Supreme Court clarifies the pharmaceutical advertising rules

The Supreme Court of Spain issued a judgment on March 4^th, 2025 (STS 222/2025, ECLI:ES:TS:2025:1030) regarding the advertising practices of a pharmaceutical company (the "Company") for a medicinal product to healthcare professionals. The case centered on whether the Company complied with the advertising regulation when executing promotional activities in the period between obtaining the marketing authorization and obtaining a resolution on the pricing and financing.

For the purposes of this analysis, the advertising of medicinal products is governed by, among other regulations, Royal Decree 1416/1994, of June 25, regulating the advertising of medicinal products for human use (the "Royal Decree 1416/1994"):

Article 10 of the Royal Decree 1416/1994 provides:

1. Advertising aimed at individuals authorized to prescribe or dispense medications must provide the necessary technical-scientific information for the recipients to judge the therapeutic value of the medication by themselves, and must at least include:

[…]

2. This advertising will include the retail price, the conditions of the pharmaceutical provision of the National Health System, if applicable, and, when possible, the estimated cost of the treatment.

The interpretation of Article 10.2 has historically been contentious. On one hand, healthcare authorities have opted for a restrictive interpretation, asserting that advertising of medicinal products should not be conducted until the administration has resolved their pricing and reimbursement status. On the other hand, the pharmaceutical industry, supported by the Farmaindustria Code of Good Practices, has adopted a more permissive stance. They argue that due to the lengthy period between marketing authorization and the final decision on pricing and reimbursement, it is reasonable to allow advertising to healthcare professionals during this interim period. The industry's position is that such advertising should clearly indicate that the pricing and reimbursement status is still pending resolution.

Background

In 2020, the Company sent a communication to healthcare professionals and healthcare centers informing them of an agreement for the supply of a new drug that had received marketing authorization. However, this communication did not include any of the elements required by Article 10.2 of Royal Decree 1416/1994 (i.e., the retail price, the conditions of the pharmaceutical provision of the National Health System, or the estimated cost of the treatment), as, at the time the communication was issued, there was no decision on these aspects.

As a result, the Viceconsejería de Humanización Sanitaria of the Comunidad de Madrid imposed a sanction of €90,001 on the Company, for failing to include the elements mandated by Article 10.2. The Company appealed the sanction, but the appeal was dismissed by the Tribunal Superior de Justicia de Madrid, leading to a further appeal to the Supreme Court.

The appellant argued that no regulation forbids advertising before the resolution of pricing and financing. The Company explained that it is not the same to <<require that the advertisement includes the price or an indicative rate of the different presentations and the reimbursement conditions by social security organizations>>, as it is to completely prohibit the advertisement of a medicinal product until it is decided whether it will be covered by the National Health System and at what price.

Furthermore, the appellant contended that Article 10.2 includes the mention "if applicable" (en su caso, in Spanish). According to its interpretation, such reference means that the information from Article 10.2 must be included if it exists and a decision has been reached in these areas. To support this interpretation, the appellant cites the judgment of the Tribunal Superior de Justicia del País Vasco (STSJ PV 246/2021, ECLI:ES:TSJPV:2021:1867), which determined that during medical visits to healthcare professionals to promote medicinal products, it was not necessary to provide information on financing conditions if these had not been approved.

Supreme Court judgment

The Supreme Court, in its judgment upheld the decision of the lower court, affirming the legality of the sanction applied.

The Supreme Court did not concur with the Company's interpretation of the "if applicable" mention in Article 10.2. The court emphasized that the article outlines a detailed minimum informational content that must necessarily be present in such activities. From this minimum informational content, the price is not an "irrelevant aspect that can be omitted", as regardless of whether the medicinal product is financed or not, the product will always have a price. Consequently, the information regarding the price must always be provided.

Moreover, the phrase "if applicable" specifically refers to the conditions of public financing and, consequently, does not exempt the obligation to necessarily include the price in the promotion, information, and advertising of medicinal products.

Finally, regarding the judgment of the Bilbao Court, the Supreme Court acknowledges that "one cannot inform about what does not exist", clearly alluding to the impossibility for pharmaceutical companies to include information regarding the financing conditions in their medical visits if there has not yet been a resolution in that regard.

The judgment thus states that "the price, an evidently essential element, exists independently of whether the medication is publicly financed or not". Therefore, it is one thing for the lack of financing decision not to prevent the medical visits, and another to eliminate the requirement to inform about the price, which does exist.

Therefore, as long as the price of the drug is provided, the Supreme Court seems to support the advertising of medicinal products to healthcare professionals even if the financing has not yet been decided.

Conclusion

In conclusion, the Supreme Court's ruling has definitively clarified that, notwithstanding the unresolved status of public financing for a medication, the advertisement directed at healthcare professionals is permissible provided that the price of the medication is disclosed. This interpretation ensures that the essential components of medicinal product advertising, specifically the price, are not omitted, thereby offering unequivocal guidance to both health authorities and the pharmaceutical industry. The decision underscores the importance of transparency and complete information in promotional activities, ensuring that healthcare professionals have all the necessary information to evaluate the therapeutic value of medications.

As a final note, it is worth mentioning that on Tuesday, April 8, the Council of Ministers approved the Draft bill on medicines and medical devices (Anteproyecto de Ley de los medicamentos y productos sanitarios), which introduces as a serious offense “the advertising of medicines authorized in Spain but not marketed, anticipating their effective commercialization”. This new wording no longer raises the question of whether it is necessary to obtain the pricing and financing resolution to promote the product. However, it raises the issue of whether the effective commercialization of the product can be announced if the pricing and financing process has not yet been finalized.