Towards a Sovereign Health Union
By Frank Vandenbroucke, Deputy Prime Minister and Minister of Social Affairs and Public Health - Belgium
With a provisional agreement on the Critical Medicines Act reached on 12 May 20261, Europe has taken a step forward towards a strong European health union. And yet pressures on Europe’s health system have never been so high and threaten the very core of its existence. These challenges to the foundational logic of the solidarity-based European welfare state coincide with other major challenges of our time such as aging populations, innovation challenges, (cross-border) health threats, climate change and bioterrorism, socio-economic disparities, migration and medicine shortages.
Pressures on Europe’s health systems
Since long, the United States has had a fundamentally different conception of health, the state and the social contract compared to Europe. By recently signing his Executive Order 14297 on Most Favoured Nation pricing on medicines, President Trump has however started framing the European model with its negotiated prices as a form of trade cheating, thereby urging European governments to increase medicine prices2.
In Europe and contrary to the United States, medicine pricing is not a discretionary policy of the executive, but rather is embedded in the logic of social insurance. Governments use pre-defined, transparent criteria to determine what society will pay for a medicine and what concrete health outcomes it will deliver.
Through this process, Europe achieves good health outcomes with near-universal health care coverage3. By only comparing the prices of medicines across the Atlantic without taking the solidarity the European HTA model provides into account – and which the American system so desperately lacks – President Trump essentially delegitimizes the European healthcare system. And yet Europe is too complacent in defending its system against such unfounded claims.
President Trump’s challenge to our health system also raises a challenge from within Europe. For too long, Europe has treated the supply of basic medicines as dispensable, allowing production of medicines to migrate to where it could be done most cheaply, thereby leading to major dependencies on active substances and critical medicines from Asian countries.
Medicine dependency is a security dependence and it’s essential that Europe invests more in strategic independence for its medicines.
The Critical Medicines Act is a first step in the right direction, but the Act should now deliver in practice. To be successful, the Act should be backed with the appropriate resources, industrial strategy and political will to make it work.
This also ties into the current bone of contention in relation to the next Multiannual Financial Framework whether public health will be funded through the broader European Competitiveness Fund as a subset of industrial policy, or rather, as it deserves, retain a standalone budget4.
Europe has also been facing competitiveness issues, making biotech firms conduct their clinical trials in China or the United Stated5. They do so as trials and regulatory approval processes are faster, the capital is deeper and the scaling infrastructure is more developed compared to Europe. The proposed Biotech Act is an opportunity to change this.
It aims to enable building an industrial fabric for advanced biomanufacturing on European soil and create a capital architecture that allows to raise serious money. Equally important to compete with the United States and China, the Biotech Act should enable more coordination and integration among member states on conducting research and development. To name a few, the design of multi-country trials should be facilitated through standard contracting practices, ethics review processes should be harmonized, and site start-up procedures facilitated. A structured commitment to more integration, be it through standardized contract templates, better quality ethics review, trial-ready site networks with shared quality standards and serious investment in the clinical research workforce is therefore essential to fix the competitiveness issue.
The path forward
The pressures to Europe’s health system are not independent but rather reinforce each other. They demand from Europe a clear and confident articulation of what solidarity-based public health systems mean. Europe needs to work on its competitiveness model, without thereby losing its foundational logic that health is a precondition for the well-functioning of its society and economy and wellbeing of its citizens. The 27 European welfare states represent together a market of 450 million insured citizens. Still, today the ‘European layer’ which would allow the health systems to function together and pool evidence, coordinate health technology assessments and coordinate supply and data, is lacking.
Where Europe is integrated, such as in the single market for goods, it is strong. Where Europe remains fragmented and acts like 27 small markets, such as in clinical trials, market access or procurement of essential medicines, it loses its attractiveness.
Europe’s attractiveness to investment is not built on high prices or fast approval rates, but rather on its welfare states with universal access, strong public institutions and a social contract that gives the market its stability and its depth.
The path forward is consequently not to choose between solidarity and competitiveness, as if they were rival claims on the same euro, but to complete the European integration project. Europe should build a European health Union that is sovereign in the full sense of the world: capable of defending its own model, securing its own supply, growing its own industry and demonstrating that universal, solidarity-based healthcare is the foundation of a stable, investable and human twenty-first century society. With the Critical Medicines Act, which concerns the medicines on which Europe is already dependent today, and the Biotech Act, which aims to ensure that the medicines of the future are also produced in Europe, there’s real momentum to do so6.
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2 The justification for MFN being that Europeans “forcing American patients to pay for a disproportionate amount of global pharmaceutical research and development” by “suppressing the price of pharmaceutical products below fair market value.”
3 In Belgium, 99.4% of the population has access to reimbursed medicines under the compulsory health insurance.
5 The Draghi report: A competitiveness Strategy for Europe, 9 September 2024.
6 Implementation of these legal frameworks should be coupled with a consistent implementation across the EU of the EU Health Technology Assessment Regulation (EU 2021/2282) which established a harmonized framework for evaluating new medicines across member states and the EU Pharmaceutical Legislation, which aims to ensure equitable, affordable and timely access to safe medicines for all patients across Europe.
