Spain Regulates Medical Cannabis in Hospitals
Is Spain Improving Access to Medical Cannabis?
Spain has taken a significant step towards improving access to medical cannabis, although this access is currently limited to hospital settings. Pharmacies and advocates are calling for broader, universal access.
Overview of the New Regulations
The Spanish Council of Ministers has approved a Royal Decree to establish a medical cannabis program in the country following over three years of study. This decree outlines the guidelines for the prescription, preparation, dispensing, and usage of standardised cannabis preparations within hospitals.
One of the key features of the decree is the creation of a registry for these standardised cannabis preparations, which will be overseen by the Spanish Agency for Medicines and Health Products (AEMPS). This entity will soon release the necessary monographs needed to integrate therapeutic cannabis into the National Formulary, categorising approved cannabis master formulas based on specific medical conditions. Laboratories interested in producing these formulas must submit applications along with the required documentation.
Manufacturers of these preparations will be obliged to adhere to good manufacturing practices, maintain documentation of their supply chains, and are permitted only to supply cannabis extracts to hospital pharmacy services or for exportation. If the preparation contains levels of THC that are deemed psychotropic, special authorisations will be required.
Cannabis Master Formulas in Hospitals
According to the Royal Decree, only specialist physicians working in hospitals may prescribe cannabis master formulas, and this can occur only when no authorised medications are available or when existing treatments have proven ineffective. Hospital pharmacy services will be responsible for preparing, dispensing, and monitoring the medication in collaboration with medical staff.
The General Council of Official Colleges of Pharmacists, which represents pharmacies in Spain, has expressed a desire to sell cannabis extracts in its stores. They argue, “There is no health, legal, or safety reason to justify limiting its dispensing exclusively to hospital pharmacy services.”
Calls for Wider Access
The Spanish Council of Pharmacists believes that master prescriptions could be safely dispensed in community pharmacies. Meanwhile, the Spanish Cannabis Observatory, a key player in the ongoing debate about cannabis regulation in Spain, has shown general support for the progress made but voiced concerns over the limited access to herbal medicines.
Carola Pérez, the president of the Observatory, has criticised the confinement of dispensing to hospitals, stating that this approach forces patients to rely on therapeutic cannabis only when conventional treatments have failed. She emphasised that restricting access to channels such as community pharmacies or home cultivation will ultimately compel patients to seek out the illegal market. "We are far behind other countries like Germany, Switzerland, and the United Kingdom," she remarked in a recent interview.
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Liz Filmer
