http://bmj.com/cgi/content/full/324/7337/563/a
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 Collections under
which this article appears: Pharmacology
and toxicology Adverse
drug reactions Children
Patient
safety / Clinical risk / Medical error Research
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The European Commission is urging the pharmaceutical industry to develop medicines that are especially suitable for children.
The initiative is designed to remedy the situation whereby 50-90% of medicinal products given to people aged under 16 years have never been specifically evaluated for use in children.
In a new consultation paper, the commission maintains that the absence of specific paediatric formulations may cause problems for Europe's 80 million younger patients when trying to swallow tablets and could lead to serious calculation errors when adult dosages are adjusted for the treatment of children. These may increase the risk of adverse reactions or lead to ineffective treatment through underdosing.
The commission is looking to remedy the situation by striking a balance between incentives and regulatory obligations. The discussion paper, which is based on earlier meetings between national and EU experts, sets out ways this might be achieved and invites feedback from the medical profession, the industry, and any other interested parties.
Among the incentives being suggested are the possibility of a longer period of intellectual property protection to reward companies that develop innovative medicines and the introduction of a new type of marketing authorisation bestowing similar property rights on new paediatric uses of older products.
The paper proposes placing an obligation on companies to carry out paediatric studies before they can receive marketing authorisation, unless the medicine is unlikely to be used in children.
The suggestion follows the example of the United States, where specific rules
to encourage the performance of clinical trials in children have been
introduced during the past four years. During that period, more than
400 studies have been started. To encourage similar developments in
the European Union, the commission raises the possibility of creating
a fund
using some of the
proceeds made from the additional profits generated by the extension
of intellectual property rightsto
finance clinical or non-clinical paediatric research.
To promote transparency of information, thought is being given to establishing a central database containing details of all relevant clinical and other studies on medicinal products approved specifically for children. The paper acknowledges that work on developing and testing child specific medicines will need to be overseen by dedicated expert regulators. It suggests that this could be carried out by a working group in the London based European Medicines Evaluation Agency. This could be accompanied by the creation of a pan-European network of specialists to pool expertise, encourage cooperation, and avoid duplication.
The commission is requesting comments on the paper before the end of April. These will be taken into account when it draws up draft legislation in the summer.
The paper can be obtained at
http://pharmacos.eudra.org/F2/
home.html (send comments to the European Commission, DG Enterprise,
Unit F/2, rue d'Arlon 88, 1/5, B-1049-Brussels, Belgium).
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Collections under
which this article appears:Pharmacology
and toxicology Adverse
drug reactions Children
Patient
safety / Clinical risk / Medical error Research
and publication ethics |
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