Collaborating on the future health of Europe: building an EU-UK Health Protection Agreement

Introduction

If we have learnt anything since 2020 – a year that saw the start of the COVID-19 pandemic and which marked the UK’s official withdrawal from the EU – it is that health protection through prevention, treatment and forward-looking cooperation, unites the world. This is why the World Health Organization has value, [1] and why there are global commitments to environmental safety through international agreement, such as the Paris Agreement [i] and the Minamata Convention. [ii]

On a smaller scale, health unites continents, through: 

• access to and receipt of supply chains that enable the production of medicines and vaccines 
• the spread of disease, as people live, work and holiday across our geography
• the impacts of our unique climates on food production, population health and animal welfare. 

While our institutions can change, our geography does not. Although politics can be upended, health needs remain commonplace, unavoidable and connected across communities, counties and nations. This is why the NHS Confederation and the Independent Commission on UK-EU Relations have joined forces to review the impacts of EU Exit on the health of our continent.

In this paper we spotlight the areas of collaboration, agreement and interoperability that the UK and EU need to develop together to ensure we maximise shared resources and collectively ensure the health of our populations is protected and improved. 

The European Commission already recognises the need for continental cooperation, which is why there is now an EU for Health Programme, introduced in 2021. [2] This has been developed despite member state independence in health policy, to maximise the benefits of collective action at continental level as well as the cooperation and innovation required by partnership between the public and private sectors. 

The United Kingdom, as a G7 power and large services and life sciences economy, can add much value to this mission through the development of more formal mechanisms of engagement and cooperation than are presently in place. This report explores the mutual benefits to EU member states and the UK, alongside recommendations on how they might be achieved.

Footnotes

i The Paris Agreement is a legally binding international treaty on climate change. It was adopted by 196 Parties at the UN Climate Change Conference (COP21) in Paris, France, on 12 December 2015. It entered into force on 4 November 2016. 

ii The Minamata Convention draws attention to a global and ubiquitous metal that, while naturally occurring, has broad uses in everyday objects and is released to the atmosphere, soil and water from a variety of sources. Controlling the anthropogenic releases of mercury throughout its lifecycle has been a key factor in shaping the obligations under the Convention

EU Exit in review

The true risks of EU Exit to the UK’s health and care system always related to the potential for rapid deviation from European standards, associated systems and arrangements and the effect this could have on UK patient access – and therefore their health and safety. 

The risk that political decision-making would be based on ideological rather than pragmatic, financial or improvement objectives was real in the immediate aftermath of the UK’s exit from the EU and when transitional arrangements were being established. But the political rhetoric of 2019, which presented the risk of a “cliff edge” through a no-deal exit, changed significantly. 

This resulted in the relatively static regulatory and operational position that now protects the UK health system and patients. In turn, this means that many of the potential risks identified prior to EU Exit have been avoided. However, there is no evidence from a health system perspective that any of the potential benefits of EU Exit have been secured. 

The avoided risks have, for now, been deferred and this makes future decisions of the UK Government critical. This includes domestic decisions now under consultation on the future regulatory regime for medical devices, which would take effect in 2030, and its potential impacts on patient access if EU manufacturers are dissuaded, because of additional barriers, from maintaining UK market access. [3]

Current arrangements with the EU

The EU-UK Trade and Cooperation Agreement (TCA) concluded between the EU and the UK and which entered into force on 1 May 2021 sets out preferential arrangements in areas such as trade in goods and in services, digital trade, intellectual property, public procurement, aviation and road transport, energy, fisheries, social security coordination, law enforcement and judicial cooperation in criminal matters, thematic cooperation and participation in EU programmes. [4] 

While the TCA makes commitments to cross-border cooperation on health matters, it does not contain specific provisions relating to health services or healthcare products supply other than to make these tariff-free in respect of both imports and exports (as with all other goods traded with the UK). 

However, those parts of the TCA which relate to mobility, regulatory cooperation and rights to paid work in member states impact on the wider NHS role in international best practice, education and continued professional development, including in relation to commercial and not-for-profit opportunities it might seek out across the EU. 

It is fair to say that the UK otherwise remains in transition, both from the European regulatory frameworks, of which we were a part for over 40 years, and towards any UK future systems and standards that are now in development. 

For the English health and social care system, this transition relates primarily to our regulatory regimes for medicines, medical devices and professional qualifications; our access to EU and rest-of-world innovation, life sciences and clinical trials collaboration; and trading arrangements impacting our access to important supplies of healthcare products from EU partners or providers.

