The European Union (EU) has launched a public consultation to define a new Pharmaceutical Strategy for Europe. The Strategy will focus on delivering quality, safety and efficacy of medicines and reinforcing the sector’s global competitiveness.
The Pharmaceutical Strategy for Europe will examine the need for legislative and non-legislative actions and EU investment into high need areas. Legislative actions may encompass follow up to the initiatives which are already in preparation, such as the review of EU Orphan and Paediatric Regulations.
This strategy is has been launched alongside other important initiatives on health in the legislative period 2019-2024 including Europe’s Beating Cancer Plan.
For more information please read here or access the consultation webpage.
MAKE YOUR VOICE HEARD: SAFE, EFFECTIVE, AND INNOVATIVE MEDICINES FOR ALL CHILDREN AND ADOLESCENTS WITH CANCER ACROSS EUROPE
This is an important opportunity to highlight the unmet needs of children and adolescents with cancer in relation to access to innovative therapies, shortages, and financial accessibility including pricing and reimbursement.
1. Pharmaceutical Strategy for Europe - Roadmap Consultation (deadline 7 July 2020)
Technical Guidance on Responding to the Feedback Consultation: find it here
SIOPE response to 1st Roadmap Consultation – Pharmaceutical Strategy for Europe: find it here
2. Pharmaceutical Strategy for Europe - Public Consultation (deadline 15 September 2020)
Technical Guidance on Responding to the Questionnaire Consultation: coming soon
Overview of key messages from SIOPE – working version: coming soon
SIOPE response to 2nd Public Consultation – Pharmaceutical Strategy for Europe: coming soon
- Position Statement: Paediatric Cancer Medicines - Urgent need to speed up life-saving innovation (last updated: September 2017)
- JARC Deliverable 1: Accessibility of standard treatment for paediatric cancer across Europe (April 2019)
- JARC Deliverable 2: Facilitating referral of children with cancer to trial centers offering innovative medicines (April 2019)
- Position Paper: Beating Cancer in Europe: Let’s not forget our children and adolescents (Feb 2020)
- ACCELERATE Platform
The SIOP Europe office remains available for any questions to facilitate contribution to this important initiative. For any questions, please contact: email@example.com
NOTES ON PAEDIATRIC & ADOLESCENT ANTICANCER MEDICINES
The major issues are underserved: focused actions should ensure safer and innovative treatments.
Cancer remains the first cause of death by disease in Europe in children older than 1 year - more than 35,000 cases are diagnosed and over than 6,000 young patients die annually.
While improvements in cure rates have been achieved for some paediatric cancers with the stringent and concerted use of old older chemotherapeutics (about 80% off-label) over decades alongside with local control modalities (surgery, radiotherapy) little progress has been made in the cure rate of several other paediatric malignancies and there is a lack of innovation for better cure overall.
In contrast to the market-driven adult cancer sector with over 150 new medicines in the last decade, only 9 of these were seen for a truly paediatric cancer indication since 2007. Access to essential medicines and innovation across the paediatric cancer spectrum (>100 molecular subtypes) is urgently needed. Dedicated international academic research platforms, cross-linked and informed by adult cancer and industry-driven research, are vital to foster therapeutic innovation in paediatric cancers. Budget allocations to novel developments in paediatric cancer research to enrich research through big data and use of Artificial Intelligence.
The EU Paediatric Medicines Regulation has benefited many childhood diseases - but not yet sufficiently cancer, which remains a most urgent human, social and public health issue in Europe. European surveys also point to issues in access to essential medicines. Access to early phase clinical trials for children in relapse or treatment failure may provide a second chance for these patients and is available in only few centres across Europe.
Age-related specificities call for tailored approaches to paediatric cancer over and above the cross-cutting issues shared with the adult cancer sector.
Pharmaceutical Strategy for Europe holds great promise for better treatments and quality of life of children and adolescents with cancer.
EU-level support is instrumental to ensure that the urgent need of paediatric anticancer medicines is not overlooked and instead become an integral part of all relevant health policies and programmes.