Warnings have been issued to the Government that Brexit may disrupt generics approvals without contingency plans being put in place, including by the Chief Executive of the Association of British Pharmaceutical Industry (ABPI) in an interview with the Health Service Journal.
After the UK leaves the EU, manufacturers would only be able to make applications for generic drugs with equivalence to branded medicines approved in the UK. This means that for drugs approved by the EU’s European Medicines Agency (EMA), but not the Medicines and Healthcare products Regulatory Agency (MHRA), there would be no valid equivalent product through which to pursue licencing of a generic.
It is worth noting that under current plans, existing EU approvals should be converted into UK approvals at point at which the UK leaves the EU, meaning that the vast majority of EU-approved drugs should obtain UK approval anyway. However each approval conversion needs to be approved by the MHRA, and requires submission of supporting information from the Market Authorisation holder, opening up the possibility that in some cases this may not happen.