The UK government marked two years since exit from the European Union with a hundred-page document entitled The Benefits of Brexit. With an enthusiastic, upbeat tone, this sets out a range of advantages across many areas of regulation, policy and spending. Days later, Jacob Rees-Mogg was appointed as a Cabinet-level Brexit Opportunities Minister to lead this agenda.
A close look at the sections which are relevant to health reminds us, though, that most of these advantages are hopes or goals rather than current realities.
Although the immediate costs for trade and migration have been felt in the UK health sector, a lack of a clear, broadly supported plan for life outside the single market means Brexit has changed remarkably little in many areas of health and care. In several areas, the UK has stood still as the EU moves on.
Breaking down each of the “benefits” relating to health shows a repeating pattern. Many of these are either areas where there is a genuine possibility of the UK doing something new and different, or where the UK has an important choice between striking out on its own and trying to remain close to bigger markets.
But a lack of planning, the difficulty in accepting the costs of the bold decisions now possible in policy areas involving life and death, and the relations the UK still has with the EU and other countries mean that a government notionally committed to seizing any opportunities offered by Brexit has actually struggled to do so openly or quickly.
“£57 billion more for our NHS”
In its first section, the document emphasises the UK’s ability to “manage its own money” and not to pay EU contributions. A bullet point follows saying that NHS spending will be £57 billion higher in 2024/25 than in the year of the EU referendum.
The document shies away from actually stating any kind of causal link. The Office for Budget Responsibility, which monitors public finances for the UK government, assumes that the net effect of Brexit means less rather than more money is available, due to a slowdown in economic growth.
The document is right to note that Brexit means the UK is not involved in the €750 billion Recovery Plan for Europe. This includes programmes that are being used for health system recovery and pandemic preparedness initiatives in the EU.
The UK is instead borrowing all funding for recovery on its own account. To some extent it is using this to invest in health, paralleling what we see in the EU. The NHS is receiving some extra money to clear waiting lists, and its capital budget is set to rise to its highest level for many years, funded by a Spending Review based on higher borrowing. However, this has come packaged with a very strong emphasis on new investment in hospital buildings and hitting targets, rather than investing in new types of care or pandemic preparedness. The UK has also limited spending horizons to its usual Spending Review period, rather than the seven-year timeframe used by the EU. This feels far from a radical new direction.
Changes to the migration system feature prominently. This is an area where the UK really did take a sharply different course – but policy changes ever since have suggested that the government could not accept the different outcomes which resulted for health and care staffing.
On January 1 last year, the government ended the free movement of labour and introduced a “points-based system”, making it effectively impossible to migrate to most social care roles and some lower-paid NHS positions, and introducing onerous new fees for employees and employers.
By summer, however, with growing concerns about NHS workforce shortages, a “health and care visa” was introduced, exempting health care workers from some of the new fees and using their pay scales as a minimum. By winter, with troubling trends in social care, workers in this sector were added to the Shortage Occupation List after years of resistance – although with a minimum required salary above what many earn.
One change has been to introduce a more rigid set of language tests for staff from the EEA, such as for doctors requiring a one-size-fits-all test by the GMC instead of assessments specific to the requirements of a job as permitted under EU rules. Even with the new visas, meanwhile, many additional costs remain, and the Health Secretary has kept alive the prospect of NHS staff migrants again being required to pay the health surcharge – an additional tax from which they have been exempted during the pandemic.
The heavy reliance on migration has always been a sticking plaster over the fundamental problem of the UK’s persistent failure to train, attract and keep enough health and care staff from within its borders. An attempt to rip it off without a long-term plan for training, or enough money to make pay in social care competitive, was always likely to end in trouble.
It might seem logical that one indirect benefit of a six-year Brexit process would be to make the UK more serious about covering staffing needs domestically. But instead the short-term response has been to turn back to immigration as the solution – while making it somewhat less efficient and attractive.
Regulating medicines, devices and science
The document contains plenty of high-level aspirations and principles for the UK’s regulatory system after Brexit: “Diverging from the EU in certain areas to give UK businesses a competitive advantage”, “a more holistic and efficient approach”, “leading from the front”. But the specific agenda for medicines, medical devices, and health research remains at an early stage, reflecting the limited capacity for policy-making and the difficulty of many of the choices on offer.
The ‘five principles’ for regulation listed in the document could all equally well be claimed by the EU. The accompanying Economic Regulation Policy Paper lists five more specific principles (accountability, focus, predictability, coherence, adaptability and efficiency) which again closely mirror EU aims, and indeed date from the period of EU membership. They tell us little about the UK making different or difficult choices.