Unilateral action by the UK

The key risks associated with EU Exit for the UK’s health and care system were addressed not via the TCA but by unilateral action in UK law and operational practice, as evidenced by the following: 

• The recognition of CE-marked medical devices for placement on the UK market, subject to the requirement to register these with the Medicines and Healthcare products Regulatory Agency (MHRA) to enable post-market surveillance.
• The light-touch assessment of European Medicines Agency approved medicines prior to placement on the UK market, on the assumption of high clinical quality.
• The unilateral recognition of professional qualifications secured in EU states, such as for doctors, nurses and healthcare professionals. In respect of professional regulation, the UK was no longer governed by the EU Mutual Recognition of Qualifications Directive. 
• This has led to the General Medical Council, Care Quality Commission and the royal colleges of nursing and midwifery unilaterally recognising overseas qualifications, with country-specific caveats, for doctors from EU countries. These changes meant up to 63,000 NHS staff and 104,000 social care workers who qualified in the EU could continue to practice in the UK with their training and experience accepted by all health and social care regulators. 
• Our pragmatic operational approach to removing trade barriers, for example in relation to unilateral recognition of EU member state batch testing of medicines entering the UK market.
• The unilateral recognition of clinical trial sponsors established in an EU member state without the requirement for an equivalent sponsor to be based in the UK.

It remains unclear if the cessation of free movement rights, and so UK workforce dependency pivoting to non-EU countries (the health and social care visa), has had a skills impact on the UK health and social care workforce (either positive or negative). 

Given UK regulatory and registration standards, this seems unlikely for doctors and nurses. Additionally, the UK will have retained EU national workforce as a result of the Home Office’s EU Exit Settlement Scheme (where accessed). 

However, in terms of access to appropriately trained health and care professionals, it is undoubtedly the case that applying a visa regime to trained EU nationals limits the pool within which the NHS is able to easily recruit, given the additional costs and limitations of that regime. 

In summary, the actions taken by the UK had to be unilateral because they could not realistically form part of the TCA given that the UK retains the right, in any future system or regulatory change yet to be implemented, to diverge as part of the legal independence it now has from EU law and institutions. 

However, similar unilateral action has not been taken to date by the EU as a bloc or by individual member states. This means there are different barriers for exports from the UK than for imports into the UK, most notably in relation to batch testing of medicines, medical devices and associated medical products.

Additional agreements between the EU and UK

Despite this, there have also been areas of significant cooperation between the UK and the EU. Most notably: 

• The UK negotiated agreement with the EU, reflected in the Windsor Framework of 2023, [5] to ensure the access of British citizens in Northern Ireland to UK medicines supply, regardless of the origins of the medicine. This represents both a bilateral political and an operational success. The framework states that this “responds to the overwhelming calls from industry for stability and certainty and can give reassurance to patients and clinicians in Northern Ireland well into the future.” It is also said to safeguard “frictionless access to the EU market for world-leading Northern Ireland pharmaceutical and medical technology firms.” For medicines, the MHRA is now responsible for approving all drugs for the whole UK, and medicines can be supplied in single packs, within UK supply chains, with a single license. Individual packs of all medicines placed on the NI market should bear a label indicating ‘UK only’, indicating compliance with UK regulations and preventing sale of these products in the EU, via the border with Eire. 
• The Windsor Framework also unlocked the political will to implement the element of the Withdrawal Agreement which legislated for ongoing UK access to the Horizon programme and its successor. UK organisations are now able to participate in Horizon Europe calls for proposals on the same terms as institutions from other associated countries. [6] Participation in Copernicus, the EU Earth Observation programme, also now enables UK access to a state-of-the-art capacity to monitor the earth and to its services, as well as provide the UK research community with access to unique data, which is often required on Horizon Europe projects.
• The UK negotiated third-country access to the EU’s first Joint Action on a European Health Data Space – TEHDAS [7] – with a view to the future sharing of patient records across participating states to support healthcare delivery or for secondary research purposes. 
• The UK negotiated associated status to the EU Critical Medicines Alliance, focused on the future production and supply of a list of critical medicines in light of wider supply chain impacts arising from geopolitical change. [8] 
• The UK negotiated a data adequacy agreement, due to expire in 2025, with the EU to ensure assimilation to the EU GDPR standards and enable the ongoing exchange of data, including for health purposes, with adequate security provisions in place. [9] 
• The UK has continued engagement with the EU Commission, led by the UK Mission for Health (Foreign, Commonwealth and Development Office), in relation to antimicrobial resistance and the solutions required at continental level to ensure the future health of all European populations. 
• The UK negotiated with the EU to disapply new EU legislation in Northern Ireland due to take effect in 2025 which, had it been implemented, would have banned the use of amalgam in dental procedures. This would have created different rights to dental treatment, and associated cost, in Northern Ireland than in the rest of the UK, creating health inequity at a complex time for the Northern Ireland health system.

