The Ministry of Health in Spain has recently finalised a draft for the medical use of cannabis and is set to approve it in the coming months. The regulatory framework, drafted by the State Agency of Medicines and Medical Devices (AEMPS), awaits approval following discussions between the Ministry of Health, led by Mónica García, and the AEMPS leadership. This development comes after a formation of subcommittee in the Congress of Deputies in June 2022, under the tenure of then-Minister of Health Carolina Darias, to study the regularisation of cannabis for therapeutic purposes.
Regulatory process
The subcommittee has been requiring the AEMPS to provide a report within six months, thus the regulatory procedure has been underway for a while. But it took a year and a half for the Ministry of Health to get the draft. The goal of the proposed Order Ministerial is to create a thorough, scientifically based cannabis medical regulation. The Ministry intends to have talks with a number of parties, such as the Medicinal Cannabis Observatory, before the regulation’s official release in order to improve it in light of scientific data and recognize cannabis as a medicine.
There will be requirements if cannabis is allowed for medical usage. Physicians that specialize in treating particular diseases or ailments may recommend cannabis to patients in order to relieve their discomfort. This action is in line with the Sumar coalition government’s commitment to a complete program of cannabis regulation, which decriminalizes the production and personal use of cannabis by supporting non-profit associations based on self-consumption in addition to medical usage.
Government commitment and timeline
The Sumar coalition supports the legalisation of medical cannabis, which is presently awaiting approval and is expected to become a reality in 2024. This support extends to the comprehensive cannabis regulation scheme. The Ministry of Health expects the regulatory clearance in the “coming months” following discussions with the appropriate parties and assessments of the AEMPS draft, while the precise timetable remains unclear.
The administration has come under fire for missing the deadlines for completing the AEMPS draft. José Miñones, the former minister of health, admitted the error and blamed it on a “excess of zeal.” He expressed regret for the wait and promised to deliver the paper by the end of the designated month; the incumbent minister complied with this promise in December.
Scientific community in Spain
Scientific associations have long supported Spain’s legalisation of medical cannabis. During its XIX National Congress in May, the Spanish Society of Pain (SED) stressed the necessity of cannabis regulation. They cited research showing a short-term pain reduction of up to 30% or more to emphasise its potential in alleviating chronic neuropathic and oncological pain. What is more, not only Spain, but all European countries show changing attitudes towards medical cannabis treatment.
The approaching legalization of cannabis for medicinal use in Spain represents a major advancement in the acceptance of the plant’s possible medical advantages. In order to ensure a safe and efficient approach to medicinal cannabis usage in Spain, cooperation between the government, scientific community, and stakeholders will be essential as the legislative system is subjected to more examination and improvement.