News Article

Green Gold Rush Limited by Regulation

Thu, 09/05/2019 - 12:53

Mexico has moved away from its prohibitional model but there are still gaps in the regulation of cannabis for medical, scientific, industrial and even recreational use. However, judicial rulings are pushing for clarity and expedited regulation, said Alejandro Luna, Partner Litigation and Life Sciences Co-chair at Olivares, during the opening presentation of Mexico Health Summit 2019, held on Thursday at Papalote Museo del Niño in Mexico City.

“Cannabis products are present in the food, beverage, medicine and textile industries, to name a few. The combination of several factors, including the fight against drug dealing and the medical benefits of cannabis, led many countries to adopt a new stance toward its use,” Luna said.

In Mexico, change was also fueled by confrontations between people looking to access cannabis-based medications and the authorities. Luna highlighted the case of Grace, a sick child whose parents were not allowed to import medicinal products with cannabidiol. After Grace’s family presented an amparo against the country’s prohibitive regulations, amendments were made to the General Health Law. “The Supreme Court was the first to take a step toward a new regulation, even in terms of recreational use,” he said.

The Supreme Court decided that the prohibition regarding cannabis use was unconstitutional. “The fundamental right to free personality development establishes that adults have the right to decide in which recreational activities they participate. This makes cannabis use an activity proper to the autonomy of each person, as long as it does not affect third parties,” Luna said

Refusal from the san.itary regulator to analyze the import of a medicine based on cannabidiol opened the door to analyze the regulation. According to Ingrid Ortiz, Associate of Life Sciences at Olivares, in 2017 former President Enrique Peña Nieto presented an initiative to revise the General Health Law and the Federal Penal Code, although this was only focused on medicinal and scientific use. Changes included the regulation for cannabis use and cannabis-based products, as long as there was a permit from the Ministry of Health, permission to plant and grow cannabis plants and the possession of up to 5g of cannabis.

“COFEPRIS established the guidelines regarding control of cannabis and derivates, which led to 62 approvals for products, including raw materials, food, supplements and medicine. However, in March 2019, these guidelines were revoked by COFEPRIS based on the argument that the guidelines surpassed medicinal and scientific use,” said Ortiz. 

Besides the revocation of permits, regulations are still unclear on how to obtain cannabis for consumption and manufacturing of cannabis-based products. Ortiz says today there are nine active initiatives to reform regulations, the last one presented only a month ago. Meanwhile, Luna highlighted the Supreme Court’s latest ruling established that, as of two weeks ago, COFEPRIS had a 180-day timeframe to develop a complete regulation that considered the sourcing, storage, distribution and commercialization of cannabis and cannabis-based products for medical and scientific use.

“There are already companies wanting to participate in the growing cannabis industry but lack of regulation prevents proper business development. Today, there is a green gold rush in Mexico and the world and even though not everyone will become a millionaire, many will get rich by selling picks and shovels for those seeking gold,” he said.

Partner litigation and Life Sciences Co-chair at Olivares and Associate of Life Sciences Co-chair at Olivares