Spain’s medical cannabis framework will finally start reaching patients over the coming days and weeks, marking a significant milestone in a four-year battle for access.
In June 2022, we reported that ‘the regulation and distribution of medical cannabis’ could be rolled out in Spain ‘by the end of the year’, following a knife-edge vote to push through proposals for a framework.
Now, more than four years later, and over a year since the Royal Decree 903/2025 came into force, the first (and only) two preparations will be delivered to around 50 public and private hospitals this week, with a broader national rollout expected by the end of October 2026.
While this marks a major victory for the country’s tireless advocates, they remain clear that there is more work to be done.
Products to patients within weeks
Curaleaf, the first company to register standardised cannabis preparations with the Spanish Agency of Medicines and Medical Devices (AEMPS), has now completed the final piece of the puzzle enabling hospitals to place orders and preparations to be delivered.
Almost exactly a year ago, on October 07, 2025, the long-awaited and already controversial Royal Decree 903/2025 came into force. However, implementation added another full year of delay.
The AEMPS gave itself a three-month deadline to publish the clinical monographs needed for prescribers and pharmacists, eventually publishing FN/2026/FMT/043 on January 20, 2026.
After Curaleaf’s CAN-1 and CAN-2 preparations were registered in July, the next three months were consumed by the operational work of standing up a national supply chain.
So far Curaleaf is the only company to have made it through the registration process out of four cultivation licence holders in Spain and has only now completed the logistics arrangements for distribution from Medalchemy’s Alicante site to the first 50 hospitals.
Curaleaf told local medical trade title Diario Médico that CAN-1 and CAN-2 can potentially supply all approximately 850 Spanish hospitals, with each batch standardised to a defined cannabinoid content within a tolerance of plus or minus 10%, and a national logistics partner lined up to handle distribution.
Specialists will be able to prescribe the cannabis preparations for four indications, including spasticity associated with multiple sclerosis, severe refractory forms of epilepsy, chemotherapy-induced nausea and vomiting, and chronic refractory pain.
Hospital pharmacists will be required to formulate the magistral prescriptions under the AEMPS monograph FN/2026/FMT/043, which caps adults at 32.4 mg of THC per day and 25 mg per kilogram of CBD per day and recommends CBD-dominant formulas as the default for children.
Sociedad Española de Farmacia Hospitalaria (SEFH), which co-developed the AEMPS monograph, told El Español that the specialist prescriber mix is tightly drawn, with anaesthetists leading on chronic pain and oncologists and haematologists on chemotherapy-induced nausea and vomiting.
Prescribers and hospital pharmacists will set up ‘closed circuits’ within each hospital to manage prescription, formulation, dispensing and follow-up. However, SEFH noted that implementation now depends on regional health systems and suppliers moving in step.
‘A first step, not the finish line’
Even so, Spain’s current framework remains particularly restrictive when compared to many of its European neighbours, and advocates have long-raised concerns it will do little to deter prospective patients from the black market.
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, has been consistent on the limitations of the current framework.
“It seems that official medical cannabis dispensation will start soon in some Spanish hospitals, especially for the management of opioid-resistant chronic pain. This is good news indeed,” Guzman told Business of Cannabis.
“Unfortunately, the approved regulatory framework is extremely restricted, with only four indications (two of them already covered by Sativex and Epidyolex) and in the very last line (in other words, after all standard medications have previously failed).”
“Moreover, primary care physicians will not be allowed to prescribe cannabis preparations, and community pharmacies will not be allowed to prepare the formulations. So, I am afraid that only a small percentage of the estimated 300,000 Spanish patients who currently use cannabis for medical purposes will have access to the programme, and most of them will therefore keep in the black market. I hope I’m wrong.”
Carola Pérez, founder of patient association Dosemociones and the Observatorio Español de Cannabis Medicinal (OECM), and one of the most prominent patient voices in the Spanish debate, welcomed the launch in a post on LinkedIn, calling the moment a vindication of years of patient advocacy.
“After years of fighting, medical cannabis is finally arriving in Spanish hospitals,” she said. “This didn’t happen by chance. It happened because patients spoke up, told their stories, and refused to be ignored. Every testimony, every meeting, every ‘no’ we turned into a ‘not yet’ brought us here.”
But, mirroring Guzman’s stance, she has warned that this marked ‘a first step, not the finish line’.
“Now we need access that reaches every patient who needs it, not just a few.”
The fight continues
These issues are already being challenged in court. In December 2025 and January 2026, the Andalusian Confederation of Pharmacy Offices (CEOFA) and the General Council of Official Colleges of Pharmacists (Cgcof), which represents Spain’s 22,000 community pharmacies, filed contentious administrative appeals at Spain’s Supreme Court.
Specifically, these have challenged Article 8 of Royal Decree 903/2025, which restricts the supply of cannabis preparations to hospital pharmacy services and export.
Both groups argue the limit has no clinical, legal or safety justification, with the Cgcof noting that community pharmacies already handle controlled medicines such as fentanyl. CEOFA’s challenge goes further, arguing the decree exceeds regulatory authority, breaches the hierarchy of norms, contradicts the Law on Guarantees and Rational Use of Medicines, and invades regional powers over facility authorisation.
The Supreme Court’s Administrative Chamber will review both appeals, with no timeline yet set for a ruling.
Reimbursement is the other open question for the launch. The Decree does not explicitly settle how hospitals should fund the cost of cannabis medicines. While the Ministry of Health has not yet specified the model, it is expected that patients will not have to pay in the public system, with hospitals absorbing the cost, while private prescriptions will depend on the healthcare provider.
