France

Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.

Generics Bulletin reviews the latest regulatory developments across the world.

France’s health technology appraisal body, HAS, is putting more emphasis on the importance of economic evaluations in light of the rising costs of health technologies, including medicines and medical devices, and increasing budgetary pressures.

HAS, the French health technology assessment body, has issued positive recommendations for several orphan drugs, including for Vyloy, which was provisionally rejected for reimbursement in the UK last year.

Debate on how to manage drug spending continues in France despite an ongoing disagreement between industry and the government about whether there was €1.2bn overspend on medicines in 2024.

Opella says FDA “lifted a clinical hold on its planned actual use trial to support the switch of Cialis” while Petros Pharmaceuticals shifts from working on its own ED-switch proposals to developing a proprietary technology-assisted platform designed for use in consumers’ self-selection of drugs made available in ACNU proposals.

France’s medtech sector is strong, growing and innovative. In Vivo spoke to several French medtech leaders about the unique features and pitfalls their industry may face.

France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.

French industry association Gemme has issued a stark warning that recent legislative proposals – including a revision to the country’s clawback mechanism and steeper financial penalties for failing to hold sufficient safety stocks – will “bring about the end of the generic economic model in France.”

Country Life Vitamins launches healthy aging support line as it announces less than half of US consumers in a recent survey were aware of biological processes that affect aging. Groupe Berken and Arctic Biosciences partner to bring to North America herring caviar oil extract in a supplement designed to support optimal health across all life stages.