NORML has obtained a copy of changes to the Medicinal Cannabis Scheme proposed by New Zealand’s Ministry of Health.
These changes appear to have already had sign-off from the top (the Minister of Health), so they are almost certainly bound to happen, and are expected to be implemented in the second half of this year.
This is great news, because while the Medicinal Cannabis Scheme allows any doctor to prescribe medicinal cannabis products to any patient, for any reason, the Scheme has been roundly criticised for exceptionally tough standards that have raised prices and restricted the availability of cannabis medicines.
The scheme came into effect four years ago but we are only now seeing the first approvals of locally made CBD and THC products. No commercial exports have been made. No locally grown flower is available yet.
Having examined the proposed changes (contained in an email sent to medicinal cannabis licence holders on 16 December 2022), NORML is confident they are ALL GOOD and will make a positive difference to patients struggling with high prices and slow processes, and to our local industry struggling with a nonviable market and exorbitant costs not faced in other countries.
Although NORML strongly welcomes these changes, we are surprised they are narrowly focused only on product standards and approvals. There are other areas for improvement, which could significantly benefit patients, and could also be achieved by amending regulations (i.e. not legislation – which seems off the agenda for now). These could include:
- reducing costs by allowing multi-year and multi-site licenses;
- allowing pharmacy compounding of customised cannabis meds (like they can do for any other medicine but cannot do for cannabis);
- allowing batch-tested crops to be supplied, like in Canada and US states, in addition to full-GMP meds (this would open the market to non-millionaires);
- affirming that non-therapeutic products derived from hemp are not medicines (this would allow food-grade herbal products and bring NZ in line with US states);
Feedback is due by 27 January 2023. It’s a truncated process. You can give comments on what they have proposed, and you can also add more proposals of your own. The email appears intended for industry/license holders but we encourage patients, advocates and anyone with an interest to also make their views known. For added impact, you could share your feedback with your local MP and the Minister of Health, so they know what is going on.
Seeking feedback on proposed improvements to the Medicinal Cannabis Scheme
The Medicinal Cannabis Agency would like your feedback on a number of proposed changes to the Medicinal Cannabis Scheme that we have developed to improve workability, clarity and functionality for the Medicinal Cannabis Industry. We would very much appreciate your responses to the following questions – together with any other feedback you may have – by 27 January 2023.
1) The current definition of ‘cannabis-based ingredient’ requires that the ingredient is both extracted from cannabis and is intended to be used in, or for, a dosage product. Would you agree with expanding the definition to include ingredients such as milled cannabis to help broaden the variety of dosage products available to patients in New Zealand?
2) The requirement for ‘starting material for export’ to meet a minimum quality standard was put in place to establish New Zealand as a high-quality producer of starting material but can be a barrier to export. Would you agree with removing the requirement for each consignment of starting material for export to meet the minimum quality standard?
3) A medicinal cannabis product that has been verified as meeting the minimum quality standard must meet the labelling requirements set out under regulation 19 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019. However, sometimes importing countries have different labelling requirements for these products, including specifying the language required. Would you agree with exempting verified medicinal cannabis products for export from needing to meet the requirements of regulation 19?
4) Currently, all cannabis-based ingredients and medicinal cannabis products are required to meet the minimum quality standard before they are imported into New Zealand unless they are specifically exempted. This applies even when samples are being imported for analytical testing and where the research to be conducted is considered to be therapeutic in nature, but the products will not be directly administered to a person. Would you agree with removing the requirement to meet the minimum quality standard for these small samples? And if so, do you believe that 200ml in the case of a liquid or 200g in the case of solid material would be an appropriate upper limit?
5) A number of tests are currently required for both extracted cannabis-based ingredients and dosage products. As manufacturers are required to manufacture in accordance with Good Manufacturing Practice (GMP) and are therefore already required to control for contamination and impurities, would you agree with removing the following testing requirements from the minimum quality standard for extracted cannabis-based ingredients if this is controlled in the dosage product:
- microbiological contamination
- heavy metals
- absence of aflatoxins
- ochratoxin A
- residual solvents?
