European Commission wants drug companies to test products for use in childrenBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7470.818-c (Published 07 October 2004) Cite this as: BMJ 2004;329:818
Pharmaceutical companies will have to secure special authorisation to market new drugs for children, under draft legislation tabled by the European Commission at the end of September. The proposal, which is the result of four years of widespread consultation, follows from a specific request from European Union governments to find ways to increase the number of drugs intended for use in children. Just under a quarter of the union's 480 million citizens are below 19 years of age. But over 50% of the drugs given to newborn babies or to adolescents have never been specifically tested for their effects in these age groups.
As a result the commission maintains that doctors cannot be sure of the efficacy of the treatment, the right dose to be given, or the possible side effects when writing a prescription for a child for an untested, unauthorised product.
The latest initiative tries to redress that situation by promoting the development of paediatric drugs while ensuring that the drugs are subject to high quality research before being authorised. If approved by EU governments and the European parliament the legislation would require drug companies to present the results of clinical trials involving children when requesting authorisation for new products. This would ensure that the effect of new drugs on children is known and that the information is displayed on the label. The same procedures would also apply to drugs already on the market and covered by a patent if a company wished to extend the use of the drug. The requirement to carry out clinical trials in children would not apply to the development of drugs designed to treat obviously adult illnesses such as senile dementia or breast cancer.
In exchange for the extra costs involved companies would effectively be given a six month extension to their patent. For orphan drugs (used to treat very rare diseases) companies would be given an additional two years of market exclusivity. The commission insists that the clinical trials on children would be entirely voluntary and in line with new EU legislation that contains standards and procedures to protect participants.
The EU proposal is partly based on experience in the United States, which adopted legislation to encourage clinical trials for children seven years ago. After four years this legislation had led to the creation of over 60 labels with new paediatric information for established drugs.
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