Spain: A Life Sciences Overview
Ambitious Reforms to the Pharmaceutical Sector
The pharmaceutical sector in Spain has experienced an unprecedented situation in recent decades. For several years, the Ministry of Health (MOH) has been promoting an ambitious reform agenda affecting a significant number of the laws and royal decrees governing the sector.
At the beginning of 2023, the MOH announced its intention to amend the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices (“LGURMPS”), the main piece of legislation regulating the pharmaceutical sector. Subsequently, throughout 2024 and 2025, additional legislative initiatives have been announced, impacting multiple areas such as advertising of medicinal products, regulation of medical devices, health technology assessments, pricing and reimbursement of medicinal products, reimbursement of medical devices for non-hospital patients, and digital health. In this context, the sector’s main challenge is adapting to these regulatory changes, which are expected to be approved in 2026 or 2027.
The new Law on Medicinal Products and Medical Devices
Of all the announced legislative reforms, the most significant is the new Law on Medicinal Products and Medical Devices (the “Draft Law”), which will repeal the current LGURMPS. On 8 April 2025, the Council of Ministers approved the Draft Law, and a public consultation was subsequently launched to allow stakeholders to submit comments.
The Draft Law is built around several strategic objectives designed to ensure the sustainability of the National Health System (NHS) and to adapt the regulatory framework to scientific and technological advances. Key proposed changes include the following:
Pharmacist substitution power
Biological medicinal products and inhaled therapies may now be substituted at the pharmacy unless the Spanish Agency of Medicines and Medical Devices expressly declares them non-substitutable. This represents a significant shift from the current requirement of physician consent and has sparked debate around biosimilar interchangeability, clinical autonomy and patient adherence.
The proposed Selected Price System for off-patent medicinal products
Under this model, companies would submit six-monthly blind price bids, with products classified into lowest-price, selected and non-selected categories. While the NHS would cover the lowest-priced options, patients choosing non-selected options would assume the price difference. Industry stakeholders have expressed concerns that an excessive focus on price could incentivise unsustainable bids, increase the risk of shortages and discourage incremental innovation. Following widespread criticism, the MOH announced that it is considering alternative mechanisms.
Free medicinal products prior to authorisation
The Draft Law also establishes a general obligation to supply medicinal products free of charge prior to marketing authorisation. Although early access is often already provided at no cost, converting this into a blanket obligation could alter the exceptional nature of compassionate use and generate distorted demand. Budgetary concerns could arguably be addressed through less burdensome cost-equalisation mechanisms.
A new accelerated and provisional reimbursement pathway
This will be introduced for medicinal products addressing unmet medical needs. These products may benefit from a binding, nationwide provisional reimbursement decision, subject to a cost-equalisation rule ensuring no additional burden for the NHS. This mechanism seeks to reduce regional disparities and legal uncertainty while facilitating timely access to essential treatments.
Promotion of medicinal products prior to pricing and reimbursement decisions
The Draft Law also addresses the promotion of medicinal products prior to pricing and reimbursement decisions, initially classifying as a serious infringement the advertising of authorised but not yet marketed medicinal products. Following its publication, however, the MOH indicated its intention to reconsider this provision and clarify the applicable framework.
The Reference Price System (RPS)
This reform introduces greater flexibility. Medicinal products offering objective clinical or strategic advantages may benefit from exemptions, corrective co-efficients or upward revisions. Hospital-dispensed medicinal products will form independent groups, and orphan and plasma-derived products are excluded. Importantly, these RPS adjustments were ultimately enacted in July 2025 through amendment to the current LGURMPS rather than awaiting the approval of the Draft Law itself. As a result, this increased flexibility is not merely prospective but already operative, marking a significant shift in pricing policy and addressing long-standing concerns that excessive rigidity within the RPS could discourage innovation or contribute to supply vulnerabilities.
