PARIS - The French government is due to publish in September a new bioethics bill that, among other things, will transpose the European biotechnology directive into national law. But that will not be the end of the matter, since the bill is certain to be debated for months in the National Assembly, which also is likely to propose amendments.

The assembly has set up a subcommittee to acquire all relevant information relating to the planned review of the country's bioethics legislation, but it did not hold its first meeting until May 9 and does not plan to issue its report until the end of the year. The subcommittee hopes the government sticks to its plan of publishing a bill in September, although its reporter, Alain Claeys, told a press conference last week the assembly would only start debating it in earnest in the first half of 2001, following the publication of the subcommittee's report.

While biotechnological considerations are only one aspect of the legislation, which covers the whole gamut of medical practice and life sciences research, Claeys maintained that the economic issues relating to the patentability of genomics information and applications was one of the main points to be looked at. Asserting that the human body was not patentable and that there should be free access to common knowledge, he said France would ask for clarification of the European directive of July 6, 1998, which is considered by some to be ambiguous in this regard.

France holds the six-month presidency of the European Union for the period from July 1 to December 31 this year, which will facilitate the task of securing an interpretation of the directive that corresponds to French attitudes. As it was, said the chairman of the Assembly subcommittee, Bernard Charles, the few countries that had transposed it into national legislation had "interpreted it to suit their requirements."

There is a widespread consensus in the French political establishment on the patentability of genomics discoveries, as was evident from the assembly's warm reception of a statement by the minister of research, Roger-Girard Schwartzenberg, on June 27. In reply to a question from Claeys, he insisted the "human genome is the common heritage of mankind and genomic information should thus belong to everyone. In no event should genetic knowledge be confiscated. Thanks to public research . . . raw sequencing data will be freely accessible to everyone.'' And he went on to reiterate the three principles governing the French government's attitude to patentability:

"Firstly, the raw sequences of the human genome should be placed in the public domain and are not patentable. Secondly, the simple discovery of what exists in the natural state is not a real biotechnological invention, which alone can be patented. Lastly, patentability implies identifying the function of a gene, not simply by computer but by experimental method, and determining the practical applications of that function for developing new medicines or genetic tests. Only at this level of inventiveness can a patent be granted.''

Schwartzenberg added that this was how the European directive should be interpreted. But he stressed the importance of patents for promoting gene-based research aimed at improving human health. "Patents protect, and thus encourage, the inventive activity of researchers who are going to develop new tests and drugs against cancer, diabetes, cardiovascular and neurological diseases.''

No Comments