Ministers akkoord met voorstellen om medicijnen speciaal te testen voor kindergebruik (en)

vrijdag 9 december 2005, 15:04

More than 50% of the medicines in Europe have not been tested and authorised for use in children. Whilst medicines for adults must have undergone extensive testing including pre-clinical tests and clinical trials to ensure that it is safe, of high quality and effective, doctors have a limited choice of medicaments for ill children. This will change soon, as the Health Council has today overwhelmingly endorsed a Commission proposal to address this issue and to improve the health of children by increasing the research, development and authorisation of medicines for use in children.

By the Council reaching political agreement, the proposal for a Regulation on Medicines for Children can now proceed to the 2nd reading in the European Parliament and should become law by 2007.

Commission Vice President Günter Verheugen stated: "I very much welcome this landmark agreement. This regulation will improve the health of children by ensuring innovation in the development of medicines for their use. I thank the UK Presidency for reaching this milestone so quickly and call on the Austrian Presidency and the European Parliament to ensure this important regulation becomes law as soon as possible. "

Through a package or requirements, rewards and support measures, the regulation will increase high quality research and therefore development and authorisation of medicines for children. The key measures elements are:

1. Requirements

  • a requirement at the time of marketing authorisation applications for data on the use of the medicine in children resulting from an agreed paediatric investigation plan[1];
  • a system of waivers from the requirement for medicines unlikely to benefit children;
  • a system of deferrals of the requirement to ensure medicines are tested in children only when it is safe to do so and to prevent the requirements delaying the authorisation of medicines for adults.

2. Rewards

  • an incentive for compliance with the requirement in the form of six-months extension to the supplementary protection certificate (in effect, six-month patent extension);
  • for orphan medicines, an incentive for compliance with the requirement in the form of an additional two-years of market exclusivity added to the existing ten-years awarded under the EU orphan regulation;
  • a new type of marketing authorisation, the Paediatric Use Marketing Authorisation (PUMA), which allows ten-years of data protection for innovation (new studies) on off-patent products.

3. Support measures

  • a commitment to EU funding into studies on off-patent medicines for children (the so-called "M.I.C.E. Programme");
  • the establishment of an expert committee, the Paediatric Committee within the European Medicines Agency (EMEA);
  • measures to increase the robustness of pharmacovigilance for medicines for children;
  • an EU inventory of the therapeutic needs of children to focus research, development and authorisation of medicines;
  • an EU network of investigators and trial centres to conduct the research and development required;
  • a system of free scientific advice for the industry, provided by the EMEA;
  • a publicly available database of paediatric studies.

Additional information, including the initial Commission proposal, the modified Commission proposal and the impact assessment, are available at:

http://pharmacos.eudra.org/F2/Paediatrics/index.htm

[1] This applies to all new innovative medicines, as well as new indications, pharmaceutical forms and routes of administration for existing patent-protected medicines

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