Approaching Judgment Day: The Influence of Brexit on the EU Pharmaceutical Framework

Abstract

Though the plans for Brexit keep changing daily at the time of writing of this article, it seems useful to identify and discuss the differences between various types of EU trade agreements with third countries as possible models for a future EU–UK relationship, whatever the outcome. At some point after all the political drama, civil servants and negotiators will need to get down to business and find practical solutions for the new situation. This article examines the impact of such a transition on the integrated EU pharmaceutical industry. First, a state of play chapter details the EU and UK legislation regarding Brexit, possible future agreements and an overview of the pharmaceutical regulatory framework. The focus of the analysis itself is the level of participation in the European Medicine Association on the basis of a European Economic Area (EEA) Agreement (Norway), a Bilateral Agreement (Switzerland), and a Free Trade Agreement (Canada). Within this framework, key regulatory complications of the EU pharmaceutical framework (Market Authorization, Research & Development and Safety Monitoring) are investigated. Finally, the article demonstrates some of the dilemmas and diverging demands of the EU and UK as new trading partners in the pharmaceutical sector.