Former United Nations (UN) Secretary General Dag Hammarskjöld often said that the UN was not created to take humanity to heaven but to save it from hell. By this aphorism, he meant that although the UN has its weaknesses and limitations, it has an irreplaceable role in our conflictive world by promoting peace, respect for human rights, and social and economic development. The UN is imperfect because it mirrors the world, with its divisions and disagreements. Nevertheless, it is the only forum where humanity speaks in its entirety and where it is able to express, as best as it can, its collective hopes and convictions.
If we consider the specific domain of bioethics, Hammarskjöld’s dictum could be applied to UN agencies that are engaged in this specialty. Although they are not able to guarantee that biomedical advances will always be used for the greatest well-being of humanity, they can at least contribute to prevent their use in a manner that would be contrary to human dignity and human rights. Among the means UN agencies use to achieve their goals (in this case, the promotion of responsible biomedical research and clinical practice), the “standard setting activity” is one of the most salient ones.
It is precisely in such a context and with such an expectation that the Universal Declaration on Bioethics and Human Rights was adopted on 19 October 2005, at the 33rd session of the General Conference of UN Education, Scientific, and Cultural Organisation (UNESCO), by representatives of 191 countries. It is interesting to point out that the drafting process was preceded by a report of an International Bioethics Committee (IBC) working group that considered the feasibility of such an instrument. The working group, chaired by Professors Leonardo De Castro (Philippines) and Giovanni Berlinguer (Italy), concluded by supporting the initiative and affirming the need to develop “a worldwide common sense to foster understanding and cohesion in relation to new ethical categories and new practical possibilities emerging from science and technology”.1 With this background in mind, the IBC, chaired at the time by Mrs Michèle Jean (Canada), prepared the preliminary draft declaration, after almost 2 years of discussions and public consultations with governmental and nongovernmental organisations. Justice Michael Kirby (Australia) chaired the drafting group, which was open to all IBC members. To ensure transparency in the process, the successive versions of the document were posted on the internet as they were being developed. In January 2005, the draft was examined by the Intergovernmental Bioethics Committee and, finally, it was revised in two successive meetings of governmental representatives, who introduced several amendments.2
Despite the great number of existing international guidelines, statements and declarations relating to bioethics, the new UNESCO Declaration makes its own remarkable contribution to this topic. It is worth mentioning that this is the first international legal, though non-binding, instrument that comprehensively deals with the linkage between human rights and bioethics. Regardless of the weaknesses inherent to this kind of instrument, the very fact that virtually all states reached an agreement in this sensitive area is in itself a major achievement. It should be noted that most international declarations and guidelines in this topic do not have the status of legal instruments because they have been issued by non governmental organisations such as the World Medical Association (WMA), the Council for International Organizations of Medical Sciences and other academic or professional institutions. Other documents, although adopted by intergovernmental bodies, cover only specific bioethical issues, such as the UN Declaration on Human Cloning of 20053 and the UNESCO Universal Declaration on the Human Genome and Human Rights of 1997, or are regional but not global instruments, such as the European Convention on Human Rights and Biomedicine of 1997.
It is important to indicate that the Declaration includes in its section II important substantive principles relating to bioethics, such as:
- Respect for human dignity and human rights (Article 3.1)
- Priority of the individual’s interests and welfare over the sole interest of science or society (Article 3.2)
- Beneficence and non-maleficence (Article 4)
- Autonomy (Article 5)
- Informed consent (Article 6)
- Protection of persons unable to consent (Article 7)
- Special attention to vulnerable persons (Article 8)
- Privacy and confidentiality (Article 9)
- Equality, justice and equity (Article 10)
- Non-discrimination and non-stigmatisation (Article 11)
- Respect for cultural diversity and pluralism (Article 12)
- Solidarity and cooperation (Article 13)
- Access to healthcare and essential medicines (Article 14)
- Benefit sharing (Article 15)
- Protection of future generations (Article 16)
- Protection of the environment, the biosphere and biodiversity (Article 17).
