Medicinal Cannabis Scheme Industry Session

First of all, I was
just saying upfront, if you’re here to learn more
about the government’s proposed referendum on the legalization
of recreational cannabis, you may need to
wait a little bit longer because
this session isn’t about recreational cannabis. This is about the
medicinal cannabis scheme, which covers medicinal cannabis
products which are only available on prescription. So it’s through
the medical model. New Zealanders will
choose whether or not to legalize or regulate
medicinal cannabis as part of a referendum to be held
as part of the 2020 election. So we’re not going to talk
about the referendum today. So just on this slide, this is
an industry-focused session. So we’re going to talk about
the background to the scheme, the context, and how
we can improve access to medicinal cannabis products. What will probably be
of great interest to you all is the quality standards
in the licensing scheme. So we’re going to cover that and
then talk about the prescribing requirements. So now, I will ask Chris to come
and talk about the background to the scheme. I’m going to talk
about why we’re here, medicinal-cannabis-wise,
and how we got here, and what we’re
trying to achieve. And then Andrea
will go through some of the more detailed stuff
around quality standards in licensing. Just as a bit of
intro about me, so I’m group manager of Medsafe. Medsafe, for those
who don’t know, is the medicines/medical device
regulator in New Zealand. Plus, we also regulate a
number of other areas– psychoactive substances. We license pharmacies. We do some work under
the Misuse of Drugs Act. And we also regulate hemp. Well, it is part of the
Misuse of Drugs Act. And we’re also responsible
for implementing the medicinal cannabis work. So I’m a pharmacist by training. I worked for about 10 years
in pediatrics and neonatology in hospitals in the
UK and New Zealand, and then came back and joined
Medsafe about 12 years ago. So came in as a pharmaceutical
chemistry assessor, and then moved into clinical
and risk communication and [? then ?]
[? into ?] management. I’ve been group manager
for around five years now. Now, a number of you in the
audience, we’ve met with. And we’ve found those
interactions really helpful in this work and with
medicinal cannabis. And a number of
you, this will be new to you around
what we’re doing here. So what we want you
to get out of this, what we’re trying to achieve– what the proposals are,
what the questions are, and the information that
we’re keen to get back from all of the groups,
such as yourself– keen to answer questions, to
help with your submissions, and to help you understand what
is in the consultation document and clarify any points
that may be in there. So I’ll move on to– really why we’re
here– the background. And the wording in red
is so we all remember what we’re trying to achieve. So the government’s
objective here is to improve access to
affordable, quality medicinal cannabis products for
people in New Zealand. Now, in doing that, this
was part of a 100-day plan for the incoming government. And the government committed
to introducing legislation to provide an exception
in statutory offense for terminally ill
people to possess and use illicit cannabis on
compassionate grounds, and, in principle, to introduce
a medicinal cannabis scheme. And that was to enable the
cultivation, manufacture, and access to medicinal cannabis
products made to a quality standard. The legislation
was also designed to deschedule
cannabidiol, or “CBD” as it’s commonly referred
to, so it would no longer be a controlled drug. Now, there is a
slightly confusing part of the legislation in New
Zealand, in that we have the Misuse of Drugs Act that
puts controls and restrictions on certain substances, such
as cannabis, such as morphine, such as heroin– various other products
that are restricted. And that’s what the
Misuse of Drugs Act does. There is also the Medicines
Act, which puts restrictions on medicines, what’s
scheduled as a medicine, how you can obtain them, can you
get them from a prescription, can you get it through
pharmacy, can you get them in the supermarket, who can
prescribe, various controls in [? there. ?] So with CBD, I’ll just
cover that off now. So with the legislation
change, CBD came out of Misuse of Drugs Act. So it’s no longer controlled
from the Misuse of Drugs Act, but remains a
prescription medicine. And that’s something
that we have seen some confusion around when
that mode of change was made. I’ll talk a bit about
what we can look and what industry
can do about CBD, and whether it should stay
a prescription medicine or whether it should be more
widely accessed in the future. So the Misuse of
Drugs Act amendment came into effect
in December, 2018. It was enacted in
December, 2018. What it did is people
requiring palliation were eligible for the
statutory [? event. ?] And it allowed
regulations to be made for all stages of
cultivation and production and manufacture
and [? sitting ?] quality standards. So it allows a license
holder under the Misuse of Drugs Act the cannabis scheme
to use locally sourced cannabis plants, fruits, and
seeds, and requires regulations on the quality
standards to be made. And these are to be made no
later than the 18th of December this year. And this is one
of the reasons why we’re having a four-week
consultation period. This is very quick in
terms of implementation to get regulations in place. It’s around two to three times
quicker than any other country has attempted to do. And that’s why we are having
to really squeeze this in, so we can make sure we get
those regulations passed by the 18th of December. Now, the blue parts of the
