967260_86977584Today, 15 February, is International Childhood Cancer Day. For the first time, the European Parliament marked this important event at a high-level multi- stakeholder meeting hosted last Wednesday, 09 February, by Member of the European Parliament (MEP), Mr. Alojz Peterle in association with SIOP Europe – the European Society for Paediatric Oncology (SIOPE). Young patients from Belgium and their families joined MEPs, experts in paediatric oncology and other cancer policy stakeholders to discuss how the rapid rate of progress previously established in childhood cancer is being forcibly arrested by the implementation of recent EU legislation.

“Your child has cancer”

This phrase is spoken many thousands of times in all European languages each year across European health systems. It is a parent’s nightmare as, most commonly their previously healthy and thriving child now faces the real prospect of distressing and rigorous treatment.

Mother and daughter, Sandy and Olivia Ferrary, from London, UK, shared their story at last week’s event. Olivia, at 11, was diagnosed with an extremely rare form of kidney cancer. Her assigned specialist was able to find unique life-saving medicines identified by recent research. The treatment worked and after extensive and successful surgery she is now back to health and school. Her mother Sandy spoke of her hope that other families can have similar positive experiences: “It was our pleasure to have been asked to represent all the children and their families who will continue to face and deal with situations that are out of their control, and which don’t always end well”.

With the rapidly changing landscape for cancer patient treatment, there are new opportunities to design less toxic, more effective therapeutic approaches to save a child’s life. However, numerous challenges are facing young cancer patients in Europe, and their carers.

‘Regulatory Fundamentalism’

The Clinical Trials Directive (1) has had a disproportionately negative effect on the initiation and conduct of trials for children, particularly due to the varying national interpretation of the Directive.

This challenge, according to speakers at the meeting last Wednesday, 09 February, will cost lives through missed opportunities. Indeed the significant progress made in paediatric oncology, resulting in approx. 80% cure rate, is under threat.

The ‘regulatory fundamentalism’ of this EU Directive, according to Prof. Stefan Bielack of Olga Hospital in Stuttgart, Germany, severely constrains the research-based approaches that have been developed and prevent newer Member States to offer new treatments. Referring to the newly-published report, The State of Research into Children with Cancer across Europe – New Policies for a New Decade (2), Prof. Richard Sullivan from the Centre for Global OncoPolicy, London, UK, emphasised the need for the immediate reduction of the bureaucratic barriers that negatively impact on the conduct of investigator-led clinical trials. “This report points out that this Directive, whilst proposing a high standard of research conduct, has generated very significant blocks to trial development, particularly in smaller countries, making it almost impossible for them to participate.

Indeed in Poland, not a single children’s clinical trial has opened since 2007!”Some attempts have been made at EU level to speed up the licensing of new drugs suitable for children’s diseases. The opportunity for the paediatric licencing of drugs, through the creation of the Paediatric Regulation (3) can truly enhance the safety of medicines for children. However, according to Prof. Gilles Vassal, Head of Translational Research at Institut Gustave Roussy in Paris, France, “The new Regulation has not had the impact upon the pace of licensing we had hoped for. The pharmaceutical industry does not perceive the childhood cancer drug market as commercially attractive because of the rarity of our young people with cancer.” He appealed to MEPs to take the special needs of young people into account and push for strategies to encourage the licensing of new drugs for seriously ill children.

Addressing Inequalities in Treatment and Care

Host of the event, MEP Alojz Peterle, noted how “Europe is still characterised by unacceptable inequalities in cancer control”. The European Standards of Care for Children with Cancer project, to be rolled out through the European Partnership for Action against Cancer initiative (4), an partnership initiative between professionals and parents, was promoted as a way of improving standards and will be highlighted by Poland when it holds the EU Presidency in the latter half of 2011.

“Through partnerships between professional and family groups, these combined efforts are already improving the support and treatment that children suffering from cancer receive”, says Benson Pau, chairperson of ICCCPO – the International Confederation of Childhood Cancer Parent Organisations.

A network for change

SIOPE President, Assoc. Prof. Ruth Ladenstein from the St. Anna Children’s Research Institute in Vienna, Austria, leads a new EU FP7-funded project, ENCCA – the European Network for Cancer research in Children and Adolescents that aims to address some of these issues. This ambitious project, involving 33 leading European institutions and organisations plans to re-structure knowledge- sharing within the paediatric oncology community and support the development of innovativetherapeutic strategies for these rare cancers.

ENCCA and the sustainability of such networks and research-based initiatives, as well as the revision of the EU Clinical Trials Directive and a call for a review of the progress of the EU Paediatric Regulation, will all be discussed once again at a meeting led by MEP Ms. Glenis Wilmott in June in Brussels.