The first New Zealand company to obtain approval to manufacture local medicinal cannabis had its licenses in jeopardy after the cannabis material was illegitimately removed from its premises by a staff member.
Last year, a Helius Therapeutics staff member took a small amount of crude CBD and crude THC extract, which Stuff understands is intended for a seriously ill relative.
It is believed to be the only material incident that has disappeared from a site since the highly regulated medical cannabis scheme was enacted.
Industry members say the incident even shows the well-connected or resourceful struggle to access medical cannabis.
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The documents show that in May 2020 Helius had manufactured two test batches of products. In the following month’s inventory he noticed quantitative discrepancies. An internal investigation “almost completely reconciled” the discrepancies and security surveillance and the records did not identify any unauthorized activity.
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Helius headquarters in Auckland.
But in September he realized the material had been removed from the site after concerns were raised with the board. An investigation was initiated. His terms of reference, in addition to investigating the removal of the material, also included whether the staff member who took the product had ordered any employee to make a medicinal cannabis solution, the investigation concluded not.
Helius subsequently changed its security systems and systems, including additional staff training, and limited access to storage. Under his license, he was to notify the Medicinal Cannabis Agency (MCA) within three days, but did not do so for six weeks, and only once the investigation was completed.
MCA also investigated and conducted a follow-up audit. The Agency was pleased with Helius’ response, apart from the time it took to be notified, and no further action was needed.
“Because the disposed product was accounted for and completely destroyed, the MCA did not consider it necessary to inform the police, and at this stage, the agency is not taking the matter further,” said Chris James, director of the Medsafe NZ group. “The MCA’s view is that the risk to public safety was properly managed.”
The agency declined to comment further, citing privacy, including the health information of those involved. Emails sent to Stuff appear to show that Helius is trying to resolve the matter with the Agency, as Covid-19 blockades delayed the audit.
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Carmen Doran, Executive Director, Helius Therapeutics.
“We agree that minimizing health risk should be the top priority. That said, it would be great to conclude the current research, as it is still pending for us,” wrote Bruce Wallace, Helius Quality Director. at the Agency in March this year, suggesting the Agency’s audit by Zoom. The audit was completed in May.
NZ Medical Cannabis Council executive director Sally King said the information she had seen showed that both Helius and MAC were taking the problem seriously.
“It’s a big problem, because we’re very regulated and we should be,” he said. “We understand the need for security. We’ve all learned from that.”
She believed the incident was timely and was surprised that it had even happened. “God for me, yes. It was well-intentioned, but it was really amazing.” The staff had jeopardized Helius’ license. As part of their licensing requirements, companies must show a high level of security.
“We’re trying to convince the community, the MCA and the prescribers, that we take all the rules under which we operate very seriously. It’s up to us to meet the standards,” King said.
“Helius has grown a lot [since then] and have acquired additional resources and experience. Such a thing would be unthinkable and very unlikely from here on out. We are all learning and growing. “
Helius executive director Carmen Doran declined to answer questions. “Last year the matter was fully addressed and I therefore recommend any comments that the Agency may make.” In an email he sent to Medsafe last year, Doran wrote that Helius was “committed to working with [MCA] identify the root causes … I see this as a learning opportunity and an opportunity for Helius to be better in the future. “
In August, Helius became the first New Zealand company to obtain approval to manufacture cannabis medicinal products, and now has two approved products on the market.
The scheme has been criticized by some industry members because it is tangled in too much bureaucracy. While it was hoped to improve access to products for patients, more than 18 months after its enactment there are only six products that meet the minimum quality standards available to patients, including the two Helius, which they contain a cannabidiol imported from the Netherlands.
Sally King said there was a “catch-22” in which even Medsafe-approved products that meet the minimum quality standards cannot be marketed to either patients or GPs, so there are few opportunities to educate prescribers.
The desperation of some to access it was widespread, evidenced by the Helius incident, said New Zealand Medical Cannabis Industry Association Secretary Abe Gray.
“The thing to take away, for me, is the lack of access and the extremes even the most resourceful individuals at the heart of the industry have to come. That’s the outrageous part.”
