Spain Legalises Medical Cannabis: Patient Access Is the Next Frontier

After years of political delay and institutional hesitation, Spain has finally taken a decisive step toward a regulated medical cannabis system. Royal Decree 903/2025, published this summer, establishes the country’s first comprehensive framework for therapeutic use — a turning point that begins to align Spain with other advanced European markets. This article examines the foundations of this new phase: the scope and limitations of the decree, the first mechanisms for patient access, and the industrial ecosystem that already places Spain among Europe’s key exporters. It also outlines five pragmatic next steps that could convert a legal framework into a functioning, patient-centred medical market.

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After years of political delays and institutional hesitation, Spain has finally crossed a historic threshold.
Royal Decree 903/2025 — published this summer — formally legalises medical cannabis use under strict conditions, transforming rhetoric into law and setting the foundations for a regulated domestic framework.

But make no mistake: this is only the beginning of a long reform process.
The decree opens the door, yet how far Spain walks through it will determine whether it builds a functional medical cannabis market or remains an export economy supplying other countries’ patients while its own citizens continue to rely on illicit channels.

At Cannamonitor, we see this as a decisive turning point — a long-awaited step that establishes the legal scaffolding for future growth but also exposes the gaps, contradictions, and opportunities of the current model.

The 2025 Spain Cannabis Market Report provides the most comprehensive update on regulation, patient access, export flows, and industrial dynamics in Spain’s emerging cannabis ecosystem.

This article summarises the key insights and data shaping the medicinal cannabis landscape.

The Door of Patient Access Opens Narrowly in Spain

Spain’s Royal Decree 903/2025 represents a long-delayed legalisation of medical cannabis — but one that remains highly restrictive in its design and implementation.

The decree allows cannabis-based preparations for therapeutic purposes to be authorised and dispensed through hospital networks.

However, prescriptions are limited exclusively to hospital specialists, and eligible products are strictly defined as extract-based formulations.
In other words, cannabis “preparations” must contain extracts — effectively excluding flower and most vaporisable products from any legal pathway.

This structure positions Spain behind most comparable European markets such as Germany, Portugal, Denmark, and Australia, where both general practitioners and community pharmacies can prescribe and dispense multiple dosage forms, including dried flower.

 

Medical Access Implementation Timeline

Beyond the legal framework, Spain’s implementation capacity remains the real test. The decree entrusts hospitals with dispensing and monitoring, yet many lack the administrative infrastructure to manage controlled substances efficiently. The same applies to private hospitals, which are legally authorised but may face obstacles in practice. Without clearer coordination and digital traceability between prescribers, pharmacists, and regulators, the new system risks stalling before it starts.

Despite these limitations, the final version of the Spanish decree does include two regulatory mechanisms that could expand access in the medium term:

  • No closed list of indications: Instead of a fixed list of conditions, medical indications will be defined through pharmacopoeia monographs. This allows future expansion without requiring a full cabinet reform.

  • Potential access through community pharmacies: Although initially limited to hospital dispensation, the decree enables the cabinet to authorise community pharmacy sales via a later resolution.

These two openings will determine the evolution of the Spanish market. If political will aligns with regulatory capacity, Spain could transition from a residual pilot program to a functioning medical system within two years.

In practical terms, the current legislature has a two-year window to enact this next phase — or risk freezing the market in its infancy. If registration and distribution procedures advance efficiently, first sales could begin by Q2 2026, giving Spain a real opportunity to build a structured, compliant market within the current political term. 

The significance of this cannot be overstated. For the first time, Spanish regulators have defined a legal route for cannabis-based medicines — a development that both industry and patients have awaited for nearly a decade.

However, legal authorisation alone will not generate prescriptions. Most Spanish physicians have received no formal training in cannabinoid medicine, and no accredited postgraduate programmes currently exist. Integrating basic cannabinoid pharmacology and clinical guidance into medical curricula and professional societies will be essential to transform legality into actual clinical adoption.

