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. This marketisation of regulation puts pressure on regulators to 'sell themselves' as the fastest in reviewing and approving drugs. Swedish regulators displayed the greatest anxieties about these matters. Unfortunately, we found it impossible to verify these regulators' worries or industry's optimism because of the secrecy that attends these Euro-procedures. Thus, a situation obtains in which a significant number of regulators are warning that the EU medicines licensing systems, which are being put in place, might well compromise safety, yet these systems are deficient in their capacity to accommodate independent scrutiny, upon which informed policy changes could be based.