David Clark has released the Supplementary Order Paper on his amendments to the Misuse of Drugs (Medicinal Cannabis) Bill.
The SOP agreed by all three support parties in the current Government contains some significant changes to:
- the definition of CBD products;
- the ability for genetics already in New Zealand to be used in the industry;
- the setting of minimum quality standards to be prescribed for a product or for the processes by which a product is cultivated, manufactured, produced, imported, or supplied;
- the group of people with serious health conditions who are eligible to use a statutory defence if they are prosecuted for possession and use of cannabis before the new regulations are implemented;
- the timeframes for setting the new regulations next year.
CBD Product Definition
The CBD definition is a bit complicated but much better than it was with the focus on ensuring cannabinoids with more than minor psychoactive effects are limited to no more than two percent of cannabidiol and other specified cannabinoids. There are some likely future issues with this wording as the sophistication of the industry and products matures, but it is a good place to get to all things considered. The next step is to have some low dose, low risk CBD products removed from the register of Prescription Medicines.
New Zealand Genetics
“Regulations made under this section that relate to products that contain any part of any plant of the genus Cannabis, cannabis fruit, or cannabis seed must not require that the variety of plant contained in the product was brought into New Zealand with authorisation, if the variety is established in New Zealand at the time the product is manufactured or produced.”
The most critical questions to be clarified for this provision are:
(a) is this an ongoing opportunity rather than a limited window amnesty?
(b) will this incentivise the illegal importation of new genetics that circumvent the phytosanitary certification required by MPI biosecurity regulations currently in place for cannabis?
(c) what will be the test for whether a variety is established in New Zealand?
(d) how will this opportunity be implemented to maximise benefits for the New Zealand medicinal cannabis industry while also providing a trusted protection mechanism for those who would like to transition from the illicit to the legal market?
We propose the answers might be along the lines of:
(a) Yes, it is an ongoing opportunity to ensure plant breeders can bring novel strains into the legal system. In Canada micro-licenses are given to specialist breeders who can grow only a limited number of plants and must only supply to licensed producers or other breeders. What Canada hasn’t allowed is for new strains to be introduced after they closed off the short amnesty window. This created massive opportunities for the first companies who received these strains and effectively gave them a perpetual monopoly on the approved varieties as every other license-holder had to access them off those who had been organised first. As the first cultivation license holder Hikurangi Cannabis Company should arguably be calling for a short timeframe and be like the first Canadian companies to grab local genetics and effectively control the market. However we don’t think this is in the best interest of patients, the industry or ultimately our company. A better approach will be to enable our company (and anyone else in New Zealand) to become a global source of genetics through the breeding programme we have developed that requires as diverse a gene pool as possible. We see this as a major competitive advantage for our company and our country to be suppliers of quality strains to the world and provide us with the best opportunities to develop novel new strains for specific markets and products. This really is our chance to be not just world class, but world leading.
(b) While this does potentially incentivise illegal importation, it also effectively eliminates the incentive for illegal importation because by definition every company can import any seed and bring the strain within the legal system itself before the product is manufactured or produced. What could be required to eliminate the already low risk of importing new diseases, are quarantine requirements for any importation if the phytosanitary requirements cannot be met in the country of origin.
(c) The test for whether a variety is established in New Zealand should simply be evidence that it is already growing here either in a licensed or unlicensed context. There will need to be freedom from prosecution for breeders bringing their strains into a licensed cultivation operation and the Bill doesn’t cover how this will be organised but the regulations can describe that process and establish the micro-licensing structure based on the Canadian example. Breeders can organise themselves into one or more cooperatives that manage the IP contributed and provide peer support and pooled resources, or they can join with research organisations and/or make arrangements directly with individual or all licensed companies.
(d) The breeders and growers that hold the IP and genetics in the illicit market have little trust in government due to decades of prohibition and the associated discrimination with the way the law has usually been enforced. An independent organisation (which could be a breeders co-operative or a trust managed by a mix of trusted growers and non-growers) could be created that is an intermediary between the illicit market and the legal use of the genetics and IP with a framework that has the confidence of growers, industry partners and government. This would allow for genetics and IP to be held in trust by those who contribute it with their interests and identities fully protected for as long as they want to participate. It would also ensure that industry can engage with the representatives of breeders as IP owners through commercial contractual mechanisms that protect those that have developed that knowledge over decades. This will support the continued development of IP and genetics by those that hold the knowledge to ensure New Zealand cements and protects a world leading position in the fast growing global industry. Without such a mechanism the best New Zealand genetics and IP are unlikely to be divulged and New Zealand will miss an amazing opportunity. Ideally this will be a permanent, longterm arrangement that protects the interests of patients, breeders, industry and public officials.
Eligibility for Statutory Defence
This is probably the most misunderstood and misreported aspect of the Bill. It is difficult to understand the scientific rationale for such a limited scope of conditions even in the expanded provision for palliation – until we consider the rhetoric coming from some politicians scaremongering about the dangers of this statutory defence being a ‘slippery slope’ to decriminalisation.
The whole point of this legislation is of course to decriminalise cannabis for medical necessity. There’s no sunset clause of the statutory defence and that may be why the eligible conditions are so limited. The new scheme to be in place sometime next year will not be limited to palliation – the opposite has been continually implied and overtly expressed in nearly every news story on the issue. The fact is this legislation does not limit medical cannabis access only to people with palliation, it does this only until the regulations are set and there has been no suggestion that a list of eligible conditions will be prescribed, in fact the politicians and officials we have spoken to have suggested the opposite – it will be up to medical professionals and their patients to decide if medicinal cannabis products might help whatever affliction is presenting with the patient.
The fact that sometime next year people suffering from chronic pain on a daily basis and other serious conditions will finally get easier access is small comfort for those who have to continue to suffer only because a bureaucratic process has to run its course. The scope could have been widened further if it hadn’t been for those meddling politicians who misrepresent the reality of the situation for patients, but the good news, that has been mentioned in only one news item to date, is that this is a very temporary limit.
Timeframes for Regulations Setting
The requirement to set the regulations within 12 months is reassuring and everyone needs to help the Ministry of Health progress this even faster if possible. The best option to ensure speedy process is for the Ministry to (a) spend money on independent consultants who can work with local stakeholders including MedSafe, patient advocates, medical professionals, industry representatives and academics to look at what might considered the best policy settings based on overseas experiences. This is such an awesome opportunity for New Zealand to literally have the world’s leading medicinal cannabis regulations that ensure patients have access to high quality, low cost products from a world class domestic industry that can leap-frog competitors in other jurisdictions hampered by overly bureaucratic and illogical rules that don’t make products safer or more affordable, and licensing systems that favour market dominance by multinational corporations over innovative and hopefully more ethical smaller companies.