What are the Changes in 2023 for Access to Advanced Therapy Medicinal Products (ATMPs) in France?

Abstract

ATMPs are the most expensive innovative treatments, thus they require special regulation. Past regulatory measures in France, such as limiting the growth of drug expenditures, the creation of a fund to finance pharmaceutical innovation, the use of performance-based contracts and greater emphasis on medico-economic evaluations in pricing have been contributing to having both universal access to innovative therapies and fair remuneration for innovation. The importance of transparency, public participation in healthcare evaluation, and the challenges of setting drug prices based on their value are not negligible either. Although further negotiations are still necessary to ensure equitable access to medicines and control rising healthcare costs, France has made pioneering steps recently which would be worthy to follow for other states. The Social Security Financing Act for 2023 introduces measures to control face prices, offers a new funding model, and encourages manufacturers to submit reimbursement claims for the full scope of marketing authorizations.