Creating Order In Chaos - The Impact Of Brexit On The Regulatory Environment In Europe And The United Kingdom

Abstract

In March 2017, the UK government invoked Article 50 of the Treaty on the European Union (EU) to withdraw from the EU (‘Brexit’) by April 2019. This research evaluates Brexit’s potential impact on EU regulatory access by examining existing marketing authorisations (MAs), MHRA’s role in EMA decision-making and parallel imports. Publically available EFPIA, EMA and MHRA data were screened up to December 2016, for the number of centrally authorised MAs, MHRA rapporteurships, and parallel imports. 966 medicines are currently authorised by the EMA (including generics and biosimilars), for which MAs will require independent approval, or for mutual recognition agreements to be put in place to avoid shortage of supply post-Brexit. Existing MAs approved through the decentralised process, where the UK is not the reference member state, will have similar requirements for national approval. The MHRA currently leads Europe in number of rapporteurships (Rapp/Co-Rapp) appointments for centralised procedures, with 136 appointed (2013-2016, 16% of all rapporteurships), Sweden in second place had 84 appointed (10% of all rapporteurships) during this period. The value of parallel imports is estimated to account for 7.5%-9.0% of UK annual pharmaceutical sales (2012-2014) equating to €1.2-€1.5 billion. The likely import tariffs and lack of parallel imports for wholesalers could significantly impact pricing. Conversely, medicines manufactured in the UK may be subject to export tariffs. Brexit has the potential to enormously impact the pharmaceutical industry and medicines regulation, not just in the UK but also in Europe, given the central role that the MHRA plays within the EMA. The outcome of negotiations between the EU and UK government in this regard will be crucial, and a number of scenarios, including the Norway- and Switzerland-models have been suggested. Finding a solution that appropriately incentivises access whilst maintaining standards and minimising disruption will likely be very challenging.