Risk/benefit evaluation of drugs: the role of the pharmaceutical industry in Germany.

Drugs that are efficacious have usually also undesired side effects. When applying for marketing authorization of a drug, demonstration of a positive risk/benefit ratio is a prerequisite for approval by the competent authorities. Once on the market, risk/benefit evaluation has to be continued in order to determine whether the risk/benefit ratio is still positive or not. The German Drug Law, by means of article 5, poses this responsibility on the pharmaceutical entrepreneur. Specific instructions on how to perform the risk/benefit evaluation can be derived from article 5, and a decision matrix was developed to support taking action if the risk/benefit ratio has changed. Historical and current examples are presented to illustrate changes of the risk/benefit ratio, problems associated with detecting risk signals, and the resulting regulatory actions. Copyright 2002 S. Karger AG, Basel