The French National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du medicament et des produits de santé, the “ANSM”) published on 22 February 2018 on its website its final recommendations for applicants and marketing authorization holders on the choice of the name of medicines (the “Recommendations”).
The Recommendations result from a consultation process held since the end of 2016 both towards the public and ANSM’s relevant consultative commissions.
They are intended to guide marketing authorization holders and applicants in the choice of the name of medicines in the framework of a national procedure, a European mutual recognition or a decentralized procedure. The European Medicines Agency’s (the “EMA”) recommendations remain applicable to any centralized procedure.
The ANSM recently faced misuse of medicines that it attributed to confusions created by umbrella brands.
French law requires that the name of medicines, which shall be approved by the ANSM, be either an invented name, or a common or scientific name together with a brand name or the name of the marketing authorization holder or the operator. Any invented name must not cause confusion with other medicines and must not be misleading with respect to the medicine’s quality or characteristics.
In this context, the ANSM has decided to prohibit the use of umbrella brands for certain products (I) and provides a number of other recommendations (II). Concerned companies should therefore integrate a rather restricted regulatory framework in their development plans (III).
I.The Recommendations significantly restricts the use of umbrella brands
Given public health concerns arising from the risk of confusion on the therapeutic action of those products, the ANSM merely prohibits the use of:
- “the same invented name for several non-prescription medicines whose marketing authorizations are held by the same holder, with a different active substance composition and different therapeutic indications”; and
- umbrella brands that would cover both medicines and products of other regulatory status (i.e. “multi-status” products).
In other words, the use of umbrella brands, or the same brand, is limited to medicines with the same regulatory status, and using the same active substance.
The ANSM intends to use the breadth of its powers to enforce these Recommendations despite the fact that umbrella brands might encompass a vast majority of products with different regulatory status beyond the reach of the Agency. If a company plans to use the name of a medicine or part of it to identify another product and this is likely to lead to an actual or potential risk of medication error, the ANSM may take any adequate measure within its area of responsibility or report the issue to any other relevant authorities.
II. Medicines denominations are subject to an updated set of rules
The ANSM has taken the opportunity of the Recommendations to update its general requirements on the construction of invented names, on the basis of which the following do’s and dont’s can be summarized:
The Recommendations make clear that compliance with the ANSM’s guidelines will be taken into account by the ANSM during the evaluation process. The new restrictions arising from the Recommendations create further challenges for companies who must strictly comply with them when choosing the name of a medicine, in order to increase the chances of getting a positive assessment from the ANSM and to avoid any risk of non-compliance with the applicable regulations. We expect that the publication of the Recommendations will reduce the number of name requests rejected and will expedite the evaluation process.
While the Recommendations do not compromise the brand registration process with the appropriate authority, the ANSM ultimately discharges its own functions by ruling on the use of brands in the name of products subject to marketing authorizations or registrations, in accordance with its mission to safeguard public health.