New regime for the financing of medical devices

he Council of Ministers has approved Royal Decree 90/2026, of 11 February, which regulates the procedure for the selective financing of medical devices charged to the pharmaceutical provision of the National Health System for non-hospitalised patients and determines the margins corresponding to their distribution and dispensation (the "Royal Decree").

The long-awaited Royal Decree had been pending since 2006, which had generated a deadlock for the incorporation of new medical devices into public financing within the pharmaceutical provision.

Main new features of the Royal Decree

Below, we detail some of the main new features introduced by the Royal Decree:

• Scope of application. The Royal Decree delimits four categories of medical devices eligible for public financing within the pharmaceutical provision: (i) healing materials; (ii) products intended for the application of medicinal products; (iii) products for the collection of excreta and secretions; and (iv) accessories intended for the protection or reduction of injuries or internal malformations.
  
  Only products that fall into these categories will be eligible for financing from the pharmaceutical benefit. 

• Classification by groups according to contribution. The medical devices subject to this Royal Decree are divided into two large groups depending on the type of contribution of the user.
  
  Firstly, those subject to income contribution, which include items of regular use such as cotton, gauze, bandages, plasters, absorbents for urinary incontinence and other related systems.
  
  In second place are products with reduced intake, intended to cover chronic or specific needs, such as inhalation devices, urine collection catheters and bags, ostomy products and tracheostomy cannulas.

• Requirements for inclusion in pharmaceutical provision. Developing the regime established in 2006 by the Law on Guarantees and Rational Use of Medicines and Medical Devices (consolidated text since 2015), it implements selective financing (compared to the regime of the previous Royal Decree 9/1996, now completely repealed).
  
  Only mass-produced medical devices that have CE marking and comply with current regulations, which are not advertised to the general public – as they are medical devices subject to prescription, in accordance with Royal Decree 192/2023, of 21 March, which regulates medical devices, may be financed.
  
  The financing will not be automatic, but will depend on an express administrative resolution of the General Directorate of Common Portfolio of Services of the National Health and Pharmacy System, after registration of the offering company in the corresponding register. 

• Distribution and dispensing margin system. The regulation introduces for the first time a system of remuneration of the supply chain by setting distribution and dispensing margins.
  
  For products with a maximum industrial price equal to or less than 59 euros, the distribution margin is 6% and the pharmacy dispensing margin is 21%, both on prices excluding taxes. For products above 59 euros, the margins are now per container: 3.77 euros for distribution and 16.69 euros for dispensing.
  
  A biennial analysis of the evolution of prices and margins is foreseen, with the possibility of updating it by ministerial order and prior economic agreement. 

• Supply obligation. The Royal Decree incorporates an explicit obligation to guarantee the supply of the financed medical devices. The bidding companies must ensure supply once the product is marketed. Likewise, the possibility of replacing them with others with similar characteristics in exceptional cases of shortages is expressly contemplated, so that the continuity of treatments is maintained. 

• Term of commercialization and loss of validity of the resolution. Once the resolution estimating financing has been notified to the offering company, this entity must notify the General Directorate of the Common Portfolio of Services of the National Health and Pharmacy System, within a maximum period of one year from the notification of the resolution, the date on which the product will be placed on the market.
  
  Failure to communicate the date of placing on the market within one year of notification of the resolution, will automatically lead to the loss of validity of the resolution, with the consequent exclusion of the medical device from the financing of the National Health System (unless there is a reasonable justification).

FENIN's assessment of the Royal Decree

The Spanish Federation of Health Technology Companies ("FENIN") has positively assessed the new regulation. Nonetheless, FENIN considers essential that new categories and groups of products can be included in the pharmaceutical provision of the National Health System to facilitate access to innovative clinical solutions, especially for chronic patients, dependent people and the elderly, underlining the benefits in cost savings and improved quality of life.

However, the federation has warned that the current regulation is designed for the pharmaceutical sector, but not for the health technology sector. FENIN has expressed its expectation that the future Law on Medicinal Products and Medical Devices —see our Legal Flash | Draft law on medicines and medical devices— will contemplate a differentiated regulation that recognizes the peculiarities and specificities of these products.

Conclusion

The Royal Decree represents a profound update of the legal framework for financing medical devices in the National Health System, replacing a regulation that had not been renewed for almost three decades.

The Royal Decree will come into force on July 1, 2026 and sets a progressive calendar between 2026 and 2028 to incorporate new products, review the prices of those already financed (which is of particular importance, as these are prices set more than twenty years ago) and apply margins according to the type of product.

For more information, please contact our specialists through the Knowledge and Innovation Area.