Concepts

The nature of fraud, possibly defined in the French language as "Un acte de mauvaise foi et de tromperie accomplie en vue de nuire au droit d'autrui," is described elsewhere in this book. In the case of falsification of scientific or clinical data, this type of fraud tries to modify the benefit risk/ratio and the therapeutic value of a new specialty to be submitted for a Marketing Authorisation (AMM in France), by improving the data. It has consequences in terms of both public health and public finance (when this new agent is reimbursed by the social security system). The origin of the fraud can be within the pharmaceutical company itself. Consequently, a marketing authorisation granted by Afssaps on falsified data, could be judged as illegal and subsequently cancelled. Marketing authorisation can also be considered as invalid and withdrawn, if the fraud was achieved outside and without the knowledge of the company.

A sponsor organising a fraud is committing a forgery, and this is envisaged and penalised in article 441-6 of the new French code pénal (criminal code). Whatever its degree, importance, or systematisation, any fraud is considered a fraud - that is, deceiving "a moral person by using fraudulent operations" - penalised in article 313-1 of the new criminal code. In any legal action against the investigator or his/her partners, the pharmaceutical company is justified in asking for (financial) compensation, according to the importance of the damage done (delay in the marketing authorisation, or the necessity for a new study to be carried out).

When an informed consent form has been falsified the new code includes a specific infringement if a study subject is enrolled in a study without written consent or maintained in the study after withdrawal. The sanction applies to both the investigator and the sponsor (company or other) when this type of practice is organised or continued after its discovery.

Article 15 of the French medical deontology code says that the physician's duty is to control the consistency of and rationale for the research projects in which he is involved and to check the objectivity of their conclusions. It is not the role of the sponsor to guarantee the morality of an investigator asked to participate in a clinical trial.

The general role of professional councils such as the Ordre des Médecins or Ordre des Pharmaciens, particularly for industrial pharmacists, is to defend the honour, integrity, and independence of these two professions. Internal disciplinary structures, aim (along with other standards of reference and for other reasons than the civil or the criminal law) for a disciplinary sanction at the worst or, preferably, the prevention of misconduct. This system is difficult to mobilise, especially when the investigator involved is working for the public health service.

Afssaps is also in charge of inspection visits, either as a routine exercise or for cause when fraud is suspected. The inspection team could be helped, when necessary, by other bodies serving more general aspects concerning irregularities, infringements, or repression of fraud.

Given the numerous possible sources of fraud the approach to prevention must be global, taking into account all aspects and all potential perpetrators (see Figure 12.1).

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