Opinion on Ethical Questions Arising from the Commission Proposal for a Council Directive on Legal Protection for Biotechnological Inventions, Group Advisers to teh European Commission on the Ethical Implications of Biotechnology, Opinion No. 3 (Oct. 1, 1993)

Own initiative.

Rapporteur: Mrs Noëlle Lenoir


The original proposal for a Directive was adopted by the European Commission in 1988. It was to harmonize the laws of the Member States on patents relating to biotechnological inventions. The procedure for its adoption was slowed down by primarily ethical issues regarding the patentability of living matter. Parliament eventually rejected the joint text on 1 March 1995, and it had to be withdrawn.

The Commission adopted on 13 December 1995 a new proposal which takes into account the importance of ethical questions.


'... [In view of] the need to protect human dignity ... there are no ethical objections to the patenting of biotechnological inventions per se ... [Nevertheless] some clarifications are urgently needed on certain concepts and on the scope of certain provisions in the Directive ... . Genes and partial gene sequences whose functions are unknown should be made expressly unpatentable .... the Community should take a stand against the commercial exploitation of the human body ... [there is a] need for measures to familiarize the public not only with the scientific and economic side of biotechnology but also with the social, legal and ethical implications. This is a democratic imperative... .'

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