Only a Matter of Time

What edge does meeting DEA-level security protocols give a company trying to break into international markets?

The pharmaceutical industry in the US is one of the most highly regulated in the world, and DEA regulates the controlled substance act through the Code of Federal Regulations, which mandates how any producer, distributor, prescriber, or dispenser of controlled substances adheres to the rules and regulations. DEA has the responsibility as the enforcement and regulatory agency, meaning it regulates the industry to the point where DEA personnel will visit different entities within the closed loop of distribution to ensure that those companies are operating in compliance. At Khiron, we are applying these regulations to the cannabis industry in Colombia and will do this within every country that we operate in so that we have consistent regulatory standards.

What investment in equipment and training had to be made to meet these protocols?

We are employing state-of-the-art technology in Colombia and our operations across the world. Talking about compliance, record keeping, security, and anti-diversion, we track and trace the entire chain. For us to comply with the regulations, we need to be able to track and trace every product. As a result of this, the company prevents misuse, abuse, and diversion from occurring throughout the supply chain.

Have you experienced any unique challenges in Colombia to maintain these standards?

We are utilizing technology that has been tried and tested in the US, including infrared and GPS tracking. It is really compliance that drives the business from the perspective that if we do not have the best compliance, it will affect our reputation negatively. We are extremely cognizant of compliance and spare no expense to ensure we are doing things to the levels that will carry our reputation to where we need it to be.

What is Colombia doing right in its legal framework that can be an example to other places?

We are extremely fortunate to have a member of our staff, Juan Diego Álvarez, be part of the process in bringing regulatory standards. As a result, the regulations were structured extensively with cooperation from the government. The way that the framework has been established is in a manner where the regulations are strict and controlled but at the same time businesses don’t have a regulatory noose around their neck. Another positive aspect is regulators doing site inspections and monitoring our activities to ensure that we adhere to the regulations. Nonetheless, all factors are still evolving because medical cannabis has only been in the country for a year and a half; some regulations will need to be tested as the industry evolves and new products are dispensed. Notably, we have been fortunate to have the Canada Capital Markets behind us, which has set us apart as we became the first Colombian-based medical cannabis company to trade on any exchange globally.

What is the potential for medicinal cannabis as an alternative to prescribed opioids?

I have an extensive background in the opioid crisis in the US, and when I was Chief of Pharmaceutical Investigations, it was the beginning of the opioid epidemic to the extent that one could buy hydrocodone online without a prescription. On the other hand, cannabis is still illegal in the US federally, though there have been no cases of anyone overdosing on cannabis. On top of that, there are new medical researches that determine the medicinal value of cannabis. Opioid users in the US who can use cannabis legally are now taking cannabis and having great results. Although there are people in extensive pain that need opioids, for those who do not, cannabis provides a great alternative. It is quite a struggle still because even in states where cannabis is legal, cannabis businesses are unable to use banks. Khiron believes cannabis should be federally legalized because it will not only bring legitimacy and credibility to the industry, but also consistent regulatory standards.