February 5, 2020

Who can request authorization to advertise medicines? Answers from the AGCM

The Italian Competition Authority (hereinafter the “AGCM“) recently expressed an opinion and addressed a recommendation to the Ministry of Health (the “Ministry”) regarding the parties entitled to request authorization to advertise medicinal products to the public (resolution No. AS1628 of December 9, 2019). With Memo No. 3/2006 (hereinafter the “Memo“), the Ministry previously limited this right to marketing authorization holders only.

According to the AGCM, this limitation, which specifically prevents retailers from advertising the products they sell, restricts competition in the pharmaceutical distribution market (both at brick-and-mortar stores and online) for no reason.

In particular, Article 10 of the Memo states that: (i) authorization for advertising can only be requested by the marketing authorization holder; and (ii) the owner of a store is responsible for improper advertising carried out in the store itself (as of now that is understood to include online advertising). This limitation is also reflected in the instructions reported on the Ministry’s website, which specify that “the manufacturer or company responsible for placing the medicine on the market” is the entity entitled to request authorization.

This imposes significant limitations on the many entities that are part of the medicine distribution chain (e.g., pharmacies and similar outlets) and that potentially might be interested in advertising the products they sell to the public; currently they are unable to do so or, in any case, are forced to resort to alternative forms of promotion.

Moreover, the position of the Ministry seems inconsistent with the applicable rules and their rationale. Indeed, Article 118 of the Code of Medicines states that no advertising of medicines to the public can be carried out without authorization from the Ministry, but does not provide any limitations regarding the parties entitled to request such authorization.

In fact, there is no reason that a promotional message targeted to a public audience and relating to a given product should not be subject to the same restrictions and constraints (in particular ministerial authorization) whether the advertising is carried out by a distributor (pharmacist) or a manufacturer, as those restrictions and constraints exist to protect the public from inaccurate messaging.

This approach is also reflected in the provisions on sanctions set by the same Code of Medicines (Article 148, paragraph 15), which states, Anyone who advertises to the public in violation of the provisions of this decree is subject to an administrative sanction ranging from EUR 2,600 to EUR 15,600.” Such sanctions may be levied on a group of different parties that includes distributors and pharmacists and not just marketing authorization holders.

Therefore, since distributors are held to the same authorization requirements and are clearly subject to the same penalties in case of breach thereof, prohibiting them from requesting ministerial authorization actually prevents them from implementing advertising activities.

Following the intervention of the AGCM, the situation described above may change. Indeed, the authority invited the Ministry to take its comments into consideration in order to promote competition as effectively as possible and to communicate to the AGCM itself the measures implemented to that end.

What about medical devices?

The situation described above is no different in the case of medical devices. In fact, the Ministry indicates on its website that only the company that manufactures a medical device or in vitro diagnostic medical device or is responsible for placing it on the market is entitled to file the related authorization request. For medical devices, the manufacturer is substantially the equivalent of the marketing authorization holder for medicines.

Additionally, the administrative sanction provided by law (Law 14/2003, Article 15) applies to “those who advertise medical devices in violation of the provisions of Article 21, paragraphs 1 and 2, of legislative decree No. 46 of February 24, 1997.” Therefore, any person who engages in prohibited conduct, including dealers/distributors who advertise, is subject to this sanction.

Clearly, the Ministry should updates its medical device procedures and allow distributors and retailers to request authorization to advertise their products legally. This change would be particularly important for medical devices, given that they are widely sold through digital channels.

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Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

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