SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
Royal Decree 90/2026, as mentioned in the forego- ing, is the relevant legislation for the reimbursement of specific devices/products for non-hospitalised patients. 8.4 Cost-Benefit Analyses Medicinal Products Spanish law does not make any reference to cost- benefit analyses when it comes to the reimburse- ment of medicinal products. However, Article 92 of Royal Legislative Decree 1/2015 includes a reference to “cost effectiveness” as one of the criteria to be considered in reimbursement decisions. Cost-effec- tiveness ratios are commonly used in price and reim- bursement proceedings, but unlike in other jurisdic- tions, no official cost-effectiveness threshold (eg, the maximum amount a decision-maker is willing to pay for a unit of health outcome) applies in Spain. With respect to the type of economic evaluation to be performed, Spanish law provides no guidance. However, the Spanish National Health System’s Advisory Committee for Pharmaceutical Financing ( Comité Asesor para la Financiación de la Prestación Farmacéutica del Sistema Nacional de Salud CAPF) published a guideline on this matter, which the MOH has informally confirmed will be used as a reference. In the guideline, it is stated that “Cost-utility analysis (CUA) will be prioritized” and that “In cases where a CUA is not feasible, justifications must be provided, and a cost-effectiveness analysis (CEA) will be con- ducted”. Finally, in 2024, the MOH launched a public consul- tation for a new Royal Decree pertaining to health technology assessment (HTA) within the framework of the NHS. This legislation, which has not yet been approved (and is currently at the stage of requesting an opinion from the Council of State – a request sub- mitted in January 2026 – will be the main legislation governing HTA in Spain. The first draft of the Royal Decree submitted for public consultation established that economic evaluations of health technologies “will provide useful information for decision-making… through a robust evaluation that considers the value of the medical technology from the perspective of relative effectiveness, the social value of the medical technology, and the impact on health-related quality
of life. This information will identify the efficiency of the new technology compared to available alternatives, as well as analyse its budgetary impact”. Medical Devices Royal Decree 1030/2006 specifically requires that any new technique, technology or process that aspires to be eligible for reimbursement must “bring about an improvement, in terms of safety, efficacy, effec- tiveness, efficiency or proven usefulness, over other currently available alternatives”. Notably, this require- ment is much stricter than the one applying to medici- nal products in Article 92 of Royal Legislative Decree 1/2015, which states that “cost effectiveness” analy- sis “shall be taken into account”. With regard to medical devices for non-hospitalised patients, Royal Decree 90/2026 expressly provides in Article 7 that, where appropriate, the technical evaluation may include a cost-effectiveness analysis, comparing the device under assessment with similar alternatives available on the market. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies Royal Legislative Decree 1/2015 governs the prescrip- tion and dispensing of medicinal products. The gen- eral rule is that prescriptions in the NHS should be based on the active ingredient/s. Prescriptions based on trade name are possible if the principle of greater efficiency for the NHS is respected, and for medicinal products considered non-substitutable (eg, biological medicinal products). When the prescription is made based on the active substance/s, the pharmacist shall dispense the lowest-priced medicinal product in the so-called homogeneous groups – ie, lists of products available for substitution. Further, it is worth mentioning that the MOH may impose “singular dispensation reserves” on medicinal products, under which the affected products may only be dispensed by NHS hospital pharmacy services – ie, not by community pharmacies.
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