In fact, the last year has been marked in regulatory terms by the EU diverging increasingly from an UK which is standing still.
As we described in last year’s report from our programme funded by the Health Foundation, the EU has brought in new regulations for medical devices applicable since May 2021, and will reform the system for diagnostic devices in May 2022. But the relevant law in Great Britain remains the law in older EU directives.
Easy movement of drugs will also be inhibited by another legal change in Brussels, the anti-fraud Falsified Medicines Directive, which places tracking tabs on medicines packs. Great Britain is not part of it – although Northern Ireland is – and imposing its own version risks complicating imports even more.
Great Britain therefore lacks any competitive advantage from modernising regulation, and is operating without safety provisions brought in by the EU following scandals such as those affecting breast implants. In practice, it is currently simply rubber-stamping EU approvals in order to eliminate burdens on imports.
The UK’s regulator, MHRA, consulted last year on reforms that would see the UK mirror the EU changes in many ways – such as a unique identifier to track each device, and new individuals accountable for complying with regulation. They would also introduce new routes to market, however: recognising other countries’ approvals, while allowing some products to skip ahead to be used on patients as they are assessed instead of afterwards.
These attempt a strategy of mostly aligning with the EU, while smoothing access to imports with a side route where Great Britain goes its own way to attract investment for some innovative products. The difficult part, however, will be the specifics of a route to market fast enough to pull innovative companies away from bigger markets – yet without endangering patients. Without this, the UK intention to accept approvals from elsewhere gives firms every incentive to introduce products elsewhere first.
On medicines, meanwhile, the new minister has stated that “we can use our freedom to approve life-saving drugs faster and at better prices than ever before”. Concrete plans are lacking: the recent rapid approval of vaccines and new routes combining medicines approval with value for money checks have been under retained EU law. Reports have suggested a strategy of general alignment, plus fast tracks for certain innovative projects. As with medical devices, the logic makes sense, but the details will be difficult.
The EU has also introduced a new Clinical Trials Regulation with a much-delayed information system making it easier to get research approved across borders. Here, again, the UK’s MHRA is consulting on its own set of changes, which the document describes as “making it faster and easier to run clinical trials”.
These mirror some of the EU changes – such as defining a class of low intervention trials – but go beyond them. This is not necessarily in the deregulatory, speed-oriented direction implied by the Benefits of Brexit document. For example, the UK proposals require more patient involvement in running trials. They propose faster deadlines for decisions, which may increase efficiency and attractiveness. The UK cannot duplicate the main selling point of the EU reforms: a single approvals system across 27 countries, with decisions passed on from one country which takes the lead.
All indications are that the pace of change in Brussels will remain rapid. The EU’s new shared "health technology assessment" process comes into effect in 2025 under Regulation 2021/2282. This process will result in a shared EU-wide assessment of clinical “added value” of new medicines and other health technologies, which will not replace national decisions to make them available in member states but must be considered in those processes. There is potential to use the huge buying power and regulatory capacity of the EU to get more value out of medicines than a smaller country can. A general medicines consultation, and a specific consultation about medicines for children and rare diseases, are expected to lead to proposals for new EU law in late 2022.
The EU’s legislative process is working through these controversial choices, perhaps less tied into the distraction of the pandemic than the UK’s single centre of power. As it does so, the UK’s ‘retained EU law’ position drifts further from the EU’s regulatory position. This will tend to increase the costs to firms of complying with both systems.
The risk is that we become stuck by default in a situation which recognises neither of the strategic opportunities – neither remaining aligned with an existing ‘giant’, nor creating a distinctively better regime, but rather becoming slowly obsolescent.
A new pro-growth data regime
This is described as though it exists, but is in reality only under consultation. We have noted for some time that the question of “data adequacy” – the ability for data to flow between UK and EU without additional safeguards – is important for medical research, monitoring of public health and at times actual treatment.
The consultation document is ambiguous as to whether this status – which the EU grants to countries whose systems broadly align – could be sacrificed in the interest of a more competitive UK system. A less demanding system that loses adequacy will advantage some, whose research or services take place entirely within the UK. But for those who seek to share data with Europe, it will mean applying two sets of rules with added paperwork to demonstrate this.
Conspicuously absent is any mention of divergence from EU law on employment conditions for health and care staff.
This is perhaps surprising, as the EU Referendum Leave campaign prominently mentioned as a health issue the Working Time Directive, as applied to doctors, meaning “hospitals no longer able to ensure that they have enough staff on hand to look after patients”.
