On 17 September 2018, the National Agency for Medicines and Health Products Safety (ANSM) introduced a single portal for health care professionals to apply for individual temporary authorisations for use (ATUs) with the aim of increasing transparency and simplifying the processing of ATU applications to ensure earlier management of patients likely to benefit from new treatments. The ANSM also published a reference table of medicinal products already delivered within the ATU framework (circa 170), which includes:
- Criteria for obtaining an ATU for each of the listed medicinal products (conditions for use, summary of product characteristics and so on).
- A new application form when adhering to those criteria (which will depend on the patient’s clinical situation).
- Best practices intended for health professionals.
The ANSM will respond to applications on the basis of therapeutic urgency and the status of scientific knowledge on the medicinal product, and applications complying with the criteria will be expedited (considered within 48 hours).
Furthermore, the ANSM intends to implement a web application (e-Saturne) to replace the current fax system, allowing health professionals to send ATU requests to the ANSM more efficiently and in a timely manner.
ATUs (whether individual or cohort) are a characteristic of the French system that, in exceptional circumstances, allow patients with serious or rare diseases early access to treatment with presumed benefits before the grant of a marketing authorisation when there is no suitable alternative available on the market and treatment cannot be delayed. The patient cannot be part of a clinical trial.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2018 Issue (Thomson Reuters).