No-deal EU Exit: Medicines and Medical Products

Monday 25th February 2019 Written Statements

[The Minister for Health (Stephen Hammond)]

Today, I am updating the House on the Department for Health and Social Care’s plans for the continuity of medicines and medical products in the event we exit the EU without a deal.

My Department has been working closely with trade bodies, product suppliers, the health and care system in England, the Devolved Administrations (DAs) and the Crown Dependencies, to ensure the continuation of the supply of medicines and medical products to the whole of the UK in the event of a no deal EU Exit. This includes the NHS, social care and the independent sector and covers medicines (prescription, pharmacy and general sales list medicines); medical devices and clinical consumables (such as needles and syringes); supplies for clinical trials; vaccines and countermeasures; and blood, tissue and transplant materials.

Together with industry and the health and care system, my Department has analysed the supply chains of 12,300 medicines, close to half a million product lines of medical devices and clinical consumables, vaccines used in national and local programmes, and essential non-clinical goods on which the health and care system relies, such as linen, scrubs and food.

We have also assessed contract risks associated with potential no-deal EU exit in the broader NHS and social care sector in England and within the DAs and are working with suppliers to ensure adequate mitigations are in place for non-clinical goods and services (e.g. hospital food, laundry, IT contracts, etc.).

This has been a very large undertaking but we are grateful for the excellent engagement from all parties—our plans are well advanced as a result.

While we never give guarantees, we are confident that, if everyone—including suppliers, freight companies, international partners and the health and care system—does what they need to do, the supply of medicines and medical products should be uninterrupted in the event of exiting the EU without a deal.

My Department has well established routine procedures to deal with medicine shortages, from whatever cause, and works closely with the MHRA, the pharmaceutical industry, NHS England and others operating in the supply chain to help prevent shortages and to ensure that the risks to patients are minimised when they do arise.

There is no hard evidence to date to suggest current issues are increasing as a result of EU exit.

My Department has overall responsibility on behalf of the Devolved Administrations for ensuring the continuity of supply of medicines, and they have opted to utilise our contingency arrangements so we can work together to ensure the supply of medical devices and clinical consumables. Therefore, all supply arrangements take into account the whole of the UK, reflecting the engagement and co-operation of our colleagues in the DAs.

Around three quarters of the registered medicines and over half the clinical consumables the UK uses come from (or via) the EU. Government estimate that the key risk to supply is reduced traffic flow at the short straits crossing (ie between Calais and Dover or Folkestone).

My Department has put in place a multi-layered approach to minimise any supply disruption:

Building up buffer stocks and stockpiling before 29 March in the following areas:

Medicines: We have analysed 12,300 licensed medicines products. Around 1,800 of these were determined to not be relevant as no longer marketed in the UK.

For the remaining approximately 7,000 ‘POM’ (prescription-only medicines) and ‘P’ (pharmacy only medicines, that can be purchased only from a pharmacy without a prescription) with an EU/EEA touchpoint, we have been working with suppliers to ensure they increase their buffer stocks to hold at least an additional six weeks of stock (over and above usual buffer stock) in the UK before 29 March. The vast majority of companies have confirmed stockpiling plans are in place. For those medicines that cannot be stockpiled because, for example, they have short shelf-lives, such as medical radioisotopes, we have asked suppliers to make alternative routes using airfreight, which some suppliers already do now.

For general sales list (GSL medicines—also known as over-the-counter or OTC products), 500 of which have a EU touchpoint, we have worked with NHS England to identify those which are important for the management of specific health conditions, and are working with suppliers to assure contingency plans for those products.

Medical devices and clinical consumables: My Department has placed extra orders for the medical devices and clinical consumables which NHS supply chain routinely stocks. Although the NHS supply chain organisation normally only covers England, we have worked closely with the national procurement and logistics services in Scotland, Wales and Northern Ireland, to ensure their demand levels for the UK are covered. Not all suppliers have the capability to hold stock of their full product range in the UK and routinely supply product directly from EU distribution centres to care providers or patients. These suppliers are working on their own contingency measures; however, we have also put in place national contingency measures to provide a reliable and responsive means of moving product into the UK, including additional daily air freight capacity from Maastricht to Birmingham.