At the pharmacy level, Spain’s hospital-only model is already showing its limits. Rural regions without reference hospitals will face structural inequities in access. Allowing accredited community pharmacies and telepharmacy services to dispense compounded preparations could expand reach while maintaining full traceability — a low-cost reform with high public-health impact.

Still, the gap between the law’s intent and its actual accessibility remains large. Without rapid expansion to pharmacies and new product categories, Spain could end up with a highly bureaucratised model serving only a few dozen patients — while the vast majority continue to rely on grey-market channels or social clubs.

A Productive and Export-Focused Medical Cannabis Ecosystem

Revenues of Medicinal Cannabis Companies
Company Creation & Investment

While Spain’s domestic market remains nascent, its production and export sector has reached industrial scale. In fact, Spain today operates one of Europe’s most sophisticated cultivation and manufacturing ecosystems — but the paradox is that almost all of it serves foreign patients.

As of 2025, the country counts around 70 active companies involved in medicinal cannabis cultivation, processing, research, or pharmaceutical services.
Cumulative investment in the sector has reached €147 million, supporting roughly 500 direct jobs, and generating around €34 million in revenues (2023) — primarily from export contracts.

Spain’s export infrastructure has matured rapidly in recent years. New facilities, standardised under EU-GMP, have positioned the country among the top 10 global cannabis exporters, producing at roughly one quarter of Portugal’s output. Exported production is expected to have exceeded 8 tonnes in 2024, rising close to 10 tonnes in 2025, with undisclosed extract shipments further adding to the total.

🇬🇧 United Kingdom and 🇩🇪 Germany: The Main Destinations

Data from commercial partners and import registries indicate that the UK and Germany are the two principal destinations for Spanish cannabis exports.
The UK remains the single largest buyer, accounting for more than half of total Spanish flower exports even after Germany’s post-CanG expansion. Germany follows as the key EU destination, particularly for high-GMP medical flower and extract segments.

Additional trading routes include Switzerland, where Spanish companies like Ondara Directorship and NaturHemp supply biomass for processing, Italy, where Linneo Health maintained an exclusive contract under the state tender, and Portugal, which also acts as a processing and re-export hub for some Spanish producers.

Spain's Industrial Maturity and Vertical Integration

The Spanish supply chain now spans the entire value chain: genetics → cultivation → processing → manufacturing → pharmaceutical services.

Core production capacity is led by companies such as Linneo Health, Alcaliber, and Medalchemy (Curaleaf) — all of which have achieved international validation for EU-GMP compliance.
Together, they represented the backbone of Spain’s exportable production in recent years.

These established players have recently been joined by a new wave of licensed exporters such as Medical Plants and Ondara Directorship, both of which began shipping flower and biomass to European markets in 2024. The trend points to steady industrial diversification, with several other licensees expected to complete GMP validation in the coming quarters.

Supporting this expansion is an emerging layer of specialised pharmaceutical services.
Companies like Ionisos (providing sterilisation and pharmaceutical validation) and Agropharm Projects (GMP facility design) are strengthening the ecosystem’s vertical integration — a sign of rising technical sophistication and readiness for domestic market entry once allowed.

Genetic development has become another area of strategic value.

Spain currently counts five licensed genetics suppliers, including Sovereign Genetics, Cannaflos Genetics S.L., and Phytoplant Research.

This segment has attracted growing international attention, though it also faces regulatory complexity — including unresolved issues around intellectual property, cross-border licensing, and lack of transparency in application procedures.

Spain's Medical Flower Exports
Main Medical Cannabis Companies in Spain

Earlier this year, the Transparency Council ruled against Spain’s Medicines Agency (AEMPS) for failing to disclose the criteria and conditions of certain licensing processes — a decision that underscores the persistent institutional opacity in the sector.

