UNESCO THE UNIVERSAL DECLARATION ON BIOETHICS AND HUMAN RIGHTS

The Universal Declaration on Bioethics and Human Rights Setting the context The promotion of responsibility in: biomedical research clinical practice The Declaration was adopted on 19 October 2005 (33rd session of the General Conference of UN Education, Scientific and Cultural Organization – UNESCO) by representatives of 191 countries.

The Universal Declaration on Bioethics and Human Rights Document elaboration process: The drafting of the UDBHR was based upon the experience of a group of experts from different countries who sat in the International Bioethics Committee (IBC) The drafting process was preceded by a report of an IBC working group that considered the feasibility of this instrument The Group was chaired by Prof. Leonardo De Castro (Philippines) and Giovanni Berlinguer (Italy).

The Universal Declaration on Bioethics and Human Rights Group conclusions: Initiative support/need to develop “a worldwide common sense in order to foster understanding and cohesion in relation to ethical categories and new practical possibilities emerging from science and technology”

The Universal Declaration on Bioethics and Human Rights In January 2005, the draft was examined by the Intergovernmental Bioethics Committee (IGBC) and it was revised/amended in two meetings of governmental representatives This is the first internal legal (though non-binding) instrument that comprehensively deals with the connection between human rights and bioethics. Most international declarations/guidelines in this field do not have the “status of legal instruments”, since they have been issued by non- governmental organizations (i.e. The World Medical Association (WMS) or the Council for International Organizations of Medical Sciences (CIOMS)) and other academic/professional institutions. Other documents, despite being adopted by intergovernmental bodies, cover only specific bioethical topics (for instance, the UNESCO Declaration on the Human Genome and Human Rights, 1997), or are regional (but not global) instruments (such as the European Convention on Human Rights and Biomedicine, 1997)

The Universal Declaration on Bioethics and Human Rights The Declaration encompasses in Section II important principles relating to bioethics. According to the interpretation provided by Art. 26, the principles are to be understood as “complementary and interrelated”. Therefore, the relationship between them has been conceived as “non-hierarchical” In case of conflict between two or more principles, the priority of one of them will be determined taking into account specific circumstances involved in each case, as well as the cultural peculiarities of each society. However, the principle of respect for human dignity should always have a primary role in every bioethical decision (for its overarching nature)

The Universal Declaration on Bioethics and Human Rights The Explanatory Memorandum clarifies that: The principles of the Declaration apply as appropriate and relevant at two different levels: (i) individuals, families, groups and communities who are affected by these decisions (ii) those who make such decisions or carry out such practices, whether they are individuals, professional groups, public or private institutions, corporations or states. The list is not exhaustive

The Universal Declaration on Bioethics and Human Rights The principles mentioned in the Declaration: Respect for human dignity and human rights (Article 3.1) “Human dignity, human rights and fundamental freedoms are to be fully respected”  Priority of the individual’s interests and welfare over the sole interest of science or society (Article 3.2) “The interests and welfare of the individual should have priority over the sole interest of science or society”.  Beneficence and non-maleficence (Article 4) “In applying and advancing scientific knowledge, medical practice and associated technologies, 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”

The Universal Declaration on Bioethics and Human Rights Autonomy (Article 5) “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” The Explanatory Memorandum makes clear that: Respect for personal autonomy is strongly linked to and, according to certain interpretations, derives from the notion of human dignity. Individuals cannot be instrumentalized and treated merely as means to a scientific end; they should be granted the authority to make autonomous decisions in all aspects of their lives where their decisions do no harm to others. Autonomy refers to the concept of acting in accordance with voluntarily accepted principles but it does not liberate the individual from taking responsibility for his or her actions.

The Universal Declaration on Bioethics and Human Rights Informed Consent (Article 6) Articles 5 and 6 are interconnected in the sense that autonomy and responsibility are the basis of informed decisions in the field of bioethics. Article 6 affirms the relevance of information in different cases of informed consent. The article deals with the concept of informed consent in two major fields. Paragraph a) deals with informed consent in the field of scientific research; paragraph b) refers to any decision or practice with regard to medical diagnosis and treatment.

The Universal Declaration on Bioethics and Human Rights Paragraph a) requires prior, free, informed and express consent of the persons concerned. This consent may be withdrawn at any time and for any reason. The term ‘free’ means voluntary consent “without inducement”. Paragraph b) goes beyond the requirement of consent by emphasizing the ongoing participation of persons in such decisions as affect them. Ongoing participation, on one hand, refers to an active role of participants (patients); on the other hand, it also indicates that informed consent is no longer a one-step requirement before the treatment, as communication should be continuous throughout the treatment.

The Universal Declaration on Bioethics and Human Rights Protection of persons unable to consent (Article 7) “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”.

The Universal Declaration on Bioethics and Human Rights Special attention to vulnerable persons (Article 8) “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” Privacy and confidentiality (Article 9) A right to privacy guarantees a control over personal information in many ways. It restricts access to personal and medical information and it provides a claim of non- interference in various private spheres of the individual. Confidentiality refers to a special and often fiduciary relationship, such as that between researcher and research subject, or doctor and patient, and provides that the shared information shall remain secret, confidential and shall not be disclosed to third persons, unless a strictly defined, compelling interest justifies disclosure under domestic law.

