240.EU, European Economic Area (EEA) Member States and Switzerland coordinate the provision of social security, including healthcare, under EU Regulations (EC)883/2004 and (EC)987/2009. This coordination has a number of features, but focuses on reciprocal healthcare provision as individuals move between Member States, and on the approval and trade of medicines.
241.As we noted in our report Brexit: reciprocal healthcare, there are four main ‘routes’ for EU and EEA citizens to access healthcare in Member States other than those in which they are ordinarily resident. The European Health Insurance Card (EHIC) is used for accessing healthcare during temporary stays in the EU, EEA and Switzerland (see Box 6). Other routes—the S1 Scheme, the S2 Scheme, and the Patients’ Rights Directive—are used in different scenarios, and are detailed in our previous report.
Provided for in Article 19(1) of Regulation 883/2004, the EHIC entitles EU/EEA and Swiss citizens to “needs-arising” healthcare in another Member State, as if they were an insured resident of that country. The EHIC also covers treatment for long-term conditions, such as the costs associated with dialysis. The EHIC is not valid for private treatment and only entitles the holder to access state-provided healthcare during temporary stays in the EU/EEA and Switzerland.
242.Licences are required in order to manufacture or import a medicine in the UK. UK medicines manufacturers must meet a minimum standard of Good Manufacturing Practice (GMP) which requires the medicine to be of consistent high quality, appropriate to its intended use and meet the requirements of its authorisation. The European Medicines Agency (EMA) coordinates licensing for medicines and medical devices in the EU. Pharmaceutical companies may choose to use the EMA’s centralised or mutual recognition procedures that allow them to sell a product throughout the EU: Regulation (EC) No 726/2004 and Directive 2001/83/EC respectively. The Medicines and Healthcare products Regulatory Agency (MHRA) is the body responsible, among other roles, for licensing and regulating medicines and medical devices in the UK. While the UK was a Member State the MHRA worked with the EMA as part of a regulatory network.
243.Member States also cooperate on cross-border health security, for example through the Early Warning and Response System (EWRS), a tool for monitoring public health threats across the EU; the European Centre for Disease Prevention and Control, an EU agency which aims to strengthen Europe’s defences against infectious diseases; and ELDSNet, the European Legionnaires’ disease Surveillance Network. EU Member States also cooperate on research through EU-wide research programmes.
244.Article 5 of Annex TBT-2: Medicinal Products of the EU-UK Trade and Cooperation Agreement (TCA) states that both Parties will recognise inspections carried out by the other and accept GMP documents issued by the other Party. This mutual recognition, however, does not extend to medical regulation processes like regulatory approvals and batch testing.
245.Article HS.1 of the TCA sets out a commitment for the two Parties to cooperate on health security, for example by informing one another of “a serious cross-border threat to health”. The EU may grant the UK “ad hoc access to its Early Warning and Response System” in respect to a particular cross-border threat to health, subject to the UK making a written request for such access, and in order to “exchange relevant information, to assess public health risks, and to coordinate the measures that could be required to protect public health” (Article HS.1(3)).
246.The healthcare aspects of the TCA were welcomed by our witnesses, but with some reservations. NHS Providers commented that the provisions give “greater clarity and certainty in a number of key areas of concern”, while adding that “some measures are transitional and require further work to be undertaken”. Dr Andrew Glencross, Senior Lecturer at Aston University, observed: “It was a relief to see health security feature in the TCA because the UK government’s Draft UK-EU Comprehensive Free Trade Agreement had not covered this topic … However, the new provisions are extremely thin when compared with the nature of the previous health security arrangement.”
247.Health Minister Edward Argar MP told us that the TCA “delivers on reciprocal healthcare, delivers continuity of supply, and delivers on health security”.
248.While the UK was a Member State, UK residents were essentially entitled to the same healthcare in other Member States as citizens of those states. EHICs covered those staying temporarily in another EU country, such as holiday makers, and separate agreements covered other potential scenarios, such as those travelling to the EU for specialised treatment. In outline, these arrangements meant that if a UK resident required treatment in another Member State, those costs were met by the UK. Reciprocal healthcare arrangements were a key priority raised by stakeholder groups in the Brexit process, as set out in our report Brexit: reciprocal healthcare.
249.Following the end of the transition period, EHICs are being superseded in the UK by the Government’s new Global Health Insurance Cards (GHICs). The GHIC covers medically necessary state-provided healthcare either at a reduced cost until the person returns home, or free of charge. It will cover both urgent and routine medical treatment, such as dialysis or chemotherapy, for UK residents while in the EU. For pre-planned treatment, travellers will be able to arrange in advance to have it paid for by the UK.
