Book I: Health protection for individuals

As stated in article 223-8 of the Criminal Code, reproduced below: “The fact of carrying out or having carried out on a person the research mentioned in 1° or 2° of article L. 1121-1 or a clinical trial mentioned in article L. 1124-1 of the Public Health Code without having obtained the free, informed and, where applicable, written consent of the person concerned, of the holders of parental authority or…

As stated in article 223-9 of the French Criminal Code, reproduced below: “Legal entities may be held criminally liable, under the conditions set out in article 121-2, for the offence defined in article 223-8. The penalties incurred by legal entities are : 1° A fine, in accordance with the provisions of article 131-38 ; 2° The penalties referred to in article 131-39. The prohibition referred to in 2° of article…

Carrying out or causing to be carried out research involving the human person in breach of the provisions of Articles L. 1121-5 to L. 1121-8 and Article L. 1122-1-2 and in breach of Articles 31 to 34 of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products is punishable by three years’ imprisonment and a fine of…

Legal entities declared criminally liable, under the conditions set out in article 121-2 of the French Penal Code, for the offence defined in article L. 1128-3 shall incur, in addition to the fine set out in article 131-38 of the French Penal Code, the penalties set out in article 131-39 of the same code. The prohibition mentioned in 2° of article 131-39 of the French Penal Code applies to the…

It is punishable by one year’s imprisonment and a fine of 15,000 euros to carry out or cause to be carried out research involving the human person: 1° Without having obtained a favourable opinion from a personal protection committee and, in the case of research mentioned in 1° of Article L. 1121-1, authorisation from the competent authority in accordance with Article L. 1121-4 or without having obtained the single decision…

Any promoter whose civil liability is not covered by the insurance provided for in article L. 1121-10 shall be punished by one year’s imprisonment and a fine of 15,000 euros.

Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulting from research involving the human person; this action is time-barred under the conditions set out in article 2226 of the Civil Code.

Failure by the sponsor to provide the investigators of chemical, pharmaceutical, biological, pharmacological or toxicological tests with the information required by law relating to the test, the medicinal products to be tested, the medicinal products used as a reference and the summary of the latest scientific knowledge required to carry out the research is punishable by two years’ imprisonment and a fine of 30,000 euros.

Failure by the sponsor to provide the investigators with the information required by law relating to the trial and the investigational medicinal products is punishable by two years’ imprisonment and a fine of €30,000.

In the context of the research mentioned in 1° of Article L. 1121-1 and Article L. 1124-1, failure by the sponsor to provide investigators free of charge for the duration of the research with the investigational medicinal products and, where applicable, the devices used to administer them and, in the case of research involving products other than medicinal products, the products which are the subject of the research, is punishable…