Cancer Leagues call for overhaul of EU drug pricing transparency rules
A new report from the Association of European Cancer Leagues says the EU’s Transparency Directive is no longer fit for purpose and is worsening inequalities in access to cancer medicines
In a new report, ‘Behind the Price Tag’, the Association of European Cancer Leagues (ECL) has renewed calls for a major overhaul of the EU’s pharmaceutical pricing rules, arguing that the EU’s long-standing Transparency Directive no longer reflects the realities of today’s medicines market.
"The Directive has not evolved with the pharmaceutical market and risks becoming increasingly disconnected from its realities. A comprehensive revision is now essential," says ECL Executive Director, Wolfgang Fecke.
Adopted in 1989, the Transparency Directive aimed to ensure that national decisions on the pricing and reimbursement of medicines were transparent, predictable, and delivered within set timelines.
More than three decades later, however, the pharmaceutical landscape has changed dramatically. Confidential discounts, complex pricing agreements, and expensive personalised cancer therapies have become commonplace.
The ECL argues that the lack of transparency particularly disadvantages smaller and lower-income EU countries, which often struggle to negotiate fair prices for innovative medicines. But even wealthier member states face delays in ensuring timely access to new cancer treatments.
According to Toma Mikalauskaitė, limited transparency around research and development costs and the actual net prices paid by governments leaves health systems negotiating “in the dark, unable to negotiate effectively”.
The report revives a debate that has been stalled for more than a decade. In 2012, the European Commission proposed a substantial revision of the directive. However, despite broad agreement that the Directive was outdated, negotiations between the European Parliament and member states stalled, and the proposal was withdrawn in 2015 due to a lack of political consensus. Since then, no further legislative attempt has been launched.
Pressure for reform has nevertheless continued to build. A 2025 report by the European Court of Auditors criticised the lack of price transparency across member states, warning that confidential discounts and inconsistent reporting fragment the EU market and contribute to unequal access to medicines. The auditors urged the Commission to improve the directive's implementation and to prepare for a future revision.
Catherine Feore
Yet the issue remains politically sensitive. Following her re-election in 2024, Ursula von der Leyen did not include revision of the directive in the mission letter for Health Commissioner Olivér Várhelyi, suggesting limited appetite within the Commission to reopen the file.
Five recommendations to update the not-so-transparent directive
The ECL’s report outlines five recommendations aimed at modernizing the framework.
The first calls for improved price transparency through an EU-wide price observatory accessible to health authorities and mandatory disclosure of pharmaceutical companies’ R&D costs.
Secondly, the report proposes minimum transparency standards for Managed Entry Agreements, including public disclosure of the type of agreement, the medicines concerned, and their therapeutic objectives. ECL say that national audit bodies should also have access to confidential annexes to assess the public financial impact, noting recent legislation in Belgium.
Thirdly, ECL calls for faster access to generics and biosimilars by reducing reimbursement timelines from 180 days to 30 days. The other recommendations call for clearer public communication around pricing decisions and improving the quality of evidence used in reimbursement and HTA decisions.
With cancer cases rising across Europe and health budgets under increasing pressure, the ECL argues that reforming the Transparency Directive is becoming increasingly difficult for EU policymakers to ignore.