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News Roundup

European MPs offer extension of patents to companies developing drugs for children

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7517.595-a (Published 15 September 2005) Cite this as: BMJ 2005;331:595
  1. Rory Watson
  1. Brussels

    European Union legislation designed to encourage pharmaceutical companies to develop drugs specifically tailored to children's needs has moved closer to the statute book after members of the European parliament (MEPs) voted to endorse it.

    Françoise Grossetête, the French Christian Democrat member who steered the bill through the parliament, said after the vote: “What concerns me are the 100 million Europeans who are under 18 years of age. Thanks to the European Union, our children will soon benefit from appropriate and safe medicines and will no longer have to depend on the good will of American or Asian research.”

    The measures, which are expected to be finally approved by EU governments before the end of the year, have also been welcomed by pharmaceutical associations.

    Greg Perry, director general of the European Generic Medicines Association, emphasised the importance of establishing correct uses, doses, and formulations of drugs for children. “This regulation will provide a better environment with stronger safeguards against abuse than similar legislation in the United States,” he said.

    The European Federation of Pharmaceutical Industries and Associations predicted that the legislation would provide “a key opportunity” for Europe's children and for its drug industry.

    Brian Ager, its director general, welcomed the MEPs' decision to strike a balance between the obligations on drug companies to conduct often complex, costly, and lengthy paediatric research and the need to stimulate this research in Europe.

    The legislation provides for the creation of a paediatrics committee within the London based European Medicines Agency. Its role would be to determine which medicines are of potential use for children and to require manufacturers to carry out the necessary research to develop a formula specifically for children.

    Although drug companies have been reluctant to produce drugs specifically for children because of the difficulty and time it takes to perfect clinical trials, the legislation now offers them an incentive. It proposes to extend by six months the life of patents or supplementary protection certificates for products they develop.

    This, it is estimated, could give each manufacturer extra profits of between €0.8m (£0.5m; $1m) and €9m, offsetting the costs of clinical trials, which can be as high as €4m.

    Companies that produce new products and manufacturers of generic drugs are also being encouraged to develop new paediatric formulations of existing products through the promise of 10 years of market exclusivity.

    The legislation also provides for incentives to promote research and development in Europe and for a network of scientists to prevent duplication of research and of tests on children.

    In addition, the European parliament is pressing governments to do more to tackle major and neglected diseases, such as malaria and dengue fever, in developing countries. In a wide ranging action plan it warns that the resource gap for HIV and AIDS, malaria, and tuberculosis alone is projected to reach €11.5bn by 2007.