Blood, tissues and transplants: NHSBT manages the blood supply in England and is working to ensure there is no disruption to this. We are largely self-sufficient in blood and blood components and do not export or import these products in large quantities. In exceptional cases we export or import very rare blood for urgent clinical need, usually in single unit quantities. NHSBT has put in place stockpiles and other contingency arrangements to ensure a continuous supply of blood (including frozen plasma) and transplant materials. NHSBT has been collaborating with the other UK blood services and is working with its EU counterparts to ensure that the current organ exchange arrangements can continue post exit. The regulators are working with licensed establishments so the import of tissues and cells from EU countries can continue.

Vaccines and countermeasures: My Department is taking the same approach to the supply of vaccines and countermeasures as we are for the supply of medicines (in terms of stockpiling, warehousing and replenishment). Public Health England (PHE) manages significant stockpiles of vaccines for the national immunisation programme across the whole of the UK, as part of their business as usual planning. PHE is working with vaccine suppliers to ensure replenishment of these existing stockpiles continues in the event of supply disruption in the UK.

Supplies for clinical trials: We are working with organisations running clinical trials and have requested these organisations to consider their supply chains for clinical trials ahead of 29 March. We have requested that they ensure contingency arrangements are in place for their supplies. Supplies of clinical trials are transported in small quantities and usually via airfreight.

Non-clinical goods and services: We have been working closely with a range of NHS and social care providers and suppliers to ensure mitigations are in place for non-clinical goods and services (e.g. hospital food, laundry, IT contracts).

Buying extra warehouse space: To ensure sufficient space to store these products, we have agreed contracts for additional warehouse space, including ambient, refrigerated and controlled drug storage. Last week we updated industry on how they can access this additional storage.

Securing, via the Department of Transport (DfT), additional roll on, roll off freight capacity (away from the short straits) from 29 March.

Contracts have been signed by DfT with two ferry companies for the next six months. These routes are away from the Dover Straits where most goods flow from the EU and will run from the following routes: Cherbourg—Poole, Le Havre—Portsmouth, Roscoff—Plymouth, Caen—Portsmouth, Vlaardingen—Immingham, Cuxhaven—Immingham and Vlaardingen—Felixstowe. The Government have purchased the tickets from the shipping freight operators, and these will be sold on at market rate.

There is cross-Government agreement that all medicines and medical products will be prioritised on these alternative routes to ensure the flow of all these products may continue unimpeded.

Companies which supply medicines or medical goods will be offered the option of buying tickets on these routes and my Department is currently engaging with industry to ascertain the likely uptake levels.

We have worked with the pharmaceutical industry to ensure that planes are contracted to bring in medical radioisotopes under the appropriate specialist conditions.

Making changes to, or clarifications of, certain regulatory requirements so that companies can continue to sell their products in the UK even if we have no deal. The MHRA has for this scenario consulted on, and published, further guidance on how medicines, medical devices and clinical trials will be regulated. This guidance can be found at: https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal.

In August, the Government also published a dedicated technical notice on the unilateral recognition of batch testing of medicines, if there is no deal. This can be found at:

https://www.gov.uk/government/publications/batch-testing-medicines-if-theres-no-brexit-deal.

Strengthening the processes and resources used to deal with shortages. My Department has put in place legislation to enable Ministers to issue serious shortage protocols that, where appropriate, enable community pharmacies to supply against a protocol instead of a prescription without going back to the prescriber first. We are working closely with the DAs to ensure a common approach across the UK.

This multi-layered approach is essential: A combination of securing freight, buffer stocks, stockpiling and warehousing, and regulatory requirements, will be needed to help ensure the continuation of medicines and medical supplies in the event of a no-deal exit.

Local stockpiling is unnecessary and could cause shortages in other areas, which could put patient care at risk. It is important that patients order their repeat prescriptions as normal and keep taking their medicines as normal.

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