Give Due Consideration ….

The new EU Regulation on health technology assessment (HTAR) provides for joint clinical assessments (JCA) of health technologies at EU level. When Member States carry out health technology assessments (HTA) at the national level, they shall give due consideration to the results of a JCA and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether JCA results have to be considered outside a national health technology assessment as well.

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

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.