1. The Safeguard Clause: An Upward Surprise
Through the Borne Mission, a report published after following a mission launched by Prime Minister Elisabeth Borne to regulate healthcare products, the government had previously proposed reducing regulation to 500 million, offset by increasing price cuts. However, there was a surprise: the M rate for 2023 has been revised slightly upwards. As part of the regulation of the reimbursed expenditure, and following a consistent recommendation from the Borne Mission, the basis for the amounts reimbursed from 2026 onwards has been reviewed, but this raises new concerns about the opacity and lack of transparency of the system, as well as its capping.
2. Early access: A New Set of Rules for the Game
The Social Security Financing Bill (“PLFSS”) legalises derogatory funding after several therapies, particularly in oncology, were not included in the “en sus” list following unfavorable ASMR V assessments after early access. This funding is now linked to the provision of new data and a commitment to a development plan, and will be combined with clawbacks to the French government. But beware: the PLFSS also strengthens the supply obligations for pharmaceutical companies. This may influence the decision to opt for early access.
3. Compassionate Access: A Broader Scope
The PLFSS relaxes the conditions for compassionate access, while refusals of early access have become commonplace. The scope of such access is widening, gradually moving away from its original objective.
4. Drug Safety: Reinforced Obligations
Stricter rules apply to drugs of major therapeutic interest (“MITM”). Pharmaceutical companies are now required to inform the French National Agency for Medicines and Health Products Safety when they decide to withdraw a product from the market. In addition, an effort must be made to find a buyer when the health of the public is at stake.
5. Tackling Shortages: A Welcome Definition
To curb shortages following the Amoxicillin rupture at the end of 2022, a more precise definition of ruptures has been introduced. In addition, as the use of hospital preparations expands, new specialty pharmacy preparations will be introduced.
Conclusion : The Social Security Financing Bill for 2024 promises significant changes for the pharmaceutical industry. It is essential to prepare for these changes, understand their intricacies and anticipate the challenges ahead.
Authored by Charlotte Damiano.