scheme up here of the slide talk about the medicinal
cannabis scheme. And this is around
the expectation– so the agency will be
operational very soon after the 18th of December date. So in law, when you
have regulations passed, you have a number of things,
such as a 28-day rule. And also, obviously,
there’s a Christmas period and closed down. And there’s
information to be put in place that can’t be finalized
until the regulations are confirmed. And it’s things like, what
are the actual forms that need to be put in place? What guidance is there? And so we expect the agency
to be operational very soon after the 18th of December. So just a bit of
international context for you on what we’re working on
to establish the scheme. There isn’t a
national context here. There are a number of
international agreements that New Zealand
has signed up to, that they aim to restrict
production, manufacture, export, import, imposition
of narcotic drugs, including cannabis. And that’s exclusively
for medical and scientific purposes. And the most relevant one
here that we’re looking at is the single convention
of narcotic drugs in 1961. And that establishes a framework
to prevent abuse and diversion of controlled drugs,
but also to facilitate the availability for medical
and scientific purposes. So under that
convention, New Zealand has an obligation to carefully
control and supervise and report on the various stages
of cultivation and production. Now, it also means that
New Zealand is required to establish an agency. And the agency is here to
regulate the cultivation and manufacture in supply. Now, a number of countries have
done this in different ways. And they all interpret
it in different ways. We’ve looked at all
of these countries. Germany has recently put in
place a state-run scheme. We’re looking at what Canada has
done over the number of years since they’ve provided access
to medicinal cannabis products. And also, there’s
obviously the US, where they have both
the federal laws but also the state laws, which
can sometimes contradict. But what we’re looking at is
putting in a pragmatic solution that allows us to align
with our conventions that the New Zealand
government signed up to, while also we’re
expecting to enable improved access for patients. Some New Zealand
context on this. We talked about the Misuse of
Drugs Act, which was very old– 1975. This is what we administer. And this legislation already
allows the import, export, and manufacture of
medicinal cannabis products, but do not allow the lawful
cultivation of cannabis plants for medicinal purposes. So we are proposing to control
the medicinal cannabis supply chain through licensing
activities and having licenses for cultivation,
manufacture, and supply. As these are
prescription medicines– so all medicinal cannabis
products will be prescription medicines at this stage– patient access will be
through a prescription from a medical professional. I have a little bit
more on that later, after Andrea has talked about
the manufacturing standards and licenses. So the agency being
put in place– effectively, we’re
already able to license under Misuse of Drugs
Act for research and scientific
research purposes. And we’re already licensing for
hemp production, for instance. So this is just another
stage in the path for us, obviously, to enable
medicinal cannabis products to be produced and manufactured
for commercial reasons. So the scheme has two
main parts, really. Obviously, we’re looking to
improve access for patients with products being made
to a quality standard. We’re also looking at increasing
the supply of products, having a sustainable
industry in New Zealand, for commercial cultivation,
and for manufacture made to minimum
standards, enabling, also, ongoing import of products
to encourage competition and to improve affordability– and also improving
access for patients by ensuring medical
practitioners have confidence in what
they are prescribing. So this is where we
get the classic balance of quality standards
versus cost, but also versus confidence from
those health care professionals that will be prescribing
for patients. The minimum standards–
obviously, they provide assurance of quality. We’re also looking for
providing information for health care professionals. These, in most cases, won’t
be like traditional medicines, where if you have a medicine
approved in the Medicines Act, you have a full medicine data
sheet with all clinical data and all information
for a prescriber who can talk through with a
patient on risks and benefits for that patient. And that includes not
just how you use it, but also possible side effects,
any possible interactions. Now, with medicinal
cannabis products, this information is not
routinely available. But there is a huge amount of
research that is happening now and is starting to come through. And so one of the key challenges
for this scheme is to make sure health care
professionals and consumers have the information they
need to make choices– know how to use these products,
know how to dose titrate, know how they may
interact with medicines that the patient’s already
on, how do you monitor them. And that’s one of the
key parts of the scheme, because if we don’t provide
that information for health care professionals, they’re
unlikely to prescribe them. So that’s the intro. I’ll hand over to
Andrea now who can go through some of the detail
around quality standards and licensing. And then I’ll come
back and talk to you about some of the
prescribing requirements. Thanks. So I’m first of all going to
cover the quality standards, which cover cultivation,
manufacture, and finished products. So why are the quality
