Pharmacists' lawsuits may delay the regulation of medical cannabis in Spain

New legal challenges filed with the Supreme Court of Spain by pharmaceutical entities may impact the timeline for implementing medical cannabis in the country. 

The General Council of Official Colleges of Pharmacists (CGCF) and the Andalusian Confederation of Pharmacies (CEOFA) have filed appeals against Royal Decree 903/2025, specifically against the restriction that limits the dispensing of products only to hospital pharmacies, excluding community units.

The action by CGCF, representing around 22,000 pharmacies in Spain, was formalized after notification in the Official State Gazette (BOE) on January 3. The move follows a similar initiative by CEOFA, carried out in mid-December. 

Both appeals aim to amend Article 8 of the decree approved in October, which establishes that standardized cannabis preparations "can only be supplied to legally established hospital pharmacy services".

The legal scenario coincides with the end of the administrative deadline set by the Spanish Agency of Medicines and Medical Devices (AEMPS). The agency had three months, starting from October, to publish clinical monographs detailing authorized uses, dosages, and prescription conditions. This period ended earlier this month, simultaneously with the filing of legal challenges.

The point of conflict

The current legislation determines that only hospital pharmacy services are responsible for preparing magistral formulas based on cannabis and their dispensing, both for inpatients and outpatients. The professional entities argue that this restriction limits access and seek the inclusion of community pharmacies in the distribution network.

The Official State Gazette opened a nine-day period from the announcement for other interested parties, including patient advocacy groups, to join the process. Although the appeals may lead to further delays in the law's implementation, the norm review has the potential to expand access points to medications in Spanish territory if community pharmacies are included.

Criteria of the new regulation

Royal Decree 903/2025 establishes the first comprehensive regulatory framework for medical cannabis in Spain. The regulation excludes the use of the plant's flower (in natura), allowing only oils and standardized extracts. The treatment is considered a last resort, authorized only when conventional medications, such as Sativex, prove ineffective.

Prescriptions are limited to specialist doctors in a hospital setting, and patients must be enrolled in a centralized registry of the AEMPS. The four medical indications authorized by the text are:

- Spasticity associated with multiple sclerosis;

- Severe refractory epilepsy;

- Nausea and vomiting due to chemotherapy;

- Refractory chronic pain.

The Spanish Ministry of Health argues that the centralized and hospital-based approach allows for continuous evidence-based updates, aiming to ensure effectiveness and safety in patient treatment.

With information from Business Of Cannabis