By Paul Manning
Last month the Ministry of Health released the final Medicinal Cannabis Scheme, but in the lead up to Christmas many may
have missed the significance of this milestone.
Officials had just 12 months to design and finalise the new medical cannabis regulations, consulting healthcare
professionals and the burgeoning industry during that time. Overall, they have done well to deliver on both the public
and parliament’s desire for Kiwi patients to have greater access to affordable medicinal cannabis products.
Key to delivering on patient access was the decision to drop the requirement for specialist sign-off on prescriptions
which had been proposed in the July discussion document.
This means all GPs will be able to prescribe medicinal cannabis products without additional oversight, and for any
condition. Unlike some other countries, there will be no list of ‘qualifying ailments’ they need to abide by.
Helius strongly advocated for GPs to be given the professional discretion to prescribe medicinal cannabis, just as they
have with any other medicine. Patients and their advocates were also concerned that specialist sign-off would inhibit
access and drive up costs.
Our work included commissioning a large Horizon Research survey of over 700 healthcare professionals in August and
publicly releasing the results.
The independent survey confirmed healthcare professional’s strong belief that GPs are already specialists in the field
of general medicine, know their patients best, and are perfectly capable of prescribing cannabis-based products on their
own. A majority of doctors made it clear that specialist sign-off was unnecessary, and in the end this view was shared
by the Ministry of Health.
With the final scheme empowering GPs, considerable complexity and time is removed for patients, and any concerns about
capacity and extra pressure on the health sector disappears.
New Zealand, for example, has a critical shortage of pain specialists, making it near-impossible to serve the 740,000
Kiwis living with chronic pain who could benefit from cannabis products. With that in mind, it’s great that the Ministry
has listened and positively responded to feedback received throughout the consultation process.
With anticipation already high, healthcare professionals will need to upskill ahead of many medicinal cannabis enquiries
from the public, with doctor education now key to patient access.
In fact, our demand modelling suggests the market here will reach around 60,000 patients at maturity. This will increase
further as clinically-proven products start coming through.
Survey results, again commissioned by Helius, revealed in April that 89% of those qualified to prescribe medicines said
they would prescribe medicinal cannabis products for one or more of 20 medical conditions, if they had enough
information, with chronic pain the condition they would most prescribe it for.
It’s good news that significant government funding will be dedicated to operating the Medicinal Cannabis Scheme.
Hopefully this will include budget for a prescriber education programme, which would make a real difference.
As it is, the scheme will help restore the quality of life to thousands of New Zealanders, delivering access to high
quality Kiwi-produced medicinal cannabis products. However, many are now asking: When will this all happen?
Minister of Health David Clark has confirmed the scheme will be operational by 1 April 2020, when a new Medicinal
Cannabis Agency will be in place to receive commercial licence applications. Existing R licence holders, such as Helius, will then need to apply for new commercial cultivation and manufacturing licences.
We’re anticipating this process to be expedited, but it could still take up to two months. Once granted, we can then
only carry 50 plants over from our already-operational facility. With the rest having to be destroyed, we’ll need to go
through a full growth cycle to produce the APIs (Active Pharmaceutical Ingredients) for our first locally made products.
Most local cannabis companies are still in early stages of development, but at Helius we have largely completed our
8,800sqm integrated GMP (Good Manufacturing Practice) facility. We are ready to move towards production, with delivering
for Kiwi patients our first priority.
We expect to be ready to start selling products around the middle of this year, and I expect we could see two or three
local cannabis companies with products in market by the end of 2020, when Helius also plans to be exporting products
across the Tasman.
In the meantime, foreign medicinal cannabis products will increasingly be imported, with more products coming in from
Canada, and perhaps Australia.
The new regulations require local products to be at GMP grade. This will give practitioners the confidence they’re
prescribing products that are of a medical grade manufacturing standard.
Other key aspects of the final scheme include cannabis-based products being allowed onto the market without clinical
trials. Exports will also be permitted, creating a significant economic opportunity.
Regulators have ensured all the right components are in place to create a new competitive export sector, with the global
industry estimated to reach $55 billion by 2025. In fact, there is no reason why New Zealand cannot become a global
centre of excellence for medicinal cannabis innovation. That should be a national goal.
The Ministry of Health has done well to deliver robust, pragmatic regulations within a tight statutory timeframe.
However, the pressure remains on officials in 2020 to get on and enable licenced manufacturing and ensure local product
supply. Thousands of suffering Kiwi patients eagerly await.
Paul Manning is the Co-Founder and Co-Chief Executive of Helius Therapeutics - the country’s largest medicinal cannabis
company.