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's tasks include:

- protecting and strengthening conditions of competition of supply in Europe, guaranteeing high-quality products;

- coordinating and revitalising scientific research;

- harmonising authorisation procedures;

- verifying information on the characteristics of pharmaceutical products for doctors, pharmacists and patients to ensure that they are clear and standardised throughout the Community;

- 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?

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 the contraindications and dangerous combinations with other drugs?

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In the specific case of the anticholesterol medicinal product containing Cerivastatin which was withdrawn on a voluntary basis by Bayer in August 2001, supervision of the pharmacovigilance of this medicinal product remains the responsibility of the Member States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

(4) OJ L 214, 24.8.1993.