3.1 Health and social care workforce

The health workforce remains the most important challenge for the NHS post-Brexit. Although the formal position of EU nationals working in the NHS has not changed during transition, the move from ‘EU citizenship’ to ‘pre-settled’ and ‘settled status’, along with the ‘hostile environment’ that underpins the government's migration policy has had a chilling effect, and many EU nationals working within the NHS have already left, or are seeking to do so. Data from the Nursing and Midwifery Council show that an inflow of nurses and midwives from the EU into the UK until 2016 (which accounts for almost all the growth on the register from 2013 to 2016) has become a net outflow ever since (Nursing and Midwifery Council, 2019). Although there has been a significant increase in non-EU nationals, mainly from India and the Philippines, joining the UK nursing workforce, overall numbers joining the register having trained overseas remain below those in 2016 (Buchan et al., Reference Buchan, Gershlick, Charlesworth and Seccombe2019). In November 2019, there were over 100,000 vacancies across NHS England (The Health Foundation, The King's Fund, and Nuffield Trust, 2018), of which almost 44,000 were in nursing, representing 12% of the nursing workforce, according to the Health Foundation (Buchan et al., Reference Buchan, Gershlick, Charlesworth and Seccombe2019). The Coronavirus Act 2020 allowed for emergency measures to plug some gaps, for instance drawing on health professional students and recently retired staff. Notwithstanding this, the extent and nature of existing staffing gaps mean that the UK will be reliant on international health professionals for the foreseeable future, particularly in key areas, and especially in nursing. Visa extensions for some frontline health workers were announced in April 2020, but do not cover many of the lowest-paid health and social care workers across the UK.

The COVID-19 pandemic has reinforced the importance to health of the social care sector, which also faces growing staffing problems and has been especially reliant on EU migration. Data for England show that vacancy rates in the sector have steadily risen to 8%. There would be even more pressure without continued growth in the EU migrant workforce, which has risen rapidly to 115,000 (Skills for Care, 2019). The potential for a dramatic exacerbation of the situation if the end of free movement changes this has been widely commented on by researchers: the UK Government Migration Advisory Committee noted that with no action on wages in the sector ‘migrant workers will be necessary to continue delivering these services’ (Migration Advisory Committee, 2018, para. 5.31).

The EU and UK negotiating positions are consistent in that they reflect the ending of free movement of people between the UK and EU, and repatriation of immigration control to the UK. Both sides envisage limited ‘mobility’ provisions, visa-free travel for short-term stays, and arrangements for students, researchers and youth exchanges. COVID-19 measures are likely to mean reduced human migration between countries in general, although migration of essential staff, including NHS workers, will continue. The UK has offered concessions to international NHS staff already in the UK as part of its adopted COVID-19 response, including temporary changes to its ‘Tier 2’ immigration processes, which apply to NHS staffing. Obviously, outside the EU, the UK will not be able to benefit from cross-border collaborations to share health workers being developed to respond to disasters such as COVID-19.

Post-transition, the rules of the Common Travel Area (which allows free movement for British and Irish citizens between the UK and Ireland) will continue to apply. None of the proposed mobility provisions will replicate EU free movement law or the Withdrawal Agreement position. Recruitment of EU nationals to the NHS workforce will be on the same basis as recruitment of nationals from the rest of the world. The terms on which non-national NHS staff live and work in the UK under the new EU−UK relationship will be significantly less secure than those for EU nationals migrating within the EU, as they will be based only on UK domestic law. The lack of detail on this makes it difficult to estimate how many who come to the UK will choose to stay and work in the NHS following registration (Buchan et al., Reference Buchan, Gershlick, Charlesworth and Seccombe2019).

The system planned for migrants from all other countries, European and non-European alike, was laid out in February 2020 in a UK Government policy statement (HM Government, 2020e). It uses a combination of shortage status, qualifications and salary to determine who can enter the UK for work. The system would mean that migrants would be allowed to take up almost any professional clinical role as long as that role is deemed to be in shortage, as they generally earn well in excess of the absolute threshold of £20,480 per year. Without shortage status, which is reviewed periodically and often subject to political intervention, some nurses and other clinicians outside London may not qualify.

Migration for the vast majority of social care roles would be impossible regardless of any shortages, as average pay is far below these levels, at around £16,200 per year in the predominantly independent English sector (Skills for Care, 2019). These positions also do not require the right level of qualifications. This has resulted in concern of exacerbating the already very difficult situation in the sector that was exposed by COVID-19.