standards important? At the moment, we
are having products coming into New Zealand which
don’t have those quality standards. But the reason why
they are important is to protect the patient. If there are no requirements
for quality, we get some things. We get potential for harm
if they don’t, for example, contain the right
active ingredients in the right dosage or they
contain harmful substances, like pesticides,
heavy metals, or microbiological contamination. If they’re not
manufactured, transported, or stored under the
right conditions, then that could affect the
quality of the product. So it is very important. And it’s one of the key
components of the scheme, is to introduce making these
products to a minimum quality. So as I said earlier,
the quality standards can be set for a process like
cultivation or manufacture. And they can also
be set for products. So let’s start with cultivation. I know that there are a number
of people in this room that have already engaged
with us to put in the applications for license
for cultivation for research or medical purposes. So let’s start with cultivation. We’re seeking feedback
on three options. The first one is
that the cultivator must meet the manufacturer’s
quality requirements. So the manufacturer sets
these quality requirements for the cultivation process
or the starting material. This would be a good
thing in the case that a manufacturer
knows what they are going to do with the product. In some cases, if they are going
to process it in a minimal way and just compress it and
maybe use it for vaping, then it’s quite appropriate to
set high standards of quality to make sure there is no
pesticide contamination or mold on the product. In other cases, they may be
taking that starting material and processing it further, in
which case some of those things can be managed throughout
the manufacturing process. So in this option,
the manufacturer decides and has a contract
with their cultivator. Or if he or she grows the
cultivation themselves, then they will set what
standards they require of that. The second option
is for the regulator to set a cultivation
process standard. And a number of things
have been discussed over the years with industry,
things like Good Agricultural Practice or the New
Zealand equivalent of agricultural
practice, like Growsafe. And then there are all these
international documents like the WHO Good Agricultural
Practice Standard. Those are ones that
could be set here. And then the regulator would
audit this cultivator’s agricultural practices against
the cultivation process standard. There will, of course, be
cost involved in all of this. The third option is to set
a product quality standard for the starting material, which
are set by the regulator, which would be similar to our
product quality standards and would specify the limits
and amounts of ingredients that the starting material
may contain or not contain, such as pesticides
or heavy metals. And the cultivator would
then test each batch of starting material to ensure
it meets the quality standard and provide evidence
of compliance. So again, this involves
the regulator auditing the cultivator. So I guess that what we’re
seeking through consultation is what industry think about
either of those three options. So this is a key thing for
you to put in your submission. The other area of intense
interest to people is the quality standards
for manufacture. So what I want to talk
about in this session, because a lot of
people have asked us– not only industry,
but consumers as well, because it does affect access– what about the
Canadian approach? Which is what we call “GPP,”
Good Production Practices. And this is also versus
the New Zealand approach to the manufacture of
medicines, which is GMP. So I do want to
spend a bit of time. Because we have gone and
looked at GPP as an option, I just want to
spend a bit of time explaining what the
differences are so that you can understand that. Because it’s not is
as simple as just having a set of rules which are
lot less stringent and easier to comply with and all of that. It has flow on effects. And the GPP system in Canada
is quite different from what we are trying to do here. So first of all, there is
the New Zealand approach to the code for the
manufacture of medicines. So this is known
as the New Zealand Code of Good Manufacturing
Practice, GMP. So I’m going to
use “GMP” from now on, because it’s a
bit of a mouthful. So GMP ensures that products
are produced consistently and are of reliable,
high quality. It’s based on an internationally
recognized system and Medsafe has all those
systems and processes set up for people to be audited and
to get a certificate of GMP. Now, the Canadian
approach is something that we looked at
in great detail. And we started off
by saying, well, what is the difference
between GMP and GPP? And on the face of it, when
we laid the two systems side by side, we sort of
figured out that there was very little difference
in the high level principles. So both GMP and GPP set out
those high level principles. What GMP does as
a code is set out some guidance on how you can
comply with those principles. So the way a code
functions is that it would set out this guidance. But if you want to do
something differently, then you have to
demonstrate how that what you’re doing differently
meets the requirements of GMP– meets the principles,
in other words. So it does provide
flexibility for you to do things and innovate
and do things in another way. But essentially, if you
comply with the code, then you are seen
to be complying with the principles of GMP. GPP, on the other hand, also
sets out those same principles. But while the [? guidance ?]
