WRITTEN QUESTION E-1537/03 by Charles Tannock (PPE-DE) to the Commission. Transition period for the upgrading of markting authorisations for medicinal products.
Date: 2003-05-07
Institutions: European Parliament, Provisional data
Subjects: accession to the European Union, approximation of laws, market approval, marketing standard, medicinal product, pharmaceutical legislation

C 280 E/164

Official Journal of the European Union

EN

21.11.2003

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.

(2003/C 280 E/181)

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authorisation will be on the market in contravention of EU law and should be withdrawn.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)

(c)

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;

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?

21.11.2003

EN

Official Journal of the European Union

C 280 E/165

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 (cid:1) 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 (cid:1) OJ L 214, 24.8.1993.

(2003/C 280 E/182)

WRITTEN QUESTION E-1538/03

by Charles Tannock (PPE-DE) to the Commission

(7 May 2003)

Subject: EU and WTO rules regarding business with companies based in tax havens

There has been some discussion within the UK about the propriety of the sale by the Inland Revenue of
tax and customs offices to the Bermuda-based company Mapeley Steps for GBP 370 million. Some of the
details of the case are laid-out on page 26 of the 21 February (cid:1) 6 March 2003 issue of the investigative/
satirical publication Private Eye which has taken a close interest in the case. The Chairman of the Inland
Revenue appears to have justified the sale of the buildings on the grounds that it is contrary to EU and
WTO rules to turn-down a contract with a company on the grounds that it operates within a tax haven,
although there appears also to be some dispute as to whether Mapely Steps was registered in Bermuda or
the UK at the time of the sale.

Can the Commission clarify the EU and WTO rules regarding the sale of government property to
companies based in tax havens and whether the government in question would be entitled to take into
account the overall net benefit to the Exchequer when deciding to make a sale? Can the Commission also
confirm whether or not it is correct that the United States government will not sign contracts or come to
arrangements with any organisation based in a tax haven, and, if so, whether that is in the opinion of the