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Market Overview
Spain has emerged as one of Europe’s largest medical cannabis producers, with substantial volumes of cannabis cultivated, imported, processed, and exported annually. Despite its strong production base, the number of commercially active domestic players remains limited, and patient access is yet to be established.
In February 2025, Spain submitted a draft Royal Decree to the European Union for approval, outlining the framework for a national medical cannabis programme. If ratified, this legislation would grant patients legal access to medical cannabis for the first time in Spain’s history—marking a significant policy milestone after years of political hesitation.
However, early indications suggest that the proposed framework will be highly conservative, allowing only the use of extract-based medical cannabis products while prohibiting dried flower for patient use. This restriction, combined with limited prescription pathways and narrow eligibility criteria, has prompted criticism from patient advocacy groups and sections of the medical community who view the measure as a missed opportunity for broader reform.
Despite its production capacity and export potential, Spain’s domestic market outlook remains constrained, with minimal scope for expansion under the current proposal.
Regulatory Framework
Spain’s forthcoming medical cannabis framework is set out under the draft Royal Decree submitted in February 2025, which establishes the conditions for cultivation, manufacture, distribution, and prescription of medical cannabis products.
Pending EU approval and subsequent implementation by Spain’s Ministry of Health, the new law is expected to enter into force by late 2025. Under the decree:
- Only extract products will be authorised for patient use (no dried flower permitted).
- All products must comply with EU-GMP standards and be dispensed through hospital pharmacies.
- Licensing and oversight will fall under the Spanish Agency of Medicines and Medical Devices (AEMPS), which currently supervises cultivation for research and export.
- Products will be prescription-only, and prescriptions must be issued electronically through authorised hospital systems.
The framework is designed to be highly controlled, following models similar to those of France and Denmark in their pilot stages.
Patient Access
Who Can Prescribe?
Only medical specialists—not general practitioners—will be authorised to prescribe medical cannabis under the new programme.
Approved Indications:
Medical cannabis may only be prescribed for a limited number of conditions, including:
- Spasticity associated with multiple sclerosis
- Severe therapy-resistant epilepsy
- Chemotherapy-induced nausea and vomiting
- Chronic, therapy-resistant pain
In all cases, cannabis-based treatments may only be prescribed as a last resort, once conventional therapies have been proven ineffective or poorly tolerated.
Distribution:
Dispensing will occur exclusively through hospital pharmacies, ensuring traceability but further limiting accessibility for patients outside specialist care.
Industry Landscape
Spain remains a major cultivation and export hub for medical cannabis, leveraging its favourable climate, agricultural expertise, and established pharmaceutical manufacturing infrastructure.
As of early 2025, over 25 companies are authorised by AEMPS to conduct activities relating to medical cannabis cultivation, research, or processing. Most of these licences are export-oriented, with Spain supplying bulk flower and extract material to Germany, Portugal, Poland, and the UK.
While the forthcoming domestic framework may open a new market segment, the scale of patient access is expected to remain small, and Spain’s industry will likely continue to prioritise international exports in the near term.
Outlook
Spain’s entry into legal medical cannabis access marks a pivotal regulatory moment for Southern Europe. However, the proposed model’s narrow prescription criteria and restriction to extracts risk limiting both clinical adoption and patient benefit.
Unless the framework evolves to accommodate a broader range of conditions and product formats, Spain’s domestic market will remain modest, even as its cultivation and export sectors continue to thrive within the European supply chain.
