Biotechnology patenting deal set for approval

Date: 20/11/1997

By Leyla Linton

THE patenting of components of the human body such as DNA is likely to be approved by internal market ministers when they meet next week, finally bringing years of wrangling over the issue to an end.

Member states are expected to reach an agreement next Thursday (27 November) on an amended European Commission proposal for EU laws on the legal protection of biotechnological inventions.

Although disquiet has been expressed by citizens in the UK and Austria over the proposed legislation, the governments of both countries are believed to have found enough room for manoeuvre to allow them to accept the latest plan.

The Dutch and the Danes are still expected to vote against the proposal or to abstain, but this will not affect the outcome as only a qualified majority in favour is needed for it to become law.

Final agreement on the plan beckons two years after the European Parliament exercised its right under the new shared decision-making powers given by the Maastricht Treaty to reject the original proposal, forcing the Commission to go back to the drawing board.

MEPs ignored calls from their own representatives to accept the deal struck with the Council of Ministers in conciliation talks, on the grounds that it did not contain sufficient ethical guarantees.

German Socialist MEP Willi Rothley, who has laboured on various versions of the draft legislation for almost a decade but failed to convince his own colleagues to support the directive first time around, insists patent protection is essential if jobs are to be created and if the Union wishes to avoid lagging behind the United States and Japan in the biotechnological market.

Pharmaceutical companies, which invest heavily in such research, have lobbied heavily in favour of the legislation, as have patient groups. "The patenting of biotechnology is essential for the application of modern and innovative technology to the prevention and cure of disease," said Alastair Kent, spokesman for the European Alliance of Genetic Support Groups.

Parliament's first reading of the proposal in the summer led to a heated debate, with the Green Group and some Socialist MEPs arguing that the plan was akin to permitting the patenting of life. But a majority of MEPs supported it and the Commission has since taken on board more than 60 of their amendments. These include changes clarifying the difference between discovery and "invention" of isolated parts of the human body, and banning human reproductive cloning and processes for "modifying the germ-line genetic identity of human beings".

The amendments agreed by the Commission also require ethical considerations to be taken into account and stress that the medical usefulness of inventions must be balanced against the suffering they could inflict on animals.