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Important points 1994-1999




No patenting of human clones


pf1601.jpg (4138 bytes)It won't be possible to patent a footballer's feet or a fashion model's lips even in the future. Biotechnological inventions, on the other hand, will be patentable. If for example a scientist discovers that a new medicine can be manufactured by using certain genetic information (known as a "gene sequence") or that, by using another gene sequence, crop plants can be made more drought- resistant and thus be cultivated in very dry regions, it will be possible for these breakthroughs to be patented.

All Parliament's hard work on this issue paid off in the end. After some tough bargaining as well as concerted efforts with Commission and Council, it managed to eliminate the legal vacuum in the area of biotechnological patents. This also means that the public and interested social groups will be better informed, as patents will be published.

Trial of strength

Hardly any topic over the last five years was as hotly contested in Parliament as the directive on the patentability of biotechnological inventions. Most MEPs were highly dissatisfied with the initial Commission proposal and even with the compromise thrashed out after protracted negotiations in the Conciliation Committee. On 1 March 1995 they rejected it. This was the first time Parliament's plenary had overridden a legislative text agreed by the Conciliation Committee.

A major bone of contention was germ line gene therapy, in which the genetic heritage in propagating material is altered so that all subsequent generations carry the altered genes. Other issues were the precise distinction between a "discovery" and an "invention", and the patentability of plants and animals.

The rejection of the legislation was welcomed by environmental organisations but sharply criticised by industry and scientists. The Commission therefore felt obliged to come up with another proposal, which it did in January 1997. However, Parliament thought this proposal too needed improvement. At its first reading in July 1997, under the codecision procedure, it adopted a large number of amendments. These sought not only to settle the disputed points but also to make the text more consistent and remove ambiguities. Parliament wanted to take account both of concerns voiced by environmental organisations, churches and individual citizens, who had contacted MEPs, and of the needs of science and industry.

The limits of patentability

The Council took on board many of Parliament's amendments as they stood so there was no need for a conciliation procedure and in May 1998 the directive was adopted. Parliament managed to have the text re-worded at several key points. As a result, only inventions can be patented, not discoveries. It is therefore not possible to patent the entire genetic inheritance of an organism but only an isolated component thereof, such as a gene segment, which must have an industrial application. It is thanks to Parliament that no-one will be able to patent the human body as a whole, even in its early stages, e.g. as an embryo. Patenting of plant varieties or animal species will not be allowed either.

Ethical issues

At Parliament's insistence it was agreed that no invention which is morally offensive, such as human cloning or germ line gene therapy, should be patentable. An ethics committee was set up, also at Parliament's prompting, to deal with any moral issues arising from the use of biotechnological patents.

MEPs successfully pressed for a ban on any patenting of the genes of human beings without their knowledge or consent. Should an invention use gene sequences of individual human beings, their names must be mentioned in the patent application and they must have given their consent, although on grounds of privacy their names will not be published.

Farmers too can breathe more easily. They will be allowed to reproduce genetically modified seed for sowing the following year and even sell it on for agricultural use but not for commercial reproduction. The same rules apply to stock farmers.

Thus, from the year 2000, once the directive has been enacted by the Member States, it will be possible to patent biotechnological inventions in the EU. This is not just a big step forward in clarifying the law for science and industry but also a major boost for freedom of information.

Further information: Judith ECKER (tel. 0032-2-284 26 29 or e-mail: jecker@europarl.eu.int)

European Parliament

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