Since it was created, the association “Imagine for Margo” and European authorities to accelerate access to more efficient medicines for children and to increase pharmaceutical laboratories financing for research on childhood and teenage cancers.

WHY TAKING ACTION?

– Cancer remains the first cause of death among children’s diseases in France and Europe
– No progress has been made on some types of tumors in decades
– We observe an increase of 13% in pediatric cancers from 1980 to 2000
– More than 50% of medicines are for adults and are not authorized nor evaluated for children
– Only 10% of children with cancer recurrence have access to new treatments in Europe

A PROMISING EUROPEAN PEDIATRIC REGULATION BUT INEFFICIENT FOR CHILDHOOD CANCERS

Since 2007, the European Regulation on pediatric medicines had obliged pharmaceutical laboratories to evaluate their medicine’s benefit in children.
When it comes to pediatric cancers however, pharmaceutical companies almost systematically obtain derogations not to develop their medicines for children, although their molecules could have a positive action on pediatric tumors.

Indeed, we count up to 60 different types of pediatric cancers, which are rare diseases, and medicines development for such diseases is not financially interesting for pharmaceutical companies.

Over 10 years, only 2 anti-cancer medicines have been developed thanks to the Paediatric Regulation. This cannot be accepted ans we are taking action to make it change.

WHY IS THE EUROPEAN PAEDIATRIC REGULATION INEFFICIENT FOR CHILDREN WITH CANCER?

Unjustified derogations:

Pharmaceutical laboratories can obtain a derogation not to develop their medicines for children if the drug is for an adult’s disease. (Art 11.b)
In oncology, industrials only develop medicines to treat cancers which do not exist in children (lung, breast, pancreas cancers etc). Thus they obtain derogations not to develop their medicines in paediatrics.
However, some adults medicines can be effective in childhood cancers: for instance, Crizotinib, a drug indicated in lung cancers (a cancers that only affects adults), obtained a derogation and was later proven efficient in several childhood cancer!
These scientifically unfounded derogations are a waste of time and a waste of children and teenarger’s lives.

Missed drug’s development deadlines:

In terms of childhood cancers, the Regulation recommends that developments should start towards the end of Phase I of adult drug’s development. This key recommendation is not respected: industrials delay as much as possible the Paediatric Investigation Plans (PIPs) submission, which only starts about 4 months before the Market Authorisation file submission for adults medicines.
No sanctions are triggered when the Regulation’s recommendations are not respected.

No incentive to develop specific childhood cancer medicines:
The European Regulation on paediatric cancer is based on developments for adults. There are no incentive to develop paediatric-only medicines when some cancers are children specific.
In the USA, the FDA (Food and Drug Administration) voted in 2012 the Creating Hope Act to Facilitate specific paediatric medicines’ development. This kind if incentive does not exist in Europe.

A DOCTORS AND PARENTS ASSOCIATIONS’S MOBILISATION RELAYED BY EUROPEAN DEPUTIES

Working closely with paediatric oncologists, European researchers from The European Society of Pediatric Oncology (SIOPE) and representatives of european associations movement Unite2cure which we co-founded in 2015, we mobilised parliament members and associations in France and Europe and this is what we obtained:
– A resolution vote at the European parliament asking the European Commission to change the European Paediatric Regulation (December 15th, 2016)
-Numerous responses to the European Commission Public consultation

2017 will therefore be a key year and with Unite2Cure and the SIOPE we remain more than ever mobilised and keep on taking action with authorities.

 European deputy Françoise Grossetête’s speech at the European Parliament to improve the Paediatric Regulation.
The resolution was voted on December 15th 2016 and constitutes a big step to make research progress.


IMAGINE FOR MARGO AT THE HEART OF MOBILISATION

We lead numerous actions with parliament members, associations and industrials.

As a founding member of Unite2Cure, we are very active in the associations’s lobbying teams: meeting with the European Parliament and to members of the European Commission (Directorate General Health) and meetings with the European Federation of Pharmaceutical Industries and Associations (EFPIA). We take part in the European project SIOPE-CCI : JOINT ACTION AGAINST CANCER (JARC) to improve children’s access to clinical trials.

In France, we initiated the creation of a study group “Cancer au Sénat” (Cancer in Senate) in May 2016; we took part in several hearings of cancer study group at the National Assembly; we met with former French health Minister Marisol Touraine and obtained the creation of a work group on Paediatric regulation at the Ministry.

We also work with the INCa (National Institute of Cancer), ANSM (National Health and Medicines Agency), LEEM (Medicines industrials) to analyse impediments of medicines’ development and propose solutions.

 

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