French Administrative Supreme Court rejects AFIPA's appeal in relation to ANSM recommendations

On 21 October 2019, the French Council of State, the Administrative Supreme Court, issued an important ruling, rejecting a request to annul certain recommendations addressed to marketing authorisation applicants adopted by the French National Agency for Medical and Health Products (ANSM). The request had been made by the French Association for the Self-Medication Industry (AFIPA), which considered the recommendations to be counterproductive and to be evidence of the ANSM exceeding its powers.

Firstly, in light of limiting umbrella branding, the recommendations indicate the precautions to be taken when choosing medicine brand names. Such practice consists of using one fantasy name for medicines with different therapeutic indications, or a name containing all or part of another health product's name. Secondly, the ANSM states that the outer packaging of non-prescribed medicines in solid oral form should favour and enhance the visibility of the common name and dosage (using larger font and colours was suggested), but the invented name and brand logo may still feature on the labelling.

The recommendations were adopted in order to reduce the risks of medication errors due to labelling and medicine names mistakes, whereby the ANSM specified the relevant elements taken into consideration in its evaluation of marketing authorisation applications.

Considering such measures to be counterproductive and evidence of the ANSM exceeding its powers, AFIPA requested their annulment. The court ruled that AFIPA's request was admissible because such recommendations, even though not legally binding, significantly affect the behaviour of applicants as well as patients, resorting to self-medication. They also adversely affect the labs commercialising such medicines.

However, the court considered that the ANSM had not exceeded its powers. The court reiterated that the precautionary principle allows implementation of protection measures in case of mere uncertainties around the existence of risks regarding health. Firstly, the court ruled that umbrella branding is likely to promote confusion between medicines with different active substance compositions and indications and may thus be misleading about their quality or properties. Secondly, the court ruled that the packaging recommendations do not add new elements but only repeat the already required mentions to improve their legibility, visibility and good comprehension. Consequently, the court rejected AFIPA's appeal.

This article was co-authored by Rada Petrovic.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2019 Issue (Thomson Reuters).