ABSTRACT

Regulation of regenerative medicine in the European Union (EU) can be understood best when viewed in the historical context of the evolution of the EU. In this chapter, reference will be made to key events and legislation over the last 52 years that led to the situation we have today (Figure 19.1). The history starts with the Treaty of Rome, March 25, 1957 (EEC 1957) that established the predecessor to the current EU, the European Economic Community (EEC). In May 1960, the European Free Trade Association (EFTA) was established as a trade bloc alternative for European countries not then part of the EEC (EFTA 1960). The Stockholm Convention, establishing EFTA, was signed on January 4, 1960 in Stockholm by seven countries (Austria, Denmark, Norway, Portugal, Sweden, Switzerland, and the United Kingdom). The EFTA still exists although 3 of the original 7 are now part of the EU.