New Zealand’s minister of health Andrew Little has confirmed he has no plans to extend transitional arrangements for the country’s new medicinal cannabis framework beyond the current September 30 deadline.
Industry stakeholders fear new rules, due to take effect from October 1 2021, will see shortages and soaring prices as companies struggle to get products approved for sale.
However, Little said extending the transitional period again would give companies supplying unverified products an unfair cost advantage with “little incentive to have their products verified against the quality standard”.
No official analysis has been done on the potential increase in costs for patients when the transitional period ends.
It has twice been extended, but Little ruled out a further delay in written answers to New Zealand Green Party drug law reform spokesperson Chlöe Swarbrick.
The minister admitted he didn’t know how many patients will be impacted when the transitional period ends or what will happen to prices.
He said: “I am advised that while Medsafe has a record of the volumes of product containing CBD and/or THC that are supplied within New Zealand under section 29 of the Medicines Act 1981, this information does not identify the number of patients using these products.”
The minister confirmed he had not commissioned or received any advice on the processes required to transition patients — said by Swarbrick to number thousands — on to alternative medication when the deadline expires and their current medication becomes illegal again.
He added: “Throughout the 18-month transitional period prescribers have been advised that products that do not meet the quality standards can no longer be supplied after the end of the transitional period. Prescribers are also notified when products are verified as meeting the quality standards, and the products are added to the list of verified products on the Ministry of Health website.
“Any decision to switch patients to alternative medication is the responsibility of the patient’s medical practitioner.”
Little said he requested a briefing from officials in July on progress with product assessments to inform the decision on a further extension.
“Medsafe advised that none of the 13 CBD products currently being supplied under the transitional period are under assessment, nine product applications were substantially missing the information required to assess compliance with the quality standard, and no applications were received for four of these products.”
Little confirmed there are currently 20 medicinal cannabis product applications under assessment to be verified against the minimum quality standard. In practice, this means the Medicinal Cannabis Agency has completed an initial check of the application and the applicant has paid the assessment fee.
Despite Medsafe having “some information” relating to the importation of CBD products by healthcare professionals entitled to do so under section 25 of the Medicines Act 1981, he said it is not “statistically recorded or reviewed”.
The minister ruled out any changes to GMP standards, which Swarbrick said were among the strictest in the world and were preventing products coming on to the market.
Swarbrick is not alone in voicing concerns about the end of the transitional period. In a report to the interim health minister Chris Hipkins in September last year, the NZ health ministry stated that “disruption to the availability and cost of products would have a significantly negative effect on patient wellbeing”.