New legislative reform strengthens the protection of medicinal products financing agreements against requests for access to public information
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SubscribeOn July 23, 2026, the Congress approved the Law Amending Regulations on the National Health System’s Neonatal Screening Program and Other Regulations, the third article of which incorporates a substantial amendment to Article 97 of Royal Legislative Decree 1/2015, of July 24, approving the consolidated text of the Law on Guarantees and Rational Use of Medicines and Medical Devices (“Royal Legislative Decree 1/2015”). The amendment expressly safeguards the confidentiality of prices and financing agreements for medicinal products within the National Health System (“NHS”).
This legislative reform addresses a legal debate that has for years pitted two fundamental principles of the Spanish legal system against each other, giving rise to various legal proceedings, some of which are pending resolution before the Supreme Court. On the one hand, the right of access to public information, recognized in Law 19/2013 of December 9 on Transparency, Access to Public Information, and Good Governance, entitles citizens to know how public resources are managed. On the other hand, there is the protection of sensitive commercial information, which Article 97 of Royal Legislative Decree 1/2015 previously granted—in general terms—to economic data provided by pharmaceutical companies in pricing procedures.
The urgency of the reform has been driven, among other factors, by the Most-Favored-Nation policy promoted by the U.S. government, which ties the purchase prices of medicinal products in the United States to the lowest prices obtained in other countries, as well as by appeals pending before the Supreme Court concerning access to information on prices and financing conditions for medicinal products within the Spanish NHS.
The new wording of Article 97 of Royal Legislative Decree 1/2015 broadens the scope of confidentiality by establishing that agreements on the financing of medicinal products, information derived therefrom, and the award prices of contracts for the supply of medicinal products shall be confidential. This information may not be disclosed by either the government or by the companies or entities that are parties to such agreements. However, access to this information is preserved for competition authorities, supervisory bodies, inspection authorities, and the relevant administrative units as required in the performance of their duties.
This reform represents a significant shift in the balance between transparency and confidentiality regarding drug prices within the National Health System. For pharmaceutical companies, it strengthens the protection of the financing terms for their drugs against requests to access such information under public information laws. For the government, it clarifies the scope of its confidentiality obligations and provides a stronger legal basis for limiting access to this type of information.
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