Business of Cannabis
Spanish regulators have taken another step towards introducing the country’s long-delayed medical cannabis framework, but patients say the legislation does not go far enough.
On Monday 30 September, the Ministry of Health published a draft royal decree for public hearing, setting out the proposed regulations for the prescription of cannabis-based medicines.
The legislation has been a long-time coming, with a snap general election and subsequent change of government in 2023, delaying the process for over a year.
The Health Committee of the Spanish Congress of Deputies first approved a subcommittee’s draft report in June 2022, setting out a list of recommendations for the regulation of cannabis-derived medicines for therapeutic use.
In January 2024, the newly-appointed Health Minister, Monica Garcia, reaffirmed her commitment to establishing a medical cannabis framework, with draft proposals put out for public consultation.
The latest framework appears to follow the Health Committee’s recommendations closely, allowing cannabis medicines to be prescribed in the form of ‘master formulas, made from extracts or standardised preparations’.
Only specialist doctors will be permitted to prescribe the treatment for a limited number of qualifying conditions. This includes: Spasticity in multiple sclerosis (MS), severe forms of refractory epilepsy, nausea and vomiting due to chemotherapy, and refractory chronic pain (persistent pain that is not relieved by standard treatments).
After issuing a prescription, doctors will be required to continually evaluate the effects of the treatment and the risk-benefit ratio, as well as reporting any adverse events.
The Spanish Agency for Medicines and Health Products (AEMPS) is expected to update the National Formulary with the publication of a corresponding monograph to which the standardised magistral formulas must comply. In line with the previous proposals, the legislation will exclude medical cannabis flower.
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