Spain moves a step closer to legalizing medical cannabis

After years of waiting, Spain is on the verge of regulating medical cannabis.

The draft royal decree has in fact been sent to the European Commission via the TRIS procedure, a compulsory step before medical cannabis can become part of common law. French patients have been waiting for the same thing for almost a year now.

If the Commission has no objections to the Spanish project, it could be approved before the summer.

Regulatory framework for medical cannabis in Spain

The Ministry of Health's draft regulations cover the controlled use of medical cannabis as a treatment of last resort for specific medical conditions. Under the proposed guidelines, cannabis-based medicines and standardized magistral formulas (such as cannabis oils) will be available for patients suffering from the following conditions:

• Spasticity and muscle spasms associated with multiple sclerosis
• Refractory forms of epilepsy unresponsive to conventional treatments
• Chemotherapy-induced nausea and vomiting
• Chronic pain unresolved despite standard treatments

The regulation excludes cannabis flower, prohibits self-cultivation (even though it is already decriminalized in Spain anyway) and restricts access to hospital pharmacies rather than community pharmacies.

In addition, only specialists, not general practitioners, will be allowed to prescribe cannabis-based treatments. According to patient advocacy groups, these provisions create unnecessary barriers to access and fail to address broader therapeutic needs.

A proposal considered conservative

Although Spain's draft royal decree represents progress, it is considered more cautious than medical cannabis programs in other countries. As the Spanish Observatory for Medicinal Cannabis (OECM) notes, the regulation limits the therapeutic scope of cannabis to predefined conditions. Cannabis will only be prescribed if existing treatments, including authorized cannabis-based medicines such as Sativex or Epidiolex, prove ineffective.

The patients claim that the government has ignored the scientific evidence in support of their claims. wider therapeutic benefits of cannabis. Research suggests that cannabis has powerful anti-inflammatory, antidepressant, analgesic and neuroprotective properties. It is already used by patients suffering from illnesses such as cancer, Alzheimer's, Parkinson's and fibromyalgia, but the current proposal does not adequately address these needs.

Critics also raised concerns about the exclusion of primary care physicians from the prescribing process. This decision, along with hospital-only dispensing, could disproportionately affect patients in rural or underserved areas. Advocacy groups stress that accessible and inclusive policies are essential to ensure widespread benefit from medical cannabis.

The long road to regulation

The road to the legalization of medical cannabis in Spain has been littered with delays and political obstacles. Civil society organizations have long campaigned for comprehensive regulation, but progress has been hampered by political hesitation.

In particular, the Socialist Party (PSOE) has always opposed legalization, citing the previous positions of the World Health Organization (WHO) on the medical value of cannabis. Although the WHO has since revised its position, the PSOE's reluctance persisted until May 2021, when Congress approved the creation of a parliamentary sub-committee to study medical cannabis programs in other countries.

The sub-committee's work resulted in the current draft Royal Decree, which reflects years of patient advocacy and political negotiation despite its currently limited scope.