Pharmacists Appeal to Supreme Court and Question Hospital Model for Medicinal Cannabis in Spain
Pharmaceutical entities challenge in the Supreme Court the exclusivity of hospitals in dispensing magistral formulas based on medicinal cannabis, as provided in a recent decree
Representatives of pharmaceutical organizations in Spain have filed an appeal to the Supreme Court against Royal Decree 903/2025, a regulation that establishes a new regulatory framework for the medicinal use of cannabis in the country, but limits the preparation and dispensing of medications to hospital pharmacies.
The Consejo General de Colegios Oficiales de Farmacéuticos (CGCOF) appealed to the Supreme Court arguing that the Spanish government's decision to reserve the preparation and delivery of magistral formulas based on medicinal cannabis exclusively to hospitals may contradict current legislation on medication distribution.
According to the Diario Farma portal, pharmacists pointed out that the exclusion of community pharmacies from the process could widen access inequalities, especially in regions where these pharmacies are closer to patients than hospitals.
In addition, the Confederación Empresarial de Oficinas de Farmacia de Andalucía (CEOFA) also filed a similar challenge, arguing that the regulation creates unnecessary barriers to patient access and unjustifiably restricts a service that, according to their interpretations, is provided for in Spanish medication law.
Decree Details and the Role of Hospitals
Royal Decree 903/2025, published in the Official State Gazette in October 2025, established a system for access to medicinal cannabis where only specialist doctors can prescribe standardized cannabis preparations with defined concentrations of THC and/or CBD. These prescriptions are clinically monitored and must be prepared and dispensed by hospital pharmacy services.
The regulation also creates a specific registry of these preparations at the Spanish Agency of Medicines and Medical Devices (AEMPS) and imposes quality, traceability, and pharmacovigilance requirements. The decree establishes a deadline, closely monitored by different sectors, for the publication of monographs in the National Formulary, which will detail clinical indications and technical information.
With the appeal pending in the Supreme Court, the debate remains open on whether the distribution of medicinal cannabis should continue to be restricted to hospitals or expanded to also involve community pharmacies in the future.
Source: DiarioFarma.