WRITTEN QUESTION P-2281/00

by Marie-Noëlle Lienemann (PSE) to the Commission

(29 June 2000)

Subject: Application of Directive 98/44/EC on the legal protection of biotechnological inventions

Does the Commission not agree that in response to the civic movements that are developing and the reaction of the scientific community, as well as the agreement between Mr Blair and Mr Clinton seeking to prohibit commercialisation of the human genome, it would be appropriate fundamentally to review the parts of Directive 98/44/EC(1) relating to the patentability of human genetic code sequences?

The fundamental principles of non-commercialisation of the human body, of free access to knowledge of the gene and the sharing of such knowledge would appear to be wide open to all manner of abuse, depending on the interpretation placed on the relevant texts and it is commercial logic that is likely to prevail. The prospect of lucrative spin-offs from research will be allowed to ride roughshod over basic principle, because any element of the human body will be considered as patentable as soon as it has been isolated and related to a function.

As matters stand, I can only agree with a great many scientists, philosophers and leading political figures that if this directive is applied, it will result in the hijacking of genetic knowledge. It is high time to act promptly, because the problem is not confined to the simple question of competition but touches on an issue of vital importance one with a direct bearing on life itself. It therefore stands to reason that in an area of human knowledge as fast-moving as this one, a review of the relevant legislative texts should be arranged promptly, even if the current versions of those texts were drawn up only recently.

(1) OJ L 213, 30.7.1998, p. 13.

Answer given by Mr Bolkestein on behalf of the Commission

(27 July 2000)

Agreement on Directive 98/44/EC of the Council and the Parliament on the legal protection of biotechnological inventions was only achieved in 1998 after lengthy and thorough discussions within both the Parliament and the Council. Much consideration was given during these discussions to the ethical considerations surrounding biotechnological inventions. The resulting Directive seeks both to address these ethical considerations and to provide the necessary incentives to encourage research and development in the area of biotechnology.

In terms of the scope of the Directive, much attention, both during the negotiations on the Directive and also since its adoption, has been focused on the protection afforded to elements isolated from the body or otherwise produced by means of a technical process and in particular sequences or partial sequences of genes.

Discoveries, which do not extend human ability, but only human knowledge, are by their very nature not patentable. This is certainly the case with the mere sequencing of a genome which belongs to the area of discovery and for that reason alone cannot take advantage of patent protection.

It is different however if a DNA sequence is released from its natural surroundings or is otherwise produced by means of a technical procedure and is made available for the first time to a industrial application. Here there is a step taken from knowing to being able. Such a gene is new in the patent sense and therefore patentable, if it was not previously accessible to the public as such, and thus technically was not available.

The position that was therefore agreed by both the Parliament and the Council after much discussion was that patents for inventions comprising of, or based on, gene sequences should be allowed. This position took account of the opinion of the group of advisers on the ethical implications of biotechnology to the Commission. Indeed the group of advisers fully recognised the stimulus provided by patents for medical research.

As mentioned in the question, the President of the United States and the Prime Minister of the United Kingdom have issued a joint statement which called for the basic raw data on the human genome to be made freely available. However this statement also recognised that intellectual property protection for gene based inventions has an important role in stimulating the development of important new health care products.

Directive 98/44/EC is fully consistent with this statement. The Commission does not believe that this statement or indeed any other developments in this field justify, at this time, a review of the provisions of the Directive. The Directive does however require the Commission to report on an annual basis as from July 2001 on the development and implications of patent law in the field of biotechnology and genetic engineering. These reports will help to ensure that the scope of the Directive remains relevant to this fast moving area of technology.