A US-based ganja research firm said Jamaica is missing out on investments in the sector because of how long it takes the Cannabis Licensing Authority (CLA) to issue licences for legitimate businesses.

Medical research firm MMJ International Holdings (MMJ) said the cumbersome process has forced it to turn to Uruguay-based Global Cannabis Production (GCP) to import raw materials and finished products so as to support the clinical trials and drug development that it was initially seeking to do in Jamaica. It had sought to collaborate with the Manchester-based Northern Caribbean University (NCU) on the project to produce pharmaceuticals from ganja.

“NCU and MMJ had started this process in 2016,” Duane Boise, CEO of MMJ, lamented as he pointed out that NCU has been unable to receive the necessary approval and licensing for the operation. “It is unconscionable to believe it is 2023 with no definitive answer from the CLA. I am not sure why they haven’t issued the licence. It is a very poor testament of the Jamaican Government’s inability to not have addressed this situation years ago. I do know that NCU is a reputable, 116-year-old Jamaican institution, and one would think that NCU would have had the first licence issued,” Boise added.

MMJ is engaged in the cultivation, research, and analysis of pharmaceutical cannabis, and the registration of final products for Food and Drug Administration (FDA) and pharmaceutical approvals.

Boise further revealed that MMJ has a US federal Drug Enforcement Administration (DEA) registration which allows MMJ to legally bank in the US with the same banks that have correspondent relationships with Jamaican banks, further enhancing its ability to do business on the island.

The CEO sees MMJ’s recent deal in Uruguay as a loss for Jamaica.

“Jamaica had the opportunity to be the first mover in the space and missed the opportunity,” he lamented.

Looking at the bigger picture, Boise underscored the importance of producing cannabis at the pharmaceutical-grade level in Jamaica, and insisted that production for recreational use and “medicinal use” alone will not guarantee the success of the industry on the island.

In making his point, he made a distinction between pharmaceutical use and medicinal use.

“This is a complex issue of regulatory compliance and pharmaceutical development,” the CEO explained. “The primary issue is the mandated FDA, DEA development of a botanical drug as a pharmaceutical makes the distinction between medical marijuana and pharmaceutical-grade medicines.”

“The only way that marijuana will be tolerated by the UN drug conventions is if it becomes a pharmaceutical product, registered, patents, licences, and international approvals,” he continued. “The FDA, DEA and United Nations (UN) directives are the future of this industry. A Jamaican project must adhere to succeed.”

He further illustrated his point in simpler terms.

“Medical cannabis doesn’t exist as such, only pharmaceutical – quality, consistency, and reproducibility,” the CEO explained. “A tourist may come to Jamaica seeking relief, suffering from a chronic disease, and find something in a dispensary that works. The problem is the next time they come back it will be named the same but not be the same product chemically, so the effects will not be the same. This is also not to mention that the product may have harmful materials such as heavy metals, muold, mildew, pesticides and aflatoxins.”

Pharmaceutical-grade cannabis is essential for drug tests because it ensures minimal variance during drug tests.

“I am not aware of any Jamaican products that can compete,” Boise said. “Most will have wild swings in chemical reproducibility each turn of the crop, thus not meeting the FDA, DEA requirements. The challenge is the chemical reproducibility as a botanical. MMJ variances are .06 per cent to 1 per cent variance each turn of the crop because of the scientific methods MMJ uses in our cultivation process.”

An MMJ/NCU collaboration, Boise insisted, would have involved cultivating and processing Jamaican cannabis to meet the necessary pharmaceutical standards.

The executive explained that the company’s consultants would have instructed NCU on the use of specialised, scientifically manufactured growing chambers that ensure the cannabis achieves the requirements for drug tests.

“MMJ had to follow the directive of the FDA in the development of a botanical drug, regardless of where we obtained the plant product or derivatives,” he explained. “MMJ would have taught NCU professors and scientists on the FDA processes of cultivation and extraction. Jamaica and NCU would have been the supplier to MMJ for further pharmaceutical manufacturing of a final-dose delivery method for patient consumption. Jamaica does not have a good manufacturing practices (GMP) FDA pharmaceutical manufacturer of soft gel capsules.”

Boise is still hopeful that there will be room for MMJ and the Jamaican cannabis industry to achieve mutual goals, and he declared a “soft spot” in his heart for the island.

“Even though Jamaica is not the first mover there is still a significant opportunity to be developed, and potentially a collaboration with the Uruguay project,” he suggested. “The MMJ team can work diligently with Jamaican universities and researchers to fill in the knowledge gaps. At the end of the day it is all about the science, safety, and quality of our products.”

Again, turning to the broader picture of Jamaica’s cannabis industry, Boise offered the following opinion on its current situation.

“The Jamaican failure of the cannabis industry is essentially that they are wrongly interpreting this industry as an agriculture business when it is a pharmaceutical industry,” he said. “The plant is one of its primary products and the chemical substances and molecules provide the basis for pharmaceutical products.”

The Jamaica Observer reached out to the CLA about the claims made by the MMJ CEO and was told that within the framework of confidentiality in which it operates, “we are not permitted to divulge information regarding the specific status of a particular application.” The regulator added: “It is, however, noteworthy that all applicants who do not progress through the various stages of the application process, are advised of any issues preventing progression and if and/or how these may be remedied.”

NCU President Dr Lincoln Edwards however confirmed to the Business Observer that “we do have a collaboration [with MMJ] and we have applied for the license and is awaiting approval but it has taken some time.”

MMJ has achieved several milestones, including identifying specific cannabis species with desired THC and CBD levels, completing FDA-mandated testing, optimising extraction processes, characterising extract components, establishing stability data, obtaining DEA approval for extract shipment, developing THC and or CBD capsule formulations, securing agreements for cannabis plant growth, and receiving FDA orphan drug approval for a clinical study on Huntington’s Chorea (Huntington’s disease) using their proprietary formulation.