Advertising non-prescription medicines is lawful even if they are not OTCs, says the Italian Council of State

By decision no. 2217/2017 of 12 May, the Italian Council of State affirmed the possibility of advertising not only over-the-counter medicines (OTCs) but all medicines that can be bought without prescription (NPMs), save the need to obtain the prior approval of the Ministry of Health for the individual advertisements.

The Council thus confirmed the correctness of the first-instance decision no. 7539/16 of the Lazio Administrative Court (TAR), which had reconstructed the succession of the relevant provisions as follows. Art. 3 of legislative decree no. 539/92 originally allowed the advertising to the public of NPMs without distinguishing between the two subcategories of OTCs and non-OTCs. Subsequently, however, art. 8 (10) of legislative decree no. 537/93, although only regulating reimbursement for medicines, had been construed as allowing advertising only for OTCs. This limitation, already doubtful, was in any case overcome by legislative decree no. 219/2006 (the so-called “Code of Medicines”), issued in implementation of Directive 2001/83/EC and currently in force: its art. 96 generally provides that all NPMs, whether OTCs or non-OTCs, “may be advertised to the public if they meet the requirements posed by the relevant laws in force and provided that the limits and conditions laid down by the same laws are complied with“. Accordingly its art. 115, in setting forth the categories of medicines the advertising of which is forbidden, does not mention NPMs. “From this it derives”, the Lazio TAR had concluded, “that the legislator did not intend to differentiate between the two sub-categories of medicines for advertising purposes … hence it is evident that in this respect the abovementioned provision has overcome the unclear foreclosure referred to in art. 8 of legislative decree no. 537/1993”.

In the judgement under review, the Council of State stated that, in fact, the distinction referred to in the abovementioned art. 8 had been made for the sole purpose of reimbursement for medicines, and not for the related advertising. In addition, in confirming the correct interpretation of arts. 96 and 115 of legislative decree no. 219/2006 made by the Lazio TAR, the Council referred to the underlying Community legislation, and in particular to art. 88 of Directive 2001/83/EC, according to which Member States shall prohibit the advertising of medicinal products which “are available on medical prescription only” and of those which “contain substances defined as psychotropic or narcotic”. “It must therefore be argued“, the Council stated, “that, on the contrary, advertising is always allowed for the remaining categories of medicines: therefore, a piece of legislation which generally introduces, in the absence of specific needs, further prohibitions, overcoming the limits set out in the above art. 88, would seriously risk Community incompatibility”.

Furthermore, the Council found ungrounded the allegation of the Ministry of Health that a differentiation between OTCs and other NPMs as regards advertising would be justified by their different degrees of danger to health. “In fact, a possible different degree of danger among these drugs could not in any case justify the extension of a general prohibition that is not based on European laws. At the utmost, this might legitimise different cautions and provisions when authorising the advertisements (which is certainly possible under the current legislation)“.