NHS England has issued further guidance for patients (25 February) on how they can continue to access their medicines and medical products in the event of a "no-deal" EU Exit, with a quick Q&A for more information. There is also updated guidance to GPs and prescribers of medicines on what action they should take when dispensing patients' medicines, to ensure patient treatment continues as normal.
This guidance follows the latest in a series of letters from Keith Willett, EU Exit Strategic Commander at NHS England, informing NHS organisations of the actions they should be taking now, including his letters to:
- NHS organisations (21 February) on the actions they need to take to ensure continuity of access to, processing and sharing of, personal data in the event of a "no-deal" Brexit.
- NHS providers and heads of procurement (11 February) on what they need to do to safeguard the availability and supply of medical devices and clinical consumables in the event of a "no-deal" Brexit.
- to clinical commissioning group (CCG) and trust chief executives (4 February) outlining the operational response that NHS England and NHS Improvement are undertaking at a national and regional level in preparation for a "no-deal" Brexit scenario, including establishing a series of regional coordination centres which will act as a single point of contact for each region.
- Letter to NHS organisations (17 January) on the work being undertaken to ensure the supply of medicines in the event of a "no-deal" Brexit
This series of letters builds on the Government's updated guidance of 20 December 2018 which outlines what providers and commissioners of health and care services in England need to know and should do now to prepare for the possibility that the UK leaves the EU without a ratified deal – a ‘"no deal" exit.
The actions outlined in the December update cover seven key areas of activity that are likely to be impacted by a no-deal Brexit, and confirm that the health and care system should continue to prepare for a no-deal scenario as part of existing local business continuity plans.
No deal operational guidance - the summary
National and local support system: The Department for Health and Social Care (DHSC) are establishing a national Operational Response Centre. This will be supported by an Operational Support Structure for EU Exit, coordinated by NHS England and NHS Improvement. The national centre will deal with any disruption to the population’s health and care, and the delivery of health and care services in England, that may be caused or affected by EU Exit. The Operational Response Centre will co-ordinate EU Exit-related information flows and reporting across the health and care system. The Operational Response Centre will also work with the devolved nations to respond to UK-wide incidents.
Revised border planning assumptions: This guidance factors in the revised border planning assumptions which show that there will be significantly reduced access across the short straits, for up to six months. This reflects the EU’s confirmation that in the event of ‘no deal’, it will impose full third country controls on people and goods entering the EU from the UK.
Despite the revised assumptions, the guidance emphasises that UK health providers – including hospitals, care homes, GPs and community pharmacies – should not stockpile additional medicines beyond their business as usual stock levels. There is also no need for clinicians to write longer NHS prescriptions and the public should be discouraged from stockpiling.
Medicines, prescribing and supply plan: Each Clinical Commissioning Group has been asked to agree a EU Exit medicines, prescribing and supply plan by 31 January 2019.
Serious Shortage Protocol: On 18th January 2019, following a rapid consultation to which the Brexit Health Alliance contributed, an amendment was published to The Human Medicines (Amendment) Regulations 2019. Regulation 226A (article 9) adds a Serious Shortage Protocol for potential shortages of medicines that could occur in scenarios such as a no-deal Brexit.
The Protocol makes provisions for pharmacists to supply a different strength, quantity or pharmaceutical form of certain medicines in particular situations. Read the explanatory notes to accompany the amendment and the communication to patients.
Workforce: EU nationals working in the health and care system have been able to register for EU settled status under the pilot scheme that was open between 3-21 December. People who did not register under the pilot scheme do not need to worry, as the scheme will open by March 2019 and remain open until at least the end of 2020, so there will be plenty of time for EU staff to register
Reciprocal healthcare: In a "no deal" scenario, UK nationals resident in the EU, EEA and Switzerland may experience limitations to their access to healthcare services (see Government guidance from 28 January 2019, updated on 28 August 2019). The Government is therefore seeking to protect current reciprocal healthcare rights through bilateral agreements with other member states.
European Reference Networks: In a "no deal" scenario, UK clinicians would be required to leave European Reference Networks (ERNs) on 31 January 2020. However, the UK will seek to strengthen and build new bilateral and multilateral relationships – including with the EU – to ensure clinical expertise is maintained in the UK.
What actions should healthcare organisations be taking
Supply of medicines and vaccines
- In a no-deal scenario, the default position will be for member states to impose full third country controls on people and goods entering the EU from the UK, meaning that we could see delays to the movement of goods between the UK and EU. In light of this, the planning assumption has been revised and it is anticipated that the flow of goods between the UK and EU could be reduced for a period of up to six months.
- The six-week stockpiling activities remain a critical part of the DHSC's UK-wide contingency plan for medicines and vaccines. Now that the assumption has been revised, the DHSC will continue to work with pharmaceutical companies to develop this plan. In addition to stockpiling, the Government is working to ensure there is sufficient roll-on, roll-off freight capacity to enable medicines and medical products to continue to move freely into the UK. The Government has also agreed that medicines and medical products will be prioritised on these alternative routes to ensure that the flow of all these products will continue unimpeded after 31 January 2020. This includes all medicines, including general sales list medicines.
- Officials in Public Health England are leading a separate programme to ensure the continuity of supply for centrally-procured vaccines and other products that are distributed to the NHS for the UK National Immunisation Programme or used for urgent public health use.
Actions for the health service:
- UK health providers, including hospitals, care homes, GPs and community pharmacies, should not stockpile additional medicines beyond their business as usual stock levels. There is also no need for clinicians to write longer NHS prescriptions.
- Chief and Responsible Pharmacists are responsible for ensuring their organisation does not stockpile medicines unnecessarily. Any incidences involving the over-ordering of medicines will be investigated and followed up with the relevant Chief or Responsible Pharmacist directly.
