MEPs put ethics under microscope

Date: 12/09/1996

By Rory Watson

SUPPORTERS and critics of moves to protect biotechnological inventions are busy sharpening their arguments as MEPs begin examining the merits of EU patenting legislation for the second time in 18 months.

Danish Europe of Nations Euro MP Ulla Sandbæk is already pressing for the debate to be widened to take account of the broader ethical questions raised by genetic engineering.

She rejects the pharmaceutical industry's arguments that decisions about moral, ethical and socio-economic aspects are not part of the patenting process.

In a working document to be discussed by the Parliament's environment committee for the first time later this month, Sandbæk states: “A global approach should be taken and ethical questions should be raised as a priority before the adoption of new technical legislation.”

She also believes that a special Ethical Council, chaired by the Commission and comprising members appointed by EU governments and the Parliament, should be established and consulted on all aspects of biotechnological inventions.

Sandbæk's views are unlikely to be fully shared by the environment committee, which is one of five committees with an input into the parliamentary report being prepared by the legal affairs committee and German Socialist MEP Willi Rothley.

The issue is one of the most sensitive facing the Union.

Earlier plans for EU-wide legislation foundered last year when the debate became polarised between Green groups arguing against the patenting of life and a pharmaceutical industry warning that without patent protection there would be little incentive to make the huge investments necessary to develop new products.

Despite the strong emotions aroused by the issue, there are indications that the debate will not be a straight replay of earlier discussions.

Previously, groups representing sufferers of genetic illnesses kept out of the debate. This time they are making their voices heard.

“Patient groups are concerned that the debate could become polarised between commercial interests and the Green groups. There is a feeling that the voice of people who could benefit from biotechnological inventions might get lost in the debate,” says John Dart, treasurer of the European Alliance of Genetics Support Groups.

This feeling is matched by a growing awareness that if the Union is to press ahead successfully with its plans for 'orphan' drug legislation, then a sensible regulatory framework with clear patenting laws is needed to enable biotechnology companies to carry out work which may not now be commercially viable.

Sandbæk's ideas have already been attacked by at least one patients' group. Last week, the Danish Cystic Fibrosis Association wrote a highly critical letter to all members of the environment committee and to all Danish MEPs.

“As patients we feel deserted by Mrs Sandbæk's document and hope that MEPs will show concern about both the general public and also about the thousands of patients who are suffering from serious disorders and whose only hope is linked to the merits of research and the development of new drugs,” it stated.

Rothley has already made clear his intention to concentrate his report on the purely technical issue of patenting. He argues that EU-wide legislation is necessary to prevent legal uncertainty and avoid any fragmentation of the law which might result from the existing structure of national rules.

The proposed directive is also designed to encourage inventive effort and to boost the Union's global competitive position. In a recent working document, Rothley noted that between 1981 and 1995, 1,175 patents had been granted world-wide for inventions to protect human DNA sequences.

Three-quarters of these were granted to industry and most of the 213 firms involved were either American or Japanese. Almost half the patents are in Japanese hands, with the rest divided equally between the US and the rest of the world.