Confidentiality of the List Price
The Draft Law further clarifies the confidentiality of the List Price (“PVL”) and reimbursement conditions, expressly recognising the confidential nature of information derived from reimbursement agreements. This intervention follows conflicting positions between transparency authorities and recent national court rulings.
Streamlining of negotiated procedures
In the area of public procurement, the Draft Law stops short of exempting innovative reimbursed medicines from procurement rules – as expected by some stakeholders – but streamlines negotiated procedures for products under exclusivity. It also allows longer contract durations (up to ten years) for certain gene therapies, and promotes joint procurement initiatives and award criteria beyond price alone.
Expansion of tax on sales
The reform also expands the scope of the tax-on-sales mechanism to cover all NHS-reimbursed medicinal products, including hospital products, revises contribution rates and modifies the allocation of funds. Companies will be required to report quarterly hospital sales, with safeguards to prevent underreporting.
Following the public consultation phase, a final draft will be submitted to parliament. Given the technical complexity of the reform and the current political context, final approval is unlikely before late 2026.
Other pharmaceutical initiatives
In addition to the Draft Law, several other legislative initiatives and regulatory reforms are underway in Spain, reflecting a broader modernisation of the pharmaceutical framework.
The Spanish Digital Health Act
One of the most significant reforms is the upcoming Spanish Digital Health Act (SDHA), which aims to align national legislation with the European Health Data Space and accelerate the digital transformation of the NHS. It will also establish regulatory pathways for digital medical devices and therapies, addressing both primary and secondary uses of health data. The prior public consultation was concluded in October 2025, with a draft expected in 2026.
Health technology assessments
In the area of health technology assessment (HTA), the MOH has published a draft royal decree to establish a national HTA system that will develop and operationalise the national phase of the EU HTA Regulation. The evaluation process will cover both clinical and non-clinical aspects. MOH officials have informally confirmed their willingness to respect the outcome and content of the joint clinical assessments (JCAs) carried out at EU level and, in principle, not to duplicate or re-evaluate the clinical assessment at national level, focusing instead on complementary national elements. Final approval is expected in early to mid-2026.
Additional measures
Additional measures include a new royal decree on pricing and reimbursement of medicinal products, intended to replace outdated legislation and update rules on reimbursement, price revision, and special reimbursement conditions.
The balance between transparency and commercial confidentiality
In addition to the legislative reforms discussed, a significant judicial matter is pending that is likely to have a major impact on the pharmaceutical sector, concerning the confidentiality of pricing and reimbursement decisions for medicinal products. The origins of the cases trace back to requests submitted by various associations to the MOH, seeking information on the PVL and reimbursement conditions for certain medicinal products. The Spanish Transparency Council issued rulings recognising the right of access to this information, highlighting that disclosure contributes to public debate on the allocation of public resources. In response, the MOH and several pharmaceutical companies have consistently defended the confidentiality of this data, arguing that full transparency could undermine their negotiating power, as companies might be unwilling to offer favourable terms if the data was publicly disclosed. To date, the courts have upheld the position of the MOH and the companies, as confirmed by three rulings of the National High Court in April 2025. These decisions have now been appealed to the Supreme Court, which is expected to issue a final ruling on the merits of the case during 2026, a decision that could set a key precedent for balancing transparency and commercial confidentiality in Spain’s pharmaceutical sector.
Importantly, the outcome of the case will be grounded in the existing regulatory regime. However, the practical impact of the Supreme Court’s judgment will ultimately depend on the final wording of the forthcoming Law on Medicinal Products and Medical Devices. As noted above, the Draft Law (as it is written now) expressly clarifies the confidentiality of the PVL and reimbursement conditions, explicitly recognising the confidential nature of information derived from reimbursement agreements (including the PVL). Therefore, even if the Supreme Court were to adopt a more transparency-oriented interpretation under the current rules, the future legal landscape will largely hinge on how the new legislation finally regulates the balance between transparency and commercial confidentiality in Spain’s pharmaceutical sector.