BRUSSELS, Belgium - The European Parliament has given its backing at last to the European Commission's plan to boost patent protection for biotechnology products.

At its plenary session in Strasbourg, France, on May 12, the Parliament formally approved the proposal for a directive on the legal protection of biotechnology inventions. This is the last serious hurdle to the new legislation, after more than 10 years' work on it.

All that remains now is for European Union (EU) ministers to put their signature to it, which should be largely a formality since they have already approved the proposal, and for national legislation to be put into force in the 15 EU member states. By 2000, the new patent regime for biotech products should be in force in Europe.

The new rules set out clearly the legitimacy of patenting biotechnological inventions, including living matter of human origin, subject to a series of clear conditions.

The conditions are based in part on the parliament's own earlier-expressed calls for limits on patents regarding the human body, and they rule out patents for cloning, manipulation of embryos and modifications of the genetic identity of humans and animals.

But - to industry's satisfaction - the new rules do accept that “an element isolated from the human body or produced by other means, including the switching or partial switching of a gene, can constitute a patentable invention, even if the structure of this element is identical to that of a natural element.“

A large majority of Euro-MPs supported the proposal. Of the 626 Euro-MPs, 432 voted for, 78 against and 24 abstained. However, there were plenty of criticisms of the proposal from smaller groups in the parliament and from individual Euro-MPs.

Gianni Tamino, a Green Euro-MP from Italy, said the proposal was “evidently absurd,“ since “a living organism is not a thing.“ Scottish Radical Euro-MP Winnie Ewing said the new measure was “debasing the currency of mankind.“

Irish Green Euro-MP Nuala Ahern accused the measure's supporters of misrepresenting the views of patients' groups. “A sustained campaign by lobbyists financially supported by [London-based] SmithKline Beecham [plc] misrepresented and misinformed Euro-MPs about the patients' organizations,“ she charged.

But in the end, the attempts led by Green Group Euro-MPs to sabotage the report failed to muster sufficient support - unlike the previous occasion when the parliament was asked to endorse a similar proposal and environmental opposition was enough to sink it. That was back in 1995, when Euro-MPs threw out the earlier draft that already had spent years in preparation.

This time the draft text was carefully prepared to avoid the accusations of imprecision on the ethical conditions that should apply to patenting parts of the human body. The new text successfully heads off opposition by making a clear distinction between an “invention“ and a “discovery,“ and conceding that mere “discoveries“ can not be patented.

Parliament also accepted with its May 12 vote that no special new ethics committee needs setting up. Instead, the existing Committee on Ethics in Science and New Technology will be enough to ensure ethical considerations are taken sufficiently into account. Parliament added another condition: “The industrial application of the switching or partial switching of a gene must be clearly stated in the patent request.“

Opponents Vow To Continue Fight

European environmentalists and animal rights and developing countries' lobbyists worked energetically up to the last minute to impede the passage of the new rules. They were loud in their expressions of anguish after the parliament's vote.

The European Farmers' Coordination (EFC), representing smaller farmers, protested against a “victory for short-term business to the detriment of the long-term interests of society and morality.“ It said that “in ceding to the enormous pressure from industry, despite a citizens' campaign against life patenting launched 10 years ago, the European Union is putting its weight behind industry's recourse to the 'genetic weapons' that such patents represent.“

The EFC vowed to fight on, together with other opponents to patents on living organisms.

But European pharmaceutical and biotechnology industries were pleased. The European Federation of Pharmaceutical Industries and Associations (EFPIA) described the vote as a firm signal to encourage the European pharmaceutical industry to invest more heavily in biotechnology. It said a harmonized legal framework will revitalize investment in biotechnology-related R&D.

In EFPIA's view, clear patent rules are vital to “dispel the uncertainty clouding the development of new medicines, treatments and vaccines“ and as a way of “redressing the systematic disadvantage that researchers in Europe, who wish to patent the fruits of their research, suffer by contrast with those in the U.S.“

Europabio, the European biotechnology industry association, said the vote signaled a leap toward safeguarding European competitiveness. *

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