The Government does not plan to set limits on the amount of THC – the main psychoactive ingredient – in medicinal cannabis products.
The move is part of the proposed regulations and standards for medicinal cannabis – covering everything from cultivation to quality standards – released by the Ministry of Health on Wednesday.
In December, the Government passed legislation paving the way for greater access to medicinal cannabis products.
The proposed regulations, out for consultation now, are part of the work the Government is doing to establish its Medicinal Cannabis Agency (MCA) ahead of the Medicinal Cannabis Scheme anticipated to come into effect in 2020.
Making medicinal cannabis more readily available had the potential to “help ease suffering of thousands of people who are living in pain, so it’s important we get these regulations right”, Health Minister Dr David Clark said.
The proposed regulations state only registered doctors – GPs and other specialties – would be able to prescribe medicinal cannabis.
When approved cannabidiol, or CBD, products – which do not produce a high – became available, these would be able to be prescribed by a nurse.
Currently, medicinal cannabis products (except CBD products) were available on prescription with ministerial approval.
Also among the proposed regulations were options on managing cultivation and manufacturing of medicinal cannabis.
Cultivation would be licensed, with different fees depending on the size of the cultivation.
Growers would need to provide details around specific plant varieties, including concentrations of cannabinoids, CBD and THC, as well as the size of the area being cultivated, the number of plants and the period of cultivation.
There were three different options around quality standards for growing medicinal cannabis.
Either no quality standard would be set by the MCA and manufacturers would determine the desired quality of the starting material; the MCA would set a cultivation process standard and would audit a cultivator’s practices; or MCA would set a product quality standard of starting materials.
MCA’s quality standard would include testing for CBD, THC or other cannibinoids to ensure there was no contamination from pesticides or heavy metals.
It also set out two options for manufacturing.
Those included adopting New Zealand’s current approach for manufacturing for all medicinal cannabis products, in accordance with Good Manufacturing Practice (GMP), or allowing for the manufacture of some product dose forms under GMP and some under Good Production Practices (GPP) and the Misuse of Drugs Act.
The Ministry of Health was not proposing to set limits for the amount of active ingredients – such as THC – in final products.
Instead, final products should have a “clearly defined” composition of active and non-active ingredients which did not change from batch to batch, the proposal stated.
The quality standards for a finished product would be the same whether it is a prescription medicine only (CBD product) or also a controlled drug (eg, THC-based medicine).
It also proposed the ministry would not need to give approval to prescribe if medicinal cannabis products met minimum standards.
Clark encouraged the health sector, industry and the public to engage in consultation so the final regulations “can be shaped by a wide range of perspectives”.
The regulations supporting the Medicinal Cannabis Scheme would be finalised by December 18.
Consultation is open to the public until August 7.