The Commons Health & Social Care Committee has published its report on its ‘Brexit: medicines, medical devices and substances of human origin’ inquiry, which includes a number of conclusions and recommendations, including:
- The Department of Health and Social Care should produce a comprehensive list of all the issues relating to the supply of medicines, medical devices and substances of human origin which require contingency planning for the UK leaving the EU;
- A request that the EU look closely at the proposals or reconsider a sectoral approach to regulatory alignment;
- The UK should aim to have a seat at the International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) in its own right;
- Publications of a detailed breakdown of the funding allocation for the DHSC from the Brexit funding;
- That the Government should implement the Life Sciences Industrial Strategy in full and at pace, with a final deadline of 2023;
- The nature and level of UK ‘regulatory drift’ in the life science sector from the EU should be systematically assessed at regular intervals by current and future UK Governments;
- The Government must seek agreement with the EU for those Qualified Persons (QPs) currently working in the UK to continue to have their work recognised in EEA countries;
- The Government should publish its contingency planning as soon as possible for a situation in which no mutual recognition of QPs in the UK and EU is agreed;
- The Government should commit to adopting the new Clinical Trials Regulation into UK law following Brexit and secure a joint statement with the EU committing to continued collaboration on clinical trials following the UK’s exit from the EU;
- The UK should look to retain full membership of the Pharmacovigilance Risk Assessment Committee (PRAC) or, if this is not possible, should endeavour to be present in PRAC meetings as an observer as an absolute minimum.
In addition, the Commons Science and Technology Committee has also published its report on ‘Brexit, science and innovation’. Key findings/recommendations include:
- The Government should state clearly that it intends to participate in the Framework Programme 9 unless there is a material unfavourable difference between the new Programme and its predecessor, Horizon 2020, and that the UK is ready to pay a fair ‘entry fee’ to secure this. If the price is too high, or the focus on excellence is diluted, a change in approach might be warranted, but the Government’s explicitly stated assumption must be to participate fully;
- The Science Minister’s position on clinical trials regulation, that “the current regulatory approval legislation will stay in place until such time as any changes are needed”, is unsatisfactory as it ignores the fact that work is needed now to ensure that the UK can participate in and lead clinical trials in the future;
- A recommendation that the Government make drafting and negotiating a science and innovation agreement an urgent priority.