Sale of medicinal products: No direct interest from merely sharing a holding

In its Judgment nº483/2025 (ECLI:ES:TSJPV:2025:3706), of 5 November 2025, the High Court of Justice of the Basque Country analyses the limits of the incompatibility provided for in article 4.1 of Royal Legislative Decree 1/2015, of 24 July, approving the revised text of the Law on guarantees and rational use of medicines and medical devices ("Royal Legislative Decree 1/2015"). The Court examines whether this incompatibility, which affects health professionals with direct economic interests in the marketing of medicines, can be extended to legal persons solely because they belong to a business group.

The decision confronts the guarantee of independence in the prescription of medicinal products with the principle of freedom of enterprise (Article 38 of the Spanish Constitution). The Court establishes a restrictive interpretative criterion for limitations on this freedom, requiring a substantive analysis of the existence of “direct economic interests” rather than an automatic application of the rule to group structures.

Applicable legal framework

Article 4.1 of Royal Legislative Decree 1/2015 establishes: 

“Without prejudice to the incompatibilities established for the exercise of public activities, the clinical practice of medicine, dentistry, veterinary medicine, as well as other health professions with the power to prescribe or indicate the dispensation of medicines, shall be incompatible with any kind of direct economic interest derived from the manufacture, preparation, distribution, intermediation and marketing of medicines and medical devices. (...)”.

On the other hand, Article 38 of the Spanish Constitution establishes:

“Freedom of enterprise is recognized within the framework of the market economy. The public authorities guarantee and protect their exercise and the defence of productivity, in accordance with the requirements of the general economy and, where appropriate, of planning”. 

Background

• Two companies in the same group applied for authorizations as retail commercial establishments for the dispensing of veterinary medicines.
• In the same business group there was also a third company dedicated to the clinical practice of veterinary medicine.
• All the companies are located at the same corporate level, all of them directly owned by the holding company. The three companies are independent of each other and work independently with their own team.
• The Directorate of Pharmacy of the Basque Government, by resolutions of November 3, 2022, refused the authorizations requested. The Administration considered that, as they were part of the same business group that included entities dedicated to veterinary services, authorizing these companies as centers for the dispensation of veterinary medicines would not be in accordance with article 4.1 of Royal Legislative Decree 1/2015.
• Following the filing of appeals by both companies, the Deputy Minister of Health Administration and Financing of the Department of Health issued a resolution on February 24, 2023 confirming the refusals. This decision was the one that was challenged before the contentious-administrative jurisdiction.

Legal grounds of the Court

The Court rejected the Administration’s thesis based on a double argument:

• The incompatibility is directed at the health professional, not at the legal person. The rule applies to health professionals (natural persons) with the power to prescribe, preventing them from having direct economic interests in the sale of medicinal products. The Administration did not establish that the health professionals had such direct interests in the group. The denial was based solely on the structure of the group, without the individualized analysis required by the law.
• Membership of a group generates, at most, an indirect interest. Even if it were admitted that the rule could affect legal persons, the economic interest derived from belonging to the same holding company cannot be classified as “direct”. The court clarifies that the profits that a group company could obtain from the activity of another are, at most, indirect, as they materialize in a higher entity (the parent company) and not directly in the company or professional affected. These are entities with their own and distinct legal personality.

Consequently, the Court annulled the contested decision and recognized the right of the applicant companies to obtain the authorizations requested, thus protecting the freedom to conduct a business against broad interpretations of the restrictive rules.

Conclusion

The Court’s judgment delimits the scope of the incompatibility of article 4.1 of Royal Legislative Decree 1/2015 in the context of business groups. The ruling clarifies that the mere existence of a holding structure is not enough to presume the existence of a "direct economic interest". The Administration must prove that the prescribing professional (natural person) has a personal and direct economic interest in the marketing of medicines, or that the corporate structure operates de facto as a single company without real autonomy between its parts. 

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