Recurrent: Novartis Gene Therapies EU Limited – Branch in Spain

Resolution appealed: R/0527/2022

In exercise of its right of access to information, the Civio Citizen Foundation submitted a letter to the Ministry of Health, requesting the express resolution, issued by the General Directorate of Basic Portfolio of Services of the National Health and Pharmacy System, establishing the financing conditions and price, within the National Health System, of the Zolgensma treatment developed by Novartis.

The refusal of access to the requested information, which occurs once the affected third parties have been heard and there is opposition to access by Novartis, is based on the concurrence of the circumstances provided in letters h), j) and k) of art. 14.1 of Law 19/2013, of 9 December, on Transparency, Access to Public Information and Good Governance, under which the right of access may be limited when it damages economic and commercial interests, professional secrecy and intellectual and industrial property, and for the guarantee of confidentiality or secrecy required in decision-making processes.

Once a complaint has been filed, the Council of Transparency and Good Governance considers it, even considering that the refusal resolution is formally motivated, understanding that the application of the access restrictions invoked lacks sufficient and proportionate justification. Thus, in relation to the first two limits (economic and commercial interests and professional secrecy and intellectual and industrial property), it is understood that it has not been specified, precisely, how access to the administrative resolution damages said interests of the pharmaceutical company, insofar as those aspects that are directly related to the company’s position of competitiveness or to its production processes are being excluded from the petition. On the other hand, in relation to the possible existence of confidentiality clauses, it points out that the information requested does not refer to the private information protected by them, but to the administrative resolution, which has a characterization of public information, while it has been generated in the exercise of the competences of the requested agency.

In conclusion, the Council does not appreciate the concurrence of the limits to the right of access to information invoked, 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