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The European Journal of Public Health 2003 13(3):246-251; doi:10.1093/eurpub/13.3.246
© 2003 by European Journal of Public Health
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Health Policy

European regulatory policies on medicines and public health needs

Luca Li Bassi1,*, Vittorio Bertele'1 and Silvio Garattini2

1 Laboratory Regulatory Policies, "Mario Negri" Institute for Pharmacological Research, Milano, Italy 2 CPMP member, "Mario Negri" Institute for Pharmacological Research, Milano, Italy

The establishment of the EMEA has been a revolutionary step in the European pharmaceutical system. The 15 Member States of the European Union now share a common system for the evaluation of new medicinal products entering the European market. The decisions taken apply to the whole EU, with important implications for both industry and patients who may benefit from new therapies. The main immediate consequences of this system are: i) the time and effort saved by Member States in the evaluation of new drug applications; ii) more consistent and quicker availability of medicines in EU countries; iii) the establishment of a homogeneous regulatory policy throughout the EU. Public health has been presented as the fundamental concern of the EMEA, the mission statement of which is ‘to promote the protection of human health ... and of consumers of medicinal products’. However, we note that there are some inconsistencies with this objective and the current system, such as those regarding drug trial requirements and the institutional location and financing of the EMEA. In this paper, some aspects of the new system are reviewed and consideration given as to how they relate to public health needs. Proposals are made for debate alternatives and improvements to the present system that would better respond to patients' health needs.

Keywords: EMEA, public policy, regulatory policy

Received 6 February 2002. Accepted 6 June 2002.

* Correspondence: Dr Luca Li Bassi, MD, DPH, Dip Mgt, Laboratory Regulatory Policies, Istituto di Ricerche Farmacologiche "Mario Negri", Via Eritrea 62, 20157 Milano, Italy, tel. +39 02 39014481, fax +39 02 3546277, e-mail: libassi{at}marionegri.it


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