Various evolutions have recently occurred in France:

• The "mini DAP" implemented (Minsterial Order of October 30, 2024);
• The publication of an additional biosimilar group for substitution in ophthalmology (ranibizumab, reference pharmaceutical product: Lucentis*, Novartis);
• A Social Security Financing Bill (PLFSS) for 2025 focused on financial regulation through the safeguard clause for pharmaceutical products and medical devices, an increase in the financial penalties imposed by the ANSM in the event of shortages, and expanded medical control measures (prescription oversight);
• Progressively more restrictive early access decisions;
• Pricing negotiations conducted by CEPS on strict legal basis.

The Ministry of Health is increasingly tightening financial and medical regulation of the pharmaceutical industry sector every year, and seeking to increase sources of savings on healthcare products.

Authored by Charlotte Damiano.