Chief Commercial Officer for the Department of Health and Social Care Steve Oldfield has written a letter outlining information relating to the end of the transition period (TP) on 31st December 2020. The letter relates specifically to a number of areas in relation to the continuity of the supply of medicines and medical products to the UK.
This follows the government’s recent confirmation that the TP will cease as planned on 31 December 2020 and there will be no extension.
Commenting in the letter Chief Commercial Officer for the Department of Health and Social Care Steve Oldfield said:
“First, I would like to thank you for the continued, crucial, role you play in helping ensure continuity of medical supplies. This has already been a challenging year due to the global impact of COVID-19 and we know many of your supply chains remain under severe strain.
“At 11pm on 31 December 2020, the UK will leave the EU Single Market and Customs Union. This will mean new border and customs procedures apply, regardless of whether the UK and EU agree the ambitious free trade agreement that the government is seeking to negotiate.
“Our shared focus should be on mitigating any potential disruption to supply into the UK across all categories of medical supplies, including, but not limited to:
- Medicines
- Medical devices and clinical consumables
- Clinical trials supplies
- Products of human origin (blood and transplant items)
- Vaccines and countermeasures
- Non-clinical goods and services (NCGS) in support of health and social care providers
“We’re asking suppliers to put in place flexible mitigation and readiness plans in preparation for new border and customs procedures.”
Re-routing away from the short straits
“A large percentage of medical supplies come from the EU or have a supply touchpoint there. The first priority of any contingency should be to maintain replenishment rates at necessary levels by securing capacity to reroute freight away from the short straits potential disruption points. Companies are encouraged to review their own logistics arrangements and consider making plans for avoiding the short straits as a matter of priority.
Supporting ‘trader readiness’ for the new customs and border arrangements.
“As the UK leaves the EU single market and customs union, businesses will need to prepare for life outside both at the end of 2020, and many have already acted.
“The government has published the Border Operating Model and launched a targeted ‘trader readiness’ communication campaign throughout the remainder of 2020. DHSC will support and supplement these to help businesses prepare for the changes at the border that will happen at the end of the year.
“As part of this, we will seek information from suppliers to understand their general needs and help identify those who may need more support, for example, with controlled drugs and cold-chain logistics.”
Buffer stocks of medical supplies where possible.
“Holding additional stock in the UK provides a further buffer against some disruption and we believe, where it’s possible, it’s a valuable part of a robust contingency plan. To build upon past work and ensure a co-ordinated approach, we will be asking suppliers to confirm their contingency plans for the end of the TP, and in particular, the balance between stock-holding in the UK, re-routing away from the short straits and readiness for new customs and border arrangements.
“We recognise that global supply chains are under significant pressure, exacerbated by recent events with COVID-19. However, we encourage companies to make stockpiling a key part of contingency plans, and ask industry, where possible, to stockpile to a target level of six weeks’ total stock on UK soil.”
Centralised stock build.
“In the run-up to EU Exit, the department, working with NHS Supply Chain, built up a centralised stock build (CSB) of fast-moving medical devices and clinical consumables. Some of this stock remains and accounting for likely demand trends for the time of year, we plan to build these levels back up to a target level of 6 weeks’ total stock. It’s important to note that the devolved nations of the UK may, in addition, choose to build their own stockpiles.”
Warehousing.
“Previous EU Exit preparations by the government included securing dedicated warehouse capacity for suppliers of medicines to stockpile in the UK. However, during 2019, utilisation of this space was extremely low. Given that the government is continuing to advocate a multi-layered approach to contingency planning and the additional preparation time companies have had before the confirmed exit date, we do not propose to intervene in this market at this time. However, we will keep this under review.”
Regulatory flexibility.
“You have been clear and consistent on your asks around regulatory clarity from 1st January 2021. In negotiations with the EU, the government put forward a proposal that minimises trade barriers and bolsters the resilience of medicines supply chains. We have entered a new, intensified stage of the negotiations and are ready and willing to reach an agreement. We will communicate to you more detail in the coming weeks. At this stage, we want to reassure you that we fully understand your requests and are working hard across the government to ensure that the needs of the health and social care sector are met.”
Shortage management response.
“Suppliers should in the first instance raise any anticipated or actual supply disruption through business as usual routes. For suppliers of medicines, the department’s Medicine Supply Team has well-established procedures to deal with actual or potential medicine shortages and works closely with the Medicines and Healthcare products Regulatory Agency (MHRA), the pharmaceutical industry, NHS England and NHS Improvement, the Devolved Administrations and others operating in the supply chain to help prevent shortages and minimise the risks to patients.
“By way of reminder, medicines suppliers have a statutory duty to provide early notification of supply disruptions to the department and contact details for the Medicines Supply Team are at the end of this letter. All other suppliers should raise supply issues through usual routes or the National Supply Disruption Response.”
National Supply Disruption Response.
“The National Supply Disruption Response (NSDR) is the service for suppliers of all categories experiencing supply and logistics challenges. The NSDR is currently stood up in order to assist with the demands on supply across the workstreams as part of our response to COVID-19. Regardless of the COVID-19 situation, NSDR will be stood up for the end of the TP as a contingency measure. At present, supply issues not related to COVID-19 should be raised through business as usual routes.
“We will continue to ask health and social care service providers to avoid local stockpiling over and above business as usual ahead of 31 December as it is unnecessary and could cause shortages in other areas, which could put patient care at risk. Nor do patients need to stockpile medicines.”
Responding to the letter from the Government to medicines suppliers about Brexit and the end of the transition period on 31 December, including a request for manufacturers to stockpile six weeks’ of medicines, RPS President Sandra Gidley said:
“I’m concerned to see the prospect of a no-deal Brexit return once again, amid one of the most challenging times in the history of the NHS.
“It’s vital the UK and EU agree on a deal on medicines regulation as soon as possible, to support our world-leading life sciences sector and ensure patients can get the medicines they need.
“As we head into winter, combined with the potential of a second wave of COVID-19, the Government must consider all the options as part of prudent contingency planning to support patient care.
“This should include changes in medicines legislation to empower pharmacists in the community to use their professional judgment to make simple substitutions when a medicine is out of stock.
“The Health Secretary has called for an and to unnecessary bureaucracy and this is one change that would speed up patient access to appropriate treatment and reduce GP workload.
“We’re continuing to raise this with the Government alongside other key lessons from COVID-19.”
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