250.Fiona Loud, Policy Director for Kidney Care UK, gave an example of why such arrangements are important:
“The cost of dialysis in an EU country … can [be] up to £500 a session. That is three times a week to stay alive. The cost becomes prohibitive if you have to pay for it yourself. As a known pre-existing condition that required treatment, insurance was never going to cover it, and you could not travel without it. There has been an enormous sense of relief from patients that they will be able, when it is safe, to start to travel again.”
251.The GHIC does not cover EEA states and Switzerland. As Kate Ling, Senior European Policy Manager for the NHS Confederation, noted: “There are some gaps … Switzerland, Iceland and Liechtenstein are not covered, so people travelling to and from those countries will have to take out insurance, and they will be chargeable.” The Minister told us that Government was working to “have that small gap filled”.
252.We welcome the replacement healthcare arrangements that the Government has established, and the reassurance this will provide for UK citizens when they travel, particularly those with long-term health conditions. We support the Government’s objective of extending those arrangements to EEA countries and Switzerland.
253.Dr Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry, told us: “The fact that we will have a tariff-free flow of trade in medicines and active pharmaceutical ingredients, which are important for manufacturing, is very welcome.” He added, “We were very pleased to see a pharmaceutical annex to the deal that includes provisions for the mutual recognition of good manufacturing standards and inspections.” The BioIndustry Association agreed: “Mutual recognition of GMP reduces the duplication of bureaucracy for medicines manufactured by one party and exported to the other.”
254.The main concern raised on medical regulation was over the absence of mutual recognition in other areas, particularly batch testing of medicines. The BioIndustry Association explained:
“No mutual recognition of batch testing means that each batch of medicine manufactured will need to undergo a second test for quality and safety when being exported from one party to the other. This creates additional bureaucratic burden on companies, and additional delay in supply chains and medicinal products reaching patients.”
255.Dr Richard Torbett told us that the Government had unilaterally decided to recognise the EU’s batch testing for two years, but noted, “After that the implication is that we would have to duplicate all those processes.” He continued:
“Any resource that is spent in a duplicative way—whether it is animal testing, whether it is the environmental impact of using solvents, which are certainly widely used in batch testing, or whether it is the people, resources and infrastructure required—it is all resource that could, frankly, be put to better use and some sort of benefit.”
256.In a joint submission, Mark Dayan, Nicholas Fahy, Tamara Hervey, Martha McCarey and Matthew Wood estimated that this “low level of alignment” could “drive a cost increase of over 5% for pharmaceuticals in the UK”.
257.Several witnesses argued that the Government should seek a mutual recognition agreement with the EU regarding medicine batch testing, with some noting precedents for the EU reaching similar agreements with other third countries. The Minister told us: “Our message to industry is that you need to work on the basis that what we have reached at the moment is what will happen and what will be the future state, so you need to prepare for no changes to it at the end of the period.” He added that it would be “premature” to speculate on the possibility of extending the mutual recognition arrangements.
258.Since we concluded our evidence-gathering, European Council President Charles Michel has publicly argued that the Government has imposed “an outright ban on the export of [COVID-19] vaccines or vaccine components” produced in the UK, indicating a deterioration of the relations around healthcare trading. The Prime Minister subsequently said: “We have not blocked the export of a single COVID-19 vaccine or vaccine components. This pandemic has put us all on the same side in the battle for global health.”
260.While mutual recognition of Good Manufacturing Practices is helpful for the medical industry, it is disappointing that such recognition has not been extended to other regulatory processes such as batch testing. We note that the EU has reached mutual recognition agreements with other third countries, and urge the Government to seek a similar agreement.
261.A number of EU laws regarding medicinal products still apply in Northern Ireland by virtue of the Protocol on Ireland/Northern Ireland. One of these is Directive 2011/62/EU, the Falsified Medicines Directive (FMD, see Box 7).
The FMD aims to prevent counterfeit medicines entering the supply chain and applies to the majority of prescription-only medicines. Any package of medicine covered by the Directive is given a unique identifying barcode, which is entered into the FMD system. Wholesalers, pharmacies and hospitals can then scan the packages on receipt to check their authenticity before dispensing them. The unique identifier is decommissioned—effectively removed from the system—when the package is supplied to a patient, or when it leaves the EU.
262.Approximately 98 per cent of the medicines used in Northern Ireland are imported either from or via Great Britain. Often originating in the EU, they are placed in warehousing in Great Britain before being exported to Northern Ireland.
