EU Exit - Frequently Asked Questions

EU Exit - Frequently Asked Questions

Preparedness

What is the Department of Health doing to prepare for EU Exit should the UK leave without a Deal?

The Department of Health fully understands that this is an uncertain and challenging time. 

The safety and well-being of people receiving health and social care service is our top priority.

We are committed to intensive contingency planning to protect the interests of the population of Northern Ireland should the UK leave the EU without a Deal.

We are working, in conjunction with colleagues in other NI and UK Departments and across the Health and Social Care system on arrangements that will maintain the supply of medicines, medical devices and other healthcare supplies should the UK leave the EU without a Deal.

Substantial planning has already been completed and work is continuing on ensuring supplies are available to support the normal day to day running of our health and social care services.

Patients using health and social care services do not need to do anything new or different and should order prescriptions and take their medicines as normal, there is no need to order extra supplies.

Hospitals, community pharmacies, GPs, dentists, care homes and other health and social care services have been advised that they should not stockpile supplies of medicines and prescribers should not issue additional prescriptions.

Should issues arise, enhanced processes have been put in place in Northern Ireland to deal with any potential disruption in supplies quickly and minimise any impact on patient care.

Within health and social care, there are already well tested arrangements for dealing with emergencies and we are working closely to ensure these are ready to respond should the UK leave the EU without a Deal.

Medicines

What guarantees can the DoH give patients on supply of medicines and medical products to N Ireland should the UK leave the EU without a Deal?

The Department has been working within a major UK-wide planning programme for medicines and medical devices to ensure that the needs of patients in Northern Ireland are fully met should the UK leave the EU without a Deal.

Across the UK, arrangements are in place to hold more supplies and to enhance transport routes.   National plans have been reviewed and are updated on an ongoing basis with detailed input from Northern Ireland through ongoing meetings. 

A multi-layered approach has been applied to continuity of supply involving a range of activities including (but not limited to) warehousing, buffer stocks and procurement of extra ferry capacity, including an express freight service and enhanced air freight for medicines and medical products.

Our medical supplies are mainly transported via ferry from Great Britain and we have ensured that Northern Ireland’s requirements for continuity of supply are included within national planning assumptions. This includes ensuring that arrangements are in place for transport of medicines and medical supplies from GB to Northern Ireland.

Advice has been issued to the health and social care service in Northern Ireland and the Department continues to update service providers including community pharmacists, GPs and hospitals on planning arrangements. 

Will there be shortages if the UK leave the EU without a Deal?

Large quantities of medicines are normally transported into the UK every day via the short straits crossings (i.e. between Calais/Dunkirk/Coquelles and Dover/Folkestone).

This has been identified as a specific area for contingency planning, given uncertainty in respect of potential customs-related delays at the EU ports.

Planning therefore includes alternative routes into the UK for medicines – by air and by ferry to various (air)ports.

Medicines and medical device manufacturers are part of a global and highly complex industry. It is important to recognise that shortages of medicines and other medical supplies are not uncommon within the health service – for reasons completely unconnected to exiting from the EU.

There are already tried and tested mitigation arrangements in place for dealing with any supply disruptions to ensure that patients continue to get the medicines and medical supplies they need. That can include, where necessary, the use of substitute medications.

To give one example – supplies of EpiPens® were disrupted in different parts of the world last year due to issues in the USA. As a result, national contingency arrangements were put in place that ensured, when stock became available it was supplied to patients most in need.

No one can provide an absolute guarantee that there will not be any disruption to the supply of medicines and medical products should the UK leave the EU without a Deal.  Such an absolute guarantee could not be given in normal circumstances, regardless of EU exit. However, we can assure the public that we are working very hard with all stakeholders to plan and mitigate against any such disruptions.

Is the DoH satisfied that there is sufficient container ship capacity on the Irish Sea for the transport of medical supplies if required?

The Department has been working with the Department for Infrastructure (DfI) locally and the Department for Transport (DfT) in London to consider transportation capacity and flows of goods into NI.

The analysis and projections for capacity and flows post EU Exit indicate that there is sufficient capacity at present and this is expected to continue post EU Exit. 

Why does NI not have its own stockpile of medicines?

UK regions do not hold stockpiles for their respective countries. 

Northern Ireland is part of a UK-wide wholesaler/supplier network which will have access to national stockpiling arrangements developed to maintain supplies of medicines to patients in all of the UK regions following EU exit. 

Will I still be able to get my prescription medicines and medical products?

