The revised French ATU framework, introduced by Article 97 of the 2017 Social Security Financing Law has been implemented by two decrees dated 21 April 2017 and 2 May 2017.
Pharmaceutical companies seeking to make unauthorised medicines available to patients under a compassionate use programme in France should be aware of the following important changes:
- If a marketing authorisation (MA) is not yet pending when the temporary authorisation for use (ATU) is requested, applicants will have to submit an MA application within one year of the ATU grant.
- Applicants for a cohort ATU now need to submit a dossier to the Ministers for Health and Social Security when they submit their application to the National Agency for Medicines and Health Products Safety (ANSM). The dossier must include: (i) the target number of patients that will benefit from the new indication on the basis of available epidemiological and medical data; and: (ii) the estimated number of patients that will benefit annually (and corresponding turnover) until reimbursement is obtained under the MA.
- Financial penalties of up to 10% of the company’s turnover can be imposed if the ATU conditions for reimbursable medicinal products are infringed. The decree sets forth the procedure, consisting of pre-notification steps, notification by the French Economic Committee for Health Products (CEPS) of the grounds and amount of the penalty, the payment deadline (within a month of notification), and the terms and deadline for appeal.
- For authorised medicinal products that were previously subject to an ATU, and which continue to benefit from post-ATU reimbursement in an indication other than the indication authorised under the MA, the reimbursement rate after the MA has been granted will be calculated with respect to the last applicable price or responsibility rate for the first indication(s) authorised by the MA.
- If the reimbursed amount (under the ATU) for the preceding year exceeds EUR 10000 per patient, ATU holders must reimburse the difference between their turnover (invoiced to hospitals) and the reimbursed amount, multiplied by the number of treated patients (excluding medicinal products for which the turnover is less than 30 million EUR).
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2017 issue (Thomson Reuters).