Drug advertising and commercial claims: the Regional Administrative Court of Lazio validates references to format-based savings

These are the conclusions reached by the Regional Administrative Court (Tribunale Amministrativo Regionale, “TAR”) of Lazio in its judgment no. 5459, issued on 17 March 2025 in a dispute between a pharmaceutical company operating in Italy and the Ministry of Health. The judgment was delivered in the context of a procedure for authorizing a television and web advertising campaign. The Court firmly reaffirmed the principle that including purely commercial elements in advertising for non-prescription drugs is lawful and not subject to ministerial authorization, since such elements do not pertain to the health-related characteristics of the product, unless they could undermine the rational use of the drug.

Background of the case

The Italian distributor  – of an OTC anti-inflammatory topical gel for joint pain submitted a request to the Ministry of Health for authorization to disseminate advertising content via television and the internet, pursuant to Article 118 of Legislative Decree No. 219/2006. Among the claims included in the proposed advertisement was the statement “more advantageous” (più vantaggioso), referring to the 180g format of the product. This was accompanied by a footnote clarifying that the claim referred to “the price per gram compared to the 100g package.”

The Ministry initially objected to the inclusion of this claim, asserting that “no reference to commercial aspects of the product is permitted, as the Ministry only authorizes health-related content and not information concerning the sale of the product”. Following the applicant’s counterarguments, the Ministry further contended the reference to a “more advantageous” format violated advertising rules for drugs. These rules (i) prohibit assimilating pharmaceutical products with consumer goods and (ii) require advertising to promote rational use by presenting the product objectively and without exaggeration. The Ministry argued that the adjective “more advantageous” is typically associated with generic consumer products and is therefore inappropriate for a pharmaceutical product, which should be purchased based on therapeutic need.

As a result, the Ministry authorized the advertisement only on the condition that the contested claim was removed. The applicant challenged this decision in the relevant administrative court, seeking the annulment of the authorization and the accompanying ministerial note that rejected its counterarguments.

The Court’s ruling

The TAR of Lazio firmly rejected the Ministry of Health’s position, deeming it manifestly illogical and disproportionate. The Court fully upheld the applicant’s appeal, annulling the ministerial decisions to the extent that they required the removal of the advertising claim referring to the product’s format.

The Court first addressed the Ministry’s argument that the phrase “more advantageous”, when used in reference to a drug’s packaging format, would lead consumers to perceive the product as a generic consumer good, thereby encouraging irrational use. The Court found this reasoning to be based on disproportionate and abstract assumptions, failing to consider the broader communicative context in which the advertisement would be interpreted. Specifically, the Court emphasized that consumers are simultaneously presented with other key information – such as the product’s name, therapeutic indications, and the requirement to read the package leaflet – all of which clearly convey the medicinal nature and intended use of the product.

In light of this, the Court found no violation of Legislative Decree No. 219/2006, in particular Article 117(1)(g), which prohibits the assimilation of medicines to food, cosmetics or consumer goods in advertising, nor of Article 114(3)(a), which requires advertising to promote rational use and present the product objectively.

The Court further clarified that commercial elements, such as references to price or economic convenience, are only relevant to the advertising authorization process if they distort the objective presentation of the product or its properties, even indirectly. That was not the case here. Finally, the Court rejected the Ministry’s assumption that the concept of “advantageousness” is inherently associated with consumer goods. It noted that economic considerations are not foreign to the pharmaceutical sector, citing the common distinction made between generic and originator drugs based on price.

Implications

The TAR Lazio’s ruling sets an important precedent in the field of drug advertising, particularly with regard to the extent of the ministerial oversight of commercial content. The Court reaffirmed the principle that including commercial information in public advertising for non-prescription drugs is lawful and does not require prior authorization from the Ministry of Health since the information does not relate to the product’s health characteristics.

Pharmaceutical companies and pharmacies may therefore lawfully promote to consumers the commercial aspects of non-prescription drugs, including price advantages, provided such initiative is not prohibited by law (e.g. prize contests or certain discount schemes[1]) and does not mislead or encourage consumers to use the drug in a way that is inconsistent with its therapeutic indications, either directly or indirectly.

We note that this is not the first time that the TAR, when called to assess denials/objections raised by the Ministry of Health in the context of the authorization of advertising campaigns concerning OTC drugs, upholds the applicants’ appeal. Indeed, also in previous cases, the TAR proved to have a different interpretation of the legal restrictions provided by Legislative Decree No. 219/2006 than the Ministry of Health, that uses to have a stricter approach: we remember for instance the case concerning the use of testimonials in advertising, where the TAR have upheld the appeal of companies against the Ministry decision to deny the authorization to the advertisement. In particular. the Court held that, although Article 117 of Legislative Decree No. 219/2006 prohibits advertising messages containing a recommendation by a person who is widely known to the public, this presupposes an active role by that person, consisting in endorsing the product and thereby encouraging the public to purchase it. Since such a role could not be identified in the mere presence of the well-known person in the advertisement – absent any expression of preference, even implicit, for the use of the medicinal product, as was the case in the matters under review – the Court ruled that the refusal was unlawful (TAR Lazio, rulings No. 5859 of 17 May 2016 and No. 8943 of 15 July 2014).

[1] i.e., the prohibition on conducting, and therefore advertising, prize contests and promotional operations involving drugs under Article 5(2) of Decree-Law No. 223/2006, or the prohibition on promotional initiatives such as “3-for-2” offers on medicinal products, which the Ministry considers likely to encourage irrational consumption and incompatible with the obligation for pharmacies to apply discounts uniformly to all customers