11 December 2025

This morning, negotiators from the European Commission, the European Parliament and the Council of the EU reached a long-awaited deal on the EU Pharma Package. European cancer leagues broadly welcome the agreement, which takes important steps to address persistent gaps in ensuring cancer patients across the EU have access to safe, effective and affordable medicines.  

Unequal access to treatment remains one of Europe’s most striking inequalities in cancer care. The high costs of innovative therapies often put them out of reach for countries with tighter health budgets, meaning that patients in some EU member states get timely access to medicines when they most need them while others are left behind. For example, between 2020 and 2023, cancer patients in Germany had access to 54 out of 56 EU-authorised medicines, while patients in Malta could only access two. 

The Pharma Package is the first major update of EU pharmaceutical rules since 2004 and concludes a years-long process that started in April 2023. The final deal is a welcome recognition of the urgent need to grant patients across Europe better and more equitable access to effective and affordable cancer drugs, and includes several measures that – if implemented correctly – could close these inequality gaps:   

• An obligation for companies to supply medicines in sufficient quantities to meet patient needs upon the request of an EU member state, ensuring that patients in smaller countries are not left behind.  

• Mandatory disclosure of public funding, requiring companies to report any direct financial support received from public authorities, cancer charities or other not-for-profit entities, for the research and development of new cancer medicines. This gives countries a fairer position in price negotiations with pharmaceutical companies.  

• Possibility for public hospitals and research centres to provide evidence to repurpose medicines for new uses, helping to make treatments more accessible.  

• Strong measures to allow cheaper generic and biosimilar medicines to become available the day after the protection periods of the original product ends, giving patients faster access to more affordable medicines. 

However, while several measures in the Pharma Package improve patients’ access to medicines, the final agreement falls short of fully addressing the issue of affordability. Generics and biosimilars will not be able to enter the market earlier than it is the case today, missing a chance to reduce costs further. EU negotiators ultimately maintained the status quo, settling on a baseline regulatory data protection period of eight years rather than adopting the European Commission’s initial proposal for a six-year period. According to the Commission’s own impact assessment, these extended monopoly rights are estimated to cost European health systems €1.13 billion each year and slow down efforts to make cancer medicines more affordable.  

“Treating cancer is impossible without timely access to safe and effective medicines. The Pharma Package is an important milestone to finally give patients across Europe fairer access to the vital drugs they desperately need, but it does not close all the gaps to further reduce costs. We call on policymakers to ensure these new rules are implemented quickly and with strong ambition,” says Toma Mikalauskaite, Policy Lead at the Association of European Cancer Leagues (ECL).   

For further information, please contact Ivonne Leenen, Communications Officer at the Association of European Cancer Leagues (ECL): ivonne@cancer.eu