Spanish Ministry of Health publishes draft Royal Decree on medical cannabis

On September 30, 2024, the Spanish Ministry of Health published a draft Royal Decree to regulate the dispensing standardized cannabis preparations for therapeutic purposes.

The text, which defines the procedures and conditions for producing, prescribing and selling dispensing of cannabis-based magistral preparations, is now open to public consultation until October 21, 2024.

Main objectives of the Royal Decree

The draft Royal Decree has its origins in in a 2021 recommendation of the Health and Consumer Affairs Commission, which called for the legalization of medical cannabis in Spain.

The challenge is to ensure that standardized cannabis formulations be made available to patients with specific therapeutic needs. The text stresses that scientific evidence support the therapeutic use of cannabis and its extracts in certain medical conditions. These include its application in the treatment of :

• spasticity due to multiple sclerosis
• refractory epilepsy who do not respond to traditional medicines
• chemotherapy-induced nausea and vomiting
• chronic refractory pain, which persists despite the usual treatments.

The regulations is setting up a system to guarantee the quality and traceability of these preparations through a public register, so that patients benefit from safe and effective treatment.

Prescription and medical monitoring

Only doctors specializing in the treatment of the specific conditions described in the decree will be authorized to prescribe standardized cannabis-based magistral preparations.

As previously revealed, Cannabis flowers will not be included in the available treatments.

To better protect patients, the decree stipulates that cannabis-based preparations must be prepared and dispensed exclusively by hospital pharmacy departments. These pharmacies will work closely with the medical teams and provide pharmacotherapeutic follow-up to ensure that patients benefit from treatment.

In addition, physicians must constantly evaluate the efficacy and safety of the cannabis treatment, with the obligation to discontinue use if the benefit-risk ratio becomes unfavorable.

To guarantee the quality and safety of standardized cannabis preparations, the draft decree introduces a complete system of traceability and quality control. Each standardized preparation must be entered in the public register of AEMPS, Spain's ANSM, before it can be dispensed. therapeutic cannabis treatments and ensure that each batch meets the necessary quality standards.

The decree also provides flexibility for future modifications. Depending on the results of its implementation and emerging scientific evidence, the system can be adjusted to better meet patients' needs.