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European Regulation for Paediatric Drugs: Fantastic news for our children (Oct 06)
The European Parliament has adopted the report of Françoise Grossetête (Member of Parliament and Vice-President of PPE-DE1) in plenary session in June 2006. This is great news for all the children of Europe, including those living with rare diseases. ‘Many of the medicines administered to our children today have not been developed for them,’ says Françoise Grossetête. ‘Quite often, medicinal products given to the younger ones are the same as those prescribed to adults. They are administered by decreasing quantities based on weight, sometimes with terrible consequences.’ The European Commission had been working on the issue since 1997, along with advocacy groups, first of which Eurordis. The European Organisation for Rare Diseases worked with national and European authorities to convince them of the importance of the establishment of a Regulation on Medicinal Products for Paediatric Use. Eurordis intervened at each stage of the regulatory decision-making process with the publication of position papers, comments, and letters to authorities between 2000 and 2006. This is an excellent illustration of the power of patient advocacy, when relentless and patient-driven. The European Commission released a first proposal of Regulation in 2004. Political agreement was finally reached by the Council of Health Ministers in December 2005, and the Regulation agreed upon on 1st June 2006. It is now anticipated that the Regulation may become law before the end of 2006.
The main measures adopted by the Regulation are the following:
Obligation for paediatric research for every new drug developed for adults and having a potential use for children, and a six month extension of the supplementary protection certificate. For drugs that are already in the public domain, paediatric research will be performed on a voluntary basis. But a development plan will be established with the EMEA (European Medicines Agency) for companies that volunteer, and a new Marketing Authorisation may be granted for 10 years and EU funds allocated through MICE (Medicines Investigation for the Children of Europe, a paediatric study programme).
Creation of an inventory of specific needs for paediatric medicinal products
Creation of a Paediatric Committee at the EMEA:
This Committee will replace the current Paediatric Expert Group at the EMEA. All Member states will be represented by one expert in the Committee. Six additional members will be appointed: three patient representatives (parents or family members) and three health professionals.
2 year extension of market exclusivity for orphan drugs for children (12 years in total instead of 10 for other orphan drugs): ‘Rare diseases were not forgotten in the Regulation,’ says Agnès Saint Raymond, Head of Sector Scientific Advice and Orphan Drugs, EMEA. ‘This means that children suffering from rare diseases aren’t “super orphans” - orphaned by their disease and orphaned by the lack of specific medicines for them. This is fantastic.’
Implementation of a process to avoid unnecessary clinical studies on children:
This process has been designed to protect children, since it will be their parents who will be in charge of signing agreements on clinical studies performed on them. The process has three main components: transparency measures for databases on clinical studies; expert advice; and the role played by the new Paediatric Committee.
’This new Regulation is a great opportunity to change the way medicines are administered to children,’ says Agnès Saint Raymond, ‘and the benefits largely outweigh the risks.’ The risks consist mainly in unnecessary studies and developments, potentially dangerous to children. ‘The Regulation will create a huge workload for the EMEA when it becomes Law,’ she says, ‘but it is necessary.’
The involvement of Eurordis and patient representatives in the process does not stop with the adoption of the Regulation. On the contrary! First, there are the three patient representatives to be appointed to the Paediatric Committee. Patient representatives will also be contacted to take part in the scientific advice process that is offered free-of-charge to pharmaceutical companies developing paediatric drugs before they apply for Marketing Authorisation (a similar process to Protocol Assistance for orphan drugs). Eurordis will be contacting rare disease patient representatives across Europe to participate in this process. We encourage you to register your interest with us now (anja.helmeurordis.org).
For more information:
1Parti Populaire Européen (Démocrates - Chrétiens)
This article was previously published in the October 2006 issue of our newsletter.
Author: Jerome Parisse-Brassens
Photo credits: patient with drugs © Noelle Barandou / Vaincre la Mucoviscidose ; Françoise Grossetête © Françoise Grossetête; antibiotics © www.freeimages.co.uk