New drug regulations in France: what are the impacts on market access? Part 1 – Overview of new drug regulations in France

New drug regulations in France: what are the impacts on market access? Part 1 – Overview of new drug regulations in France

2013 J Mark Access Health Policy

Remuzat, C. | Toumi, M. | Falissard, B. | Volume: 1, Issue: , Pages: 20891, France, Market access,

Access to the French drug market is being impacted by an ongoing dramatic shift in practice as well as by
two laws that came into force in December 2011. This new environment has been described and analyzed in
two separate articles. The first article aims to describe the recent changes in access to the French drug market.
The severity of the condition being treated, which used to be the main determinant of the drug’s reimbursement level in France, has now been replaced with the drugs’ efficacy criterion. Moreover, the effect
size required for acknowledging drug innovation has substantially increased. Perceived evidence might also be more important than actual evidence. Comparative evidence and real-world data are considered critical
conditions for marketing authorization. Cost-effectiveness studies will now be part of the market access
requirements for all drugs in order to satisfy the selection criteria for medico-economic assessment.