Feelings running high over patent rules

Date: 10/07/1997

By Rory Watson

SUPPORTERS and opponents of biotechnological inventions are set to clash next week as the European Parliament considers new patenting rules for the industry.

The debate will reopen many of the arguments which surfaced a little over two years ago when MEPs surprised EU governments and the pharmaceutical industry by rejecting an earlier version of the patent legislation.

“That is the only time the Parliament has rejected EU legislation after a compromise had been worked out with governments. The proposal still faces a lot of opposition, but MEPs will also be acutely aware of the possible repercussions if they reject it a second time,” said one parliamentary official.

There is little chance that Euro MPs will throw out the revised draft proposal when they pronounce their verdict on the first reading next Wednesday (16 July). That course of action is only likely to be a possibility during the second reading early next year.

But opponents, led by the Greens and some Socialists, will use next week's parliamentary plenary session in Strasbourg to table a series of amendments to try to shape the text to reflect their views more closely.

The report's rapporteur, German Socialist MEP Willi Rothley, who has followed the biotechnological debate for more than a decade, is optimistic that the text he steered through the Parliament's legal affairs committee with just five dissenting voices and three abstentions will eventually be adopted by all MEPs.

“The legal affairs committee has backed most of my compromise amendments. I am hoping that the Parliament's plenary does the same and that the Commission puts forward a modified proposal soon which takes most of our demands into account,” he said.

The draft legislation makes a distinction between inventions and discoveries. Under the plan, the latter could not be patented, but the former - defined as a technical process with an industrial application - could be. The proposal also sets out to give European industry better legal protection for biotechnological inventions than at present, and would establish a special committee to advise on all the ethical implications of biotechnological developments.

Critics of the draft legislation insist it makes little sense to consider patenting rules for biotechnology in isolation given that the Commission has recently called for a general overhaul of patent regimes in Europe.

They also believe that the existing provisions do not set firm enough limits on biotechnological research on the human body.

“We want to offer people a clear choice on where the line should be drawn. We want to draw it in a different place from where the Parliament's legal affairs committee has placed it,” said one opponent.

Critics maintain that the existing provisions contravene the advice of the Commission's own ethical advisers, who said the “human body ... as well as its elements” did not constitute patentable inventions.

The current wording would allow human DNA, genes and gene sequences to be patented outside the human body even though they had an identical structure to that of the natural element.

Equally, while accepting that the legislation would not allow the patenting of “procedures for human reproductive cloning”, they point out that it would still permit the patenting of human spare-parts production or of human/animal hybrids.

Critics also highlight the absence in the draft legislation of any provisions for informed consent to the patenting of human tissue taken from individuals and of any substantive rules protecting biodiversity or indigenous peoples' cultural and intellectual property rights.

The criticism is rejected by pharmaceutical companies, which invest heavily in biotechnological research, and by patient groups, who hope to benefit from the process.

The European Alliance of Genetic Support Groups (EAGSG), which represents the views of people suffering from genetic diseases throughout Europe, maintains that the legislation would offer significant hope for patients and their families.

“The patenting of biotechnology is essential for the application of modern and innovative technology to the prevention and cure of disease. The draft directive on the legal protection of biotechnological inventions will allow this to continue,” said EAGSG president Alastair Kent, adding that there was no effective treatment for 85&percent; of known diseases.