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Legislative framework for biotechnology

Speaking at the General Assembly of the new European Biotechnology Association, Mr. Mario Monti, European Commissioner responsible for the internal market, defended the Commission's proposal for a Directive on the legal protection of biotechnological inventions.

The Commissio...
Speaking at the General Assembly of the new European Biotechnology Association, Mr. Mario Monti, European Commissioner responsible for the internal market, defended the Commission's proposal for a Directive on the legal protection of biotechnological inventions.

The Commissioner stressed the vital importance of biotechnology to society in general, affecting, as it does, advanced technologies and products in the health field, in agriculture and the food industry and in the environmental field. He pointed out, however, that "Given the huge investments necessary for developing new biotechnology products and processes, it is essential that the questions raised in connection with the legal protection of biotechnological inventions should be resolved. otherwise the investments will no longer be forthcoming".

The Commission's original proposal for a Directive in this area aroused lengthy public debate reflecting the public's concern over the ethical implications of biotechnological inventions. The Commission, however, believes that the key issues can be properly addressed through its new proposal (put forward in March 1996) which further clarifies scopes, limits and procedures.

Moreover, in order to address public concerns in this area, the Commission has consulted the Group of Advisers on the ethical implications of biotechnology on ethical aspects of the patentability of inventions involving material of human origin.

Commissioner Monti reported on the opinion of this group, delivered on 26 September 1996. The Group of Advisers stressed that the affirmation of the citizen's rights in the European Union implies that the economical advantages derived from biotechnological developments should not affect the respect of ethical requirements. With this principle in mind, the Group proposed four ethical guidelines:

- The ethical principle of non-commercialization of the human body;
- The ethical principle of informed and free consent of the person from whom retrievals are performed;
- The knowledge related to the human body or its elements is relevant to scientific discovery and cannot be patented;
- An invention issued from the knowledge of a human gene or partial human gene sequence is acceptable only if, on one hand, the identification of the function attached to a human gene allows new possibilities (for instance the production of new drugs) and, on the other hand, if the intended use of the patent is has been sufficiently specifically identified.

Taking account of this opinion, the Commission believes that its proposal fulfils the ethical requirements concerning the question of the patentability of inventions involving elements of human origin.
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