1.Introduction
The College prepared a briefing after a UK Academy no deal EU exit update on Thursday 21 March, 2019. The update was primarily delivered by Keith Willet, EU Exit NHS Strategic Commander, to medical royal colleges. This briefing also included College work around Brexit.
At the time, the UK Government and the EU had agreed an extension to the initial exit date of 29 March 2019. If the Prime Minister at the time, Theresa May, could get her withdrawal deal through Parliament, the withdrawal date would be pushed back to 22 May to give time to pass the necessary legislation.
If the prime minister couldn’t get the deal through, the UK would have to propose a way forward by 12 April for EU leaders to consider. This transpired and the withdrawal date was extended to 31 October.
On 11 September, the College took part in a second update with Keith Willet and the UK Academy. The update is covered in the next section.
The latest information beyond this briefing can be found on the NHS Confederation website and the NHS National Services Scotland website.
2.Update by Keith Willet on 11 September 2019
- Advised that a no deal exit is the most likely outcome and that civil servants are preparing for it.
- Alternatives to a no deal exit are: revoke Article 50, extent Article 50, or strike a deal with the EU.
- Keith Willet’s team are “in the middle” of a roadshow, preparing NHS Trusts and Boards for no deal. The team are asking Trusts and Boards how prepared they are – it’s important for the UK Government to know this.
- The four phases as outlined in section 3 have not changed, and are still being applied.
- There will be two COBRA meetings a week if there’s a no deal exit.
- Shortage Response Groups with experts will monitor supplies and identify need after the withdrawal date.
- Of the 12000 medicines that the UK imports, 7000 have an EU “touch point”.
- It was discovered after March that pharmaceutical suppliers had created their own supply arrangements in preparation for a no deal exit.
- Social care: no deal presents a risk here with staff leaving the sector to gain seasonal retail work at Christmas. Also the risk that devaluation of the pound will drive low paid EU social care staff away from the UK.
- Medicine suppliers are legally obliged to inform the UK Government of any medicine shortages but not medical devices or clinical consumables.
- Teams are “walking the floor” on NHS sites to ensure that services supplies can be maintained.
- Flu vaccine: all flu vaccines will be available after EU exit. The quadrivalent vaccine was in short supply but the situation is believed to be under control.
3.Background
- 76% of medicines and 56% of devices are imported from or through the EU.
- Of the EU imports, 74% of medicine products and 90% medical devices (volume) travel via channel ports.
- 4% medicine products and 1% medical devices (volume) travel via air.
- The UK Government has in place four key phases to prepare for no deal: (1) testing department of health and social care and government planning assumptions; (2) make ready the health and care system; (3) assurance of system preparation; and (4) the transition to incident(s) response.
- We are currently at stage 3, ready to transition to stage 4 as and when required.
National workstream contingency planning has focused on:
- Medicines
- Vaccines and other public health issues (PHE)
- Clinical trials, research and clinical networks
- Medical devices and clinical consumables
- Non-clinical consumables, goods and services
- Blood and transplant
- Workforce
- Reciprocal healthcare and overseas visitors
- Data
4.Continuity of Supply
The NHS operational response team has prepared for at least 6 week delay in the supply chain – but have prepared for several months of disruption. There is a 6 week stockpile “buffer” of medicine stock which will be replenished. The idea behind the buffer stockpile is to make products available should there be any shortages or pinch points in the supply chain.
There is acute awareness that many products have a short shelf life. An overnight delivery system is in place to deal with this. There is also a fast track system which involves two cargo flights per day into the UK.
The medicines supply team has and will continue to liaise with key cogs in the supply chain to source medicines.
The Medicine Shortage Response Group (MSRG) has been established, which will have clinical input. It will analyse the impact of shortages. Royal Colleges may be consulted for clinical advice in this regard.
The UK Government has asked manufacturers to stockpile for a 6 week period to prepare for no deal. This is mostly in place according to the NHS operational response team. If supplies of certain medicines are expected, manufactures will flag this up as soon as possible.
