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.
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.”
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