The Sovereign Health Union: Defending the Soul of Europe

17 februari 2026

Keynote address by Frank Vandenbroucke, Deputy Prime Minister and Minister of Social Affairs and Public Health, Belgium

Conférence ‘L’Europe de la santé’, Paris, 17/2/2026.

During the Belgian Presidency of the Council, in the first half of 2024, we articulated a vision for what the European Health Union should become.[i] It was a Europe that cares, prepares and protects. Cares, in the sense that it would implement ambitious prevention strategies around food, alcohol and tobacco, overuse of antibiotics, and tackle the slumbering health workforce crisis. Prepares, in the sense that it would strengthen our capacity to deal with serious health crises. And protects, to help Europe deal with medicine shortages and dangerous dependencies. This was a broad agenda, dealing with the question how Europe can sustain national health systems as a ‘holding environment’, that both nourishes and protects them.

That was less than two years ago, but it already feels like a different era.

Since then, the geopolitical ground beneath us has shifted. A new American administration has launched what I can only describe as an ideological offensive against the very foundations of European social security systems. At the same time, Europe's own internal machinery has traded many of its climate, social and health ambitions developed over the past 10 years for a strategy oriented towards competitiveness, defence and security.

I want to speak to you today about what I call a triple squeeze on European health systems. From the West, an ideological attack on solidarity-based health care and universal coverage. From the East, dangerous dependencies on supply chains we do not control. And from within, a drift toward treating public health policy as a subset of industrial policy.

These three pressures are not independent. They reinforce each other. And they demand from us a clear and confident articulation of what solidarity-based public health systems mean to Europe, and what we are prepared to do to defend them.

Movement 1: The Squeeze from the West

Let me begin with what is happening across the Atlantic, because it is more than a trade dispute. It is a collision between two fundamentally different conceptions of health, of the state, and of the social contract.

In May 2025, President Trump signed Executive Order 14297, directing his administration to implement Most Favoured Nation pricing on medicines: the principle that Americans should pay no more for medicines than other developed countries do. While this, in itself, is an understandable and admirable objective, the stated justification is that Europeans are, and I quote, "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."[ii]

This framing is not innocent. It casts the European model – our Health Technology Assessments, our evidence-based reimbursement, our negotiated prices – as a form of trade cheating. It suggests that when a Belgian or German or French authority evaluates a medicine and determines what it is worth to its society, this is an act of unfair competition rather than an act of responsible governance.

This view is actively supported by PhRMA, the Pharmaceutical Research and Manufacturers of America. The way PhRMA explains the problem to the American administration is interesting, as it shows the extent to which the attack on our European health care systems is not merely about adjusting price levels by some x% or y%. The attack on our European governance of health care is systemic, and PhRMA does not shy away from being very explicit about this: “In many countries outside of the United States, governments are the primary payers of medicines and in effect dictate the price of medicines and the extent and timing of patient access to medicines. This dominant position often results in US trading partners failing to appropriately recognize the value of innovation in their pricing and reimbursement policies, instead engaging in actions that distort markets and artificially depress prices below what a competitive market would provide and delay patient access to medicines. Foreign governments increasingly employ a range of measures, including biased health technology assessments, mandatory price cuts and revenue claw backs, international reference pricing, unreasonable reimbursement delays and erosion of intellectual property protections. These measures often are layered to exert maximum pressure to artificially devalue the medical innovation that these countries receive.”[iii] PhRMA urges the US Trade Representative to use trade negotiations, not simply about prices, but to secure systemic reforms in other countries, notably in European countries.

In fact, his description of the issues at hand is profoundly misleading about what is actually happening on both sides of the Atlantic.

