20th anniversary of the Oviedo Convention: a text at least put into question


Late October, the Council of Europe’s Committee on Bioethics (DH-Bio) organised two days of conferences for the 20 years of the Oviedo Convention in Strasbourg. The Committee saw this as the opportunity to “question the relevance of the principles made sacred” via this text, and to think about how the rapid development in the field of biomedicine “should be dealt with”. Before going over the content of this symposium, Gènéthique wishes to revisit the making of this convention, an international reference text in the field of bioethics.

 

 

After the Nuremburg Code (1947) and the Helsinki Declaration (1964, revisited in 1975), which set the principles applicable to medical research, in the 70s, the Council of Europe began reflecting over the ethical principles that should preside over biomedical ethics. It thus came up with a certain number of recommendations on specific themes: rights of the sick and dying persons, prenatal diagnosis, genetic testing. In 1983, a first internal committee, the CAHGE[1], was created to study the issues raised by genetic manipulation techniques and determine a common policy for all member states. It was replaced in 1985 by a second committee [2]. Its role is to fill the political and judicial voids which appear alongside the development of biomedical science: finding a consensus proves a delicate task. The CAHBI issued two recommendations which proved insufficient; it was then that the idea of a Convention to which all member countries should subscribe emerged.

 

 

In 1990, the CAHBI was therefore in charge of preparing this framework convention that was to deal with the rights of human beings while considering the previous recommendations. In 1992, the CAHBI was replaced by the CDBI[3] which shortly after published a convention project. In 1996, after months of discussion, the Committee of Ministers of the Council of Europe approved the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, called the “Oviedo Convention”. Open for signature on April 4th 1997 in Spain, it is the first international text judicially compelling in this field. It has since been completed by four additional protocols concerning human cloning, organ transplantation, biomedical research and genetic testing carried out to medical ends.

 

 

Though it has the merit of being the first text providing the signatory States with a common framework of ethical principles, it is regrettable that these principles were kept to a minimum. For example, the framework established for test-predicting genetic diseases does not apply to human embryos or foetuses. Plus, the article 18 which “supervises” human embryonic research demands adequate protection without defining that protection, thus allowing more or less permissive interpretations.

 

Besides, the thirty-eight articles of the Convention insist on the primacy of the human being over the interests of society or science, a fair access to health care, the importance of the patients’ free and enlightened consent but also the respect of private life. The article 13[4] is topical: it bans all medical intervention leading to hereditary human genome modifications as well as all non-hereditary human genome modifications which are not justified by prevention, diagnosis or therapeutic reasons. Without it being written explicitly, it is admitted it does not ban research on germ cells [5]. It is therefore applicable to genome editing, that has widely spread these past two years. This was reaffirmed in a resolution adopted last 12th October by the Parliamentary Assembly of the Council of Europe.

 

 

The European Convention on Bioethics prevails over national laws. It influences the European Court of Human Rights’ rulings and number of national rulings. However, it came into application in only 29 of the 47 Member States of the Council of Europe. Germany, Ireland, Malta and the United Kingdom for example, refused to sign or ratify it, judging it too permissive for some and too restrictive for others. As for France, it ratified it in December 2011 in view of its application from April 2012. However, this subscription brought no significate changes as the legislator saw no contradiction between the French law and the Convention.

 

 

Currently, a certain current claims a revision of the Convention, believed necessary considering the “advancement of science”, and particularly the evolution of genetics. In France the Office charged with informing the parliament about scientific and technological questions, the OPECST, agrees: in its report on CRISPR technology published last March, it wrote: “this convention remains quite global and with the development of CRISPR Cas9, we urgently need to reconsider it by specifying and clarifying the terms and conditions in which research can be carried out”. The Inserm, the French public organism, agrees, and is considering remodelling the articles 13 and 18, rendering the ban on genetic interventions on the human germline temporary and the creation of human embryos for research possible. Alarming perspectives which found an echo at the last symposium organised at the end of October.

 

 

[1]  ad hoc experts’ committee on ethical and judicial issues concerning human genetics

[2]  Ad hoc experts’ Committee concerning the progress of biomedical sciences

[3] The Steering Committee on Bioethics; replaced by the current DH-BIO Bioethics Committee, directly attached to the Steering Committee for human rights. Its missions remain the assessment of the new ethical and judicial issues in the fields of biomedical science and technology and the development and implementation of the principles inscribed in the Oviedo Convention.

[4]Article 13-Intervention on human genome:

An intervention which goal is the modification of the human genome can be carried out only for preventive, diagnosis or therapeutic reasons and only if it does not aim at introducing modifications in the genome of the descendance.

[5] Thus, according to this interpretation, research modifying the genome of human embryos is possible with the condition that these embryos are not implanted but rather destroyed.