Health authorities in New Zealand have confirmed that a review of the much-criticised Medicinal Cannabis Scheme will begin “soon” as concerns grow that onerous quality standards are strangling the industry.
Consultation documents are being drawn up as the government aims to improve the “workability” of the scheme.
It follows growing frustration from industry leaders that too few companies have been able to get products to market. Fears are also rising that firms are struggling to stay afloat.
Sally King, executive director of the New Zealand Medicinal Cannabis Council, said some elements of the framework “just don’t work”.
“The regulations were written very quickly and consultation was limited, so it was inevitable some adjustments were going to be necessary,” King told Cannabiz. “Some parts of the regulations…seem bewilderingly restrictive such as testing parameters and export requirements. Many fixes are quite simple, like harmonising our interpretations and settings with Europe.
“The critical factor for the industry, though, is export which is essential for achieving scale. Export ultimately creates accessible and affordable products to patients. The export settings require a genuine rethink because the current settings hamper quality and raise costs.”
The frustration for growers and manufacturers is heightened as the issues are remediable, and would not impact patient safety, she said.
“It would be fair to say the Ministry response times are unreceptive to commercial factors, such as cash burn,” King added. “The Ministry has simply been far too slow. It’s such a shame. This has impacted small or undercapitalised businesses [with] some struggling to stay afloat.”
The ministry of health acknowledged it has faced “enquiries” from the industry since the scheme was introduced.
“Over the last two years of operation, the Ministry has received enquiries and comments from the industry on the workability, clarity and functionality of the Medicinal Cannabis Scheme, focused on the requirements of the minimum quality standards and the licensing regime,” a spokesman said.
“We are currently reviewing the medicinal cannabis regulations to improve the workability of the Scheme. The Ministry is preparing a consultation document, which is anticipated to be released for comment soon.”
But King questioned the parameters of the review.
“Indications we have had from the Ministry is that the review is looking to make minor adjustments,” she said, adding that the review was likely to focus on technical and policy changes.
Despite the “real challenges” of the regulations, King said the industry has enjoyed “very real progress”.
“Council members were recently in Europe and reported high interest in New Zealand’s products,” she said. “Awareness of medicinal cannabis is growing in New Zealand with patients and prescribers. We are seeing growth, but more importantly, a more mature understanding of what cannabis-based medicines may offer.”
She added: “We have had a recent Government vote of confidence with a significant research grant. We just need to get the regulations finetuned to unleash the potential of medicinal cannabis for patients.”