Introduction

The development of modern pharmaceutical products has led to a vast improvement in health care globally. Drugs and vaccines have virtually eradicated some of the major health scourges of years gone by, such as smallpox. Improvements in treatment of what were regarded as fatal conditions, such as HIV/AIDS, have resulted from the development of drugs such as AZT. Nonetheless, whilst such developments have great potential, sadly there have been some instances in which pharmaceuticals have been viewed in a considerably less positive light. The drug Thalidomide, given to pregnant women in the 1960s, was linked to the development of major congenital disabilities. Less than a decade later, it was alleged that the pertussis vaccine resulted in infant brain damage. The controversy regarding the administration of vaccines continues to this day, in the light of claims made linking the administration of the combined MMR (measles, mumps and rubella) vaccine to autism. Thus, much of the legal (and political and ethical) debate regarding pharmaceuticals has focused upon the risks which they pose and the need for appropriate regulation, and the prospect for compensation should harm arise from the use of a pharmaceutical product. These concerns are also reflected in the developments which have taken place in EU law in this area.

In this chapter, which considers the regulation of pharmaceuticals, in common with our overall approach in this book, the focus is on the effects that legal norms promulgated at EU level with respect to the regulation of pharmaceuticals have on national health law and policy in the Member States.