The Roles & Responsibilities of EU's Authorities

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.

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. Notably, in 2009, it has conducted the rapid assessment of vaccines against H1N1. 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, the Paediatric Committee, and the Committee for Advanced Therapies. The Agency brings in a network of over 4,000 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.