Overview
This policy brief, prepared at the request of the European Parliament Committee on Public Health, sets out the Institute’s proposals for reforming cancer drug pricing and health technology assessment across the EU in the context of the new Joint Clinical Assessment Regulation.
The problem
The EU’s new Joint Clinical Assessment (JCA) Regulation, which came into force in January 2025, harmonises the clinical evidence base for oncology drug reimbursement decisions. This is a significant step forward. But it addresses only half the problem.
Pricing — determined through bilateral negotiations between manufacturers and individual member states — remains fragmented, opaque, and systematically disadvantageous to smaller and lower-income countries.
Our proposals
A reference price corridor. We propose a mandatory price corridor within which member states must negotiate, anchored to GDP per capita and disease burden. This preserves flexibility while preventing the most extreme divergences.
Transparency in managed entry agreements. Confidential MEAs should be replaced with a standardised, EU-level reporting framework. Full pricing information should be accessible to all member states.
Pooled negotiating capacity. The EU should establish a standing negotiating body — analogous to COVAX for vaccines — that can negotiate on behalf of willing member states, particularly smaller nations lacking leverage.
Performance-linked pricing. Payments should be linked to real-world outcomes data collected through mandatory registry reporting, reducing uncertainty for payers and incentivising genuine clinical value.