SPAIN Trends and Developments Contributed by: Lluís Alcover, Joan Carles Bailach and Claudia Gonzalo, Faus Moliner
Pricing and reimbursement of medical devices for non-hospitalised patients In February 2026, the MOH published a new Royal Decree on the reimbursement of medical devices for non-hospitalised patients. This new Royal Decree repeals the current Royal Decree 9/1996 and updates the regulatory framework for these products. The objectives of this regulation are twofold: • to set the retail price of reimbursed medical devices and the margins corresponding to the activities of wholesale distribution and dispensing to the public; and • to update the content of pharmaceutical provision by including new medical devices, altering them and excluding those that are not marketed. Advertising on medicinal products and medical devices In April 2023, the public consultation of the new Royal Decree on the promotion of medicinal products for human use was launched. This new regulation is intended to replace the current regulations dating from 1996. The proposed draft is aimed at addressing digital advertising, the use of social media and audiovisual means, and the distribution of competencies between the state and the regions. It also includes obligations for ensuring accessibility for individuals with sensory disabilities in advertising. As regards medical devices, the MOH published the draft Royal Decree governing the advertising of medi- cal devices in March 2024. This draft encompassed several elements, such as streamlining the process for obtaining prior approval for the public promotion of medical devices, introducing a requirement for a responsible declaration in advertising specific devic- es and prohibiting hospitality in promotional meet- ings except for professional-scientific events. It also explicitly bans off-label promotion and offers detailed guidelines on permissible and prohibited content in advertisements directed to the public. This Royal Decree is expected to be approved during 2026.
Relevant Case Law In addition to the legislative developments, two Supreme Court rulings of significant relevance were issued in 2025. Promotion of medicinal products prior to reimbursement As mentioned earlier, in March 2025 the Supreme Court ruled on whether a medicinal product could be advertised once it has been authorised but before a decision on pricing and reimbursement has been made. In recent years, a key controversy in the Spanish pharmaceutical sector has been whether a medicinal product can be promoted before a pricing and reim- bursement decision is issued. The issue arose when the Community of Madrid ( Comunidad de Madrid – CAM) sanctioned a company for sending letters to healthcare professionals about a product that had an MA but lacked a price and reimbursement resolution. The CAM argued that promotion was not allowed until the official resolution was in place. The first-instance court upheld the sanction, inter- preting that promotional materials must include the product’s reimbursed price or, if not reimbursed, the notified price (the price that the company notifies the MOH will apply to units that are not reimbursed by the NHS). Since this information was not yet available, the court considered the promotion prohibited under Article 10.2 of Royal Decree 1416/1994. In March 2025, the Supreme Court confirmed the sanction but clarified the reasoning. The Court empha- sised that once a product is authorised, it may be promoted even if the pricing and reimbursement deci- sion is pending, if the promotional material includes the product’s price (any price at which the product is supplied, without it necessarily being the PVL, which for obvious reasons is not available before the pricing and reimbursement procedure has been concluded). Regarding reimbursement conditions, the Supreme Court held that these should only be included “when available”, because it is not possible to report on what does not exist.
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