In European health systems, governments indeed use pre-defined, transparent criteria to determine what society will pay for a medicine. The principle is that every euro of public money must deliver concrete health outcomes. When a new medicine arrives, we ask: does it offer genuine added therapeutic value compared to what we already have? What is the evidence? And, importantly: what would we have to give up, elsewhere in the health system, if we pay the price being asked? These are legitimate questions of responsible stewardship. Through this process, we achieve good health outcomes with near-universal coverage. In Belgium, 99.4% per cent of the population has access to reimbursed medicines under the compulsory health insurance.[iv] In the EU and EEA as a whole, approximately 450 million citizens benefit from universal health insurance.[v]

I do not want to idealize this model. European HTA systems still struggle with timely access to innovation, particularly for patients in smaller markets and for high-cost medicines. The gap between marketing authorization and actual patient access can stretch to years (but finally we reach a conclusion after discussions and negotiations with all relevant stakeholders). And even in a system built on universal coverage, we face hard trade-offs: between rising public expectations and finite budgets, between the promise of breakthrough treatments and the need to keep the system solvent for everyone. These are real tensions, and we do not always resolve them well. But the foundational logic – that public money should deliver demonstrated health value – is sound. It is this logic that is under attack.

President Trump says he wants American prices to come down to European levels. One might expect, then, that he would study how we achieve those levels, and perhaps conclude that transparent, evidence-based assessment is part of the answer (together with a correct engagement of stakeholders). But that is not what is happening. The MFN Executive Order simultaneously denounces our pricing mechanisms as unfair, yet proposes to import their results by forcing companies to lower their prices to the same level. It condemns the method but covets the outcome.

Because this is the central incoherence: it is logically impossible to argue that European prices are unfairly suppressed and that they should serve as the ceiling for American prices. If our prices are illegitimate, then benchmarking to them spreads the illegitimacy. If they are legitimate, then the accusation of freeloading collapses.

The truth is that the Trump administration wants European prices without the European model. It wants lower numbers on the invoice, but not the solidarity that produces them. It wants the outcome of HTA without the principle that public investment decisions should be guided by what society gets in return.

The accusation that drives this is that Europeans freeload on American innovation. That our lower prices force American patients to carry a disproportionate share of the cost of global pharmaceutical R&D. This is a serious charge. It deserves a serious answer. And the answer, I believe, shows that the accusation is also factually questionable on many counts.

First of all, where does the American dollar spent on healthcare actually go?

The United States spends more per capita on health care than any country in the world – roughly 12,555 dollars per person per year, compared to around 6,600 in Belgium.[vi] If that premium were simply flowing to research, we might have a debate. But it is not that simple.

To understand why the reality is more complex, you need to understand something about the American pharmaceutical market that has no equivalent in Europe: the role intermediaries take in the system, such Pharmacy Benefit Manager, or PBM. In Europe, the state negotiates medicine prices on the basis of transparent criteria, and the result is a price that applies to all patients. In the United States, there is no single negotiator and no single price. Instead, there are private intermediaries – PBMs – who sit between the manufacturer, the insurer, and the patient.

Three companies – CVS Caremark, OptumRx and Express Scripts – control approximately eighty per cent of this market. Each of them is vertically integrated with a major health insurer and a pharmacy chain. They negotiate confidential rebates from manufacturers in exchange for placing a drug on a preferred formulary, the list of medicines that an insurance plan will cover. These rebates do not go back to the public system; rather they vanish into the intermediary's margin.

According to a 2024 Interim Staff Report from the Federal Trade Commission, the parent conglomerates of the 'Big 3' PBMs saw their adjusted operating profits surge by 133% between 2016 and 2023. The Commission’s findings suggest that vertical integration enables these entities to 'retain levels of dispensing revenue well above estimated drug acquisition costs,' effectively internalizing profits within their own corporate ecosystems at the expense of transparent market pricing.[vii]

The result is what analysts call the "gross-to-net bubble" – the gap between the publicly visible list price and the actual transaction price after confidential rebates. In the United States, this gap has been estimated at 356 billion dollars – or roughly 330 billion euros – in 2024.[viii] For comparison, the gross-to-net bubble in Belgium for reimbursed medicines in ambulatory care was situated at 2.3 billion euros during that same year.[ix] Adjusted for population, the American gross-to-net bubble is therefore roughly five times larger than in Belgium.

