Pharmacists in Spain Appeal to the Supreme Court Over the Exclusion of Pharmacies from the Medical Cannabis Framework

The new decree authorizing medical cannabis to treat a limited number of conditions (spasticity caused by multiple sclerosis, severe forms of refractory epilepsy, nausea/vomiting due to chemotherapy, and refractory chronic pain) currently excludes the network of community pharmacies, which has raised significant concern among pharmacists and patients.

After its publication in the BOE, a three-month deadline was set for the AEMPS (Spanish Agency for Medicines and Medical Devices) to publish the clinical monographs detailing the indications, dosages, and treatment guidelines for each formulation. This was released a few days ago. 

Pharmacists argue that the proposed model unnecessarily restricts access: local pharmacies cannot dispense medical cannabis, forcing patients to travel to hospitals to receive treatment.

Patient associations have also voiced concerns about whether this limitation could create supply issues in practice.

Pharmacists Take Legal Action

In response, two organizations from the pharmaceutical sector have taken the dispute to court. In December 2025, the Confederación Empresarial de Oficinas de Farmacia de Andalucía (CEOFA) filed an administrative lawsuit against Royal Decree 903/2025.

A few weeks later, the Consejo General de Colegios Oficiales de Farmacéuticos (CGCOF) filed a similar challenge with the Supreme Court.

Both appeals specifically target Article 8 of the decree, which reserves the preparation and dispensing of magistral cannabis formulations exclusively for hospital pharmacies. The associations contesting the decree justify their appeal primarily on grounds of access and competition.

According to CEOFA, the decree "constitutes regulatory overreach" by contradicting the law governing medicines, as it "unduly restricts an activity that the law does not restrict."

They argue that the regulation excludes community pharmacies "without justification and without technical reasoning" by limiting participation in the preparation and dispensing of these cannabis-based medicines to the hospital setting.

CGCOF, for its part, warns that there is "no health, legal, or safety reason" to justify dispensing medical cannabis only in hospitals. These organizations also point out that community pharmacies already handle other highly controlled drugs (such as opioids) under strict supervision, making the current exclusion appear arbitrary.

The Legal Key Points of the Challenge to the Royal Decree on Medical Cannabis

The two organizations outline several key arguments in their filings:

• CEOFA (Andalusian pharmacies) argues that RD 903/2025 encroaches on regional authority in pharmaceutical matters. It notes that current legislation already recognizes the ability of community pharmacies to prepare magistral formulations (according to the National Formulary) when they have adequate facilities. Therefore, it claims that this limitation unjustifiably excludes community pharmacies from functions the law does not prohibit, reserving them solely for hospitals.
• CGCOF (community pharmacies) highlights the lack of technical justification. In its statement, it stresses that there are no health or safety reasons to prevent dispensing through the pharmacy network. According to this organization, limiting dispensing to hospitals exacerbates difficulties for patients-especially those who live far from a hospital-making it harder to access approved treatments for serious conditions.
• Common argument: both organizations point out that the extensive network of community pharmacies ensures accessibility and territorial equity, providing close and professional pharmaceutical care even in rural areas. Restricting these functions "without legal or technical basis" constitutes, in CEOFA's words, "an unnecessary barrier to patients' access" to potentially beneficial treatments.

What Happens Next? Timelines and Next Steps

After the appeals are filed, the Third Chamber of the Supreme Court must admit both cases for consideration and decide whether Royal Decree 903/2025 is lawful. Administrative proceedings can last months or years, especially in complex areas such as health regulation. For now, the publication in the BOE has opened a nine-day window for interested parties (such as patient associations or the Ministry of Health itself) to join the litigation.

Publication of the AEMPS Clinical Monographs: A Key Step Toward Real Implementation of the Law

AEMPS has just published the corresponding monographs in the National Formulary, fulfilling the legal requirement needed for medical cannabis treatments to begin being prescribed within the Spanish health system.

 Their publication represents a major step forward, providing specialist doctors and hospital pharmacists with a clear technical and legal framework to work from. However, it also confirms the restrictive nature of the regulation: the monographs do not cover the use of flower, therapeutic self-cultivation, or dispensing through community pharmacies.

In practice, this means that medical cannabis in Spain is beginning to become a regulated reality, but limited to a tightly controlled model that excludes many patients who were already using cannabis therapeutically through other channels.

The publication of the monographs does not end the debate, but it does mark the start of a new phase: the real clinical rollout of medical cannabis, with the possibility that these technical guidelines will expand and evolve as scientific evidence and clinical experience grow.

Patients and associations have been calling for a more open regulatory framework for years, and the current legal dispute reflects the tension between strict centralized control and the demand for genuine accessibility. The outcome will determine the extent to which Spain's health system embraces greater integration of medical cannabis or maintains a highly restricted model-at least in this first phase of legalization.