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Why is it necessary to switch the European Medicines Evaluation Agency (EMEA) to the Directorate General of the European Commission responsible for health and consumer protection?
Leaflet N°11
09 September 2002

Medicines are not like other industrial products. The EMEA should not be attached to the Enterprise Directorate-General since there is a directorate for public health within the Health and Consumer Protection Directorate-General.


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The European Medicines Evaluation Agency (EMEA) was created by a European Regulation in 1993, and has been in force since 1995. The EMEA's role is to co-ordinate scientific resources provided by Member States, with a view to the evaluation and surveillance of medicines. It comprises consultative bodies, mainly the Committee for Proprietary Medicinal Products (CPMP) and working groups made up of experts. The European Commission grants centralised marketing authorisations for the European market taking into account the opinions of the CPMP.

Perhaps because the European Commission did not include the Health and Consumer Protection Directorate-General (SANCO) in 1993, the EMEA became attached to what is known today as the Enterprise Directorate-General. This attachment seems now illogical and risky: is responsible for maintaining and boosting industrial enterprises, not monitoring health and consumer protection, which is the role carried out by SANCO. From the Enterprise Directorate-General's point of view, the role of the EMEA is to favour easy and rapid marketing of new medicines, so as not to hinder medicines development and competitiveness of EU pharmaceutical firms. This vision relegates public health concerns to a position of secondary importance.

A member of the CPMP publicly deplored the attachment of the EMEA to the Enterprise Directorate-General, noting, "If the concerns for public health were paramount, the approval of new medicines by the EMEA would depend on their benefit to patients and would only be approved for precise clinical uses and after thorough evaluation". Other CPMP experts joined him in demanding that the EMEA be attached to the Health and Consumer Protection Directorate-General.