OBJECTIVES

: By 29 March 2019, the European Medicines Agency (EMA) will have relocated from London to Amsterdam and the UK may not perform a regulatory role within the European Union/European Economic Area with existing Member States taking on additional workload. Research on the impact of Brexit predominantly focuses on the UK. This research evaluates the contribution that the UK, through the Medicines and Healthcare products Regulatory Agency (MHRA), provides to the EMA and discusses the impact of its loss.

METHODS

: Publically-available EMA database of European human medicines regulatory experts was screened (http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/landing/experts.jsp - 8 January 2018).

RESULTS

: There are 3,024 European human medicines regulatory experts currently listed in the EMA database (excluding EMA employees), involved in marketing authorization(s) and the supervision and maintenance of medicinal products for human use. Germany currently leads Europe in the number of these experts with 13% of the total (404/3,024), followed by Spain [291/3,024 [10%]], and the UK in third place, providing 226 experts, 7% of the expert pool. Not only is this expertise numerically substantial, but as previously reported, the MHRA currently leads Europe in number of rapporteurships (Rapp/Co-Rapp) appointments for centralized procedures with 136 appointed (2013-2016, 16% of all rapporteurships) (Wang and Macaulay, 2016, ISPOR Glasgow).

CONCLUSIONS

: Given the central role the UK plays within the EMA, ‘Brexit’ has the potential to enormously impact the function of the EMA and hence access to medicines not just in the UK but also more widely in Europe. The outcome of negotiations between the EU and UK government in this regard will be crucial with ongoing discussions on a potential continuing role for the MHRA in supporting EMA functions and the UK benefitting from EU regulations and fostering regional harmonization.