Issuance of the Decree no. 2020-730 of June 15th, 2020

pertaining to the gifts offered by persons manufacturing or marketing health products or services: entry into force postponed to October 1st, 2020, pending the implementing decrees.


Long-awaited, the Decree no. 2020-730 of June 15th, 2020, pertaining to the gifts offered by persons manufacturing or marketing health products or services (“the Decree of June 15th, 2020”) was published in the French Official Journal of June 17th, 2020. This text specifies the conditions of application of Order no. 2017-49 of January 19th, 2017, pertaining to the gifts offered by persons manufacturing or marketing health products or services, and Act no. 2019-774 of July 24th, 2019, pertaining to the organisation and transformation of the health system.

  1. As a reminder, Article L. 1453-5 of the French Public Health Code (“CSP” – Code de la Santé Publique) prohibits persons providing health services (i), producing (ii) or marketing (iii) health products mentioned in Article L. 5311-1 of the CSP that are reimbursed (with the exception of tattoo products, cosmetic products and non-corrective ocular lenses) from offering or promising gifts to the persons mentioned in Article L. 1453-4 of the CSP (i.e. health professionals, students, associations and learned societies, and civil servants and government employees).

The Decree of June 15th, 2020 provides a necessary clarification by codifying, in article R. 1453-13 of the CSP, an exhaustive list of “persons providing health services”. These are the following natural or legal persons:

  • who engage in an activity subject to an authorisation, approval, accreditation or declaration provided for in Part 6, and in particular health institutions, medical biology laboratories or biologists having manager duties;
  • who exercise an activity subject to an authorisation or approval by the regional health agency and provided for in Book III of the French Code of Social Work and Family Matters, i.e. social and medico-social institutions and services;
  • who provide a service reimbursed either by the compulsory social security schemes under sickness, invalidity or maternity insurance, or by state medical aid, or by the state under Titles I and II of Book II of the French Code of Military Invalidity and War Victims’ Pensions.
  1. In addition, the Decree of June 15th, 2020, sets out the terms and conditions for the application of prior checking. Indeed, by way of derogation from the prohibition on offering gifts, agreements entered into with health professionals are subject to a declaration (i) or authorisation (ii) regime, depending on a threshold, the amount of which remains to be defined:
  • agreements subject to a prior declaration must be transmitted, if necessary with attachments, no later than eight working days before the day on which the gift is granted;
  • agreements subject to prior authorisation must be reviewed by the competent authority (medical association or regional health authority) within two months of receipt of a complete application file.

Applicants must leave nothing to chance when transmitting files for the purpose of an agreement subject to prior authorisation, as the competent authority may request additional documents, and thus postpone the date on which the two-month period begins to run.

The absence of an answer from the competent authority shall be deemed as a tacit authorisation. However, in the event of refusal, it will be possible to submit an amended agreement within 15 days, and the authority will then have a period of 15 days in which to make a decision.

Also, an accelerated procedure allowing a response within three weeks is available where the urgency of the application is justified.

  1. Finally, the Decree of June 15th, 2020, specifies the information to be included in the agreement, listed in Article R. 1453-14 of the CSP. The following documents must be attached to the agreement, where appropriate:
  • the programme of the event;
  • an authorisation, for the relevant public officials, to simultaneously pursuit several activities, in accordance with decree no. 2020-69 of January 30th, 2020, pertaining to inspections on professional ethics in the civil service;
  • the summary of the research protocol or assessment protocol;
  • the draft observation notebook or the data collection document provided for by the protocol for other research or scientific evaluation activities.

The system of prior authorisation and the time limits for processing applications by the competent authorities will certainly shake up the habits of both pharmaceutical companies and medical associations, whose decisions may be challenged before the administrative courts.