Spain has converted its long-running medicines reform into a formal legislative proposal. The Council of Ministers approved the Medicines and Medical Devices Bill (Proyecto de Ley de los Medicamentos y Productos Sanitarios) on 21 July and authorised its transmission to Parliament. If enacted, it would replace the 2015 framework and establish new statutory mechanisms for access, pricing and supply.
The bill would allow conditional financing of selected innovative medicines where unmet need or urgency supports earlier access despite remaining uncertainty. Treatment outcomes would be monitored in the National Health System (Sistema Nacional de Salud, SNS), with manufacturers required to compensate the SNS if agreed outcomes are not achieved or the definitive price is lower than the provisional price.
For off-patent medicines, the bill retains reference pricing and adds a separate dynamic-pricing mechanism. Prices could fall progressively as generic, hybrid or biosimilar competition develops, although the two systems could not apply simultaneously to the same medicine.
The government-approved version changes an important aspect of earlier drafts. Previous wording specified initial price reductions, including a general 40% reduction for newly launched generics and staged reductions in established competitive markets. Those percentages have been removed. The bill now leaves the reductions and detailed operation of dynamic pricing to regulatory development.
The text also weakens the explicit statutory connection between price intervention and cost-effectiveness assessment. Cost-effectiveness remains among the broader financing criteria, but the direct cross-reference used in the previous draft has been removed.
The bill also formalises the category of ‘strategic medicine’. The Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) and government could use regulatory and economic measures to maintain vulnerable but clinically important products on the market.
The legislation therefore establishes the main architecture of the new system while leaving important pricing parameters to the forthcoming financing and pricing Royal Decree. Parliamentary amendments and that secondary legislation will determine much of the eventual commercial effect.
Source: Ministry of Health
Link: El Gobierno aprueba el proyecto de ley del medicamento: más sostenibilidad, autonomía estratégica y modernización para el SNS (Government approves Medicines Bill: greater sustainability, strategic autonomy and modernisation for the National Health System)
Date: 21 July 2026
Source: Diariofarma
Link: La bajada inicial de precio de los genéricos no estará en la Ley sino en el RD de Financiación (Initial generic price reduction will not be in the Law but in the Financing Royal Decree)
Date: 30 July 2026
