On 29 June 2016, the French Administrative Supreme Court confirmed the validity of Decree No 2014-1703 of 30 December 2014 modifying the rules on Temporary Recommendations for Use (RTUs), rejecting the respective requests for annulment lodged by the French pharmaceutical industry association LEEM, Roche and Novartis. The court also denied the applicants’ requests for a preliminary reference to the CJEU.
Pursuant to Article R. 5121-76-1 of the Public Health Code, an RTU can be issued by the French National Agency for Medicines and Health Products Safety (ANSM) to authorise the off-label use of a medicinal product if there is no medicinal product with the same active substance, the same dosage and the same pharmaceutical form that is already authorised in the considered indication or conditions of use. The Decree thus allows the ANSM to issue an RTU even if a therapeutic alternative is available, provided that the above criteria are satisfied.
The court rejected all arguments raised by the applicants on the basis of, in particular:
- The rules regarding the marketing authorisation of medicinal products, because the Decree specifies that only therapeutic considerations should guide the prescription of a medicinal product under RTU and that such prescription be based on the patient’s specific medical needs.
- The right to the protection of health, because the Decree requires better information to physicians and monitoring of patients, and contains additional safeguards concerning the presumed safety and efficacy assessment of the product.
- The fundamental freedom to conduct a business, because: (i) the Decree does not require an RTU holder to submit a marketing authorisation variation application; (ii) the additional pharmacovigilance and information obligations imposed by the Decree do not constitute a disproportionate burden on the RTU holder; and (iii) a specific liability exemption cannot be required.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2016 Issue (Thomson Reuters).