Strasbourg, 15th December 2016
Unite2Cure, Cancer Research UK, and the European Society for Paediatric Oncology (SIOPE) – representing the united voice of parents, researchers and health professionals active in childhood cancer – welcome the adoption of the Resolution on the Regulation on Paediatric Medicines, seeking to improve the current EU Regulation on Paediatric Medicines.
The European Parliament adopted the Resolution during its plenary session in Strasbourg. A key aim of the Resolution is to limit pharmaceutical companies’ scope to avoid the obligation the existing law imposes on them to investigate and develop drugs for children.
Today, companies can ask for a waiver from the obligation to investigate the potential benefit of a drug in a child if the adult cancer for which the drug was originally developed does not exist in children. However, such drugs can still be used to treat other childhood cancer types. For example, – a new drug for adult lung cancer can benefit children with neuroblastoma.
The Parliament Resolution proposes that the existing Regulation is revised by the European Commission to reflect this important distinction, ensuring that the Regulation goes as far as it can for children with cancer in the UK and across Europe.
The Resolution was tabled by Members from across a range of political groups in the European Parliament. It calls on the European Commission to modernise the current legislation to better address the needs of children and adolescents with a life-threating disease, facilitating a more rapid and better prioritised development of innovative therapies for children including for childhood cancer.
Cancer is the leading cause for death by disease among children, with 6000 young people dying of cancer every year in Europe. It is vital that European legislation allows for a more enabling environment when it comes to the research and development of new cancer drugs and medicines for children.
“We, parents and patient advocates want our children to have a chance at a long and healthy life. We will not give up on this. But the problem is that there is still not enough research, not enough drugs and not enough options. At Unite2Cure, we are calling for very specific changes to the Paediatric Regulation to develop more drugs and save our children” commented Patricia Blanc, Anne Goeres, Nicole Scobie, Chris Copland and Delphine Heenen – just some of the many parents and patient advocates at Unite2Cure.
Professor Pamela Kearns, clinical adviser for Cancer Research UK and SIOPE Board member said: “The adoption of this Resolution, advocating important changes to the current regulation, is essential to support a regulatory environment that safely enables and promotes the development of new cancer drugs for children. We urgently need more studies into new cancer treatments for children to improve the lives of children and adolescents diagnosed with the disease.”
Professor Gilles Vassal, SIOPE Past President and Board member said: “The need to accelerate the development of safe and effective innovative anticancer therapies for children and adolescents as well as the need for more studies to obtain paediatric information for paediatric medicines is today a matter of consensus supported by the pan-European paediatric haemato-oncology community and at the global level”
We call on the European Commission to revise the 2007 Regulation on Paediatric Medicines and introduce measures facilitating the testing and developing of new drugs that could potentially be beneficial for children and young people.
Contact details for Journalists: Ms Samira Essiaf, CEO of SIOPE (the European Society for Paediatric Oncology)