The Spanish cabinet has approved plans to legalise medicinal cannabis, but there are still regulatory and parliamentary hurdles to clear.
The Spanish Cabinet on Tuesday approved a decree to legalise cannabis for medicinal use in certain situations.
For the time being, however, the exact details remain unclear and the plans still need to be studied and approved by health agencies as well as passing a vote in the Spanish Congress.
The draft text also indicates that the final law could be different from plans previously floated for medical cannabis prescriptions for specific conditions and settings.
“It’s a long-awaited demand by the Congress of Deputies, by professionals and by patients,” said Spain’s Health Minister, Mónica García, during the press conference to announce the decision.
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The decision represents a decisive and long-awaited step in the integration of cannabis into the Spanish healthcare system.
The Spanish Medical Cannabis Observatory (OECM) estimates that some 300,000 people in Spain use cannabis for medicinal or therapeutic purposes.
The decree approved on Tuesday does not, however, establish a closed list of acceptable conditions for which prescriptions can be made. Previous plans outlined by the ministry in 2024 suggested that only specific patients with specific conditions, for whom there is already pre-existing scientific evidence of the benefits of medical cannabis, would be able to access it.
The conditions included types of multiple sclerosis, refractory epilepsy, nausea and vomiting caused by chemotherapy, and chronic refractory pain.
Instead, the draft law states that the authorised clinical uses, together with the specific conditions for preparation, dosage and prescription, will be set out in a report published within three months by the Spanish Agency for Medicines and Health Products (AEMPS).
This could make the rules more flexible than originally envisaged, as the first versions of the text strictly included its application for the four listed conditions only.
This does not mean that the list of conditions will necessarily be extended further, but it does give the opportunity to expand the list of conditions included as evidence builds.
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A statement from the Health Ministry said: “This model allows for continuous updating based on scientific advances and available clinical evidence, opening the door to the incorporation of new prescriptions in the future, always under rigorous criteria of efficacy, safety and medical necessity.”
For the time being, cannabis can only be prescribed exclusively by medical specialists in a hospital setting, when there are documented clinical reasons for their use. Previously it had been widely reported that pharmacies in Spain would be able to dispense prescriptions but it is now unclear.
Prescriptions for now should only be prepared by authorised hospital pharmacies. It remains unclear if patients will be given specially prepared cannabis oils or flower.
The decree also creates a public registry, managed by the AEMPS, in which all standardised cannabis preparations used to prepare prescriptions must be registered.
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