The Spanish Ministry of Health has made public this week the draft Royal Decree establishing the conditions for the elaboration and dispensation of tailor-made master formula for standardized cannabis preparations (hereinafter the "Draft Royal Decree"). The Draft Royal Decree aims to regulate the therapeutic use of cannabis in Spain.

According to the document the scientific evidence has shown a clear benefit of cannabis and its extracts in some therapeutic indications, such as the treatment of spasticity due to multiple sclerosis, refractory epilepsy, nausea and vomiting due to chemotherapy, and refractory chronic pain. While there are authorized drugs for some of these indications, the Spanish authorities consider that formulations can be a personalized alternative when conventional treatments fail. Thus, the Draft Royal Decree seeks to facilitate access to medicines containing standardized cannabis preparations for certain patients for whom authorized medicines have not been effective. 

The Draft Royal Decree states that the Spanish Agency on Medicines and Medical Devices ("AEMPS") will publish a monograph for the master formula for the standardized cannabis preparations. The monograph will include the legally recognised action and indications for these drugs and will be updated if further indications are found.

The Draft Royal Decree establishes the conditions for the elaboration and dispensation of tailor-made master formula for standardized cannabis preparations and creates a registry to ensure the traceability and quality of the standardised cannabis preparations used in the elaboration of master formulas.

The prescription will be limited to health professionals meeting certain criteria when authorised drugs are not available or do not meet the patient's needs, and the master formulas of standardised cannabis preparations will be only elaborated in hospital pharmacy services.

The goal is to ensure that cannabis-based medical treatments are safe, effective, and accessible, while preventing misuse.

The document is currently undergoing a public hearing and information process, which means that citizens with legitimate rights and interests affected can contribute their opinion to the published draft. Comments can be filed until October 21, 2024.