Online sale of non-prescription medicines: green light for intermediaries

published on 12 July 2024 | reading time approx. 4 minutes

In the sphere of e-commerce in medicines, a recent ruling by the Court of Justice of the European Union clarified the limits that a Member State may place on the distance sale of not subject to compulsory medical prescription. The Luxembourg judges ruled on the case involving Doctipharma, an online platform able to connect pharmacists and customers for the purchase and sale of medicines. The Court's decision sets an important precedent that could also have a significant impact in Italy, where, to date, very restrictive rules apply.

The dispute stems from accusations made by Union des Groupements de pharmaciens d'officine (an association of pharmacy groupings, also known as "UDGPO"), which sued Doctipharma. The latter is an online website that allows its users to purchase non-prescription medicines from registered pharmacies.

According to UDGPO, Doctipharma's activity did not comply with French legislation which prohibits the sale of medicinal products without having the status of pharmacist.

Instead, Doctipharma claimed to be a mere intermediary, as the purpose of the service was only to connect pharmacists with customers.

After a long judicial process, the Paris Court of Appeal decided to refer the case back to the Court of Justice.

The Court of Justice first specified that "a service provided on a website, consisting of putting pharmacists and customers in contact for the sale, from the sites of pharmacies that have subscribed to that service, of non-prescription medicines, falls within the concept of 'information society service". Therefore, Doctipharma was held to be the provider of an information society service on the assumption of the definition of 'information society service' within the meaning of Article 1(2) of Directive 98/34/EC.

Afterward, the CJEU provided an interpretation of Article 85c, Dir. 2001/83/EC. This article sets out the conditions that Member States must comply with in order to regulate the supply of medicinal products at a distance.

According to the Court, Member States may prohibit the sale of medicinal products to persons who are not pharmacists. On the other hand, Member States may not restrict the provision of services of intermediaries for the sale and purchase of medicinal products, even when provided by persons who are not qualified as pharmacists.

Accordingly, Member States may prevent the online trading of medicinal products by persons selling in their own name without qualifying as pharmacist, but they may not prevent the activity of mere intermediation by anyone. In the writer's opinion, it is crucial to understand with whom the purchaser signs the sales contract. Since contracts are often not signed in such purchases, it is the one who issues the sales invoice (or the sales receipt) who will be considered the seller. Therefore, only the latter must qualify as a pharmacist. On the other hand, the platform that receives a fee for the intermediation activity does not sell the medicines to patients and, consequently, can perform it without the qualification of pharmacist.

Which impact does this ruling have on Italian companies?

Article 112-quater, paragraph 3, of Legislative Decree 219/2006 (the so-called “Codice del farmaco”, in english “Medicines Code”), implementing Dir. 2001/83/EC, establishes that medicines not subject to compulsory medical prescription may be supplied remotely by pharmacies, and by the commercial outlets referred to in Article 5, paragraph 1, of Legislative Decree 223/2006, provided that they have received authorisation from the relevant region (or autonomous province) and, if necessary, from the other authorities established by regional laws.

Circular 25654 of 10 May 2016 of the Ministry of Health also states that 'the use of intermediary websites, e-commerce platforms (marketplaces) or mobile applications for smartphones or tablets (APPs), functional for the online management of the processes of purchasing medicines offered to the public by authorised websites, is not permitted as online sales are only allowed to authorised subjects through the site indicated for this purpose, which must coincide with the one registered in the list of authorised subjects for the online sale of medicines, published on the Ministry's portal'.

The Ministry of Health has therefore further broadened the scope of the prohibition, prohibiting the use by pharmacies also of intermediary websites and so-called marketplaces for the sale of medicines.

The decision of the Court of Justice, however, could open a margin for the misapplication of Circular 25654 by the Italian Courts. In fact, the ruling goes in the opposite direction to the circular, establishing the full legitimacy of the activity of brokering medicines at a distance.

The judgment in question presents innovative profiles that might affect the e-commerce of medicinal products. In fact, it establishes that Member States may impose limits on the sale of medicines online, but may not prohibit brokering activities.

This ruling also has a major impact on the Italian e-commerce market for medicinal products because, in fact, it contravenes the Ministry of Health's Circular, which states that even brokering activities should also be prohibited.

In light of this, companies are advised to monitor the legislative framework of reference, hoping that the Ministry will retrace its steps and no longer ban this activity. In this regard, it is recalled that the judgments of the Court of Justice bind all national courts to comply with the principles expressed.

However, due to the lack of clarity in the matter, the associated legal risks can be manifold. It is therefore advisable for companies to seek the advice of experienced professionals who can provide solutions to prevent legal problems so that they can protect themselves and choose the right course of action.