The French Economic Committee for Health Products (CEPS) can negotiate or set paybacks on products reimbursed by the French health insurance system (known as “conventional paybacks” or “product paybacks”). The company then pays back a portion of the sales made on the pharmaceutical product, which results in a decorrelation between its “face” price (retail price) and its “net” price (price after paybacks).

The legality of these paybacks and their calculation methods have been the subject of several recent law cases, providing valuable insights (see our article on price/volume paybacks and reimbursable indications). 

The most recent judgement was issued on March 7, 2024, by the Administrative Court of Paris concerning a “mutualized paybacks” mechanism, which consists in triggering and calculating paybacks based on the sales of several products with a similar nature or with a similar therapeutic application. The judge partially annulled the CEPS decision to charge Cook France paybacks for 2021, and consequently ordered the reimbursement of 208,191 euros to the company. 

Reminder: in the event of an extension of a MD’s reimbursable indications, the CEPS is not obliged to review the price/volume clause

In the judgement of March 7, 2024, the indication of Cook France’s medical device (MD) had been extended in 2018, increasing its target population from 100 to 940 patients per year. However, the CEPS did not amend the paybacks clause.

In this regard, the court recalled, as already ruled by the Administrative Court of Appeal of Paris at the end of 2023[1], that the CEPS is under no obligation to renegotiate the price/volume clause in the event of an extension of the reimbursable indications (and therefore of the target population) of a MD (see our article on price/volume paybacks and reimbursable indications). 

The CEPS cannot apply a mutualized payback to products with different indications, if the pricing agreement applies to products sharing the same indications

In the judgement of March 7, 2024, Cook France’s MD was reimbursed in a broader scope of indications than its competitor (due to the extension of indication obtained in 2018) during the year 2021 (the year for which the paybacks in dispute applied). 

However, the pricing agreement expressly provided that the paybacks clause was mutualized with products “sharing the indications [of Cook France’s MD]”. 

The administrative court deduced that, since the scope of reimbursable indications for the two products differed in 2021 (Cook France’s MD then having a broader scope of indications than its competitor), the CEPS could not calculate the paybacks clause based on the sales generated by the two companies. 

The paybacks charged to Cook France were therefore reduced to the amount it would have had to pay in the absence of mutualization.

This judgement illustrates once again the importance of the choice of terms used in pricing agreements, and particularly in paybacks clauses. In the case of disagreement with the CEPS, the pricing agreement will be interpreted strictly, without any search for a “balance” between the parties (it should be remembered that the pricing agreement does not have the value of a contract, but of a regulatory act, like the unilateral decisions of the CEPS).

GD Avocats advises and supports companies in their market access strategies and the related litigations. Contact us by e-mail:

[1] Administrative Court of Appeal, December 29, 2023, Cook France, no. 23P00909 and no. 22PA04005.

You are currently viewing Product paybacks: pricing agreements must be strictly interpreted (annulment of a CEPS decision)

Your last news