Spain Formalizes Medical Cannabis Regulation, Offering New Treatment Options Under Strict Oversight
Spain has officially taken a significant step forward in its healthcare policy by approving a royal decree that formally regulates the medical use of cannabis-based medicines. This landmark decision, reached by the Council of Ministers on October 7, 2025, aims to provide a regulated therapeutic alternative for patients suffering from specific serious or chronic conditions that have not responded to conventional treatments. The move marks the culmination of a process that has been underway for over a decade, driven by persistent advocacy from patient groups and health professionals.
The New Regulatory Framework Explained
The newly approved decree establishes a tightly controlled framework for the prescription and use of medical cannabis. The core of this regulation lies in the provision of “standardized preparations” and “master formulas” derived from cannabis. These products are intended to offer a therapeutic alternative for conditions where approved medications have proven insufficient. The Spanish Agency for Medicines and Health Products (AEMPS) will play a pivotal role in overseeing this process, maintaining a comprehensive register of the specific formulas used in treatments. These products must adhere to strict guidelines regarding their cannabis content, including defined proportions of THC (tetrahydrocannabinol) and CBD (cannabidiol), with THC content not exceeding 0.2% to avoid higher tax rates.
Approved Conditions and Strict Oversight
Under the new decree, medical cannabis will be accessible for a defined set of serious medical conditions. These include chronic refractory pain—persistent pain that has not responded to other therapeutic options—severe forms of refractory epilepsy, and muscle spasticity associated with multiple sclerosis. It may also be considered for managing nausea and vomiting caused by chemotherapy when other medications fail. Health Minister Mónica García emphasized that “a precise dosage” will be administered to ensure effectiveness and prevent adverse effects.
The regulation mandates that all medical cannabis treatments must be prescribed exclusively by specialist doctors within the hospital system. General practitioners and private clinics are not authorized to prescribe these medications. Furthermore, medical cannabis preparations will only be dispensed through hospital pharmacies, rather than regular community pharmacies, ensuring strict control over distribution. Each patient’s case will be meticulously monitored by a doctor to supervise clinical effectiveness and prevent any adverse reactions or addiction.
Background and Future Implications
The journey to this regulation has been lengthy, marked by various proposals and delays. Earlier iterations of the framework were presented, debated, and revised, with a draft royal decree initially published for public consultation in September 2025. This final approval signifies a major breakthrough, moving Spain towards aligning with international standards and scientific evidence regarding the therapeutic benefits of cannabis.
While the government has highlighted that the decree allows for continuous updating based on scientific advances and clinical evidence, paving the way for potential future indications, some patient advocacy groups have expressed concerns that the framework remains highly restrictive. They point to limitations such as the exclusion of cannabis flower as a product form, the restriction to hospital pharmacies, and the sole authority granted to specialist doctors for prescriptions. Despite these criticisms, the regulation is seen as a crucial first step towards a more comprehensive approach to medical cannabis in Spain, offering legal avenues for new cannabis products and potential brand innovations within the strict confines of medicinal use. The government views this as an opportunity to demonstrate the reliability and performance of cannabis-based drugs, fostering further research and development in this evolving field.
The regulation is effective immediately, granting regional health authorities access to a tracking system for product distribution. This move is expected to improve the quality of life for many patients while also contributing to a more robust understanding and application of cannabis-based medicines in clinical practice.
