SPAIN Trends and Developments Contributed by: Joan Carles Bailach, Lluís Alcover, Laia Rull and Pablo Mansilla, Faus Moliner
tion to public procurement and measures aimed at guaranteeing the supply of essential and stra- tegic medicinal products. The official draft is expected to be published during Q1 2025, allowing all interested parties to submit comments or objections. Subsequently, the government will need to approve the final proposal and forward it to Parliament (Congress and the Senate) for debate and final approval. Further changes may be made during the parlia- mentary process. Final approval of the new law is not expected in 2025. Pricing and Reimbursement of Medicinal Products The MOH launched a public consultation on the draft Royal Decree on the pricing and reim- bursement of medicinal products, which seeks to repeal Royal Decree 271/1990 and establish an updated regulatory framework. This new regulation is intended to regulate the inclusion and exclusion of medicinal products from pharmaceutical provisions, establish spe- cial reserves and financing conditions, establish a system for revising the minimum ex-factory price ( precio de venta al público PVL) and pro- vide new indications, among other things. Although this public consultation is very wel- come, representing another step towards the much-needed revision of the regulations of the public funding of medicines, holding the consul- tation before the approval of the new RDL 1/2015 (and even before the official publication of its draft via a public hearing) is not, in the authors’ opinion, the most appropriate approach. As explicitly stated in the consultation, the objective should be to implement the new RDL 1/2015. Logically, the public consultation and the draft- ing process for the Royal Decree should take
place once RDL 1/2015, establishing the basic framework, has been finalised. Therefore, in the authors’ view, conducting the public consulta- tion after the publication of RDL 1/2015 publica- tion would be more appropriate. It is expected that the draft of this new Royal Decree will be published during 2025. Pricing and Reimbursement of Medical Devices for Non-Hospitalised Patients A draft of the new Royal Decree on the financing of medical devices for non-hospitalised patients has also been published. This new Royal Decree aims to repeal Royal Decree 9/1996 and update the regulatory framework for these products. The objectives of this regulation are twofold: • to set the retail price of funded medical devic- es and margins for the activities of wholesale distribution and dispensing to the public; and • to update the pharmaceutical provisions by including new medical devices and excluding those that are not marketed. It is expected that this new Royal Decree will be approved during 2025. Health Technology Assessment The MOH published the draft of the new Royal Decree on health technology assessment (HTA) in August 2024. This new Royal Decree was a response to the judgment of the Spanish Nation- al High Court that declared void the “Plan for the Consolidation of the Therapeutic Position Reports” . The MOH proposes the creation of an HTA sys- tem separate from the price and reimbursement system, such that health technology evaluations will be separated from the decision-making pro- cess.
326 CHAMBERS.COM
Powered by FlippingBook