The licenses of the first New Zealand company to obtain approval to manufacture local medicinal cannabis were compromised after an employee illegally removed cannabis material from its facility.
A small amount of raw CBD and THC extract was ingested last year by a Helius Therapeutics employee who Stuff understands is intended for a critically ill relative.
This is believed to be the only incident where material has disappeared from a website since the highly regulated medical cannabis program came into effect.
Industry officials say the incident even shows the well-connected or resourceful struggle for access to medical cannabis.
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Documents indicate that Helius had made two trial batches of products in May 2020. During the inventory in the following month, quantity deviations became known. An internal investigation “almost completely resolved” the inconsistencies and security monitoring and records did not reveal any unauthorized activity.
Helius’ headquarters in Auckland.
However, in September it became known that material had been removed from the site after concerns were raised with the board of directors. An investigation has been launched. In addition to investigating the removal of the material, his assignment also included whether the employee who had ingested the product had instructed an employee to make a medicinal cannabis solution – the investigation showed that this was not the case.
Helius then changed its security precautions and systems, including training staff and restricting memory access. Under its license, it was supposed to notify the Medicinal Cannabis Agency (MCA) within three days, but did not do so for six weeks and only after the investigation was completed.
MCA also investigated and carried out a follow-up audit. The agency was satisfied with the response from Helius – apart from the length of the notification – and no further action was required.
“Since the removed product has been fully recorded and destroyed, the MCA did not consider it necessary to notify the police and the agency is not proceeding at this point,” said Chris James, Group Manager, Medsafe NZ. “The MCA believes that the public safety risk has been adequately managed.”
The agency declined to comment, citing data protection, including the health information of those involved. Emails posted to Stuff appear to show that Helius is trying to resolve the matter with the agency as Covid-19 lockdowns delayed testing.
Carmen Doran, CEO of Helius Therapeutics.
“We … agree that minimizing the health risk must have top priority. Still, it would be great to finalize the current investigation as it still hangs over us, ”wrote Bruce Wallace, Chief Quality Officer of Helius, to the agency in March of this year, suggesting the agency review by Zoom. The audit was completed in May.
NZ Medical Cannabis Council executive director Sally King said information she had seen indicated that both Helius and MAC were taking the problem seriously.
“This is a big deal because we are heavily regulated and we should be,” she said. “We understand the need for security. We all learned from that. “
She believed the incident was an isolated incident and was surprised it had happened at all. “Gosh, yes. It was meant well, but it was really surprising. ”The employee had endangered Helius’ license. As part of the admission requirements, companies must demonstrate a high level of security.
“We’re trying to convince the community, the MCA, and prescribers that we take all the rules we work by very seriously. It’s up to us to meet the standards, ”said King.
“Helius have grown enormously [since then] and have taken on additional resources and know-how. Something like that would be unthinkable and very unlikely from now on. We all learn and grow. “
Helius boss Carmen Doran declined to answer questions. “The matter was dealt with in full last year, so I refer you to any comments made by the agency.” In an email she sent to Medsafe last year, Doran wrote that Helius was “obliged to work with” [MCA] Identifying the causes … I see this as a learning opportunity and an opportunity for Helius to improve in the future. “
In August, Helius became the first company in New Zealand to receive approval to manufacture medical cannabis products and now has two approved products on the market.
The system has been criticized by some industry members as being too bureaucratic. Although it was hoped to improve patient product access, more than 18 months after its launch, there are only six products available to patients that meet minimum quality standards, including the two from Helius, which contain a cannabidiol imported from the Netherlands.
Sally King said there was a “catch-22” in the fact that even Medsafe-approved products that meet minimum quality standards cannot be marketed to patients or general practitioners, so there is little opportunity to train prescribers.
The desperation of some for access was across the board, as evidenced by the incident at Helius, Secretary of New Zealand’s Medical Cannabis Industry Association, Abe Gray.
“The insight for me is the lack of access and the extreme efforts that even the best-equipped people at the heart of the industry have to go through. That’s the scandalous part. “