The Spanish Ministry of Health has drafted a Royal Decree to regulate the use of medical cannabis for specific health conditions. The proposal has been opened for public consultation as the government responds to a 2021 subcommittee recommendation for medical cannabis regulation.
The text states that “scientific evidence has shown a variable degree of benefit from cannabis and its extracts in some therapeutic indications,” highlighting its use in the treatment of spasticity due to multiple sclerosis, refractory epilepsy, nausea and vomiting from chemotherapy, and chronic refractory pain. While authorised medications exist for some of these conditions, standardised magistral formulas may provide a personalised alternative when conventional treatments fail.
The following health conditions that could benefit from medical cannabis. These include:
- Spasticity from multiple sclerosis: A condition involving muscle stiffness and spasms. Cannabis can help relieve muscle spasms and stiffness associated with multiple sclerosis. It may also improve sleep quality and reduce neuropathic pain in these patient.
- Refractory epilepsy: CBD, a non-psychoactive component of cannabis, has been shown to effectively reduce the frequency and severity of seizures in certain types of epilepsy, particularly in cases of epilepsy resistant to conventional treatments.
- Nausea and vomiting from chemotherapy: Cannabis could be used as an alternative when standard medications fail to alleviate symptoms. Cannabis can help reduce nausea and vomiting induced by chemotherapy. Additionally, it can stimulate appetite, which is beneficial for patients experiencing weight loss and lack of appetite due to treatment.
- Chronic refractory pain: Cannabinoids, such as THC and CBD can relieve persistent pain that remains unaffected by typical pain-relief methods. These annabinoids interact with the body’s endocannabinoid system, helping to reduce the perception of pain.
This regulation will allow patients suffering from these conditions to access standardised cannabis preparations when conventional treatments are ineffective.
Prescription and dispensing rules
The new regulation provides guidelines for the safe prescription, preparation, and dispensing of cannabis-based formulas. These products must meet strict quality controls and therefore, the government will closely monitor and regulate cannabis-based medical products. The Health Ministry emphasises that improvements and updates to the regulation will be made based on patient needs and medical developments. Furthermore, the proposal includes the creation of a specific registry for cannabis-based medical products.
Also read: Spanish parliament agrees to regulate medicinal cannabis