Spain’s Council of Ministers has approved regulations concerning the use of medical cannabis in the country. The regulations are highly restrictive, but a start.
Requested by the Health and Consumer Affairs Committee of the Congress of Deputies, the regulations integrate medical cannabis into Spain’s healthcare system.
While the associated Royal Decree doesn’t list qualifying conditions, medicines must be prescribed by specialist physicians in a hospital setting, prepared only in authorized hospital pharmacy services, and follow related standards. However, authorized clinical uses, along with the specific conditions for preparation, dosage, and prescription, will be established within three months.
According to a press release from Spain’s Ministry of Health (translated):
“With this regulation, the Government reaffirms its commitment to more personalized, safe, and evidence-based medicine, offering an alternative for those who find no effective response in approved medications.”
Under the regulations, cannabis flower is not allowed, only standardised oils. The decree also creates a public registry in which all standardized cannabis preparations that are utilised to create master formulas must be registered.
Translation:
“These products must have a defined composition of THC and/or CBD, comply with strict manufacturing, traceability, and quality requirements, and are subject to additional inspection when they contain more than 0.2% 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.
In 2023, Spain had a developing but yet to be fully implemented medical cannabis program providing access to standardized cannabis preparations for patients with certain conditions
Prior to this, Spain had no specific medical cannabis laws or regulations, but recreational use and public possession remained illegal. Patients were able to source cannabis products through a regulatory loophole involving participating in cannabis social clubs. However, CBD was legal in Spain and freely available, as long as preparations contained no more than 0.2% THC.
In October 2024 the nation’s Ministry of Health published a draft of the royal decree approved this week, with an expectation it would be approved by the summer of 2025. So, a little late, but better late than never.
