A medicine could clear European regulatory approval and sit on pharmacy shelves the same day, yet remain financially out of reach for the people who need it most. That is the warning from Valentina Strammiello, executive director of the European Patients' Forum, responding to a proposal from Europe's pharmaceutical trade body to launch new treatments across all EU member states before national governments settle pricing and reimbursement. The idea sounds efficient on paper. In practice, it raises a harder question: access for whom?
A Proposal With No Teeth Yet
The plan comes from the European Federation of Pharmaceutical Industries and Associations, whose director general, Nathalie Moll, floated it at the European Health Forum Gastein. Under the concept, a newly approved drug would reach every member state immediately, well ahead of the often lengthy national processes that determine whether, and at what price, a health system will pay for it. Moll was candid that this would serve "a very small group of patients," since reimbursement, the mechanism that makes a drug affordable at scale, would not yet exist. There is no draft legislation behind the idea. It is, for now, a talking point.
Strammiello does not reject it outright. She calls it potentially "interesting," but only if governments build parallel mechanisms, similar to compassionate use frameworks, that let patients access these treatments without first paying full freight. Absent that, day-one availability becomes a two-tier system: approved and shipped everywhere, but affordable only where someone can cover the bill out of pocket or through private insurance. "Accessible on day one, but only for those who can pay," as she puts it.
Old Tools, New Urgency
What's notable is that Strammiello isn't asking for untested fixes. Mechanisms for staged access already exist across European health systems: prioritizing patients by disease severity, narrowing eligibility by age range, starting with a small cohort and expanding later under transparent criteria. None of this is new. The real gap, she argues, is political will and operational capacity, not a shortage of policy tools.
She points to Article 59 of the EU's revised pharmaceutical legislation as a signal, though not a mandate, that Brussels recognizes the scale of inequality in treatment access across the bloc. It encourages broader launch but does not require it. Whether member states actually use the instruments available to them, she says, depends on willingness, administrative bandwidth, and, increasingly, competing crises pulling health budgets in other directions.
Funding Pressure Meets Political Fatigue
The access debate isn't happening in a vacuum. Strammiello flags a broader fiscal squeeze, including the shift of public funds toward defense spending, as a complicating layer that makes future patient access harder to forecast. Patient organizations themselves are feeling the pinch. The EU4Health programme, despite a substantial funding pool, required a co-funding contribution from applicants that many nonprofit patient groups simply cannot meet, since they don't generate profit margins to draw from.
That operational strain matters beyond advocacy circles. Patient organizations often serve as early warning systems for drug shortages and access gaps, a role Strammiello says should be formalized rather than left informal. Without core funding to sustain that work, groups like EPF end up "doing more with less," spending time on their own financial survival instead of contributing to the policy debates shaping how, and when, patients actually get treated.
- Day-one launch would make a drug physically available, not financially accessible, without reimbursement decisions in place.
- Article 59 encourages broader rollout across member states but carries no binding obligation.
- Existing compassionate-use style mechanisms could bridge the gap, provided governments adopt transparent eligibility criteria.
- Patient organizations face their own funding constraints, limiting their capacity to monitor access and shortages.
The underlying tension is straightforward: faster regulatory approval means little if the systems meant to pay for treatment lag years behind. Strammiello's message to governments is not that the industry's proposal is wrong, but that it is incomplete without a parallel commitment to equitable access built in from day one.
