Europe considering drug regulation reforms

The European Commission is considering wide-ranging reforms to the European Union's 1995 pharmaceutical law, reports the British Medical Journal. However, before any changes can be implemented, they must first be approved by EU governments and the European parliament.

The commission is proposing to follow the United States by introducing a fast track registration procedure for products of major therapeutic interest, allowing them to be assessed and authorised quickly and efficiently.

It is also recommending consideration of conditional marketing authorization, which would enable a company to market a product for one year if there is an important expected health benefit for the patients concerned, provided that the company undertakes additional monitoring and clinical studies.

Another innovation would introduce a Europe-wide system to make medicines available before they are authorised, on grounds of compassionate use – ensuring that patients are not discriminated against on the basis, in particular, of the location of clinical trials performed by a particular company.

The reform package also recommends various changes to the European Medicines Evaluation Agency, the centralized agency that evaluates medicinal products for marketing authorisation, to allow it to provide scientific advice to pharmaceutical companies.

Furthermore, pharmaceutical companies would be able to provide information on prescription drugs directly to patients with AIDS, diabetes or asthma; but the EU's ban on direct to consumer advertising of prescription drugs would remain.

Source: Rory Watson, EC moves towards 'direct to consumer' advertising, News Roundup, British Medical Journal, July 28, 2001.

For text http://bmj.com/cgi/content/full/323/7306/184
For more on European Drug Regulation http://www.ncpa.org/pi/health/hedex7q.html


FMF\1 August 2001