Inside Spain’s New Medical Cannabis Law: Access, Regulation, and Next Steps
The new law is a major shift in regulating medical cannabis in Spain.
On October 7, 2025, the Spanish government approved a royal decree legalizing the medical use of cannabis under a tightly regulated framework. The new law marks a major shift in Spain’s health policy after years of debate. For the first time, patients will have hospital access to medical cannabis to treat conditions in cases where conventional medicines fail. Critics say that the regulation is too limiting, featuring only a handful of medical diagnoses for which doctors can prescribe cannabis.
Spain Legalizes Medical Cannabis: What the New Law Means for Patients and the Industry
Under the new royal decree adopted by the Spanish government, specialist physicians could prescribe medical cannabis to patients in several different categories, including chronic pain, epilepsy, multiple sclerosis, cancer, and other cases where patients don’t respond well to traditional medicines, according to the Spanish Ministry of Health.
“This regulation will allow us, when conventional treatments do not work, to have a therapeutic alternative supported by all the scientific evidence - and, of course, with full safety - so that standardized cannabis preparations can be used, with precise dosing and the highest guarantees,” Spain’s Health Minister Mónica García said, according to local coverage.
Key Provisions of Spain’s New Medical Cannabis Law
Here’s how the new legislation changes Spain’s cannabis regulatory landscape:
- Only hospital specialists may prescribe cannabis medicines. Only medical specialists (such as neurologists, oncologists, etc.) working in a hospital setting may prescribe cannabis to patients. Primary care doctors will not have prescription authority under this law.
- Medical cannabis can be prescribed when standard treatment fails. The law limits medical cannabis use only to cases where conventional treatments do not deliver satisfactory health results for patients. Eligible conditions include severe refractory epilepsy, chronic pain, spasticity due to multiple sclerosis, nausea and vomiting caused by chemotherapy.
- Doctors will prescribe standardized cannabis preparations. The new decree does not authorize the use of unprocessed plant material, such as dry flower. Medical professionals can only prescribe standardized formulations with preset concentrations of THC and/or CBD.
- Distribution of cannabis medicines will be limited to hospital pharmacies. Medical cannabis preparations will be dispensed only by authorized hospital pharmacies around Spain.
- The Spanish Agency for Medicines and Health Products (AEMPS) will act as a regulatory body. The agency will publish clinical guidelines to instruct how cannabis medicines should be dispensed (information on dosages, indications, and conditions of use). AEMPS will maintain a public registry for all approved medications and will seek strict requirements for product quality, traceability, and safety, especially for cannabis medicines with over 0.2% THC.
What Remains Restricted
- No recreational legalization. Spain’s new cannabis law applies solely to medical use. Recreational use remains officially illegal.
- Family doctors cannot prescribe cannabis. General practitioners cannot prescribe cannabis medicines under the current law. THC preparations will not be available for purchase as over-the-counter medicines.
- Limited list of eligible medical conditions. The law starts with a relatively narrow set of approved health conditions for which doctors can prescribe medical cannabis, however, this is expected to change over time.
Impact on Patients and Healthcare
For many patients, this change could offer legal access to treatments they’ve long sought. Those suffering from severe conditions - for example, patients who have drug-resistant epilepsy and their seizures cannot be controlled with regular medicines - should now have easy access to high-grade cannabis preparations.
“We recognize the potential benefit that this measure will bring to patients with neuropathic chronic pain or cancer-related pain, among others, providing additional therapeutic options that, for these patients, can make a real difference,” said pain specialist Dr. Jesús de Santiago.
Some access hurdles remain, however. Since prescription must come from hospital specialists, patients in rural or underserved areas may face obstacles. Also, the exclusion of general practitioners and regular pharmacies may limit convenience and raise travel or cost barriers. Scaling up hospitals’ capacity to serve new cannabis patients may take time as well.
These restrictions have frustrated some members of the medical community in Spain. “This decree - while better than nothing - remains highly restrictive. The approved conditions are limited, access to dispensation is costly and tightly regulated,” Manuel Guzmán, Professor of Biochemistry and Molecular Biology, told Business of Cannabis earlier this year, while the law was still in the making.
The AEMPS will play a key role in making sure that the system for delivering cannabis medicines to patients works. During its mandate, the health agency will keep authority to add new eligible medical conditions based on scientific evidence. In the meantime, medical professionals will need training and resources to prescribe cannabis preparations correctly, monitor patients, track down adverse reactions, and comply with stringent safety and traceability rules.
Industry Implications
The decree opens opportunities, but within limits. Companies producing standardized cannabis extracts or oils will be able to supply hospital pharmacies and benefit from those transactions. However, those with focus on flower or less processed forms of marijuana are restricted under the current law.
Operators will need to meet quality, safety and other standards as defined by AEMPS. Some of the practices will involve strict adherence to precise and accurate labeling of cannabinoid content.
Spain’s medical cannabis market has the potential to grow over time, given that new eligible conditions are added, and if national regulators expand patients’ access to medicines. For now, it will be early entrants complying with the current restrictive rules, that can gain advantages from the legal switch.
How Does Spain’s New Medical Cannabis Law Differ from Other European Laws?
Spain’s approach is cautious compared to some countries, such as Germany or Netherlands. Most European countries where medical cannabis is regulated permit broader forms of medical cannabis or allow non-hospital dispensing at least in a limited capacity. Nevertheless, the Spanish law aligns with the European tendency to craft legal frameworks that balance patient need, safety, and strict regulatory oversight.
The AEMPS’s ability to update guidelines and possibly expand the list of medical indications based on new scientific research, gives Spain room to adapt as things move forward. This flexibility may be crucial for building a healthy medical cannabis market.
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Stephen Andrews
