Intellectual & Industrial Property Industrial Property

Biotechnological inventions: Commission amends proposal to take account of Parliament's views

The Commission has adopted an amended proposal for a directive on legal protection for biotechnological inventions which takes account of the amendments adopted by the European Parliament on 16 July. As Mr Monti, Member of the Commission with special responsibility for the single market, announced during the plenary debate, the Commission has incorporated 65 of the 66 amendments adopted by Parliament, including all those relating to the ethical dimension of biotechnological inventions. The cloning of human beings is now explicitly outlawed, as is any form of manipulation of germ line genetic identity. Once the directive has been adopted, an independent committee will be responsible for assessing the ethical aspects of biotechnology.

`We have struck a much sought-after balance between the vital need to take account of ethical considerations concerning the protection of the human body, on the one hand, and economic demands arising from the need to ensure completion of the single market, on the other,' Mr Monti commented. `As Parliament has confirmed, there is no doubt that a component of the human body in isolation can be patented, provided that it meets the criteria for patentability. However, thanks to Parliament's input, the amended proposal makes it abundantly clear that procedures involving cloning for purposes of human reproduction and involving modification of the germ line genetic identity of the human being, as well as particular uses of human embryos are not eligible for patenting.'

The debate in Parliament stressed the need to ensure that the ethical dimension is never forgotten and that it remains open to scrutiny at all times. Accordingly, Parliament adopted an amendment calling on the Commission to set up, prior to the directive's entry into force, an ethics committee charged with assessing the ethical aspects of biotechnology in all their diversity. As announced during the plenary debate, the Commission states in its amended proposal that this task is to be entrusted to its Advisory Body on the ethics of biotechnology, whose mandate is due to be renewed at the end of the year. Its membership and remit will be changed at the same time so as to guarantee absolutely that it is independent and represents a range of different opinions, and to take account of Parliament's concerns about transparency.

Only one of the amendments adopted by Parliament was not incorporated by the Commission into its amended proposal. The amendment in question sought to use patent law to establish a system of proof ensuring that, in cases where an invention is of human, vegetable or animal origin, the material concerned has been removed with the consent of the person concerned or in accordance with the laws of its place of origin. If such were not the case, the penalty imposed would be a ban on patenting. Firstly, the Commission notes that, as regards protection of biodiversity and access to genetic resources, this amendment goes beyond the international commitments entered into by the Community and its Member States in adopting and ratifying the Rio Convention on Biological Diversity of 5 June 1992. Secondly, as regards obtaining the consent of the person concerned, the amendment does not meet the stipulations relating to the protection of personal data enshrined in Directive 95/46/EC of 24 October 1995. However, the Commission has taken into account the spirit of Parliament's amendment in stating that the directive will not affect the Member States' obligations under the Biodiversity Convention. Moreover, the free and informed consent of the person from whom the material concerned was taken is required in order to file an application for a patent on the use of such material.

Following Parliament's vote and publication of the amended proposal, the Council is now to adopt its common position. The Commission hopes that this can be done at the meeting of the Single Market Council on 27 November, as the proposal for a directive is one of the four priority measures identified by the Action Plan for the Single Market.

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