Brussels, 22/12/2002 (Agence Europe) - The European Commission has decided to send a reasoned Opinion to the nine Member States who have failed to transpose the directive on the legal protection of biotechnological inventions: France, Germany, Austria, Belgium, Italy, Luxembourg, Netherlands, Sweden, Portugal. These Member States have two months to reply to the Commission's opinion before an infringement procedure comes into effect. However the Commission announces that it "will maintain contact" with Member States to "help them in the process of transposition" on this sensitive issue. The text, adopted after ten years of debate in the Council and the Parliament, was supposed to have been transposed by July 30th 2000. Article 5 of the directive relating to the patentability of isolated parts of the human body is still a source of considerable debate amongst the Member States.
The Commission underlines in a communiqué that it is fully aware of the fear that this directive may have generated amongst the public in some Member States, to the extent that this directive concerns the patentability of biological material which may incorporate isolated elements of the human body where the patent conditions are met. However the directive contains clear and precise provisions setting out the guarantees especially with regard to the respect of the dignity and the integrity of human dignity. The Court of justice's ruling on October 9th 2001 recalled that the directive fully complied with these key principles.
We would point out that the Commission has set up a group of experts to examine two sensitive issues from an economic and legal point of view: the patentability of stem cells and patentability of genetic sequences or partial sequences of isolated genes of the human body (see EUROPE on October 12, p.16). A report is due to be submitted in 2003.