Recurrent: Ministry of Health

Recurred resolution: R/0023/2023

In exercise of her right of access to information, a citizen submitted a letter to the Ministry of Health requesting information regarding the financing price and the impact on the health budget, within the National Health System (SNS) of the drug Lanadelumab (Takhzyro©) developed by the company Takeda Pharmaceutical Spain S.A.

The Ministry, having heard the third parties concerned and expressing its opposition to access by the pharmaceutical company, denies access on the basis of the circumstances set forth in art. 3 (h), (j) and (k). 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, professional secrecy and intellectual and industrial property, and for the guarantee of confidentiality or secrecy required in decision-making processes.

In its resolution, the Council of Transparency and Good Governance estimates the claim on the grounds that the application of the access restrictions invoked lacks sufficient and proportionate justification. Thus, there is no harm 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 that is contained in the contract to acquire it. This public expenditure has a characterization of public information, as it has been generated in the exercise of the competences of the requested agency.

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.

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 from the Ministry in this regard, and it is configured as public information, it is also appropriate to estimate it.

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 informing the financing price and the impact on the health budget, within the National Health System, of the drug Lanadelumab.