WRITTEN QUESTION P-2281/00 by Marie-Noëlle Lienemann (PSE) to the Commission. Application of Directive 98/44/EC on the legal protection of biotechnological inventions.
Date: 2000-06-29
Institutions: European Parliament, Provisional data
Subjects: biodiversity, biotechnology, ethics, genetic engineering, patent, patent law

C 81 E/184

Official Journal of the European Communities

EN

13.3.2001

(2001/C 81 E/234)

WRITTEN QUESTION P-2281/00

by Marie-Noºlle 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 (cid:129) 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 (cid:129) 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)

the Council and the Parliament on the legal protection of
Agreement on Directive 98/44/EC 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.

13.3.2001

EN

Official Journal of the European Communities

C 81 E/185

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.

(2001/C 81 E/235)

WRITTEN QUESTION P-2283/00

by Jens-Peter Bonde (EDD) to the Commission

(29 June 2000)

Subject: Legal certainty

Has the Commission apologised to the Nordvestjydsk Folkecenter for Vedvarende Energi now that the
Danish Public Prosecutor has found that there were no grounds for prosecution for fraud involving EU
resources?

Will the Commission impress it on OLAF that a person has to be treated as innocent until prosecution or
conviction?

Does the Commission believe that legal certainty is served if the withdrawal of charges by the Public
Prosecutor is followed by civil proceedings, bringing fresh uncertainty to the Nordvestjydsk Folkecenter for
Vedvarende Energi to follow the three years it has already suffered?

Answer given by Ms Schreyer on behalf of the Commission

(8 September 2000)

The fact that criminal proceedings have not been the outcome of the investigation by the European Anti-
Fraud Office is a matter for the judicial authority alone; neither the Office nor the Commission has any say
in the matter. Consequently, there is no reason for the Commission to apologise.

Community law recognises important fundamental principles, and the arrangements connected with the
setting up of the Office (1) provide that its investigations must be conducted in accordance with the Treaty
and with full respect for human rights and fundamental freedoms. The very nature of the Office(cid:146)s work
(administrative investigations) means that it cannot infringe the presumption of innocence, since it is not
empowered to undertake judicial proceedings.

The civil proceedings aimed at recovering sums wrongly paid are being carried out in accordance with the
rules laid down in the contracts and the relevant legislation. They are independent of any criminal
prosecution, though they can, if necessary, be joined to such proceedings.

In this case, it should be noted that the Commission has cancelled the specific contract with Folkecenter
and asked for full repayment of all the money that has been paid under this contract since the summer of
1997.

(1) See Regulation (EC) No 1073/1999 and Regulation (Euratom) No 1073/1999 of the European Parliament and of
the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (OJ L
136, 31.5.1999).