EMEA Board
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Responsibility for pharmaceuticals in the European Union is divided between the governments of the 27 member states* and the
EU's institutions. The principal EU bodies concerned are the European Commission in Brussels and the European Medicines Agency
in London. However, the decision making process also involves other EU institutions—including notably the European Parliament
and the EU Council of Ministers.
The Commission department most directly involved, the Pharmaceuticals Unit in the Directorate General for Enterprise, is tasked
with developing and maintaining a favorable environment for medicinal products in the EU. At the same time it is responsible
for ensuring a high level of protection of public health, helping to create a single EU market in pharmaceuticals, and fostering
a stable and predictable environment for pharmaceutical innovation.
In terms of regulation, it is the Commission that maintains, updates, and simplifies EU pharmaceutical legislation, and that
formally grants marketing authorizations for the EU market. It supports the member states in the mutual recognition and decentralized
authorization procedures and in operating national mutual authorizations. And it provides guidance on pharmaceutical legislation
and ensures that it is properly implemented within the EU.
European Commission Staff and EMEA Personnel
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In terms of industrial policy, the Commission supports pharmaceutical innovation in the EU, helps market access for new medicines,
and contributes to meeting the health needs of European citizens. The Commission also promotes international regulatory harmonization,
and negotiates and applies mutual recognition agreements with non-EU countries.
The main responsibility of the European Medicines Agency is to protect and promote health, through the evaluation and supervision
of medicines. It conducts the scientific evaluation of applications for EU marketing authorizations via the centralized procedure.
It constantly monitors the safety of medicines through a pharmacovigilance network, and takes action if adverse drug reaction
reports suggest changes to the benefit/risk balance of a medicine.
The agency also has a role in stimulating innovation and research in the pharmaceutical sector, with scientific advice and
protocol assistance to companies for the development of new medicinal products. It publishes guidelines on quality, safety,
and efficacy testing requirements. A dedicated office provides special assistance to smaller firms.
The agency's scientific committees comprising representatives from the member states conduct the main scientific work—notably
the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products, and the Pediatric Committee.
A sixth scientific committee—the Committee for Advanced Therapies—will be established at the end of 2008. The Agency brings
in a network of over 4000 European experts. It also contributes to the European Union's international activities.
*Three non-EU countries, Iceland, Liechtenstein, and Norway, have also reached an agreement to bring many of their policies,
including for pharmaceuticals, into the EU regime. The eight countries that feature in the EU's current enlargement policy—Turkey
and seven states in the Western Balkans—are also bringing their pharmaceutical regulation and policies in line with the EU.
Peter O'Donnell, View from Brussels columnist, is a freelance journalist who specializes in European health affairs. He is based in Brussels,
Belgium.