I want to be clear: I am not saying that prices for brand-name originators (who innovate) are not higher in the United States than in Europe. We know that manufacturer gross prices for brand-name originators are higher, whilst prices for unbranded generics are lower. The rebates (the discounts which make the difference between gross and net prices) offered by the industry in the US are very considerable, and reduce the price gap in net terms significantly. Nonetheless, it is fair to assume that there is also a gap in net prices. However, since the rebate system is highly complex, it is difficult to estimate its exact impact, and it is very unclear to what extent patients benefits from these rebates.[x]

Whether higher net prices paid to manufacturers linearly lead to more R&D is a matter of controversy within the US. Between 2016 and 2020, the fourteen largest pharmaceutical companies spent 577 billion dollars on share buybacks and dividends, compared to 521 billion on research and development. More money was returned to shareholders than was invested in new treatments. This is documented by the U.S. House Committee on Oversight, based on companies' own financial disclosures.[xi]

On marketing, the picture is contested but telling. Estimates of what the pharmaceutical industry spends on marketing and promotion vary significantly depending on definitions – from around eight per cent of global sales[xii] to over twenty per cent when broader promotional activities are included.[xiii] What is not contested is that the United States is one of only two countries in the world, alongside New Zealand, that permits direct-to-consumer advertising of prescription medicines. That alone should give pause to anyone who argues that high US prices are simply the cost of innovation.Moreover, a correct debate should not only focus on the role of the private sector. Let us not forget that the US government also funds an impressive amount of basic research through NIH. Space forbids to pursue this, but it is clear that the competitive edge Europe needs also requires sufficient and efficient public funding of R&D in Europe.

Let me be clear: I am not arguing that net revenue of the private sector is irrelevant to innovation. Companies need sustainable margins to fund the long and risky journey from molecule to market. The point is that the relationship between price levels and R&D investment is not the simple, linear transmission mechanism that the American administration’s and PhRMA’s freeloading argument assumes. High revenue also flows to shareholders and intermediaries, not only to laboratories.

But I am not here to lecture the United States on its health system. We should, after all, respect other nations’ policy choices, if they do not interfere with our policy choices. I am here because the pressure on Europe is real.

Whatever the merits of the argument, the political reality is that the Trump administration is prepared to use trade coercion to force European governments to change their pricing practices. We have seen this openly.

At Davos, in January of this year, President Trump publicly recounted how he had pressured President Macron to raise French medicine prices – threatening twenty-five per cent tariffs on all French exports and one hundred per cent on wine and champagne. The Élysée responded stating that the President does not set medicine prices. Social security does.[xiv] This is not only a constitutional fact but also a philosophical one: in the European model, medicine pricing is not a gift of the executive to be traded in bilateral deals. It is embedded in the logic of social insurance.

But the response also illustrates something structural – something that matters enormously for what comes next. When the United States pressures France, it does not pressure France alone. It pressures the European Union. Trade policy is an exclusive EU competence. This means that tariffs on France are, legally and practically, tariffs on the entire Single Market. And they trigger the retaliatory capacity of the entire Single Market – a bloc of 450 million consumers representing the world’s second-largest economy. The United States would have to be prepared to absorb counter-tariffs on American goods and services worth hundreds of billions of euros.

This is not a theoretical scenario: the Commission has demonstrated its willingness to retaliate in previous trade disputes, and has prepared defensive instruments precisely for this purpose. This is why, to date, no individual EU member state has been forced into the kind of concession that the United Kingdom – no longer protected by the EU’s collective weight – made last year, conceding higher prices on medicines and lower industry clawbacks.[xv] The EU is effectively a protective armour against bilateral bullying, and we should explain this to the public far more clearly than we do.

However, that does not set us free from a thorough reflection on how we can resist – together, as Europeans – the pressure by pharmaceutical companies in Europe to raise prices, to be less demanding in our HTA,… We cannot be complacent about our European health care systems: to maintain them, they must be buttressed by more cooperation, smarter regulation and more and more efficient public investment. But the objective must be to maintain our solidarity-based systems. I will return to this in a moment, but let me first look to the East.

