ABSTRACT
In this chapter, we explain why the research-based pharmaceutical industry wants European, and indeed global, harmonisation of medicines regulation. These industrial interests are strong supporters of a single European market for pharmaceuticals and exert considerable influence on the regulatory regime in Europe. We also trace the origins of the Europeanisation of medicines regulation, and discuss the gradual development of the ‘weak’ European regulatory state from 1975 to 1995. This period saw the establishment of a body of expert scientists, known as the Committee for Proprietary Medicinal Products (CPMP). In particular, we examine why that ‘weak’ European regulatory state failed to achieve European harmonisation, and how it was supplanted by a ‘strong’ regulatory state in 1995, with the establishment of the European Agency for the Evaluation of Medicinal Products (EMEA) and binding arbitration to settle disputes between Member States of the EU. The EMEA, together with other supranational regulatory institutions such as the CPMP and the Commission, attained greater authority over both national regulatory agencies and the industry. This ‘efficiency regime’ requires Member States to mutually recognise each other’s assessments and marketing approval recommendations much more readily and quickly. Finally, we discuss efforts to harmonise procedures for monitoring the safety of medicines already on the market: that is, pharmacovigilance, an area that remains relatively underdeveloped within the overall harmonisation project in Europe.
