Contingency Planning Update from DHSC
Dear Colleagues,
Further to my letter of 29 October, and the agreed extension of Article 50 to 31 January 2020, I am writing to provide additional information about the recommended next steps in relation to continuity of supply.
The multi-layered approach put in place by the Department of Health and Social Care (DHSC) remains central to helping ensure the continued supply of medicines and medical products across the UK if we leave without a deal. An update on the six components is below.
It is important to remember that the aim of the multi-layered approach is to support continuity of supply of medicines and medical products in the event that the UK leaves the EU without a deal. If the UK leaves with a deal and enters an Implementation Period, existing regulatory and customs procedures will remain in place, so supplies will continue to flow as today, during that Implementation Period. Our continued collaboration remains vital, whatever the circumstances.
- Improving trader readiness for new border arrangements
Companies need to continue to prepare for new customs and border arrangements that would come into place if the UK leaves the EU without a deal on 31 January 2020. To support industry in their preparations, on 8 October, I announced the establishment of a dedicated trader readiness 'Support Unit' to provide assistance to suppliers of medical goods. Since its launch, the unit has responded to queries from suppliers as well as proactively contacting those companies reporting to not be ready, to offer support. This service will remain operational throughout the extension period, via BeTraderReady@dhsc.qov.uk. - Building up buffer stocks
We are incredibly grateful to industry for their efforts in building up buffer stocks. This remains an important aspect of our contingency planning. The response and action we had in advance of 31 October, enabled us to give patients and the public reassurance that collectively, robust preparations were in place for all foreseeable eventualities. Whilst we recognise that the end of year period creates specific challenges regarding inventories, nevertheless, we ask that suppliers make every effort to retain the level of stockpiles they had in place in advance of 31 October. - Procuring extra warehouse 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 then DHSC previously agreed contracts for additional warehouse space, including ambient, refrigerated and controlled drug storage. We will continue to provide warehousing capacity for use at market rates. - Securing freight capacity
The Department for Transport put in place a four-year framework for freight capacity, which DHSC is able to call-off against as needed to meet the capacity requirement for health and social care. The current Government freight contracts, announced on 11 October, provides 6 months' worth of capacity covering all the requirement for medical products. This means that capacity will be available from 31 January if the UK leaves the EU without a deal on that date. We will continue to work closely with the Department for Transport and use the freight procurement framework put in place in September to secure further capacity if needed. For those of you that have already registered to use the capacity your access codes will still be valid, please ensure your hauliers also register. If you haven't already registered you can do so via this link, please do register as it will allow you timely access to the Government freight capacity.
DHSC also procured an Express Freight Service, an end-to-end logistics solution to transport medicines and medical products into the UK within a short timeframe. These contracts have been postponed until January 2020 when we expect to remobilise the service. - Clarifying or changing regulatory requirements
So that companies can continue to sell their products in the UK even if we leave without a deal, the Government has 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. These clarifications and changes will remain in place should we leave without a deal on 31 January 2020. - Strengthening the processes and resources used to deal with shortages
In addition to the normal shortage management routes, which have been strengthened, DHSC 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.
In the run up to 31 October, the Department again stood up a National Supply Disruption Response (NSDR) function. The NSDR has now been reduced to core operating hours, in the interim, but will be stood up again for extended hours if we approach the new deadline of 31 January 2020 without a ratified deal.
Message to the NHS and the public
Our message to the NHS, the adult social care sector, patients and the wider public remains unchanged.
DHSC, working with partners across government, industry, the health and social care system, devolved administrations and crown dependencies, is 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.
Improving our preparations
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.
As is usual, we will reflect on our preparations, approach and how we worked with you to achieve a level of readiness in excess of the level we achieved together in advance of March/April. Learnings from this exercise will inform our future work together.
I remain extremely grateful for your excellent engagement and support over the past few months. I want to reassure you that I am committed to keeping you updated, and I will do all I can to ensure you have the information you need to be able to plan properly.
Steve Oldfield
Chief Commercial Officer