Movement 2: The Squeeze from the East

The second squeeze on European health systems is not ideological. It is material and all about security. And the question it poses is not whether we understand the problem – we do – but whether we are prepared to act at the scale the problem demands.

For decades, Europe treated the supply of basic medicines – antibiotics, insulin, painkillers, essential anaesthetics – as dispensable. We allowed production to migrate to wherever it could be done most cheaply. Many critical medicines are supplied by only one or two manufacturers, leaving supply chains highly fragile and dependent. These suppliers have often outsourced manufacturing processes or moved production of their finished product or active pharmaceutical ingredients (API) outside of the EU. For generic medicines, it has been calculated that between 60 to 80% of the API production has been outsourced to China over recent years, and an increasing part of other inputs to the manufacturing supply chain are being outsourced to Asia.[xvi]

During the COVID-19 pandemic we witnessed the societal cost of such dependencies: face masks, paracetamol, ingredients for vaccine production were all in short supply, exposing our health workers and citizens to a deadly virus.

These risks only have grown since the pandemic. In a world of escalating geopolitical tension, medicine dependency is no longer only a public health concern. It is a security concern. Consider a scenario that is not far-fetched: the supply chain of antibiotics is interrupted in the midst of an armed conflict. Eighty to ninety per cent of the world's antibiotics are manufactured in Asia, mostly in China. Without them, routine surgeries become high-risk procedures. Easily treatable infections turn fatal. Field hospitals cannot function. A Europe that cannot guarantee the supply of basic antibiotics is a Europe whose defence capabilities are compromised at the most fundamental level.

This is why last year eleven EU health ministers – from Belgium, Germany, Spain, Greece, Portugal and six other member states – called publicly for medicine security to be integrated into Europe's broader security framework.[xvii] Just as the United States uses its Defense Production Act to designate pharmaceutical supply chains as a national security priority – enabling it to map vulnerabilities, direct investment and issue priority-rated contracts – Europe needs instruments of comparable seriousness. Medicine security is a precondition for any successful defence strategy.

Europe understood this early. During the Belgian Presidency in 2024, we launched the Critical Medicines Alliance and built the political consensus that led the Commission to propose the Critical Medicines Act in March 2025. The diagnosis was sound: map the vulnerabilities, diversify supply, reshore strategic production, reform procurement to reward resilience over lowest cost, and coordinate stockpiles so that the panic-buying of one large member state does not create the shortage of its smaller neighbour.

But a diagnosis is not a cure. And when I look at where we stand today, I worry that we are producing a paper tiger which lacks the teeth to do what is necessary.

The Commission's initial proposal allocated roughly eighty million euros to the Critical Medicines Act.[xviii] For context: Eli Lilly alone committed twenty-seven billion dollars in new US manufacturing investment as part of its deal with the Trump administration.[xix]

Belgium abstained when the Council adopted its position in December. We did so because the text had become less ambitious than the Commission's original, when in fact the Commission proposal already seemed too modest. The strategic objective on security of supply was deleted. The provisions on stockpile coordination were weakened. It felt, at times, like we were negotiating to contain ambition rather than to unleash it.

The European Parliament has since adopted a more promising position: a dedicated critical medicines fund in the next EU budget, procurement criteria that properly reward European-based production, and a redistribution mechanism for stockpiles. These are the right instincts and I hope they will stand the trilogues.

But I want to raise a harder question; one that goes beyond this particular Act. Over the past few years, Europe has responded to strategic vulnerabilities with a growing catalogue of legislation. The Chips Act for semiconductors. The Critical Raw Materials Act for rare earths and lithium. Now the Critical Medicines Act. Each was announced with ambition. Each addressed a real problem. But we must ask ourselves, plainly: are they delivering? Is Europe producing significantly more chips? Securing significantly more critical raw materials? If the evidence so far is mixed – and it is – then we need to ask not just whether we are passing the right laws, but whether we are backing them with the resources, the industrial strategy and the political will to make them work.

China does not announce strategic objectives and then allocate pocket money. It builds. The United States, for all the contradictions in its health policy, has just mobilised tens of billions in pharmaceutical investment through a combination of executive pressure and fiscal incentives. If we believe that the supply of essential medicines is a matter of European sovereignty – and I believe it is – then we must act like it.

