Yesterday, the French National Agency for Medicines and Health Products Safety (ANSM) provided some clarifications with respect to its Recommendations for applicants and holders of marketing authorisations on the labelling and packaging of human medicinal products dispensed in solid oral form and its Recommendations on the choice of medicinal product names (dated February 2018) (see our prior posts: ANSM publishes recommendations prohibiting use of umbrella brands in health products and ANSM publishes recommendations on the labelling and packaging of oral medicinal products).
In response to recent industry criticism, the ANSM in the first place clarifies that the recommendations do not endorse a “neutral packaging” for medicinal products, in particular by removing the brand name thereof. It also reminds companies that the recommendations are not mandatory, while explaining that they only provide guidance on the placing and layout (font, colours, pictograms….) of information on the packaging, but do not recommend that any additional information (in comparison to what is currently required under the regulatory framework) be added to the packaging. The ANSM also underlines that the aim of the guidelines is to promote safe use of medicinal products and eliminate medication errors, in line with the WHO objectives. According to the ANSM, the brand name should not be placed preeminently with respect to the information that is necessary to ensure proper use of the product, in particular the active substance, dose, administration route and target population, which should all appear on the front.
While the recommendations are not binding, the ANSM encourages compliance by the French pharmaceutical industry, which is however sceptical about the recommendations’ (presumed) benefits. The French Federation of the Pharmaceutical Industry for Responsible Self-Medication (AFIPA) recently challenged the recommendations on grounds that their implementation will – ironically – increase risks and entail “potentially dramatic effects”. AFIPA emphasises the essential role of the brand name as a fundamental and easily memorised reference for the patient, as opposed to complicated non-proprietary names of active substances. In this respect, the preeminent use of the non-proprietary name of active substances as opposed to the brand name (or other distinctive features such as the brand logo) on the packaging reduces readability and standardises packaging among different products. AFIPA provides data confirming that 25% of the population in France will experience increased difficulties to identify and understand the information on the packaging pursuant to the recommendations, as compared to the current packaging requirements, with up to 96% of respondents ignoring the name of an active substance or its intended use (which may explain why most of the pharmacists are also wary about how these new recommendations may impact patient safety). Finally, AFIPA contests the absence of significant scientific data supporting ANSM’s position on the (presumed) medication errors stemming from the current packaging requirements (with only 2.7% of medication errors identified between 2005-2016 being due to confusion among self-medication/non-prescription products dispensed orally).
Watch this space for future updates.
This article was co-authored by Maud Vanlierde.