Patients seeking cannabis-based medicines could see a range of products available from next year. Photo / Getty
What's the problem?
Patients seeking pain relief from cannabis-based medicines currently have legal access to only one product, Sativex, which costs about $1000 a month.
That has only led to a black market, with thousands of people potentially making themselves open to more harm with low quality products with unknown ingredients, loss of continuous treatment, fear of prosecution, and unregulated prices.
Last year the Government passed a law to increase access to medicinal cannabis, with a one-year timeline to put a regulatory framework in place.
The Ministry of Health released its proposed framework yesterday for public consultation.
But if it doesn't lead to more affordable and accessible medicines, the black market - and the harm that comes with it - will keep chugging along.
What is being proposed?
From next year, a patient could seek a prescription from a doctor for a medicinal cannabis product.
Medicines containing only cannabidiol (CBD), a non-psychoactive cannabinoid, could be prescribed by a doctor and, if the product is approved by Medsafe, also by a nurse practitioner.
Medicines with 2 per cent or more of psychoactive cannabinoid THC would be a controlled drug and, if Medsafe-approved, could be prescribed by a doctor.
Medsafe approval would mean there would be more certainty about the medicine's quality and safety, as well as its ingredients.
But clinical trials that lead to Medsafe approval are a long and costly process - hence the high cost of Sativex - so it is likely that non-approved products would hit the market first.
With less certainty about these medicines, sign-off from a specialist would be needed.
What is a specialist?
This is up for debate, according to Dr Russell Wills, chairman of the Medicinal Cannabis Advisory Group appointed to oversee the establishment of the scheme.
"If we require a specialist to give an opinion for chronic pain and only four [out of 20] DHBs have those specialists, that's an unreasonable barrier to access," Wills said.
"So in those DHBs without a chronic pain team, what counts as sufficient expertise?"
Specialists may also be few and far between in rural areas.
Wills said the bar could be lowered in terms of what qualifies as a specialist, but the trade-off could be reduced expertise and safety.
"Having to get a specialist's approval gives the GP a defence for saying, for example, 'let's try physiotherapy and psychological treatments first because we know they work'," Wills said.
Public feedback will be valuable in determining what level of expertise a specialist should have, he said.
It is also possible, following consultation, that the need for a specialist might be included for higher risk patients, regardless of whether the product is Medsafe-approved.
This could apply to people under 25 for medicines containing THC, which has been shown to be harmful on developing brains, or for children with complex epilepsy.
"CBD is very low risk, but does interact with other medicines, particularly anti-convulsants and epilepsy," Wills said.
"Currently, very few doctors would prescribe for a child with complex epilepsy. Should prescribing be solely the prerogative of paediatricians and paediatric neurologists? That's a very reasonable question."
Being gatekeepers is expected to put a lot of pressure on doctors, particularly considering that some patients will be highly distressed and in debilitating pain, and ready to believe questionable claims about the benefits of some medicines.
While doctors can be confident in Medsafe-approved products, the evidence behind non-approved ones is still developing, and there are fears that desperate patients could push doctors into prescribing medicines of dubious quality.
What kinds of products?
Smoking a product would not be supported, nor would edibles. But vaping - which would be a quicker way to get pain relief - could be allowed.
Other possible products include dried cannabis, oils, ointments or balms, tablets or capsules, and patches.
There are no proposed restrictions on potency.
A new body, the Medicinal Cannabis Agency, would oversee the scheme and have the power to impose penalties for non-compliance, and order products to be seized and destroyed.
What are the safeguards?
Safety is a chief concern, and the Ministry of Health has proposed quality standards for products as well as for the manufacturing process.
Standards for growing cannabis would be set by either the manufacturer or the regulator.
There are two options for the manufacturing standard:
• The Good Manufacturing Practice (GMP) under the Medicines Act, which is the global standard; all products for export would need to meet this standard.
• The GMP as well as the Good Production Practices (GPP) under the Misuse of Drugs Act.
Wills said that there has been concern that only having a GMP standard would lead to costly and lengthy processes, but there was currently no data to suggest that a GPP process might take less time and be cheaper.
The group is seeking feedback on whether it might be.
As happens now, a specialist would still be able to prescribe for a product that did not meet these standards, and the Ministry of Health would continue to review the product's information to minimise risks to patients.
Who can work in the industry?
Helping to build an economy for the industry is also one of the major aims of the framework.
Health Minister David Clark has said the global market for medicinal cannabis is estimated to grow to $80 billion by 2025.
The framework has an emphasis on Treaty of Waitangi issues and equity of access, not only to medicines, but to make medicines.
Those wanting a licence to grow cannabis or make medicines would be declined if they had any drug-related or dishonesty convictions in the past seven years, whether in New Zealand or overseas.
But those wanting to work in the industry would have no such restrictions, meaning people who had illegally grown cannabis could put their skills to use in a legal market.
Whether that is enough incentive for gang members to get on the right side of the law remains to be seen, but about 100 people involved in the cannabis black market have shown an interest in the hemp-growing course at the Eastern Institute of Technology in Ruatoria.
Licensed growers who had access to illegal cannabis seed would be able to make a declaration, pay a fee up to $1500, and then use that seed to grow cannabis for medicinal products.
There are suggestions that New Zealand's clean, green brand could lend itself well to potential export earnings from New Zealand-made cannabis medicines.
The proposed framework has been set up in harmony with Australia's medicinal cannabis scheme, potentially giving exporters easier access to the market across the Tasman.
What about prices?
High prices would deter patients from abandoning the black market.
Competition should lower prices, but that could take time, especially for Medsafe-approved products to hit the shelves.
Allowing people to buy online or direct from manufacturers could also see lower prices, given the mark-up of products in a pharmacy. But buying in this way would see patients miss out on the advice of a pharmacist about the medicines.
Having low fees to enter the market would also help, and the proposed prices for an annual licence - $23,200 for growing a large amount of cannabis, $14,716 for making medicinal cannabis products - are only meant to cover the costs of the licensing process.
Pharmac could also fund medicines when the evidence behind them becomes more robust.
"It's not there yet, although it's getting closer every day," Wills said.
Hikurangi managing director Manu Caddie is hopeful to have products cheaper than Sativex available by March or April next year, which Wills said would be a great start.
"In the end, what everybody wants is for patients to have access to effective medicines for reasonable costs. The question is how we balance safety and access."
Wills urged people to submit feedback, which is open until August 7.
"The consultation matters and it will affect the outcome."
Leaders call for community-driven health campaigns to address bowel cancer inequities.