A new report from the European Federation of Pharmaceutical Industries and Associations (EFPIA), prepared by the Swedish Institute for Health Economics (IHE), highlights continued disparities in access to innovative cancer treatments across Europe. While regulatory approvals have accelerated significantly, many patients still face delays before new medicines become available in clinical practice. According to the report, cancer could become the leading cause of death in the European Union by 2035. However, several countries have already recorded a decline in cancer mortality rates over the past decades.
Access gap persists despite regulatory progress
The report suggests that centralized approval by the European Medicines Agency (EMA) is no longer the main bottleneck. Instead, delays often occur after authorization, when medicines must be incorporated into national, regional, or local reimbursement systems, formularies, and clinical guidelines. Countries such as Italy, Spain, and Sweden are cited as examples where additional regional approval processes can slow patient access to newly approved therapies.
Between 1995 and 2024, EMA approved 194 oncology medicines, alongside more than 300 new indications for existing products. Yet access remains highly uneven. Western European countries generally provide broader and faster reimbursement than countries in Central and Eastern Europe. In some smaller markets, including Malta, Estonia, Slovakia, and Romania, only around 20% of cancer medicines approved between 2019 and 2022 had secured reimbursement. In Latvia and Lithuania, reimbursement procedures can take up to 900 days.
Structural barriers still limit uptake
The report identifies several factors that continue to hinder the adoption of innovative oncology medicines across Europe. These include differing pricing and reimbursement systems, variations in health technology assessment (HTA) requirements, insufficient reimbursement for companion diagnostics, and limited molecular diagnostic infrastructure in some countries.
Despite these challenges, the gap in the uptake of new cancer medicines has narrowed in recent years. The difference between the highest- and lowest-performing countries fell from 5.3-fold in 2018 to 3.3-fold in 2023. Austria, France, and Switzerland are among the fastest adopters of new oncology therapies in clinical practice.
Recommendations for a more equitable system
To improve access, the report calls for greater use of managed entry agreements (MEAs), including outcome-based arrangements, and more flexible HTA pathways that prioritize medicines with demonstrated clinical value. Additional measures include wider use of biomarker-driven patient stratification, optimization of treatment sequencing, and greater adoption of generic and biosimilar medicines.
The authors also highlight the need for stronger real-world evidence collection through disease registries to support healthcare decision-making. Looking ahead, Europe’s evolving pharmaceutical legislation and the implementation of the EU HTA Regulation could help accelerate reimbursement decisions and encourage broader availability of innovative cancer medicines across all Member States. However, questions remain around national acceptance of joint clinical assessments and Europe’s competitiveness as a destination for oncology clinical research.