The Spanish cabinet approved a royal decree on Oct. 7 to regulate medical cannabis in “standardized preparations” as a therapeutic alternative for patients in the country’s health care system.
Under the decree, specialist physicians could prescribe medical cannabis to those with chronic or refractory pain, severe epilepsy, spasticity due to multiple sclerosis, cancer and other conditions where conventional treatments have proved ineffective, according to the Spanish Ministry of Health.
Spain’s Council of Ministers – the executive branch’s decision-making body headed by Prime Minister Pedro Sánchez – authorized the decree at the country’s Ministry of Health proposal. Spain’s Congress still needs to vote on the proposal.
“This regulation, requested by the Health and Consumer Affairs Committee of the Congress of Deputies, represents a decisive step in the integration of medical cannabis into the health care system, ensuring its use with scientific, clinical and health control guarantees,” according to the Ministry of Health.
Per the decree, patients will be limited to accessing medical cannabis that’s exclusively dispensed in Spain’s hospital pharmacy services. The Spanish Agency for Medicines and Medical Devices (AEMPS) will be tasked with ensuring that the medical cannabis formulas prescribed by doctors meet certain quality, safety and dosage standards.
The decree leaves many of the specifics of a forthcoming government program to be determined by various health agencies. But the decree intends to provide a model that’s flexible to changes based on “scientific advances and available clinical evidence,” according to the Ministry of Health.
In addition to scientific evidence, many countries often shape their cannabis policies with international control in mind, as well as treaty obligations under the United Nations’ 1961 Single Convention on Narcotic Drugs.
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Canada, which legalized adult-use cannabis in 2018, is the first Group of Seven (G7) nation to reform its policies to regulate a commercial cannabis program that allows for dispensary sales to nonmedical consumers.
In Europe, Germany reformed its cannabis laws in 2024 to reclassify the plant as a non-narcotic, allowing for personal possession and home grows. This policy shift didn’t necessarily change perception. According to a report published Oct. 6, many of Germany’s general practitioners remain reluctant and rarely prescribe medical cannabis.
Could Spain be different?
“Scientific evidence endorsed by international organizations has demonstrated benefits for some specific clinical conditions,” according to the Spanish Ministry of Health. “In these cases, authorized medications may be insufficient, and master formulations made from standardized cannabis preparations constitute an alternative with potential therapeutic value, always under strict medical and pharmaceutical supervision.”
The royal decree approved this week does not establish a fixed list of qualifying conditions, as most states in the U.S. provide under their state-sanctioned medical cannabis programs. Instead, the decree requires the AEMPS to establish authorized clinical uses based on scholarly monographs and publish them within three months in the National Formulary.
In other words, it’s unclear if cannabis flower or other smokable forms will be available to Spain’s patients, or if the government intends to limit access to other product forms, such as oil.
The AEMPS will also be tasked with managing a registry of standardized product formulas that are lab-tested for THC and/or CBD, with products containing more than 0.2% THC subject to more stringent regulatory standards for manufacturing, distribution, traceability and quality.
“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,” according to the Ministry of Health.
While the Spanish cabinet approved the decree, it’s not a done deal. The Spanish Congress is expected to vote on the proposal and could amend what becomes the final law.
The reform momentum comes seven months after the Spanish Observatory of Medical Cannabis (OECM), a patient advocacy group, dissolved its organization after a decade of fighting to advance the country’s cannabis policies, the Canna Reporter reported.
OECM estimated that more than 300,000 people in Spain use cannabis to self-treat their medical conditions.
