The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which considered the regulatory arrangements needed for the safe and effective supply of medicines and medical devices post-Brexit (see our blog here).
Of particular interest to life sciences companies, the response states that:
- The safety of patients is of paramount importance to the UK Government’s exit negotiations. The Government is preparing for all potential outcomes but is “increasingly confident that the prospect of a ‘no deal’ scenario is highly unlikely”.
- The UK Department of Health and Social Care (DHSC) is currently assessing the impact of Brexit on the supply chain for all medicines and devices used in the UK National Health Service (NHS).
- The Government recognises the importance of a close and cooperative relationship between the UK and EU in relation to medicines and devices regulation. The Government wants to explore the terms on which the UK could remain part of EU agencies, including the European Medicines Agency (EMA).
- Under the terms of the implementation period (from the UK leaving the EU in March 2019 until the end of 2020), the UK will no longer be an EU Member State but businesses will be able to trade on the same terms as now until the end of 2020. This includes that the EU will continue to accept UK batch testing, release and inspections, UK-based Marketing Authorisation Holders (MAH) and other key roles including QP certification.
- During the implementation period, the current EU principles and guidelines of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) will continue to apply in the UK. There is no current policy intention for any divergence, though the UK MHRA will have the power to update these principles and guidelines in the future to reflect evolving best practice.
- In relation to goods, including medicines and devices, the Government’s position is that the UK-EU border should be as frictionless as possible and products should only need to undergo one set of approvals to be sold in both the EU and UK.
- UK citizens participating in on-going trials in the UK will not be affected by the UK’s exit from the EU or the end of the implementation period.
The full response is available here.
Further negotiation recommendations relating to the pharmaceutical sector were published by the BEIS Select Committee earlier this month (see our blog here).