sharing and the greatest possible flow of knowledge concerning
scientific and technological developments as well as the sharing of benefits,
in particular with developing countries;
-
to
safeguard the interests of present and future generations.
General [Fundamental]
Principles
Article 3 - Human Dignity, Human Rights and Justice
{{Bearing in mind that the term human person should
not be based on the existence of certain abilities;
bearing in mind that human persons are subjected to discrimination and stigmatization
and bearing in mind }}Any decision or
practice within the scope of this Declaration shall be made or carried out with
full respect for the inherent dignity of the human person, human rights and
fundamental freedoms and for the universal principle of justice.
Article 4 - Beneficence and Non-Maleficence
{{Any decision or practice within the scope of this
Declaration [to which this Declaration applies] shall maximize the positive
benefits and reduce the harms of such decision or practice to the persons
concerned }}
Article 5 - Respect for Cultural Diversity and
Pluralism
Any decision
or practice within the scope of this Declaration shall take into account the
cultural backgrounds, schools of thought, value systems, historical and
philosophical traditions, religious beliefs and like considerations. However,
cultural diversity [such considerations] shall not be invoked to infringe upon
the universal principles set out in this Declaration, nor to limit their scope.
Article 6 - Solidarity, Equity and Cooperation
Any decision
or practice within the scope of this Declaration shall respect the solidarity
of humanity, ensure equity and encourage international cooperation [, in order inter alia to avoid discrimination and
stigmatization of an individual, a family or a group].
Article 7 - Responsibility towards the Biosphere
Any decision
or practice within the scope of this Declaration shall have due regard for
their impact on all forms of life and their interconnection and the special
responsibility of human beings for the protection of {{human and non
human}}biodiversity and the biosphere within which human
beings exist.
Article 8 - Primacy of the Human Person
Any decision
or practice within the scope of this Declaration shall be founded on the
recognition of the primacy of the human person, which shall prevail over the
[sole] interest of science or society.
Article 9 -
Non-Discrimination and non-Stigmatization
In any decision or practice within the
scope of this Declaration, no one shall be subjected to discrimination based on
any grounds, including physical, mental or social
conditions, diseases or genetic
characteristics, nor shall
such conditions or characteristics be used [invoked] to stigmatize an
individual, a family or a group.
Article 10 - Autonomy and Responsibility
Any decision
or practice within the scope of this Declaration shall respect the autonomy of
a person as an expression of his / her liberty to make decisions without prejudice
to the autonomy of others. {{However the term
should be seen within the framework of societal realities}}.
Article 11 - [Informed] Consent
a) The
prior, free, informed and express consent of the persons concerned shall be
obtained in all medical or scientific research, treatment or diagnosis. Such consent may be withdrawn at any
time.
b) When,
in accordance with domestic law consistent with international human rights law,
a person is incapable of giving consent, such consent [authorization] should be
obtained from his / her legal representative, having regard to the best
interest of the person concerned.
c)
{{Consent The human rights of people
with disabilities who are unable to consent are not to be violated by medical
and other invasive interventions}}
Article 12 – Privacy and Confidentiality
Any
decision or practice within the scope of this Declaration shall be made or
carried out with [full] respect for the privacy of the persons concerned and
the confidentiality of their personal information. Such information cannot be used or disclosed
for purposes other than those for which it was collected, except with the
consent of the person concerned or in cases restrictively provided for by
domestic law consistent with international human rights law.
Article 13 - Sharing of Benefits
In accordance with
international and domestic law, benefits resulting from scientific research and
their applications should be shared with the society as a whole and the
international community. In giving
effect to this principle, benefits may take any of the following forms:
{{(i) assistance
for the social well being of the persons that have taken part in the research
and for persons with the same characteristics who did not participate in the
research;}}
(ii) access to medical care;
(iii) provision of new
diagnostics, facilities for new treatments or drugs stemming from the research;
(iv) support for health
services;
(v) access to scientific and
technological knowledge, in particular for developing countries;
(vi) capacity-building
facilities for research purposes;
(vii) any
other form consistent with the principles set out in this Declaration.
Article 14 -
Honesty and Integrity
Any decision or practice within the scope of
this Declaration shall:
(i) be
conducted with independence and intellectual honesty;
(ii) respect
the need for integrity in scientific and other research;
(iii) avoid
conflict of interest and duty; and
(iv) pay due regard to the need to share
knowledge about such decisions and practices with the persons affected, the
scientific community, relevant bodies and civil society.
Article 15 -
Transparency and Openness
Any decision or
practice within the scope of this Declaration shall:
(i) be made transparently and openly;
(ii) be determined with particular regard to the
circumstances known to the persons concerned;
(iii) be subject to respect for privacy and
confidentiality[, as stated in Article …..];
(iv) be available for appropriate scrutiny by the
persons concerned and by civil society; and
(v) be susceptible to informed and pluralistic
public debate, including in the media.
Article 16 -
Scientific and Rational Methods
Any decision or
practice within the scope of this Declaration shall:
(i) be
made on the best available scientific information;
(ii) pay
due regard to any different information on the subject reasonably available to
the decision-maker;
(iii) be
considered rigorously and in a principled manner;
(iv) observe,
when appropriate, proper procedures of risk assessment; and
(v) be
considered individually, allowing for the possibility of exceptions to general
rules and practices.
