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<\/a><\/p>\n\u201cThis 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,\u201d according to the Ministry of Health.<\/p>\n
Per the decree, patients will be limited to accessing medical cannabis that\u2019s exclusively dispensed in Spain\u2019s 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.<\/p>\n 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\u2019s flexible to changes based on \u201cscientific advances and available clinical evidence,\u201d according to the Ministry of Health.<\/p>\n 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\u2019 1961 Single Convention on Narcotic Drugs.<\/p>\n RELATED: Rescheduling Cannabis: Would 1961 Drug Treaty Be a Possible Wrench?<\/a><\/p>\n 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.<\/p>\n In Europe, Germany reformed its cannabis laws<\/a> in 2024 to reclassify the plant as a non-narcotic, allowing for personal possession and home grows. This policy shift didn\u2019t necessarily change perception. According to a report<\/a> published Oct. 6, many of Germany\u2019s general practitioners remain reluctant and rarely prescribe medical cannabis.<\/p>\n Could Spain be different?<\/p>\n \u201cScientific evidence endorsed by international organizations has demonstrated benefits for some specific clinical conditions,\u201d according to the Spanish Ministry of Health. \u201cIn 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.\u201d<\/p>\n 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.<\/p>\n In other words, it\u2019s unclear if cannabis flower or other smokable forms will be available to Spain\u2019s patients, or if the government intends to limit access to other product forms, such as oil.<\/p>\n 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.<\/p>\n \u201cWith 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,\u201d according to the Ministry of Health.<\/p>\n While the Spanish cabinet approved the decree, it\u2019s not a done deal. The Spanish Congress is expected to vote on the proposal and could amend what becomes the final law.<\/p>\n<\/a><\/p>\n![\"Advertisment:](\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2025\/10\/eh-360-web-banner-728x90.onRNDRFUze.avif\")
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