This is essentially the question that the Council of State referred to the Court of Justice of the European Union (“CJEU“) in a ruling dated December 30, 2021 (req. no. 449049).

As a reminder, Article L. 162-16-4-3 introduced into the Social Security Code (“CSS“) by the Social Security Financing Act for 2020 allows the Minister to set a maximum selling price for medicinal products on the “collectivity” list and medical devices financed under hospitalization benefits.

The procedures for setting the maximum sale price to health care institutions were specified by Decree no. 2020-1437 of November 24, 2020 (OJ of November 25, 2020).

The legality of this decree was challenged by the LEEM in the context of a dispute brought before the Council of State. In a ruling dated December 30, 2021, the Council of State asked the CJEU whether the system of capping sales prices to health care institutions complied with European Union law.

How will the legality of the price cap on sales to healthcare facilities be assessed?

The question referred to the CJEU aims to determine whether the system of price caps on sales to health care institutions constitutes a “price freeze on all medicinal products or on certain categories of medicinal products” within the meaning of Article 4 of the Transparency Directive, when it only concerns certain individual medicinal products.

If the CJEU rules that this measure constitutes a price freeze within the meaning of the “transparency” directive, the Council of State will cancel the price cap on sales to healthcare institutions. Indeed, the “transparency” directive imposes various procedural requirements on States that introduce this type of price freeze, in particular by requiring them to re-examine annually the relevance of this measure. However, the national regulation in question does not meet these procedural requirements.

We will have to wait about a year to know the interpretation of the CJEU and another 6 months for the Council of State to give a final ruling on this case (which brings us to the second half of 2023).

What will be the consequences for manufacturers if the decree specifying the methods for setting the maximum sale price to healthcare institutions is cancelled ?

  • The price decrees adopted by the ministers since November 26, 2020 (the date of entry into force of the system for capping sales prices to health care institutions) may be cancelled (since they were adopted on the basis of illegal provisions);
  • As a result, the manufacturers concerned will be able to ask the administration for compensation for the damage caused by the setting of a maximum sales price;
  • If the administration wishes to reintroduce a ceiling on sales prices to health care institutions, it will be obliged to provide for an annual review of the relevance of the maximum prices imposed.