WRITTEN QUESTION P-1533/03 by Frédérique Ries (ELDR) to the Commission. Innovative medicinal products in the enlarged European Union.
Date: 2003-04-30
Institutions: European Parliament, Provisional data
Subjects: accession to the European Union, approximation of laws, data protection, market approval, marketing standard, medicinal product, pharmaceutical legislation

21.11.2003

EN

Official Journal of the European Union

C 280 E/163

Member State of the institution which pays the costs of the health care for the pensioner (and to which he
may pay social security contributions), provided that this Member State has opted for this solution and is
listed in an Annex included for this purpose in the Regulation.

(1) Regulation (EEC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to
last updated by Council Regulation (EC)

employed persons and their families moving within the Community,
No 118/97 of 2 December 1996 (cid:1) OJ L 28, 30.1.1997.

(2) Proposal for a Regulation of the European Parliament and of the Council on coordination of social security

systems (cid:1) OJ C 38, 12.2.1999.

(2003/C 280 E/180)

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:

(cid:1) 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;

(cid:1) 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.

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?