On September 9, patients in Mexico hoping for legal access to medical cannabis were supposed to wake up to new rules that would create a regulatory framework for the country’s medical cannabis law.
That day, the last deadline given to the Ministry of Health by the Supreme Court to create rules for the production, research, export, and import of cannabis and its derivatives for medical purposes in the country, came and went, but patients were left hanging.
Medical cannabis patients in Mexico are used to delays. The regulation has been anticipated since former President Enrique Peña Nieto issued a decree in 2017 amending the General Health Law to authorize cannabis for medical use. The decree gave the Ministry of Health 180 days to regulate the industry, but it failed to do so.
In August 2019, Mexico’s Supreme Court ruled in favor of Carlos Aviles, a 15-year-old boy who suffers from severe epilepsy and had been unable to secure the medicine he needed because there were no official regulations. The Supreme Court ruled that the Health Ministry had infringed on the rights of a child with a disability by failing to issue the rules on the therapeutic use of cannabis. The high court then ordered the Ministry of Health to regulate the 2017 amendment for the medical use of cannabis, once again granting the health authority 180 days.
The deadline for the regulation was originally in June, but the coronavirus outbreak prompted the Supreme Court to extend it to September 9.
The regulation had been under public consultation, with various stakeholders filing comments on different drafts. The latest version appeared ready for publication in the Official Gazette, where new laws and regulations are published before they take effect. But the Ministry of Health blew past that deadline.
“More than 1,010 days have gone by since the regulation was first due to be issued on December 18, 2018,” Luisa Conesa, Carlos Aviles’ attorney, told Cannabis Wire. “We consider the delays to be very serious and that is why we have been critical of the justice system, because we believe that the law should be much more protective of the patients’ rights.”
While the Ministry of Health hasn’t publicly declared the reason for its delay, Cannabis Wire learned that it is due to efforts on the part of the Mexican government to comply with international trade requirements. In a ruling reviewed by Cannabis Wire, a judge granted the MInistry 70 additional working days to comply with these international trade rules before posting the regulation. This means the new final deadline would be January 5, 2021.
By issuing these medical cannabis regulations, the Federal Commission for Protection Against Sanitary Risk (COFEPRIS), Mexico’s equivalent of the Food and Drug Administration, would finally open up the Mexican market for legal medical cannabis. Until now, most patients had to turn to the illicit market for access.
“It is a historical landmark,” Erick Ponce, who created the Cannabis Industry Promotion Group, which represents more than twenty cannabis companies and associations, and who participated in a public consultation on the proposed regulation, told Cannabis Wire. “We have been waiting three years for this document, the last step needed to formally start the regulated market of local, national, and international medical cannabis in Mexico.”
Importantly, the regulation would not address adult use cannabis. But a sweeping cannabis proposal that seeks to establish the framework for the adult use and hemp industries is expected to advance in Mexico’s Congress when it reconvenes. The Supreme Court has been pushing back the deadline for lawmakers to enact this policy change, which is now due on December 15.
This effort to legalize adult use cannabis dates back to October 2018 when the Supreme Court ruled that an absolute ban on recreational use of cannabis was unconstitutional, leaving it to lawmakers to regulate consumption by October 2019, a deadline that has been postponed several times for various reasons, including the coronavirus outbreak.
(Read Cannabis Wire’s extensive coverage of Mexico’s path to legal medical and adult use cannabis).
How the medical regulations would function alongside a new more comprehensive law for adult use remains unclear.
On the medical cannabis front, the draft regulatory document issued by COFEPRIS, which could be amended before it comes into effect, addresses all stages of the supply chain for medical cannabis and its derivatives. It would allow the production and transformation of dry cannabis flower into derivative products for commercialization—both inside and outside the country, which has a population of about 130 million. It also calls for strict monitoring of the production chain, from seeds to distribution to the commercialization of medicines. For example, defining safety protocols for facilities where cannabis is researched, processed and sold; applying cannabis traceability; setting a sanitary grow environment; and using certified seeds. Cannabis-based medicines could only be prescribed by doctors, homeopaths, and dental surgeons.
“There is no doubt that the main objective is to supply the local market, but it also speaks of Mexico’s capacity to export the finished product,” Ponce told Cannabis Wire. “The intention is for Mexico to participate internationally in the market.”
Under the draft regulation, cannabis-based medications could be imported and sold in the country until the industry develops to meet Mexican patients’ needs.
Luis Suárez Rodríguez, president of the Mexican Medicinal Marijuana Association, who also participated in the public consultation, told Cannabis Wire that the document would set up a rigorous and standardized process for the development of cannabis-based products.
“It would be a very good first step because it would lay the foundation of a cannabis-based medicinal industry that is safe for patients, and well-founded on research,” he said. “It would also encourage the generation of a local industry that produces the flower to nourish the market, at the same time allowing for the export of the product.”
Suárez says that although the medical market would take some time to fully develop, “the new framework would be a significant step forward in helping patients obtain access to medicinal cannabis treatment” that they need.