Decree on Financing and Price of Medicines: what point it is at and what is needed for its approval

Health expects to approve the regulation before 29-N, but the text still needs to complete its administrative processing and go through the Council of Ministers, while doubts about its schedule and possibilities persist.

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Elecciones generales del 29 de noviembre · Demócrata

Despite the fact that the Ministry of Health has publicly stated that it plans to approve the Royal Decree on Financing and Prices of Medicines before the elections on November 29, there are doubts that this will be the case in the sector due to possible dissenting voices within the Mónica García portfolio, as published by DEMÓCRATA. What is the status of the proposal, what path awaits it, and what possibilities does it have?

The initiative, promoted by the Ministry of Health, does not require any type of parliamentary processing due to its nature as a royal decree. It should not even be submitted to a vote in the Permanent Deputation. Consequently, the last and only word rests with the Government.

The latest official milestone is the closure of the public hearing and information process, held in July 2026, so it would be pending final approval by the Council of Ministers.

Health opened the hearing on June 19 for citizens, organizations, and affected sectors to present observations on the text and its regulatory impact analysis report, a period that ended on July 21 as the deadline.

What is needed to approve the decree

The closure of the hearing does not mean that the text is ready for approval. From that moment on, the promoting department must assess the contributions received, decide whether to incorporate modifications, and complete the regulatory file.

The ordinary procedure for the preparation of regulations, regulated by the Government Law, includes the review of the text and its impact report, as well as obtaining the reports and consultations that may be required by its content. In a regulation of this scope, the intervention of the relevant ministerial departments and territorial administrations must also be determined.

The file must also be submitted to the opinion of the Council of State when it is mandatory. This body examines the legal adequacy of the project before its approval. It is not recorded in the consulted sources that it has already issued its opinion on this royal decree.

Once the processing is completed and the relevant observations are resolved, the text may be submitted to the Council of Ministers for approval. The final step will be its publication in the Official State Gazette (BOE), where the final wording and the date of entry into force will be included, including any possible transitional periods.

The immediate question is when Health will complete the remaining procedures and if the text will reach the Council of Ministers and, in that case, if it will do so without substantial changes.