A major change to the Medicinal Cannabis Bill recommended in official advice to the Health Select Committee will ensure New Zealand made products are affordable and available as early as next year.
Our team at Hikurangi Cannabis Company was excited when we realised the plants we have been cultivating over the last two years fit the new definition of a CBD product. Cannabidiol (CBD) is a major compound found in cannabis plants that reduces the psychoactivity of the more well-known THC. CBD is also effective in treating epilepsyand is the cannabinoid used in the first cannabis drug approved by the US Federal Drug Administration.
Testing by ESR that we commissioned for plants grown at our cultivation site near Ruatoria revealed the cannabinoid content of our extracts was eighty eight percent CBD, eleven percent CBG (another awesome cannabinoid) and only one percent THC. Under the original Billa CBD product had to be ninety eight percent CBD but the Ministry of Health has amended the definition of a CBD product to include no more than two percent THC or other psychoactive compounds.
It probably doesn’t sound like a big change but this is huge for us. We no longer need to undertake expensive further refining to isolate the CBD and instead can focus on offering a full spectrum, whole plant product that is non-psychoactive but is likely to deliver significant therapeutic benefits.
The Ministry of Health have said it could take until the middle of 2020 before the regulations are set for medicinal cannabis production. We want to see the regulations operational within six months of the law changing but CBD products could sit outside of these regulations as a dietary supplement once removed from the list of Prescription Medicines as some health officials have recently proposed.
Last week the National Party released their recommended changes to the Misuse of Drugs (Medicinal Cannabis) bill current before Parliament. Advice to the Health Select Committee received from the Ministry of Health was also released on the same day, but largely overlooked by news outlets. The Select Committee report includes the two major parties position on proposed changes as well as a revised version of the Bill based on submissions and MOH advice that they considered before agreeing to disagree.
The Select Committee received 1,611 written submissions on the Bill There were 1,539 submissions received from individuals and 72 from organisations including:
- 11 health care professional (HCP) bodies and medical associations
- 13 companies interested in being involved in the medicinal cannabis industry
- 48 other organisations such as patient support groups.
The Committee heard 158 oral submissions.
Of the 778 submissions that commented on the Bill:
- 27% supported the Bill in its entirety
- 6% did not support the Bill at all
- the rest were unclear
- 52% of submitters who commented on the Bill (including the majority of individuals who were against the Bill) indicated that it did not go far enough.
Ministry of Health officials recommended only five changes to the Bill as a result of the feedback received from the public, patients, industry and health professionals.
The first recommended change is to allow for (not to include) regulations to prescribe standards for all stages of cultivation, production and manufacture, and criteria for when the regulations will apply. The technical detail of the standards will be published by the Director-General of Health. Dr Shane Reti’s shadow bill goes further by setting some of the regulations for each area of the industry: cultivation, production, manufacture, distribution and prescribing. This absence of any detail on what the regulations will be is the biggest issue National have with the current bill and, justifiably, they don’t want to see the Minister and officials having all the say over the standards.
The second significant change proposed by the Ministry of Health is designed to allow the provision of information about the availability of medicinal cannabis products to appropriate health professionals. This important provision will allow health professionals to be fully informed about new products, it will also be useful for patients and the industry to be able to share details of product availability, cannabinoid composition, etc.
The third recommendation revises the Bill so that substances related to tetrahydrocannabinols that are naturally found in cannabis, are no longer captured under the Act where there is evidence that they have little to no psychoactivity. This is a critical change to allow CBD and other therapeutic and beneficial cannabis products to be more accessible and affordable. Hikurangi and others argued strongly that other cannabinoids and bioactive compounds like terpenes with no psychoactive effect on users, should not be regulated in the same way THC is. We are pleased that this change is being made.
The major change recommended by Hikurangi and adopted by the Ministry of Health is to revise the definition of CBD product (clause 4 of the Bill) to allow not more than two percent of the total cannabinoids in the product to consist of THCs and related psychoactive substances that are naturally found in cannabis. This is a critical change to allow CBD products to be more accessible and affordable. Under the original bill this extract would not meet the definition of a CBD product without expensive further refinement, but this recommendation to the Select Committee is a game-changer. Low-THC, whole plant products with a potent combination of other therapeutic compounds that deliver what is known as the ‘entourage effect’ is what we have been planning to include in our clinical trials starting next year and this change will enable such medicines to get to market very quickly and much more affordably.
The final recommendation is an administrative change shifting a clause from one section to another – while the statutory exemption clause is the major bone of contention, the officials’ recommendation has no material impact on the draft legislation. Patient advocates legitimately want the scope of exemption broadened from only those with less than a year to live while National see it as somehow the thin edge of a ‘grow you own’ wedge. This issue will be the major sticking point in the two major parties finding a compromise everyone can live with. NZ First seems keen to find a way through the most controversial aspects to deliver a win-win-win-win for the patients, public, producers and even the politicians.
Hopefully a compassionate compromise can be agreed that not only allows those with a medical cannabis card to be exempt from prosecution if found with a few plants, but also provides subsidies for severely epileptic children who may require more frequent and higher doses to keep spasticity under control. Many of these young people require fulltime care and do not even make it adulthood – the government will need to work closely with health professionals and medicine manufacturers to get safe, affordable products to parents as quickly as possible.
Eighty eight percent of submissions support individuals being able to use cannabis for medicinal use, only one percent of submitters (strangely including three healthcare professional bodies) were not in support. There is clearly much work to be done in raising awareness amongst medical practitioners of the low risk profile of medical-grade cannabis products and in taking a compassionate approach to regulations while maintaining public safety and confidence in the new system.
Medicinal cannabis is not a silver bullet to cure all diseases, in fact the range of conditions it is proven to help with is currently very small, but New Zealand has a great opportunity to provide affordable access to people who desperately need it and to invest in clinical research to contribute to the global knowledge of what this plant can help with. Let’s not stumble at the last hurdle, let’s do this, now.