WRITTEN QUESTION P-2477/00 by Avril Doyle (PPE-DE) to the Commission. Genetic ownership.
Date: 2000-07-12
Institutions: European Parliament, Provisional data
Subjects: bio-ethics, biotechnology, genetic engineering, invention, patent law, publication, research results

C 113 E/104

Official Journal of the European Communities

EN

18.4.2001

(2001/C 113 E/104)

WRITTEN QUESTION P-2475/00

by JosØ Ribeiro e Castro (UEN) to the Council

(11 July 2000)

Subject: Recognition of the specific nature of sport in the Treaties

The recent summit in Feira, the last to be held under the Portuguese presidency, included in its conclusions
the following statement: (cid:145)The European Council requests the Commission and the Council to take account
of the specific characteristics of sport in Europe and its social function in managing common policies(cid:146).

In a recent interview (1), Mr Jacques Delors commented: (cid:145)(cid:133) To decide on the free movement of footballers
by analogy with the free movement of workers is a measure with damaging consequences for the future of
sport from the educational and popular viewpoints. ((cid:133)) I have reminded Jacques Chirac and Lionel Jospin
of the need for a protocol introducing a(cid:146)sporting exception(cid:145)(comparable to the existing(cid:146)cultural exception(cid:145))
in Europe, with a view to injecting a moral dimension into sport and insisting on its educational aspect.
((cid:133)) Every professional club playing in a national league in an EU Member State should be obliged to use
at least six players of its home nationality. ((cid:133)) It is their responsibility [i.e. that of the French presidency]
to include the protocol which I am campaigning for in the Treaty of Nice in December 2000.(cid:146)

President Jacques Chirac,
introducing the main points of the French presidency(cid:146)s programme at the
European Parliament in Strasbourg on 4 July 2000, made, in his turn, the following guarantee. (cid:145)We must
ensure that the European Union takes better account of the specific nature of sport and its role in society.
There is a real problem which needs to be studied and tackled. The French presidency will make every
effort to do so.(cid:146)

In view of the position adopted by the Portuguese presidency and strongly reiterated by the French
presidency before the European Parliament, can the Council state what practical action it is taking with a
view to the forthcoming adoption of a protocol to the Treaties which will properly recognise the specific
nature of sport and provide an appropriate and balanced response to the problems which have already
been the subject of a wide-ranging and detailed debate, given the social, popular and educational
dimensions of sport, even in the professional context?

(1)

(cid:145)Le Figaro(cid:146), 4 July 2000, first section, p. 13.

Reply

(16 November 2000)

While it is aware of the debate surrounding the possible inclusion of a reference in the Treaties to
recognition of the specific nature of sport, the Council cannot prejudge the outcome of the current
Intergovernmental Conference on the revision of the Treaties. It would point out, moreover, that any
amendment to the Treaties is adopted by the Member States by common accord.

(2001/C 113 E/105)

WRITTEN QUESTION P-2477/00

by Avril Doyle (PPE-DE) to the Commission

(12 July 2000)

Subject: Genetic ownership

In the wake of the recent Human Genome Project and Celera Genomics announcements of the finalisation
of a draft copy of the full human genetic code, and in light of the philosophical, ethical, and moral
implications of these announcements, would the Commission explain its position on the patentability of
the human genome and its strategy for addressing the legal and scientific results of these announcements?

18.4.2001

EN

Official Journal of the European Communities

C 113 E/105

Answer given by Mr Bolkestein on behalf of the Commission

(12 September 2000)

The relevant Community legislation concerning the patentability of biotechnological inventions is Directive
98/44 of the Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological
inventions (1).

Agreement was only achieved on this Directive in 1998 after lengthy and thorough discussions within
both the Parliament and Council. Much consideration was given during these discussions to the ethical
aspects of biotechnological inventions. The resulting Directive seeks both to address these ethical aspects
and to provide the necessary incentives to encourage research and development.

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 distinction between discoveries and inventions in this field
and also 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. It is often argued that all biotechnological inventions, which deal with human, vegetable or
animal genes, involve materials which already occur in nature and can therefore under no circumstances
be invented but only discovered. 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 by means of a technical
procedure and made available for the first time to a commercial application. Such an element isolated from
the human body or otherwise produced is not excluded from patentability since it is, for example, the
result of technical processes used to identify, purify and classify it and to reproduce it outside the human
body: techniques which human beings alone are capable of putting into practice and which nature is
incapable of accomplishing by itself. Such a gene is (cid:145)new(cid:146) 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 agreed by both the Parliament and Council was that patents for inventions
comprising, 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, while fully recognising the stimulus provided by patents for medical research, considers that
patentability criteria must take also into account ethical principles and that the intended use of the patent
must be sufficiently specific and identified. Furthermore, the directive gives explicitly mandate for the
Group to evaluate ethical aspects of biotechnology.

The Directive therefore provides that inventions based on or comprising of, gene sequences or partial gene
sequences are patentable provided that they satisfy the normal criteria for any invention namely that they
are novel, involve an inventive step and are capable of industrial application. In this last respect, the
Directive took note of some of the controversy surrounding some of the earlier patent applications for
gene sequences that were filed and indeed granted before the Directive was agreed. In particular the
Directive makes clear that patents should not be granted where the application is silent on the industrial
application of the gene sequence.

In March of this year, the President of the United States and the British Prime Minister issued a joint
statement which called for the basic raw data on the human genome to be made freely available whilst at
the same time recognising that intellectual property protection for gene based inventions has an important
role in stimulating the development of important new health care products. The approach taken by
Directive 98/44/EC is entirely consistent with this statement.

The Commission will continue to monitor the development and implications of patent law in the field of
biotechnology and genetic engineering and as required by Directive 98/44/EC will provide regular reports
on these issues to the Council and the Parliament.

(1) OJ L 213, 30.7.1998.