On 23 August 2018, the UK Government began publishing technical notes on the effect of a no-deal Brexit. These notes are intended to provide guidance to citizens, businesses, public sector bodies and Non-Governmental Organisations in the United Kingdom on how to prepare for the possibility of the UK leaving the EU next March without concluding a Withdrawal Agreement. SPICe Spotlight is providing analysis and comparative information on a number of the notices. The first blog provided an overview of the UK Government’s Preparations for a no-deal Brexit
Along with a series of six technical notes covering regulation of medicines, clinical trials and medical devices (see No-deal EU Exit preparations: the regulation of medicines, clinical trials and medical devices ), the UK Department of Health and Social Care also issued contingency planning guidance, mainly covering the supply of medicines.
The Department of Health and Social Care (DHSC) undertook an analysis of the supply chain for medicines, including radioisotopes and vaccines, which identified those products that are imported from the EU and the European Economic Area (EEA). Without a deal, the supply chains for these products may be affected by changes to border processes and procedures.
source: US Airforce
The UK Government established a Medicines Supply Contingency Planning Programme to consider the smooth and continued flow of medicines into the UK should there be no deal. The programme has set up a system by which marketing authorisation holders (companies that have a licence from the Medicines and Healthcare Products Regulatory Agency (MHRA) to bring medicines into the UK) are asked to inform the DHSC what contingency planning they have in place for the medicines they supply.
The Programme covers prescription and pharmacy only medicines that come from or via the EU/EEA via road, sea and rail. It does not cover:
- medicines from outwith the EU/EEA, or
- medicines coming from the Republic of Ireland
- vaccines that are part of the national vaccination programme
- medical devices and clinical consumables
- unlicensed medicines, as well as some other categories.
A letter from the Secretary of State for Health and Social Care accompanied the technical notes and contingency planning guidance were accompanied . The letter focused on the continuity of supply of medicines in the event of ‘no deal’, and planning to ensure that a six-week supply of medicine is secured by pharmaceutical companies.
The Scheme also includes separate arrangements for the air freight of short shelf-life medicines, such as medical radioisotopes Suppliers are being asked to ensure planning is in place for these to avoid any border delays that might arise in the event of no deal There was also a highlighted warning that hospitals (and Boards), GPs and pharmacies should not stockpile any medicines, nor write longer prescriptions, and that any evidence of this happening would be investigated.
Other areas covered in the letter were:
- Immigration, settled status and skilled worker visa cap
On immigration, the Home Office issued a ‘toolkit’ for employers of EU citizens designed to offer reassurance and information on applying for settled status. The Secretary of State reminded stakeholders that the cap on skilled worker visas would not apply to doctors and nurses, who can be employed through the Tier 2 visa route. There is no mention of any similar rule for social care staff. This guidance was last updated on 5 November 2018.
- Supply of medical devices and consumables (these would include things such as testing strips for blood sugar monitoring for example). See SPICe Briefing SB 18-45, The Regulation and Governance of Medical Devices in Scotland
Separate contingency plans were being developed for these products.
- Research and reciprocal healthcare
These were not covered in any detail but are acknowledged as issues under consideration.
The UK Government were putting measures in place to cover the continuity of research funding and pan-European clinical and research collaborations. The Treasury is extending the government’s guarantee of EU funding to underwrite the UK’s allocation for structural and investment fund projects under this EU’s budget period to 2020. The Treasury will also guarantee funding for UK organisations, for the lifetime of a project, that successfully bid directly to the European Commission for project funding up to the end of 2020.
The Healthcare (International Arrangements) Bill 2017-19 is currently being considered by the UK and Scottish Parliaments and would allow the UK Government to fund and implement reciprocal healthcare schemes with other countries post Brexit. A future blog will cover this Bill in more detail.
UK Parliament scrutiny of no-deal preparations
The UK Parliament’s Health and Social Care Select Committee is currently conducting an inquiry into the impact of a no-deal outcome on health and social care. The Committee took oral evidence from a number of witnesses on 23 October, followed by evidence from the Secretary of State, Rt Hon Matt Hancock MP.
Anne Jepson, SPICe Research