The following arrangements have been made to ensure that continuity of supply is achieved:
- Understand sources of products and supply chains
- Regulatory changes for manufacturers
- Increase supply channel volumes and protect and prioritise the NHS
- Generate stockpiles upstream with suppliers
- Increase warehouse capacity
- Manage suppliers nationally where there is wide NHS exposure
- Dedicated NHS supply channel for time-critical or shortage items
- Use that buffer to maintain uninterrupted flow to patients and staff
- Generate stockpiles and/or secure supply of vaccines, blood and tissues
In terms of preparing NHS Trusts and Boards to handle possible medicine shortages, the following advice has been issued:
- Do not stockpile: It is not helpful or appropriate for anyone to stockpile locally –organisations stockpiling risks pressure on availability of medicines. GPs should reassure patients that extra medication is not required and avoid issuing longer prescriptions.
- Business as usual shortages management applies: A national Medicines Shortage Response Group (MSRG) has been established to provide clear governance, communication and decision-making during the EU Exit period.
- Local collaboration and communication: Senior pharmacy leaders will be expected to support local collaboration to meet patient needs. Regional medicines panels are being formed from various healthcare sectors, overseen by Regional Pharmacist, to enable good communication and escalation.
- Provide information: A priority for NHS pharmacy leaders is to provide information and advice to patients and health professionals about plans for continuity of supply: a priority over the coming weeks.
- Monitoring and reporting: DHSC, NHS England and NHS Improvement are working together to further develop monitoring capacity to support effective and informative reporting and for local and national responses. Incidences involving over-ordering of medicines will be investigated by relevant Chief Pharmacist.
5.Continuity of Services
- Mitigate changes in population health demand and migration in UK and EU
- Anticipate and mitigate workforce changes
- Secure data and information storage, transfer and database access
- Organs, tissues and cells are almost always transported by air.
6.Vaccines
The advice on vaccines is also that they should not be stockpiled beyond business-as-usual levels. Over-ordering will be investigated.
- All organisations should reassure patients that arrangements are in place to ensure that the vaccines they may need will be available post-29 March.
- Pharmacists and emergency planning staff should meet at a local level to discuss and agree local contingency and collaboration agreements.
- Local cross-system medicines supply continuity plan should be developed and agreed at trust/CCG board level –including arrangements for collaboration to ensure shortages of locally procured vaccines are dealt with promptly.
- There will be a Shortage Response Group for nationally and locally procured vaccines co-ordinated by PHE with NHSE and Devolved Administrations. This will provide subject matter expertise to support development of national policy.
7.Clinical trials, research and clinical networks
It is important to ensure that R&D departments are aware of and are following the relevant guidance and a series of DHSC technical notices to help organisations running trials.
The following has also been established:
- Trusts and others providers who are involved in clinical research including trials (e.g. primary care) should liaise with trial Sponsors to understand their arrangements for ensuring supply for clinical trials and investigations.
- If multiple sites are involved within the UK, then coordinate with the lead site or Chief Investigator in the UK, or organisation managing the clinical trial/investigation to ensure a single approach to the Sponsor.
- Continue participating in and/or recruiting patients to clinical trials and investigations up to and from 29 March 2019. This should occur unless you receive information to the contrary from a trial Sponsor, organisation managing the trial or clinical investigation, or from formal communications advising that a clinical trial or investigation is being impacted due to trial.
8.Workforce
The EU medical workforce is around 6%-8% in the UK. A concern of the operational response team is that EU nationals working in the NHS feel unwanted and unwelcome. It’s not clear whether we are seeing a loss of staff but a key area of concern is nursing in particular. Boards and Trusts have been asked to publicise the EU Settlement Scheme to EU staff (and encourage partner organisations in the wider health and care system).
The following advice has also been issued:
- Assess the number of staff who are EU nationals. Monitor levels regularly in order to escalate potential shortages to regional teams.
- Develop local contingency plans to mitigate workforce shortages and feed these into Local Health Resilience Partnership and Local Resilience Fora. This should include implications of shortages across the health and care system such as adult social care impact this may have on your organisation.
- Approve these workforce plans at Board level.
- Commissioners to ensure their providers are preparing in line with these steps.
