A Lethbridge company needs a regulatory exemption from Ottawa to grow the crop and produce medicinal ingredients
An Alberta company that wants to grow poppies on a commercial level and process them into ingredients for medications is awaiting federal government approval for its plans.
API Labs, based in Lethbridge, submitted an application to Health Canada in September seeking a regulatory exemption that would allow it to cultivate a patented variety of poppy that produces high levels of thebaine.
The alkaloid is used to make medications such as naloxone, which helps combat opioid overdoses, as well as various pain medications used on post-operative patients and in end-of-life care.
Glen Metzler, managing director of API Labs, said he is hopeful the federal government will make a decision by the end of this year.
His firm has a patent on its high-thebaine variety of poppy in Canada, Australia and the United States, said Metzler. Southern Alberta test plots have shown the crop can be successfully grown and harvested in Canada, and this year it tested some pre-emergent herbicides on the crop with successful results.
The federal government has provided about $3 million in the last 10 years to assist in research and development. More recently, the Blood tribe in southern Alberta has provided funds to the project and expressed interest in growing the crop and partnering in the processing plant if either of those plans comes to fruition.
“We rely on our Canadian farmers for our own food. Why can’t we rely on our Canadian farmers for medications that can be produced the same way as our food can,” said Metzler.
As it stands, Australia provides about 90 percent of the world’s thebaine, and all other G7 countries except Canada grow or process some amount of the poppy derivative. Given lessons learned about supply chains during the COVID-19 pandemic, Metzler said Canada would be wise to provide at least some of its own needs.
“It just shines a light on how vulnerable Canada’s drug supply is and how important it is.”
API Labs has been working on its poppy project since 2007.
Thebaine is a controlled substance under Canadian regulations, which Metzler said is the reason for government caution in granting approval. The fear is that the poppies could be diverted for illegal uses and purposes.
“If you have a poppy that doesn’t contain any morphine, you can’t convert it to illicit material. Australia has been growing high-thebaine poppies now for over 10 years, and there has not been any incident,” Metzler said.
“This mentality that this poppy poses a threat or a risk of diversion for nefarious means has no basis. There’s no logical explanation of that.… To try to process thebaine into something that could be used for illicit means, the process is too complex and expensive.”
Dr. Joel Loiselle, an anesthesiologist who instructs students at the University of Manitoba and also provides palliative and end-of-life care, said derivatives of thebaine are important in patient treatment.
Naloxone and naltrexone are key in treating opioid addiction, and hydromorphone is useful in treating chronic pain. Thebaine derivatives are also useful in keeping COVID-19 patients comfortable if they are on ventilators, he said.
As a result, the cost of drugs used for that purpose has risen drastically.
“This sort of crisis can quickly drain the drug supply, leaving other countries high and dry,” said Loiselle.
“I’m quite passionate about this class of drugs.”
There are alternatives to thebaine-derived drugs in human medicine, he said, but they aren’t ideal for various reasons. Though he has not experienced drug shortages in his practice, a heavy reliance on another country for product seems risky, Loiselle added.
“Thebaine itself is probably low risk in terms of diversion. Thebaine itself is a stimulant, not something that can be easily derived into an opioid and active agonist.
“That’s something to bear in mind, but a lot of these drugs are essential in terms of safe care of people in various contexts, including the perioperative setting, early recovery after surgery and (used) very commonly, very importantly in the palliative or end of life realm and that’s where I’m advocating for continuous access.”
Metzler said API Labs has the support of the Alberta provincial government in its federal application for thebaine poppy commercial cultivation. He is hopeful the exemption will be granted.
“Considering the fact that they’ve already approved marijuana, I don’t know why approving something like this, that has no illicit potential yet is a benefit in the middle of an opioid crisis … more people in this country have died from the opioid crisis than have (from) COVID,” he said.
“If we have a situation where we ran out of naloxone in this country, it would be devastating.”
After more than a decade of working toward poppy commercialization and processing, Metzler said a federal government refusal to grant the exemption would likely force the business to move.
“If we can’t get going in Canada, then we really don’t have any other options at this point but to … take the technology out of Canada, which would be really frustrating and disappointing but I don’t know what other options we have.
“It doesn’t make a lot of sense to me that a federal government would provide the funding and the opportunity for you to develop these technologies but then not enable you to be able to commercialize.”