ECPC Press Release - 6 June 2006

Brussels, 6 June 2006

The European Parliament and Member States, under the chairmanship of the Austrian Presidency, reached agreement on an important piece of legislation - Medicines for Children. The Regulation will ensure that in future Europe’s children will benefit from medicines that have been specifically tested and authorised for their use.

ECPC welcomes this long overdue Regulation that would guarantee the maximum possible safety in child medication and end the anomaly that at least 50 % of the medicines given to babies, toddlers and adolescents - according to Commission figure - have never been tested in children.

Cancer is the leading cause of death in children outside of accidents. Each year in Europe about 13 000 children will develop cancer and 3 000 will die of the disease. Yet these children’s access to innovative therapy is extremely limited. Children whose metabolism is different from adults may respond differently than their elders to medicines.

“The new legislation will ensure that clinical research takes place in this area and will be to the highest ethical standards to protect the vulnerability of this population group”, stated Lynn Faulds Wood, President of the European Cancer Patient Coalition. “Stringent pharmcovigilance measures are essential to meet the specific challenges of collecting safety data in this group, including data on possible long-term effects.”  Where there is a particular concern, pharmaceutical companies who conduct the research will be required to submit and implement an appropriate risk management system and/or perform specific post-marketing studies as a condition for the granting of the marketing authorization.

Central elements of the Regulation are the introduction of a Paediatric Investigation Plan and the setting up of a Paediatrics Committee. When drawing up the plan two principles need to be applied. Firstly, studies should only be conducted if there is a potential therapeutic benefit to children and duplication of studies must be avoided. Secondly, the requirements for studies in children should not delay the authorisation of medicines for adults.

The new Paediatric Committee within the European Medicines Agency will determine the cases in which there is a potential therapeutic benefit for children and request specific studies.

“ECPC is pleased that important transparency issues have been addressed. From now on details of the results of all Clinical Trials conducted on children will have to be made public by the European Medicines Agency, whether or not the trial was terminated prematurely. Importantly this will avoid  the possibility of duplication and allow better sharing of scientific knowledge -  an absolute must in this most vulnerable group of patients,” said Hildrun Sundseth, Head of EU Policy, European Cancer Patient Coalition.

A balanced system of obligations and incentives will encourage pharmaceutical companies to invest in the clinical studies and develop safe medicines for children.  A key provision of the new legislation is a six-months extension of patent protection, provided that all measures included in the Paediatric Investigation Plan are complied with, the product is authorised in all Member States, and the relevant information the result of the trials is provided in the product information.

The Regulation will close a serious gap in the area of public health. The way is now open for speedy implementation of the Regulation across Europe to guarantee the maximum possible safety in children’s medicines.

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Notes to the Editor

The European Cancer Patient Coalition was founded in 2003 under the slogan “Nothing about Us, Without Us. It is committed to improving cancer prevention, screening, early diagnosis and best treatment, reducing disparity and inequality across the EU. ECPC seeks to ensure that policy makers, politicians, health professionals, the media and the general public recognise the serious nature of cancer and the need for concerted action to reduce unnecessary death and suffering. Further information can be found at www.ecpc-online.org.