MADRID, SPAIN – 2016/05/07: People celebrating the Global Marijuana March demanding regulation for … [+] Marijuana. (Photo by Marcos del Mazo/LightRocket via Getty Images)
LightRocket via Getty ImagesSpanish patients could soon have access to medical cannabis as regulators push forward with a new bill. However, its use is expected to be strictly limited to specific medical conditions, highlighting the cautious approach being taken.
After the request of the subcommittee for the Health and Consumer Affairs Commission in 2021, the Ministry of Health of Spain introduced last week a draft royal decree for a public hearing that seeks to regulate medical cannabis. With this decree, the government aims to provide patients who do not respond to authorized treatments with a supply of standardized cannabis medicines.
This development marks progress in Spain’s cannabis policy, where medical cannabis remains unregulated. Currently, the cultivation of cannabis or its derivatives is legally permitted only for export to firms licensed in their countries of origin. As for recreational cannabis, its production, import, and sale are prohibited, while consumption and personal cultivation by adults in private spaces are decriminalized. Since the 1990s, hundreds of cannabis social clubs and user associations have emerged across Spain, with the majority concentrated in Barcelona, Catalonia.
Spain’s Proposed Medical Cannabis Framework
The proposed royal decree on medical cannabis sets guidelines for the prescription, preparation, and dispensing of standardized cannabis formulations. As cannabis is classified as a narcotic under international treaties, its use is restricted to medical and scientific purposes. The decree relies on scientific evidence demonstrating cannabis’s benefits for conditions such as multiple sclerosis-related spasticity, severe refractory epilepsy, chemotherapy-induced nausea, and chronic refractory pain.
Key points of the draft include the use of standardized cannabis preparations, meaning only THC and/or CBD extracts registered with Spain’s Medicines and Health Products Agency are allowed. These formulations are standardized for consistent dosage and quality.
Only specialists can prescribe cannabis-based treatments when authorized medications fail, and this must be recorded in the patient’s medical history, and patients must be informed of the medical cannabis’s benefits and risks.
The pathologies listed in the decree that can be treated with medical cannabis preparations include spasticity in multiple sclerosis, severe refractory epilepsy (unresponsive to conventional treatments), chemotherapy-induced nausea and vomiting, and refractory chronic pain (persistent pain not relieved by standard treatments).
The draft royal decree also states that the National Formulary will outline the legally approved uses for cannabis-based drugs, allowing for future adjustments based on scientific evidence and regulatory decisions.
Formulations are prepared and dispensed exclusively by hospital pharmacies under strict quality control regulations, which also monitor treatment outcomes and side effects.
A national registry tracks cannabis products with over 0.2% THC, subjecting them to stricter psychotropic substance laws.
Manufacturers must follow EU Good Manufacturing Practices (GMP) and audit suppliers.
Healthcare providers must report adverse reactions to regional pharmacovigilance centers.
Limits
Similarly to a bill introduced in 2022, the proposed royal decree seems to limit the medical conditions for which patients can access medical cannabis despite other conditions having scientific evidence supporting treatment with the substance.
Also, the measure excludes family doctors and other physicians from prescribing medical cannabis preparations for the treatment of the above-listed medical conditions.
Furthermore, as the draft regulates the prescription, preparation, dispensing, and use of standardized cannabis formulations, establishing a specific registry to ensure their quality and traceability, it appears that the preparations will be in oil or similar forms containing active cannabis ingredients, excluding the direct use of cannabis flowers, as is done in other European countries like Germany and Italy.
Currently, two cannabis-based medicines are approved for sale in Spain: Sativex, an oral spray with dronabinol and cannabidiol that can be prescribed by specialists to over-18 patients who need relief from spasticity, and Epidiolex, an oral solution with cannabidiol to be used against epilepsy in adults, adolescents, and children from two years of age. Apart from these, the import of nabilone and dronabinol has been allowed in particular cases, as well as for severe multiple sclerosis, and when it is necessary to use them as antiemetics during the treatment of tumors.
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