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Sociedad Española de Hematología y Oncología Pediátricas

SEHOP

1º) Reunir a todos los interesados en la Hematología y/o Oncología Pediátricas, defender sus intereses profesionales y velar por la ética de todos los asociados. 2º) Fomentar el desarrollo de la Hematología y de la Oncología Pediátricas en sus facetas preventivas, asistencial, de formación, docencia e investigación. 3º) Asegurar el derecho que todo paciente en edad pediátrica tiene a ser asistido en instituciones que dispongan de los medios necesarios y por personal sanitario suficientemente cualificado en Hematología y Oncología Pediátricas, mediante esquemas terapéuticos reconocidos a nivel nacional o internacional. 4º) Promover que la Administración dicte leyes que favorezcan la atención a los niños afectos de enfermedades hematológicas y/o oncológicas y permita el desarrollo de programas de investigación tendentes a la mejora en el pronóstico de estos pacientes.

Lobbying Activity

Response to EU Life sciences strategy

15 Apr 2025

SIOPE, the European Society for Paediatric Oncology, represents healthcare professionals committed to delivering care and research in childhood cancer across Europe. Despite significant increases in survival rateslargely driven by academic, cross-border collaborationchildhood cancer remains the leading cause of disease-related death in children and adolescents. Recent findings from the OCEAN project underscore major inequalities in access to high-quality care and clinical trials across Europe, threatening progress and limiting opportunities for children in under-resourced settings. The European Commission must address regulatory and operational barriers that perpetuate unequal access and hinder collaborative progress. As rare diseases, childhood cancers require EU-wide research capacity and collaboration. Clinical cross-border trials are essentialparticularly early-phase trials for children with relapsed or refractory disease. Yet under Directive 2011/24/EU on patients rights in cross-border healthcare, such trials are not reimbursed, leaving many families without access due to geography. A dual approach is needed to increase access and drive innovation: 1. Enable reimbursement and regulatory support for cross-border academic clinical trial participation. 2. Strengthen the paediatric oncology research ecosystem, via the ERN PaedCan network. To foster innovation, ERN PaedCan should formally integrate research and Comprehensive Childhood Cancer Infrastructures should be recognised and expanded within the ERN PaedCan structure. This aligns with the EUs vision for adult cancers while addressing the specific biological and clinical needs of paediatric oncology. These require dedicated tailored research strategies, trial designs, and infrastructuresan approach that has already shown success and must be preserved and strengthened. Further challenges include inconsistent national interpretations of the GDPR, leading to fragmented data protection frameworks. Harmonised implementation of the European Health Data Space (EHDS) is urgently needed to enable secure, efficient data sharing across Member States. The current Paediatric Regulation, which relies on adapting adult therapies for children through Paediatric Investigation Plans (PIPs), rarely leads to meaningful innovation due to widespread waivers. The market routinely fails children with cancer: in the past decade, only 16 anticancer drugs were approved for paediatric use, compared to more than 150 for adults. Low commercial incentives, complex regulatory pathways, and small patient populations deter investment. Academic research is therefore the main driver of therapeutic innovation in paediatric oncology and must be better supported. EU frameworks must ensure therapies developed in academic settings can be recognised and reimbursed across Member States. This includes support for repurposing medicines using academic data and enhanced regulatory assistance from the European Medicines Agency (EMA) for academic and non-profit developers of advanced therapies. In parallel, the EU should facilitate public-private partnerships and adapted pathways to market for academic products, particularly in rare disease areas. Paediatric cancers depend on EU-wide coordination in both care and research. An EU-level solution must remove barriers to cross-border clinical trial access and reimbursement, expand ERN PaedCan to include research, and ensure sustainable funding. Artificial Intelligence (AI) and Big Data offer transformative potential to personalise treatment, accelerate innovation, and improve outcomes. To realise this, the EU must invest in interoperable data systems, digital infrastructure, and sustained cross-border research funding. Finally, new mechanisms must enable EU-wide recognition and authorisation of therapies developed by academic centresthrough regulatory facilitation, support for public-private partnerships, and dedicated pathways from research to delivery.
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