E-DRUG: EU Legislation improving medicines for children
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[Drug companies rarely do clinical trials to test/prove efficacy/safety of (adult) drugs in children. So paediatricians mostly prescribe them "off-label": their dosages and indications are not formally approved by drug regulatory agencies.
To stimulate drug companies interest, a 6-month patent extension (for the adult drug!) is proposed by the EU.
The UK is also active in the drugs & children debate: it is planning to issue a BNF for children, and has a GBP 100m bag of money to stimulate research. What do e-druggers think is the better approach?
WB]
http://www.euractiv.com/cgi-bin/cgint.exe/1?204&OIDN=1508129&-tt=
EU Legislation improving medicines for children in the pipeline
A new EU law would oblige pharma companies to carry out trials to ensure the quality and effectiveness of paediatric medicines. The proposal is expected to come out in September.
The Commission is currently finalising a new legislative proposal which aims at improving the quality and effectiveness of medicines prescribed to children. The new law would promote the research and development of pharmaceuticals for this age group. The college of commissioners is expected to approve the proposal in September.
According to figures from the Commission, at least 50 per cent of the medicines given to newborn babies or to adolescents have never been tested for their impact on these age groups. As a common practice, doctors prescribe smaller or less frequent doses of medicines intended for adults. Other forms of medicine, for instance liquid instead of tablets, would often suit young patients better.
To reduce the risks of unexpected side-effects, the Commission is proposing a new piece of legislation introducing obligations for pharmaceutical companies to improve the medicines given to children. The new law would, for instance, require companies to present the results of clinical trials involving children at the time of the authorisation of drugs. The same would apply to patent-protected medicines already on the market if they wished to extend the use of the drug. Some of this information would then be made available to the public. Pharmaceutical companies would be compensated for the extra costs involved in complying with the new requirements with a six-month extension of their patent. The Commission will also propose incentives for new studies on the paediatric efficacy of generic medicines (not covered by a patent).
Ahead of the approval of the EU law, the UK's Department of Health launched a new paediatric medicines strategy on 18 August, devoting 100 million pound sterling (around 148 million euro) to encourage the development of medicines for children. Part of this budget will be spent on providing prescribers with better information about the impact of medicines on children.
The EU consultation paper (comments had to be sent by April 2004) is still available at:
http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/mar/Paediatric%20consultation%20document%20final%208%20March%2004.pdf
A new initiative to encourage the development of more medicines designed specifically for use in children was announced today by Health Minister, Lord Warner.
Most medicines are designed for and tested on adults but are widely prescribed for children. The evidence shows that children and adults respond very differently to medicines and that a treatment which is effective in adults may not be as suitable for children.
These new plans will encourage manufacturers of medicines to research and develop medicines geared to the needs of children. They will also make sure prescribers have better information about the impact of medicines on children.
The new paediatric medicines strategy includes:
strongly encouraging companies to provide much better paediatric clinical trial data for new and current medicines;
provide better information on the use of medicines on children in patient information leaflets
publishing for the first time, a separate British National Formulary for Children;
investing part of the additional �100 million announced in the Budget to promote research into medicines for children through new research networks which will be coordinated by the UK Clinical Research Collaboration.
The UK position is at:
http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4087889&chk=KA5hje
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