The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products in the manner specified in the proceedings is in breach of Italian law on advertising of medicinal products and amounts to an act of unfair competition.

Case details

DOC Generici S.r.l. (“DOC“) is an Italian manufacturer of generic medicinal products. DOC decided to give visibility to its portfolio of OTC generic medicinal products on the company website, listing information on its products such as the name of its generic medicinal products, the names of the corresponding reference medicinal products, their classification, price and reimbursability in Italy. Similar information was also published as an advertisement in an Italian magazine. Bayer contested that making available such information to the public, which included a reference to some of its products as reference medicinal products, was in breach of the law on the advertising of medicinal products. As a consequence, this behaviour also amounted to an act of unfair competition. DOC responded that the publication was exclusively intended to inform the public on essential data concerning the reimbursability of the products that corresponded to the regulatory information made available by the Italian medicines agency (AIFA) in the transparency list. Such list is compiled by AIFA in order to allow pharmacists to inform the consumers on the availability of a generic medicinal product having the same composition, dosage, pharmaceutical form and route of administration of a reference medicinal product. In that case, the reimbursability by the National Health System is limited to the lower price of the generic medicinal product.  DOC further argued that, according to Italian and EU law, trade catalogues and price lists cannot be regarded as advertising. By way of background, it is worth noting that advertising of OTC medicinal products in Italy is allowed only upon previous authorisation of the advertising message by the Ministry of Health. In the present case, such authorisation was not requested by DOC on the assumption that the information could not be deemed to be advertising.

The finding of the Court

The Court of Milan found that the information published by DOC in the website should be regarded as advertising of medicinal products on the following grounds:

i) As the information related only to DOC’s generic medicinal products, the Court rejected DOC’s argument that the information was legitimate by the public interest of promoting the use of generic medicinal products in Italy:

“the purpose of promoting among consumers the use of generic medicinal products instead of the originators’ products cannot be pursued by a single manufacturer with exclusive regard to its products by using means having a clear promotional nature – which for their very nature cannot be effectively controlled, if not previously authorised […] – being such interest more properly pursued in general terms both through the activity of the competent authorities (AIFA, including by means of the transparency lists) and the HCPs, who may advisedly counsel and inform the consumers […]”.

ii) In the light of the Court of Justice’s Judgement of 5 May 2011, case C‑316/09, MSD Sharp & Dohme GmbH vs. Merckle GmbH, the Court held that an information to the public may qualify as advertising, if it is presented in a way that shows a promotional intent, as it happens if the advertiser selected or manipulated the content of regulatory data:

“[the information provided by DOC] related only to its products and therefore did not provide to the consumer an objective and general information as to the differences between the originators’ medicinal products and the generic medicinal products, whilst the attention of the reader was brought only to the products of DOC with the explicit purpose of promoting the purchase of its products instead of those formerly patented. Moreover, the information was subject to a selection – as it was partially obtained from more general transparency lists – and also to manipulation, not in the sense that it presented a distorted representation as compared to the reality, but in that that the information differed from the officially provided by AIFA both for the addition of classification criteria not encompassed by the transparency list and for the inclusion of other information (excipients) on the products commercialised by DOC. Finally, the information was addressed not to qualified professionals but to the public at large with technical modalities of visualisation that did not require a proactive research by the internet users, much less by the readers of the magazine in which the communication appeared as an advertisement, so that it must be concluded that also individuals not interested in the medicinal products at stake were subject to the view of the information, thereby confirming the general promotional intent underlying the communications at issue”.

iii) The information was not considered to be publication of catalogues and lists of prices, as:

“From the one hand, the listing of single products and prices does not amount to a catalogue – a document that includes all the products of the manufacturer. On the other hand, it must be observed that such provision [i.e. the exemption of catalogues from the definition of advertising] clearly refers to the relationship between the pharmaceutical companies and healthcare professionals (distributors, physicians and pharmacists, etc.) and not to the general public of consumers, while – on a different note – the content itself of the communications at issue and the already discussed additional information not pertaining to a catalogue concur to exclude the application of this exemption”.

Based on the above, the Court came to the conclusion that the information disseminated by DOC to the public was advertising of medicinal products, which was unlawful as it was not previously authorised. As the violation of regulatory provisions unjustly conferred upon DOC an advantage on the market, such behaviour was held to amount to an act of unfair competition.

Comment

The Judgement of the Court of Milan, which is subject to appeal, is one of the few decisions of Italian civil courts addressing the issue of advertising of medicinal products in breach of the law for the possible implication of unfair competition. Indeed, advertising issues in pharmaceutical sector do not often escalate to litigation in Italy, given the requirement of a previous authorisation by the Ministry of Health for any OTC product’s advertisement. While pharmaceutical companies may appeal the refusal of the authorisation before the administrative court, this does not frequently happen. However, as the case at hand proves, there may be room left for other remedies under Italian civil law, in consideration of the inevitable impact of unfair advertising in the market.