Health policy, and the politics of health, are two very different things. When Otto von Bismarck set about his mammoth social insurance reforms of the 1880s, he was motivated by one thing: politics. Specifically, he wanted to stifle and negate the allure of the Social Democrats, who had been steadily gaining support in the Reichstag.
The best way to defeat the socialists, thought Bismarck, was to play them at their own game, and copy their flagship policy of pensions and sickness funds.
Outraged, the Social Democrats initially refused to vote in the reforms – but in the end, Bismarck won out. Privately, Bismarck thought it was a bad policy. In his memoirs, he wrote next to nothing about it at all – it was merely a means to an end. Ironic then, that the German and French health systems are still commonly described as Bismarckian.
The politics of health often trumps the academic, evidence-based needs of health policy. There are implicit trade-offs in making health policy, and there is no such thing as an undeserving cause. As a previous UK Health Minister once said: ‘There is virtually no limit to the amount of healthcare an individual is capable of absorbing.’
One development which has been simmering away behind the scenes for the past decade is the concept of the ‘Europeanisation of Health.’ According to the Lisbon Treaty, health is and remains a member state competency, especially when it comes to issues of funding and prioritisation of needs. However, incremental movements towards a more unified ‘European Health Union’ have been made in recent years, notably during the pandemic through EU-led joint procurement of vaccines and the development of a common approach to personal health data in the EU. That presents the UK with a political and policy dilemma.
One of the largest movements in the direction of the Europeanisation of health is the impending arrival of a new process in January 2025: the so-called Joint Clinical Assessment (JCA). Already, new medicines seeking to launch in the EU require European regulatory approval via the European Medicines Agency (EMA). However, the JCA goes one step further in its ambition: it will provide a common framework for the clinical evidence used to make decisions about the relative effectiveness of new therapies in member states. While decisions about how to fund the treatment will continue to be made by national or regional agencies, the JCA is potentially an early step on the way towards a European common market for medicines. Indeed, there are many in the Commission who would like to see the concept of EU-wide joint procurement applied not only to special cases such as vaccines, but expanded towards a wider set of circumstances, such as medicines for rare diseases.
Is this good for patients in Europe? The proof will be in the pudding. If it acts to speed up processes, reduce barriers, and enable European patients to access innovative new medicines earlier than they do today, then there would be no complaints.
However, if the JCA only serves to create another layer of bureaucracy and red tape – as many close to the new JCA believe it will – then it will not only impact European competitiveness, but also anger EU health stakeholders, most important of whom will be patients. The head of IQWiG, one of the key German health assessment bodies, recently said there were ‘ big challenges in the regulation’, but that it was ‘about upholding the European idea,’ an admission which is often the fallback if regulations are not actually helpful.
The UK is not part of the JCA and so will be exempt from its decisions, so where does that leave the UK in this debate?
The UK’s Strategic Dilemma
Theresa May said in 2017 that the UK Life Sciences Industry was ‘the most strategically important of any industry’ for UK Plc.
Since then, the UK has fallen behind in its position as a global life sciences leader. A few things have happened. Firstly, the UK’s exit from the European Union has taken jobs and the prized European Medicines Agency away from London to Amsterdam. NICE, the UK’s drug pricing watchdog, is known the world over for its stringent use of cost-effectiveness analysis – and is viewed as an increasingly impenetrable force by global companies. The measure of an ‘economically justifiable price’ for a new medicine launching on the NHS has not been updated for inflation since 2004, for example.
Arguably before Brexit, NICE would have been one of the agencies (alongside the German IQWiG and Dutch ZIN) taking centre stage in creating the framework for the European assessment.
However, by being out of the picture, the UK can now sidestep the almighty political bunfight and bureaucratic quagmire that the JCA has the potential to become. If it seizes this opportunity, the UK can become more nimble, more progressive and ensure that it provides faster and more tailored access to new treatments. But this requires work.
The UK cannot escape the fact JCA will make it a much smaller market compared with the behemoth of the EU. What to do? One option would be to work more closely with likeminded countries, to deepen projects like the Access Consortium (a collaboration between Australia, Canada, UK, Singapore, and Switzerland), strengthen bi-lateral agreements with countries like South Korea and Japan and ensure that the UK is able to engineer scenarios where it is more than the sum of its parts. Would these countries ever join a cohesive ‘bloc’ to mirror the EU JCA? It is not unthinkable.
As patient access to new treatments continues to come with additional layers of regulation, the other thing the UK can do is to utilise its world-class policy institutions and life sciences expertise to provide a more bespoke option – one example is the world-first CMA guidance on the use of combination therapies in oncology, or the nods to improving the UK’s competitiveness in life sciences through the Darzi Review and new industrial strategy.
In such matters, the UK now has the potential to be a zippy skiff on the water, compared to the EU’s slow-moving oil tanker. Tweaking its processes and regulations to ensure it is a growing rather than a diminishing voice in global pharma boardrooms. The opportunity is there. As Sanofi boss Paul Hudson said recently, the UK is ‘at the back of the race of turtles’ when it comes to government policy to support the development of new medicines. This implies the UK is not doing all it could, but it also implies that its competitors in this race would be easy to catch.
The Europeanisation of health is far from inevitable – but it is trending in that direction. The UK must adapt to the changing dynamics in the politics of health. Making the most of its regulatory freedom is the smart way to stay ahead of the pack.
Click here to subscribe to our daily briefing – the best pieces from CapX and across the web.
CapX depends on the generosity of its readers. If you value what we do, please consider making a donation.