These UK measures are understood to be responding to the desire of the British public, expressed in the EU referendum vote, to ‘take back control’ of domestic borders. However, the National Centre for Social Research (What UK Thinks, 2020) suggests that the UK population sees all health sector positions, no matter how lowly paid, such as ‘healthcare assistant’, as ‘skilled’; and that there is strong support (77% agree) for the new immigration system to prioritise people coming to work for the NHS. Sixty-seven percent of those polled also felt that ‘care worker’ is a ‘skilled’ job. These views have probably been strengthened by COVID-19. Nonetheless, unless the direction of travel of UK immigration law and policy changes to reflect this perception, given the likely outcome of the EU−UK negotiations on future relationship(s), it is likely to become more difficult for the UK to recruit and retain EU nationals in the NHS and social care workforce than it was pre-referendum. It is also worth noting the possible impact of COVID-19 on perceived safety of working in frontline care in the UK. If COVID-19 deaths of care and health workers are very high relative to other countries, this, in future could serve to dissuade foreign nationals from considering such work here.

In at least two respects, however, we can expect the future EU−UK relationship(s) to facilitate continued recruitment and retention of healthcare professionals. First, if agreement can be reached, employment rights such as working time (discussed below) may be retained. Second, both the EU (Council of the European Union, 2020, para. 43) and the UK (HM Government, 2020d, para. 48–9) seek a framework for the mutual recognition of qualifications, although the EU's position is that this is only where it is in the EU's interest. Although the overall context in which this part of the EU−UK Agreement will be found (services and investment) is likely to be modelled on a much less close trade relationship than EU membership (such as EU−Canada, or EU−Japan), the key difference in the context of professional qualifications is that the EU and the UK are beginning from common frameworks and current mutual recognition, rather than building towards such a position. Although the new rules will not be enforceable by individual health professionals, as under EU law, in practice individual enforcement is the exception. The coordination of qualification rules through collaborative processes is more important. Both the EU's [European Commission, 2020b, para. SERVIN 1.14(2)] and the UK's (HM Government, 2020a, Articles 8.4 & 13.13) draft texts envisage a new institutional framework for such coordination: a Specialised Committee on Trade/Trade in Services and Investment/Sub-Committee on Recognition of Qualifications. In practice, this may result in a relatively unchanged regulatory environment, unless the UK decides to depart significantly from medical professional qualifications standards set by the EU. While most relevant professional organisations support alignment, some, such as the Royal College of Surgeons, suggest some changes to domestic law would be desirable.

What will certainly change is the easy exchange of information between the EU and UK about professionals providing medical services across borders where there are concerns about fitness to practise, using the Internal Market Information (IMI) system. Running since 2008, the IMI is a multilingual online tool through which national public authorities of the EU Member States exchange information about the functioning of the internal market, including to improve professional mobility. By 2018, over 4000 alerts had been sent concerning disciplinary sanctions taken against doctors, just over 30% of all alerts sent (European Commission staff working document, 2018). The UK has been one of the most frequent users of the system, reflecting the number of doctors it employs from EU Member States. Although the IMI Regulation envisages the possibility of access for third countries, this is under stringent conditions, including the application of EU law in the relevant third country. No non-EEA country (not even Switzerland) currently has IMI access. Unless the EU changes its position, exchange of data about medical professionals' fitness to practise will no longer be possible through IMI after the end of transition. This will mean that, unless another agreement covers such information exchange, the UK will need to increase vigilance and oversight of fitness to practise in order to maintain standards of patient care at pre-transition levels.

3.2 Financing

3.3 Medical products and substances of human origin

The EU−UK agreement will cover trade in products, including pharmaceuticals, medical devices, medical equipment [including personal protective equipment (PPE)], and consumables. Substances of human origin (blood, plasma, human tissue and cells, human organs) are not conceptualised as products in EU law, and are not explicitly mentioned in the negotiating positions. Products made from substances of human origin will be included in the terms of the agreement. As the main focus of the envisaged agreement is trade in products, this aspect of post-transition will have the least effect on health and the NHS. One area that is likely to be secured is continued access to medical isotopes [HM Government, 2020d, para. 25(d); Council of the European Union 2020, para. 85]. The expected outcomes are far from the potentially life-threatening effects on supply chains associated with No Deal, but that is not to say that there will be no effects. Trade in relevant products, and the components which are used to make those products, will continue post-transition on the basis of an agreement which goes some way – but not all the way – to replicating the trade patterns that apply before the end of transition. The UK's negotiating position seeks to go further in this regard than the EU's.

