Spain rewrites pricing and funding rules for medical products and devices
Published on 22nd July 2026
The Ministry of Health is driving the most significant reform for medicines within the Spanish NHS in more than a decade
The draft Royal Decree regulating the procedure for the funding and price setting of medicines within the Spanish National Health System (SNS), currently subject to public consultation, introduces far‑reaching changes for both the pharmaceutical industry and patients.
The draft aims to consolidate in a single legal instrument the rules governing the inclusion and exclusion of medicinal products from public funding, their price-setting and the monitoring of funded products. Its purpose is to make the system more transparent and predictable, and to link it more closely to the actual therapeutic value treatments.
Clear and enforceable deadlines
The draft establishes a regulated procedure with specific deadlines: six months for innovative medicines and 30 days for competitors (generics and biosimilars). It also introduces a three-month hearing period for the marketing authorisation holder following the proposal of the Interministerial Commission on Medicines Prices (CIPM), the duration of which is not included in the decision-making timeframe.
The decree also creates the Medicines Adoption Group, a collegiate body responsible for assessing the relative position of the medicine within the applicable therapeutic strategy. Its adoption report, which is technical and not-binding, will serve as the basis for the proposals submitted to the CIPM.
Conditional and provisional funding
The draft introduces two early access routes for medicines that address an unmet medical need or provide a significant clinical benefit.
Conditional funding allows the medicine to be included in the NHS benefits package in exchange for the marketing authorisation holder generating additional data on its effectiveness in real-world clinical practice.
Provisional funding facilitates temporary access to the treatment while the standard assessment procedure is completed.
Both forms of funding will have a maximum duration of two years, extendable for a further year, and the Ministry must issue its decision within three months.
More competitive pricing systems
One of the most significant innovations is the introduction of a dynamic pricing system. It is designed to speed up the effective entry of competition once the regulatory exclusivity of the reference medicinal product has expired.
The mechanism operates through a maximum manufacturer's price for reimbursement, below which pharmaceutical companies can compete by offering lower prices. The ministry is also empowered to review prices in line with the actual development of competition.
The draft also makes the reference pricing system more flexible, allowing the CIPM to apply adjustment factors or grant exemptions where justified by specific circumstances.
Dual pricing
The draft allows for the same product presentation to simultaneously carry a maximum manufacturer's price for reimbursement and a notified manufacturer's price for dispensing outside the scope of public funding, provided that the latter is higher than the former.
This provision paves the way for the so-called dual pricing for medicines sold in pharmacies, allowing different economic conditions depending on whether dispensing is charged to the SNS or paid for privately. However, the specific mechanism for distinguishing the destination of dispensing are still subject to regulatory development.
Transparency and confidentiality
The draft includes a new transparency framework. As a general rule, the economic terms of funding and access agreements, including discounts, net prices, adjustment formulas or spending thresholds, will be treated as confidential, as well any individualized data whose disclosure could compromise the legitimate interests of market operators or the public pricing policies themselves. By contrast, the notified price, the general access conditions and the type of agreement applied in each case will be made public.
Osborne Clarke comment
The draft represents the most ambitious reform of the medicines funding and pricing regime in Spain in more than a decade. However, several important issues remain to be developed at a later stage, including methodological criteria, mechanisms for differentiated pricing, thresholds for dynamic prices and the publication of the Nomenclátor. It should be read as part of a regulatory framework still under construction, pending a future law on medicinal products and medical devices. Companies in the sector would be well advised to start assessing now how this new framework will affect their pricing and market access strategies.
