Spain Approves Long-Awaited Regulation of Cannabis-Based Medicines

OG Article By Sarah Sinclair

October 09 2025

Historic Decision

• Spain’s Council of Ministers passed a Royal Decree on October 7, 2025.

• Regulates medical cannabis preparations in hospital settings.

• Follows years of patient advocacy.

Framework Details

• Specialist physicians in hospitals can prescribe cannabis-based oils.

• Cannabis flower not permitted.

• No fixed list of conditions; uses defined by AEMPS monographs within three months.

“This allows continuous updating based on scientific evidence,” said the Ministry of Health.

Access and Equity

• Prescriptions limited to hospitals with clinical justification.

• Remote dispensing possible for vulnerable patients or those with geographical barriers.

• No cost for patients through hospital pharmacies.

“A victory for all patients,” said activist Carola Pérez on LinkedIn.

Long Journey

• Health Committee approved draft recommendations in June 2022.

• Delayed by 2023 election and government change.

• Pérez: “Twelve years of meetings, tears, and hope.”

Challenges Ahead

• Healthcare professionals need training on cannabis prescriptions.

• Pérez: Regions must align to avoid politicization.

• Expected surge in patient demand.

Concerns

• Regulations exclude cannabis flower and limit prescribing to specialists.

• Only hospital pharmacies can dispense, not high street pharmacies.

“The decree is too restrictive,” said Professor Manuel Guzmán to Cannabis Health.

Outlook

• Ensures safe, evidence-based access.

• Expands treatment options for patients unresponsive to standard medications.

• Sets stage for future indications based on research.