Movement 3: The Squeeze from Within – What Is European Health Policy For?

The third squeeze is perhaps the most insidious, because it comes from inside our own institutions. And it takes us beyond medicines, to the broader health agenda I described at the start. It operates on two fronts: a retreat from prevention, and a retreat from health as a standalone political priority.

Let me take these in turn.

Prevention: the great equalizer we keep postponing

Last November, I gave the Sidney Ball Lecture at the University of Oxford, in which I argued that solidarity and responsibility are inseparable.[xx] Solidarity means we help each other. But responsibility has two faces. We can ask responsibility of citizens – that they take care of their health, that they make good choices. We do that, and we should. But there is another face of responsibility that we talk about far less: the responsibility that governments must take – the responsibility to create conditions in which healthy choices are actually possible.

This is the most concrete thing in health policy. Because a large and growing share of the burden of disease in Europe today is caused by what we eat, what we drink, what we inhale, and how little we move. Cardiovascular disease. Diabetes. Cancers linked to tobacco, alcohol and diet. These are the diseases that fill our hospitals, strain our budgets and, critically, entrench inequality, because they strike hardest in the communities that can least afford their consequences. Illness is class-related. Prevention is, in that sense, the great equalizer. To the extent you can prevent people from getting sick, you prevent the inequities that cascade from illness: lost income, educational disadvantage, shortened lives.

And yet. Look at what Europe is actually doing.

Take vaping as an example. There are electronic cigarettes on the market today – sold to children – that come with built-in video games: Pac-Man, Tetris, virtual pets that you feed by puffing. One device, the URSA Pocket, includes a digital pet that thrives when you vape and starves when you stop.[xxi] I want you to sit with that for a moment. A product that is engineered to create nicotine addiction in children by exploiting their emotional attachment to an electronic creature. These products are forbidden in Belgium. Next to this, we have banned disposable vapes, and we are moving to ban all flavours except tobacco. I have called this industry what it is: a criminal industry that deliberately targets minors.

But here is the problem. Every national regulation we pass is, in effect, sticking plaster on a wooden leg. As long as flavoured vapes, gaming vapes and candy-coloured nicotine devices can be legally manufactured and sold elsewhere in the Single Market, they will flow across our borders. Freedom of movement of goods is a foundational EU principle – and rightly so. But it means that effective tobacco and nicotine control must be harmonized at European level. Last year alone, we seized over 140,000 disposable vapes.[xxii] A Belgian ban without an EU ban is an exercise in futility.

The same inertia that hampers our control over nicotine is visible in how we approach our food environment. If we accept that the state bears a fundamental responsibility to create the conditions for healthy choices, then we must confront the reality of our supermarkets. Today, we ask citizens to be part-time nutritionists, navigating a landscape of complex labels and hidden fats. A clear, harmonized front-of-pack label like the Nutri-Score could empower them to make better choices. And while a European-wide front-of-pack label was promised in Europe's Beating Cancer Plan and the Farm to Fork Strategy, its implementation has been postponed indefinitely.[xxiii] [xxiv]

Europe's retreat from prevention policy is a threat from within for our health care systems.

In Belgium, the arithmetic of this retreat is already catching up with us. Estimations learn that over 800,000 people – roughly 7% of our population – are currently being treated for diabetes type 2, a figure that has increased by nearly a third in just a decade. If we include those living with the condition undiagnosed, we are likely looking at one in ten citizens. The financial weight of this single chronic disease now exceeds two billion euros annually.[xxv]

This brings us to the heart of the third squeeze. When Europe stalls on prevention, when it hesitates to regulate the commercial determinants of health, it does not simply "delay" a policy. It actively creates a future burden that our health systems are expected to absorb.

This internal retreat from prevention is the most insidious pressure of all. It makes the solidarity of our health systems increasingly fragile, as we ask taxpayers to fund treatments for diseases that we, as a society, have the tools to prevent but lack the political will to address. If we can harmonize the rules of the Single Market to protect the movement of goods, we must find the courage to harmonize them to protect the longevity of our people. If we don't, the squeeze from within will eventually prove just as destructive as any pressure from across the Atlantic and the East.

