Healthy Skepticism Library item: 11807

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Garattini S.
How can we regulate medicines better?
BMJ 2007 Oct 20; 335:(7624):803
http://www.bmj.com/cgi/content/short/335/7624/803?etoc

Abstract:

Current European licensing regulations give precedence to the interests of drug companies. Silvio Garattini and Vittorio Bertele’ suggest changes to ensure they meet the needs of patients and doctors

Despite the undoubted advantages of the establishment of the European Medicines Agency (EMEA)w1 criticisms have been made, mostly about its independence and transparency and the evaluation criteria.1 2 3 The 2004 European Commission law expanded the agency’s remit but did not significantly changes the methods of regulation.w2 We offer a few proposals aimed at bettering the work of the agency. These may require important changes in current law regulating the pharmaceutical system.

Agency’s role
The agency gives opinions on the quality, safety, and efficacy of new drugs that manufacturers want to market in the European Union. The European Commission uses the agency’s opinions to decide whether to grant a licence.

Unlike the US Food and Drug Administration, the European agency is not autonomous but an expression of the national agencies in the European Union, which approve most new products. Evaluation through the centralised procedure has become mandatory for biotechnology products and drugs for HIV, . . .

Added value of new drugs

Independent research and development

Disclosure of drug information

Implementing active pharmacovigilance

Removal of bias

Summary points

S Garattini garattini@marionegri.it