ANSM recommendations prohibit use of umbrella brands with respect to health products in France
01 March 2018
Last week, the French National Agency for Medicines and Health Products Safety (ANSM) published its final recommendations for applicants and holders of marketing authorisations (MA) on the choice of medicinal product names (the Recommendations). The Recommendations were issued following a public consultation by the ANSM in October-November 2016 (see our previous blog post: ANSM opens public consultation with respect to its draft recommendations on medicinal product names) and unanimous positive opinions of the ANSM consultative commissions on 16 November 2017.
EU and French law require that the name of a medicinal product is "either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder." The French Public Health Code further clarifies that invented names must not create confusion with other medicinal products and must not be misleading as to the characteristics or properties of a medicinal product.
The Recommendations provide guidance on the criteria the ANSM uses during the review of medicinal product names (both invented and non-proprietary names) in the context of national or DCP/MRP MA applications, and specifically emphasise that compliance with the recommendations will be taken into account by the ANSM during its evaluation. While the Recommendations have been developed in accordance with the 2014 EMA naming guidelines for centralised MA applications, they include additional recommendations such as:
- An explicit recommendation to use the non-proprietary name for generic medicines,
- Stricter conditions for the mentioning of the aroma in the name of a medicine, and
- A prohibition to use "umbrella brands" in certain circumstances.
More specifically, the Recommendations prohibit the use of umbrella brands for:
- Medicinal products (subject to optional medical prescription) with different compositions and/or indications.
- Medicinal products and other health products (e.g. medical devices, cosmetics, food supplements) with different regulatory classifications.
Consequently, a proposed invented name for a medicinal product (five of which can be proposed in one application) will be refused by the ANSM if the company markets or – as suggested by the guideline – marketed (i) any medicinal products with different compositions and/or indications under the same name, or (ii) any other health products under the same name or a part of that name. Inversely, in case a company wants to use (part of) a medicinal product name for another health product, the ANSM may take adequate measures for products within its competence or inform the relevant competent authorities.
The Recommendations explain that the use of umbrella brands in these cases may lead to confusion between the products, and that a possible misuse of medicinal products resulting thereof may lead to over-dosage or other safety and/or efficacy risks. For these reasons, other national regulatory authorities have adopted guidance on the use of umbrella brands as well. However, the UK MHRA, for example, does not prohibit the use of umbrella brands per se and specifically states that it "does not intend to impose unnecessary impediments to companies using a particular name and recognises that other features such as pack design and labelling can help distinguish between products."
These additional restrictions on the use of invented names create extra challenges for companies given the increasing difficulty of finding an appropriate invented name in light of the rising number of products on the market. The prohibition to use umbrella brands also deprives them of an important instrument to build consumer trust and recognition for a similar range of products. In addition, as indicated above, companies have to take into account different national naming guidelines, de facto often requiring them to follow the strictest recommendations if they intend to market their product in several EU member states under the same name.
In contrast, the additional guidance provided in the Recommendations will hopefully decrease the number of rejected product names and speed up – at least the national – evaluation process for new medicinal products. In 2016, for example, the ANSM rejected more than 269 invented names out of 400, and naming discussions often took more than six months (see our previous blog post: Majority of invented names for medicinal products rejected). When deciding on the name of a medicinal product, regulatory requirements therefore play an increasingly important role and should be taken into account from an early stage.