In December 2019, the Ministry of Health released the final Medicinal Cannabis Scheme. The new regulations come into effect in 1 April 2020 – but that do they mean for New Zealand?
Paul Manning, Chief Executive of Helius Therapeutics, the country’s largest medicinal cannabis company, and foundation sponsor of MedCan Summit 2020, shares his thoughts.
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&D 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.
By Paul Manning, Co-Founder and Chief Executive of Helius Therapeutics, Foundation Sponsor of MedCan Summit 2020.
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