07 janvier 2020

France’s supreme audit institution criticizes the deficient controls performed by the French Medical Council under the anti-benefits rules

By Mikael Salmela, Partner, and Anne-Laure Morise, Knowledge Lawyer

On 19 January 2017, major modifications were adopted in France to the regulations on interactions between the industry and healthcare professionals (and other stakeholders). These new "anti-benefits regulations" were supposed to become effective at the latest on 1 July 2018, following the adoption of one implementing decree and two implementing orders.

To date, these implementing regulations have not been adopted but they will be in the coming weeks. The long-awaited implementing decree and orders will set, in particular, the thresholds above which an authorisation will be necessary, the required content of the agreements concluded between healthcare professionals and the industry, and the definition of "persons providing healthcare services". The final drafts must be reviewed by several authorities (i.e., the High Council of Paramedical Professions, the French Data Protection Authority, and the French Administrative Supreme Court) before final adoption. Draft regulations have already circulated, and many industry players have started to anticipate the changes in their interactions with healthcare professionals.

While the adoption process finally reached its final step and the new regulatory framework will soon become effective, the Cour des comptes (France’s supreme audit institution) published on 9 December 2019 a report on the French Medical Council. The audit of the Medical Council was conducted between April 2018 and January 2019 and covers the years 2011 to 2017. The Cour des comptes examined notably the controls performed by the national and regional medical councils on the agreements concluded under the current anti-benefits regulations between doctors and pharmaceutical or medical device industries.

The Cour des comptes concludes that these controls are "heterogeneous" and "deficient" for various reasons, notably:

-       the agreements concluded by one doctor are examined independently of each other without any accumulation of remuneration or benefits received;

-       doctors are not sanctioned when agreements are implemented despite an unfavourable opinion;

-       in practice, only investigators of the French General Directorate of Competition, Consumer Affairs and Fraud Control carry out regular checks.

The Cour des comptes acknowledges that the French Medical council is not solely responsible for this situation. For many years, the Medical Council has requested extended powers, notably to impose sanctions if its opinions are not complied with. The new anti-benefits regulations will address some of these issues by making remote transmission of agreements mandatory, and extending the authorities that can investigate violations of the regulations.

On the same day of the publication of the report, the Medical Council posted a detailed response on its website. The Medical Council replied that it "has not been able to fulfil its mission" of controlling relations between doctors and the industry, "because although the regulations have given it a preventive role which it immediately took over, the repressive role has been given to other bodies, including the DGCCRF [French General Directorate of Competition, Consumer Affairs and Fraud Control], which have not made referral to the criminal courts their priority".

Today more than ever, the various stakeholders are eagerly awaiting the adoption of the implementing decree and orders, and more generally the entry into force of the new anti-benefits framework.

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