92002E0544

WRITTEN QUESTION E-0544/02

by Elly Plooij-van Gorsel (ELDR) to the Commission

(28 February 2002)

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

In 1997, Parliament approved Directive 98/44/EC(1) on the legal protection of biotechnological inventions. In 2001, the Court of Justice in Luxembourg dismissed an application by the

Netherlands Government for annulment of this directive (case C-377/98). Thus the Netherlands must comply with its obligations with regard to European legislation. However, the Dutch legislature (the Lower House of Parliament) has so far refused to transpose the directive into national law, despite the fact that this should have been done by 30 July 2000. This is very detrimental to existing and new biotech companies in the Netherlands and Europe at large.

1. Is the Commission aware of this situation?

2. What measures will the Commission take to hold the Netherlands to its European obligations, particularly its duty to swiftly and completely transpose the above directive?

3. Which other Member States have not yet transposed the directive?

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

Answer given by Mr Bolkestein on behalf of the Commission

(30 April 2002)

The Honourable Member has drawn the Commission's attention to the difficulties encountered in some Member States in implementing Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.

1. The Commission is fully aware of the fact that Directive 98/44/EC has not been implemented in some Member States. The Commission would like to echo the comments made by the Honourable Member regarding the binding obligation upon Member States to immediately transpose this Directive, especially since the deadline for transposition has long since expired. In addition, any ambiguity there may have been about the legality of this Directive has been dispelled following the Court of Justice's rejection on 9 October 2001 of the application for the annulment of the Directive.

2. The Commission would like to point out that a letter of formal notice was sent on 30 November 2000 to those Member States which had not, at that time, transposed Directive 98/44/EC. It should be noted that the next stage in this procedure is to send a reasoned opinion on account of a failure to notify national transposition measures.

3. To date, five Member States have transposed Directive 98/44/EC: Denmark, Greece, Ireland, Finland and the United Kingdom.