SPAIN Trends and Developments Contributed by: Lluís Alcover, Joan Carles Bailach and Claudia Gonzalo, Faus Moliner
Faus Moliner Rambla de Catalunya 135 08008 Barcelona Spain Tel: +34 93 292 2100 Email: bcn@faus-moliner.com Web: www.faus-moliner.com
The pharmaceutical sector in Spain is currently fac- ing an unprecedented situation in recent decades. For several years, the Ministry of Health (MOH) has been promoting an ambitious reform agenda affecting a significant portion of the laws and Royal Decrees governing the sector. At the beginning of 2023, the MOH announced its intention to amend the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices ( Ley de Garantías y Uso Racional de Medi- camentos y Dispositivos Médicos – LGURMPS), the main piece of legislation regulating the pharmaceuti- cal sector. Subsequently, throughout 2024 and 2025, additional legislative initiatives have been announced, impacting multiple areas such as the advertising of medicinal products, regulation of medical devices and in vitro medical devices, health technology assess- ment (HTA), procedures for pricing and reimbursement of medicinal products, reimbursement of medical devices for non-hospital patients and digital health. In this context, the sector’s main challenge is adapting to these regulatory changes, which are expected to be approved in 2026 or 2027. The following sections outline some of the key legislative initiatives currently underway, and the main challenges and opportunities they present. Draft Law on Medicinal Products and Medical Devices On 8 April 2025, the Council of Ministers approved the Draft Law for the Law on Medicines and Medi- cal Devices (the “Draft Law”), which once approved will replace the LGURMPS. Shortly thereafter, a public consultation phase was opened to allow stakeholders to submit contributions to the Draft Law.
The Draft Law is structured around several strategic objectives aimed at ensuring the sustainability of the National Health System (NHS) and adapting the regu- latory environment to scientific progress. Some of the main changes include the following. Revised regulation of the pharmacist’s substitution authority Under current regulations, products such as biological medicinal products and respiratory therapies admin- istered via inhalation are considered non-substitut- able; thus, the express consent of the prescribing physician is required for any change. The Draft Law modifies this rule, allowing pharmacists to substitute these medicinal products at the point of dispensing. According to the proposed text, only medicinal prod- ucts that the Spanish Agency of Medicines and Medi- cal Devices ( Agencia Española de Medicamentos y Productos Sanitarios – AEMPS) explicitly determines to be non-substitutable “due to their characteris- tics” will be exempt from this authority. This shift has sparked debate regarding the clinical equivalence of biosimilars, the preservation of the physician’s clinical autonomy and the potential impact on patient treat- ment adherence. Introduction of the new selected price system (SPS) for homogeneous groups The SPS represents a more aggressive price selection model. Pharmaceutical companies will be required, every six months, to submit blind price offers to the MOH for their off-patent products, which will then classify presentations into three distinct categories: lowest price, selected prices and non-selected pres- entations. Unlike previous systems, the Draft Law allows for a range of package sizes and “compara-
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