The budget

This brings me to the second front of the squeeze from within.

In the negotiations on the Multiannual Financial Framework for 2028 to 2034, the Commission has proposed absorbing EU4Health – Europe's dedicated health programme – into a broader European Competitiveness Fund, alongside agriculture, biotech and the bio-economy.[xxvi]

At first glance, this may look like a necessary measure to make the EU budget simpler and more agile. However, in doing so, we are changing what European health policy is for.

Let me make this concrete. EU4Health was created in the wake of COVID-19 with a ten-fold increase in funding, precisely because the pandemic exposed how dangerously underinvested European health cooperation had been. It funds cancer screening programmes, rare-disease networks, crisis preparedness, the work of our regulators, and the patient organizations and public health NGOs that hold governments to account. It finances Joint Actions – a mechanism unique to the health domain – through which member states pool expertise on antibiotic resistance, on mental health, on vaccination strategies. These are the activities that keep the European Health Union tangible to citizens’ daily lives.

Under the new proposal, all of this disappears into a competitiveness fund, a single budget line shared with agriculture, biotech and the bio-economy. If the Commission proposal for the new MFF is pursued, there will be no separate allocation for health.

The logic of a competitiveness fund asks: how does this euro strengthen firms, exports, value chains? The logic of EU4Health is fundamentally different: how does this euro prevent disease? Build crisis preparedness? Support cancer screening programmes? Fund rare-disease networks? Strengthen regulators? Keep patient organizations and public health NGOs afloat? These are activities that will never win the contest for resources inside a broad competitiveness window, precisely because their return cannot be measured in competitiveness outcomes. They are investments in the public good.

After COVID, we said – and we were right to say – that health security is as strategic as energy or digitalization. The Council Conclusions on the Future of the European Health Union explicitly call for EU policies to support resilient, equitable and accessible health systems. If we now fold health into a competitiveness window, we send the opposite signal: that health is primarily an instrument of industrial policy. That the purpose of public health spending is to serve economic growth, rather than the other way around.

There is a deep irony here. In my first movement, I criticized President Trump's failure to understand and appreciate the power of solidarity-based social security systems. In my second, I showed that Europe recognizes the strategic threats to those systems but has not yet matched that recognition with the resources and boldness the moment demands. Now, in my third movement, I must ask whether Europe itself recognizes the responsibility it bears toward those systems. Because that is, in the end, the question. Europe has a responsibility to protect the welfare systems that define it. But recognizing a threat is not the same as accepting that responsibility. Folding health into a competitiveness fund is an act of forgetting. It says: health was important during the pandemic, but now we have moved on to more serious things.

We cannot credibly defend European solidarity abroad if we quietly dismantle it at home.

The Path Forward

To resist the three squeezes I have described – from the West, from the East and from within – we have to tackle an unmistakable weakness of our European health systems: their incompleteness. Europe's health systems are strong, but the architecture that connects them is weak. We have twenty-seven welfare states, each with deep institutional roots, each capable of delivering good outcomes for its citizens. Together, they represent a market of 450 million insured citizens – the largest bloc of universal health coverage in the world. But we have not yet built the European layer that would allow those systems to function together: to pool evidence, coordinate supply, share data, and project collective strength.

We know what happens when that European layer exists – and when it does not. Where Europe is integrated – in trade, in competition, in the single market for goods – it is strong. No individual member state has been bullied into concessions on medicine pricing, because trade policy is an EU competence and tariffs on France are tariffs on the entire Union. But where Europe remains fragmented – in clinical trials, in market access, in procurement of essential medicines, in prevention – it is weak. Not because the principles are wrong, but because we act like twenty-seven small markets instead of one big one.

