The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. The Committee’s report sets out recommendations for the UK Government in its negotiations with the EU on the terms of the UK’s withdrawal from the EU and any future trade deal with the EU. The recommendations are not the Government’s formal negotiating position, but will inform that position.
The overriding recommendation of the report is that the UK and EU must prioritise patient safety and look to secure the “closest possible regulatory alignment” between the UK and EU for the life sciences sector, to ensure that patients in both the EU and UK are not disadvantaged by Brexit.
The report also sets out a number of more detailed recommendations as to the position that the UK Government should adopt in the Brexit negotiations, including seeking:
- “associate membership” of the European Medicines Agency (EMA), recognising that the EU would also benefit from continued access to the expertise and capacity of the UK Medicines and Healthcare products Regulatory Agency (MHRA) (a proposal already outlined in Theresa May’s speech on 2 March 2018);
- regulatory alignment with the EU during and after a transition period, including in the long term;
- free and frictionless trade with the EU and arrangements to maintain parallel trade in medicines with EU member states in any future trade deal;
- continued access to EU data sharing networks and pharmacovigilance systems, including Eudravigilance (medicines) and EUDAMED (medical devices);
- mutual recognition of pharmacovigilance activities and the activities of Qualified Persons for Pharmacovigilance residing and working in each other’s territories; and
- continued involvement in EU research and funding programmes such as Horizon 2020 on the same terms as at present.
The Committee also urges the Government to adopt the new EU Clinical Trials Regulation into UK law following Brexit to ensure that patients, particularly those with rare conditions, can participate in Europe-wide clinical trials. The new Regulation will come into force after the UK has left the EU in March 2019 and therefore will not be automatically implemented into UK law under the proposed EU (Withdrawal) Bill.
The report, which precedes the recent political discussions on the draft Withdrawal Agreement, also warns of the serious adverse impact on the lives of individuals and the life sciences sector in both the EU and UK that would result from a “no deal” Brexit and highlights the need for more transparent contingency planning by the Government.
The full report is available here.