Recurrent: Novartis Pharmaceutical, S.A.

Recurred resolution: R/0204/2023

In exercise of the right of access to public information, a request was submitted to the Ministry of Health to obtain information on the financing price, approved the National Health System, for the drug Zolgensma® and the impact on the health budget.

The Ministry, after granting a hearing procedure to the affected pharmaceutical company – now a recurring one – and stating its opposition to access, denies it on the basis of the limits provided in letters h), i), j) and k) of article 14.1 of Law 19/2013, of 9 December, on Transparency, Access to Public Information and Good Governance (LTAIBG), under which the right of access may be limited when it damages economic and commercial interests, economic and health policy, professional secrecy and intellectual and industrial property, and for the guarantee of confidentiality or the secrecy required in decision-making.

In its resolution, the Council of Transparency and Good Governance estimates the claim on the understanding that the application of the restrictions invoked lacks sufficient and proportionate justification, analysing, in particular, the allegations presented by the laboratory.

After recalling the previous resolutions of the Council on this matter, the alleged existence of a specific legal regime for access to information displaced by the LTAIBG is ruled out, in accordance with the jurisprudence of the Supreme Court which points out that the specific provisions in sectoral laws, although they are of preferential application, do not exclude the supplementary application of the LTAIBG, and the weighting required by Article 14.2 LTAIBG must be carried out in any case.

The concurrence of the limit of article 14.1.h) LTAIBG is also not appreciated, insofar as no harm is detected to the economic and commercial interests of the company because what is requested is only the final price paid by the SNS and not the agreements reached with the Ministry in the procedure of pricing and financing of the drug (which could contain information that make up the know-how of the laboratory). With respect to article 14.1.j) LTAIBG, it is clear that there is no specific reasoning on the harm to professional secrecy and industrial property. With regard to the guarantee of confidentiality protected by article 14.1.k) LTAIBG, the resolution recalls that sectoral confidentiality reservations cannot be understood in absolute terms and that, in this case, the one contained in article 97.3 of the consolidated text of the Law on Guarantees and Rational Use of Medicines and Medical Devices refers to the information provided by the company (technical, economic and financial aspects) in the context of the application procedure for the inclusion of the medicine in the SNS and not to the price of the medicine.

As regards the possible concurrence of the limit of Article 14.1.i), it has not been proven that disclosure of the public price of a medicinal product will result in anti-competitive conduct between several companies. Nor that it may be contrary to the interests of Spain, in order to avoid the negotiating advantage of other States in obtaining more competitive prices in a European market, since, applying the strict and restrictive interpretation imposed by the jurisprudence of the Supreme Court in relation to the application of the limits of the LTAIBG, it must be subject to the provisions of the State policies in this matter strictu senso.

In relation to the issue of the impact that the financing of the drug has had on the health budget, since there is no pronouncement of the Ministry in this regard, and it is configured as public information, the estimate of the same is agreed.

In conclusion, the Council does not appreciate the displacement of the LTAIBG or the concurrence of the limits to the right of access to information invoked in the course of hearing by the company concerned, at least in the terms set out by the parties, and therefore considers the claim in order to provide the requesting entity with the resolution informing the financing price of the drug Zolgensma®.