Both parties seek to secure a free trade area in goods: in other words, there will be no tariffs or quotas restricting trade. But there will be a number of other hindrances, and these will impede trade in the products that the NHS uses as much as any other sector. Hindrances include rules of origin, possible anti-dumping and anti-subsidy duties, and economic safeguards, to protect domestic producers. Although the agreement is likely to include ‘customs facilitation’ (measures to reduce ‘red tape’ at borders), there is no avoiding the need for significant changes to the (electronic) paperwork needed for products, and components, coming from the EU into the UK, and time taken to process them. The costs of these new processes are likely to be passed on to consumers of the corresponding products, which in this case is the NHS. Both independent research and the Government's own modelling suggest a free trade agreement-type relationship with the EU would increase costs of medicines, devices and equipment to the NHS by around 5% – not as much as No Deal Brexit (7.5%), but a significant cost to the NHS budget, estimated in November 2018 (Health and Social Care Committee, 2018) at £400 million per annum.

Further, the EU−UK agreement will address ‘non-tariff barriers’ (measures other than direct tariffs that have the practical effect of restricting imports or exports of goods or services). Here, the UK and EU positions diverge to some extent, which makes it difficult to assess likely outcomes and therefore implications for health and the NHS. One of the EU's most impressive achievements is the removal of these de facto hindrances to free trade, with consequent benefits arising from economies of scale. In part, the EU has done this through deep cooperation in setting safety standards, using European agencies, made up of experts from its Member States, which agree standards that all EU countries can support. This system operates for medicines licensing, and links to clinical trials regulation. The EU also has the CE system of automatic recognition of the assessments of private standards entities that check conformity with technical regulations, irrespective of where those bodies are established in the EU. This system operates for medical devices and equipment. Compliance with these dense EU rules, and submission to oversight and dispute settlement through EU or EEA institutions, secures access to the EU's market.

The UK's negotiating position suggests that the UK seeks access to that market on terms better than those, say, for Canada, but without consenting to the package of internal market law that the EU insists is indivisible. In many respects, the UK's negotiating documents are directly equivalent to the EU−Canada Comprehensive Economic and Trade Agreement (CETA). But in a few, the UK wants to go further, and some of these involve medicines, devices and medical equipment (including PPE). For example, unless covered in the EU−UK Agreement, UK-based standards entities will no longer be recognised by the EU post-transition. As such, for instance, firms marketing medical devices in the EU will need a CE mark from an EU-based body. Further, under the new Medical Devices Regulations, firms will also have to have an EU-based authorised representative who will be liable for defective devices along with the manufacturer, thus ensuring legal redress by patients within the EU. The EU's position refers only to cooperation with international standards bodies, whereas the UK proposes detailed provisions on mutual acceptance of the results of each other's conformity assessments, including UK access to the EU's electronic information exchange systems for these administrative purposes [HM Government, 2020a, Annex 5A, Article 5(1)]. The UK's position is, in effect, to seek continuity post December 2020, by proposing an automatic continuity of recognition of UK standard setting bodies' ability to recognise compliance with EU standards.

Another example is the UK's proposed annex on medicinal products (HM Government, 2020a), for which there is no equivalent in the EU text. This annex aims to ‘reinforce competitive market conditions based on principles of openness’ and ‘maintain cooperation to foster continued mutually beneficial development in trade’ (italics added), suggesting a continuity that is absent in the EU position. Alongside good manufacturing practice recognition (which is covered by trade agreements like CETA), mutual recognition of pharmaceutical batch release control regulations (based on the EU−Israel agreement on conformity assessment (Protocol to the Euro-Mediterranean Agreement Establishing an Association between the European Communities and Their Member States, of the One Part, and the State of Israel, of the Other Part, on Conformity Assessment and Acceptance of Industrial Products, 2013) which covers some, but not all, pharmaceuticals, and which involves Israel aligning with EU rules), the UK position seeks to include mutual recognition of good clinical practice. Many UK-based companies supplying the health sector have in fact already set up subsidiaries in the EU, so that they can ensure the compliance with EU standards and procedures, such as batch-testing of medicines, necessary to continue to supply the larger EU market: the UK position of mutual recognition would make it easier for UK-based companies to continue to supply that market. Furthermore, though exactly how access would be arranged is left for subsequent technical discussions, the UK seeks continued sharing of information about adverse post-market effects of new medicines (pharmacovigilance) and clinical trials information, currently done through the European Medicines Agency, again neither of which is covered by CETA.

By contrast, the EU does not seek agency-level arrangements in areas relevant to health and the NHS, although the future EU−UK relationship is likely to continue some agency-level cooperation (for instance in aviation, and nuclear energy). While in the EU, the UK was part of a single licensing system for medicines marketed anywhere in the EU, based on a single clinical trial system, applicable to all EU cross-border clinical trials. The EU's position is that the UK, by deciding to leave the internal market and eschew formal regulatory alignment with its rules, has taken itself outside the clinical trials system processes, and their benefits. These benefits include the ability to access larger patient populations (important for trials of medicines for rare diseases); to sell to a large market without the costs of altering technical standards; and to respond to pharmacovigilance information drawn from a large patient population. From the point of view of the EU, the UK will not be able to be part of the processes overseen by the European Medicines Agency, which relocated from London to Amsterdam on 1 March 2019, or the EU's technical standards processes for medical devices or equipment. Given the divergence of the positions, the agreement is likely to require only that the UK and the EU work through international standards bodies, such as the International Organization for Standardization (ISO) and the International Council on Harmonisation (ICH) (Flear, Reference Flear2018).

