On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation.
The briefing paper summarises the current UK/EU regulatory framework for both medicines and medical devices, the impact of the relocation of the EMA, and options for future UK regulation post-Brexit. It is a briefing document, not a position paper, which draws together not only relevant legislation and guidance, but also statements and commentary from a number of sources, including the UK Secretary of State for Health (Jeremy Hunt), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), EMA, European Commission and press.
In relation to the relocation of the EMA, the briefing paper references the impact on staff retention at the EMA, the effects on resource and workload for both the EMA and MHRA if the UK no longer contributes to EMA activities, relocation costs and possible delayed access to medicines in the UK. The UK has traditionally had a very close relationship with the EMA, in part from the proximity of the MHRA to the EMA in London. The MHRA works with the EMA as part of the EU regulatory network and contributes significant resources - the MHRA is believed to lead on around 25% of new EU medicine assessments and the EMA had indicated that 15% of its experts are from the UK and carry out 20% of the EMA's scientific work. The costs of the EMA relocation are reported to be in the region of EUR 580 million and how they will be covered in the final "divorce bill" is yet to be agreed.
The degree to which the UK will continue to work closely with the EMA following Brexit also remains to be agreed as part of the withdrawal negotiations. The UK Government has consistently expressed a desire to continue close cooperation with the EMA and this is emphasised again in the briefing paper. The UK Secretary of State for Health has previously indicated that he does not expect the UK to stay in the EMA but rather that any relationship would likely be based on a mutual recognition agreement. This was reiterated in the Government policy paper on Collaboration on Science and Innovation published in September, which refers to existing mutual recognition agreements between the EMA and third countries such as Switzerland, USA and Canada as providing a precedent on which the UK could build. The briefing paper specifically mentions Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and medical device notified bodies as areas that could be included in any mutual recognition arrangement between the EU and UK.
The briefing paper sets out options for future UK regulation post-Brexit, which include not only a mutual recognition arrangement between the UK and EU but an "ambitious" option whereby the UK and the European Commission would abide by each other's recommendations to authorise new medicines. The briefing paper also discusses possible changes to the current UK authorisation process, such as making the UK licensing process faster than the EU process, the MHRA and National Institute for Health and Care Excellence (NICE) assessing new medicines in parallel to speed up authorisation and reimbursement in the UK, and approving medicines based on authorisations in other markets such as the US, Australian and Japan.
The briefing paper also covers the potential impact on parallel imports of medicine from other EU markets to the UK, directly quoting from Hogan Lovells' Dr Fabian Pfuhl's blogpost on the principle of exhaustion of trademark rights which can be read here.
In relation to medical devices, the paper confirms that the new EU regulations on medical devices, which have come into force but will not yet apply on Brexit day, will not be automatically converted into UK law under the European Union (Withdrawal) Bill. However, the paper notes the MHRA is continuing preparations to implement the new Regulations, suggesting that separate UK legislation to implement the new regulations is likely.
A UK Commons Health Select Committee inquiry on the regulatory arrangements needed to guarantee the safe and effective supply of medicines and medical devices post-Brexit is currently underway, with oral evidence sessions scheduled for December.
The briefing paper, together with the submissions to the inquiry, will be used in formulating the UK's negotiating strategy on medicines and devices regulation going forward. The UK Parliament briefing paper is available here.