On October 10, 2025, CPE, together with the Asociación Española Contra el Cáncer (AECC) and the Fundació HiTT, hosted the event “Access to Medicines for Cancer Patients: Spain’s Response to the New European HTA Regulation” at the Congreso de los Diputados in Madrid. This high-level discussion analysed the implementation of the European Health Technology Assessment (HTA) Regulation and its implications for patient access, evaluation of medical innovations, and the future of oncology treatments in Spain.
The European Union’s new Health Technology Assessment (HTA) regulation, effective from January 2025 for oncology treatments, marks a significant shift in how health technologies are evaluated and approved across Europe, including Spain. This event brought together Spanish stakeholders to discuss these changes, ensuring a smooth transition and positive outcomes for patients. A key focus was on precision oncology, specifically ESR1 mutations in metastatic breast cancer, highlighting the importance of collaboration, patient empowerment, and awareness in successfully implementing the new HTA framework in Spain.
The event highlighted that the new EU HTA Regulation represents a turning point in the evaluation of medical technologies, formally integrating patients’ experiences into assessments and consultations. Key discussion points included the importance of removing language and knowledge barriers, providing robust patient training, and ensuring that engagement opportunities are inclusive and accessible to a broad range of voices. The overarching message was that meaningful patient participation requires preparation and support, empowering patients not just to speak, but to influence decisions that affect their care.
Another central theme was the potential of the regulation to reduce inequalities in access to treatment across Europe and within Spain. Participants emphasized that access to innovation and survival outcomes should not depend on geography, calling for harmonized evaluation systems and earlier, fairer availability of new therapies. The discussion also reflected the real-world impact of delayed access, reinforcing the need for patient-centered approaches to ensure equitable, timely, and effective healthcare for all.
Experts from the research, clinical, and policy communities echoed this sentiment, stressing that equitable access to precision oncology requires more than scientific progress alone. Sustained investment in genomic infrastructure, training, and coordination at the national level will be essential to make innovation available to all who need it.
The event concluded with a shared commitment to advancing equity in cancer care through collaboration among policymakers, clinicians, researchers, and patients. CPE reaffirmed its dedication to making the new EU HTA framework a driver of fairness, faster access, and stronger patient voices in European healthcare.
