The Italian Council of State (Italy’s highest administrative court) has recently clarified the scope of permitted advertisement to the public of medicinal products in Italy: by its decision No. 2217 of 12 May 2017, it confirmed the admissibility of the promotion to the public of all non-prescription medicines (NPMs, also known with the acronym “SOP” in Italy), and not only of over-the-counter medicinal products (OTCs).
Italian law contains a distinction between NPMs and OTCs (a sub-category of NPMs that can be directly accessed by patients in pharmacies and other authorised retailers). This originates from a set of rules under Italian law that precedes Legislative Decree 219/2006 (Italian Medicines Code – which implements Directive 2001/83/EC in Italy). Under these old rules, advertising to the public was only permitted for OTCs and not for other NPMs.
Based on this interpretation of Italian medicines law, the Ministry of Health denied Kwidza Pharma GmbH and Chefaro Pharma Srl the authorisation to advertise an antitussive medicinal product (a NPM not qualifying as an OTC) to the public. The companies challenged the denial before the administrative court of the Lazio Region (TAR Lazio), which upheld the companies’ complaint by decision No. 7539 of June 2016. The Ministry of Health appealed the TAR decision before the Council of State based on the TAR’s wrong interpretation of the Italian medicines rules, among other grounds.
The Council of State rejected the Ministry’s appeal and held that the advertising of all NPMs to the public is permitted in Italy (subject to Ministerial authorisation). In particular, the Council of State found that:
- the Italian Medicines Code refers to OTCs only with respect to certain specific aspects (e.g., labelling and reimbursement by the National Health Service) whereas it does not make any distinction between NPMs and OTCs with regard to advertising. The restriction on the advertisement of non-OTC NPMs is therefore superseded by the Italian Medicines Code;
- Article 88 of Directive 2001/83/EC (implemented by the Italian Medicines Code) specifically identifies the categories of pharmaceuticals for which advertising to the public is prohibited (in particular, prescription-only medicinal products). Therefore, it can be inferred that all other categories of medicines may be advertised to the public. Moreover, any national provision introducing additional prohibitions to those foreseen by Directive 2001/83/EC is likely to be incompatible with EU law.
This decision has clarified the interpretation of the Italian rules on advertising of NPMs that are not OTCs, which was previously considered not allowed in Italy. In addition, pharmaceutical companies may rely on this precedent in case of future denials by the Ministry of Health to issue an authorisation for advertising NPMs to the public.