Spain's Medicines and Medical Devices Bill has been formally published in Congress and referred to the Health Commission under the urgent procedure, opening the stage at which parliamentary amendments can change the government's proposal.
The parliamentary text does not materially alter the architecture approved by the Council of Ministers in July. It retains conditional and provisional financing for selected medicines and the new dynamic-pricing system for off-patent competition. No parliamentary amendments have yet been incorporated.
The full text makes the access timetable clearer. Ordinary medicine financing and price decisions would have to be issued within 125 working days. Accelerated, conditional or provisional financing would have a 65-working-day maximum. The latter route was already announced in July, but the published bill now places it within a wider statutory timetable for pricing and reimbursement decisions.
Dynamic pricing also remains substantially as previously proposed. It would apply principally to publicly funded medicines dispensed through community pharmacies once generic, hybrid or biosimilar competition exists, with successive price reductions linked to market-share development. Hospital medicines bought through competitive procurement are excluded. A new market-share observatory would monitor utilisation, financed prices and competition.
The July bill had removed the fixed reduction percentages contained in earlier drafts, and the parliamentary text maintains that approach. Initial and subsequent reductions would still be determined through secondary legislation rather than fixed in the Act itself. The competition authority's subsequent recommendations for clearer price-review criteria therefore remain relevant to development of the accompanying pricing and financing Royal Decree.
The reform has consequently moved from government approval to an amendable parliamentary text, while the principal commercial uncertainty remains in the detailed rules that will determine how quickly dynamic prices fall as generic and biosimilar penetration increases.
Source: Congress of Deputies
Link: Proyecto de Ley de los medicamentos y productos sanitarios (Medicines and Medical Devices Bill)
Date: 11 September 2026
Source: Government of Spain
Link: El Gobierno aprueba el proyecto de ley del medicamento (Government approves the Medicines Bill)
Date: 21 July 2026
Source: National Markets and Competition Commission
Link: La normativa de financiación de medicamentos mejorará la eficiencia y la revisión del gasto farmacéutico(Medicine financing rules will improve efficiency and the review of pharmaceutical expenditure)
Date: 14 August 2026
