Spain adopts first national regulation for medical cannabis use
Spain’s Council of Ministers has formally approved a Royal Decree establishing the country’s first regulatory framework for the medical use of cannabis in standardised preparations. The decision aims to provide an alternative therapeutic option when conventional treatments fail—particularly for chronic pain, refractory epilepsy, multiple sclerosis–related spasticity, and chemotherapy-induced nausea or vomiting.
Under the new system, cannabis-based medicines will be prepared and dispensed exclusively through hospital pharmacies, prescribed only by qualified specialists. All standardised formulations must be registered with the Spanish Agency of Medicines and Medical Devices (AEMPS) to ensure quality, safety, and consistent dosing.
The Ministry of Health emphasised that the measure integrates medical cannabis within the national health system, guided by principles of scientific evidence and patient safety. While cannabis remains a controlled substance under international law, clinical data support its therapeutic potential in specific indications.
The decree also calls for a robust monitoring system covering prescription, production, and patient outcomes, aligning with national pharmacovigilance and controlled substances regulations. This marks an important policy step for Spain, balancing access, medical oversight, and prevention of misuse.
Although initially limited in scope, the new framework opens a regulated pathway for patients who have exhausted other treatment options. It also positions Spain among a growing number of European countries formalising access to medical cannabis under evidence-based standards.
