Unveiling of Medical Cannabis regulations "Bittersweet"

Today, the Medical Cannabis Regulations have been released, the reaction from patients has been mixed, with some excellent gains made around prescribers and access pathways, leaving the patients uphill battle for access squarely as a socio-economic issue.

Prescribing Unleashed
"The unleashing of GP Prescribing for is a great result, with no list of conditions to refer to, it grants favourable prescribers complete freedom to prescribe, and treat MC with the same caution as other controlled drugs"

"Clearly the Ministry heard concerns around equity of access and arguments from professional bodies around the lack of specialists, we applaud them for taking our concerns onboard and amending the proposed regulations"

"We are grateful to the Ministry staff who have worked tirelessly this year to meet the deadline, this was a huge piece of work for those involved," Says MCANZ Spokesperson Mark Crotty.

Patient costs not directly addressed.
Disappointingly, however, costs have not been directly addressed, leaving products to continue being unaffordable to those who need them most. Costs have been gradually coming down over the last 18 months, as the recreational market in Canada has greatly increased supply and delivered economies of scale, while more recently competing products have entered the market. Locally made products could be cheaper again, - eventually once prescribing stigma has been reduced and if exports take off.

"The products will remain out of reach for those on supported living payments and the like, and without hard clinical data, ACC is unlikely to be funding patients in its care either. With these headwinds for the patients with the highest needs, breaking the law will still remain a viable option for those seeking a better quality of life."

"Medical Cannabis will likely remain a "middle-class medicine" for the near future, as PHARMAC can only fund products with a justifiable amount of research supporting it with a sharp price point. As we have seen with Sativex, the research adds cost that makes it a poor use of PHARMAC funds."

"For the patients that the government seeks to deliver the most benefits for, criminalization remains the best course of action"

"It will be bittersweet for patients knowing that prescribing is as easy as we could have possibly hoped for, only for costs to still pose an insurmountable barrier for many"

"The compassionate aspect of the law, providing a statutory defence, was only extended to those requiring palliation, so for those patients to poor for legal Medical Cannabis, the 'Reeferendum' is looking like a better solution. Says Mark.

Ministry to tackle prescriber education
A key driver of success is prescriber willingness to trial medical cannabis for their patients, in many other jurisdictions, some doctors become specialists in Medical Cannabis and provide huge portions of regions prescribing. In order to tackle this, the Ministry is asking for money for prescriber education.

"We applaud the MOH for tackling this head-on, and not washing their hands of it entirely, as has been the case overseas".

"If the funding is approved, this means that some balanced and up to date information will be supplied to prescribers from trustworthy sources, as opposed to the highly polarized misinformation that is available currently." Says MCANZ Coordinator Shane Le Brun.

Technical details could help drive costs down further with more tweaks.
With Pharmaceutical GMP standards being set, the best way to drive patient affordability is via economies of scale for the cultivation and manufacture of products, this will be hard to achieve with an already overcrowded market of companies, with 20 having research licenses already.
Economies of scale can be achieved by
• Successful exports and maximum support to achieve that, via MBIE etc,
• Greater uptake, without prescription requirements for some relatively safe products,
• A successful adult-use market that allows companies to supply both.
• Allowing Supply of Biomass from hemp growers for extraction.

MCANZ Understands that the peak industry body, the NZMCC has been in talks with MOH around making certain low dose CBD products over the counter (OTC). This would be a great compromise compared to overseas regions where CBD is not a medicine and the supplements industry has become a "wild west", and those at the other end of the spectrum where it is a prescription-only product, remaining "unobtanium" for many. So far, only South Africa has blazed (no pun intended) a path forward with CBD at doses 20mg or less per day being treated as health supplements and higher doses remaining as medicines. Such a regime in NZ would greatly enhance patient access while removing some pressure on prescribers and delivering volume to support an NZ Industry.

Regarding Hemp Biomass the current laws and regulations prohibit those with Industrial hemp licenses supplying any biomass for Cannabinoid extractions for medicine. Biomass from hemp crops post-seed harvest is a waste stream with residual, usable and financially viable amounts of Cannabidiol (CBD).

"At least 2000 Hectares of hemp is under cultivation this season, and the waste biomass post-seed harvest could be harnessed and extracted for CBD Medicines. This would deliver revenues for hemp farmers, and cheaper CBD for both producers and ultimately, patients. Its heartbreaking that Hemp farmers are essentially composting 'free' CBD that patients can't afford." Says Richard Barge, chair of the NZ Hemp Industry association.

Referendum implications
Regarding the referendum, MCANZ has yet to have a position on it, and have been awaiting these regulations. MCANZ will be consulting with its membership over the holiday season before formulating a position before the end of January 2020.

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