263.Under the terms of the FMD, applicable medicines which travelled from the EU to Northern Ireland via Great Britain would be decommissioned, causing significant disruption to the supply chain. In autumn 2020 the pharmaceutical industry was expressing uncertainty and concerns about the supply of medicines to Northern Ireland after the transition period. On 5 November the Government announced that the European Commission had agreed to a 12-month grace period before the FMD will be enforced in Northern Ireland, providing businesses with additional time to adjust, and this was subsequently agreed via unilateral declarations in the Withdrawal Agreement Joint Committee. On 11 December the MHRA published guidance on the supply of medicines to Northern Ireland both before and after 31 December 2021.
264.Dr Richard Torbett told us:
“I think we are now much clearer on how the Falsified Medicines Directive will work. The 12-month period will have to be used to good effect by companies to re-engineer their supply chains so that they will be able to comply. Often that will mean companies redirecting supply away from GB so that it goes only through the European Union.”
265.In addition, the Minister informed us:
“There are options either around supply chain re-routing … or, for example, around bonded warehouses and cabotage, and whether a route to explore might be that, technically, something has not left the EU if it is sealed in one of those warehouses before it carries on. We continue to discuss those things with industry.”
266.We welcome the grace period that the Government has secured to allow businesses time to adjust their supply routes to accommodate the post-Brexit application of the Falsified Medicines Directive in Northern Ireland. We also welcome the Government’s continuing engagement with the sector: if disruption once the grace period has elapsed is to be minimised, it will be essential to explore the alternative possibilities mentioned by the Minister, such as bonded warehouses and cabotage.
267.Kate Ling welcomed the ability for the UK to request access to the EWRS, as did NHS Providers. Dr Andrew Glencross, however, raised some concerns:
“There is … no automatic access to the EWRS. Temporary access is at the discretion of the EU and pursuant to a case-by-case request by the UK. Hence the two-way sharing of epidemiological and other public health data will be much more limited, while the ability to coordinate a cross-border response in a crisis will be similarly impaired.”
Mark Dayan et al suggested that, as well as making “such requests as are necessary for ad-hoc participation in cooperation against cross-border threats to health”, the UK “should seek over time to establish such participation on a more regular footing”.
268.When we asked the Health Minister whether the Government had requested access to EWRS in relation to the COVID-19 pandemic, he told us:
“On 30 December, I instructed my officials to request that access, and I have to say that it was granted and approved seamlessly within a matter of hours, if not minutes, by the Commission and by the EU. I take that as a reflection of the common sense and mutual interest that is being applied, and that I would expect to see in any future health pandemics or serious health challenges.”
269.We are encouraged that the Government was prompt to request access to the Early Warning and Response System in relation to the COVID-19 pandemic, and that the EU was equally swift to grant that access. This bodes well for future cooperation on monitoring cross-border health threats. To ensure transparency on the use of this measure, we urge the Government to make a statement to both Houses whenever such a request is made, and to confirm whether or not it has been granted.
270.The TCA secures the UK’s ability to continue participating in a number of EU research programmes. The Bioindustry Association told us that “the key benefit is that involvement will allow the UK to continue to be able to join and coordinate collaborations, working more closely on research with countries around Europe”. Emlyn Samuel, Director of Policy at Cancer Research UK, explained why that coordination is important:
“About a third of the clinical trials that Cancer Research UK funds involve patients from EU Member States. That is primarily in rare and childhood cancers, where we simply do not have the patient numbers in the UK to run the trials ourselves, so we absolutely need to collaborate with our European neighbours on research endeavours to produce new medicines and treatments for those patient groups.”
271.However, he went on to highlight that “if you have a trial that is led from the UK but needs to recruit patients across the EU, at the moment the UK sponsor will have to set up legal representation in the EU”. This has significant financial implications, as Cancer Research UK explained:
“EU-based legal representation for multi-state trials can cost between £20,000 to £300,000 per year. This would be prohibitively expensive for many non-commercial Sponsors (e.g. universities). Cancer research is particularly vulnerable to these costs, as approximately 40% of all UK cancer trials have non-commercial Sponsors.”
272.Cancer Research UK also told us that “the UK has unilaterally agreed to recognise EU/EEA Sponsors of clinical trials, meaning UK researchers will face minimal legal and administrative barriers when participating in EU-led clinical trials”. Emlyn Samuel asked that the Government seek mutual recognition of clinical trial sponsors, to better enable UK-led clinical trials to recruit patients from the EU.
