Two weeks ago at DIA Europe, I listened to Virginia Acha, Niklas Blomberg, Jan Geissler, Emer Cooke, Niklas Hedberg, Joep Muijrers, María Jesús Lamas Díaz, Max Wegner and Rainer Becker debate whether Europe can still compete for pharmaceutical innovation.
I’m not a regulator. I work at the intersection of evidence strategy and market access. And I left carrying a question I haven’t been able to put down.
Is Europe fixing its access problem from the wrong end?
There was genuine optimism in the regulatory sessions. FAST-EU is delivering. The Biotech Act is ambitious. PRIME is expanding. EMA leadership spoke about speed, simplification, and access with real conviction.
But the small number of market access professionals and biotech executives I spoke with in the corridors didn’t share that optimism. Not even close. And I have to be honest: neither do I.
The gap between the regulatory worldview and market access reality felt wider at this conference than I’ve ever experienced.
Regulators see acceleration. Market access sees what’s waiting at the other end of that acceleration: an HTA system that will request dozens of PICOs, including off-label comparators the clinical trial was never designed to address, assessed against methodological guidelines where anything less than a randomised controlled trial with an active comparator carries significant uncertainty. And after that, payers with constrained budgets and limited willingness to pay for whatever uncertainty remains.
As one moderator put it: “We’re just approaching that red light faster.”
Jan Geissler put the human cost on the table: 120–150 million Europeans without timely access. Only 29 of 170+ centrally authorised medicines reach all EU member states. And then he said what I think was the most important sentence at the conference: “We don’t have an innovation problem. We have an access problem.”
If he’s right — and the data suggests he is — then the question is whether the solutions being legislated address the right part of the system. Faster timelines address regulatory speed. They don’t address HTA risk acceptance or payer willingness to pay. Those sit at member state level, where the actual access decisions are made.
What concerns me further is the investment picture. Europe’s share of global clinical trials has dropped from 22% to 12% over the past decade, while China rose from 8% to 18%. European life sciences VC represents just 7% of the global market versus 63% in the US and 14% in China. The R&D investment gap between the US and Europe has grown from €2 billion to €25 billion in twenty years.
And MFN is accelerating these trends. Recent research showed that 84% of the top 37 cancer drugs by US sales would have had a negative net present value had MFN pricing been in place at the time of their FDA approval, with an average price reduction of 67%. From conversations in the corridors it’s clear that companies are already walking away from European negotiations. When return on European launches falls, the first budget cut is the European-specific evidence generation programme — the very evidence that might have given payers enough confidence to say yes.
So we may be in a situation where the regulatory front end is accelerating while the assessment back end remains risk-averse, investment is leaving, and the commercial incentive to fund the evidence that bridges the gap is weakening.
2026 feels like a pivotal year. The first JCA reports will publish. The new pharma legislation enters implementation. MFN begins to reshape launch economics. And I keep asking myself: when we look back at this moment in five or ten years, what will we see?
Will we view the pre-2026 years as the golden era when Europe still had the clinical trials, the investment, and the innovation pipeline that it’s now losing? Will we see 2026 as the year the pressure finally forced real structural reforms in HTA risk acceptance, in pricing frameworks, in how Europe thinks about the relationship between evidence and access?
Or will we see the beginning of a continent with 450 million people and declining access to the medicines being developed elsewhere?
I genuinely don’t know. But the question deserves honest examination, not just regulatory optimism.
When Geissler reminded the room: “It’s our skin in the game,” everyone was thinking about the patients. I think he was referring to us all — to every citizen in Europe.