Spain’s competition authority has proposed substantial changes to the draft regulation that will govern medicine financing and price-setting in the National Health System. It supports the overall direction of the reform but argues that several provisions could do more to promote competition and transfer resulting savings to the public system.
The National Markets and Competition Commission (Comisión Nacional de los Mercados y la Competencia, CNMC) publicised its assessment on 14 August. Its formal report, dated 21 July, examines the draft Royal Decree on medicine financing and price-setting (Proyecto de Real Decreto por el que se regula el procedimiento de financiación y fijación de precios de los medicamentos en el Sistema Nacional de Salud).
CNMC questions the general restrictions on discounts and recommends examining ways for more supply-chain savings to reach the National Health System (Sistema Nacional de Salud, SNS). It also proposes reviewing wholesale remuneration so that payments better reflect services and costs, alongside a possible clawback of part of distribution discounts.
The authority wants notified prices for medicines outside public financing restricted to exceptional, objectively justified cases. It also seeks clearer links between technical assessment and final financing decisions, including specific justification where the decision departs substantially from the technical findings.
For dynamic pricing, CNMC calls for clearer price-review criteria and tighter justification of exceptions based on supply, resilience or economic viability. It recommends measuring effects on generic and biosimilar uptake, financed prices and savings to the SNS. Similar periodic assessment should apply to reference pricing and homogeneous groups.
The recommendations are consultative. They nevertheless address several of the detailed pricing mechanisms that the July Medicines Bill leaves to secondary legislation, placing competition, supply resilience and the distribution of savings among the issues to be resolved before the Royal Decree is finalised.
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
Source: National Markets and Competition Commission
Link: Informe sobre el proyecto de Real Decreto por el que se regula el procedimiento de financiación y fijación de precios de los medicamentos en el Sistema Nacional de Salud (Report on the draft Royal Decree regulating the procedure for financing and setting medicine prices in the National Health System)
Date: 21 July 2026
