The implementation of special hospital preparations and the amendment to the framework agreement concluded between the French professional organization of pharmaceutical companies and the government on price increases in the light of health sovereignty.

In line with government announcements, these two new regulations emphasise the security of supply for advanced therapy medicinal products and essential pharmaceutical products. The pharmaceutical sector is being heavily challenged by the authorities on these two fronts, with the aim of avoiding shortages.

The clinically relevant comparators defined by the Transparency Commission (health technology body) will once again play a key and decisive role in price increases, with all the constraints that this entails.

The amendment to the framework agreement on the new derogatory scheme for market entry called “direct access” updates the negotiation timetable and the arbitration procedure, which essentially means: signing an amendment to the agreement addressed by the Economic Committee, or withdrawing the reimbursement request by the pharmaceutical company, or taking a unilateral decision on prices and clawbacks...

These regulations confirm the increasing legalisation of the French Economic Pricing Committee's positions and the legal, regulatory and/or contractual arguments on which they are based, resulting in "harsh" positions.

Undoubtedly, further legal debates lie ahead......