is developing on that, it just sets out the
principles and says, OK, Mr. Manufacturer or
Mrs. Manufacturer, you tell us how you’re going to
comply with these principles. So it’s very much open
to interpretation. When we went to look
at the Canadian system, we found out that prescription
medicines like the New Zealand system are required to
be manufactured to GMP and there is a
premarket authorization process and a whole system
set up for medicines, which is almost– we hadn’t gone into the great
detail of whether it’s exactly the same. But that’s like the New Zealand
system for the manufacture of medicines. So they already have an approach
for prescription medicines. But in addition, Canada then
decided that they would put in the system of GPP for what
they called “non-prescription health products
containing cannabis.” Now the key difference here
is that it only applies to the non-prescription
classes of cannabis, like fresh and dried
cannabis and cannabis oils. And later on this
year, they will be adding to that list
edibles and topical creams. So there’s the difference. There’s a reason why they call
it “good production practices” as opposed to “manufacturing
practices,” just to highlight what the difference is, and
also because they are minimally processed. So these products are only
allowed to contain cannabis, and with a little
bit of allowance for carrier oils and
the cannabis oils. So essentially, they are
not prescription medicines as we know them. And I think that is
a key difference. The other difference,
which I won’t go into, or Chris won’t be
going into later on with the prescriptions,
is that access to these non-prescription health
products containing cannabis is through going
to see your doctor and getting a medical document. So the system in Canada, it’s
not the same as a prescription because there isn’t
that oversight. But the Canadians spent
a lot, lot of time looking at the access
model, and basically saying that you can get a medical
document from your doctor that will enable you to
either grow your own, get someone to grow it for you,
or get it from the producer. So that is something
that we haven’t looked at in terms of these
non-prescription health products containing cannabis. We are looking here about
prescription medicines and making that available
through the prescription process. So when we were challenged
by our medicinal cannabis advisory group to
say, well, what actually is the difference? And so we went
into great detail. As I mentioned, the
GMP process gives you a code which provides you with
detailed compliance on how to comply. The GPP system is less detail. It just sets out a
set of principles and said, tell me
how you are going to achieve these outcomes. That in itself is
probably a lot more work, because then industry
will then have to interpret those
principles and come up with a way of meeting them. From a regulator
point of view, we are then going to have
to go into detail on what the manufacturer is proposing
to do and then assess whether or not we think those
will meet the principles. So there’s quite a bit of
interpretive work on both sides and, I would imagine, quite
a bit of toing and froing. However, if I was industry,
what I’d be going is to say, what’s GMP? What are the GMP requirements? And that would be
my starting point. But then that’s
entirely up to industry. There are two other
key differences which are part of GMP
which are not part of GPP. One is a validation
program which is inherent in every step of
the production process for GMP. Why is that important? Because it ensures
that the product that you have come
out the other end is consistent within a batch. So the same bottle of
pills, for example, that came out of a batch, every
pill, every dose is the same. And it’s the same as one that
was manufactured a month ago or six months into the future. It provides that consistency. And that’s really important as
far as medical professionals are concerned. Because if they are
going to prescribe it, then they want to know that
whatever they’re prescribing is going to be the
same every time. The other issue is
stability testing required. And with the medicinal
cannabis products, there isn’t a lot
of information that has been done about how
stable the products are– whether or not
what you buy today is still going to have the
same active ingredients six months down the track, how
long will it be stable for. And this is the approach taken
in most other jurisdictions. Canada, at the moment, is the
only one that requires GPP. So they don’t have the
validation program, and they don’t have
stability testing. And Canada, while their
GPP requires batch testing, that only says that the
dose that you are testing meets the requirements
of the finished product. It doesn’t say whether all
the other doses in that pack meet those requirements
or whether it’s the same as the one you
manufactured one month ago or six months into the future. So these are the key
differences between GMP and GPP. And I am highlighting
these because that’s what may be important when we
get them to the prescribing. What do prescribers want? So here are the two options. And then there are
probably others. And if you have
alternative options, then please feel free to tell us
through the submission process. So adopting the New
Zealand approach to the manufacture of medicines,
which is basically saying, requiring GMP for all products,
or adopt the New Zealand approach and, like Canada,
allow for some forms of products to be manufactured
to GPP, as in Canada. This was something
that we would look at. But in Canada, be aware
that it only applies to fresh and dried and oils. As I said, the advisory
group challenged us to set out, what exactly
are the differences, and beyond actually what
the manufacturer has to do? What are the setup costs? How much does it cost to set
up a GMP facility versus a GPP facility? And how long will it take
an under/either option will it take to get
products to the market? And then, what impact does it
have on finished product cost? And on setting up a
