This is the third in a series of posts written by guest blogger Charlotte Sellier from École de Formation professionnelle des Barreaux de la Cour d'Appel de Paris (EFB), the bar preparation school of Paris.
The European Parliament and Council’s Directive 2001/20/EC dated April 4, 2001, which has been modified several times, is related to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The directive does not, however, deal with the general civil and criminal liability of the sponsor and the investigator.
Fortunately, France is very protective of clinical trial subjects (France’s Huriet-Sérusclat law of 1988) and the liability of their actors. The protection of public health and patients subjected to clinical trials are two fundamental notions which justify drastic rules about the relations between pharmaceutical firms and physicians.
The principle is simple and clear: the fewer the connections between physicians and pharmaceutical firms, the better the patient will fare. One of the principal’s major axes is to avoid conflicts of interests through a strong control of financial links (advantages) by France’s national board of doctors, the Counseil National de l’Ordre des Médecins (CNOM).
A discussion of the major provisions of two different texts (the French code of medical ethics and the anti-cadeaux [no bribery] law), and how both influence the exercise of drafting a clinical study agreement with French investigators, can be helpful.
The Huriet-Sérusclat law of 1988 governs biomedical researches on humans. However, it does not answer all ethical questions. The French code of medical ethics (hereafter the code) and the anti-cadeaux law complete the legal system.
On one hand, Article 5 of the code states no physician can alienate his or her professional independence in any way. This independence is certain when the physician is acting according to his or her own judgment and conscience. Its sole objective is to act on behalf of the patient’s interest (primacy of humans).
Therefore, no personal advantages may influence the physician’s actions. Financial advantages taken into consideration are direct, such as kickbacks, or indirect, such as discounts or commissions.
Moreover physicians shall not exercise medicine as a commercial activity. Thus, advertising is prohibited in France (Article 19) and physicians must be vigilant that the conduct of their clinical study does not have to affect the patient’s trust or course of treatment (Article 15). Consequently, the physician needs to be objective and not under the influence of financial or personal interests.
On the other hand, the anti-cadeaux law has been codified in Article L. 4113-6 of the French public health code (PHC) to combat bribery. It concerns relations between healthcare professionals and pharmaceutical firms (and their subcontractors) who market drugs and products reimbursed by the social security system.
The law intends to prohibit any advantages. However, there are exceptions, and advantages are allowed if they concern:
- Hospitality (hotel, transportation, and meal) expenses for the physician only; expenses have to be reasonable and for promotional or scientific meetings
- Payments for evaluation or research activities approved by the CCTIRS (entity approving biomedical research for data protection matters)
- Normal conditions of work (articles drafting, formation)
- Insignificant gifts (the jurisprudence considers that the maximum is 30 euros per year and per physician)
Physicians cannot receive and firms can not propose any gifts. Both parties are co-liable. It is a criminal offense punished by two years of imprisonment and a fee of 75,000 euros (Article L. 4163-2 of the PHC). Judges can even decide that a physician is not allowed to practice medicine for a period 10 years.
Attention should be given to the fact that the statute of limitations is three years from the date of the offense. It is therfore advisable to keep all research documents for at least the length of the clinical trial process and three years after.
The CNOM controls the respect of the code’s provisions and as well as the famous anti-cadeaux law. All agreements concerning a healthcare professional need a prior and binding opinion of the CNOM. From the date CNOM receives a request, it has two months to respond. If it remains silent, the agreement is deemed approved.
Article R. 4113-105 of the PHC decrees the list of documents the deponent must attach to the request.