Spain’s Medical Cannabis Decree Faces Supreme Court Appeal
The Legal Arguments
Both appeals challenge the decree on multiple grounds, with a strong emphasis on patient access and equity rather than business interests.
CEOFA’s December appeal argues the decree ‘incurs in a regulatory excess, violating the principle of normative hierarchy and directly contradicting the provisions of the Law on Guarantees and Rational Use of Medicines and Health Products.’
The confederation contends that current legislation already recognises community pharmacies’ legal capacity to prepare compounded medications according to the National Formulary when they have the necessary resources.
The appeal argues that Article 8 ‘unduly limits an activity that the law does not restrict’ while ‘invading regional powers in matters of pharmaceutical regulation, such as the authorisation of facilities and formulation laboratories.’
CEOFA also contends the decree ‘usurps functions that belong to the AEMPS, an independent technical body to whom the law attributes the classification of medicines and the determination of its prescription and dispensing conditions.’
Central to both appeals is the question of patient access. “The network of community pharmacies guarantees accessibility, territorial equity, and close, professional pharmaceutical care, especially in rural areas or those with limited healthcare resources,” CEOFA stated in its appeal.
“Excluding them without a legal or technical basis represents an unnecessary obstacle to patients’ access to treatments that the Royal Decree itself recognises as potentially beneficial for serious illnesses.”
The Cgcof’s January appeal focuses on the lack of justification for the restriction. “There is no health, legal, or safety reason whatsoever that justifies limiting its dispensing exclusively to Hospital Pharmacy services, preventing the preparation of compounded medications and patients’ access to them through the network of community pharmacies,” the organisation stated.
Cgcof President Jesús Aguilar has emphasised that community pharmacies already routinely handle controlled medications, including opioids like fentanyl, under strict regulatory oversight, making the exclusion of cannabis preparations appear arbitrary.
Both appeals also point to internal contradictions within the decree itself. While Article 8 explicitly reserves cannabis preparation and dispensing for hospital pharmacies, Additional Provision Two and Article 9.3 acknowledge that autonomous communities may establish ‘non-face-to-face dispensing measures’ in cases of ‘vulnerability, dependency, or geographical remoteness.’
What happens next?
The Supreme Court’s Administrative Chamber will now review both challenges, though the timeline for a decision remains unclear. Spanish administrative law cases can take months or even years to resolve, particularly when they involve complex questions of regulatory authority and constitutional principles.
The nine-day window for additional parties to join the appeals is set to close this weekend, though it remains unclear whether any patient advocacy groups, industry stakeholders, or other pharmacy organisations will opt to join either challenge.
In the meantime, implementation of the medical cannabis framework continues. The AEMPS was required to publish clinical monographs detailing authorised uses, dosage parameters, and prescription conditions within three months of the decree’s October publication, a deadline that falls today (January 09, 2026). Whether the agency will proceed with publishing these monographs while the legal challenges are pending or await the Supreme Court’s decision remains to be seen.
The outcome of these appeals could significantly reshape Spain’s medical cannabis landscape. If successful, the challenges could force the Ministry of Health to revise the decree to include community pharmacies, potentially expanding access to thousands more patients, particularly in rural areas. However, such a revision would likely delay implementation further, extending the wait for patients who have been advocating for legal access since 2022.
