PARIS - The French government still seems to be no nearer transposing the European biotechnology directive into its national legislation, despite indicating earlier this year that a bill to that effect would be drafted by September.
All member countries of the European Union were due to transpose the directive - No. 98/44/CE of July 6, 1998 - into their legislation by July 6 this year. In France, however, a broad lobby composed of government ministers, National Assembly deputies, doctors and researchers take the view that the directive is ambiguous and incompatible with French laws, including the 1994 bioethics act, the industrial property code and the civil code banning the marketing of the human body.
With a view to drafting a new bioethics bill that would, among other things, give effect in France to the provisions of the EU directive, the government asked the European Commission in June to clarify certain aspects of the directive. It received a reply in October and is studying the Commission's observations before taking a final decision on whether to transpose the directive into national legislation. The European Commission earlier warned French authorities that it would take the matter to the European Court of Justice if France did not apply the directive as it stood.
Even if the French government does decide to introduce the necessary legislation, it is unlikely to be enacted before next summer. The bill first will be examined by a subcommittee of the National Assembly before being debated by the full chamber and then by the Senate. Both houses of Parliament are likely to introduce amendments to it, so it is likely to be many months before it reaches the statute book.
Meanwhile, the leading French opponent of the directive, Jean-Frangois Mattii, who is both a geneticist and a deputy in the National Assembly, has just submitted a petition signed by some 10,000 people to French President Jacques Chirac. He and his followers are worried that the European Patents Office will officially endorse the patentability of human genes during a week-long meeting of its member governments taking place Nov. 20-29, without national parliaments being given the opportunity to debate the issue.
Mattii is calling for an immediate moratorium on the deliberations of the Patents Office to enable EU member states to undertake a review of the directive. He claims the governing board of the EPO already has changed its regulations and "made the patentability of certain genes operational since September 1999." According to the EPO, however, it does not formulate policy but simply implements the provisions of directives approved by the European Parliament.