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Drugs agency reminds companies of duty to report side effects

BMJ 2002; 324 doi: (Published 20 April 2002) Cite this as: BMJ 2002;324:938
  1. Rory Watson
  1. Brussels

    The London based European Agency for the Evaluation of Medicinal Products is reminding pharmaceutical companies of their responsibility to report any previously unknown side effects that might emerge when new drugs are put on the market.

    The initiative reflects the agency's determination since the start of the year to emphasise its establishment of a strong pharmaceutical vigilance system to ensure the safety of drugs, in addition to its role of granting licences for new products.

    Under existing rules companies have to report any adverse effects of a drug every few months for three years. Thereafter the frequency is reduced to half yearly and then annually.

    Most companies comply, but, according to an agency spokesman, “some need reminding,” while others have to be encouraged to put in place the necessary infrastructure to meet these requirements.

    The agency believes that side effects that do not emerge in clinical trails with a limited number of participants can appear when drugs are licensed and used on a far wider scale. It plans to name and shame companies that fail to comply with the reporting obligations and could ultimately ask the European Commission or national authorities to bring a prosecution.

    The agency is also keen to stress that its responsibilities go far wider than simply licensing new drugs for the EU market. It is involved in five information technology projects designed to support regulatory bodies and the pharmaceutical industry and to provide information to patients and health professionals.

    It is currently developing the EudraVigilance system, which will enable instant information exchange between regulatory bodies of any adverse effects of particular drugs. The agency is working with half a dozen companies on a pilot scheme and expects the system to be up and running within two years.

    Another project, EuroPharm, is a comprehensive database of the properties, side effects, and other features of every licensed drug on sale in the European Union. Due to be completed by 2005, the database will offer different levels of access for regulators, pharmaceutical companies, the medical profession, and patients.

    The agency is also expanding its work on “orphan” drugs (for rare diseases), anti-bioterrorism programmes, and the help it gives to authorities in central and eastern Europe. This expansion has led the agency to ask for an increased budget of €94m (£58m; $83m) next year and a further 62 staff, bringing its complement to just over 300. While some €54m can be expected in revenue from licensing fees, the agency is now looking for the EU to raise its contribution from €14m this year to €28m in 2003.

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