ABSTRACT

Medicines play a key role in public health. The twentieth century has seen the advent of many new and efficient drugs (from penicillin to tritherapy HIV treatments, as well as cortisone or antidepressants, for example) and these have become the main tools of modern medicine. They have therefore become an important part of our daily lives; on average each French person consumes one box of pharmaceutical products every week. However, crises such as cerivastatin (Baycol, Lipobay) 1 in 2001, hormone replacement treatments for menopause in 2002, rofecoxib (Vioxx) 2 in 2004, and benfluorex (Mediator) 3 in 2009, regularly remind us that medicines also constitute a threat to populations and that their adverse effects are one of the foremost causes of mortality. Given the high stakes for health care and the weakness of the European Union's competence in health-related issues (Greer 2009a), as well as the importance of medication in national economies and public finance, one could expect the EU's involvement in this domain to be relatively low. Yet, pharmaceutical policies are very firmly implanted within a common European framework. Not only has the EU become involved in pharmaceutical economic policies (regulating the length of patents and the procedures for fixing prices and reimbursements), but also drug safety control now largely takes place on a European scale. Since 1995, the European Medicines Agency (EMA, formerly EMEA) has coordinated the assessment and monitoring of medicinal products sold in Europe and has become a key figure in defining world standards in this domain. This chapter will focus upon these later health policies, analyzing the history of, and current issues at stake within, what I call a “Europe of Medicines.”