92003E1537

WRITTEN QUESTION E-1537/03

by Charles Tannock (PPE-DE) to the Commission

(7 May 2003)

Subject: Transition period for the upgrading of markting authorisations for medicinal products

Under the accession requirements, Candidate Countries are required to bring all existing medicinal marketing authorisations in line with EU standards by the date of accession. Any medicines without this authorisation will be on the market in contravention of EU law and should be withdrawn. Five of the Candidate Countries (Cyprus, Lithuania, Malta, Poland and Slovenia) requested and were granted a transitional period during which the full requirements of the acquis will not be applied.

Each country was required to produce a list of those marketing authorisations that would be upgraded during the transitional period. The lists were not made public and apparently have not been subjected to any independent scrutiny from either a legal or a public health perspective.

Lists of pharmaceutical products eligible for transitional periods negotiated with Cyprus, Lithuania, Malta, Poland and Slovenia which will be annexed to the Accession Treaties are believed to contain substantial inaccuracies or deficiencies which require rectification.

The most serious problems are:

(a) the list contains products which are not yet approved in Candidate Country markets;

(b) the lists contain products which are the same as products approved through the centralised procedure of the EU, and which will, therefore, be illegal from the day of accession and should be removed from the market;

(c) the lists contain local copies of the same centralised products, despite the paper of the Pan-European Regulatory Forum on phasing-in issues clearly stating that nationally authorised generic versions of centrally-approved products cannot stay on the market in the CC's after accession.

Examples include Bactoban (a copy of a patented GSK product (Poland)), Clopidrogel and Klopidrogel (not registered, despite being copies of a Sanofi-patented product (Poland)), Betaferon (centrally-approved by Schering (Malta, Slovenia)), Taxotere (centrally approved by Aventis (Slovenia)) and Viagra (centrally-approved by Pfizer (Cyprus, Lithuania and Slovenia)).

The lists were not made public during the negotiations. How soon will it be before the lists are revised and can the Commission confirm that copies of centralised products must be withdrawn from the market on the day of accession?

Answer given by Mr Liikanen on behalf of the Commission

(13 June 2003)

The Member States decided to incorporate into the Accession Treaty lists of the medicinal products covered by the transitional period. This transitional period is foreseen in the section on free movement of goods in the Accession Treaty of five Candidate Countries. The Commission does not have any information on how far the Member States checked the lists as provided by the Candidate Countries. As the lists are part of the Accession Treaties as signed on 16 April 2003 in Athens, a revision of these lists would require changing the concerned Accession Treaties.

The provision on the transitional period as foreseen in the draft Accession Treaty is worded in a rather restrictive way, being limited to aspects of quality, safety and efficacy (by way of derogation from the requirements of quality, safety and efficacy laid down in Directive 2001/83/EC(1) ). Other aspects than those of quality, safety and efficacy such as the respect of other legal or procedural requirements of the Community pharmaceutical legislation are not referred to.

National marketing authorisations for medicinal products, which are not in compliance with European legislation and which are not covered by the transitional period, must be withdrawn immediately after accession. Such national authorisations granted by the new Member States, before accession, for generic copies of products authorised via the centralised procedure become inapplicable on the day of accession.

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.

For medicinal products authorised via the centralised procedure, only the European Agency set up under Regulation (EEC) No 2309/93(2) 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 become illegal and have to be withdrawn upon accession.

(1) 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 OJ L 311, 28.11.2001.

(2) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal products OJ L 214, 24.8.1993.