Introduction

Because medicinal products are the most highly controlled and sensitive of healthcare products, European and national health authorities have a very active role to play in combating fraud. Despite the harmonisation of drug development, registration, evaluation, and monitoring in Europe since the early 1960s, and the creation of the European Agency for the Evaluation of Medicinal Products (EMEA) in 1995, rules to control the specific problem of fraud in clinical research have not yet been commonly addressed and implemented. Neither the European Commission nor the national agencies have specific passages about fraud in medical research in their pharmaceutical regulations. The new European Parliament and Council Directive, published in May 2001, relating to the implementation of good clinical practice in the conduct of clinical trials,2 addresses indirectly the question of fraud, but only by referring to the "credibility of data" through the ICH (International Conference on Harmonisation) GCP text.3 There are no specific sections on properly managing fraud once it is suspected.

France, as one of the 15 member states of the European Union, has agreed to develop quality assurance systems as well as national inspection programmes, as called for notably by such directives. The EMEA inspection unit has only a co-ordinating role between member states; it is charged to establish European inspection rules and methods, but has no right or possibilities for any direct inspection, which remains at the national level only.

*This chapter is dedicated to Professor Eigill Hvidberg (DK), "Father of the European GCP" texts, who has recently died.

In France, the notion of fraud is codified only in the general legislative texts that cover all activities (for example, civil or criminal law). In principle, silence is the general and, in practice so far, the official and professional golden rule. Such absence of clear and specific legislation about fraud in biomedical research may explain the few official reports on fraud. Thus there are no official figures for the prevalence of fraud in clinical trials on drugs/medicinal products, which come under the responsibility of the "Agence Française de Sécurité Sanitaire des Produits de Santé" (Afssaps), even though a figure of 2% has been reported elsewhere.4

In spite of the creation of the European Union nearly 50 years ago, there are still profound cultural differences between member states, and this is shown by the diversity of their approaches to fraud. Clearly common rules must be adopted so that each country can communicate uncontaminated data to the others. It is not a question of interfering with issues specific to each country, but rather of allowing harmonisation of working rules so that results achieved by one country are acceptable to all.

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