Harmonising and competing for medicines regulation : how healthy are the European Union's systems of drug approval ?
Europeanised procedures of marketing authorisation for medicines are becoming increasingly important within EU Member States relative to national licensing systems.
Since 1 January 1998 parallel national applications for drug approvals in EU Member States have disappeared and it is only possible to market a new drug in more than one Member State via Europeanised procedures.
Yet the implications of these Euro-procedures for public health remain little researched or debated.
This paper discusses the health and safety implications of three key features of such Europeanisation, namely, the harmonisation of drug safety standards, the competition between the national regulatory agencies of Member States for application fees from industry and the industrial capture of regulators within the regulatory process.
Drawing on 42 interviews in Brussels, Germany, Sweden, the Netherlands and the UK, the perspectives of European regulators, industrial scientists and regulatory affairs managers on these matters are analysed.
While most industry sources believe that the new Euro-procedures will not harm public health, at least half of the regulators were concerned that European harmonisation of safety standards and competition between national agencies to accelerate approval times in order to attract industry fees pose a threat to public health and safety.
National regulatory agencies find themselves in an internal EU market competing for regulatory fees from industry. (...)
Mots-clés Pascal : Union européenne, Europe, Système santé, Organisation santé, Régulation, Harmonisation, Politique sanitaire, Coopération internationale, Industrie pharmaceutique, Contrôle
Mots-clés Pascal anglais : European Union, Europe, Health system, Public health organization, Regulation(control), Harmonization, Health policy, International cooperation, Pharmaceutical industry, Check
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0313039
Code Inist : 002B30A04C. Création : 16/11/1999.