News Release: Championing Paediatric Regulation in Future Revision of EU Pharmaceutical Legislation



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Brussels, 29 September 2022

Championing Paediatric Regulation in the Future Revision of the EU Pharmaceutical Legislation

Civil Society Calls for Strong Political Momentum and Engagement for the Benefit of Children and Adolescents with Cancer


Brussels, Belgium – Delayed access to affordable novel medicines for children with cancer poses severe threats to patients’ lives and quality of survival. The upcoming revision of the 2006 EU Paediatric Regulation is a unique opportunity to address challenges and deserves the highest momentum. The EU  has a once- in a- decade opportunity to advance life-saving changes for children and adolescents with cancer. It is time to form an ambitious and well-functioning regulatory environment for the benefit of this vulnerable population. These were the key messages from the MAC-SIOPE policy webinar co-organised with ECL and CCI-E on 29 September 2022 for Gold September – Childhood Cancer Awareness Month. The event was attended by over 160 participants.

Over the past 50 years, childhood cancer survival has improved substantially, in particular, due to academic-driven efforts using available medicines developed for adults. However, progress has plateaued in recent years, and long-term complications in survivors remain serious. Lack of therapeutic innovation in paediatric oncology is a principal cause. New medicine development for adult cancers has thrived but childhood cancer patients do not benefit from the same dynamic environment. Although the EU Paediatric Regulation has been favourable for many childhood diseases, it has not sufficiently addressed urgent needs in paediatric oncology.

The European civil society formulated evidence-based recommendations to ensure a fit-for-purpose Paediatric Regulation. These include introducing mechanism-of-action-based paediatric investigation plans and better-tailored incentives. Recommendations were discussed with stakeholders during today’s webinar to answer: “What can the EU do to ensure there is sufficient investment in underserved disease areas?” The need for strong political will, collaboration between EU institutions and stakeholders, and specific attention to the Paediatric Regulation file emerged as clear directions to benefit children and adolescents with cancer in Europe.

“Cure for all children with cancer is at the heart of SIOP Europe’s ambitions and advocacy. Developing better treatments is our core objective and strong political will and commitment to the revision of the EU Paediatric Regulation will be crucial to ensure a fit-for-purpose regulatory environment that includes the right incentives and obligations to promote acceleration of paediatric cancer medicines development,” said Prof Pamela Kearns, SIOP Europe Board Member.

As the mother of a child with cancer, I dream of a more collaborative environment where patients’ needs are at the centre of the discussions. The Paediatric Regulation must be amended to guarantee that, whenever there is preclinical or clinical evidence that a compound can help young patients with cancer, all stakeholders collaborate with a real sense of urgency towards the same goal: ensuring that those patients have access to that drug through a scientifically sound and safe clinical trial, explained Delphine Heenen, CCI Europe Committee Member.

Dr Ward Rommel, Chair of the Access to Medicines Task Force of the Association of European Cancer Leagues (ECL) said: “We need to bring the right medicine, at the right time, to the right person. The ECL Access to Medicines Task Force and our partners are worried that health is often discussed as a marketing product instead of a public good. We must ensure that the current unsustainable paradigm is changed for the benefit of young patients, that civil society has a say in improving the EU Paediatric Regulation and that Member States are aware of changes in the pharma sphere at the EU level.”





Cancer continues to be the leading cause of death by disease among children aged over one in Europe. Each year, more than 35,000 new cases are diagnosed and more than 6,000 young lives are lost to the disease. In addition, most of the estimated 500,000 childhood cancer survivors in Europe experience long-term adverse side-effects following treatment. In this way, paediatric cancer remains an urgent health and socio-economic issue.

To read all recommendations of the European childhood cancer organisations following the European Commission’s Evaluation of the Legislation for Medicines for Rare Diseases and Children, please click here.                               


About the European Society for Paediatric Oncology (SIOP Europe, SIOPE)

The European Society for Paediatric Oncology (SIOP Europe, or SIOPE) is the only pan-European organisation representing all professionals working in the field of childhood cancers. With more than 2,600 members across 35 countries, SIOP Europe is leading the way to ensure the best possible care and outcomes for all children and adolescents with cancer in Europe, working to this end in close partnership with childhood cancer patient, parent and survivor groups across Europe.

#PaedOnc| @SIOPEurope |          


About MEPs Against Cancer (MAC) Interest Group

The MEPs Against Cancer (MAC) Interest Group was founded in 2005 by a group of committed MEPs for MEPs. MAC remains the largest and oldest (and until 2020 the only) dedicated group for cancer policy at the European Parliament. MAC members work together in order to improve cancer control and prevention in Europe, in the belief that European cooperation adds value to member states’ actions.

#MissionPossible | @MAC_MEPs |                    


About the Association of European Cancer Leagues (ECL)

ECL is a non-profit, European umbrella organisation of 31 national and regional cancer societies across 26 countries. ECL provides a unique platform for cancer societies to collaborate with their international peers, primarily in the areas of cancer prevention, tobacco control, access to medicines and patient support, and creates opportunities to advocate for these issues at the EU level. ECL provides the Secretariat for the MEPs Against Cancer Interest Group at the European Parliament. 

#LetsTalkAccess | @CancerLeagues | 


About Childhood Cancer International – Europe (CCI Europe, CCI-E)

Childhood Cancer International – Europe (CCI Europe) represents 67 childhood cancer parent, patient and survivor groups as well as other childhood cancer organisations in 34 European countries. CCI Europe works together with all relevant stakeholders for the same aim: help children and adolescents with cancer to be cured, with no – or as few as possible – long-term health problems/late effects.

#KidsCancer |@cci_europe |



Olga Kozhaeva
Director, Policy Affairs
The European Society for Paediatric Oncology (SIOP Europe, SIOPE)

Marko Ocokoljić
Policy Officer
Childhood Cancer International – Europe (CCI Europe, CCI-E)

Wendy Yared
Association of European Cancer Leagues (ECL)