New Royal Decree reshapes financing for medical aids in Spain

On February 11, 2026, Royal Decree 90/2026 was issued, regulating the selective financing procedure for certain health products – specifically, some types of medical aids – covered under the pharmaceutical benefit of the National Health System (NHS) for non-hospitalized patients, and establishing the margins for their distribution and dispensing.

The regulation updates the framework in place since 1996, adapting it to the NHS’s current needs and prioritizing efficiency, sustainability, and clinical value. The 1996 decree had become obsolete because, after almost 30 years, it no longer reflected the legal, technological, and healthcare developments that had taken place, while subsequent laws had revised the rules on financing and pricing. The new framework establishes a clear, transparent, and structured system for selective financing and price-setting, with uniform criteria for the inclusion, modification, and exclusion of certain types of medical aids for non-hospitalized patients. It aims to strengthen efficiency and clinical value in public funding and to support the sector’s industrial development, as well as research and innovation policies. The new system allows the incorporation of new suppliers and products, promoting competitiveness and patient access to innovation.

To be eligible for public financing, health products must belong to one of four general categories:

• Wound care materials; 
• Products for the administration of medicines;
• Products for the collection of excreta and secretions;
• Products for the protection or reduction of internal injuries or malformations.

Within these categories, products are divided into two groups according to the level of patient contribution:

• Those subject to income-based co-payment (such as cotton, gauze, bandages, dressings, elastic supports, incontinence absorbents, and related items);
• Those with reduced co-payment for chronic or specific needs (including inhalation devices, urinary collectors and bags, ostomy products, and certain cannulas and filters). 

Eligible products must be mass-produced, bear the CE mark, comply with current regulations, not be advertised to the general public, and require a prescription or dispensing order. Public financing is not automatic and requires an explicit administrative decision by the General Directorate of the Common Package of Benefits of the National Health and Pharmacy System. The procedure includes a technical and economic evaluation assessing clinical usefulness, comparison with alternatives, cost-effectiveness, budget impact, and price information from other EU Member States.

Pricing is determined through a structured mechanism similar to that used for medicines. The Interministerial Commission on Medicines Pricing sets the maximum industrial price (PVL), and the final public price includes distribution and dispensing margins as established in Annex IV to the Royal Decree. For products with a PVL of €59 or less, margins are calculated as percentages; for products above €59, margins are fixed amounts per package. The regulation also mandates biennial monitoring of price and margin evolution, with the possibility of updating margins.

The regulation introduces a system of homogeneous groupings and “lowest price” rules, requiring pharmacy substitution when a prescribed product exceeds the lowest-priced option within its group. It also allows the administration to impose special restrictions, such as prior authorization requirements, indication limitations, periodic price reviews, spending caps, or risk-sharing mechanisms, to ensure appropriate use and system sustainability.

The Decree establishes explicit supply obligations for financed products and permits substitution with similar products in cases of shortages to guarantee treatment continuity. It also sets out clear procedural rules: authorities must issue a decision within six months; companies must notify the authorities of the product’s market launch within one year; and structured procedures are established for price revisions, changes to approved conditions, and possible exclusion from public financing.

The regulation will enter into force on July 1, 2026, with a phased implementation between 2026 and 2028 for the inclusion of new products, price reviews, and application of margins, beginning with urine bags and cannulas in 2026 and concluding with ostomy products in 2028.

The full details in Spanish can be found here and here.

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