In response to the proposed Social Security Finance Bill (PLFSS) 2023 by the Government, Leem have described it as a ‘complete U-turn on France’s ambitions on health innovation and manufacturing sovereignty’ further, ‘which turns back the clock on a five-year period of reforms’.
Notably, the drug expenditure for 2023 has been allocated €24.6 billion, which is 7% lower than the estimated expenditure of €26.4 billion in 2022.
Leem report the changes set out by the Government will heighten the difficulties already being faced by France with access to medicines, by ‘increasing the risk of supply disruptions and hampering access to innovation’.
Alongside this safeguard clause, some of the other measures proposed in the PLFSS by Government are:
- Introduction of a targeted safeguard clause targeting medicines with strong growth (10% or more for two years) and high turnover (exceeding €50 million)
- Acceleration of the early access process reformed in July 2021 by acceptance of a positive CHMP opinion and not having to wait for the judgement of the ASNM
- A tender system set up where reimbursement by Health Insurance system of certain medicines is implemented on the condition of a reference product that meets the same therapeutic need
- Outcomes-based agreements for ATMPs that utilises the annuity model of staggered payments and payment according to real-world results
- Penalties will come into force for manufacturers who do not continue to maintain supply of older drugs when they introduce new therapeutics to their portfolios
- Imposition of discounts for manufacturers that fail to apply for reimbursement for all approved indications covered by a drug’s label
- Imposition of discounts for innovative therapeutics that are eligible for a European price
- https://www.leem.org/presse/plfss-2023-plus-de-3-milliards-d-euros-d-economies-sur-le-medicament PLFSS 2023: MORE THAN 3 BILLION EUROS IN SAVINGS ON MEDICINES! Accessed: 03/10
- https://www.ordre.pharmacien.fr/Communications/Les-actualites/PLFSS-2023-les-principales-mesures-interessant-les-pharmaciens PLFSS 2023: the main measures of interest to pharmacists, Accessed: 07/10