On 13 June 2018, the committee in charge of assessing social security financing laws at the French Senate submitted a report on early access to new medicines to the Senate Presidency. The report assesses the conditions applicable for making new treatments accessible at all stages (from clinical trial to authorisation and marketing) and provides recommendations that would help patients and also maintain France’s attractiveness for the healthcare sector. In particular, the report:
- Assesses the framework applicable to temporary authorisation for use (ATU) and encourages loosening the conditions for obtaining an ATU for disruptive new medicines and treatments, as well as changing the authorisation framework to cover ATUs per therapeutic indication (and not per product) and reassessing pricing conditions (namely, the “retroactive price reduction scheme” as described in the 2017 Social Security Finance Act).
- Recognises the need to find balance between (equitable) early access, on the one hand, and the safety and economic sustainability of (constrained) healthcare systems, on the other, within a context of the stark increase in the price of new medicines and the complex negotiations between the industry and the authorities concerning pricing and reimbursement of medicines. It recommends setting up an accelerated marketing authorisation procedure for priority new treatments, and to assess new price fixing methods (prices per indication, per efficacy, and so on) including, amongst others, a modification of the system of reimbursement of (hospital) medical acts (liste en sus).
- Recognises the role of clinical trials in early access of new treatments. In this respect, the report recommends increasing the French National Agency for Medicines and Health Products Safety’s resources dedicated to clinical trials; as well as including only those ethic committees (CPP) that are specialised in the clinical trial field in the random draw (tirage au sort) that will elect the CPP in charge of conducting the ethical review process for the trial.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, June 2018 Issue (Thomson Reuters).