PARIS - France seems to be on a collision course with the European Commission over the 1998 biotechnology directive that member countries of the European Union are due to transpose into their national legislation by July 6.
Justice Minister Elisabeth Guigou set the tone when she told the French National Assembly on June 7 that the directive - No. 98/44/CE - was "incompatible'' with several pieces of French legislation, namely ''the 1994 bioethics law, the industrial property code and the civil code banning the marketing of the human body.''
Now an advisory body to the French government, the National Consultative Ethics Committee, has arrived at a similar conclusion, having been asked to look into the matter by the secretary of state for Industry. In a nine-page report published last week, the committee advocates that "France should suggest a fresh discussion of the provisions of the directive'' and "call for an international debate on industrial property issues in the field of the genome. Such discussion should result in the creation of a body with the task of reconciling the necessary protection of biotechnological inventions with ethical principles.''
While France seems bent on trying to secure an amendment of the directive, the European Commission has warned French authorities that it will take the matter to the European Court of Justice if France does not apply the directive as it stands. The nub of the problem, in the committee's view, is that there is no clear distinction between an invention and a discovery in the field of genetics. "Knowledge about the human genome is so linked to the nature of the human being, so fundamental and necessary to his future well being, that there is no way it can be appropriated,'' it argues.
One member of the committee, geneticist Axel Kahn, said it was "surprising'' that a European directive should "go against free access to knowledge.'' The Justice Ministry's first draft of a bill to transpose directive 98/44 into French law sought to clarify the invention/discovery dichotomy by stipulating that "the industrial application of a gene must be clearly set out in the patent application,'' but Kahn does not think that is a sufficient safeguard.
The European directive already sought to draw the line by asserting that "the human body . . . including the sequence or the partial sequence of a gene, cannot constitute patentable inventions,'' and then qualifying that general statement of principle by adding: "An element isolated from the human body, or otherwise produced by a technical process, including the sequence or the partial sequence of a gene, can constitute a patentable invention, even if the structure of that element is identical to that of a natural element.''
An unofficial campaign against the directive is being waged by another French geneticist, Jean-Frangois Mattii, a deputy in the National Assembly, who has launched a petition that has so far obtained more than 4,000 signatures in France and Germany.