- NHS hospital and CCG Chief Pharmacists in England to meet at a local level to discuss and agree further local contingency and collaboration arrangements. Each CCG should agree a “EU Exit medicines, prescribing and supply plan” by 31 January 2019. Regional pharmacists and regional emergency planning staff will want to agree such plans. The Chief Pharmaceutical Officer will be holding a meeting with the chairs of regional hospital and CCG Chief Pharmacist networks (and representatives of private hospital Chief Pharmacists) in January 2019 to help inform those plans.
Supply of medical devices and clinical consumables
- The DHSC is developing national plans to ensure the continued movement of medical devices and clinical consumables supplied from the EU. Work is being undertaken at local and national levels to identify suppliers who source products from EU countries and to review their supply chains to determine what measures they need to take to ensure that healthcare providers have access to the products they need. Read the updated guidance from NHS England on the supply of medical devices and clinical consumables from 4 February and 11 February.
Actions for the health service:
- Despite the planning assumption being revised, there is currently no need to stockpile additional medical devices and clinical consumables beyond business as usual stock levels.
Supply of non-clinical consumables, goods and services
- NHS Trusts’ procurement leads have been asked to undertake internal reviews of purchased goods and services to understand any risks to operations if there is disruption in supply. This excludes goods and services that are being reviewed centrally, such as food, on which the Department has written to procurement leads previously.
Actions for the health service
- Trusts should continue commercial preparation for EU Exit as part of usual resilience planning.
- For those Trusts which have not submitted the results of their self-assessment on non-clinical consumables, goods and services, they should return this to email@example.com. Further guidance to be issued by the Department in January 2019. This will be based on an analysis of trusts’ self-assessments.
- EU nationals working in the health and care system have been able to register for EU settled status under the pilot scheme that was open between 3-21 December. People who did not register under the pilot scheme do not need to worry, as the scheme will open by March 2019 and remain open until at least the end of 2020, so there will be plenty of time for EU staff to register.
Actions for the health service
- Employers should publicise the EU Settlement Scheme to their health and care staff who are EU nationals.
- In a "no deal" scenario, UK nationals resident in the EU, EEA and Switzerland may experience limitations to their access to healthcare services (see Government guidance from 28 January 2019, updated 28 August 2019). The Government is therefore seeking to protect current reciprocal healthcare rights through bilateral agreements with other member states.
- The Government is seeking to put in place transitional bilateral agreements with EU, EEA member states and Switzerland to continue reciprocal healthcare arrangements, broadly, on the same terms as today. However, this will depend on decisions made by other EU and EEA member states.
Actions for the health service
- The current arrangements for reciprocal healthcare and for overseas visitors and migrant cost recovery will continue to operate until 31 January 2020. NHS organisations should maintain a strong focus on correctly charging those who should be charged directly for NHS care.
- The Government will issue advice via www.gov.uk and www.nhs.uk to UK nationals living in the EU, and to UK residents travelling to the EU and EU nationals living in the UK. It will explain how the UK is working to maintain reciprocal healthcare arrangements, but this will depend on decisions by member states.
Research and clinical networks
- Funding: The Government has guaranteed funding committed to UK organisations for certain EU funded projects in the event of a "no deal" scenario. This includes the payment of awards where UK organisations successfully bid directly to the EU while we remain in the EU, and the payment of awards where UK organisations are able to successfully bid to participate as a third country after Exit, until the end of 2020.
- Clinical trials: Organisations running investigator-initiated trials, other industry collaborative trials or non-commercially funded trials of investigational medicinal products (IMPs), or clinical trials or investigations using medical devices in the UK, should liaise with trial and study sponsors to understand their arrangements for ensuring continuity of supply of IMPs and medical devices which come from or via the EU or EEA. Queries regarding IMPs or clinical devices for research should be directed to firstname.lastname@example.org.
- European Reference Networks: In a "no deal" scenario, UK clinicians would be required to leave European Reference Networks (ERNs) on 31 January 2020. However, the UK will seek to strengthen and build new bilateral and multilateral relationships – including with the EU – to ensure clinical expertise is maintained in the UK.
Supply of blood and other products of human origin
- Blood and blood components: The UK is largely self-sufficient in the supply of blood and blood components, though DHSC will continue to engage with the health and care sector and industry bodies to prepare for any possible disruption.
- Organs: Officials in NHS Blood and Transplant are working with the regulator for organs, the Human Tissue Authority (HTA), to ensure that appropriate written agreements are in place with EU organisations to allow organ exchange to continue after 31 January 2020.
- Licensed UK establishments that import or export tissues or cells will need written agreements with the relevant EU licensed establishments to continue importing and exporting. DHSC is working with the HTA and the Human Fertilisation and Embryology Authority (HFEA) to ensure licensed UK establishments are prepared for Brexit so that the import of tissues and cells from the EU can continue.
Actions for the health service
- Transplant centres do not need to take any further action.
- Queries regarding importing or exporting blood or blood components to or from the EU should be directed to the MHRA.
- Queries regarding non-reproductive tissues and cells should be directed to the HTA.
- Queries regarding reproductive cells, should be directed to the HFEA.
Business continuity planning
- Undertake an assessment of risks associated with EU Exit by the end of January 2019, covering, but not be limited to:
- The seven key areas identified nationally
- Potential increases in demand associated with wider impacts of a "no deal" exit
- Locally specific risks resulting from EU Exit
- Continue business continuity planning in line with your legal requirements under the Health and Social Care Act 2012, taking into account the instructions in this guidance and working with wider system partners to ensure plans across the health and care system are robust. These organisational and system-wide plans, and preparatory actions, should be completed at the latest by the end of January 2019.
Information published by DHSC on 7 December 2018.