Spain’s Council of Ministers voted to approve regulations regarding the use of cannabis for medical purposes in the nation. Although the regulations are extremely restrictive, they represent a first step.
These regulations were requested by Health and Consumer Affairs Committee of Congress of Deputies and integrate medical cannabis in Spain’s healthcare systems.
Although the Royal Decree associated with it does not specify qualifying conditions, all medicines prescribed must be in a hospital environment, only prepared by authorized hospital pharmacy services and adhere to standards. The approved clinical uses will also be determined within 3 months, as well as the conditions of preparation, dosage and prescription.
According to Press release (translated by) the Ministry of Health of Spain:
The Government has reaffirmed its commitment to a more personalized, evidence-based, and safe medicine. This regulation offers an alternative option for patients who do not find effective results from approved medication.
According to the regulation, only oils standardised are allowed. This decree establishes an online public database where all standard cannabis preparations which are used in master formulae must be recorded.
Translation:
The products have to meet stringent manufacturing, quality and traceability standards, as well as strict requirements for their manufacture and production. They are also subjected to an additional inspection in the event that they exceed 0.2% of THC.
While some patient advocates and industry players feel the regulations are too restrictive, the news is viewed by others as the thin edge of the wedge – representing an important starting point to demonstrate medical cannabis can be a part of the country’s healthcare system without the major issues feared by opponents.
Spain was developing a medical cannabis program in 2023 that would provide access to standard cannabis preparations to patients suffering from certain diseases.
It was illegal to use recreational cannabis or possess it in public. Through a regulatory loophole, patients were able obtain cannabis products by joining cannabis social clubs. CBD, however, was available in Spain, and it is legal, so long as the preparations do not contain more than 0.2% of THC.
The Ministry of Health of this nation published in October 2024 a draft of a royal decree that was approved last week. It is expected to be finalized by summer 2025. It’s a bit late but it is better than never.