April 4, 2024

Online sale of medicines without a prescription: The Court of Justice of the European Union approves intermediary sites

The Italian version of this article has been published on March 20, 2024 on AboutPharma.com, within our bi-monthly column “Digital impact in Life Sciences: Legal Corner”.

The Court of Justice of the European Union (CJEU)[1] weighed in on the online sale of medicines, opening the door for intermediary platforms to get involved.

The court indicated the criterion for distinguishing between sale of non-prescription medicines remotely to the public (reserved for entities meeting certain requirements established by national rules) and intermediation carried out by platforms that simply put selling pharmacists in contact with end customers.

The issue before the CJEU was raised in a dispute between the company Doctipharma SAS (“Doctipharma” or the “Company”) and the French pharmacy group Union des Groupements de pharmaciens d’officine (“Udgpo” or the “Association”) and concerns the legality of Doctipharma’s platform offering non-prescription medicines for sale online.

Origin of the dispute

Doctipharma is the owner of an eponymous online platform where users purchase medicines sold by pharmacy sites in partnership with the Company. The platform provides a pre-compiled catalogue of medicines, and orders are then transmitted to Doctipharma’s partner pharmacy sites.

Udgpo sued the Company before the French court on the grounds that it was engaged in the business of selling medicines without meeting the requirements under French law (i.e., qualification as a pharmacist).

The French court of first instance took the side of the Association.

The Court of Appeals then overturned the first-instance ruling, arguing that the platform did not sell medicines directly to the public, but was merely an intermediary.

In turn, the French Court of Cassation argued that the company nevertheless played a role in the electronic sale of medicines, albeit as an intermediary, and it overturned the decision of the appellate court on remand. The Court of Appeals then referred several questions to the CJEU for a preliminary ruling on the interpretation of Directive 98/34, which governs information society services, and Directive 2001/83, i.e., the European medicines code.

In essence, the court asked about the compatibility of EU law with French legislation prohibiting an entity that does not meet the requirements for the online sale of medicines from performing such intermediary activity.

Online drug trading platforms are considered “information society services”

For the purposes of bringing the activity carried out by the platform in line with the provisions of the European medicines code regarding the distance sale of medicines to the public through information society services, the CJEU expressed itself on the interpretation of Directive 98/34[2] in relation to the definition of “information society services.”

It noted that in order to qualify as an “information society service,” a service must be:

  1. Provided for remuneration;
  2. Provided remotely and electronically;
  3. Requested by users/operators of the platform.

Regarding the first condition, the court noted that although Doctipharma’s platform did not directly receive remuneration from users accessing the service, it did obtain compensation (through a monthly subscription) from pharmacies using the service to attract new customers.

Consequently, the first condition could be considered met. The second condition was also found to be met by the platform in that contact between the customer and the pharmacy was provided remotely via a website.

For the third condition, the court noted that the service could be requested both individually by pharmacists, who had to join the platform’s website to gain access, and by the individual customer, who needed a customer account to access the websites of pharmacists of their choice to purchase medicines. The court concluded that the Doctipharma platform qualified as an “information society service,” in line with the attorney general’s views.

Therefore, French law on sale of medicines through the platform must be evaluated in light of the relevant provision of the European medicines code.

Distinction between remote sales platform to the public and pharmacist-customer connection platform

The court made an important distinction between platforms that sell non-prescription medicines remotely to the public, which must meet all the requirements of national legislation on the sale of medicines, and platforms that merely connect customers with pharmacies, which are not subject to such requirements. The court was also asked whether the European code left Member States free to prohibit or not prohibit the provision of a service consisting of connecting pharmacists and customers through websites, for the purpose of sale via the websites of pharmacies participating in the service.

The court noted that Title VII-bis of the European code governs distance selling to the public by providing that it must be authorized or made lawful by Member States, thus leaving it up to them to determine conditions and modalities.

However, the court noted, Member States[3] may impose conditions only on remote sale of medicinal products to the public by means of information society services and only to the extent that they are “justified on grounds of the protection of public health.” It follows that Member States may not restrict the exercise of an activity that has nothing to do with the sale of medicines, such as the work performed by a platform that acts only as an intermediary between pharmacist and customer without participating directly in the sale.

The court grants the referring court the right to determine whether the concrete way the platform is managed and operated makes Doctipharma a mere intermediary or an entity that sells medicines.

Impact in Italy

This ruling certainly marks a turning point in the interpretation of legislation on e-commerce of medicines by basically declaring lawful—as it complies with EU law—an activity that previously was prohibited in France and Italy.

The Italian Ministry of Health[4]  states that “the use of intermediary websites, e-commerce platforms (marketplace), and mobile applications for smartphones and tablets (apps) for online management of medicine purchasing processes offered to the public by authorized websites is not permitted, as online sales are allowed only to authorized subjects through sites indicated for that purpose.”

The circular also says that “the use of technological platforms that from the product, chosen by the user, go back to an accredited seller selected by the system” is not allowed, as that would be “contrary to citizens’ right to free choice of pharmacy.”

This ministerial position has always seemed more restrictive than what is expressly stated in the law,[5] which merely requires that sales take place on authorized sites displaying the national identifying logo, without placing express limits on the use of intermediary “showcase” platforms that allow a user to enter the site of an authorized pharmacy, the only seller of the product.

However, this position has blocked development of such platforms in Italy.

An important precedent

Therefore, as highlighted above, the ban on the use of marketplaces/medicine brokerage sites in Italy is not clearly enshrined in law but is rather the result of a ministerial interpretation.

The potential for impact from this CJEU ruling, which condemns the similar position adopted by French legislation for not being compatible with EU law, is certainly very strong.

Obviously, this is the case as long as the brokerage platform merely connects users and sellers without participating in the sale. Following this pronouncement, the Italian Ministry of Health can be expected to reevaluate its 2016 circular.

In the meantime, should new commercial initiatives of this kind (i.e., brokerage platforms and marketplaces for non-prescription medicines that connect users with the sites of authorized pharmacies) be undertaken in Italy, there would certainly be an excellent argument to counter any challenges.

[1] In the judgment of February 29, 2024.

[2] As amended by Directive 2015/1535.

[3] Under Article 85 paragraph 2 of the code.

[4] Circular of May 2016.

[5] Article 112-quater of the medicines code.

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