The Universal Declaration on Bioethics and Human Rights Equality, justice and equity (Article 10) “The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably” According to the explanatory memorandum: Article 12 deals with three notions closely connected with one another. ‘Equality’ in a legal sense refers to the equal treatment of individuals in a similar situation, while the term ‘equity’ refers to a discretion, which serves as a corrective mechanism to formal equality by looking at the special circumstances of particular cases. ‘Justice’ in the philosophical sense is a normative principle that refers to a judgement on the arrangement of institutions, society, groups of individuals. A common definition of justice could be “treating the equal equally and the unequal unequally”.

The Universal Declaration on Bioethics and Human Rights In Article 1 of the Universal Declaration on Human Rights, the concept of equality was articulated in the following way: “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”. In the present declaration, this concept of brotherhood, expressed in a contemporary way, is further elaborated in Article 13 on Solidarity and Cooperation. In addition to the general meaning, principles of justice play an important role in many decisions and practices in the field of bioethical issues, such as in allocating health care services and setting priorities in health care, both in general and in single cases.

The Universal Declaration on Bioethics and Human Rights Non-discrimination and non-stigmatization (Article 11) “No individual or group should be discriminated against or stigmatized on any grounds, in violation of human dignity, human rights and fundamental freedoms” It focuses only on unlawful, unfair or unjustifiable discrimination between people based on any grounds, such as gender, age, ethnicity, disability or other physical, mental or social conditions, diseases or genetic characteristics. The list is not closed. Discrimination may distort scientific progress. For instance, the routine exclusion of women from research trials has led to the fact that many of the conditions specific to women remained unknown or uninvestigated and that discoveries that were applicable to men were simply assumed to be applicable for women patients. There are many similar instances affecting stigmatized or disadvantaged groups.

The Universal Declaration on Bioethics and Human Rights Respect for cultural diversity and pluralism (Article 12) “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”

The Universal Declaration on Bioethics and Human Rights Solidarity and cooperation (Article 13) “Solidarity among human beings and international cooperation towards that end are to be encouraged” Article 13 reflects the commitment that the declaration is based not only on the individualist concept of rights but also recognizes the importance of solidarity between individuals and across communities. Serious inequalities in access to health care worldwide increase the importance of including solidarity as one of the principles of the declaration.

The Universal Declaration on Bioethics and Human Rights Access to health care and essential medecines (Social responsibility and health, Article 14) “The promotion of health and social development for their people is a central purpose of governments that all sectors of society share. 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: access to quality health care and essential medicines, especially for the health of women and children, because health is essential to life itself and must be considered to be a social and human good; access to adequate nutrition and water; improvement of living conditions and the environment; elimination of the marginalization and the exclusion of persons on the basis of any grounds; reduction of poverty and illiteracy”.

The Universal Declaration on Bioethics and Human Rights Benefit sharing (Article 15) “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: special and sustainable assistance to, and acknowledgement of, the persons and groups that have taken part in the research; access to quality health care; provision of new diagnostic and therapeutic modalities or products stemming from research; support for health services; access to scientific and technological knowledge; capacity-building facilities for research purposes; other forms of benefit consistent with the principles set out in this Declaration. Benefits should not constitute improper inducements to participate in research”.

The Universal Declaration on Bioethics and Human Rights Protection of future generations (Article 16) “The impact of life sciences on future generations, including on their genetic constitution, should be given due regard” Protection of the environment, the biosphere and biodiversity (Article 17) “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 respect for traditional knowledge and to the role of human beings in the protection of the environment, the biosphere and biodiversity” .

The Universal Declaration on Bioethics and Human Rights Section III (Application of the principles) is devoted to those principles of a more procedural nature, such as: The requirement for professionalism/honesty/integrity/transparency in the decision-making process regarding bioethical issues (Article 18) The need to establish independent/multidisciplinary/pluralist ethics committees (Article 19) The call for an appropriate risk assessment and management in the biomedical field (Article 20) The need for justice in transnational research (Article 21) .

The Universal Declaration on Bioethics and Human Rights The Declaration’s key aspects The principles enshrined in the document are formulated in very general terms. It does not give almost any definition of their precise meaning (except for basic descriptions in the Explanatory Memorandum accompanying the preliminary draft declaration) The methodology used is a common practice in law. Except for technical words, lawmakers normally prefer not to provide precise definitions. They rather tend to leave the task to common understanding/the courts’ interpretation to avoid being limited by rigid definitions For what reason? It would have been impossible to reach a global agreement on the specific meaning of terms such as “human dignity”, “autonomy”, “justice”, “benefit”, “harm” or “solidarity”, which have a long philosophical history and are – to some extent – influenced by cultural factors. .

The Universal Declaration on Bioethics and Human Rights In addition, the generality in the formulation of the principles can also be justified by the need to find a balance between: Universalism of some bioethical norms Respect for cultural diversity The Declaration is a kind of compromise between a theoretical conceptualization made by experts and what is practically achievable given the political choices of governments. Governments, not independent experts, have the last word in all declarations/conventions issued by UN agencies Non-binding nature (a soft law instrument). This enables States to take on commitments they otherwise would not have taken, because they assume mere political obligations that are not legally binding. .

The Universal Declaration on Bioethics and Human Rights What’s the final goal? Not to elaborate new bioethical principles or to provide the solution to a growing list of bioethical dilemmas. Its main purpose is to gather some basic standards in order to help States to promote responsible biomedical research/clinical practice, in compliance with the principles of international human rights law.   .

Thank you for your attention! E-mail: l.persampieri@lumsa.it