Yes.  The Department of Health and HSC organisations have been working with the UK Government and other Devolved Administrations to make sure medicines and medical products continue to be available in all scenarios. Occasionally, however, the health service does experience temporary shortages of specific medicines. If this happens, you will be prescribed the best alternative to your usual medication, as is normal practice. This will ensure that your treatment continues as normal.

Should I keep ordering my repeat prescriptions and taking my medicines as normal?

Yes. There is no need to change the way that you order prescriptions or take your medicines. Always follow the advice of GPs and other health professionals who prescribe your medicines and medical products. There are enough medicines and medical products to meet current needs but if patients order extra prescriptions, or stockpile, it will put pressure on stocks, meaning that some patients may not get the medicines they need.

Should I ask my GP for a larger or longer prescription?

No. GPs will continue to prescribe medicines and medical products as normal.

Will I still get my medicine if I am on a clinical trial?

The Department of Health and HSC organisations are working with the UK Government to ensure that research continues as normal in the coming months.  Organisations running clinical trials have been encouraged to consider their supply chains for clinical trials and to ensure appropriate supplies of trial drugs and medical products are in place.

Will any routine health service operations be cancelled?

Planning for EU exit has been developed to try and make sure that there is as little impact upon the health service as possible, to prioritise care for patients in emergencies and minimise disruption to routine patient care.

What is being done to make sure medicines and medical products continue to be available?

The Department of Health has been working, in conjunction with other NI and UK Departments and across the Health and Social Care system, on arrangements that will maintain the supply of medicines, medical devices and other healthcare supplies after the UK leaves the EU.

Substantial planning has already been completed and work is continuing on ensuring supplies are available to support the normal day to day running of our health and social care services.

Where these medicines have a short shelf life, companies have been asked to ensure that they can fly these medicines in from the EU in the event of the UK leaving the EU without a Deal and extra stocks are being held within the supply chain.

To ensure that there will be enough space available for extra stocks of medicines and medical products, extra warehouse space has been secured within the UK including refrigerated and controlled drug storage that companies can use to store products.

Extra shipping has also been arranged for suppliers to use on a variety of routes to ease pressure on the short straits crossings from the EU to Dover and Folkestone. This includes capacity on ferries to Poole, Portsmouth, Plymouth, Immingham and Felixstowe.  Medicines and medical products will be prioritised on transport routes.

What medicines and medical products are being included in the stockpiles?

The stockpiling programme is for medicines and medical products that would require a prescription or that you would usually get under supervision from a community pharmacist, and that are either made in the EU or contain ingredients or components that are made in the EU.

Will information about specific medicines and medical products be made available?

The health services across the UK will be monitoring the medicines and medical products supply chain very carefully and already have well-established mechanisms to deal with supply issues if they do arise.

The Department of Health receives regular updates about supply issues affecting medicines used in primary care and secondary care which are circulated to hospitals and the Health and Social Care Board for onward transmission to community pharmacies in Northern Ireland when needed. Where necessary, there will be liaison with specialist clinical groups, patient groups and other relevant networks to share information about supply issues that may affect specific patient groups.

There are existing systems in place to cascade messages quickly to the health service and others for patient safety alerts, important public health messages and other safety critical information and guidance. If a specific medicine shortage emerges then prescribers and pharmacies will be quickly alerted to the situation and advised accordingly.

Will there be a problem with the supply of medical radioisotopes?

Hospitals in Northern Ireland already receive their supplies of medical radioisotopes via air freight. HSC organisations are continuing to work closely with suppliers to ensure that these arrangements continue as normal in order to maintain service provision to patients.

We are continuing to work closely with the Department of Health and Social Care (DHSC) to monitor the situation regarding medical radioisotopes and to ensure that the needs of patients in Northern Ireland are fully considered as part of ongoing planning for EU Exit.

What about over-the-counter medicines and medical products?

Pharmacy medicines, which can be bought over the counter from a pharmacy are covered in our stockpiling plans. The scope also includes some general sales medicines, which can be sold in general retail outlets without the supervision of a pharmacist are also included in this stockpiling work.  This is because there are multiple alternatives available should any of these medicines and medical products be subject to a short-term supply disruption.

What about the supply of blood and blood products?

There are some medicines that are derived from blood plasma such as immunoglobulin, albumin, and clotting factors. As these are licensed medicines, they are included in the medicine supply plans.

The United Kingdom is largely self-sufficient in blood and blood components and does not routinely export or import these products, except for relatively small quantities of plasma which are imported by NHS Blood and Transplant for use in those born after 1996 as an agreed safety measure.  

