The European Medicines Agency (EMA) has clarified some details of the expected consequences of Brexit, including the changing status of Britain’s Medicines and Healthcare products Regulatory Authority (MHRA). In a statement from April 2018, the EMA explains that the UK’s portfolio of responsibilities will be redistributed to the remaining member states, allowing the removal of the MHRA from the current system.
From 30 March 2019, the MHRA will no longer act as a (co-)Rapporteur in the various committees and groups within the EMA, allowing its roles to be reassigned as other European expertise allows. The focus of the EMA and the European Commission is to allow continuity of business, ensuring that assessment and approval of medicines within the Union are not compromised by Brexit.
The Times has reported that bodies such as the Ethical Medicines Industry Group (EMIG) suggest that the exclusion of the MHRA from EMA processes could result in the MHRA losing some of its statuses, and could harm its future sustainability.
The Prime Minister had suggested that the Government would seek to maintain membership of the EMA in Brexit negotiations, meanwhile, the EMA has assumed this won’t be the case. Should the situation remain the same, drugs manufacturers will still be able to have their products approved for use in the UK after Brexit, but this will require an additional process on top of that for Europe through the EMA. Although the Government will seek continued membership with the EMA after Brexit, companies should prepare for the outcome of Britain no longer acting as a member.