Protecting Fundamental Values and Progress: International Deliberative Initiatives and Their Legal Foundations

Laurence Lwoff, Head Bioethics Unit, Council of Europe

In her recent document published in September 2020 in the context of the Covid-19 pandemic, Ms Marija Pejčinović Burić, Secretary General of the Council of Europe, acknowledged "the need to promote societal dialogue between the public, scientists and policy makers in order to build trust in the management of the crisis." Such dialogue is not novel; the importance of public debate on developments in the biomedical field was underlined more than twenty years ago by the drafters of the Convention on Human Rights and Biomedicine (ETS n°164, 1997)–the “Oviedo Convention.” 

The Global Observatory and its objectives echo some of the concerns that guide the Council of Europe’s work on the protection of human rights in biomedicine. Notably, Article 28 the Oviedo Convention provides that "the fundamental questions raised by the developments in biology and medicine are the subjects of appropriate public discussion in the light in particular, of relevant medical, social, economic, ethical and legal implications and that their possible applications is made the subject of appropriate consultation.”

As stated in the Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020-2025) adopted at the Council of Europe in November 2019, today “governance models are required to guarantee that the protection of human rights is a guiding consideration throughout the entire process of research, development and application. In addition, ongoing dialogue between the public, scientist and policy makers should be ensured so that technological developments are robustly deliberated, democratic and legitimate.” Adopted by the 47 European States in the Council of Europe’s Committee on Bioethics (DH-BIO), the Strategic Action Plan comprises a pillar on the governance of technologies, including new genome editing technologies, asserting that “governance arrangements need to be considered, which seek to steer innovation process in a way which connects innovation and technologies with social goals and values.” It is striking to see that there is consensus on the need for public debate on genome editing applications, namely on human germline editing; there is no paper, statement or report, including the most recent ones coming from scientific experts, that does not refer to this need.

The Oviedo Convention remains the only legally binding legal instrument at international level addressing human rights protection in biomedicine. It represents intergovernmental agreement on legal provisions at the pan-European level and is also an important reference at the global level.

As stated in the Explanatory Report to the Oviedo Convention, “it takes account of developments in medicine and biology, while indicating the need for them to be used solely for the benefit of present and future generations.” Further, these concerns are affirmed at three different levels:

  • The first is the level of the individual, who must be protected from any threat to resulting from improper use of scientific developments.
  • The second is at the level of society, where the individual must be considered as part of a social corpus sharing a number of ethical principles and governed by legal standards. This concerns any choice that goes to the heart of how we want to shape the lives of individuals and the broader society. 
  • The third is the level of the human species. This relates to concerns raised, in particular, by developments in genetics. While acknowledging the considerable actual and future progress for human health regarding these developments, it is no longer the individual nor society but the human species which may be at risk. In this context, the Oviedo Convention refers to the benefits of present and future generations and to all of humanity. 

Article 13 of the Oviedo Convention, which refers to intervention on the human genome, limits the purpose for which an intervention seeking to modify the genetic characteristics of a person and prohibits any such intervention which aims at introducing a modification in the genome of any descendants.

This provision was drafted more than 20 years ago. Some would argue that the situation has changed now and that the new technological developments make it necessary to reconsider it. Without entering in this discussion, this does not mean that the concerns guiding Article 13 are obsolete.


Article 13 of the Oviedo Convention cannot be limited to matters of safety, risks and benefit for the individual concerned. Human dignity, concerns about possible eugenics practices, identity and the principle of equitable access to healthcare, all of which the Oviedo Convention aims at protecting, remain relevant for debate at international level on the fundamental questions raised by recent technological developments. Scientific perspectives are an integral part of such debate and cannot be considered paramount and disconnected from the social, legal and ethical issues.


When calling for “public debate” or “dialogue,” it is necessary to clarify the terms of this multidisciplinary and pluralistic exercise and not to be limited to a mere reference to it but for there to be a genuine process of engagement. Legal principles are not only an integral part of a governance mechanisms providing the necessary framework within which more flexible approaches can be developed. They also provide a fundamental basis on which to guide the discussion for its development. 
The aim of the work of the Council of Europe has always been to protect both fundamental values and progress. The emphasis it places on societal dialogue remains crucial today. The Global Observatory for Genome Editing fully reflects these concerns.