This statement provides an update on my Department’s plans to support the continuity of supply of medicines and medical products into the UK if we leave the EU without a deal on 31 October.
The multi-layered approach put in place by my Department remains essential to help ensure the continuation of medicines and medical supplies across the UK if we leave without a deal. An update on the components are below.
My Department is today writing to pharmaceutical companies, medical device manufacturers and the adult social care sector. As part of working closely with the devolved Administrations (DAs) and Crown dependencies, communications will also be shared with healthcare providers across the scope of the programme.
Improving trader readiness for new border arrangements.
Companies need to ensure they are “trader ready” for the new customs procedures involved with importing and exporting goods that will come into place if we leave the EU without a deal. To support industry in their preparations, I am today announcing that, following engagement and feedback with trade associations, suppliers and distributors, the Government are establishing a dedicated trader readiness “support unit” to provide assistance to suppliers of medical goods. These teams of specialists will be able to provide traders operating in the health and social care sector with up-to-date advice and practical guidance on the steps they need to take to prepare. Details on how to access the support unit are being communicated to industry today.
Building up buffer stocks.
My Department’s approach to buffer stocks remains unchanged from 26 June and involves a range of national measures and asks of industry that are designed to provide contingent measures for medicines, medical devices and clinical consumables, blood and transplants, vaccines and countermeasures, supplies for clinical trials and non-clinical goods and services.
Procuring extra warehousing space for stockpiled medicines.
To help ensure sufficient space to store stockpiled medicines ahead of Brexit on 31 October if we were to leave without a deal, my Department previously agreed contracts for additional warehouse space, including ambient, refrigerated and controlled drug storage. We will continue to provide warehousing capacity.
Securing freight capacity.
The Department for Transport-led cross-government procurement for securing freight capacity by 31 October is progressing as planned. On 20 September, as announced by the Secretary of State for Transport, eight companies were successfully appointed to the freight procurement framework. These include ferry operators Brittany Ferries, DFDS A/S, Irish Ferries, P&O Ferries, Seatruck and Stena, as well as operators from the aviation and rail industries, Air Charter Services and Eurotunnel.
Also, on 20 September, DfT launched two call-off mini-competitions, which set out the Government’s freight requirements in preparation for leaving the EU. These provided freight operators on the framework the opportunity to bid for contracts to transport medicines and medical products—and other category one goods—into the UK in a no-deal scenario. The deadline for framework suppliers to submit bids was 1 October. Subject to evaluation, contracts with successful freight operators to provide capacity on specific routes will be agreed shortly. Once known, Government will inform industry of the details as soon as possible. In advance of this, the Department is today inviting suppliers of medicines and medical goods to register to access this freight capacity.
My Department is also leading a procurement for an “express freight service” to provide access to an end-to-end solution for medical products to deliver small parcel consignments and pallets. This is designed to be used only if suppliers’ own contingency measures encounter difficulties or there is an emergency need for specific medical products. The bid response window for this procurement has now closed and we are currently reviewing the bids. Again, my Department is looking to award the contract(s) as soon as possible.
Changing or clarifying regulatory requirements.
So that companies can continue to sell their products in the UK even if we leave without a deal, the Government have made changes to, or clarifications of, certain regulatory requirements. Statutory instruments, covering the regulation of human medicines, medical devices and clinical trials were considered and approved by Parliament.
Strengthening the processes and resources used to deal with shortages.
In addition to the normal shortage management routes, my Department has also put in place legislation to enable Ministers to issue serious shortage protocols that, where appropriate, enables community pharmacies to supply against a protocol, for example, to issue a substitute medication instead of the prescribed medication without going back to the prescriber first.
My Department will again be standing up a national supply disruption response (NSDR). The NSDR processes will monitor the supply situation and co-ordinate actions to address supply disruption incidents that occur after Brexit where normal procedures are unable to provide a resolution.
Message to NHS and the public.
Our message to the NHS, the adult social care sector, patients and the wider public remains unchanged.
My Department, working with partners across Government, industry, the health and social care system, devolved Administrations and Crown dependencies, are putting in place these arrangements to protect medical supplies from any potential disruption if we leave without a deal for the whole of the UK and its Crown dependencies, so that service providers, patients and members of the public do not have to take action themselves. Local or personal stockpiling remains unnecessary and could cause shortages in other areas, which could put patient care at risk. It is important that patients keep taking their medicines and order their repeat prescriptions as normal.
As the NAO’s recent report recognised, the scale of the challenge has been unprecedented and the Department, working with pharmaceutical companies and medical device manufacturers, has already achieved a great deal in preparing for leaving the EU, whatever the circumstances. I am confident that the Department is doing everything appropriate to prepare for leaving without a deal on the 31 October.