Strict standards for medicinal cannabis have been in place since April last year, but so far only four imported medicines and one local company - Helius - have been approved. Photo / Helius
Strict standards for medicinal cannabis have been in place since April last year, but so far only four imported medicines and one local company - Helius - have been approved. Photo / Helius
The Ministry of Health looks set to ease strict standards for cannabis medicines, which the industry says will be is a huge step towards making them more affordable without compromising safety.
But the changes won't have any impact on the looming issue at the end of this month, when thetransitional medicinal cannabis scheme expires after Health Minister Andrew Little chose not to extend it.
The period was put in place to allow more products to be available while local companies tried to get their products to market.
But no local medicines have emerged 17 months after the safety standards came into force, and the market will shrink because the end of the period will make 13 CBD products currently being used illegal.
That's because they fall below the required GMP (Good Manufacturing Practices) standards, which the ministry is reviewing.
Green Party MP Chlöe Swarbrick says ending the transitional medicinal cannabis scheme when so few products are available will mean thousands of patients will suffer. Photo / Dean Purcell
Green MP Chlöe Swarbrick welcomed the ministry changing "our overzealous, strict and expensive GMP standards".
"But for the minister to refuse to extend the reprieve to patients in the time it'll take for that to happen is unnecessarily callous," she said.
"Letting the transitional period lapse will leave thousands of patients in the lurch and cause unnecessary suffering. And it can be fixed by the stroke of a pen."
NZ Medicinal Cannabis Council chair Manu Caddie said ending the transitional period would likely push patients to the black market, where the quality of medicines cannot legally be assured.
The council surveryed its members, and six of the nine companies that responded wanted the transition period to remain until patients had access to a wider selection of products from a range of suppliers that meet the New Zealand standards.
The other three did not have a position.
Helius, the only company so far to be granted a licence to manufacture cannabis medicines, has previously opposed extending the transition period.
Dr Waseem Alzaher, chief executive of the Cannabis Clinic, said thousands of patients use the 13 products that will no longer be legal next month.
"Some will have been on these medications for a few years, and have stopped other medications," he said.
"It's a complicated process to reverse that. From a clinical doctor perspective, it would take at least three to six months to do that safely.
"I suspect, at the clinic, we are going to have adverse health events from people who might not have been notified or understood this change, and therefore will face an abrupt cessation of their medicines."
Clinic staff had been doing their best to inform their thousands of patients of the change.
"But we're a small team."
A spokesperson for Little said the minister was too busy with the Delta outbreak to be interviewed.
Answering a parliamentary written question at the end of June, Little said it would take time before local companies could put "affordable, quality products on the market".
He noted the four medicines, from Canadian pharmaceutical company Tilray, that have been approved for use since the new regulations came into force, "indicating that the standards are achievable".
Health Minister Andrew Little has decided not to extend the transitional medicinal cannabis scheme, which ends at the end of this month. Photo / Mark Mitchell
Manu Caddie was optimistic about the ministry's upcoming regulatory changes, which he said would make the development process easier without compromising safety.
"We have heard in the last week that things like the requirement for a GMP lab to test all stages of the product will change to an ISO-accredited lab (International Organisation for Standardisation) for most tests.
"There will still be some that will require GMP, but because there are no GMP labs in New Zealand, that's meant massive delays."
He said Rua Bioscience, of which Caddie is a co-founder, has experienced such delays.
"We had product stuck in Customs for 53 days in Australia, waiting for it to get to a GMP lab. They had to send the product to Canada because they couldn't do all of the tests in Australia.
"So some of those tests will be able to be done in New Zealand, and that'll speed things up hugely."
He said the changes wouldn't have an impact on the medicines that are currently awaiting approval, which might be market-ready by the end of the year or the start of next year.
But they would make a huge difference to the next cohort of medicines to be submitted for approval, which might shorten the whole process to six months instead of more than 18 months.
In the first 15 months of the regulations coming into force, in April last year, 39 products were submitted for approval from 15 companies.
Nineteen of them didn't pass the initial check for completeness of information, and of the 20 products still going through the process, none have made it to market.
Medsafe group manager Chris James said the Medicinal Cannabis Agency, which administers the medicinal cannabis scheme, was not ready to announce details of any changes to the standards.
He confirmed the agency was looking at the limitations of commercial lab testing in New Zealand, and whether an ISO-accreditation might be appropriate for some or all of the tests required to meet the safety standards.
