France has enacted new rules on the off-label use of medicines. A new Decree amending the rules on Temporary Recommendations for Use (“RTU”) established pursuant to Article L5121-12-1 of the French Public Health Code (“PHC”) was published on 31 December 2014 (the “Decree”). This Decree follows the adoption of the amended social security budget bill in August last year, which introduced revisions to the preexisting Article L5121-12-1 PHC. According to the legislative history of the law, this change may have been intended to allow off-label prescription of Roche’s cancer drug Avastin® after reformulation to treat the eye condition age-related macular degeneration, instead of the Novartis product Lucentis®, which is specifically developed and approved for that indication.
According to the new Article R5121-76-1 PHC, an RTU can be issued to authorize the use a medicinal product off-label if there is no medicinal product with the same active substance, the same dosage and the same pharmaceutical form that is already approved or under a Temporary Authorization for Use (“ATU”) in the considered indication or in the considered conditions of use. Thus, the French Medicines Agency (“ANSM”) can now issue an RTU even if a therapeutic alternative is available, provided that this alternative does not have the same active substance, dosage and pharmaceutical form. Article L5121-12-1 PHC specifies that only therapeutic considerations should guide the prescription of a medicinal product under RTU. The new law further requires that prescription of a medicinal product under RTU be made after a thorough examination of the patient and based on the patient’s specific medical needs.
Under the former rules, only three RTUs have been granted. With this new legal framework, the ANSM is now in a position to allow more widespread off-label use of medicines. One can expect that more RTUs will be granted in the near future. In particular, it will be interesting to see how the notions of “same active principle, same dosage and same pharmaceutical form” will be interpreted by the ANSM, and in particular, whether purely therapeutic considerations – as opposed to economic ones – will drive the ANSM’s assessment.
The new requirements for issuing RTUs depart significantly from the initial rules on off-label use from December 2011. The rules originally required the absence of a therapeutic alternative for the off-label use of medicines under RTU. The new RTU rules reflect a recent trend in favor of off-label use of medicines in Europe with a number of Member States broadening such use, sometimes openly for economic reasons. Such approach undermines the marketing authorization system as the decisions promoting off-label use, such as the RTUs, are adopted without the same level of data on the quality, safety and efficacy of the products as provided for their approved use, and also not through the same procedures that need to be followed for a marketing authorization.
Companies should closely monitor further developments regarding off-label use in France but also in other EU countries as this is a hot topic throughout the EU.