That means, though, that the EU and the UK will each be permitted to require that products sold in their markets meet their own safety standards. The Medicines and Medical Devices Bill HC Bill (2019–21) [90], when it comes into force, will allow ministers to amend domestic law on medicines and medical devices without primary legislation. The delayed conclusions of the Cumberlege Review (Independent Medicines and Medical Devices Safety Review, 2020) on safety of medicines and devices are likely to feed into decisions in this policy space. The Bill envisages that the relevant executive authorities may amend all relevant areas of law currently regulated at EU level, subject to a duty to pay attention to safety and availability of medicines and devices in the UK, as well as ‘the attractiveness of … the UK as a place in which to conduct clinical trials or supply human medicines’. The Bill has been welcomed by some industry actors, who see the ability to avoid primary legislation as enabling the UK regulatory environment to respond rapidly to technological change. Others are concerned about the costs of regulatory drift from the EU, and especially about the lack of a time-limit on executive power in such broad policy areas. Compliance with obligations in the EU−UK agreement will provide some constraints on the UK's and the EU's ability to require regulatory standards higher than those that currently apply without scientific justification, as to do so would introduce ‘non-tariff barriers’, contrary to the agreement. But these obligations are mainly procedural: each party to the agreement will retain power to determine its own safety and health standards. Because the UK will be outside of the EU's medicines licensing, clinical trials approvals and medical device standards decision-making processes, it will be unable to influence these directly, except through international bodies like the ICH. There will be no constraints on the UK adopting lower standards than the EU's, other than soft incentives to align with the larger EU market, and the vague objective of convergence based on international standards. Non-alignment is likely to mean increased costs in terms of regulatory compliance (as companies would have to show compliance with two sets of processes and standards), and less UK bargaining power with the global industry. Those factors could mean that UK patients faced delays in access to innovative medicines and vaccines.

Finally, the EU has used joint procurement processes, for instance for PPE, ventilators, and laboratory equipment to respond to COVID-19 (European Commission, 2020c), as the European Commission sought to do with swine flu vaccines in 2009, using its bargaining power as a bloc. The UK belatedly indicated it would join that joint procurement for COVID-19 in late March 2020: it will be unable to join similar initiatives post-transition. Also, after December 2020, the UK would be subject to any export bans the EU imposes on essential products. This may affect the UK's ability to source medical equipment, medicines or vaccines necessary to respond to a second wave of COVID-19 after that date. During the first wave the EU banned the export without authorisation of face shields, masks and many other types of protective equipment for a period of six weeks (European Commission, 2020a).

3.4 Information

Three information dimensions of the EU−UK agreement are information exchange within the EU's internal market (discussed above); comparable data about health and health systems; and regulation of data sharing, in particular protection of personal data.

One of the advantages of European cooperation is comparing and learning across countries, and the EU's comparative data is a key resource for doing so. The European statistical system coordinated by EUROSTAT, the EU's statistical office, is central, but neither the UK nor the EU seeks for the UK to remain integrated within this system, which is likely to lead to divergence of data over time and reduced comparability. Other specific mechanisms for collecting and sharing comparable data include the European Centre for Disease Prevention and Control (the ECDC). Data on COVID-19 illustrate the impact of this. While some data are available through a variety of global sources, the ECDC is able to provide enhanced data through more in-depth collection and reporting for the EU (and the UK, during the transition period). While the UK will remain part of the World Health Organisation (WHO) and thus remain integrated within the WHO's data structures, these inevitably do not have the same degree of coverage or harmonisation as EU data systems. The EU's draft legal agreement does also include the possibility of the EU granting temporary access to its Early Warning and Response System (EWRS), which is a system for sharing information and coordinating response between governments to public health threats such as COVID-19, though it is not included in the UK's negotiating position.

Both negotiating mandates envisage data protection rules being established autonomously by the EU and UK, with each then allowing flows of personal data to the other provided that the data protection rules of the other side are deemed to provide adequate protection (HM Government, 2020d, para. 59; Council of the European Union, 2020, para. 13). There will no longer be a common mechanism between the UK and the EU for the protection of personal data, nor any ambition to establish one. In the short term, this is unlikely to cause serious issues, but in the longer term some divergence seems likely, with implications for cross-border trade in services requiring the processing of personal data between the UK and the EU.

3.5 Service delivery

3.6 Leadership and governance