The Conseil national de l'ordre des médecins ("CNOM") has just published its 2020-2022 evaluation report on physician-industry relations, taking stock of its practice in terms of monitoring the application of the anti-gift law.

This document, which has been awaited since the entry into force of the new framework for benefits stemming from the January 19, 2017 order on benefits offered by persons manufacturing or marketing health products or services, sheds some welcome light on the Ordre's practice in this area.

Although the principle of publishing such evaluation reports was established in articles L. 1453-14 and R. 1453-19 of the Public Health Code ("CSP"), it is the order of February 2, 2023 specifying the nature and presentation of the information that must be included in this evaluation report that has finally allowed their publication!

Following the example of the CNOM, the other professional bodies will be required to publish their evaluations in the coming weeks. We are also awaiting the publication of the ARS.

The CNOM's assessment of the evaluation of agreements under the "benefits framework" system

The CNOM thus shares with us its first assessment of the files submitted to it, whether in the context of declaration or authorization procedures. We can note the following main points:‍

A low evaluation of the files submitted to the declaration procedure

Not surprisingly, given the large number of files transmitted electronically (153,239 in 2022), the CNOM has indicated that it cannot process all the files within the 8 working day time limit set by the regulations.

With regard to this declaration procedure, he notes a multiplication of declarations for the same event or the same health professional, a practice which is not a use foreseen by the system.

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Highlights of the files submitted to the authorization procedure

The CNOM first explains the main reasons for refusal, namely:

• Submission of files after the deadline,
• Too much money in terms of hospitality (accommodation, food, transportation) and fees.      

Although it emphasizes the excessive amounts, it does not specify its internal doctrine on the subject. On the other hand, it mentions the difficulty of assessing the proportionality of the remuneration to the service rendered.

• Excessive time off in relation to the duration of the scientific program and the lack of scientific interest in the physician's participation in an event abroad,
• The absence in the files of the authorization to combine activities ("ACA") signed by the hospital and/or university hierarchy, and the problems of concordance of the information between the content of the ACA and the agreement,
• Hospitality offered to students,

On this last point, the CNOM asks about the possibility of opening the system to junior doctors, associate practitioners and interns with a doctoral degree, a question that seems to be welcome since it raises so many difficulties in practice.

With regard to the content of these agreements, he notes that the description of the services provided by the physician is often too generic and may require requests for additional information.

On the instruction procedure, he notes the practical difficulties of applying the 2-month time limit and managing the time limits in the event of a request for additional information.

Clarification of the grounds for accepting urgency

The CNOM then provides us with a list of situations under which the emergency procedure in an authorization procedure may be accepted.

The urgency can be justified for reasons related to remuneration, such as waiting for the decision of the National Management Center on the availability of a physician, or related to hospitality, such as the late transformation into a face-to-face meeting of an investigators' meeting initially planned to be virtual, or an error in the applicable regime between recommendation and authorization, a change of speaker, etc.

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Evaluation difficulties encountered by the CNOM, identification of final and indirect beneficiaries

It is not surprising either that the CNOM stresses the difficulties encountered in identifying the final and indirect beneficiaries of agreements concluded with associations or service providers acting on behalf of these associations.

The same applies to indirect benefits granted through a commercial company , which do not allow the amount of benefits actually received by the physician to be determined. The CNOM calls for greater transparency on this point and recommends that the amount paid to the indirect beneficiary be indicated on the contract.

The CNOM once again reiterates its ethical concerns about the practice of commercial activity by health professionals.

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The relevance of the thresholds set by the order of August 7, 2020

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Finally, on the question of the thresholds set by the decree of 7 August 2020 above which an agreement provided for in article L.1453-8 of the CSP and stipulating the granting of benefits is subject to authorisation, the CNOM has announced that it is in favour of an increase in these thresholds, whether for fees or hospitality. This approach is consistent with the current trend in the cost of living and would encourage a reduction in the number of cases subject to the authorization procedure in favour of the declaratory system.

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Focus on the issue of influencers

In addition to the questions relating to the system for regulating benefits, the CNOM draws attention to the subject of physician influencers and reminds us that such services may be contrary to the provisions of the code of medical ethics relating to independence and professional dignity.

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