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Cannabis Campaigners' Guide News Database result:
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Spain Approves Long-Awaited Regulation of Cannabis-Based Medicines Sarah Sinclair Cannabis Health News Wednesday 08 Oct 2025 Following years of advocacy on behalf of patients and campaigners, the decision marks a decisive step toward the integration of medical cannabis into the country’s healthcare system. The new framework, proposed by the Ministry of Health, establishes the conditions for the prescription of ‘standardised master formulas’ made from cannabis preparations, by specialist physicians in hospital settings. The regulations extend to the prescription of cannabis-based oils only, and do not permit the use of cannabis flower. The decree does not define a set list of indications for which these products can be prescribed. Instead, authorised clinical uses, along with the specific conditions for preparation, dosage, and prescription, will be established in the monographs published by the AEMPS in the National Formulary within the next three months. The Ministry of Health said this 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 legislation has been a long-time coming. The Health Committee first approved a draft report setting out a list of recommendations for the regulation of medical cannabis in June 2022, but a snap general election and change of government the following year delayed the process considerably. Under the new system, medical cannabis formulations may only be prescribed by specialist physicians in hospital settings, where there is documented clinical justification. However, the Ministry of Health added that there may be mechanisms for remote dispensing in “exceptional cases of vulnerability, dependency, or geographical barriers” to “ensure equitable access to these treatments”. The government said in a press release: “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.” A long-awaited ‘victory’ Carola Pérez, a patient and activist who has campaigned for legal access to medical cannabis in Spain for over a decade described the news as a “victory for all patients”. Sharing the news in a LinkedIn post on Tuesday (7 October) she said: “Today, Spain takes a historic step — one that recognises the dignity, pain, and strength of thousands of patients who have been waiting for far too long. Twelve years of meetings, reports, testimonies, tears, and hope. Twelve years of patients standing up, doctors speaking out, and families refusing to give up. “This isn’t the end of a road — it’s the beginning of a new chapter. A chapter of responsibility, science, and compassion. A chapter where patients are finally seen, heard, and protected.” However, speaking to Cannabis Health, Pérez cautioned 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.” Too restrictive? While the news has been welcomed by advocates, some have concerns that the regulations are “too restrictive” by not including cannabis flower, or permitting GPs and high street pharmacies to prescribe and dispense products. Manuel Guzmán, Professor of Biochemistry and Molecular Biology, member of the Spanish Royal Academy of Pharmacy, and member of the Board of Directors 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. “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.” https://cannabishealthnews.co.uk/2025/10/08/spain-approves-regulation-of-cannabis-based-medicines/
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