The appeal admitted for consideration by the Supreme Court refers to the Resolution 1076/2021 the Council, in which we recognised the right of access requested by Civio to the administrative resolution of the Ministry of Health that established the financing conditions and the price of the drug Luxturna, developed by Novartis.
Both the ministry and the pharmaceutical company appealed the decision, and although in the first instance the Central Court of Administrative Litigation No. 9 declared it adjusted to law, confirming our decision, the National High Court revoked it in the appeal procedure.
In his sentence, the National High Court considers that Article 97 of the Consolidated Text of the Law on Guarantees and Rational Use of Medicines and Health Products (TRLGURM), by declaring confidential the technical, economic and financial information provided by laboratories in the pricing procedures, establishes a specific legal regime that operates with preference over the Transparency Law, which remains as a substitute.
The judgment argues that facilitating access to information would compromise the confidentiality guaranteed by the aforementioned Article 97, since the combined knowledge of the industrial price and the financed price would allow to infer strategic data on costs, margins and negotiating conditions, essential to safeguard the negotiating position of the National Health System in a competitive international market.
The Council, on the other hand, considers that Article 97 does not establish a complete access regime but a partial limit; and recalls that the application of the limits on access to public information must be justified and proportionate to its object and purpose of protection and must take account of the circumstances of the specific case, especially the concurrence of a higher public or private interest that justifies access.
Given that in the case that is the subject of the controversy the request is the price finally fixed by the Administration (without reference to the prices recommended by the laboratory), as well as the final conditions in which this medicine is to be financed, the Council understands that its knowledge, insofar as it involves the use of public resources, is of undoubted interest to the citizens.
The Council also considers that the application of the limit laid down in Article 14(1)(h) LTAIBG in this case is not justified and proportionate, since it has not been specified to what extent access to the administrative decision damages the economic and commercial interests of the pharmaceutical company, bearing in mind, moreover, that the authorisation and price negotiation process has been completed.
Nor does it apply, in the opinion of the Council, the limit on professional secrecy and intellectual and industrial property laid down in Article 14.1.j) LTAIBG, especially since the pharmaceutical company has the protection granted to it by the patent granted in respect of the medicinal product in question.
Three issues of casational interest
In his application for admission of appeal, of December 17, 2025, the Supreme Court declares that the issues of objective casational interest for the formation of jurisprudence consist in determining:
- If Article 97.3 of the TRLGURM establishes a specific regime of access to information that supposes its preferential application on the provisions of the Transparency Law, for the purposes provided in paragraph 2 of its first additional provision.
- To interpret Article 97 to determine whether the confidentiality reserve of the information on technical, financial and economic aspects provided by the pharmaceutical laboratory to the Ministry of Health also covers the price and financing conditions of the drug;
- If the guarantee of confidentiality is justified only when the decision-making process is in progress, or if it is also extended once the decision has been made.
Access the resolution, the judgments and the order of admission of the cassation appeal in this link
The admission of this cassation appeal by the Supreme Court is in addition to that of another resource on a Council resolution on the financing conditions and price of the Zolgensma treatment also developed by Novartis.