regulatory regime, these are the
challenges that we are going to have to balance
about whether the regulatory requirements will result
in two higher cost products or setting the
regulatory requirements at a level that gives us
that assurance of quality. So the ideal situation
is for us to see it reasonable
standards of quality and that will result
in lower cost products. So the setup cost, there
are some suggestions that we could start with
GPP and move to GMP. So we have been talking to
some of the Canadian industry and the Canadian regulators
and say, how about this? Could we start with GPP
and move towards GMP? Now, we don’t have
anything concrete on that, but we have a lot of
anecdotal evidence and people in industry. We’ve talked to some
industry in Canada that have said that’s not necessarily
cheaper or as difficult. So the requirements
are different. It’s in the setup cost. So starting with
one, and it’s not an option to gradually step
and move to the next one. That’s a different
set of requirements. It’s difficult to compare
the costs of GMP versus GPP because we haven’t come across
anyone who has done both. So you can’t say, well, actually
we manufactured this product under GMP, and this
is the product cost; or we manufactured this same
product [? under ?] GPP, and it was a lot less or more. So I just want to
reiterate that Canada has a medicines regime, which
is similar to our New Zealand regime– manufacture to GMP and premarket
assessments of products. So the other thing that
we were looking at is, how long does it take to
get products to market? In Australia, they took 2 and
1/2 years from implementation to having the first
products come out. And I think they are only
a few manufacturers that are producing those products. We think we can do better. And we need your
help to do this. So this is really what
this is about, is saying, could we get products on
the market in less than 2 and 1/2 years at a high
quality and low cost? That’s the challenge. Just moving onto the
product quality standards, the question that we have
asked in the consultation is, should these product
quality standards as set out in the appendix to the
consultation document– should that apply to
starting material, active pharmaceutical
ingredients, or finished dose form products? We’ve proposed that there
be a quality standard set for the API that they must
meet the product specifications listed in that monograph. Part of GMP says
that it’s important that you have quality active
pharmaceutical ingredients, because then you will be able
to manufacture your products to that specified quality. And that Product Quality
Standard Monograph that said alternative tests,
methods, or limits can be used, but they must be
scientific-justified. The monograph lists the product
specifications for the product, what you must meet,
the kinds and amounts of ingredients that are
allowed or not allowed, and defines the test, methods,
specifications, and limits, which are required to meet to
verify that your product meets those specifications. For the finished
product, we are proposing that the products must meet the
product specifications listed in the New Zealand Product
Quality Standards Monograph and the products must
also meet the dose form requirements and
requirements for stability, shelf life, packaging
and labeling, and quality of the
non-active ingredients. We’re proposing that
certificates of analysis will provide evidence that
the product meets the quality standard. And those certificates
of analysis will have to be presented
to the regulator before these products can
be supplied into the market. But there’ll be
more on that later [? in ?] the distribution. Now, the finished does
forms under the scheme, we’re not proposing
to allow smoking. So we’re proposing that
some of the higher risk dose forms, like the
modified-release dose forms and medicines
required to be sterile are only allowed if it’s been
approved or provisionally approved by the Ministry. So they still come
under the scheme, but there needs a higher level
of risk assessment [? on top ?] [? of ?] these. Food containing
medicinal cannabis is not allowed
under the Food Act. And cannabis-based dietary
supplements, natural health products, and
nutraceuticals, because there is no regulation of that
and because cannabis as a prescription
medicine, [? or ?] CBD products are
prescription medicine, then they must meet the
requirements of the scheme. So they are all covered
under the scheme. So there are some
general requirements that are required for
all of the licenses. So we’ll be wanting
details of the applicant and then details
of the premises, including geographical location. Because the licenses will be
issued to specific locations, we are, [? at ?] [? this, ?]
proposing that we would require applicants, directors,
partners in a partnership, and responsible persons to be
vetted under this legislation. And licenses can be
issued, as I said, before for a specific location. So we are not proposing
to put restrictions on locations with regard to, for
example, proximity to a school. So that won’t be outlined
in the legislation, but just be aware that
it is at the discretion of the minister or
his delegate to decide on these applications. So if there are particular
issues associated with an application– for example, an
applicant might try and set up or apply to set up
activities next to a school– we would be aware of that. And we would look at that. And there might be requirements
to engage with your neighbors. But at the end of the
day, while we’re not sort of putting hard
and fast rules on what is allowed and not
allowed, that’s at the discretion of the
minister or his delegate. So these things can be decided
on a case-by-case basis. And if there are concerns
about the location or its proximity
to sensitive areas, then this can also be considered
on a case-by-case basis. So we’re setting general
requirements out here. We will also be requiring
detailed security plans, because under the
