On 24 February 2017, the French Administrative Supreme Court (Conseil d’Etat) rejected requests from Novartis and Roche to annul a Temporary Use Recommendation (RTU) issued by the French National Agency for Medicines and Health Products Safety (ANSM). The RTU allows Roche’s anticancer medicine Avastin to be used off-label in wet age-related macular degeneration (AMD) despite authorised treatments being available (including Novartis’ Lucentis), though at a higher price. The decision follows the court’s September 2015 ruling denying the interim suspension of the RTU.
In June 2016, the court also confirmed the validity of Decree No 2014-1703 of 30 December 2014 modifying the rules on RTUs, rejecting the respective requests for annulment lodged by the French pharmaceutical industry association LEEM, Roche and Novartis.
The French Administrative Supreme Court – unlike its Italian counterpart – denied the applicants’ requests for a preliminary reference to the CJEU, and rejected all arguments raised by the applicants on the basis of, in particular:
- The rules regarding the marketing authorisation of medicinal products. The court considers the fact that the ANSM can only issue an RTU in the absence of a medicinal product with the same active substance, dosage and pharmaceutical form is in line with Article 5 of Directive 2001/83/EC and existing case law (Novartis Pharma GmbH v Apozyt GmbH (Case C-535/11) Official Journal C 156, 01/06/2013 p.9).
- The protection of health. The court considers that the provisions requiring the ANSM to assess the presumed safety and efficacy of the product on the basis of all available information provide a sufficient safeguard for the protection of health. The specific provisions included in the patient monitoring protocol should seek to guarantee a high level of protection of human health as well.
- The fundamental freedom to conduct a business. The court considers that this freedom is not affected because the RTU does not: (i) require the RTU holder to submit a marketing authorisation variation application; and (ii) prevent the marketing authorisation holder from ceasing the commercialisation of the authorised medicinal product.
- The principle of legitimate expectations. The court considers that marketing authorisation holders cannot expect to be protected from the extension of indications of authorised medicinal products with different active substances or from evolutions in physicians’ prescribing practices.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2017 Issue (Thomson Reuters).