The Government has finally announced a scheme for regulating medicinal cannabis but there are concerns over the delay, and barriers to access due to the prescription and fee regime. Laura Walters reports.
Industry experts say the Government’s proposals for a regulated medicinal cannabis market in New Zealand are a step in the right direction, but could go further.
The consultation document, which covers proposed licensing, cultivation, manufacturing and product standards along with the prescription and enforcement regime, was released on Wednesday.
It comes after the Government passed legislation aimed at increasing accessibility and reducing health inequities in December last year.
Those in charge committed to having a scheme created in 12 months, but that timeline has been pushed out, with the Government only now going to consultation.
There are also some concerns over the high fees and prescription regime.
The Government and the Ministry of Health are asking for feedback from industry, medical professionals, potential users and the wider public by August 7, in order for the scheme to be finalised by the end of the year and operational in the first quarter of next year.
Co-founder of medicinal cannabis producer and supplier Zeacann, Chris Fowlie, said it was important to impose the year-long timeline when legislation was passed, and at the time it was understood the scheme would be in place by Christmas this year.
But the Government and officials were now stretching that timeline, saying the scheme would be finalised in theory by the end of the year, but not up and running until 2020.
By the time licensing processes were actually up and running it would likely be the middle of the year, and cultivators would be lucky if they were ready to start growing the following summer of 2020/21, Fowlie said.
This could create confusion as the timeline crossed over into the discussions around next year’s referendum on the legalisation of cannabis for personal use.
And in other jurisdictions, medicinal cannabis schemes had been given time to bed in, ahead of recreational regulations.
Most importantly, it would further delay access for those with chronic pain and conditions who would continue to risk their health and prosecution by accessing unregulated products, he said.
National Party health spokesperson Michael Woodhouse was also critical of the time it was taking to develop the scheme, which would now not be truly up and running for well over a year after legislation was passed.
“The Government has really mucked up the order when passing its medicinal cannabis Bill last year.”
“New Zealand was losing export market share while the Government lets officials talk,” he said.
Prescription barriers eased
The proposals contained in the lengthy document include making it easier for registered doctors to prescribe medicinal cannabis, and removing the need for Ministry of Health approval.
Currently, medicinal cannabis products (except CBD products) are available on prescription with ministerial approval.
But most prescriptions would still need specialist sign-off under the proposed scheme.
Approved cannabidiol (CBD) products – which do not produce a high – would be able to be prescribed by a nurse.
NZ Drug Foundation director Ross Bell said the process could be further streamlined if GPs were trusted to prescribe without needing further sign-off.
This need for sign-off could also affect patients who did not have access to a specialist.
In recent months, experts have highlighted the importance of doctors having good knowledge of medicinal cannabis. They also needed to be confident in the scheme, which meant there needed to be a robust framework.
Costs remain high
The consultation document also outlined a range of fees for the different specific licences.
The final costs will depend on which quality standards are opted for. There are two options: the current Good Manufacturing Practice (GMP) for all medicinal cannabis products, or allowing for some forms of medicinal cannabis products to be manufactured in accordance with GMP and others under Good Production Practices (GPP).
The legislation aims to increase accessibility, but the proposed licensing fees for cultivation, manufacturing, product supply and product assessment are high – in some cases tens of thousands of dollars.
There is concern the costs will be passed onto consumers, as new medicinal cannabis products will not be covered by Pharmac subsidies.
Bell said these fees meant price would continue to be a barrier for many people.
The limited products currently available could cost patients more than $1000 a month. And while cannabis medicines are likely to become cheaper over time, it could take years.
“Where is the safety net for patients in the meantime? Without this, patients will be forced to continue turning to the black market,” Bell said.
Zeacann’s Fowlie, who is also a founder of the Medicinal Cannabis Council, said the fee model and the number of licences the Ministry of Health expected to approve – mostly in the single digits – lent itself to a more corporate model.
The new product assessment fee would be more than $21,000 (if they went with the GMP option).
Those high fees, and the low number of expected licence holders, would likely to stifle new product innovation, Fowlie said, adding that it would limit consumer choice and export potential.
No edibles or smoking
Certain forms of doses have also been ruled out, including edibles, patches, and ‘sterile doses’ such as injectables and ear and eye preparations.
While doses that can be inhaled as vapour will be included in the proposed scheme, smoking will not be included.
Those who currently had illegal cannabis seed would be able to legally use that seed for legal cultivation of medicinal cannabis by making a declaration.
The document also includes the proposed standards and testing regime for cultivators and manufacturers to follow.
The Government does not propose any limit to THC – the active psychoactive substance – in cannabis.
Instead, final products will have a clearly defined composition of active and non-active ingredients which must remain consistent, and will be batch tested.
The quality standards for a finished product would be the same whether it was a prescription medicine – CBD – or also a controlled drug – with THC.
There are three different options for quality standards for growers proposed: either the manufacturers would set the standards; the regulator would set the cultivation process and carry out audits; or the regulator would set the quality standards for starting materials.
The Medicinal Cannabis Agency will be established to oversee the scheme. Its duties will include overseeing the licensing scheme, monitoring the overall scheme to see whether it meets its objectives, data collection, and compliance monitoring.
One step closer
The document said the scheme was being established to increase access to medicinal cannabis products, including increasing supply by making it possible for these products to be made in New Zealand and requiring products to meet quality standards, so medical practitioners (doctors) and nurse practitioners can prescribe with confidence.
It also stressed the importance of equitable access to the industry for Māori and iwi.
Health Minister David Clark said making medicinal cannabis more readily available had the potential to help ease the suffering of thousands of people who were living in pain.
“So it’s important we get these regulations right…
“The legislation Parliament passed in December paved the way for greater access to medicinal cannabis products and ultimately will allow New Zealand companies to manufacture quality medicinal cannabis products for local and international markets,” Clark said.