European regulatory policies on medicines and public health needs.
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.
Li Bassi
Luca
L
Laboratory Regulatory Policies, "Mario Negri" Institute for Pharmacological Research, Milano, Italy. libassi@marionegri.it
Bertele
Vittorio
V
Garattini
Silvio
S
D004358:Drug Therapy / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D008389:Marketing of Health Services / Q000592:standards; D004364:Pharmaceutical Preparations / Q000592:standards*; D011640:Public Policy; D011785:Quality Assurance, Health Care
D004364:Pharmaceutical Preparations