Policy



"Enlarged G8 Meeting Devoted to Bioethics Takes Position Against the Patentability of Human Genes"

Jean-Yves Nau
June 26, 2000

The meeting, held Saturday 24 and Sunday 25 June in a castle on a large vineyard of Bordeaux, brought together Research Ministers of the G8 countries (USA, UK, Germany, Italy, Russia, Japan, Canada and France) plus those of Brazil, China, Mexico and India, and was devoted to bioethics. It closed with no common declaration at the end.

The meeting of Research Ministers of the G8 countries organised on Saturday 24 and Sunday 25 June - on the eve of the international announcement that the first phase of sequencing the human genome has been completed - was marked by a general consensus against the direct patenting of genes which constitute an inherited patrimony forming part of what is, in the terms of the Universal Declaration on the Human Genome under UNESCO, a "common heritage of humankind".

"The exchanges we were able to have during the meeting have established that there is a strong convergence of views on the patentability of life forms," said Roger-Gérard Schwartzenberg, French Minister of Research, to Le Monde. "All participants are in agreement that the raw data produced by genome sequencing cannot be appropriated, must imperatively stay in the public domain and should not be the subject of any patent. France explicitly took this position in 1998. We were joined by the United States and Great Britain on 14 March 2000 when Bill Clinton and Tony Blair made a joint statement on this matter."

For the participants of the G8 meeting in Bordeaux, only true innovations made on the basis of the structure of genes could in the future be protected by patents. In other words, the mere discovery of a gene must remain outside the field of patentability. Biotechnological innovation would start at the identification of the function of a gene through an experimental method, leading to the description of diagnostic or therapeutic applications.

Once these principles are put forward, the main difficulty and the possible divergences between international patent offices will arise from the definition of "identification of a function". Biologists themselves do not always agree on this matter. Defining this is all the more delicate since one gene can have several functions. During the scientific colloquium which preceded the G8 meeting, Professor Jean Weissenbach, Director of Génoscope in Evry, explained that the concept of "function" of a gene is very vague and that the notion of a pair formed between a gene and the protein that it is supposed to synthesise is outmoded today. "Beyond the traditional characteristics of novelty and applicability, we will have to reach a much clearer idea of the criteria for inventiveness which would justify patenting in this field," Mr. Schwartzenberg said.

This is precisely the question at the centre of a controversy right now regarding the transposition into French law of the 1998 European directive on the protection of biotechnological inventions (Le Monde of 25-26 June). This directive, which was put into national law by a few countries of the European Union these past weeks, was not directly addressed by the G8. The problem was nevertheless raised to the extent that the European Commissioner responsible for Research, Philippe Busquin, was present in Bordeaux. "It is clear that the directive is rather poorly drafted, especially in the second line of Article 5," says Mr Schwartzenberg. "A reading of the whole text, including the preamble, gives a clear impression. However, the European Union does not have legislative or normative competence in the field of ethics and therefore the most important aspects are relegated to the preamble."

"For my part," he continued, "I hope there can be a concertation between the European Commission and the European Patent Office. It would also be good if France requests from Brussels an interpretation of the directive. If the European Commission confirms that this interpretation falls in line with our own interpretation then we can save a lot of further discussion and negotiation."

The G8 meeting did not progress on the question of research on human embryos. During the scientific colloquium preceding the meeting of Research Ministers, several French and foreign biologists explained how promising these researches are in terms of new therapies. The discovery of the extraordinary plasticity of certain cells ("stem cells") of embryos, which are capable of differentiating and recomposing different tissues of the organism has raised numerous hopes about treatments and the development of a new medicine called "regenerative medicine".

Given the profound divergences between G8 countries on the status of the human embryo and on the possibility of using embryos in research, the participants of the G8 meeting barely delved into the issues. In France, this whole question will be examined by Parliament when it reviews the laws on bioethics of 1994. This review was scheduled for 1999 and no one in the government knows if it will take place before the end of 2000.

** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed for research and educational purposes only. **



Last Updated on 6/27/00
By Dan Ellis
Email: karen@biotech-info.net

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