When assessing the medical benefit (SMR) and the expected benefit (SA) of a healthcare product, the French Transparency Commission (CT) and the French National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) may specify the additional studies they consider essential for its reassessment[1].
The judge hearing the application for interim measures (Juge des référés) of the Conseil d’Etat has recently provided insightful clarifications on the consequences that the administration may draw if these studies are not provided within the time limit set by the French National Authority for Health (HAS)[2].
This litigation was initiated by the company DiLo Médical, which had been requested by the CNEDiMTS to conduct specific post-inclusion studies (EPI) to reassess the SA of its medical devices, I-STOP and PELVI-STOP. Considering that, in the case of I-STOP, the company had provided EPI that did not strictly comply with the CNEDiMTS’ request and that, in the case of PELVI-STOP, the company had not provided any EPI, the French ministers decided to put an end to the reimbursement of these devices.
The company convinced the Juge des référés of the Conseil d’Etat that there was an urgent need to suspend the application of these ministerial decrees and that there were serious doubts as to their legality. Six weeks after the case was referred to him, the judge suspended the contested ministerial orders until the Conseil d’Etat issues a ruling on their legality.
What type of urgency may justify the suspension of a decision ending the reimbursement of a product?
Urgency, which is one of the two conditions required to obtain the suspension of a decision, may take various forms.
Economic peril is the urgency most frequently invoked in matters of market access, but the judge often considers that it is not sufficiently serious or not sufficiently demonstrated to justify a suspension.
On the contrary, in the DiLo Médical case, the judge upheld the existence of economic urgency given that:
- the medical devices for which the French ministers had ended reimbursement accounted for two-thirds of the company’s turnover[3] ;
- the company had produced information relating to its operating balance and financial statements.
Can the failure to produce the studies requested by the HAS led to a withdrawal of reimbursement?
In the case of I-STOP, the Juge des référés considered that there was a serious doubt as to the legality of the withdrawal of reimbursement, since it was justified solely by the fact that the EPI produced did not strictly comply to the CNEDiMTS’ requests.
More specifically, the judge noted that:
- the French ministers did not examine whether the company should be granted additional time it requested to provide studies that complied with the CNEDiMTS’ request;
- there was no reason to challenge the data on which the initial SA recognition had been based.
The Juge des référés went even further in the case of PELVI-STOP, considering that there was a serious doubt as to the legality of the withdrawal of reimbursement, justified by the absence of EPI, given that:
- the company’s application for renewal was not considered incomplete by the administration;
- no specific issue attributable to the medical device was reported.
In other words, according to the judge, there was a serious doubt that the absence of the EPI requested by the CNEDiMTS can, on its own, justify an insufficient SA and the subsequent withdrawal of reimbursement of the products.
This issue is expected to be definitively settled in the coming months, when the Conseil d’Etat rules on the merits of the case. To be continued…
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[1] Article L. 165-11 of the French Social Security Code for medical devices and article R. 163-18 of the same code for pharmaceutical products (which stipulates that the applicant may be required to submit additional studies essential to the reassessment of the medical benefit).
[2] Juge des référés of the Conseil d’Etat, February 4, 2025, Société DiLo Médical, req. no. 499982.
[3] The company had six employes and a turnover of €1.465 million in 2023.
