Increasing financial regulation of the pharmaceutical sector by the French government

Various evolutions have recently occur 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.

Next steps

The presentation of the PLFSS 2025 is to be followed closely as soon as the parliamentary process advances and the "49-3 procedure" initiated by the government.

Authored by Charlotte Damiano.