Spanish court defines the role-players in online medicine services

2025-09-01T13:32:00
Spain
Setting the boundary between information society services and unlawful intermediation in the online sale of medicines
Spanish court defines the role-players in online medicine services
September 1, 2025

On June 12, 2025, the Central Administrative Court nº3 issued the judgment nº103/2025 (ECLI:ES:AN:2025:3655) which resolves a contentious-administrative appeal brought by BERDAC SMART SERVICES, S.L. ("Company") against the Spanish Agency of Medicines and Medical Devices ("AEMPS"). In essence, the Court concludes that the Company’s digital platform does not constitute unlawful "intermediation" in the remote sale of medicines, but rather constitutes a lawful information society service that merely connects end-users with duly authorised pharmacies.

Background

 The dispute originates from the AEMPS resolution of February 21, 2024, imposing on the Company a monetary fine of €27,000 –a minor infringement under Arts. 111.2 a) 2º and 10º of Royal Legislative Decree 1/2015. The authority concluded that the Company engaged in unlawful "intermediation" in the distance sale of medicinal products and failed to cooperate with the health administration in the evaluation and control of medicines.

The Company filed an administrative reconsideration (recurso de reposición), which AEMPS rejected by administrative silence. On 13 November 2024 the Central Administrative Court admitted the Company’s subsequent judicial appeal.

Factual context and claims

The Company operates a digital platform that (i) enables users to select a pharmacy of their choice for the preparation of personalised pill dispensers and (ii) arranges, under a mandate (contrato de mandato), the collection of those pre-packed dispensers from the pharmacy and their delivery to the end-user. Crucially:

  • The platform does not advertise, offer, price, sell, purchase, store, or otherwise handle medicinal products.
  • The Company never takes title to—or physical possession of—medicines beyond the collection of packages already dispensed by the pharmacist to a patient.
  • No payment for medicines is processed through the platform; any commercial transaction occurs directly between patient and pharmacy.

On that basis the Company argued that it merely supplies an information society service: a neutral digital interface combined with a mandate for courier services, both fully protected under EU e-commerce law. It therefore denied acting as an “intermediary” in the sale or distribution of medicines.

AEMPS, by contrast, contended that the combined digital and logistical services amounted to prohibited intermediation in distance sales and that the Company’s refusal to shut down the platform constituted non-cooperation with the health authority.

Ruling of the Central Administrative Court

The Central Administrative Court fully upheld the Company’s challenge, set aside the €27,000 fine, and ordered the Agency to bear the costs arguing the following:

  • Mischaracterisation of the activity. After examining the factual record and conducting an evidentiary hearing, the Court concluded that the Company «does not place medicinal products at the disposal of users in the web (…), nor does it offer any medicines on its website», but rather provides a service which «connects users with the pharmacy» and collects the package as mandatary. It therefore ruled that «the service is not a sale of medicines».
  • Inapplicability of distance-sale regulations. By direct reference to the Court of Justice of the European Union in Doctipharma (C-606/21, ECLI:EU:C:2024:179) the Court observed that, where an online platform confines itself to connecting pharmacists and patients, «such a service cannot be prohibited». Similarly, the Court reasoned that the national distance-sale rules invoked by the Agency were held to be irrelevant to the Company’s activity.
  • Absence of duty to collaborate in the evaluation and control of medicines. The infraction invoked under Article 111.2 a) 2.º (“failure to collaborate in the evaluation and control of medicines”) is not applicable because the Company «does not buy, sell, distribute, nor manufacture medicinal products of any kind and therefore cannot be subject to such a duty of evaluation and control».

Conclusions

The judgment brings Spanish administrative practice into line with Doctipharma, confirming that an online platform limited to matchmaking and ancillary logistical services falls outside the restrictive regime governing distance sales of medicines. Neutral digital intermediaries that merely connect pharmacies with patients qualify as information society services, not pharmaceutical intermediaries.

The decision is final (it can not be appealed) and is likely to influence future AEMPS enforcement actions concerning marketplace platforms.

 

September 1, 2025