EPLR 3/2018 – Core Regulatory Challenges in the Pharmaceuticals Field

Policy makers and courts tend to slow down their output during the summer, and this is no different for those working in the pharmaceutical community. With EMA focused on moving their headquarters to Amsterdam in the wake of Brexit, this trend is particularly pronounced. However, this does not mean that there were no legal and regulatory developments which merit our attention. Indeed, issue 3/2018 of EPLR features two articles on core regulatory challenges in the pharmaceuticals field: allegations of excessive pharmaceutical pricing and the contentious topic of off label use.

In addition, we have also included reports from Germany and the United Kingdom and a topical report on biosimilar authorisation. The issue concludes with a timely Case Note by Minssen and Bostyn who criticise the Court of Justice for failing to clearly determine ‘when a product is protected by a basic patent’.


View all articles of EPLR 3/2018.