WRITTEN QUESTION E-0472/00 by Béatrice Patrie (PSE) to the Commission. Access to generic pharmaceuticals.
Date: 2000-02-24
Institutions: European Parliament, Provisional data
Subjects: consumer protection, directive (EU), generic drug, health costs, interpretation of the law, market approval, pharmaceutical expenses, pharmaceutical industry

21.11.2000

EN

Official Journal of the European Communities

C 330 E/169

(2000/C 330 E/191)

WRITTEN QUESTION E-0470/00

by Isabelle Caullery (UEN) to the Commission

(24 February 2000)

Subject: Programmes, Community projects and European initiatives in the ˛le-de-France region

Can the Commission draw up an exhaustive list of the various European programmes and projects or
Community initiatives of which the ˛le-de-France region is a beneficiary (cid:129) indicating to what extent (cid:129) by
virtue of its associate status?

Can it also give a full list of European programmes and initiatives organised for the various bodies situated
in the ˛le-de-France region, that is to say research centres, associations, universities, municipalities and
other bodies organisations, indicating to what extent each of them benefit?

Supplementary joint answer
to Written Questions E-0469/00 and E-0470/00
given by Mr Prodi on behalf of the Commission

(5 May 2000)

Because of the length of the answer, which includes a number of tables, the Commission is sending it
direct to the Honourable Member and to Parliament(cid:146)s Secretariat.

(2000/C 330 E/192)

WRITTEN QUESTION E-0472/00

by BØatrice Patrie (PSE) to the Commission

(24 February 2000)

Subject: Access to (cid:145)generic(cid:146) pharmaceuticals

The procedures for authorising the marketing of pharmaceuticals in certain Member States effectively
prevent the registration of cheap (cid:145)generic(cid:146) products if the pharmaceutical company manufacturing the
original product has withdrawn its licence for the product for commercial reasons and replace it with a
substitute. This places the consumer in a particularly unfavourable position and is based on a questionable
interpretation of Council Directive 65/65/EEC (1) and, in particular, Article 4(8)(a)(iii).

This obstacle to the registration of (cid:145)generic(cid:146) pharmaceuticals is entirely contrary to the stated policy of the
Commission set out
sector
(COM(98) 588), Parliament(cid:146)s position as set out in the Read Report (A4-0205/1999) and that of the
Council as set out in its resolution of 18 May 1999, all of which call for better access for consumers to
(cid:145)generic(cid:146) pharmaceuticals.

in its communication on the internal market

in the pharmaceutical

What specific action will
pharmaceuticals?

the Commission take to end this obstacle to the availability of

(cid:145)generic(cid:146)

What measures will the Commission take to ensure that (cid:145)generic(cid:146) pharmaceuticals can be registered, even if
the pharmaceutical company which manufactured the original product has withdrawn its licence in favour
of a similar product for reasons which are not dictated by public health considerations?

(1) OJ 22, 9.2.1965, p. 369.

Answer given by Mr Liikanen on behalf of the Commission

(23 March 2000)

The availability of generic pharmaceuticals is one of the Commission(cid:146)s main priorities, as set out in various
documents. The Commission is keen to implement this policy and is drafting recommendations based on
various judgements of the Court of Justice which allow an interpretation more favourable to generic
pharmaceuticals.

C 330 E/170

Official Journal of the European Communities

EN

21.11.2000

Following the judgements of 3 December 1998 in case C-368/96 and of 16 December 1999 in case
C-94/98, even if the holder of a marketing authorisation for an original medicinal product withdraws that
authorisation in favour of one for a medicinal product the formula of which contains the same active
ingredients but different constituents although it still has the same therapeutic effect, a marketing
authorisation may be granted for the generic medicinal product by referring to either formula.

Following these judgements and others concerning medicinal products, it is necessary to improve the
information available on this subject. Supplementary information will be therefore be published in the
notice to applicants for marketing authorisations as provided for in the Annex to Council Directive 75/
318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical,
pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary
medicinal products (1). This is currently being prepared in cooperation with the Member States.

(1) OJ L 147, 9.6.1975.

(2000/C 330 E/193)

WRITTEN QUESTION E-0477/00

by Hiltrud Breyer (Verts/ALE) to the Commission

(24 February 2000)

Subject: Sellafield reprocessing plant and Cap de la Hague

Numerous data from university institutes and reliable environmental organisations substantiate the
progressive contamination of Europe(cid:146)s seas. The Commission has been aware of such information for
years (Petition 393/95). It has also been kept informed of worsening findings in the intervening period. As
a contracting party to the OSPAR Convention, the Commission aims by 2020 to bring down measurement
values for radioactivity throughout the European marine and North East Atlantic biotope to natural levels.

1. What information in terms of emission levels and radioactive contamination of the coastal and
marine biotope by the Sellafield reprocessing plant and Cap de la Hague has been forwarded to the
Commission by the public authorities of the operating countries in the past few years?

2. Why has the Commission taken no account of the alarming findings of university institutes and
reliable environmental organisations? Why has it until now relied exclusively on the findings and
interpretations communicated by the operating countries(cid:146) public authorities when assessing the situation?
How does it rate their scientific independence?

Is it the Commission(cid:146)s opinion that it has fulfilled its duty of care, having inspected the Sellafield

3.
reprocessing plant and Cap de la Hague only once in each case over a 10-year period (1989-1999)?

Answer given by Mrs Wallstr(cid:246)m on behalf of the Commission

(31 March 2000)

The information which the Honourable Member seeks,
in respect of the provision of information by
Member States of levels of radioactivity in the environment, and of the manner in which the Commission
interprets this information and that from other sources, has been supplied in response to the Honourable
Member(cid:146)s Written Question E-2585/99 (1).

The Commission, as a contracting party to the Convention for the protection of the marine environment
of the north east Atlantic, is playing an active role in contributing to the implementation of the Oslo-Paris
Commission (OSPAR) strategy with regard to radioactive substances. The manner in which the Commi-
ssion could most effectively contribute to the implementation of this strategy was discussed by contracting
parties at the OSPAR Radiation absorbed doses (RAD) meeting, hosted by the Commission, in Luxembourg
from 18 to 21 January 2000. As a result of this, and earlier discussions, the Commission has undertaken
to carry out several actions to assist the implementation of the strategy,
including a commitment to
undertake an update of
the Mar(cid:237)na project on the radiological exposure in the Community from
radioactivity in north European marine waters.