273.The UK’s recognition of EU-based clinical trial sponsors is helpful, but the lack of mutual recognition risks both significantly harming the UK’s ability to conduct clinical research and reducing UK patients’ access to clinical trials on rare diseases and children’s cancers. We recommend that the Government seek EU recognition of UK-based clinical trial sponsors, and in the meantime take steps to ensure UK-based researchers have the funds available to establish EU-based legal representatives.
274.In the EU, the handling of personal data by individuals and organisations, and data transfers to a third country, are governed by the 2016 General Data Protection Regulation (GDPR). Under the GDPR, the European Commission may issue an ‘adequacy’ decision confirming that a third country provides a level of data protection comparable to that in EU law. The practical effect of an adequacy decision is that cross-border data transfers to the relevant third country can take place without any further safeguards.
275.On 19 February the European Commission published a draft data adequacy decision indicating that the UK should be found ‘adequate’. That decision will be shared with the European Data Protection Board for a ‘non-binding opinion’, before being presented to EU Member States for formal approval. The UK and EU have reached an agreement that allows the temporary flow of data in the interim.
276.Many of our witnesses spoke about the importance of a positive data adequacy decision to the healthcare sector. According to Fiona Loud, “Detailed patient data has to be exchanged between the person in the UK and the unit or facility that will be giving treatment in an EU country. All sorts of details about blood groups and medicines and things need to be shared for the re-charge, and for the treatment. That needs to be as easy as possible.” And Emlyn Samuel highlighted that “it is absolutely crucial that a data adequacy agreement is put in place to ensure that the data flows for clinical trials can continue”.
277.The NHS Confederation told us that “failure to reach a positive decision on data adequacy would result in burdensome and costly alternatives for the processing and transfer of personal data”, while the BioIndustry Association argued that any alternative approaches would “add additional bureaucracy and the need for safeguarding checks”.
278.On 3 December 2020 the EU Services Sub-Committee wrote to the Rt Hon Gavin Williamson CBE MP, Secretary of State for Education, warning that many universities and third sector organisations engaged in research and education were unaware of the possibility and consequences of no adequacy decision.
279.The flow of data between the UK and EU is important for enabling both patient treatment and clinical research. In the absence of a positive data adequacy decision from the EU, the Government will need to provide advice on data protection to the healthcare industry and researchers, and support them in forming alternative arrangements for data sharing.
280.Since freedom of movement between the UK and EU ended on 31 December 2020, the Government has implemented a points-based immigration system that grants a visa only to those individuals who meet the scheme’s requirements.
281.Several of our witnesses raised concerns about this system in the context of social care. Kate Ling informed us:
“Nearly all professional healthcare workers will meet the points-based entry criteria for a visa … It is a different story with social care. Front-line care workers do not qualify under the new points-based immigration system. They do not qualify for visas to enter the UK because they do not earn enough and they do not have high enough qualifications.”
She added that the Cavendish Coalition had estimated a gap of about 112,000 care staff in the UK.
282.NHS Providers argued that “it will take a number of years to grow the domestic workforce supply, and in the interim the NHS and social care will need to recruit additional staff internationally”. They were also “concerned that the points-based system may exacerbate shortages across the social care workforce as many potential international staff are left without a valid migration route”.
283.On 29 September 2020 the Migration Advisory Committee wrote to the Home Secretary, Rt Hon Priti Patel MP, stating that “we would expect the end of freedom of movement to increase the pressure on the social care sector, something that would be particularly difficult to understand at a time when so many care occupations are central to the COVID-19 pandemic frontline response”, and advising the Government to add senior care workers and several other health occupations to the shortage occupation list. Such a step would reduce both the relevant salary threshold and the visa application fees.
284.The Home Secretary said in response that the Government intended to “pause and assess how the UK labour market develops [following the end of free movement] and how quickly recovery is evidenced post-Covid 19”, before deciding whether to implement the Migration Advisory Committee’s recommendations, although on 4 March “senior care workers” were added to the shortage occupation list.
285.The Health Minister told us that the Government was focusing on developing a “homegrown” social care workforce. He also acknowledged “the strain—I could probably use a tougher word than that—of dealing with COVID, and the emotional and physical drain that dealing with COVID will have had on our workforce in the social sector”.
286.The UK’s NHS and social care workforce has been subject to unprecedented and unforeseeable pressures over the last 12 months. The inevitable impact of the COVID-19 pandemic on recruitment and retention of staff will compound the existing and alarming shortages in the sector.
287.We see no evidence of a credible plan from the Government to address the shortage of social care staff in the UK. While we support its ambition to encourage more ‘homegrown’ care workers, such measures will take years to materialise, and the need is immediate.
