The Medicinal Cannabis Scheme was signed off by Cabinet last month after proposals were consulted on earlier in 2019.
A Cabinet committee approved the regulations, which will come into effect under the administration of the Medicinal Cannabis Agency from April 1.
Mr Caddie said the proposals included a wide range of regulations that would be good for prescribers, patients and producers.
The Regulatory Impact Assessment prepared by the Ministry of Health describes the key features of regulations Cabinet had to approve by December 18 under legislation the Government passed in 2018.
Mr Caddie said patients and those in the industry would be disappointed there were no mechanisms to provide a subsidy for cannabis medicines. This would continue to restrict access for the majority of patients.
On the positive side, the Ministry had accepted specialists would not be needed to sign off prescriptions.
This would enable any GP to provide prescriptions for any cannabis products that met the quality standard.
Rua Bioscience is cultivating 10,000 cannabis plants near Ruatoria and has almost completed construction of a medicines manufacturing facility in Gisborne. It is due to open next month.
The company is one of more than 110 applicants intending to apply for a commercial licence to cultivate, manufacture and/or supply medicines to the pharmaceutical GMP standard agreed to by the Ministry of Health.
GMP certification will also be required for all products imported by New Zealand distributors, a change from the current system that has no quality standard on imports.
“There was a lot of debate about whether GMP should be the standard but I think in the end both prescribers and industry agreed that sick people need certainty about the consistency and safety of their medication,” said Mr Caddie.
During consultation on the legislation and regulations, many patients and advocates supported the right of patients to grow their own medicine but the Ministry of Health document said this would not be suitable while CBD and THC — compounds from the plant — remain as “prescription only” medicines.
Mr Caddie said the industry had been working with Medsafe to look at reclassifying some low-dose CBD products to make them available in pharmacies but without a prescription, the regulations do not go this far yet.
Another Ministry of Health strategy to minimise compliance costs is to set “risk proportionate requirements for security to ensure the scheme enables rather than stifles industry”.
Mr Caddie said this was a common-sense approach. Unlike regulators overseas who required onerous security requirements, the New Zealand Government was trying to be sensible around security expectations.
This may also open up opportunities for large-scale hemp farmers who grow low-THC plants in open fields to supply the medicinal cannabis market with biomass for CBD extraction and purification, an opportunity Rua Bioscience has been exploring with grower partners around the country.
Ministry of Health figures suggest there will be over 5000 medicinal cannabis prescriptions this year and the document recognises the need to monitor prescriptions to ensure the regulations are improving access for patients.
The Ministry also believes the scheme will support job creation in regions where cultivation and manufacturing is occurring, as well as providing opportunities for illicit growers to transition into the legal market.
Mr Caddie said he was pleased to see a lot of detail and full transparency on licensing activities to be undertaken by officials in the Medicinal Cannabis Agency, with associated costs and calculations based on estimates of application numbers. These estimates mean the annual cost of licences have reduced from much higher fees proposed during the consultation period.
Licence applications will have a pre-screening fee of just $345 and a basic licence will cost $2588, with additional costs depending on which commercial activities are intended under the licence. The fees structure will be reviewed after a few years to ensure costs are being covered and licence holders are not overcharged.
The Ministry has set a maximum of 50 plants but no limit on seeds that can be transferred from current research licences to the new commercial production licences enabled by the scheme.
“It is really good to have only one licence to deal with in terms of the application and reporting” said Mr Caddie. “There was a lot of industry concern about the complexity of having multiple licences so we are very pleased to see the Ministry of Health has listened and looked at the Australian system, which has only just recommended changing to a single licence to reduce costs and complexity.”
The Ministry of Health said prescriptions and any adverse effects experienced by patients would be monitored, along with regular prescriber surveys to track access over time.
The Ministry is seeking $650,000 from the Government to support a prescriber education programme to help medical professionals understand the latest evidence on medicinal cannabis, the range of products available and how the Medicinal Cannabis Scheme works.