So the path forward is not to choose between solidarity and competitiveness, as if these were rival claims on the same euro. The path forward is to complete what we started. To build a European Health Union that is sovereign in the full sense of the word: capable of defending its own model, securing its own supply, growing its own industry, and demonstrating to its citizens and to the world that universal, solidarity-based health care is not a relic of the twentieth century but the foundation of a stable, investable, and humane twenty-first-century society.

I have taken good note of the concerns expressed by industry, including by EFPIA.[xxvii] They warn that Europe has lost a quarter of its global share of pharmaceutical R&D investment over the past two decades, and that without action, companies will continue to invest elsewhere. Those concerns deserve a serious answer. But the answer must begin from what Europe actually is. Europe's attractiveness to investment is not built on high prices. It is built on welfare states with universal access, strong public institutions, and a social contract that gives the market its stability and its depth. Budgetary stewardship is part of what makes Europe investable, because a market is only attractive if the buyer can keep paying.

Starting from there, there is a lot that we can and should do.

Consider clinical trials. Europe has world-class universities, excellent hospitals, and strong regulatory science. Belgium has invested heavily in accelerating evaluation timelines, and we are proud of the results. But clinical trial competitiveness is not only a regulatory question. It is an ecosystem question. A sponsor designing a multi-country trial in Europe today faces contracting practices that vary not just between countries but between hospitals within the same city. Ethics review processes that, despite the Clinical Trials Regulation, still function with considerable national variation. Site start-up procedures that add months between regulatory approval and the first patient enrolled. We have to admit: the European eco-system for multi-country trials is too complex to compete with the US and China.

A sponsor who has a difficult experience with a European trial simply designs the next one elsewhere. We need a structured commitment to integration: be it standardized contract templates, better quality ethics review, trial-ready site networks with shared quality standards, and serious investment in the clinical research workforce.

But trials are only the beginning. There is also what happens after a medicine is authorized. The European Medicines Agency grants a single marketing authorization. And then that single authorization enters twenty-seven separate pricing and reimbursement procedures, each with different timelines, different comparators, different expectations. The result is staggered launches, duplicated assessments, and slower access – especially for patients in smaller markets.

The Joint Clinical Assessment under the HTA Regulation is designed to break this pattern. It is being rolled out in phases – starting with oncology and ATMPs, then orphan medicines, then other centrally authorized products. Belgium, through NIHDI, is leading the Framework Contract Consortium that is doing the actual work in this critical launch phase, and we take that responsibility seriously. If we make this system work – if the scoping is rigorous, if the outputs are usable, if national bodies genuinely take up the results – then Europe's HTA system becomes better and more efficient, opening a more streamlined reimbursement pathway to 450 million patients. That is an offer no other market in the world can match – not even the US. But it will only work if member states take the work of the JCA as a serious political commitment.

And then there is the question that Mario Draghi's report forced us to confront: why does Europe keep the science but lose the industry? European biotech firms relocate to the United States not because the science is better there – in many fields, it is not – but because the capital is deeper, the scaling infrastructure more developed, and the path from laboratory to market more navigable. EU funding for life sciences is spread across so many instruments and mechanisms that sustaining financing across an entire development cycle becomes an exercise in bureaucratic endurance. Late-stage venture capital barely exists at European scale. And when a company needs serious growth capital, it faces a patchwork of national stock exchanges, none of which offers the liquidity that a single integrated market should provide.

The Biotech Act that the Commission is preparing is an opportunity to change this – but only if we are honest about the scale of what is required. That means building an industrial fabric for advanced biomanufacturing on European soil. It means creating a capital architecture that does not force every promising company to cross the Atlantic to raise serious money. And it means establishing an institutional actor with genuine operational muscle – something closer to what BARDA provides in the United States – that can de-risk investment, issue advance commitments, and give European companies a reason to stay.

But I want to be clear about something. Everything I have just described – the integrated evidence framework, the trial ecosystem, the industrial strategy – requires health systems that are financially sustainable and are well organized. An industrial strategy should therefore not come in lieu of a credible European health programme.

