As the UK approaches another deadline for leaving the EU, and as the prospect of no-deal Brexit is openly presented as a possibility by the Government, the British Heart Foundation (BHF) has been hard at work advocating for people affected by heart and circulatory diseases, BHF’s researchers and the wider research environment. We are monitoring discussions on the detail of our future relationship with the EU and, if that relationship cannot be defined in the near-term, how to mitigate any risks that may arise if the UK leaves without a deal.
Working alongside the Association of Medical Research Charities, the Brexit Health Alliance and the Richmond Group, and directly with Government, the BHF believes that the following areas must be prioritised in negotiations:
Continued supply of medicines and medical devices
Likely delays at ports following any “no deal” departure pose risks to the supply of medicines and medical devices imported from the EU to the UK. The Government has issued information to patients and NHS Trusts offering assurances of adequate contingency plans. The BHF is asking for further assurances that co-ordinated contingency plans are in place, prioritising imports of medicines and medical goods. This includes clinical trials materials, active pharmaceutical ingredients, medical devices and raw materials for manufacturing medicines.
We have written to the Department for Health and Social Care (DHSC) seeking clarification of arrangements made for the most common heart medicines and medical devices. While we regularly attended DHSC stakeholder meetings on continuity of supply and contingency planning with industry, we have been seeking more detailed assurances that contingency plans are sufficiently robust.
Reciprocal healthcare arrangements between the UK and the EU
Whether a withdrawal agreement is reached by 31 October or not, the BHF calls on the UK Government and the remaining EU states to take whatever action is necessary to ensure the continuation of reciprocal healthcare arrangements for UK citizens living in, working in or visiting the EU, and for EU citizens living in, working in or visiting the UK.
While the BHF welcomed the Government’s pledge to temporarily cover the healthcare costs of 180,000 British nationals living in the EU for 6 months in the event of no-deal, there remains a high level of uncertainty for UK nationals in the longer term.
Continued UK-EU collaboration on science and research
UK science and research is greatly enhanced by close international collaboration, particularly with EU researchers and institutions, and through pan-EU scientific networks. As a leading charitable funder of medical research, we believe it is vital that these ties are preserved as the UK leaves the EU, and that EU researchers’ ability to live and work in the UK and contribute to UK-based research projects is not hindered.
We believe that it is critical for the UK to associate with the next Frameworks Programme, Horizon Europe, at least in the short-term. This will ensure researchers continue to have access to traditional EU grant mechanisms, while allowing the UK government to strategically develop alternate funding mechanisms that could thrive with any new opportunities presented.
We are encouraged that UK Research and Innovation (UKRI), the Government body responsible for research and innovation funding, has taken concrete steps to protect current funding streams by committing to underwrite payments for researchers in receipt of Horizon 2020 grants until the UK’s departure from the EU. Association with Horizon Europe, however, remains unclear, allowing uncertainty within the research community to grow. We are already starting to see the effects of this uncertainty with a decrease in the number of EU research projects led by core Russell Group universities since 2016.
Regulatory alignment for clinical trials, data access and medicines approval
The licensing of medicines and therapeutic devices in the UK is currently subject to EU regulations via the European Medicines Agency (EMA). Clinical trials in the UK are subject to the EU Clinical Trials Directive, which is implemented and managed by the Medicines & Healthcare products Regulatory Agency (MHRA). This enables an aligned regulatory environment across the EU, facilitating cross-border clinical trials, which are vital for all patient populations but critical to rare disease and paediatric research in particular. The ability of patients to access new treatments, and of scientists to carry out cross-border clinical trials, may be jeopardised if the UK fails to maintain regulatory alignment with the EU after Brexit.
The BHF does not believe that sovereign replication of those institutions is the best way forward in the short term. It is imperative that arrangements are made for continued UK participation in the mechanisms of the EMA, previously hosted in the UK. The BHF has joined voices across the medical research sector calling on the Government to align with the EMA so that patients can continue to have access to cutting-edge treatments across the UK and the EU.
Additionally, it is vital for the UK to continue to participate in key data sharing platforms that protect the public from health threats such as pandemics, unsafe medicines and products and unsafe practitioners.
Are you a patient or researcher?
While this sets out the major areas that the BHF has prioritised since the 2016 referendum, we have no doubt that there will be unanticipated questions or concerns that arise as 31 October approaches. If you are affected by heart or circulatory disease, please do not hesitate to contact the heart helpline (by phone at 0300 330 3311 or by email [email protected]), if you have any questions. You may also wish to check the Government’s Frequently Asked Questions about patients’ access to medicines after Brexit page for more information.
If you’re a BHF-funded researcher, please contact us with questions at [email protected] and check out this webpage summarising the latest government guidance as it relates to research.