New medicines are reaching Europe later than the US. A recent study says two separate policies are to blame, and that the damage is the worst when they meet.
New medicines are reaching Europe later than the US. A recent study ‘Most-Favored-Nation pricing meets Joint Clinical Assessment: early evidence of compounding pressure on European drug launches’ says two policies are behind it. And that the harm is worst where they overlap.
The first is Most-Favored-Nation (MFN) pricing. A US executive order signed on 12 May 2025 ties the American price of a medicine to the lowest price paid by other wealthy countries. The second is Joint Clinical Assessment (JCA), a single European Union review of a medicine’s clinical evidence. It is in force since 2025, which replaces separate national reviews.
Compound damage
Apart, each looks manageable. Together, they compound. The study counted new drug launches in the year before and after the US order. They fell 10.5 per cent in the US, 29.9% across a 19-country reference basket, and 37.8% in the 11 EU states that face both policies at once. The steepest drop lands exactly where MFN and JCA overlap.
The clearest sign is in rare disease medicines. They should be the most resilient, because much of their value sits outside the US. Outside JCA’s scope they barely moved, down 1.4 per cent. Inside it, the cancer drugs and advanced therapies JCA already covers, they fell 22.9%. The only real difference between the two groups is the assessment itself.
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The pressure looks set to grow. In 2028, JCA extends from cancer drugs and advanced therapies to all rare disease medicines. And a new launch-or-lose rule in the EU pharmaceutical package could force a company to supply a market or lose its protection there. Sreeram Ramagopalan, of the Centre for Pharmaceutical Medicine Research at King’s College London and a co-author of the study, spoke to EU Perspectives about why the two policies bite hardest together, what it means for patients, and how worried we should be.
Your study asks whether new medicines are reaching Europe later, and whether two policies are behind it. Most people would treat MFN pricing and Joint Clinical Assessment as two separate stories. Why did you decide to look at them together?
Because companies don’t experience them separately. When a manufacturer decides where and when to launch a new medicine, it’s weighing everything at once. What a European price will do to its US price under MFN, and what evidence burden JCA adds on top. If you study MFN alone, you’d conclude that Europe as a whole is losing launches, which is true. But it misses that this isn’t uniform. If you study JCA alone, you’d struggle to see its effect at all. Because it’s masked by the much larger MFN signal.
Looking at them together let us find the one group of medicines where JCA’s fingerprint is visible: rare disease products. These are largely shielded from MFN pressure. Because a lot of their commercial value can come from outside the US. So for them, delaying a European launch may cost more financially than it saves. Rare disease launches outside JCA’s scope were essentially flat. But rare disease launches inside JCA’s scope, cancer drugs and advanced therapies, fell about 23%. That gap is very hard to explain by MFN alone. And it’s invisible unless you stratify by both policies at once.
The cheapest way to protect the US price is not to create the reference point: launch later in Europe, launch in fewer countries, or don’t launch at all. — Sreeram Ramagopalan, Centre for Pharmaceutical Medicine Research
For readers meeting these for the first time, how does each one give a company a reason to hold back a European launch? And how do they end up landing on the same medicines?
MFN works through price. If the US price of a medicine will be benchmarked against the lowest price in a basket of other wealthy countries, then every European launch, especially at a lower price, potentially drags down the price in the US, which is the largest pharmaceutical market. The cheapest way to protect the US price is not to create the reference point. Launch later in Europe, launch in fewer countries, or don’t launch at all.
JCA works through evidence and timing. It’s a single EU-level review of a medicine’s clinical evidence. And it asks broader questions than many companies planned their trials to answer, more comparators, more patient subgroups. If your evidence package isn’t ready for that, launching triggers a review you may not do well in. The rational response is to wait until the evidence is ready.
They land on the same medicines because JCA currently applies to cancer drugs and advanced therapies. These are categories that are also central to MFN’s scope. A new oncology product faces both at once: launching in Europe creates a price that echoes back to the US and starts the clock on a demanding evidence review.
Launches fell much more in the countries facing both policies. Do you think that’s really the two pressures compounding, or could those countries just be harder places to launch anyway?
They might be harder places to launch, but that would explain a low level of launches, not a sudden change. We compared the same countries with themselves: matched 12-month windows immediately before and after the executive order. Any fixed difficulty of those markets is present in both windows and cancels out.
That said, we’re careful in the paper: this is 12 months of data, and confounders like national cost-containment measures and the EU pharmaceutical legislation revision can’t be fully excluded.
Rare disease drugs held up well overall, but the ones inside JCA scope fell a lot more. What does that tell you?
It tells us JCA is exerting its own independent pressure, not just riding along with MFN. Rare-disease products are the natural control group for MFN: their commercial value is high outside the US and their European prices are typically premium. So under MFN alone we’d expect them to keep launching, and outside JCA scope, they did, almost exactly (only a 1.4 per cent decline, essentially noise).
