Kia ora MCA team,
Please find my responses below, on behalf of both Chill Division
Limited and Pause Labs Limited, of whom the Cultivation license application is
currently underway with you. However I was previously sent this from
my time at Skyman Industries, and as such still consider it worth responding
and providing input. Although we are only applying for a Cultivation license at
present, we also consider the implications on patients and accessibility at the
forefront of our responses as well.
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?
As we are only obtaining a cultivation license, this is unlikely
to impact us.
We are always interested in ways that patient accessibility can be
improved, however without knowing more about the original intentions behind not
including that (was it an oversight?) we would abstain from providing a
perspective on this.
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?
Yes, we wholeheartedly agree that this should be removed. This should have
never been the case from the outset, especially given other countries couldn't
care less about our regulations by the time it arrives on their shores.
This needlessly creates barriers to exporting, as well as
double-handling of certifications of product, not to mention we can only
imagine this being a pointless burden on the Medicinal Cannabis Agency.
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?
Yes, we agree. As per above, other countries that are importing products
from us don't specifically care about how "we" feel it should be labelled, and this only adds to the cost / delays in
exporting products. This should be exempted also.
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?
Yes, removing the upper limit seems very sensible.
If the 200ml / 200g limit is all that's available, sure. Given
this will not impact us, please take our input with a grain of salt, however we
would even suggest that potentially those amounts do not go far enough. Instead
we would suggest perhaps 500mL & 454g (1lb) may be more beneficial in terms
of removing the need to "double handle" and import multiple amounts
for testing.
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
- pesticides
- 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.
Although this will not directly impact us in cultivation, this makes sense,
given those shouldn't be present regardless. Even if there were trace amounts
previously present, those should also be removed through the extraction process
(depending on the extraction method residual solvents may remain), and as such
we support this.
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
- pesticides
- absence of aflatoxins
- ochratoxin A
- foreign matter
- loss on drying
- total ash
- residual solvents
- identification of cannabis
- identification of active ingredients?
Although this will not directly impact us in cultivation, we
agree, and would even go so far as to suggest that all testing should be able to
be undertaken by an accredited to ISO/IEC17025 laboratory. We find it amusing
that the standards have been made so strict there isn't a company that can test
for them all, nor is there any indication of one being able to some 3-odd years
after the Medicinal Cannabis Scheme implementation. As such, we take that as a
strong indication that the regulations absolutely must be relaxed.
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?
Although this will not directly impact us in cultivation, we agree, this should
be changed. Further compliance options will reduce the financial obligations /
burdens on vendors and will be a net win for patients and the industry as a
whole.
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.
No, we do not believe the current associated limits are appropriate, and
this also impacts on many cultivators' ability to export even starting materials
at present.
The current requirement for 200g CFU/g (10²) for inhalation
stipulated in Eu Ph 5.1.4 is ridiculously strict and
has very little scientific basis for remaining, especially given it was
originally intended for use in cold-inhaled products such as asthma inhalers.
In order to vape / inhale dried-flower
cannabis products, they are heated past a level at which any remaining CFUs of
bacteria will remain. Combine this with many other jurisdictions in the USA
permitting 10,000CFU/g or 100,000CFU/g where there is a limit at all, and to
our knowledge Canada applies a 500,000CFU/g limit, we would recommend at a
minimum relaxing this to 20,000CFU/g (10⁴).
Although we are aware that patient safety and wellbeing should be
a priority, especially given there may be cancer patients or other immunocompromised individuals taking these products,
striking a balance is important and we strongly believe this is a
misinterpretation of the original intention for this when the European
Pharmacopoeia originally set these levels in 1969.
Contrasting this, in order to meet these excessively prohibitive
levels, products are often gamma irradiated, which is counterintuitive to offer
to patients when many are seeking a herbal remedy to
avoid radiation.
On this basis, we strongly believe the minimum that this should be
amended to should be 20,000CFU/g (10⁴), however
we would have no hesitation in supporting that being increased all the way to
100,000CFU/g for inhaled products that are heated for decarboxylation.
This would strike a much fairer balance between patient safety and providing a cleaner product, while removing the inadvertent requirement for gamma / e-beam / cryo pasteurization of flower products being tested for inhalation.
In addition, the requirement of stability trials to have 3x batches tested has made the de-facto incentive to export, simply so that as a cultivator we don't have to sit on 3 seasons worth of harvest while those 3x batches are tested. In addition, should one of those batches fail testing for whatever reason, that's an astronomical loss that no company would be willing to risk. It's completely unnecessary and serves little purpose other than adding additional cost overheads to bring a product to market, and is a time-sink that we're sure that the MCA would rather not deal with. That legislation has inadvertently provided a massive incentive to import product from overseas in tiny batches, or the exploitation of other such loopholes in the legislation whereby the manufacturing / supply license company does not do the cultivation. This greatly penalizes vertically integrated companies.
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?
Yes, although this will not directly impact us in cultivation, we agree with
this proposed change.
We suggest instead that up to a specified percentage they be
exempt from the assay limits of 90-110%, however the
contents of minor cannabinoids should still be noted
where possible perhaps from 0.1% -> 2%. This is because testing can still
ascertain the cannabinoids within a product even if
they are almost impossible to subsequently moderate / maintain in a full-spectrum oil at such minor levels.
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?
Yes, although this will not directly impact us in cultivation, we agree with
this proposed change.
However we believe that batch-testing could / should still state
minor cannabinoid levels appropriately over a
specified level, such as 0.2%. Such a minimum level for minor cannabinoids should be set so that where a plant has (for
example) under 0.1% of CBN or CBC it is not a requirement to have that stated
on the packaging.
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?
Yes, although this will not directly impact us in cultivation, we agree with
this proposed change.
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?
Yes, at present any genetics created within New Zealand are limited to New
Zealand and could never go offshore or be shared with the broader international
cannabis community who could also further improve upon these genetics.
We can only imagine how restricted the local medicinal cannabis
market would be if no seeds could legally (or illicitly, and declared) be
brought into the country.
We are unsure of any benefit to maintaining the status quo.
Cultivators / breeders are not obligated to supply their seeds internationally,
however providing them with the option to do-so (should they so desire) seems
sensible.
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?
Yes, we support this amendment, however we think that it could / should go
further and instead be incorporated under a Cultivation license, as cultivation
is required in order to generate the seeds. This would simplify the licensing
requirements down to just Cultivation, Manufacture, and Supply.
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.
Yes, although this will not directly impact us in cultivation, we agree with
this proposed change. This would empower cultivators such as ourselves
to find other international offtake agreements who could further (optionally)
process it in accordance with their own local regulations. We believe this
should have been the case to begin with.
Ngā mihi nui,
Josiah
Chill Division