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Juli 2007

The Invaluable Role of Soft Law in the Development of Universal Norms in Bioethics

Ein Beitrag zum Workshop "Die Umsetzung bioethischer Prinzipien im internationalen Vergleich" (Auswärtiges Amt, 15.02.2007)

Roberto Andorno


In the last decade, UNESCO has been involved in the elaboration of international standards that are aimed at encouraging and guiding states in their efforts to ensure that biomedical activities are consistent with full respect for human dignity and human rights. To this end, the organization has clearly opted for the use of "declarations" (soft law) instead of "treaties" (hard law). The aims of this paper are, first, to argue that soft law instruments, far from being purely rhetorical as some may believe, play an important role helping to promote legislative responses to the emerging challenges posed by biomedical advances; and second, to explain the reasons why soft law is preferred in the field of international bioethics.

1. Why is soft law really law?

Historically, there are two main sources of international law: treaties and customary law. Treaties are agreements between states which are legally binding, while customary law is derived from the continuous practice of states insofar as such practice is motivated by the sense of legal obligation. Soft law is a third source of international law that has rapidly developed in recent decades, especially to deal with sensitive matters such as human rights, the protection of the environment and bioethical issues. The category of soft law includes a great variety of instruments: declarations, recommendations, charters, resolutions, etc.

Soft law agreements are often defined, by opposition to treaties, as "non-binding instruments". This characterization is not entirely wrong but may be misleading because although soft law does not have per se binding effect, it is conceived to have such effect in the long term. This means that while treaties are actually binding (after ratification by states), soft law instruments are only potentially binding. Soft law is indeed conceived as the beginning of a gradual process in which further steps are needed to make of such agreements binding rules for states. It should be noted that if the binding effect were totally absent from such instruments, then they would not be "law" at all, because one of the main distinctions between "ethics" and "law" is precisely that law is made up of enforceable norms while ethics is not enforceable.

This clarification is crucial because it is common to affirm that soft law just creates moral or political commitment for states. This is only true if we consider the immediate effect of soft law. But the fact is that, in a more indirect and persuasive way, soft law instruments have an influence on states which is not very different from that of treaties. We should not forget that, after all, as formal intergovernmental agreements, such instruments have a legal and not a merely ethical nature. Precisely here lies the major difference between the UNESCO Declarations relating to bioethics and some guidelines adopted by non-governmental organizations such as, for instance, the famous Declaration of Helsinki of the World Medical Association.

Moreover, there is no doubt that the UNESCO Declarations have been adopted with the intention that in the long run, in a way or another, they will become binding rules for states. This "hardening" of soft law may happen in two different ways. One is when declarations are the first step towards a treaty-making process, in which reference will be made to the principles already stated in the declarations. Another possibility is that non-treaty agreements are intended to have a direct influence on the practice of states, and to the extent that they are successful in doing so, they may lead to the creation of customary law. As some experts explain, declarations may "catalyse the creation of customary law by expressing in normative terms certain principles whose general acceptance is already in the air (…) and thereby making it easier and more likely for states to conform their conduct to them".1

2. Why is soft law so attractive in international bioethics?

During the preparatory work of the Universal Declaration on Bioethics and Human Rights of 2005 it was clear from the very beginning that a soft law approach was the best, if not the only, available option. In 2003, the International Bioethics Committee (IBC) produced a report that expressly recommended the form of a "Declaration". The circumstance that this kind of instruments is especially adapted to achieve a broad and relatively rapid consensus among governments, the scientific community and the public in general played a decisive role in this respect.2

It is also interesting to point out that, in realistic terms, the difference between the efficacy of a treaty and that of a declaration is not as great as it may seem. Moreover and surprisingly, according to some studies, declarations and treaties are in fact complied with to largely the same extent.3

Why soft law instruments may represent an attractive alternative to law-making by treaty? There are several reasons for this.

First, declarations present the advantage of allowing countries to gradually become familiar with the proposed standards before they are confronted with the adoption of enforceable rules at the national or international level. This gradual procedure leaves more room for discussion and achieving consensus on issues that are particularly complex or sensitive, or exposed to change, like those related to scientific developments.4

Second, it may be easier to reach agreement when the form is soft law because states areusually reluctant to bind themselves to treaties which may restrict their sovereignty and eventually lead to sanctions in case of violation of the treaty provisions.5

Third, soft law agreements differ from treaties in that they do not require formal ratification by states and, therefore, can have a more direct and rapid influence on the practice of states than treaties.6 In this way, soft law may provide more immediate evidence of international support and consensus than a treaty whose impact may be heavily diluted by reservations and the need to wait for a ratification and entry into force.7 It should be stressed that the relatively short time that is needed to develop a Declaration is of great value in a domain characterized by rapid developments like that of biomedicine. It seems clear that the formulation of global responses to the challenges posed by science cannot wait until governments are able to conclude a treaty, which could take several years of negotiation.


In sum, soft law instruments play an invaluable role in the development of universal norms in bioethics. They should not be underestimated by the fact that they do not create per se binding rules. They operate in a more indirect way, by persuasion, not by coercion. However, experience shows that they have a real influence on the practice of states, by encouraging them to implement the common standards proposed. In the long term, they may create binding norms, either by leading to a treaty or by being recognized as customary law. As a matter of fact, soft law agreements provide at present the only realistic means of dealing with bioethical issues at a global level.

1) Paul C. Szasz, "International norm-making", in: Edith Brown Weiss (ed.), Environmental change and international law: New challenges and dimensions, Tokyo, United Nations University, 1992, p. 41-70.

2) UNESCO International Bioethics Committee (IBC). Report on the Possibility of Elaborating a Universal Instrument on Bioethics (Rapporteurs: L. de Castro and G. Berlinguer), 13 June 2003, paragraph 42. Available online at:

3) Hartmut Hillgenberg, "A Fresh Look at Soft Law", European Journal of International Law, 1999, n° 3, p. 499-515, at 502.

4) Noëlle Lenoir; Bertrand Mathieu, Les normes internationales de bioéthique, Paris, PUF, 1998, p. 47.

5) Andrew T. Guzman, "The Design of International Agreements", European Journal of International Law, 2005, vol. 16, n° 4, p. 579-612, at 592.

6) This advantage is especially to be considered when legislative support at the domestic level is lacking or uncertain. In this respect, it is interesting to point out that one of the reasons why the Universal Declaration of Human Rights of 1948 took the form of a soft law instrument was the foreseeable perspective of non-ratification by the US Senate. See: Mary Ann Glendon, A World Made New. Eleanor Roosevelt and the Universal Declaration of Human Rights, New York, Random House, 2001, p. 71.

7) Alan Boyle, "Some Reflections on the Relationship of Treaties and Soft Law", International and Comparative Law Quarterly, 1999, vol. 48, n° 4, p. 901-913.

Dr. Roberto Andorno ist wissenschaftlicher Mitarbeiter am Institut für Biomedizinische Ethik am Ethik-Zentrum der Universität Zürich. Zwischen 1998 und 2005 war er als Vertreter Argentiniens Mitglied des Internationalen Bioethik-Ausschusses (IBC) der UNESCO.



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