
EFPIA White Paper: Unlocking Precision Oncology Access in Europe
The EFPIA Oncology Platform’s white paper, “Advancing Precision Oncology Treatment and Testing Across Europe,” launched on March 5, 2026, at a high-level event in Toledo, Spain, makes an urgent call for better European coordination to improve precision oncology access. Despite breakthroughs in molecular diagnostics, genomic profiling, and targeted therapies, persistent barriers—such as low awareness, inadequate infrastructure, workforce shortages, and outdated reimbursement models—result in uneven delivery within and across EU Member States. Drawing from 15 case studies across Europe and beyond, the paper identifies system “archetypes” hindering progress and proposes a practical implementation toolkit prioritizing three areas: raising awareness among patients, professionals, and payers; strengthening infrastructure like molecular testing platforms and multidisciplinary tumor boards; and aligning funding for diagnostics and therapies. For full details, see the EFPIA press release.
Key insights from the white paper highlight measurable successes in overcoming barriers, supported by real-world data. For instance, France’s INCa network expanded oncogenetic consultations sixfold to 94,855 in 2022, with rapid turnaround times (e.g., 11 days for non-small cell lung cancer testing), demonstrating how national coordination boosts awareness and service uptake. The Netherlands’ Hartwig Medical Foundation achieved 99.2% concordance in whole-genome sequencing (WGS) via the WIDE study, enabling 71% of patients to access new options and building a database of over 5,000 cases for evidence generation. Germany’s DKTK consortium scaled liquid biopsy workflows across sites, while Australia’s Omico-PrOSPeCT screened 22,000+ patients, with 57% receiving targeted recommendations, illustrating scalable hub-and-spoke models. These examples reveal trends toward centralized bioinformatics, virtual tumor boards, and data backbones that reduce turnaround times and inequities, with testing volumes doubling in places like Sweden (10,000 solid tumor tests annually via GMS560 panels).
Case Study Blueprints for Scalable Systems
The white paper’s evidence base, stemming from a rigorous methodology: a year-long process of expert interviews, bilateral consultations, and a multi-stakeholder workshop involving clinicians, payers, patients, health economists, and industry. Case studies were selected for geographic diversity, covering centralized (e.g., Sweden’s GMS) and decentralized systems (e.g., Catalonia’s OMIQ-HES), with quantitative metrics like testing volumes (e.g., Catalonia’s 23,135 NGS reports, altering 24.7% of treatment plans) and qualitative assessments of scalability. Archetypes—recurring issues like “pilot-heavy fragmentation” or “budget silos”—enable systems to self-diagnose maturity, linking to tailored recommendations such as standardized counseling or hub models.
Reshaping Economics and Reimbursement Pathways
The white paper emphasizes precision oncology’s potential to optimize resource use amid rising cancer costs—projected at €58.7 billion annually in lost productivity by 2040. By reducing overtreatment (e.g., Italy’s DBO tracking de-escalation in breast cancer) and enabling higher response rates with fewer side effects, these models promise system savings, as evidenced by cost analyses showing next-generation sequencing (NGS) panels outperforming sequential single-gene tests. Fast-track pathways like Belgium’s (tripling reimbursed indications to 23,000 tests by 2023) and Germany’s automatic companion diagnostic coverage post-EMA approval minimize therapy-test lags, accelerating uptake for novel therapies.
Scaling access via EU levers—IVDR quality standards, Genomic Data Infrastructure, and EU4Health continuity—could enhance patient outcomes through interoperable registries, and position Europe as a precision oncology access leader, yielding healthier populations and sustained economic resilience.