international obligations, we have an obligation to
ensure that the cannabis is not diverted to illicit purposes. So the security plans will
cover physical security, operational and
procedural security, and personnel security,
which is around making sure that you have systems and
processes in place to employ suitable staff. We aren’t proposing to put
such vetting restrictions on people you employ. That is your responsibility
as an employer to make sure that the people
that you employ are suitable. How you do that is up to you. So I’m moving on to licenses
to cultivate cannabis. What they will be
issued for a year. It’s a new industry. We’re seeking feedback on this. And we’ve also looked
at the Canadian approach and proposed that there be
small scale and large scale. But it’s a nominal amount which
is based on Canada’s operations and making that distinction. And we’d like some
feedback on whether that’s set at the right level. We are also proposing
a difference between if you want to grow
high THC or low THC crops, and also requiring
crops to be separated. So if you have an
industrial hemp license and you want to grow cannabis
for industrial hemp purposes, then you can do that. If you then want to also
grow medicinal cannabis, you need a medicinal
cannabis license, but you need that to keep
the two crops separate. The purpose of the
cultivation is, you need to provide
us with details on the purpose of
the cultivation and the details of the
cultivation activity. So a few are growing to
supply to a manufacturer, or you are going to
carry out research– the details of the
cultivation activity, for example, the cultivars and
cannabinoid profile, the area, or the number of plants
under cultivation. So we are required to
report that annually to our international
organization. The amendment in December
also made a provision to bring illicit New Zealand
seed into legitimate supply chain. So this is basically saying
that at the time that you apply or after you have
your license, you can declare an amount of seed
that you got from a New Zealand source and to bring that into
the legitimate supply chain. However, that
isn’t the intention of this scheme to allow there
to be an ongoing illicit source. So we think that
it is worthwhile bringing that New Zealand
seed and New Zealand cultivars into the supply
chain, but if somebody wants to get into the
business of supplying you, then they will need
a license to do so. So that would be through
a declaration process. And we’re seeking feedback on
how many times you can declare, how much you can declare– all of those sorts of things. We have been asked
about the transition from cultivation for
research and the cultivation for commercial purposes. So there are a
number of companies that maybe have
applied or are seeking to apply for research
into breeding cultivars. And if they did come up
with a super cannabis plant, then we’re not going
to say, sorry, you have to destroy that. The whole purpose of breeding
is to find a preferred cultivar with your preferred
characteristics. And you will be
allowed to transition an amount into the new system. However, that doesn’t
allow you to start stockpiling all
your plants now so that once the regulations
come into place, you can just plant them
out and get a head start. It is to allow you to carry
through your breeding research into the commercial area,
but not in terms of stock. A number of people have
sort of asked whether or not we can just automatically
transfer a research license into a new commercial license. At the moment, we’re saying
unlikely, because the research licenses are given
on the understanding that you’ve only got a
small number of plants and you want to be able
to get that research. And we have said that at
the end of that research, you will need to
destroy all your plants. Because the purpose
is not allowing you to breed all these plants
in anticipation of what might come out of the research. But as I said, we will
allow for the transition of a limited number of plants
to maintain your cultivar. We don’t know what
the regulations are going to come out. So that new application
for commercial cultivation will need to be assessed
against these new requirements. So a license to manufacturer
medicinal cannabis products– I talked before about the
standard GMP versus GPP. The licensed manufacturer
will include packaging as a manufacturing activity. But if we land on GMP as
a manufacturing standard, then the license to
manufacture will be issued under the Medicines Act. If we land on GPP for
some forms of cannabis, then that license to
manufacture will be issued under the Misuse of Drugs Act. CBD products– because,
as Chris mentioned, they are prescription medicines
but not controlled drugs– the license to
manufacture CBD products will be issued under
the Medicines Act. So the Medicines Act– the supply license is a license
to sell medicines by wholesale under the Medicines Act. So again, for CBD
products, we are proposing that they must meet
the requirements of a finished product quality standard. So when we talk about
the supply chain, the Medicines Act proposals– we already have a
pathway for consent or provisional consent for those
medicinal cannabis products. Those pathways
can still be used. So you can still apply
for your products to be fully consented or
provisionally consented under the act. And then just more on what all
that means in the next section. So for CBD products, there
will be a requirement for the finished product
to meet the quality standard as a minimum. Once that has been
verified, then the product can be added to
a license to sell your medicines by wholesale. And that will allow that product
to enter into the supply chain. As I mentioned before, approved
and provisionally approved medicinal cannabis products will
be also able to be applied for. For these products,
you will also need a license to deal under
the Misuse of Drugs Act because they are also
controlled drugs. The majority of products that
will be entering the supply chain will be unapproved, simply