Section III (“Application of the principles”) is devoted to principles of a more procedural nature such as:
- The requirement for professionalism, honesty, integrity and transparency in the decision-making process regarding bioethical issues (Article 18)
- The need to establish independent, multidisciplinary and 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).
Three Basic Features of the Declaration
At this point, three basic features of the declaration should be emphasised.
Firstly, the principles it contains are formulated in very general terms; the declaration does not give almost any definition of their precise meaning (which are only provided, to some extent, by the explanatory memorandum that accompanied the preliminary draft declaration). This method, which may surprise some, is in fact a common practice in law, in conformity with the old maxim “Omnis definitio in jure periculosa est”. (Every definition in law is perilous.) Except for very technical terms, lawmakers normally prefer not to define precisely most of the words they use. Rather, they tend to leave that task to common understanding and, ultimately, to courts’ interpretation, in order not to be constricted in advance by rigid definitions. In the case of the UNESCO Declaration, this strategy can also be explained for practical reasons, because it would have been impossible to reach a global agreement on the precise meaning of terms such as “human dignity”, “autonomy”, “justice”, “benefit”, “harm” or “solidarity”, which have a long philosophical history and are, to some extent, conditioned by cultural factors. Thus, the generality in the formulation of the principles can ultimately be justified by the need to find a balance between the universalism of some bioethical norms and the respect for cultural diversity.
A second feature of the declaration relates to the nature of UNESCO itself as an intergovernmental body. This should not be forgotten because it would be a mistake to assess with purely academic criteria an instrument such as the declaration, which is not the exclusive product of academic work, but rather a kind of compromise between a theoretical conceptualisation made by experts and what is practically achievable given the political choices of governments. We need to keep in mind that governments, not independent experts, have the last word in every declaration or convention issued by UN agencies. This is not to say that the quality of such instruments is necessarily affected negatively by the requirements of governments. It is true that the IBC draft was more precise on several points than the version adopted by governmental representatives, as Justice Kirby himself has admitted.4 Personally, I regret for instance that the recognition of the precautionary principle as a risk management tool for public health purposes has been removed from the final version of the document. On the other hand, I acknowledge that some of the amendments introduced by governmental representatives really enhanced the declaration, such as the more detailed provision regarding research on people unable to consent (Article 7) and the reference to human vulnerability (Article 8). What I intend to argue here is that the approach to bioethics followed by international instruments such as the new declaration is not only an academic but also a political one, and therefore must be assessed with different, broader criteria.
A third important characteristic of the declaration is its non-binding nature. Like any declaration adopted by UN agencies, the new UNESCO document makes up part of the so-called soft law instruments—that is, instruments that are weaker than conventions because they are not intended to oblige states to enact enforceable rules inspired by the common standards, but to encourage them to do so. This procedure permits states to take on commitments they otherwise would not have taken, because they assume just political obligations that are not legally binding. Furthermore, soft law instruments present the advantage of permitting countries to gradually become familiar with the proposed standards before they are confronted with the adoption of enforceable rules or with the development of a binding instrument—that is, a convention.5 In addition, it is helpful to remember that, if the same non-binding standards are reaffirmed in successive declarations, in the course of time they may become binding rules, in the form of customary law and jurisprudential criteria, as it happened with the Universal Declaration of Human Rights of 1948.6
The following sections of this chapter will focus on two serious criticisms that have been levelled against the new declaration. The most fundamental one is the involvement of UNESCO itself in bioethics. The other one relates to the use of a human rights framework to achieve common standards in this discipline.
Regarding the first charge, it has been advanced that UNESCO would be in an “obvious attempt at meddling in the professional domain of another UN agency, WHO” and that “it is entirely unclear why UNESCO should concern itself with such a matter”.7 Similarly, it has been argued that “UNESCO is clearly overstepping its mandate and encroaching on that of the World Health Organization (WHO)”.8