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18.4.

2001 EN Official Journal of the European Communities C 113 E/151

The approach that the Commission is proposing, following finalisation of the conciliation process for a
revision of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment
of genetically modified organisms (1), will be a first step towards a more constructive and responsible
strategy on GMOs, and for biotechnology in general.

The importation and placing on the market of GMOs in the Community requires authorisation under
Community legislation. Directive 90/220/EEC covers both experimental releases and the placing on the
market of GMOs. Applications for such releases require, as a pre-requisite, a comprehensive assessment of
risks to human health and the environment.

The objective of the risk assessment, on a case-by-case basis, is to identify and evaluate potential adverse
effects of the GMO, either direct or indirect, immediate or delayed, on human health and the environment
which may arise from the deliberate release or placing on the market of a GMO. The risk assessment is
conducted with a view to identifying whether there is a requirement for risk management measures and if
so, the most appropriate methods to be used.

An authorisation is only granted on the basis that there is no reason to believe that the release will have an
adverse effect on human health or the environment under the conditions of consent.

The question of liability in terms of damage to health or property is addressed under Council Directive 85/
374/EEC of 25 July 1985 (2), as modified by Directive 1999/34 (3), which concerns liability for defective
products. This directive imposes strict liability on the producer (or importer) of a defective product, and
joint liability in cases where more than one person is liable for the same damage. Producer is defined as
‘the manufacturer of a finished product, the producer of any raw material or the manufacturer of a
component part and any person who, by putting his name, trade mark or other distinguishing feature on
the product presents himself as its producer’.

As a follow-up to the white paper on environmental liability (4), the Commission intends to prepare a
framework directive which will deal with environmental liability in a more general way, including any
potential damage caused to the environment by GMOs.

(1) OJ L 117, 8.5.1990.


(2) OJ L 210, 7.8.1985.
(3) OJ L 141, 4.6.1999.
(4) COM(2000) 66 final.

(2001/C 113 E/157) WRITTEN QUESTION E-2686/00


by Armando Cossutta (GUE/NGL) to the Commission

(1 September 2000)

Subject: Transposition of Directive 98/44/EC

Two Member States, Italy and the Netherlands, have brought an action before the Court of Justice
concerning Directive 98/44/EC (1). Moreover, the opinion delivered by the French National Bioethics
Committee on 8 June 2000 expresses grave reservations about the substance of the Directive, among
other things because the legislative text fails to make a proper distinction between invention and discovery.

1. Does the Commission not consider that it would be useful to await the Court ruling on the appeal by
Italy and the Netherlands before instituting infringement proceedings against Member States which are not
transposing the Directive into their national law?

2. Does it not believe that it should accept the opinion of the French National Bioethics Committee and
therefore revise the wording of the Directive without delay?

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


C 113 E/152 Official Journal of the European Communities EN 18.4.2001

Answer given by Mr Bolkestein on behalf of the Commission

(9 October 2000)

1. The Netherlands, backed by Italy, has brought before the Court of Justice an action for the
annulment of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the
legal protection of biotechnological inventions. Further to this action, the Netherlands has also initiated
proceedings for interim measures to suspend the above Directive.

The President of the Court dismissed this request in an Order dated 25 July 2000 on the grounds, in
particular, that it was unlikely that any patents would be granted during the period between the entry into
force of the Directive(30 July 2000)and the Court issuing its judgment. Moreover, for requests made before
the entry into force of the Directive, the Netherlands may grant patents containing a resolutory clause
relating to a possible annulment of the Directive. Therefore, there are no serious or irrevocable reasons to
justify deferring the transposal of this Directive into national law.

2. Furthermore, the Directive makes a clear distinction between an invention and a discovery. The mere
discovery of genes cannot, under any circumstances, be the subject of patent protection (Article 5(1)). This
Directive is in keeping with general patent law which precludes even temporary ownership of mere
discoveries.

A gene can only be entitled to patent protection if it has been isolated, for example, by means of technical
processes which have made it possible to identify, purify, classify and reproduce it outside the human
body.

Moreover, a patent can only be granted for such inventions in as far as the general requirements for
patentability have been fulfilled, i.e. the invention must be new, involve an inventive step, and be
susceptible of industrial application.

Article 5(3) of the Directive states, in this respect, that the industrial application must be disclosed in the
patent application. Therefore, a mere sequence of deoxyribonucleic acid (DNA), with no indication of a
function and containing no technical information, is not a patentable invention.

(2001/C 113 E/158) WRITTEN QUESTION E-2688/00


by Christopher Huhne (ELDR) to the Commission

(1 September 2000)

Subject: Staff disciplinary procedures

1. Will the Commission reconsider its response to my Written Question E-0557/00 (1) concerning
disciplinary procedures for its own staff given (a) the very small numbers of employees of the Commission
who are dismissed and (b) the answer given by the British Parliament to Mr Matthew Taylor MP (113608)
showing that 0,1 to 0,2 per cent of the non-industrial civil service employees are dismissed or discharged
each year?

2. Does the Commission take the view that there may be an inverse relationship between its very low
rate of disciplinary action against employees and the evidence of malpractice, inefficiency and delays (for
example in making due payments)?

3. Can the Commission indicate the civil service of any Member State that dismisses proportionately
fewer of its own employees in any given year?

4. If not, is it aware of any evidence that its own employees are intrinsically less likely to succumb to
temptation or sloth than the employees of any other organisation or institution?

(1) OJ C 374 E, 28.12.2000, p. 105.