The only thing that distinguishes orphan drugs inside JCA scope from those outside it is JCA itself. Yet the in-scope group fell 22.9 per cent, a 22-percentage-point gap between two sets of medicines facing the same MFN environment. When the group that should be most resilient shows a material decline, and the only differing exposure is the assessment framework, that’s the clearest early evidence we have that JCA preparation is already influencing launch behaviour.
You link that drop to the work of preparing for JCA. What is it about that preparation that actually delays a launch?
Three things, mainly. First, the evidence question is broader than what many pivotal trials were designed to answer. JCA assessments can involve multiple member states’ questions about comparators and patient populations, sometimes dozens of PICO (population, intervention, comparator and outcome) combinations, and a trial designed for regulatory approval against placebo or one comparator may simply not contain those answers. Generating them takes indirect comparisons, additional analyses, sometimes new data collection.
Second, the timing is unforgiving. The JCA process runs in parallel with EMA (European Medicines Agency) approval, so the evidence dossier has to be ready early. If it isn’t, the company faces a choice between entering the assessment underprepared, and carrying a weak assessment into every national pricing negotiation, or holding the launch until the package is ready.
Third, for small companies developing advanced therapies, this is a genuine capacity problem, not just a strategic one. Building an HTA-grade (health technology assessment) evidence package for 27 member states’ questions requires expertise and money that a biotech with one asset may not have. The result in all three cases is the same: the launch waits for the evidence.
Your study counts launches but never names them. Which medicines are behind these figures? Can you point to a real drug that launched later in Europe than in the US?
The analysis is built on a commercial launch database counting brand–country combinations, over 500 launch events in the pre-period alone, and the finding is a pattern across that whole population, not a story about any single product. If I held up one drug as “the MFN delay case,” I’d be attributing a strategic motive to a specific company’s launch decision, and that’s an inference our data can’t support.
Several manufacturers have publicly discussed reassessing European launch sequencing since the executive order. What our data adds is the systematic picture: this isn’t a handful of anecdotes, it’s a measurable shift of roughly 200 fewer launch events in one year across the 11 EU states we studied, concentrated exactly where the policy logic predicts.
Orphan cancer drugs and advanced therapies inside JCA scope fell 22.9 per cent. What kind of treatment does that mean in practice?
Think of the newest generation of treatments for rare and hard-to-treat cancers, and one-time therapies for genetic diseases. These are precisely the medicines where a delay is most consequential for the individual patient.
Someone with relapsed lymphoma who is a candidate for a cell therapy, or a child with a progressive genetic condition where a gene therapy exists, often doesn’t have the option of waiting a year for the launch schedule to catch up.
You warn that when JCA expands in 2028, and the launch-or-lose rules take effect, the gap could widen. What would that actually look like for a patient?
Today, rare disease medicines are the resilient part of our data, but our results suggest that resilience holds only where JCA doesn’t yet apply. In 2028, JCA extends to all orphan medicines, so every new rare-disease therapy inherits the evidence burden that we can already see suppressing orphan oncology and advanced-therapy launches today. Concretely, it means a patient’s postcode starts deciding what medicine they can get. Imagine a family whose child is diagnosed with a rare genetic condition in 2028. A gene therapy exists, patients in the US are already being treated, but in their country, the company hasn’t launched: the JCA dossier isn’t ready, or the price a launch would set is one the company can’t afford to have echoed back into its US benchmark. For that family, the medicine is real, approved, and out of reach.
Each policy is individually defensible; together, they compound. — Sreeram Ramagopalan
How worried should we actually be at this stage, and how worried are you?
I’m measured about the patient-access numbers so far, it is only twelve months of data, launches can be deferred rather than lost. Where I’m genuinely worried is what this signals about Europe as a place to do life sciences.
Launch decisions are the visible tip of investment decisions. When a company decides Europe is a market to enter late, cautiously, or not at all, that logic doesn’t stop at the launch calendar, it flows upstream into where clinical trials are placed, where manufacturing is sited, where R&D partnerships are formed, and ultimately how much of a global development budget is allocated to a region. Europe is already fighting a well-documented, two-decade drift of pharmaceutical R&D investment toward the US and, increasingly, China. What our data shows is companies responding rationally and fast to incentives that make Europe less commercially attractive, and MFN has, in effect, weaponised Europe’s lower prices against European access, at exactly the moment JCA adds a new evidence burden and the pharma package adds launch conditionality. Each policy is individually defensible; together, they compound.
The deeper risk is a feedback loop. Fewer launches mean less European revenue, which justifies less European investment, which means fewer trials here, less clinical infrastructure, fewer patients accessing innovation through research, which in turn makes Europe an even less natural first market for the next generation of medicines. Once trial networks and expertise relocate, they don’t come back quickly. That’s the outcome I’d genuinely worry about.