because, as Chris mentioned, there won’t be– at least in the short-term– that clinical data,
clinical trials that will talk about
safety and efficacy. So the license to supply
unapproved medicinal cannabis products under the
Misuse of Drugs Act– so the non-CBD products–
in other words, the ones that have THC in them– you need to provide
evidence, again, that the product meets the
requirements of the finished product quality standard. And once verified, the product
will be added to the license to supply. So, again, your
license to supply under the Misuse of
Drugs Act or your license to sell medicines by wholesale
will allow your products to enter the supply chain. But that needs to be verified
that it meets the product quality standards. For approved or provisionally
approved products, they don’t require a separate
assessment against the finished product quality standard
because the finished product quality [? standard ?] will
be the minimum requirement. And there is a
separate assessment under these other schemes. A license to import or
export for non-CBD products, because they are
controlled drugs, need an import
and export license under the Misuse of Drugs Act. We are proposing to require
that imported and exported medicinal cannabis products must
meet the New Zealand quality standards as a minimum and that
it comprises the manufacturing quality standard and the
product quality standard. So a number of
industry players are interested in the export of
medicinal cannabis products. It makes sense, because
of economies of scale. And ultimately, that will
provide cheaper products that are available
in New Zealand if there are those economies
of scale in allowing export. So we are proposing to allow
export of unapproved products that meet the quality standards
and standardized, packaged, and labeled raw cannabis that
meets the quality standards. Being aware that if you apply
for an export license here, you also need to have an
import license to verify that they will take the product
from the importing country. Like other countries,
we are proposing to not allow the export
of unprocessed or bulk raw cannabis. So we’d be interested
in your views on that. Fees and charges. Our fees and charges section may
be a bit difficult to follow. So we’re following the
treasury guidelines, which is basically full cost
recovery of the direct cost– things like some of the
compliance activities and policy development. And the costs of those
aren’t really included. So this is sort of based
on the hours and the effort that it has taken to
approve your application. So that includes the
assessments and the audits. The proposed fees are
calculated for two fees models for licenses to manufacture. So the first set of
fees is if we just had the GMP model of manufacture. And so all the licenses will
be issued under the Medicines Act for manufacture. And that is the first [? set. ?] If the second option is taken
where some products are allowed under GPP and some under
GMP, then the second model [INAUDIBLE] [? is ?]
the number of licenses that will be applied
for for manufacturing will be half GMP and half GPP. So the fees sit under
the Medicines Act. They’re not changing
at this time. But some of you will be aware
that we are developing new legislation– the
Therapeutic Products Bill– which will eventually
replace the Medicines Act. And the Medicines Act fees may
be reviewed as part of that. They’re just some years away. So, Chris, have you
had enough of a rest? And now we can hand you back
to talk about the prescribing requirements. OK. So I just want to take you
through the access parts and prescribing requirements. A little bit of
information about what “approved,”
“provisionally approved,” an “unapproved” means,
because that’s really medicine terminology. And I just want you to
be aware of what that is. Go through what we’re proposing
that doesn’t change, and then some proposals for change. Obviously, this is why we’re
coming out for consultation. So we are very keen
to get your thoughts on what we’re
proposing to change and what we’re
proposing not to change. So just some information to
start with around approvals. So effectively, you
have an approval which in the legislation
and Medicines Act is called “consent.” We tend to use “approval”
because no one really knows what “consent” means. But effectively,
you get approval to distribute a medicine. And this is where
there’s evidence supporting the efficacy,
safety, and the quality of the products. And this evidence is assessed
by Medsafe and the Ministry. And then a consent is given by
the minister in the Medicines Act, or a delegate. So that’s the approval. A provisional
approval is a clause in the legislation
that allows us to give an early approval or
a provision or an approval with conditions to distribute a
medicine on a restricted basis. And it’s based on clinical
need and potentially on a limited number of patients. Now, we use this in a number
of ways in the Medicines Act to do things like put
conditions on medicines. So there’s a medicine
used in mental health, for instance, that
is very effective, but also can have
serious side effects as far as effects it can
have on your blood cells. So we use a provisional
consent pathway to say, this can be approved, but you
must have a white blood cell monitoring system in place. This provisional
consent has also been used in the past for early
access to antiretrovirals. So decades ago when the
clinical data was quite limited and was developing,
the clinical need meant that these products
needed to be approved. And so they were. And what it meant was,
you can give an approval while the clinical
studies were continuing. And then there’s
unapproved products, where the safety and
efficacy and quality has not been assessed
by the Ministry. So happy to answer
questions if there’s any further
clarification needed. But that’s really
the key parts to it. So firstly, on what we’re
not looking at changing. So CBD products– no change,
other than, obviously, them coming out of the
Misuse of Drugs Act. [? They’re ?]
