Spain Takes Steps to Regulate Medical Cannabis: New Royal Decree Draft Released
On Monday, the Ministry of Health in Spain unveiled a draft Royal Decree aimed at establishing conditions for the preparation and dispensing of standardized magistral formulas for cannabis preparations, focusing on the therapeutic use of cannabis. According to the Ministry, which is led by Mónica García, this regulation seeks to streamline access to medications containing standardized cannabis formulations for patients who have not found relief from authorized treatments.
The draft highlights scientific evidence pointing to a variable degree of benefit derived from cannabis and its extracts in treating certain medical conditions. Among the listed therapeutic indications are the alleviation of spasticity due to multiple sclerosis, management of refractory epilepsy, control of nausea and vomiting caused by chemotherapy, and relief for chronic pain that does not respond to conventional therapies.
While there are existing medications authorized for some of these conditions, magistral formulas are being considered a viable personalized alternative for patients who remain underserved by standard treatments. Importantly, the Royal Decree draft specifies that the monograph of the National Formulary will outline the legally recognized indications for these cannabis-based medications. This allows for the flexibility to update the list of indications as new scientific evidence emerges and as future regulatory decisions are made.
The responsibility of publishing the monograph for standardized magistral formulas of cannabis preparations will lie with the Spanish Agency for Medicines and Health Products (AEMPS). Additionally, these standardized preparations must be entered into a public registry established by the AEMPS. To ensure quality and compliance, laboratories producing these formulations must adhere to the EU Good Manufacturing Practices (GMP) for pharmaceuticals. This includes maintaining rigorous audits on their suppliers and documenting the entire supply chain for each starting material.
In terms of prescription, the standardized magistral formulas will be utilized when no authorized medications exist, or when current treatments fail to meet the specific needs of the patient. The physician is required to document the rationale for the treatment within the patient's clinical history and ensure that the patient is well-informed about the clinical evidence, benefits, and risks associated with the treatment.
Moreover, physicians are expected to conduct periodic evaluations regarding the effectiveness and safety of the treatment, weighing the benefits against potential risks, with the obligation to discontinue the treatment if the risk-benefit ratio becomes unfavorable.
As Spain moves forward with this draft decree, it signals a significant step in recognizing the potential of medical cannabis as a therapeutic option for patients who have exhausted conventional avenues. The emphasis on regulation aims not only to enhance access to treatment but also to ensure safety and efficacy as part of an evolving healthcare landscape.
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