ACCELERATE Paediatric Oncology Multi-stakeholder Platform
ACCELERATE
ACCELERATE is a unique multi-stakeholder international platform providing a transparent forum to discuss and address overarching issues to accelerate innovation in drug development for children and adolescents with cancer.
ID: 553056941424-52
Lobbying Activity
Response to EU Civil Society Strategy
5 Sept 2025
ACCELERATE welcomes the European Commissions plan to establish an EU Civil Society Strategy. Based in Brussels with a global outlook and a strong European footprint, ACCELERATE is an international multi-stakeholder platform dedicated to accelerating the development of innovative therapies for children and adolescents with cancer. We unite patients and parents, survivors, clinicians, researchers, regulators, policymakers, and industry to co-develop solutions that directly improve young lives. Our work is formally recognised and strongly supported by the European Medicines Agency (EMA) as highlighted by Emer Cooke, the EMA Executive Director: The work of ACCELERATE, particularly through the Paediatric Strategy Forums, stands as a stellar example of multistakeholder interaction impacting regulatory decision-making, not only within the context of the EU Paediatric Regulation, but also on a global scale. ACCELERATEs patient-based foundation is truly unique and serves as an inspiring model o collaboration. This recognition confirms ACCELERATEs value as a loyal, trusted and effective civil society partner in ensuring that paediatric drug development responds to real public health and unmet childrens needs. Civil society organisations like ACCELERATE are vital to EU policymaking. We combine the lived experiences of children, adolescents and families with regulatory, scientific and policy expertise. Our independence from pharmaceutical funding safeguards impartiality and strengthens trust with institutions and citizens. By operating in a pre-competitive space, we enable collaboration across sectors and borders, reinforcing Europes leadership in health equity and innovation. Yet organisations like ours face structural barriers. The absence of predictable, long-term funding threatens continuity and limits strategic planning. EU programmes remain largely project-based, administratively heavy, and provide insufficient pre-financing, creating risks for small teams and discouraging voluntary engagement. Volunteerswho form the backbone of patient advocacy and civil society in healthremain insufficiently recognised and supported. Without structural solutions, independence and sustainability remain fragile. The EU Civil Society Strategy can address these barriers by creating an enabling environment for organisations that advance EU values, democratic resilience and public trust. We encourage the Strategy to include: Sustainable funding: predictable, multi-annual core support for organisations with demonstrated European and global added value. Monitoring through simplified procedures: proportionate application, reporting and compliance rules that free resources for impact. Recognition of voluntary contributions: valuing the expertise and time of patient and community advocates. Structured dialogue: a European Civil Society Platform co-designed with CSOs, to institutionalise transparent and inclusive engagement with EU institutions. Embedding these measures will ensure civil society remain independent, credible and impactful. For ACCELERATE, it will mean we can continue to convene stakeholders, generate regulatory-relevant recommendations, and act as a trusted bridge between citizens and institutions. This is especially timely as EU pharmaceutical legislation enters its final negotiation phase. ACCELERATE is ready to help ensure this new legal framework delivers for children and adolescents with cancer. ACCELERATE is committed to working with and for European citizens, while leveraging global collaboration. Our ambitions align both with EMA and the European Union: to create a development environment that adapts to evolving evidence, accelerates the authorisation of much-needed medicines, and ensures they reach childrens bedsides. With sustained EU support and recognition of civil society, platforms like ACCELERATE can continue to strengthen democracy, uphold EU values, and translate policies into tangible benefits for society.
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
27 Apr 2021
ACCELERATE, the international multi-stakeholder platform which aims to accelerate innovation in drug development for children and adolescent with cancer, welcomes the revision of the general pharmaceutical legislative framework in the scope of the pharmaceutical Strategy for Europe. ACCELERATE agrees with the European Commission that there is a need to address unmet medical needs and market failures for non-orphan and paediatric medicines. The unmet medical needs in childhood cancer have not been properly addressed to this day, while the innovation, research, and development in the therapeutic area of adult cancers has evolved drastically (introduction of precision oncology, immunotherapy, and targeted therapies).
ACCELERATE shows the value of multi-stakeholder cooperation, bringing together representatives from academia, industry, regulatory agencies (EMA, FDA and agencies from other geographical jurisdictions worldwide) and patient advocates working together to improve and accelerate innovative therapies for childhood cancer patients. In line with the objective of ensuring access to affordable medicines in the scope of this impact assessment, ACCELERATE acknowledges that it is also important to improve access to innovative medicines.
We believe unmet medical needs should be defined in a multi-stakeholder setting rather than through criteria-based regulation. ACCELERATE has demonstrated the feasibility and value of a multi-stakeholder initiative through the development of Paediatric Strategy Forums with EMA in collaboration with FDA to define unmet therapeutic needs in paediatric malignancies. The pharmaceutical legislation should enforce a structural framework where unmet medical needs would be continuously identified and evaluated through multi-stakeholder collaborations and the latter would further prioritize medicinal products from these evaluations. We believe prioritisation of oncology drugs should be established in a multi-stakeholder setting to match unmet medical needs in children with cancer to the best available therapies.
ACCELERATE endorses the revision of the system of incentives to attract and promote innovation, especially in areas of highest medical need such as childhood cancers. The revision should build on past achievements rather than completely replacing the current system. We believe better tailored and optimised incentives should be established to reward early start of paediatric medicines development, addressing unmet needs. Within an ACCELERATE multi-stakeholder working group, the representatives proposed to define interim and final deliverables to attract a reward on completion of the paediatric investigation plan.
In addition, novel rewards, such as transferable vouchers, would incentivise both the development of paediatric medicines addressing the specific biological alterations of paediatric disease (first in child product development) and approval of products for unmet needs.
Ways to increase and accelerate product development and authorisation in areas of unmet need, ACCELRATE highlights that there is a variety of experimental medicines that are ‘shelved’ after their development is terminated, but not because of lack of efficacy or safety issues. Facilitating science-driven repurposing of ‘shelved’ experimental medicines would contribute to accelerate innovation to address unmet medical needs.
Finally, ACCELERATE highlights that multi-stakeholder, international collaboration is paramount because each paediatric cancer is individually rare and developing innovative therapies is necessarily a global endeavour. ACCELERATE is currently working to identify current barriers for academic and industry sponsored international trials.
Reinforcing cooperation towards greater alignment is needed to accelerate approval of the global science-driven paediatric development of medicinal products to address unmet therapeutic needs of children suffering from cancer or other rare life-threatening diseases.
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