What Is Possible and What Is Not? The Development of a Legal Framework for Drug Pricing Mechanisms in the EU

摘要

As a result of the constantly increasing number of innovative but exceedingly high priced medicines, many Member States have implemented price-regulating mechanisms to ensure the financial viability of their healthcare systems. However, the European Court of Justice applies strict criteria to these measures – some of them have already been suspended for the purposes of the free movement of goods. The European Union (EU) allowed the development of an ever-stricter case law on one hand, without changing the legal frame on the other hand. Considering the importance and the binding nature of the Court’s judgements, this leaves great uncertainty for national legislators about which measures to remedy the pricing problem are legally possible and which are not. In order to provide clarity, this article seeks to analyse the development of the case law and to define the legal scope for pharmaceutical pricing mechanisms in the EU.