[? around ?] access. So there’s a definition. CBD products– medicinal
cannabis products that contain less than
2% of the cannabinoid THC or other controlled drugs
or psychoactive substances. So we have had some
feedback on that definition. I’m keen to get feedback
on that definition, as well, through your
consultation process. And please send that through. So no changes proposed for
approved or provisionally approved CBD products
that can be prescribed by a medical practitioner
or a nurse practitioner, for instance. Unapproved CBD
products could only be prescribed by a
medical practitioner. And this is because
the Medicines Act has that terminology in it. The Medicines Act is 1981. As Andrea said, we
have just consulted on getting that
legislation updated. But there is probably
a couple of years away. So that’s the key difference
there between approved CBD products and unapproved
CBD products. Now, talking about CBD, they
are prescription medicines that are scheduled in
the Medicines Act now. They have to be prescribed. The way to change that
access in the Medicines Act is to look at a
classification change. And that’s something
that I imagine industry would be very interested in. And what we do is look
at an application, for instance, on the safety and
access balance for a product, for a substance such
as CBD, and then get some expert advice on that. So I guess the key
way to describe it is, is this
product sufficiently safe that a patient can go
in and self-diagnose and self-select? Or should they really be having
a conversation with a health care professional? Is that a pharmacist, so that
you can have it in a pharmacy and sell in a pharmacy? Is it a pharmacist
where you have to have a
consultation, where you have to go and talk
to the pharmacist before you get it
from the pharmacy? Or should you be going to see a
medical practitioner or a nurse practitioner and
get a prescription? Or a pharmacist practitioner,
prescriber, as well. So there is a way that
CBD can be looked at, as far as access goes. We know that it has wider
access in other countries. We’ve talked to
industry representatives about that process
and how you can have a look at
where the CBD should be widened in terms of access. Unapproved medicinal
cannabis products, that’s the other part
of the prescribing change we looked at. We’re not looking
at changes where unapproved products that do
not meet the quality standards. This is for unapproved
medicinal cannabis products they aren’t CBD products. We’re looking at
no changes there where a specialist can
continue to prescribe those with Ministry approval. And what typically
happens is information comes to the Ministry about
the quality of the product and some clinical information,
and our chief medical officer has a look at the
clinical information. We look at the
quality information and help provide
some advice back to the prescriber
about that product to help them make the
decisions for the patients. So it’s really for
informed consent, but also so prescribers know
what they are prescribing if it’s an unapproved product. Now, onto the new proposals. There’s approved products– so
non-CBD products are approved products, such as we
currently have the moment, is [INAUDIBLE]. But that may grow in the future. Now, on-label use– and
what I mean by “on-label” and “off-label” is [INAUDIBLE]
is approved for treatment of spasticity in
multiple sclerosis. And that’s through
clinical trial data that they’ve sent through. And [? an ?] approval
was [? administered. ?] That’s what’s termed
as “on-label.” Use of [INAUDIBLE] for anything
else is called “off-label.” So it can be
prescribed, but that’s the difference between the two. So the proposal was
for on-label use that these products
can be prescribed by medical practitioners. And currently they have to be
recommended by a specialist. We propose removing that. For off-label use, they
can also be prescribed by medical practitioners. They will need endorsement by
a specialist or recommendation by a specialist, but [? we’ll ?]
remove any requirement to have to send these through
the Ministry of Health. So at the moment,
any prescribing of [INAUDIBLE] for
off-label use, for instance, has to come through
the Ministry of Health. We’d propose removing that. Now, for unapproved products
that meet the quality standards, we’re
proposing that they be prescribed by specialists
and also remove the requirement for Ministry approval. Also, adding a provision
for medical practitioners to prescribe with
specialists’ recommendation. So what we’re looking at here
is a balance between access and looking at barriers
to access for patients with who should be
prescribing these and what sort of
specialty do you need. This is obviously a key
question that we have for– well, for all groups. Obviously, health
professionals are going to provide us with quite
a lot of feedback, as well. We’re really interested
in what industry thinks about this, too. Should all of
these products just be open and be able
to be prescribed by any medical practitioner
or authorized prescriber? Should you require specialists? Should you not? What sort of specialists? We’re really keen to get
feedback on this, as well as, obviously, the rest of it. Now, the consultation
period, just to close off, running for four weeks
from the 7th of August. We typically try to run
these for a bit longer, but I’ve talked to you about why
we’ve had to condense this down to four weeks. We’re running information
sessions obviously here in Auckland. We’re also running sessions in
Wellington and Christchurch. We’re talking to
industry groups. We’re talking to medical
professionals and consumer groups so we can get
everyone’s views. Obviously, as
probably no surprise, there are quite diverse views
on these products around access and around quality. Our expert advisory group, the
Medicinal Cannabis Advisory Group, will be meeting
early September to look at reviewing the
regulatory proposals– so looking at all the
consultation information, looking at the
key themes, seeing which proposals
would go forward, and which proposals
should change. And that’s why your submissions
are really important here. We’re then looking at
[? cabinet ?] approval for draft regulations
in October, and then approval of the
regulations in December. Thanks very much
for your attention.

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