The new financing of health products

The Council of Ministers has approved the Royal Decree that regulates the procedure for selective financing of health products in the pharmaceutical benefit for non-hospitalized patients.

Thus repeals the current regulations since 1996, establishing a new framework for the financing and pricing of these products, adapting it to the current needs of the National Health System (SNS), prioritizing criteria of efficiency, sustainability and clinical value and guaranteeing supply against shortages.

“With this Royal Decree we update a rule that had been pending renewal for 20 years, it focuses on the value of health and not on the logic of the market, and guarantees that health products financed by the National Health System improve people’s lives and do so in an equitable and sustainable way,” said Minister Mónica García in the roundtable after the Council of Ministers.

The rule, which will come into force on July 1, 2026establishes a staggered calendar between 2026 and 2028 for the inclusion of new products, review of prices of those already included and application of margins according to the type of product (starting with urine bags and cannulas in 2026, and ending with ostomy products in 2028).

One of the main novelties of the new system is that unlocks an existing and long neglected situationallowing the incorporation of new suppliers and health products to the pharmaceutical provision of the SNS, and thereby promoting competitiveness and patient access to innovation in this type of health products.

Also creates a legal framework which is similar to that of medicines, providing the necessary conditions of transparency and legal certainty to the health products sector, and where we must highlight the intervention of the Interministerial Commission on Medicine Prices as the body that sets the financing prices of these health products.

The Royal Decree establishes an express obligation to guarantee supply for financed health products. Compared to the previous situation, in which there was no such specific and detailed regulation in this area, the new standard requires offering companies to ensure supply once the product is placed on the market. Furthermore, substitution with products with similar characteristics is expressly enabled in exceptional cases of shortages, guaranteeing the continuity of treatments.

Finally, the standard introduces a structural change in the remuneration of the supply chain by setting distribution and dispensing margins, with fixed amounts for higher priced products. This change will also favor the availability of these products throughout the territory, regardless of where the patient resides.

In this way, García explained that this new Royal Decree aims to reduce the problems of shortages of a series of health products that “they are necessary for many patients”as is the case of urine bags, catheters, material for dressings, diapers, etc., regulating these products in the image of the regulation of medications.

What products are financed and under what conditions

Likewise, it establishes requirements so that medical devices can be financed charged to the pharmaceutical benefit of the SNS. Thus, only mass-produced products that have the CE marking and comply with current regulations are financed; the product cannot be the subject of advertising aimed at the general public; and must require a medical prescription or dispensing order to be financed.

Public financing is not automatic and requires an express administrative resolution from the General Directorate of the Common Portfolio of Services of the National Health and Pharmacy System. The bidding company must be previously registered in the corresponding registry.

The procedure incorporates a technical and economic evaluation that assesses the clinical utility, the comparison with available alternatives, the cost-effectiveness and the budgetary impact for the National Health System, as well as price information in other Member States of the European Union.

For a medical product to be financed, must necessarily belong to one of the four categories general provisions provided for in the standard: healing materials; medical devices intended for the application of medicines; sanitary products for the collection of excreta and secretions; and utensils intended to protect or reduce internal injuries or malformations.

Within these categories, medical devices are classified into two groups based on of the type of user contribution. On the one hand, products subject to user contributions based on their income, which include: commonly used items such as cotton, gauze, bandages and plasters; eye dressings and patches; elastic fabrics to protect against injuries or malformations; absorbents for urinary incontinence and other related systems, as well as trusses, jockstraps, irrigators and their accessories.

And on the other hand, products with reduced contribution, intended to cover chronic or specific needs. This group includes, among others: inhalation devices – such as chambers, inhalers and insufflators; probes and urine collection bags, with their corresponding collectors and accessories; ostomy products, such as colostomy, ileostomy and urostomy bags, together with their accessories, dressings and irrigation systems; as well as tracheostomy tubes, laryngectomy and filters.

Patient organizations

Another novelty has been the approval of the Draft Bill on Patient Organizationsa legislative initiative aimed at strengthening its institutional role in the National Health System. The text recognizes for the first time their legal uniqueness and their function as key agents in the defense of the rights and interests of patients, family members and caregivers.

This norm responds to a long-posed demand: the absence of a specific legal framework that regulates the participation of these entities as active actors in the construction of the National Health System. Until now, its activity was framed in Organic Law 1/2002, of March 22, regulating the Right of Associationwithout there being any regulations.

The preliminary draft has, for now, had contributions from the Platform of Patient Organizations, the Spanish Patients Forum, the General Alliance of Patients, the Spanish Federation of Rare Diseases, the Spanish Diabetes Federation and the Spanish Mental Health Confederation, whose contributions have been incorporated during its preparation.