How can we regulate medicines better?
BMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39281.615706.94 (Published 18 October 2007) Cite this as: BMJ 2007;335:803
- Silvio Garattini, director,
- Vittorio Bertele', head of the regulatory policies laboratory
- Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milano, Italy
- Correspondence to: S Garattini garattini{at}marionegri.it
- Accepted 16 June 2007
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, cancer, neurovegetative disorders, diabetes, rare diseases, the autoimmune system, and viral diseases. The European agency is important because central authorisation is increasing and because national agencies cannot justify adopting methods and criteria inconsistent with those of the central agency. When national agencies come to differing decisions, the European agency makes a final decision that is binding in all member states.
Added value of new drugs
Too many drugs are approved on the basis of surrogate end points that are not validated predictors of therapeutic end points. Numerous cancer treatments have been authorised on the basis of tumour response that is not correlated with an improvement in quality or duration of life.4 Manufacturers often object that it would take too long …
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