Please note that if in response to the feedback received on question 1 a proposal is put forward to include milled cannabis as a cannabis-based ingredient, then the applicability of this proposed change for milled cannabis will be considered.
6) Under the Regulations, testing to demonstrate compliance with the minimum quality standard must be performed by a GMP-certified manufacturer or laboratory. However, no GMP-certified testing laboratory in New Zealand can currently perform all the tests required by the minimum quality standard, and there is no indication of when or if such a laboratory will be established. Would you agree with allowing the following lower-risk tests for assessment against the minimum quality standard to be undertaken at ISO/IEC 17025:2017 accredited laboratories:
- microbial contamination
- heavy metals
- absence of aflatoxins
- ochratoxin A
- foreign matter
- loss on drying
- total ash
- residual solvents
- identification of cannabis
- identification of active ingredients?
7) Dosage products may only include an excipient for which there is a monograph in the European Pharmacopoeia. What is your opinion on allowing the use of excipients with monographs from the British Pharmacopoeia and/or United States Pharmacopoeia in dosage products?
8) Do you consider that the current tests, test methods and associated limits specified in the minimum quality standards are the most appropriate? If not, what alternative tests, test methods and associated testing limits would you like to see incorporated into the minimum quality standard? If you would like to see certain tests included, please specify which pharmacopoeia (including version) you are referring to.
9) It can be difficult to measure very low levels of active ingredients in cannabis-based ingredients and medicinal cannabis products, and controlling very small levels of active ingredient within specified ranges can be of limited value. Would you agree with allowing ‘less than’ assay limits to be applied to the stated content of active ingredients when they are present at very low levels in cannabis-based ingredients and medicinal cannabis products?
10) Due to the variable cannabinoid content in cannabis biomass, the assay limits of 90-110% of stated content can be difficult to achieve, and may not be appropriate for some simple full spectrum cannabis-based ingredients. Would you agree with removing the current assay limits for active ingredients in cannabis-based ingredients, and allowing manufacturers to determine their own assay limits in accordance with GMP?
11) Currently, cannabis-based ingredients or medicinal cannabis products must be packed in a container made of a material that complies with chapters 3.1 and 3.2 of the European Pharmacopoeia. However, under GMP the manufacturer is already responsible for ensuring that any container used to store an ingredient is made with material that does not alter the quality of the ingredient. Would you agree with allowing cannabis-based ingredients that are stored and manufactured into medicinal cannabis products at the same site to be stored in appropriate containers consistent with GMP?
12) Whilst cannabis seeds can be supplied within New Zealand to the holder of a medicinal cannabis licence or to a person authorised to receive medicinal cannabis seeds under a medicinal cannabis licence, medicinal cannabis seed cannot be exported. Would you agree with allowing the export of cannabis seed under the Scheme? And if so, would you agree with enabling this through the ‘cultivation’ and ‘nursery’ activities on a medicinal cannabis licence?
13) As the Agency has only ever issued medicinal cannabis licences with a ‘nursery’ activity for seed supply purposes, would you agree for the nursery activity to be renamed ‘seed supply’ and for the importation of cannabis plants to be removed from this activity?
Additionally, we would be interested in your preliminary thoughts on whether we should consider removing the requirement for New Zealand exports of domestically manufactured cannabis-based ingredients or medicinal cannabis products to meet the minimum quality standard. Please note that export requirements may also be affected by the Therapeutic Products Bill that was recently introduced into Parliament and there will be an opportunity to provide feedback on the Bill during the Select Committee stage.
We are very conscious it is a busy time of year so we would like to take this opportunity to thank you in advance for making the time to provide feedback on the proposed changes. Should you have any questions or require any background information, please feel free to contact us via email (medicinalcannabis@health.