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.
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.
If approved, the medical use of cannabis will come with certain prerequisites. Medical specialists will be able to prescribe cannabis for the alleviation of pain coming from with specific diseases or conditions. This move aligns with the Sumar coalition government’s commitment to a comprehensive cannabis regulation program, endorsing not only medical usage but also advocating for non-profit cannabis associations based on self-consumption, thereby decriminalising production and personal consumption.
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 government has faced criticism for delays in fulfilling the deadlines set for the AEMPS draft. Former Health Minister José Miñones acknowledged the lapse, attributing it to an “excess of zeal.” He apologised for the delay and pledged to present the document before the end of the specified month, a commitment fulfilled by the current minister 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.
Spain’s imminent approval of medical cannabis signifies a significant step forward in embracing the potential therapeutic benefits of the plant. As the regulatory framework undergoes further scrutiny and refinement, the collaboration between the government, scientific community, and stakeholders will play a pivotal role in ensuring a safe and effective approach to medical cannabis use in Spain.