Conclusion

To conclude, our Sovereign Health Union must therefore do three things:

First, it must defend and articulate the value of its health care model in the world. I say this deliberately, because we have been remarkably poor at it. When we are told that our pricing systems suppress the fair market value of medicines, too many European voices respond defensively – as if solidarity-based health care were a concession to be justified rather than an achievement of our post-world war societies. It is not. Evidence-based pricing, universal coverage, and budgetary stewardship are the reasons our health market is stable, our populations are insured, and our public finances can sustain long-term investment. That is not a weakness, but our strength.

Second, it must build. Europe needs two things it currently lacks, and they are related. It needs a genuine ecosystem for life sciences innovation and a credible security architecture for critical medicines. These are not competing objectives. A Europe that can both develop and manufacture its own medicines is a Europe that can also secure its own supply. Development and production go together

Third, it must protect the sustainability of its health systems – and invest in making them stronger. A health system that is consumed by the cost of preventable disease has no fiscal space left for the innovation, the preparedness, and the workforce investment that sovereignty demands. Every euro spent treating a diabetes type 2 case that better food regulation could have prevented is a euro not available for a breakthrough therapy. A clear health agenda with an ambitious prevention strategy and a visible, separate budget in the Multiannual Financial Framework must therefore be pursued.

[i] https://www.consilium.europa.eu/en/press/press-releases/2024/06/21/european-health-union-council-calls-on-commission-to-keep-health-as-a-priority/

[ii] https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/

[iii] PhRMA, Letter to the USTR, Junie 27, 2025. Document USRT-2025-0011, p. 3.

[iv] https://kce.fgov.be/en/publications/all-reports/performance-of-the-belgian-health-system-report-2024

[v] Most European countries have achieved universal (or near-universal) coverage of the population, although there are vast differences in the type of benefits and the cost-sharing. https://health.ec.europa.eu/state-health-eu/health-glance-europe/health-glance-europe-2024_en

[vi] https://www.oecd.org/en/publications/health-at-a-glance-2023_7a7afb35-en/full-report/component-13.html

[vii] https://www.ftc.gov/system/files/ftc_gov/pdf/pharmacy-benefit-managers-staff-report.pdf

[viii] https://www.drugchannels.net/2025/07/gross-to-net-bubble-hits-356b-in.html

[ix] https://www.riziv.fgov.be/SiteCollectionDocuments/MORSE_rapport_2024_EN.pdf

[x] International Prescription Drug Price Comparisons: Estimates Using 2022 Data, Report for the Assistant Secretary for Planning and Evaluation (ASPE), U.S. Department of Health and Human Services, February 2024.

[xi] https://oversightdemocrats.house.gov/imo/media/doc/COR%20Staff%20Report%20-%20Pharmaceutical%20Industry%20Buybacks%20Dividends%20Compared%20to%20Research.pdf

[xii] https://www.gao.gov/assets/gao-18-40.pdf

[xiii] https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0050001

[xiv] https://www.lemonde.fr/en/international/article/2026/01/22/french-presidency-calls-out-fake-news-after-trump-drug-price-comments_6749677_4.html

[xv] https://ustr.gov/about/policy-offices/press-office/press-releases/2025/december/us-government-announces-agreement-principle-united-kingdom-pharmaceutical-pricing

[xvi] https://health.ec.europa.eu/document/download/3da9dfc0-c5e0-4583-a0f1-1652c7c18c3c_en?filename=hera_cma_strat-report_en.pdf

[xvii] https://www.euronews.com/my-europe/2025/03/09/europes-dangerous-medicine-dependency-is-the-achilles-heel-of-its-defence-strategy

[xviii] https://health.ec.europa.eu/medicinal-products/legal-framework-governing-medicinal-products-human-use-eu/critical-medicines-act_en

[xix] https://www.cnbc.com/2025/02/26/eli-lilly-to-invest-27-billion-in-new-us-manufacturing.html

[xx] https://vandenbroucke.belgium.be/nl/nieuws/sidney-ball-lecture

[xxi] https://tobaccocontrol.bmj.com/content/early/2024/07/18/tc-2024-058794

[xxii] https://www.belganewsagency.eu/belgium-seizes-over-140000-illegal-disposable-vapes-in-2025