Medicinal cannabis removal highlights desperation

The first company in New Zealand to gain approval to manufacture local medicinal cannabis had its licences jeopardised after cannabis material was illegitimately taken from its facility by a staff member.

A small quantity of crude CBD and crude THC extract was taken last year by a Helius Therapeutics staff member, who, the Sunday Star-Times understands, intended it for a seriously ill relative.

It’s believed to be the only incident of material disappearing from a site since the highly regulated Medicinal Cannabis Scheme was enacted.

Industry members say the incident shows even the wellconnected or resourced struggle to access medicinal cannabis.

Documents show that in May 2020 Helius had manufactured two trial batches of products. At the following month’s stocktake it became aware of quantity discrepancies. An internal investigation ‘‘almost entirely reconciled’’ the discrepancies and security surveillance and records did not identify any unauthorised activity.

But in September it became aware that material had been taken off-site after concerns were raised with the board of directors. An investigation was launched.

Helius subsequently changed its security arrangements and systems, including further training staff, and limiting storage access. Under its licence it was supposed to notify the Medicinal Cannabis Agency (MCA) within three days, but didn’t do so for six weeks, and only after the investigation was completed.

MCA also investigated, and had a follow-up audit. The agency was satisfied with Helius’s response – apart from the length of time it took to be notified – and no further action was required.

‘‘As the product removed was fully accounted for and destroyed, the MCA did not deem it necessary to inform police and at this stage the agency is not taking the matter further,’’ Medsafe NZ group manager Chris James said.

‘‘The MCA’s view is that the risk to public safety was adequately managed.’’

The agency declined to comment further, citing privacy, including of the health information of those involved. Emails released to the Star-Times appear to show Helius attempting to resolve the matter with the agency as Covid-19 lockdowns delayed auditing.

‘‘We ... agree that minimising the health risk has to be the top priority. Having said that, it would be great to conclude the current investigation as it is still hanging over us,’’ Helius’ chief quality officer Bruce Wallace wrote to the agency in March this year, suggesting the agency audit by Zoom. The audit was finalised in May.

Executive director of the NZ Medical Cannabis Council, Sally King, said information she had seen showed both Helius and MAC took the issue seriously.

‘‘It’s a big deal, because we’re heavily regulated, and we should be,’’ she said. ‘‘We understand the need for security. We all learned from this.’’

She believed the incident was a one-off and was surprised it had even happened.

‘‘Goodness me, yes. It was well-intentioned, but it was really surprising.’’ The staffer had jeopardised Helius’ licence. As part of its licensing requirements, companies must show a high level of security.

‘‘We’re trying to convince the community, and the MCA, and prescribers, that we take very seriously all the rules under which we operate. It’s incumbent upon us to meet the standards,’’ King said.

‘‘Helius have grown a huge amount [since then] and have taken on additional resources and expertise. Such a thing would be unthinkable, and very unlikely from here on in. We’re all learning and growing.’’

Helius chief executive Carmen Doran declined to answer questions. ‘‘The matter last year was fully dealt with and so I refer you to any comment the agency may have.’’

In an email she sent to Medsafe last year, Doran wrote that Helius was ‘‘committed to working with [MCA] to identify root causes . . . I am seeing this as a learning opportunity and a chance for Helius to be better going forward.’’

In August, Helius became the first company in New Zealand to gain approval to manufacture medicinal cannabis product, and now has two approved products on the market.

The scheme has been criticised by some industry members as being entangled in too much red tape. Although it was hoped to improve product access for patients, more than 18 months on from its enactment there are just six products that meet minimum quality standards available to patients, including Helius’ two, that contain a cannabidiol imported from the Netherlands.

King said there was a ‘‘catch22’’ in that even products approved by Medsafe as meeting minimum quality standards cannot be marketed to either patients or GPs, and so there is little opportunity to educate prescribers.

The incident at Helius highlighted across-the-board desperation for access, secretary of the New Zealand Medical Cannabis Industry Association, Abe Gray, said.

‘‘The takeaway, to me, is the lack of access and the extreme lengths even the most wellresourced individuals at the heart of the industry have to go to.

‘‘As the product removed was fully accounted for and destroyed, the MCA did not deem it necessary to inform police.’’ Chris James Medsafe NZ group manager

‘‘That’s the scandalous part.’’