Recommendations for paediatric cancer following launch of the Pharmaceutical Strategy for Europe



On 25 November 2020, the European Commission released the Pharmaceutical Strategy for Europe and launched the Roadmap Consultation on the Orphan and Paediatric Regulations. This follows the publication of the European Commission evaluation of the legislation for medicines for rare diseases and children earlier this year.

On this occasion, the European childhood cancer community unveils the 6 Key Recommendations  to advance patients’ access to medicines, accelerate innovation and improve regulatory environment for children and adolescents with cancer.

These recommendations will be discussed with all stakeholders on the occasion of the International Childhood Cancer Day (ICCD21) – a virtual event on 3 February 2020. 

Paediatric Cancers in Europe: Inequalities and unmet needs

The lack of sufficient investment and the slow pace of innovation has stalled the progress in curing paediatric cancers, which remains the first cause of death by disease in children older than one year of age in Europe. Neither regulation served the urgent needs of children and adolescents with cancer, and those who are fortunate to survive their cancers must also cope with acute and persisting adverse long-term side effects caused by older medicines. Furthermore, there are still inequalities in access to new and essential medicines for children and adolescents with cancer across Europe.

Call for Urgent Action

SIOP Europe and CCI Europe welcome the recognition of the unmet needs for innovation in paediatric cancers in the European Commission evaluation of the Orphan and Paediatric Regulations and put forward 6 Key Recommendations for Paediatric Cancers, which also have relevance to other Paediatric Life-Threatening Rare Diseases.

More broadly these recommendations apply to what the childhood cancer community would like to see addressed within the Pharmaceutical Strategy for Europe.

Recommendation 1: Align the Regulations with Science and Unmet Needs of Children

Recommendation 2: Ensure Child Specific and First-In-Child Innovation

Recommendation 3: Implement Multi-Stakeholder Cooperation and Prioritisation as a Standard

Recommendation 4: Allocate Public Investment in Medicine Development for Children

Recommendation 5: Align Global Regulatory Environment

Recommendation 6: Ensure Equal Access to Essential and Novel Anticancer Medicines and to Supportive Care Medicines




International Childhood Cancer Day (ICCD21)  hosted by MEP Loucas Fourlas, will further these recommendations under the topic of ‘Action to Improve Access to Medicines for Paediatric Cancers in Europe: Eradicating inequalities and addressing unmet needs’.

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