Medical Cannabis in Spain: The Royal Decree That Changes History

On October 7, 2025, Spain marked a historic milestone with the approval of Royal Decree 903/2025, which regulates the use of medicinal cannabis in the country for the first time. This regulation, long awaited by patients and healthcare professionals, opens the door to cannabinoid treatment under strict medical and hospital supervision.

What exactly changes with the new legal framework?

The Royal Decree establishes an exclusive hospital system for the prescription and dispensing of medicinal cannabis. Standardized THC and CBD preparations can only be produced in hospital pharmacies, guaranteeing the highest quality and traceability of each product.

Prescription will be reserved for medical specialists in specific pathologies, when conventional treatments have not been effective. Initial indications include refractory epilepsy, multiple sclerosis, refractory chronic pain, and chemotherapy-induced nausea, although the list may be expanded as scientific evidence progresses.

The hospital model: a guarantee of safety

Unlike other European countries, Spain has opted for a restrictive and controlled model. Patients will not be able to acquire medicinal cannabis in community pharmacies, but only through hospital pharmacy services. This approach seeks to ensure rigorous pharmacotherapeutic monitoring and continuous evaluation of treatment efficacy.

The Spanish Agency of Medicines and Medical Devices (AEMPS) will publish official monographs within three months, specifying the exact dosages, compositions, and conditions of use. In addition, a public registry will be created where all standardized preparations used must be registered.

Economic perspectives and sector opinions

Although the sector celebrates the progress, producing companies consider the regulation insufficient. The Business Association of Medicinal Cannabis of Spain (AECAME) points out that the exclusion of flower and initial restrictions leave "90% of the national productive fabric out."

However, entrepreneurs like Borja Iribarne from ProfesorCBD highlight that broader regulation could generate up to 20,000 jobs and 500 million euros in taxes. In the medium term, the sector estimates that the domestic market could reach between 250 and 400 million euros annually.

The German example as a reference

The Spanish Royal Decree contrasts with the German model, which since April 2024 has allowed dispensing in community pharmacies and has experienced exponential growth. Germany imported 37 tons in the first quarter of 2025 alone, becoming the main destination for Spanish exports.

Spain reported a production of 51.3 tons in 2024, with 100% destined for export. This paradox shows that while the country is consolidating itself as one of the seven largest producers worldwide, its domestic market is only just beginning to develop.

What does it mean for patients?

For thousands of people suffering from chronic pathologies unresponsive to conventional treatments, the Royal Decree represents a real hope. Legal and supervised access to medicinal cannabis eliminates legal uncertainty and guarantees pharmaceutical quality products with verified compositions.

However, the hospital model means that only those who meet strict clinical criteria and obtain specialized prescriptions will be able to access treatment. Non-presential dispensing will only be allowed in exceptional cases due to patient vulnerability or geographical barriers.

Royal Decree 903/2025 marks the beginning of a new era for medicinal cannabis in Spain, although the path towards broader and more accessible regulation is still long. The experience of other European countries and the evolution of scientific evidence will determine the next steps of this healthcare transformation.