92003E1533

WRITTEN QUESTION P-1533/03

by Frédérique Ries (ELDR) to the Commission

(30 April 2003)

Subject: Innovative medicinal products in the enlarged European Union

The enlargement of the European Union became a reality in Athens on Wednesday, 16 April 2003 when the Accession Treaty was signed by ten new Member States. This historic event has already had a tangible impact in that the new Member States are already beginning to participate in Community affairs. In this respect, enlargement gives rise to a number of questions concerning the protection of pharmaceutical innovation in some accession countries.

The European Commission and the European Parliament have on several occasions voiced the need to safeguard pharmaceutical innovation, not least by means of the registration data protection granted at the time marketing authorisation is issued for new products.

It now seems necessary to ensure the full and inclusive application of registration data protection, which is an integral part of the Community acquis, in the new Member States as soon as they join the European Union.

There are still certain doubts and fears as regards the situation vis-à-vis registration data protection for products that are covered within the European Union by a Community marketing authorisation granted via the centralised route.

Could the Commission indicate, in these specific but very frequent cases:

- whether the registration data protection granted under the centralised Community procedure for placing on the market will apply in full in the new Member States as soon as they join the European Union;

- and whether the marketing authorisations granted by local authorities in the candidate countries to generic copies of such products prior to accession will become null and void as soon as those countries join the European Union, with the de facto result that these copies are withdrawn from the market?

Answer given by Mr Liikanen on behalf of the Commission

(21 May 2003)

The Commission can confirm that for medicinal products authorised according to the centralised procedure set out in Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(1), the data protection set out in Article 13(4) of this Regulation read together with Article 10(1)(a)(iii) of Council Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(2) fully applies in the new Member States as from accession. As a consequence, a new application for a generic product submitted in the new Member States after accession cannot benefit from the abridged procedure set out in Article 10(1)(a)(iii) of Directive 2001/83/EC as long as the reference product is still covered by data protection.

The wording of Article 10(1)(a)(iii) of Directive 2001/83/EC implies that an abridged application can only be lodged with the authority that evaluated and authorised the reference product. It is only this authority that holds the full dossier on the reference product, to which the generic applicant wants to refer and which is indispensable to assess the generic application.

This interpretation has already been set out in section A 2(a) 1 of the Commission Communication of 1998 on the Community marketing authorisation procedures for medicinal products(3).

For medicinal products authorised via the centralised procedure, only the European Agency for the Evaluation of Medicinal Products set up under Council Regulation (EEC) No 2309/93 holds the full dossier, not the agencies of the acceding Member States.

As a consequence, the national authorisations for generic copies of centrally approved medicines lose their legal effects with accession.

(1) OJ L 214, 24.8.1993.

(2) OJ L 311, 28.11.2001.

(3) OJ C 229, 22.7.1998.