Medical cannabis is just one step away from reaching Spanish hospitals. One year after the entry into force of Royal Decree 903/2025 and the publication of the monograph of the National Formulary, the regulation finally materializes in specific preparations with which the treatments that Spanish patients will receive can be formulated.
In July, Curaleaf became the first and, to date, the only company to register with the Spanish Agency for Medicines and Health Products (Aemps) two standardized cannabis preparations, CAN-1 and CAN-2, which will serve as raw material for the production of master formulas. According to their forecasts, they will imminently begin distributing their preparations, initially in 50 hospitals. By the end of the month, they note that medicinal cannabis could be available in hospitals.
The American company is a supplier of cannabis consumer products and has manufacturing and R&D facilities in Alicante from which it develops part of its activity for Spain and other international markets.
The registration milestone
In Spain, Alejandro Gil Escolano, director of Regulatory Affairs at Curaleaf, explains that the main challenge has been precisely regulatory: "From February to July, our work focused on responding to requests for additional information from the Aemps, to which we responded systematically and quickly," he points out. However, they started from several years of previous work. "Since 2020, the manufacturing processes and stability studies of CAN-1 and CAN-2 have been developed and validated, which have subsequently been the subject of continuous improvements."
The registry certifies that both preparations meet the quality requirements established in the monograph of the National Formulary, which allows hospital pharmacies to prepare standardized master formulas. For pharmacists it means having "a standardized raw material, of controlled quality and with a known cannabinoid content," explains Gil Escolano. For doctors, it opens a regulated avenue for prescribing cannabis "when authorized alternatives have not worked or are not available."
Standardization implies that each batch is adjusted until a defined cannabinoid content is reached, with a tolerance of ±10%, so that pharmacists start from known concentrations of THC and CBD. Both preparations are manufactured at Medalchemy, Curaleaf's Alicante plant, in accordance with the EU Good Manufacturing Standards (EU-GMP), and each batch is released if it meets the established quality specifications. In this way, it is guaranteed that the preparations maintain "consistent and reproducible" characteristics, explains Gil Escolano.
Last steps
Once the regulatory process has been passed, the next step is to make the arrival of CAN-1 and CAN-2 effective to hospitals. The preparations can now be made available to pharmacy services and prescribing doctors, although their supply will depend on completing the logistical and quality procedures necessary to organize distribution.
The company finalizes these aspects with a logistics partner who must guarantee national coverage. "CAN-1 and CAN-2 can potentially be supplied to all hospitals in Spain, approximately 850, so we needed a reliable and consolidated partner, with distribution routes that cover the entire national territory," explains Gil Escolano. Once these procedures are completed, Medalchemy will supply the preparations to the logistics operator and hospitals will be able to place their orders as the prescriptions are produced.
Spanish regulation contemplates the use of medicinal cannabis as a last-line option in four clinical situations: spasticity associated with multiple sclerosis, certain severe forms of refractory epilepsy, chemotherapy-induced nausea and vomiting, and refractory chronic pain. "The choice of the indication and the patient is a clinical decision that corresponds to the specialist," says Gil Escolano.
Patient access
Financing conditions should not be a barrier to access, the company says. "According to the information we have, patients should not have to pay," says Gil Escolano. The company's forecast is that the cost of CAN-1 and CAN-2 will be assumed by the budget of each hospital. In private healthcare, it would depend on each center and the patient's healthcare or insurance coverage.
The company also does not expect inequalities to occur between autonomous communities. "CAN-1 and CAN-2 are registered for supply throughout the country and there should be no regional restrictions that prevent doctors from prescribing or using this legal alternative," says Gil Escolano.
The care circuit will be similar to that of other hospital master formulas. The specialist must evaluate the patient and confirm whether he or she meets the criteria for cannabis prescription. If he considers the treatment indicated, he will issue a prescription in which he will specify the composition and concentration of cannabinoids.
The hospital pharmacist will prepare the formula from the Curaleaf preparations and dispense it to the patient. Subsequently, "the medical team and the hospital pharmacy will jointly monitor the treatment," explains Mikael Sodergren, medical director of Curaleaf.
In German pharmacies
Sodergren points out that there are precedents in other European countries. "Community pharmacies and online pharmacies are involved in dispensing, showing that it can be done as long as the right controls are in place: traceability, training and appropriate storage conditions."
In Europe, very different models of access to medicinal cannabis coexist. Since 2018, the United Kingdom has contemplated a prescription limited to specialists included in a register of the General Medical Council (GMC). In this country, much of the care takes place in private clinics and, as in Spain, medicinal cannabis is not used as a first-line therapeutic option.
However, in Germany the prescription is broader and dispensing has been done through community pharmacies since 2017. "Any doctor can prescribe it as a first-line treatment," says Sodergren.
Faced with these examples, the company qualifies the Spanish model as "more prudent", as it is led from the hospital, is limited to specific indications and relies on hospital master formulation. "This provides a solid and controlled starting point, although it poses certain limitations for patients," Sodergren warns.
The experience accumulated in other countries leaves several lessons according to Curaleaf's medical manager: "The training of prescribers, the constant quality and availability of products, and the systematic collection of data from real clinical practice are essential elements for any framework to function properly," he emphasizes.
