Deal or no-deal: explaining the government's Brexit guidance

With the release of the government's first batch of guidance papers in the event of a no-deal Brexit, as well as a letter from health secretary Matt Hancock aimed at frontline staff and six technical documents, RCP president-elect Dr Andrew Goddard explains the wider ramifications and outlines the RCP's position on each.   

We’ve said from the start that patient safety must be at the centre of Brexit planning. We are pleased that the government has heard the calls from the sector and is taking a transparent approach by making public the Brexit no-deal scenario guidance which relates to health care. We’ll continue to encourage the government to work with the EU, the NHS and health organisations to ensure that whatever the outcome of the negotiations, patients’ access to healthcare is protected

We continue to be concerned though about the lack of clarity on the proposed immigration policy in the event of a no-deal and ask for urgent clarification. It’s critical we understand the proposed approach as soon as possible so that the NHS can continue to recruit health professionals from the EU and internationally to support safe staffing levels.

We’ve taken a look at the detail to help inform members and fellows about what the guidance means, and how it might impact the profession in the event of a no-deal. We’ll continue to keep you updated as more guidance is released. 

Letter from Matt Hancock MP to frontline staff: supply of drugs

The Department for Health and Social Care have released a letter from Matt Hancock to frontline staff, whose trust will be vital in ensuring continuity of care. The letter sets out the key headlines staff should be aware of. We know that ultimately it is doctors, who patients will look to for reassurance that their treatment plans will continue unhindered by Brexit. One of the key messages relates to the supply of drugs, with the letter explaining that industry has been asked to ensure an additional 6 weeks’ supply by March 29, with air freight arrangements for items with a short life span. 

... there must be no circumstances where a patient finds themself without access to medicines because of a lack of supply

Dr Andrew Goddard, RCP president-elect

The Department of Health and Social Care has asked doctors to advise patients that contingency plans are in place, not to prescribe longer prescriptions, not to stockpile locally and to encourage patients not to seek to stockpile medications. This is helpful information and the transparency is welcomed, however further questions remain such as:

  • What detailed information will be provided to clinicians?
  • How will any shortage issues be dealt with and escalated?
  • Why has a 6-week timeframe been chosen?

We will be looking for government to demonstrate that these measures will be adequate to deal with a no-deal situation, as there must be no circumstances where a patient finds themself without access to medicines because of a lack of supply.

Medical regulation

The guidance on medical regulation in the event of a no deal, explains that the UK wouldn’t participate in the European Regulatory Network and MHRA would take on additional responsibility from the EU. This would require some changes to the law that MHRA will be consulting on in the Autumn.

This seems a sensible approach, but support and resource from across the sector must be combined to support MHRA to fulfil its expanded role, in the event of a no deal.

Batch testing medicines if there’s no Brexit deal

We welcome the pragmatic approach taken in the guidance which will allow manufacturers to batch test medicines which are accepted by the MHRA that is likely to include EU and EEA countries. We would expect the MHRA to publish the confirmed list before March 2019.

It’s also welcome news that the UK will follow a similar process for the Investigational Medicinal Products ensuring patients still have access to key medical trials. Safety of patients is key and we are pleased that the guidance indicates that the government recognises the importance of maintaining access whilst keeping patients safe.

Quality and safety of organs, tissues and cells if there’s no Brexit deal

The movement of organs, tissues and cells can be a life and death matter for patients. While the number of organs shared between the UK and EU countries is small it’s vital that this movement can continue unhindered in the event of a no-deal Brexit. The guidance makes clear that establishments licensed to work in this area will need to create new written agreements with EU and EEA member establishments.

It also notes that this ‘…will for the most part be a minimum burden on the industry’. We would hope however that the Department for Health and Social Care would work with organisations as a priority in the event of no-deal scenario to ensure there are no delays in getting agreements in place. 

Any potential barriers on the movement of goods could cause significant patient safety risks and must be addressed by government

Dr Andrew Goddard, RCP president-elect

Ensuring blood and blood products are safe if there’s no Brexit deal

The guidance sets out that the 'Blood Safety and Quality Regulations 2005' would be retained in UK law under the ‘EU (Withdrawal) Act’ powers. The regulation would maintain the current standard of blood quality and safety on exit day, and keep the regulation under review to protect patients.

The MHRA will have a crucial role in ensuring that there are no delays or issues in the event of a no-deal  Brexit in the transportation and movement of blood and blood products. Any potential barriers on the movement of goods could cause significant patient safety risks and must be addressed by government.

Research

The new regulations surrounding clinical trials will not be in effect by March 2019, so will not be transferred to UK law. However the government has stated that the UK will aim to align its regulatory framework where possible which will be particularly important for the life science industry. It is also welcome that the Government will underwrite Horizon 2020 funding for UK participants.

However, in the event of a no deal, UK researchers would only be able to apply to the programmes that offered third party access. Further discussion needs to take place around the potential change in status of existing participants from member to third party and Horizon 2020 participants will be asked to submit information on a government portal shortly (Gov.uk), to be managed by UK Research and Innovation.

The RCP hopes to see further recognition by both the UK and EU of the importance of research collaboration, even in the event of a no-deal. As much reassurance as possible should continue to be given to researchers at this uncertain time.