11 March 2019
The PHG Foundation’s mission is making science work for health. As a week of crucial parliamentary votes on Brexit begins, what are the potential implications for the life sciences and for healthcare?
The Department of Health and Social Care (DHSC) have estimated that pharmaceutical companies who manufacture medicines and medical devices could face border disruption when bringing goods into the UK after a no- deal Brexit. It has been estimated that ports could see a significantly reduced flow of goods for at least six months. Speaking at the Royal Pharmaceutical Society’s Science and Research Summit last month, Chief Medical Officer for England Prof Dame Sally Davies called the prospect of a no deal Brexit ‘hair-raising’ due to the potential shortages that could ensue.
Potential border delays for medicines and medical devices would be due to the UK Medicines and Healthcare products Regulatory Agency (MHRA) having to re-establish itself as an independent regulator. At the moment, governments work together through the European Medicines Agency (EMA) to license medicines for use throughout the EU. The MHRA have drafted an amendment to current regulations to allow them to operate, but it is yet to be reviewed and signed off by parliament. Meanwhile, the DHSC has confirmed that in the event of any disruption at the border, medicines will be prioritised, and the government has attempted to secure additional transport capacity between the UK and EU specifically for critical goods such as medicines.
Concerns have been expressed that those living with rare diseases would be hit hard by the effects of a no deal Brexit, especially if increased costs of bringing new medical products to the NHS deter developers from accessing the UK market. The BMA has warned that exclusion of the UK from the European Rare Disease Network could result in disruption for almost a million patients receiving treatment for rare diseases, whilst the necessity to source important radioisotopes outside of EURATOM could delay diagnosis and treatment for some cancer patients.
The ABPI has further warned that a no-deal Brexit would result in the UK dropping out of the new Europe-wide Falsified Medicines Directive (FMD) which aims to protect patients from fake medicines. Chief Executive Mike Thompson said: “Not being part of the safest medicines system in the world…makes no sense”.
Recent analysis in The Lancet notes that the health workforce is arguably ‘the most important challenge for the NHS after Brexit‘, warning that if Brexit were to result in a mass exodus of health professionals from the EU and EEA, existing staffing shortages will be exacerbated. It further concludes that all scenarios for Brexit are ‘worse for the NHS than remaining’ but that a No-Deal Brexit would be ‘by far the worst option’.
A new report from Health Foundation asserts that although government moves towards using international recruitment to plug staff shortages are positive, they are not enough to address urgent NHS staffing needs. They propose that more roles should be swiftly added to the Shortage Occupation List (for which less stringent immigration rules apply) along with nurses, including allied health professionals and certain medical specialties.
A strong UK life sciences sector is needed in order to sustain a pipeline of new healthcare technologies for the NHS to utilise, requiring a skilled workforce to maintain the UK’s global, competitive position in commercial and academic science research. The Life Sciences Industrial Strategy was clear that any UK withdrawal from the EU must continue support for a sector that employs more than 233,000 scientists and related staff and generates a £64 billion annual turnover.
Leading biomedical research funder the Wellcome Trust has asked that the UK develops a simple, swift post-Brexit immigration system for skilled researchers, technicians and innovators. The current Minister of State for Universities, Science, Research and Innovation (Chris Skidmore, MP) recently called for the post-Brexit immigration policy to be amended, telling the House of Commons Science and Technology committee that the £30,000 salary cap was “quite detrimental to the science community”. Reactions to the ongoing uncertainty over Brexit have included AstraZeneca freezing its UK investments until there is clarity on the way forward and Wellcome announcing that it will allow its researchers to transfer their grants outside the UK.
In January the DHSC updated the guidance for how medicines, medical devices and clinical trials would be regulated in the event of a no-deal Brexit. Clinical trials are managed nationally in the UK by the MHRA, although some aspects of clinical trials are shared across the EU Medicines Regulatory Network (EMRN). For example, a clinical trial sponsor or legal representative for clinical trials in the EU should be based in the EU/EEA.
Should the UK leave the EU without a deal, UK clinical trial applications will continue to be authorised by the MHRA. The Government has committed to seeking to preserve the agreement that a clinical trial sponsor or legal representative for clinical should be based in the EU/EEA, anticipating that it will also be necessary to have an individual based in the UK with overall responsibility for the trial. However, there is uncertainty as to whether such an agreement can be struck, and such requirements could also disproportionately affect companies who do not have physical representation in both places.
Wellcome have been clear that they believe best option for UK and EU clinical trials after Brexit is full UK participation in the EU clinical trials system on a similar basis to Member States. They argue that the UK should implement the EU Clinical Trial Regulation (CTR) and have access to the single EU clinical trials portal and database alongside being a part of relevant regulatory discussions.The Government have committed to align regulation with the CTR, however. as yet, no deal has been struck with the EU.
The Royal Society has also previously called for a deal that enables access to all aspects of the EU’s research and innovation programme, Horizon Europe, with full engagement and influence. Within the current withdrawal agreement, yet to be ratified, there are assurances that UK entities’ right to participate in Horizon 2020 would be unaffected by the UK’s withdrawal from the EU for the lifetime of current projects. Beyond Horizon 2020, the government have committed to explore the option of full association to research and innovation programmes, but there are no guarantees of success.
The Brexit Health Alliance brings together a range of health professional, patient and health and care organisations such as the Academy of Medical Royal Colleges, Association of UK University Hospitals, Faculty of Public Health, National Voices, NHS Confederation and the Richmond Group of Charities. This highly influential group have called for a deal that delivers the closest possible alignment and regulatory cooperation between the UK and the EU with respect to medicines and medical devices, to guarantee patient safety and public health.
Both the NHS and the UK life sciences industry desperately need clarity and certainty to plan successfully for Brexit, and time has almost run out. Decisions rest in the hands of the UK parliament, who this week will come under greater scrutiny than ever. However, even the ‘least worst’ option will clearly have profound implications for UK science and health.