In a landmark decision, Spain’s Council of Ministers has approved a Royal Decree regulating the medical use of cannabis-based preparations in hospital settings, marking the country’s first comprehensive framework for cannabis-derived medicines.
Integration Into Healthcare
The measure, proposed by the Ministry of Health, sets out conditions for the prescription of ‘standardised master formulas’ made from cannabis preparations. These will be prescribed exclusively by specialist physicians in hospitals. The regulation applies only to cannabis-based oils and explicitly excludes cannabis flower.
Rather than defining a fixed list of indications, the decree mandates that authorised clinical uses, dosage parameters, and prescription conditions will be detailed in forthcoming monographs from the Spanish Agency for Medicines and Health Products (AEMPS). These will be incorporated into the National Formulary within the next three months.
According to the Ministry of Health, this approach will ‘allow for continuous updating based on scientific advances and available clinical evidence, paving the way for the incorporation of new indications in the future, always under rigorous criteria of efficacy, safety, and medical necessity.’
The decision follows years of campaigning by patients and advocates. Spain’s Health Committee first endorsed a report outlining recommendations for medical cannabis regulation in June 2022. However, political changes and last year’s snap general election delayed progress.
Under the new framework, cannabis formulations can only be prescribed in hospital settings where there is documented clinical justification. The Ministry indicated that mechanisms for remote dispensing may be introduced in “exceptional cases of vulnerability, dependency, or geographical barriers” to “ensure equitable access to these treatments.”
A government statement said: “With this regulation, the Government reaffirms its commitment to more personalised, safe, and evidence-based medicine, offering an alternative for those who find no effective response in approved medications.”
Día 8 de Octubre de 2025.
Día histórico para los #pacientes de #dolorcrónico.
España aprueba el Decreto de Ley de Cannabis Medicinal.
Gracias @carolaperez . Gracias por todo!!!pic.twitter.com/73Xu0kDFl0
— Moviendo. Asociación de Endometriosis de España (@MoviendoSpain) October 8, 2025
Years in the Making
The decision follows years of campaigning by patients and advocates. Spain’s Health Committee first endorsed a report outlining recommendations for medical cannabis regulation in June 2022. However, political changes and last year’s snap general election delayed progress.
Under the new framework, cannabis formulations can only be prescribed in hospital settings where there is documented clinical justification. The Ministry indicated that mechanisms for remote dispensing may be introduced in ‘exceptional cases of vulnerability, dependency, or geographical barriers’ to ‘ensure equitable access to these treatments.’
A government statement said: “With this regulation, the Government reaffirms its commitment to more personalised, safe, and evidence-based medicine, offering an alternative for those who find no effective response in approved medications.”
UK Has Imported More Cannabis From Spain than Any Other Country Since 2021, New Figures Show
Read More »March 17, 2025 No Comments
Spain Finally Takes Step Toward Medical Cannabis, But ‘Feeble’ Proposals Disappointing for Patients
Read More »February 10, 2025 No Comments
Where is Spain’s Long Awaited Medical Cannabis Market?
Read More »November 8, 2024 No Comments
Patient Advocates Welcome the Move
For long-time campaigners, the decision represents a major milestone. Carola Pérez, a patient advocate who has spent more than a decade pushing for medical access, described it as a “victory for all patients.”
She told Cannabis Health, that the next steps would be crucial, with many healthcare professionals not having the necessary training in the prescription of cannabis-based medicines.
“One of the reasons for this strict prescribing model is to avoid bad practice,” she said.
“We hope that all the regions will be on the same page and that this will not end up being treated as a political issue rather than a scientific one. They will have to get their act together because the flood of patients is going to be huge.”
Pérez went on to highlight that Spanish patients do not have to pay for prescriptions issued through hospital pharmacies, meaning cost and accessibility will not be an issue, as has been the case in other countries.
“We don’t have to pay for the oils or products, so this allows access for everyone, regardless of their personal financial situation,” she added. “We see now how other patients in other countries cannot afford the treatment. Here that won’t happen.”
Concerns Over Restrictive Scope
Some researchers and clinicians have expressed reservations that the regulations may be too limited in scope. Manuel Guzmán, Professor of Biochemistry and Molecular Biology, member of the Spanish Royal Academy of Pharmacy, and board member of the International Association for Cannabinoid Medicines, told Cannabis Health:
“I’m happy that, at last, Spain has a medicinal cannabis dispensing program. However, the royal decree is too restrictive in my opinion. It does not allow herbal cannabis, does not allow general practitioners, but only specialists to prescribe cannabis preparations, and the preparations must be prepared and dispensed to patients at hospital pharmacy services, and not on high street pharmacies.”
He added: “So, on the one hand, I am very happy about this achievement, and would like to thank the Spanish government, the Ministry of Health and the political parties who approved this, however, I would have liked the royal decree to be more expansive.”
The post Spain Becomes Latest European Medical Cannabis Market as First National Rules Given Green Light appeared first on Business of Cannabis.
Continue reading...
