HIBAPRESS – Chafiq Anouri
The Spanish government approved, on Tuesday, the royal decree that regulates the use of cannabis for therapeutic purposes within the country.
The Spanish newspaper "El Faro" revealed that the decision will allow the use of pharmaceutical formulations prepared from standard cannabis extracts in cases where traditional treatments do not show effectiveness. Health Minister Mónica García said that the aim of this regulation is to provide a safe therapeutic alternative supported by scientific evidence, explaining that "this rule will allow us a guaranteed treatment option when traditional treatments fail," according to what was stated at a press conference following the cabinet meeting. According to the Spanish newspaper, García considered the decision a response to a long-awaited demand from the parliament, medical circles, and patients, stressing that it "aims to alleviate real suffering through an effective, accurate, and evidence-based therapeutic alternative." The "El Faro" website reported that the new decree will be applied in specific clinical cases such as chronic pain, muscle spasms, treatment-resistant epilepsy, and nausea or vomiting resulting from chemotherapy, adding that the ministry did not rule out expanding its list of uses in the future if scientific studies prove additional benefits. The same source explained that the medical preparations will be allowed to be prescribed by specialized doctors within hospitals, when there are documented medical justifications for this. The formulations will also be prepared in the pharmacy departments of licensed hospitals, according to good manufacturing practices and the technical standards specified in the "National Compounding Guide." According to the Spanish website, the decree also stipulates the establishment of a public registry managed by the Spanish Agency for Medicines and Health Products (AEMPS), in which every product of cannabis used in pharmaceutical formulations is recorded, adding that "it is required that these products contain precise percentages of THC and/or CBD, and adhere to strict requirements related to traceability, quality, and safety, provided that products containing more than 0.2% of THC are subject to additional monitoring." According to "El Faro," the decree also obliges the producing laboratories to ensure the quality of manufacturing and distribution and to document and review all stages of the supply chain, following that the treating physician, in cooperation with the hospital pharmacy, will monitor the effectiveness of the treatment and its side effects on a regular basis. The same source mentioned that the Ministry of Health provides, in exceptional cases or areas experiencing geographical difficulties, the possibility of adopting remote dispensing mechanisms that ensure patients' equal access to treatment, adding that the royal decree does not set a closed list of permitted medical uses, as the Spanish Medicines Agency will publish detailed guides on manufacturing conditions, doses, and method of prescription during the next three months. According to "El Faro," this system aims to enable continuous updating based on scientific and clinical progress and to open the field for expanding the medical use of cannabis in the future "under precise standards of effectiveness, safety, and medical necessity," continuing that with this decision, "Spain joins the list of European countries that have regulated the use of cannabis for medical purposes, within a controlled health model that relies on scientific research and provides complete guarantees for patients."