This lack of digital integration and public reporting continues to hinder evidence-based policymaking and market confidence. Transparency and data integration have become the next frontier. Spain’s Medicines Agency still operates largely through opaque manual licensing processes, lacking a public registry of production or authorisations. Modernising these systems would strengthen accountability and investor confidence while improving regulatory efficiency.

Despite these governance weaknesses, the industrial foundation is clear: Spain is already a major global producer and exporter, with the physical and technical capacity to supply a large-scale domestic market — if and when policy catches up.

The Road Ahead: Transforming Industrial Capacity into Patient Access

Ultimately, Spain’s medical cannabis reform will be judged not by tonnes exported but by patients treated.

Up to 8 million Spaniards could benefit from cannabinoid-based therapies — mainly for chronic pain, neurological disorders, epilepsy, and sleep conditions. Yet under the restrictive framework of Royal Decree 903/2025, only a few hundred are expected to gain access initially.

In Germany, medical cannabis currently reaches around 13% of the country’s market demand. A model with s comparable penetration in Spain implies a potential market of 80 tonnes per year, worth roughly €0.5 billion — but the current system will capture only a fraction of that: in a escenario 

Without community-pharmacy dispensing, diversified dosage forms, and training for prescribers, the Spanish model risks remaining a bureaucratic micro-market rather than a functional health service.

Five pragmatic steps to consolidate Spain’s regulated medical cannabis framework:

1️⃣ Update and expand therapeutic monographs

    • Regularly revise the National Formulary to incorporate new preparations, dosages, and administration routes.
    • Include emerging evidence on conditions such as anxiety, insomnia, and neuropathic pain, allowing clinical judgement to guide prescriptions rather than fixed lists.

2️⃣ Strengthen prescriber training and autonomy

    • Consolidate prescribing capacity in both public and private hospitals, improving coordination across care levels.
    • Integrate accredited cannabis medicine education in medical curricula and professional societies to ensure evidence-based practice.
    • Authorise family doctors and extrahospital specialists to prescribe within defined protocols.

3️⃣ Prevent bottlenecks and decentralise dispensing

    • Enable telepharmacy and remote patient follow-up — especially in regions with limited hospital density — ensuring safety and traceability.
    • Incorporate qualified community pharmacies with the technical capacity to prepare and dispense magistral formulations.
    • Guarantee supply diversity, price stability, and public reimbursement mechanisms to promote equitable access.

4️⃣ Launch experimental access programmes and build national evidence

    • Authorise controlled pilot projects using medical cannabis flower and new formats under hospital or academic supervision.
    • Engage hospitals, universities, and licensed producers in applied research programmes to generate real-world data.
    • Create a National Medical Cannabis Observatory to coordinate evaluation, standardisation, and policy recommendations.
 

This incremental, evidence-based strategy fits Spain’s institutional reality. Rather than reopening narcotics law, it focuses on execution: training doctors, mobilising pharmacies, and building data systems that convert legality into access.

Royal Decree 903/2025 delivers Spain’s long-awaited legal foundation, but its success depends on operational follow-through. Today, Spain exports tens of tonnes of medical cannabis each year to serve foreign patients while its own remain excluded — a paradox that underscores both industrial strength and regulatory inertia.

The conditions for progress are already in place: €150 million in certified assets, an advanced GMP manufacturing base, and a strong research network. What remains is administrative alignment. The Transparency Council’s recent ruling exposed the root challenge: opacity, not capacity.

If Spain accelerates implementation and embraces open data, it can balance control with access — maintaining export leadership while building a legitimate domestic market.

Legalisation is no longer the question; legitimacy is. With transparency, competence, and evidence, Spain can finally move from being an exporter of others’ medicine to a provider of its own.

Tags :
Cannaflos,Curaleaf,Exports,Linneo Health,Medalchemy,Medical,Medical Plants,Ondara Directorship,Phytoplant,Sovereign Genetics,Spain
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