The new just announced regulatory scheme for cannabis
based medicines is generally positive. But the government may be significantly
underestimating the demand for licenses, raising the spectre of an underfunded
industry regulator.
What is good about the new regime is the requirement that
medicinal cannabis producers meet Good Manufacturing Practice (GMP) quality
thresholds. This will ensure cannabis-based medicines meet the same high
standards as all other pharmaceutical products. That high quality standard will
be good news for patients. Provisions allowing the rapidly developing industry to access the
vast knowledge and cannabis cultivars that already reside in the underground
medical cannabis community are both positive and sensible. And the licence fee
structure being proposed is broadly supportive of the industry and should not
inhibit its development.
The Ministry of Health says its expects to issue 110
medicinal cannabis licences in the first year, while at the same acknowledging
the inherent difficulty in estimating the number of industry participants in
what is an emerging NZ industry. There has to be some concern, therefore, that
the Ministry of Health may not be able to cope any unexpected surge in licence
applications. Moreover, there is the additional risk the Ministry may have underestimated
the time and cost of monitoring - especially planned and unplanned surveillance
audits – and subsequent enforcement action where breaches and/or illegal activities
are identified. It would be a major concern if the implentation of the new
regime were to fall down or become subject to substantial delay because the
regulator’s office was inadequately resourced.
However, so long as long as the government remains committed
to quickly resourcing the new regulatory agency to meet actual demand, then the
regime should be introduced relatively smoothly. But, the absence of
appropriate resourcing would likely create a significant bottleneck to industry
growth, especially if the numbers of applications are consistent with market
expectations and not the Ministry’s more conservative estimates.
If there are bottlenecks which lead to significant
delays New Zealand patients will be the loser. At best, this will mean local
patients will be paying more for relatively expensive overseas products. At
worst, patients with limited financial means may continue to suffer
unnecessarily or turn to the black or grey market,which is precisely what the
Ministry is trying to avoid.
Overall, the new scheme will open
the door to offering many New Zealanders relief from chronic pain and other
symptoms, with non-addictive cannabis-based medicines. Cost-efficient New Zealand
medicinal cannabis producers should enjoy a strong cost advantage and, in some
cases, quality advantage relative to offshore-based providers of these
cannabis-based medicines.
While the potential is there to establish a quality
cannabis based medicines industry in New Zealand, progress could still be frustrated
if the government does not put in place the appropriate infrastructure and
oversight to allow medicinal cannabis products to be developed and brought to
market in a timely manner. It has already taken two years to achieve regulatory
certainty, and there is no excuse for further delay or uncertainty.
By way of disclaimer, I am Chair of SETEK Therapeutics,
one of the new companies becoming involved in this market. SETEK is a New
Zealand owned bioscience company looking to cultivate, process and manufacture
pharmaceutical grade, pure organic, cannabis-based medicines and
cannabis-infused skincare and wellbeing products for New Zealand, Australia,
the Asia Pacific region and beyond.
My comments, however, are made from the perspective of
someone with a long interest in this issue, who began the process of making
access to cannabis based medicines more available to New Zealanders over five
years ago (including declassifying CBD under the Misuse of Drugs Act), and who
is generally pleased with the progress made subsequently. Interest, tolerance
and understanding, both within government and the public, have grown
considerably in that time, and the opportunity now exists to establish a viable
cannabis based medicines sector in New Zealand.
On that note, Dunne Speaks takes its leave for 2019.
Best wishes to everyone for a safe, and happy Christmas with family, friends,
and those dearest to you. 2020 will offer a whole fresh set of challenges and
opportunities, and Dunne Speaks will be back in a few weeks to comment on those
as the year unfolds. Meantime, Merry Christmas!