Conclusion and recommendations

The negative impacts of EU Exit on the UK’s health, and that of EU member states and Europe as a continent, have been mitigated as a primary and direct result of unilateral actions by the UK and through piecemeal negotiation of specific associate agreements with the EU Commission. 

These unilateral or negotiated actions have, in addition to the free trade arrangements secured in the Trade and Cooperation Agreement and the avoidance of a ‘no deal’ Brexit, served to protect the UK health system and its patients from the worst effects of EU Exit. They also demonstrate the pragmatic, mutually beneficial and patient-focused nature of the UK’s relationship with the EU Commission since 2021, when the transitional period concluded.

Put together this provides for a solid foundation for future, closer cooperation, albeit not necessarily within the narrower confines of the Trade and Cooperation Agreement now due to be reviewed in 2026, which does not focus on health matters (this being uncommon for an international trade deal). [iii] The most specific health provisions within the TCA are limited to the mutual and ongoing access to healthcare when travelling across the EU and UK, though with some additional restrictions for certain health conditions, such as kidney dialysis. This is now referred to as the Global Health Insurance Card, replacing prior arrangements on use of the European Health Insurance Card (EHIC). 

While it is feasible in reviewing the TCA to seek adaptations to existing content, for example to establish a mutual recognition agreement under Article 2, its scope is relatively limited in relation to wider considerations of health policy and health cooperation. This is also a position reflected in the EU Commission’s comments to date, at both political and official level.

We note that the Labour Party manifesto committed to securing a Veterinary Agreement with the EU to mitigate the impacts of border checks on phyto-sanitary products, the scope of which might be extended to include plants as well as animal products. This is a matter of health, pertaining to our access to high-quality food and plant products, which would be mutually beneficial. However, we think the scope of such an agreement, if secured, would also preclude wider matters of health policy and health access discussed here. 

We therefore recommend that the government consider, at the right point and with the right sequencing, proposing and seeking to secure a standalone Health Protection Agreement with the EU. Such an agreement could incorporate the following and act as a foundation for medium-term expansion to other areas of health policy: 

It is worth underscoring that none of the proposals would undermine the regulatory or political autonomy of either the EU or the UK. Instead, the proposed Health Protection Agreement would be consensual and subject to iterative review. 

Nor does the proposed agreement offer either signatory any trading, economic or political advantage, given the truly mutually beneficial nature of its proposed scope and inclusions. 

In making these proposals, the UK is not seeking to re-gain the benefits of EU membership without the responsibilities of the same. This is because health as an area of policy is not a formal pillar of the EU Treaty and so of the Commission’s leadership. Instead, it was, prior to 2021 and remains, within the autonomous domain of each member state. This is why the concept of a Health Union of member states is in development and being supported by the EU Commission, as well as why EU4Health is available by association to non-member states.

Health, in respect of preventing future harm, maximising opportunities for collaboration and working towards the highest regulatory and safety standards, is unique. In a complex global landscape and given the threat of further pandemics and health crises – from antimicrobial resistance to the disruption of supply chains, from the benefits of medical technologies to the risks they pose to patient safety – it is right to take collective action, and to do so as the continent of Europe.

With strong leadership on both sides – a re-elected Head of the EU Commission building on the wider agenda for pan-EU health, and a new British government keen to expand its relationship with the EU, and with a strong electoral mandate to do so – now is an important opportunity to seize. 

This is not about trade, or free movement, nor current or previous politics. It is about geographical and capability-led pragmatism: working together, building on existing positive engagement and cooperation since 2021 to maximise the future opportunities for health protection in partnership and with purpose. 

That health is unique is also why a bespoke approach to building this partnership should be taken, with prompt action on a Health Protection Agreement between the EU and the UK working to the advantage of all populations across the continent.

Footnotes

iii The TCA is due to be reviewed by the new Labour government and the EU Commission in 2026. That process is underway at official level with engagement via the UK and EU Domestic Advisory Groups.

iv  The UK has a data adequacy agreement with the EU due to expire in 2025 unless further extended on review.

References