On 21 March 2018, the UK House of Commons Health and Social Care Committee published a report outlining its recommendations to the Government in relation to Brexit negotiations with the EU and the impact of Brexit on medicines, medical devices and substances of human origin. The Committee recommends the closest possible regulatory alignment with the EU in order to protect patient interests. The full report is available here.
Key Recommendations in the Report
The Report followed an Inquiry carried out by the Committee, which received over 100 written submissions and oral evidence from witnesses (including representatives of patient and workforce groups, industry, experts and Ministers).
In the Report, the Committee recognises and supports the Government’s stated intention to maintain regulatory alignment with the European Medicines Agency (EMA). However, it also sounds a warning that the European Council, while emphasising a desire to maintain the UK as a close partner, has excluded participation in the Single Market on a sector-by-sector basis. In that context, the Committee warns of the risk that would arise in the event of regulatory divergence, particularly in the event of a ‘no-deal’ Brexit.
The Committee’s principal recommendations to the UK Government include:
- Patients first: Urging the UK and the EU to ensure that any future trade deal prioritises a high level of protection of human health (including ensuring that patients are not disadvantaged, that there is availability in the UK market for innovative products and ensuring that the UK continues to play a leading role in promoting public health);
- Associate EMA membership: Supporting the Government’s intention to negotiate a close relationship with the EU, including associate membership of the EMA, on the basis that this would be of mutual interest;
- Pharmacovigilance mechanisms: Seeking mutual recognition of pharmacovigilance mechanisms between the MHRA and EMA as a priority in the next round of Brexit negotiations. This would include membership of all of the major EU systems and databases including EUDAMED (medical devices) and EudraVigilance (medicines);
- Trade: Supporting ‘free and frictionless’ trade with the EU and considering the impact of the loss of parallel imports on the UK and the need for contingency planning for supply chain management in the event of shortfalls in pharmaceutical products;
- Global representation: Seeking representation of the UK at the International Council of Harmonisation of Technical Requirements of Pharmaceuticals for Human Use;
- Clinical trials: Ensuring that the UK Government commits to adopting the new Clinical Trials Regulation into UK law and continues its collaboration with the EU on clinical trials post-Brexit;
- Data Protection: Seeking 'more than just an adequacy agreement' and ensuring regulatory alignment on data protection rules;
- Qualified persons: Measures to provide for retention in the UK of qualified persons (QPs) (and contingency plans for training and recruitment of new QPs in the event of a failure to reach agreement with the EU on mutual recognition of QPs); and
- Research and Development: Seeking the UK’s continued membership of the EU Research and Development funding schemes (e.g. Horizon 2020 and Innovative Medicines Initiative).
Since the publication of the Report, the UK and EU have reached an agreement in principle over a Draft Withdrawal Agreement providing for a transition period post-Brexit. If adopted in its current form, the transition period would extend until 31 December 2020. During that period, it appears that UK agencies and businesses will still have to comply with relevant EMA rules and regulations; however, the UK’s own terms of engagement with the EMA during that transition period remain unclear.