France – Impact of the 2020 Social Security Financing Bill for life sciences companies

This year, the LFSS includes life sciences-related provisions:

• Generic medicines reimbursement. Last year’s LFSS encouraged generic medicines substitution by capping the amount reimbursed for originator medicines to that of generic ones. This year’s LFSS introduces a two-year transition period (starting on the official publication of the price for the first generic medicine to be marketed for a given medicine) during which the limitation does not apply.
• Biosimilar medicines. The 2020 LFSS quashed the biosimilar medicine substitutability provision created by the 2014 LFSS due to the difficulty in implementation and in the absence of the necessary implementing order.
• Medicine shortages. Pharmaceutical companies must now have emergency stock for their marketed medicines and face greater sanctions if they fail to implement legal measures to fight against shortages.
• Transparency. The scope of the French Sunshine Act is now broader as companies producing or marketing healthcare products will have to disclose their interests with influencers.
• Cannabis experiment. The LFSS sets up a two-year pilot project that authorises the medical use of cannabis (see our latest blog post: First phase of French medical cannabis pilot programme officially started). The implementation conditions (such as the number of patients, import, manufacturing conditions, and so on) will be defined by regulation. Within six months before the end of the programme, the French government must submit to Parliament a report enabling it to evaluate, in real-life situations, the relevance of the prescription and dispensing system, the adherence of health professionals, and patients under these conditions. It will also provide the first French risk-benefit data from the main indications retained.
• Medical devices. The key provisions concerning medical devices include: (i) a new obligation for reimbursed medical device operators (a newly created status) and retail suppliers to declare their devices’ intermediary price to the Economic Committee for Medicinal Products (CEPS); (ii) the introduction of a selective indexing procedure through which a medical device operator can apply to be reimbursed (the procedure endeavours to lower prices in the sector while selecting devices for reimbursement based on a criteria such as quality or sales volume); (iii) the reform of the early market access procedure; and (iv) provisions on the reprocessing and reuse of some single-use medical devices.

Other measures include new provisions on Temporary Authorisations for Use (ATU), and parallel import and distribution.

This article was co-authored by Alexandra Lauré.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2020 Issue (Thomson Reuters).