WRITTEN QUESTION E-2644/01 by Luciana Sbarbati (ELDR) to the Commission. European Agency for the Evaluation of Medicinal Products.
Date: 2001-09-28
Institutions: European Parliament, Provisional data
Subjects: European Medicines Agency, approximation of laws, consumer information, consumer protection, marketing standard, medicinal product, pharmaceutical legislation

C 81 E/198

Official Journal of the European Communities

EN

4.4.2002

(2002/C 81 E/236)

WRITTEN QUESTION P-2638/01

by Bartho Pronk (PPE-DE) to the Commission

(21 September 2001)

Subject: Further questions concerning case law in relation to the Belgian State Pensions Service

On 16 July I submitted questions (E-2263/01) (1) on the subject of non-compliance by the Belgian State
Pensions Service with the case law of the Court of Justice.

The Commission has since given a reply to those questions.

With reference to the Commission(cid:146)s reply:

1. Has the Belgian Government responded to the Commission(cid:146)s request for clarification?

2. Has the Belgian Government(cid:146)s reply led to a procedure under Article 226 of the EC Treaty being

initiated?

(1) OJ C 40 E, 14.2.2002, p. 230.

Answer given by Mrs Diamantopoulou on behalf of the Commission

(18 October 2001)

The Commission would inform the Honourable Member that it has not yet had a reply to its letter of
18 July 2001 requesting information within two months on the follow-up of the Court(cid:146)s case law
established in the judgment delivered in the Engelbrecht case, C-262/97.

Consequently, the Commission has sent the Belgian authorities a reminder. The Honourable Member will
be kept informed of the outcome.

(2002/C 81 E/237)

WRITTEN QUESTION E-2644/01

by Luciana Sbarbati (ELDR) to the Commission

(28 September 2001)

Subject: European Agency for the Evaluation of Medicinal Products

The EU budget provides for EUR 14 million to fund this Agency (EMEA), which was set up in 1995 as a
result of cooperation between the Commission, Parliament and the ESC and currently has a staff of 220
(this figure will increase to 250 in 2002).

The Agency(cid:146)s tasks include:

(cid:129) protecting and strengthening conditions of competition of supply in Europe, guaranteeing high-quality

products;

(cid:129) coordinating and revitalising scientific research;

(cid:129) harmonising authorisation procedures;

(cid:129) verifying information on the characteristics of pharmaceutical products for doctors, pharmacists and

patients to ensure that they are clear and standardised throughout the Community;

(cid:129) carrying out post-marketing surveillance through a pharmacovigilance coordination system in the

individual Member States.

Given the priority which should be given to the social dimension of the pharmaceutical sector, will the
Commission state what responsibility the Agency had in the recent anticholesterol drugs crisis, involving
patients in various European countries?

4.4.2002

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Official Journal of the European Communities

C 81 E/199

Could the Agency have played a more significant role in verifying both the ingredients of the drug in
question and the description contained in the box?

Could it have taken more effective action to make doctors and health staff more aware of
contraindications and dangerous combinations with other drugs?

the

Answer given by Mr Liikanen on behalf of the Commission

(16 November 2001)

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the
authorisation and supervisions of medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products (1) established this Agency in 1995. The tasks of
this Agency are laid down in Article 51 of this Regulation. Second Council Directive 75/319/EEC of
20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products (2) was also amended in 1993 (1)
laying down specific
responsibilities for pharmacovigilance for medicinal products which are authorised by national Member
States or through a mutual recognition procedure and these provisions also came into effect in 1995.

In the specific case of the anticholesterol medicinal product containing Cerivastatin which was withdrawn
on a voluntary basis by Bayer in August 2001, supervision of the pharmacovigilance of this medicinal
product remains the responsibility of the Member States that have authorised the product.

Nonetheless, it should be noted that the Agency has put in place certain measures to ensure the co-
ordination of pharmacovigilance information including the establishment of a Pharmacovigilance Working
party and a system for exchange of both urgent and non-urgent information on pharmacovigilance
between Member States. These systems were successfully used to ensure communication and discussion of
the problems associated with the use of this product and to ensure that the same regulatory action was
taken across the Community.

The Commission considers that the Agency fulfilled its co-ordination role with respect to its current legal
responsibilities ensuring that appropriate information about the risks of this product, in particular the need
to contraindicate its use with another medicinal product, was included in the product information and
patient leaflet.

With respect to communication with health care professionals, the Agency fulfilled its co-ordination role
ensuring that the same information could be made available at the same time through the respective
authorities to the health care professionals in all Member States.

It should also be noted that, as part of the current review of the pharmaceutical legislation, adopted by the
Commission on 18 July 2001 (3), the Commission has outlined its plans to strengthen the European
pharmacovigilance system. These measures include provisions to give the European Medicines Evaluation
Agency a stronger role and to increase the speed and efficiency of the Commission(cid:146)s procedures for
adopting emergency measures. In addition, it is proposed to increase the frequency of periodic safety
reporting, to expand the reporting requirements for adverse reactions, in particular for serious adverse
reactions, to make the use of a common international terminology for pharmacovigilance reporting more
widespread, and to promote the general use of a database for this information. These changes will have
budgetary implications for the Community subsidy to the Agency.

Methods to improve the communication between all stakeholders including patients and doctors will also
need to be considered.

(1) OJ L 214, 24.8.1993.
(2) OJ L 147, 9.6.1975.
(3) http://pharmacos.eudra.org/F2/review/index.htm.