Recurrent: Ministry of Health

Resolution appealed: R/00533/2022

In exercise of its right of access to information, a private foundation submitted a request for access to information addressed to the Ministry of Health to obtain information on financing conditions and price of the drug Yescarta (axicabtagén ciloleucel), developed by the laboratory Gilead Sciences S.L.U.

In the absence of a response, the requesting entity filed a complaint with the Council of Transparency and Good Governance, which was estimated because it understood that there were no restrictions or limits on access that could be applicable and considered that the knowledge of the information requested is directly related to the objective and purposes of the Transparency Act. The Council, in particular, considered that this type of public information helps to promote an informed public debate on the problems of the current system of R&D and medical innovation and its impact on access to medicines and on the sustainability of health systems, inside and outside our country, an objective that ties in with the spirit of the LTAIBG to know how public authorities make decisions that affect citizens, especially on the issue of public health and its financing, of marked social interest.

In response to this decision, the Ministry of Health filed an administrative appeal, which was decided by Judgment No. 4/2022 of 13 January, issued by the Central Administrative Court No. 3 (p.o. 14/2020), which ordered the retroaction of proceedings in order to give hearing to the pharmaceutical laboratory in the complaint procedure followed by the foundation against the silence of the Ministry.

In compliance with the aforementioned judgment, this Council granted a hearing to the pharmaceutical laboratory in order for it to state what it considered appropriate to its right, in the terms of the provisions of Article 24.3 LTAIBG, initiating a new procedure. Once the allegations were made, the Council decided to reconsider the claim submitted by the foundation, which was also appealed by the Ministry of Health.

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

Thus, the Council considers that there is no specific legal regime of access that moves the LTAIBG, since the Supreme Court has already considered the regulation of health products as a partial provision on access to public information, and with regard to the confidentiality clause that establishes its regulation, it should not be understood as an absolute confidentiality, but it will have to accommodate the LTAIBG, in particular the exercise of weighting that is exercised with its limits.

On the other hand, the Council underlines the nature of public information on the request, and does not consider that the procedure for the inclusion of the drug Yescarta in the national health system and the setting of its price and financing conditions is in progress.

In relation to the concurrence of the limits invoked, there is no prejudice to economic and commercial interests because what is requested is not the information provided by the laboratory relating to the technical, economic and financial nature of the company (which is protected by a confidentiality clause) but the financing price approved by the SNS; that is, the price paid for such medicines contained in the purchase contract, excluding from the request those aspects that are directly related to the competitiveness position of the company or its production processes.

On the other hand, with regard to the limit on the protection of professional secrecy and industrial property, the Council points out that no specific reasoning can be discerned on this point. With regard to the guarantee of confidentiality, the resolution recalls that sectoral confidentiality reservations cannot be understood in absolute terms and that, as 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) and not to the price of the medicine.

With regard to the protection of economic and health policy, the Council considers that the considerations expressed in claims regarding the ability to negotiate between pharmaceutical companies and States in a European medicines market cannot be integrated within the limit of Article 14(1)(i) LTAIBG.

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 forth by the parties in this proceeding, and therefore considers the claim in order to provide the requesting entity with the resolution informing the financing price of the drug Yescarta.