261 Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems, , 30 April 2004
262 Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure for implementing Regulation on the coordination of social security systems , 30 October 2009
263 European Union Committee, (13th Report, Session 2017–19, HL Paper 107)
264 Medicines and Healthcare products Regulatory Agency, ‘Apply for manufacturer or wholesaler of medicines licences’: [accessed 12 February 2021]
265 Department of Health and Social Care, ‘Good manufacturing practice and good distribution practice’: [accessed 12 February 2021]
266 House of Commons Library, Brexit and medicines regulation, Briefing Paper, , 9 April 2019
267 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, , 31 March 2004
268 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, , 6 November 2001
269 House of Commons Library, Brexit and medicines regulation, Briefing Paper, , 9 April 2019
271 The TCA’s Protocol on Social Security Coordination purports to secure continuing reciprocal healthcare between the UK and EU Member States by making provision for both Parties to seek reimbursement for healthcare provided in the other’s territory.
272 Written evidence from NHS Providers ()
273 Written evidence from Dr Andrew Glencross ()
275 European Union Committee, (13th Report, Session 2017–19, HL Paper 107)
276 Department of Health and Social Care, ‘UK launches Global Health Insurance Card’: [accessed 12 February 2021]
277 NHS Confederation, ‘What the Brexit deal means for the NHS’: [accessed 12 February 2021]
282 Written evidence from The BioIndustry Association ()
286 Written evidence from Professor Tamara Hervey, Mark Dayan, Dr Nicholas Fahy, Martha McCarey and Dr Matthew Wood ()
287 (Prof Richard Torbett) and the NHS Confederation ()
288 Written evidence from Professor Tamara Hervey, Mark Dayan, Dr Nicholas Fahy, Martha McCarey and Dr Matthew Wood () and The BioIndustry Association ()
291 European Council, ‘A Word from the President’: [accessed 16 March 2021]
292 HC Deb, 10 March 2021,
293 Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, , 8 June 2011
294 Northern Ireland Assembly, ‘Official Report: Minutes of Evidence Committee for Health, meeting on Thursday, 17 September 2020’: [accessed 12 February 2021]
295 Letter from the Chair of the EU Environment Sub-Committee, Lord Teverson to Minister for Health at the Department for Health and Social Care, Edward Argar, dated 28 October 2020:
296 Cabinet Office, ‘UK statement following the meeting of the Ireland/Northern Ireland Specialised Committee 5 November 2020’: [accessed 12 February 2021]
298 Cabinet Office, ‘Unilateral declarations by the European Union and the United Kingdom of Great Britain and Northern Ireland in the Withdrawal Agreement Joint Committee on human and veterinary medicines’ (17 December 2020): [accessed 23 February 2021]
299 Medicines and Healthcare Products Regulatory Agency, ‘Supplying authorised medicines to Northern Ireland’, (31 December 2020): [accessed 12 February 2021]
303 Written evidence from NHS Providers ()
304 Written evidence from Dr Andrew Glencross ()
305 Written evidence from Professor Tamara Hervey, Mark Dayan, Dr Nicholas Fahy, Martha McCarey and Dr Matthew Wood ()
307 Written evidence from The BioIndustry Association ()
310 Written evidence from Cancer Research UK ()
313 Regulation (EU) of 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), , 27 April 2016
314 European Union Committee, (3rd Report, Session 2017–19, HL Paper 7)
315 Department for Culture, Media and Sport, ‘UK government welcomes the European Commission’s draft data adequacy decisions’, (19 February 2021): [accessed 16 March 2021]
318 Written evidence from the NHS Confederation ()
319 Written evidence from The BioIndustry Association ()
320 Letter from the Chair of the EU Services Sub-Committee, Baroness Donaghy to the Secretary of State for Education at the Department for Education and Skills, Gavin Williamson, dated 3 December 2020:
321 Home Office, ‘Promotional material, An introduction for employers (accessible version)’ (4 January 2021): [accessed 12 February 2021]
324 Written evidence from the NHS Confederation ()
325 Written evidence from NHS Providers ()
326 Migration Advisory Committee, ‘Corporate report, Review of the shortage occupation list: 2020 - letter to the Home Secretary’, (19 October 2020): [accessed 12 February 2021]
327 Migration Advisory Committee, Review of the Shortage Occupation List, 2020, September 2020: [accessed 12 February 2021]
328 Letter from the Secretary of State for the Home Office, Priti Patel to the Chair of the Migration Advisory Committee, Professor Brian Bell, dated 22 October 2020:
329 Home Office, ‘Rule changes to make it easier to recruit health and care staff’, (4 March 2021): [accessed 9 March 2021]