In part, this may be driven by commitments in the 2020 Trade and Cooperation Agreement with the EU not to reduce labour and social protections – although the EU could only act against lower standards if they affected trade or investment. Another factor may be the likely downsides in cutting protections for a workforce that the NHS needs to retain in the wake of a gruelling pandemic.
The document refers several times to changes to how the NHS purchases services. “Through the Health and Care Bill currently before Parliament, we are establishing a new bespoke health procurement regime to enable our NHS to arrange health care services more flexibly, reducing bureaucracy and waste.” However, these proposals are not in fact contained in the Bill itself and have yet to be published in full.
Our research last year underlined that officials and NHS managers have quite different expectations, hopes and concerns about these changes. Some believe they will reduce waste, others that they risk increasing legal action, or enabling cronyism. Similar changes would have been possible before Brexit by abolishing the “internal market” in the English NHS. The removal of underlying EU law on how such markets should work allows the NHS market to be watered down without being officially dropped, creating more ambiguity.
The “benefits of Brexit” are identified as benefits to the UK. But in reality, many of these areas of possible divergence cannot apply to Northern Ireland, which remains part of the EU single market for nearly all physical products.
This is not just a matter of phrasing. If regulations in Great Britain do make it more competitive relative to the EU, they will also make it more competitive relative to Northern Ireland, disadvantaging one of the UK’s poorest parts. Meanwhile, the more divergence occurs, the harder it may be for medicine suppliers to justify carrying out a separate process to keep supplying Northern Ireland with the full range of products that Great Britain get.
“A world of future opportunity”
The document’s sections on trade again emphasise a high level of general ambition, although many international processes are at a very early stage. There is considerable discussion of trade promotion and diplomatic activities which are not dependent on Brexit.
The prospects of the UK entering CPTPP, a Pacific trade bloc, are featured prominently. As we have noted, while this has benefits for sectors facing tariffs, this is generally not the case for health-related products. The agreement would introduce Investor-State Dispute Settlement systems sometimes associated with legal action against public health measures by large corporations, and may limit the UK’s room for manoeuvre in regulating food and drink.
The starting point is that the UK has sacrificed a close trade relationship with a big market for less close relationships it is only starting to build. The port of Felixstowe on the cover of the report had to turn away container returns in the autumn of last year because they were too full. Medicines exports to the EU have fallen considerably without rising for non-EU countries.
As we heard from those we interviewed last year, there are new types of global cooperation that could support health care and science, including global funding programmes and greater sharing of medicine and device approval. These are not mentioned, even though the UK and its regulators actually have approached international joint working programmes on cancer medicines and medical devices.
Transparency and trust
The way in which the agenda of divergence is being approached risks magnifying backlashes or misunderstanding once more progress is made in some of these contentious areas.
The tendency to only describe upsides means stakeholders and communities who might be concerned by decisions could discover this suddenly and feel that it has been kept from them. This dynamic has derailed other health policies in recent years – notably successive attempts to build a centralised database of general practice records. The rhetorical emphasis on deregulation is likely to increase concerns in sectors like health where privacy and safety are common considerations.
Transparency remains limited. The document promises an open list of retained laws to inform public debate, which is welcome but does not exist currently. The Retained EU Law Review established last year appears to be a very closed process, with no public calls for evidence or open consultation.
The document suggests using “sunset clauses” for some regulations, whereby they would automatically expire. This might cause uncertainty and regular controversy unappealing to researchers or investors.
Some of the health-related or arguably health-related fields prioritised, such as gene editing and the use of artificial intelligence, will be particularly difficult to regulate with the confidence of the public unless trust is built up.
Facing up to the reality
The underlying aim of the 2020 Withdrawal Agreement was to regain scope for the UK to make our own rules, even at the cost of reducing trade with the EU.
In principle, this can indeed offer benefits to set against the financial cost and loss of trade. It should be possible for a smaller country such as the UK to make rules that are more adapted to our specific strengths and weaknesses than the ‘giants’ of the US or the EU are able to – or to pick and choose where we align with the major players.
But this is not easy. In fields like data, going our own way might benefit some, but it will make it harder for us to forge close research relationships with our nearest neighbours. In medicines and devices, aligning with the major players has only limited benefits, but a new UK system needs to trade off the interests of different sectors, and even of safety and innovation. Not everyone can be a winner.
For the real "benefits of Brexit" to be realised, a much more honest analysis and debate is required, one that recognises costs and realities rather than just hopes and goals.