Medical Cannabis in Spain: Where Do We Stand and How Long Until It Becomes a Reality?

In recent months, the debate has taken a step forward with the publication of a draft Royal Decree by the Ministry of Health, which finally outlines a potential regulatory framework.

Yet the inevitable question remains: are we genuinely moving closer to the regulation of medical cannabis in Spain, or does this still feel like a 'so close, yet so far' scenario?

Spanish Law Today: The Limits of Medical Cannabis Access

As surprising as it may seem given the regulatory progress across much of Europe, Spain still lacks a general law on medical cannabis. The therapeutic use of the plant remains unregulated - unlike in many other European nations and countries around the world where clear frameworks already exist.

There are, however, two cannabis-based medications currently approved in Spain:

• Sativex, an oromucosal spray containing both THC and CBD, indicated for the treatment of spasticity in patients with multiple sclerosis.
• Epidyolex, an oral cannabidiol solution authorised for refractory epilepsy associated with syndromes such as Lennox-Gastaut or Dravet.

Both medicines have been authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS) and are available only by prescription. However, access remains highly restricted, costly, and limited to very specific clinical cases.

Meanwhile, the AEMPS authorises the cultivation of medical cannabis in Spain, but the vast majority of this production is intended for export and research rather than domestic use. In other words, while tons of cannabis are being grown under strict pharmaceutical standards, Spanish patients see little to no benefit.

The Draft Royal Decree: Regulation on the Horizon

The long-awaited breakthrough arrived in 2024, when the Ministry of Health released a draft Royal Decree for public consultation, aiming to regulate the so-called typified magistral formulas based on standardised cannabis preparations. Put simply, if approved, the Royal Decree would legalise cannabis-derived pharmaceutical preparations, which would be prescribed and dispensed in hospitals.

According to the draft text currently under consultation, these standardised formulas would be indicated for a very limited number of conditions:

• severe refractory epilepsy
• spasticity associated with multiple sclerosis
• chemotherapy-induced nausea and vomiting
• chronic pain unresponsive to conventional treatments

Under this future legal framework, only specialist doctors would be authorised to prescribe these preparations, which would be dispensed solely through hospital pharmacies.

From Draft to Decree: The Road to Spain's Medical Cannabis Regulation

The question persists: what is the real state of this elusive legal framework, which always seems just beyond reach?

Steps Completed So Far:

1. Public consultation (February–March 2024): The Ministry of Health opened a channel to gather input from patients, doctors, autonomous communities, and associations.
2. Draft unveiled (September–October 2024): On 30 September 2024, the draft Royal Decree was officially published and remained open for public comments for a three-week period.
3. European review (January–April 2025): The draft was submitted to Brussels for examination by the European Commission, and opened to comments. Spain received several observations, but none were considered blocking, allowing the process to move forward.
4. Review by the Council of State (September 2025): On 18 September 2025, the Council of State reviewed the text, pointed out several technical aspects, and issued formal observations for consideration before final approval.

Where Do We Stand Today?

The draft has already passed through public consultation, European review, and the Council of State's opinion. In other words, the text is mature and ready to be approved. What remains are the final steps:

• Approval by the Council of Ministers: The Government must formally approve the Royal Decree in one of its weekly sessions.
• Publication in the Official State Gazette: The regulation will have no legal effect until the Royal Decree is published in the Boletín Oficial del Estado (BOE).
• Official AEMPS Monographs: After the decree enters into force, the Spanish Agency of Medicines and Medical Devices must publish the magistral formulas so that hospitals and laboratories can manufacture them safely and with guaranteed quality.

Remaining Gaps

Although the draft marks a historic milestone, patient associations and activists argue that it still falls well short of meeting real patient needs:

• Exclusion of dried flower: The draft explicitly prohibits the use of cannabis buds or whole plant material for medical purposes.
• Ban on therapeutic self-cultivation: There is no legal avenue for patients to grow their own cannabis plants for medical use.
• Unclear coverage: It remains uncertain whether these preparations will be covered by the public health system.
• System capacity: Concerns persist over whether hospitals and pharmaceutical labs will be able to meet patient demand.

Europe: The Mirror for Spain

The contrast with other European countries is increasingly evident. Germany has had a medical cannabis framework in place since 2017, allowing doctors to prescribe it in various forms - including dried flower - with costs covered by health insurance.

Portugal also allows patients access to standardised preparations, while in the United Kingdom prescriptions are technically permitted but remain rare in practice.

Spain's delay is striking: while the country debates medical access, other European nations - including Germany, Malta, and the Czech Republic - are already moving toward the legalisation of cannabis for recreational use.

At the same time, both the United Nations and the World Health Organisation have formally recognised the therapeutic value of cannabis, adding further international pressure for reform.

The Impact on Patients

To this day, many patients continue to rely on the black market or cannabis associations to obtain medical cannabis, exposing themselves to products that lack both safety guarantees and medical supervision. With the Royal Decree, some of these patients will finally gain access to regulated preparations, but only in hospital settings and under strict conditions. The rest will remain trapped in legal limbo, forced to rely on informal channels.

Patient groups are clear: while they welcome this step, they insist that regulation must be broader, more inclusive, and more accessible. The real needs of patients extend far beyond four conditions or a single mode of consumption.

Spain is at a turning point: the draft Royal Decree represents the state's first genuine commitment to regulating medical cannabis nationwide. Yet the path toward a comprehensive framework remains unfinished and incomplete. The challenge for the coming years will be to expand this initial framework into a fairer and more effective model that is firmly grounded in scientific evidence.

Update (October 7, 2025): At the time this article was written, the law regulating the use of medical cannabis in Spain had not yet been approved by the Council of Ministers. However, on Tuesday, October 7, the Government officially approved its legalization, marking a historic milestone for regulated access to cannabis-based treatments in the country.