Article 17 -
Community and Expert Consultation
Any decision or
practice within the scope of this Declaration, including those depending upon
specialized scientific or other knowledge, shall take into account the need to
reconsider regularly the state of such knowledge and different opinions about
it and the need to engage in a regular dialogue with:
(i) persons
affected by any such decision or practice;
(ii) members
of relevant disciplines;
(iii) appropriate
bodies; and
(iv) civil
society.
Article 18 -
Fair Decision-Making Process
Any decision or practice within the scope of
this Declaration, where differences arise, shall be resolved following full and
free discussion and in accordance with fair procedures.
Procedures
Article 19 - Risk Assessment
When there is scientific
evidence of threats of
serious or irreversible damage to public health and human welfare or the
environment [biosphere], provisional adequate and proportionate measures shall
be taken in a timely manner. Such measures shall be based on the best
scientific knowledge available and carried out in accordance with the
principles set out in this Declaration and with respect to human rights and
fundamental freedoms.
Article 20 - Ethics Committees
Independent,
multidisciplinary and {{truly pluralistic}} ethics committees should be
established, promoted and supported at the appropriate level in order:
(i) to assess the ethical, legal and social
issues related to scientific research projects and technological developments;
and
(ii) to devise guidelines and
recommendations on issues within the scope of this Declaration, in accordance
with the principles set out therein.
Article 21 - Ensuring Public Debate
States
should ensure that citizens have an opportunity for informed, pluralistic
public debate, ensuring the participation of all the stakeholders concerned and
the relevant bioethics committee, and the expression of various socio-cultural,
religious and philosophical opinions.
Article 22- Transnational Practices
[International
research should be subjected to ethical review in the country providing
financial support for the activity as well as in the country where the research
is to be carried out. This review should
be based on the principles set out in this Declaration and on the ethical and
legal standards adopted by the States concerned.]
[……………………..]
Promotion and Implementation
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, States should endeavour to foster all forms of bioethics
education and training at all levels as well as to encourage information and
knowledge dissemination programmes about bioethics. These measures should aim at specific
audiences, in particular researchers and members of ethics committees, or be
addressed to {{all stakeholders and
the public at large. }}
{{a2) bioethics education should include the
views of marginalized groups in regards to all bioethics issues
a3) bioethicists and their students should
learn about the views and situation of marginalized groups in order to be better
able to ascertain the impact of bioethics issues on marginalized groups}}
b) States
should encourage the participation of international and regional
intergovernmental organizations and international, regional and national
non-governmental organizations in this endeavour.
Article 25 - 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 sphere of education, training and public information.
b) States
should establish a framework for the assessment and management of risks. This framework should include the
identification of the issues, the characterization of risks and benefits, the
development of options, the implementation of the decisions and the monitoring
of the results.
Article 26- Roles of the International Bioethics
Committee (IBC) and the Intergovernmental Bioethics Committee (IGBC)
a) The
International Bioethics Committee (IBC) and the Intergovernmental Bioethics
Committee (IGBC) shall contribute to the implementation of this Declaration and
the dissemination of the principles set out therein. On a collaborative basis,
the two Committees should be responsible for its monitoring and for the
evaluation of its implementation, in particular on the basis of reports
provided by States. The two Committees should be responsible in particular for
the formulation of any opinion or proposal likely to further the effectiveness
of this Declaration. They should make recommendations in accordance with
UNESCO’s statutory procedures, addressed to the General Conference.
b) Reports provided by States {{and other stakeholders}} will be addressed every two years to the
International Bioethics Committee, which, after having examined them, will give
its advice following the statutory procedures of UNESCO. After having examined the advice of IBC and
the reports provided by States, the Intergovernmental Bioethics Committee will submit its opinion to the Director-General for
transmission, together with the advice and recommendations of IBC, to the
Member States, the Executive Board and the General Conference.
Article 27 - Follow-up action by
UNESCO
a) UNESCO
shall take appropriate action to follow up this Declaration so as to foster
progress of the life sciences and their applications through technologies,
based on respect for human dignity and the exercise and observance of human
rights and fundamental freedoms.
b) UNESCO
shall reaffirm its commitment to dealing with all aspects of the biosphere and,
if necessary, shall elaborate guidelines and international instruments, as
appropriate, on ethical principles related to the environment and other living
organisms.
c) Five
year after its adoption [and thereafter on a periodical basis], UNESCO shall
take appropriate measures to examine the Declaration in the light of scientific
and technological development and, if necessary, to ensure its revision, in
accordance with UNESCO’s statutory procedures.
d) With
respect to the principles set forth therein, this Declaration could be further
developed through international instruments adopted by the General Conference
of UNESCO, in accordance with UNESCO’s statutory procedures.
Article 28 -
Interpretation
In their interpretation and application the
principles set out in this Declaration are interrelated and each principle
should be construed in the context of the other principles.
Article 29 -
Restrictions
No
restrictions shall be placed on the principles set out in this Declaration
other than those prescribed by law [and necessary in a democratic society] in
the interest of public safety, for the prevention of crime, for the protection
of public health or for the protection of the rights and freedoms of others.
Article 30 - Denial
of acts contrary to human rights, fundamental freedoms and human dignity
Nothing in this Declaration may be interpreted as implying for any States,
group or person any claim to engage in any activity or to perform any act
contrary to human rights, fundamental freedoms and human dignity, including, in
particular, the principles set out in this Declaration.
