The French Government continues its desire to implement ecological transition through measures introduced in Article 29 of the French Social Security Financing Bill for 2024, one of which will have a significant impact on reimbursable medical devices.

The first part of Article 29 is a step in the right direction, as it allows healthcare establishments to experiment with the reprocessing of medical devices, which was previously prohibited by the French Public Health Code. This measure is based on the experience of our European neighbours and will have to be accompanied by an appropriate traceability system.

However, the second part of the article is far from unanimous. It introduces a mandatory clawback mechanism for branded medical devices that have a negative environmental impact, particularly due to their packaging or the additional waste they may generate compared to their competitors. This negative impact will be evaluated in the opinion issued by the Medical Device and Health Technology Evaluation Committee (“CNEDiMTS”) when the devices are assessed for reimbursement. Medical device companies will therefore have to monitor this new environmental criterion as part of the French National Authority for Health (“HAS”) assessment of their product, as well as the improvement in expected service, which is a key criterion for pricing.

This proposal raises a number of questions for at least two reasons.

On the one hand, the calculation of the clawback introduced by this article is vague and arbitrary. It leaves considerable room for manoeuvre both for the CNEDIMTS, which will determine whether the appliance is more polluting than one of its competitors, and for the Economic Committee on Health Care Products (“CEPS”), which will calculate the clawback, even though the criteria for applying these clawbacks are supposed to be laid down by decree.

On the other hand, this measure comes at a time when several other environmental measures have not yet taken full effect (combating plastic pollution, the anti-waste law for a circular economy, etc.). It would have been appropriate, before opting for a system of penalising medical device companies by means of mandatory clawbacks, to draw all the consequences of these measures and to take account of the specific nature of the medical devices sector.

The French Government will undoubtedly be able to review its plans and replace the clawback system with a "green bonus" that would be applied in the negotiation of the price of medical devices, in order to take into account the efforts of medical device companies in the field of environmental protection.

Authored by Charlotte Damiano and Saliha Rhaimoura.