In very special cases NHS Blood and Transplant do export or import very rare blood for urgent clinical need, usually in single unit quantities.  The NHS Blood and Transplant is leading on contingency planning at a national level for blood and blood components to ensure continuity of a safe blood supply which includes requirements for Northern Ireland.

What about vaccines?

Public Health England (PHE) manages significant stockpiles of vaccine for the national immunisation programme which includes Northern Ireland as part of their business as usual planning.  It is working closely with vaccine suppliers to ensure replenishment of these existing stockpiles continues in the event of supply disruption in the UK, for example, agreeing increases in supplier’s own UK stockpiles.

The DHSC is also working to ensure that there are sufficient stockpiles of vaccines for other health service and non-health service uses i.e. uses outside of the national vaccination programmes such as for travel and occupational health purposes within its medicines contingency programme.  Northern Ireland requirements are included within those plans. 

What about unlicensed medicines and specials?

There has been engagement at a national level with a large number of unlicensed and specialist suppliers.  They have been asked to ensure that they have a minimum of six weeks additional supply in the UK in case the UK leaves the EU without a Deal.  This includes requirements for Northern Ireland. 

In addition, unlicensed medicines and specials manufacturers are working to ensure sufficient ingredients in the UK to ensure continuity of supply.

Will medicines still be licensed following exit from the EU?

The UK currently has procedures for assessing applications to have a medicine licensed (as long as that medicine is not within the scope of the “centralised procedure‟).   There are two ways of currently obtaining a licence for the UK:

  • applying for a licence in the UK through the national procedures of the MHRA; or,

  • applying for a licence through the European Medicines Agency (EMA), which relates to all EU Member States, known as the centralised procedures

If a medicine does not fall within these categories, companies can still submit an application under this procedure as long as the medicine concerned is “a significant therapeutic, scientific or technical innovation, or if its authorisation would be in the interest of public health”. Applications through the procedure are handled directly by the EMA.

In the event of that the UK leaves the EU without a Deal, the UK’s participation in the European Medicines Regulatory Network would cease and the MHRA would take on the functions currently undertaken by the EU for human medicines on the UK market.  Transitional provision within legislation will ensure that all currently granted Centrally Authorised Products (CAPs) automatically become UK Marketing Authorisations (MA) on exit day, and so all medicines licensed at that point will be continue to be licensed in the UK.   However, MA holders will have a short period of time after exit day within which to opt out of having a UK MA.

The MHRA has published detailed guidance on licensing arrangements for medicines following exit from the EU.   

What will be the arrangements for regulation of medical devices following exit from the EU?

Currently in the UK, all devices placed on the UK market are subject to EU legislation which requires a manufacturer to place a CE mark on their product to attest compliance to applicable European standards.  CE marking for a medical device is a claim of compliance with the relevant safety, quality and performance requirements of the relevant legislation made by the manufacturer and indicates that the device is safe and performs as intended.    

The applicable EU Directives and regulations are:

  • Directive 90/385/EEC on active implantable medical devices (EU AIMDD)

  • Directive 93/42/EEC on medical devices (EU MDD)

  • Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD) Regulation 2017/745 on medical devices (EU MDR)

  • Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)

The EU directives are transposed into UK law in the Medical Devices Regulations 2002 and the EU Regulations came into force in May 2017 with a 3 and 5 year transition period. 

If the UK leaves the EU without a Deal, the UK’s current participation in the European regulatory network for medical devices would end, and the MHRA would take on the responsibilities for the UK market currently undertaken through the EU system. 

The UK Medical Device Regulations 2002 will still apply and a new Statutory Instrument (SI) the Medical Devices (Amendment etc.) (EU exit) Regulations 2019 (UK MDR 2019) will amend the UK MDR 2002 in part by fixing deficiencies in those Regulations to reflect the new regime for our departure from the EU and also transpose all the key elements contained in the new EU MDR and EU IVDR, which will be brought into force in line with the transitional timetable being followed by the EU for the full application of those regulations. There therefore will be little regulatory change and close alignment with existing regulations. 

The MHRA will perform market surveillance of medical devices on the UK market and be able to take a decision over the marketing and supplying of a device in the UK.  The MHRA will also continue to allow devices to be placed on the UK market that have been CE marked under and fully conform to applicable EU legislation. 

Detailed guidance on actions required by manufactures to register a medical device or in vitro diagnostic medical devices following exit from the EU in the event of the UK leaves the EU without a Deal is available online.

Cross Border Healthcare 

What would be the impact of ‘No Deal’ on cross border services and reciprocal healthcare?

