Breaking up the band: European regulatory cooperation in a post-Brexit world

Abstract

Since 1995, the European Medicines Agency (EMA) has progressed from harmonising regulation for human and veterinary medicines across the European Union Member State national competent authorities, to galvanising one of the most successful cooperative initiatives for regulation globally. Although the EMA is the focal point for stakeholders, regulation is delivered through the European medicines regulatory network, in which national authorities, like the UK’s Medicines & Healthcare products Regulatory Agency (MHRA), contribute. As with any collaboration, contributions by individual members vary, and the MHRA has been noted as an innovative and highly productive member of the network. Progress in regulation not only in Europe – but also around the world through convergence – can be attributed to this unique European cooperation. The decision by the UK to leave the European Union threatens to mark the end of this cooperation; we argue here that the best decision is to maintain regulatory cooperation under new structures.