Since 2020, when the UN reclassified cannabis in the list of narcotics from Schedule I (prohibited substance) to Schedule IV (permitted substance for medical and scientific use), there has been a significant growth in the regulation of medical cannabis worldwide.
María Ángeles Muñoz Marín, Quality and Regulatory Affairs Director Linneo Health, AEFI Regulatory Affairs Member Central Section. Madrid, Spain, 07 March 2024:
In the United States, a total of 38 states have legalized medical cannabis, including among them the most conservative. In October 2018, Canada was the first G20 country to take this step forward and the second in the world, after Uruguay made the initiative driven by former President José Mujica a reality in 2013.
Currently, patients in 21 European countries can be treated with medical cannabis, with the United Kingdom and Germany being the first countries to legislate its consumption, and Ukraine the last in December 2023. The latter accelerated the legalization process in order to alleviate the effects of post-traumatic stress caused by the war.
Regulators in other European countries such as Italy, Poland, France or Portugal were adopting a pragmatic approach to the cannabis industry, based on experiences from other countries, such as the benefits of approaching regulation from a health-oriented perspective or the potential economic benefits of fostering the cannabis industry. To this end, countries such as Ireland, France, Denmark and Luxembourg conducted, or are conducting, pilot programs in order to finalize and subsequently issue regulations governing the quality, safety and efficacy of medical cannabis.
As an example, France launched a three-year pilot program in 2021 with 3,000 patients. The program establishes requirements in terms of supply, healthcare professional training, dosage, dosage forms and indications, and although the program ends in March 2024, the French government has already announced that the products used in the study may be registered with a 5-year authorization, where the indication will be authorized on a case-by-case basis. During the trial there were no serious adverse events, unlike opioid drugs, no addictions were reported, a great advantage for patients with chronic pain treatment or in palliative care.
In the rest of the world, Israel, Australia, New Zealand, Uruguay, Argentina, Colombia, Mexico, Brazil, and several countries in both Africa and Asia have opened their doors to legislate and give pain patients access to this plant with known therapeutic use since 2,600 years B.C.
Spain, despite this great advance worldwide, only authorizes the cultivation and manufacture of products derived from cannabis for medicinal use, but not its use, allowing only exports to countries where it is regulated, and thus favoring patients from practically the rest of the world, but not Spanish patients.
In June 2022, a subcommittee was held in the Congress of Deputies that commissioned the Spanish Agency of Medicines and Health Products (AEMPS) a report with a six-month deadline that was not met. The former Minister of Health, José Miñones, apologized for the delay and attributed it to an “excess of zeal”, and finally, on January 26, 2024, the new Minister, Mónica García, assured before Congress that she would regulate medical cannabis in the coming months.
Thousands of patients have to resort to self-cultivation or the clandestine market to alleviate their pain and improve their well-being, and these thousands of patients are eagerly awaiting such regulation. In any case, there is still a lot of uncertainty about the future of the use of this product in Spain: flower? dispensing in community pharmacies? prescription by specialist doctors? reimbursement? There are several factors that can make this Ministerial Order really achieve good patient access to medical cannabis as a therapeutic alternative, or frustrate those patients even more, if possible, by having a regulation that makes access difficult for them. And there we would still be at the bottom of Europe and the world, as well as frustrated and hopeless. Let us hope that this is not the case.