Arrangements for the provision of specific cross border healthcare services made between the Department of Health in Northern Ireland and the Department of Health in Dublin (such as the Paediatric Congenital Heart Service or the North West Cancer Centre) should not be affected by EU Exit as they are not based on EU legislation but arrangements underpinned by memorandum of understandings and service level agreements.

The UK Government has given an aspiration to a broad continuation of reciprocal healthcare whatever the outcome of leaving the EU. Legislation has been made to enable the UK to continue to facilitate reciprocal healthcare post exit. However, it is possible in the event of a no deal exit that reciprocal healthcare arrangements may change. It is recommended that those planning a visit to an EU country after this date should continue to buy travel insurance to access healthcare, if it is needed.

In respect of Ireland, UK and Ireland have signed an overarching memorandum of understanding on the common travel area (CTA) which states that:

The CTA affords British citizens residing in Ireland and Irish citizens residing in the UK the right to access emergency, routine and planned publicly funded health services in each other’s state, on the same basis as citizens of that state.

The Department is also continuing to work with DHSC and the Department of Health in Dublin to ensure that the reciprocal healthcare rights established under the Common Travel Area are maintained following EU Exit.

Professionals working in health and social care in the UK before exit will be covered by legislation which sets out what would happen in relation to the recognition of professional qualifications obtained in the EU, in the event of a no-deal, specifically that:

  • anyone who has registered using an MRPQ route before the date of exit would retain their registration

  • anyone who has applied using an MRPQ route before the date of exit would be able to proceed with their application through that route including any appeals

  • applications for registration after the date of exit would be considered depending on a number of factors set out in the statutory instrument.

This is mirrored in the EU by the EU commission’s guidance which states that post exit in a no deal:

  • if a qualification is already recognised as valid, it will remain valid

  • UK nationals who want to get their professional qualifications recognised in the EEA or Switzerland will be assessed under the rules of the individual country

  • UK nationals wanting to provide temporary and occasional professional services in the EEA or Switzerland will have to do so under each country’s national policies and rules

More information

How many EU nationals work in HSC and live in NI?

Given the EU’s freedom of movement of people principle, the EU nationality of staff was not recorded.  The indications are that the number of non-UK or non-Irish EU citizens working in the HSC system here is small; however, these staff members are crucial and continue to make an important contribution.

What efforts has DoH made to communicate with these EU nationals?

Significant efforts have been made to communicate with staff to encourage them to apply under the EU Settlement Scheme pilot in December 2018, which was targeted at the health and social care sector across the UK.  Communication efforts continue as the scheme is rolled out up to the 31 December 2020 deadline.

How many HSC employees live in the Irish Republic and cross the border to work?

HSC employers estimate that the figure is around 750, with half of these in nursing and midwifery.  The NI Social Care Council estimates that there are around 400 individuals in the independent social care sector.

What contacts has the Department of Health had with the Republic’s Government on ensuring continuity of cross border health care arrangements should the UK leave the EU without a Deal?

The Department is working with DHSC in London and the Department of Health in Dublin to ensure that the reciprocal healthcare rights established under the Common Travel Area are maintained following the UK leaving the EU.  Arrangements for the provision of specific cross border healthcare services made between the Department of Health in Northern Ireland and the Department of Health in Dublin (such as the Paediatric Congenital Heart Service or the North West Cancer Centre) will not be affected by the UK leaving the EU as they are not based on EU legislation.

What representations has DoH made with London and Dublin on mutual recognition of professional qualifications between the UK and EU states post Brexit?

Legislation introduced on 7 March 2019 means health and social care workers with professional qualifications from EU and Swiss institutions who are currently registered can continue to practise in the UK as they do now, guaranteeing their ability to work in the HSC.

Employment contracts will not need to be changed if the UK leaves the EU without a deal, and staff won’t have to reapply for their current positions after exit day.

EU or Swiss qualified persons entering the UK after exit may have their qualifications recognised, if we leave the EU without a deal.

Will patients already booked to receive treatment in EU states under the Directive on cross border healthcare still be reimbursed post Brexit?

The Department of Health has made regulations to ensure that, in a no deal, reimbursements for treatments facilitated under the EU cross-border healthcare directive and started before exit day will be honoured for up to one year; that is where:

  • an application is received for authorisation before exit day

  • an application is authorised before exit day, or 

  • treatment had already started before exit day

The regulations also allow for the Directive to continue where the UK Government has reached arrangements with EEA states to continue existing reciprocal healthcare arrangements on a bilateral basis.

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