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Spain’s Ministry Of Health Publishes Medical Cannabis Draft Royal Decree

Spain's Ministry Of Health Begins Process Of Enacting Medical Cannabis Regulations

The road to properly regulated medical cannabis in Spain has been long and full of twists and turns. However, the effort to bring Spain’s medical cannabis policies into the modern age passed a major milestone with the nation’s Ministry of Health publishing a draft royal decree focused on medical cannabis.

“After three years of delays, Spain’s Ministry of Health published on Monday 30 September the draft royal decree to allow the prescription of cannabis preparations, a text that will now be submitted for hearing and information before its final approval.” reported Sur in its domestic coverage.

“The draft establishes broad restrictions on the medical use of cannabis and specifies very specifically the pathologies for which it can be used: multiple sclerosis (stiffness and muscle spasms associated with the condition); severe forms of refractory epilepsy (certain types of epilepsy that do not respond to conventional treatments); nausea and vomiting caused by chemotherapy; and refractory chronic pain (persistent pain that is not relieved by the usual treatments). In all these cases, experts believe that there is “scientific evidence” of the benefits of medical cannabis.” the media outlet also reported.

Back in February 2024, Spain started the process of crafting the draft royal decree that was recently published. As we reported at the time, before a royal decree is officially issued, the public is afforded the opportunity to provide input, with Spain’s government having previously set up an email address dedicated to receiving such input (normativa.aemps@aemps.es).

“The Ministry addresses this regulation based on the conclusions of the Subcommittee of the Congress of Deputies for the analysis of experiences with the regulation of cannabis for medicinal use, which called on the Spanish Agency for Medicines and Health Products to prepare a roadmap to approve the regulation.” Spain’s government stated in a press release (translated from Spanish to English) at the time.

“The proposed regulation guarantees the quality of the products and the safety of patients, enabling the legal avenues available to have therapeutic compounds based on standardized cannabis preparations that have shown evidence in relieving pain and the suffering of patients, considering the oral administration of these compounds as it is the most appropriate in terms of therapeutic effectiveness and safety for patients.” the government’s press release stated.

“This regulation is designed to evolve dynamically, allowing new elements to be incorporated as more information and the experience of the therapeutic cannabis program becomes available. In addition, it will contribute to generating more and better evidence on the use of cannabinoids for therapeutic purposes.” Spain’s government also stated.

Despite the lack of proper regulations in Spain, the nation’s cannabis industry is thriving, albeit not within a regulated system. Suffering patients deserve to have safe access to safe medical cannabis therapies, and entrepreneurs and investors deserve to operate in a business environment that is built on a strong foundation of certainty.

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