Submitters and witnesses to the inquiry raised various issues relating
to the regulation of medicinal cannabis.
The first part of this chapter examines the issues associated with the
way medicinal cannabis is currently regulated in Australia, drawing on evidence
from academics, organisations and individuals who contributed to the inquiry.
The second part of this chapter explores comments made by submitters and
witnesses in relation to the specific reforms proposed by the Bill.
Issues arising from Australia's current regulatory approach to medicinal
Submitters and witnesses presented evidence that the current regulatory
environment in Australia is not conducive to the proper evaluation and
implementation of medicinal cannabis products. Issues raised over the course of
the inquiry included: the lack of information available about the current use
of illicit cannabis in Australia for medicinal purposes; the inability of state
and territory governments to implement reforms in this area without
Commonwealth assistance; and the difficulties associated with gaining approval
for medicinal cannabis products through the Therapeutic Goods Administration
Information about the use of cannabis
for medicinal purposes in Australia
One issue complicating the debate surrounding the regulation of
medicinal cannabis in Australia is the absence of any clear data in relation to
current usage of illicit cannabis for medicinal purposes. Professor Allison
Ritter, Director of the Drug Policy Modelling Program at the National Drug and
Alcohol Research Centre (NDARC), confirmed that there is currently no data available
or independent researchers trying to objectively assess this issue in
Despite this lack of official data, the committee did receive information from
various groups that help illuminate, at least partially, the level of use of
medicinal cannabis in Australia.
Medicinal cannabis advocacy user groups that contributed evidence to the
inquiry included the Medicinal Cannabis Users Association of Australia, which
claims to represent over 6,000 Australians currently involved in the production
or use of cannabis for medicinal purposes.
Mr Lance Feeney, Policy Analyst at the National Association of People
Living with HIV Australia, stated that recent survey data from HIV-positive
individuals in Australia indicates that approximately 20 per cent of
respondents use cannabis for therapeutic and symptom relief.
Epilepsy Action Australia commented on the current usage of medicinal
cannabis products for epileptic conditions:
We understand from social media and other sources that a
number of consumers (parents) in Australia are gaining access to cannabis
derivatives to treat seizures in the form of tinctures and oils. Given the
catastrophic and debilitating nature of their children's epilepsy conditions it
is not difficult to understand their desperation. These parents report immense
improvement in the severity and frequency of their children's seizures and
overall quality of life.
Throughout the course of this inquiry, the committee received evidence
from many individuals who relayed how medicinal cannabis products had assisted
them or their family members in alleviating the symptoms associated with a
range of medical conditions, many of extreme severity. Two of their stories are
included here as case studies.
The first case study is of Mrs Lucy Haslam, who gave evidence at the
committee's public hearing in Sydney about her son Daniel's use of medicinal
cannabis to provide relief during chemotherapy treatment for bowel cancer, from
which he sadly passed away in early 2015.
Case Study 1 – Mrs Lucy Haslam
Daniel was diagnosed with stage 4 bowel cancer when he was 20. He
had three years of treatment, which involved a lot of major surgeries but also
a lot of chemotherapy. He was three years into chemotherapy and he was told
basically that for as long as he lived he would require chemotherapy.
But for him chemotherapy was not just something that you slotted
into your routine; it was a major issue for our whole family because he became
so violently ill from the chemotherapy. Daniel developed what is called
anticipatory nausea, which is quite common in young people who are on very
strong chemotherapy. Just the thought of chemotherapy would actually make him
vomit. So, the day before chemotherapy, he would start being unwell. He would
initiate all sorts of stalling tactics on the day of chemotherapy, because he
would start vomiting, and he would usually vomit on the way to chemotherapy. He
would vomit all through chemotherapy. He would vomit on the way home. And
usually, invariably by midnight that night, after hours of vomiting, it would
be an emergency trip to Accident and Emergency to have some fluids and to have
more IV antiemetics. He tried literally every antiemetic that was available
pharmaceutically...They worked to a degree, but this became such a psychological
issue as well—a bit like Pavlov's dog, I guess. We tried to seek help for this
in all number of ways, and nobody really was equipped to help us deal with it.
At the point where Daniel tried cannabis, he was three years into
this treatment. The chemotherapy was not working. They were saying he needed to
go back to the original chemotherapies that they had tried, which did not last
very long with him because the side effects were so severe... [The next time
Daniel had chemotherapy], he had a couple of puffs on a cannabis joint, and it
was amazing. I really cannot understate that. It was as near to a miracle as I
have ever seen... He would come home with a chemotherapy pump on, so he would be
out of the clinic but effectively still hooked up to chemotherapy, and he would
be [extremely white] for days. He had a couple of drags; the colour came back
into his face, and he just went: 'Wow! I'm hungry. Mum, can I have something to
eat?' We just went: 'What is going on here? This has never happened'—because
this kid would lie in a hospital room for days and days not eating. This was
just such an incredible change. It was life-changing for all of us. We just
looked at each other and thought, 'Well, if this is what it takes, this is what
The second case study is of Mrs Joelle Neville, who gave evidence to the
committee at its Brisbane public hearing in relation to using cannabis oil as a
last resort treatment for her daughter's severe seizures.
Case Study 2 – Mrs Joelle
I am the mother of a ten year
old child that was diagnosed with Tuberous Sclerosis at the age of five months.
As a result of the genetic condition she has been severely epileptic since
birth. Prior to starting medication she was having 15-20 seizures a day.
Over her short life she has
trialled over twenty anti-epileptics, had two brain surgeries and trialled
various diets/ supplements. Other than a six month period when she was 18
months old, when we briefly managed to find the perfect balance of medication
and brain development, she has never been seizure free. As a result of her
epilepsy, she has an intellectual disability diagnosis and currently attends a
special needs school. She has also never slept more than a four hour period.
She has needed constant care and supervision all her life. As you can imagine,
this has placed a huge strain on our family and massive limitations on our
August of 2014 saw us hit a
particular low point when Ava's seizures became worse despite being on maximum
doses of four anti-epileptics, one of which we were trialling off-label and was
costing us almost $4000 a month. Each of the drugs have horrible, potential
side effects. At this time, Ava was having 6-8 seizures a day, some of which
were lasting up to ten minutes and sending her back to sleep for hours.
I was able to obtain a few syringes
of 18% CBD Hemp Oil and began her at a tiny dose (approx. 1/6ml twice a day).
Within a week Ava's seizures completely stopped. Now, six months later, we have
completely weaned Ava off of all her medications and she is currently on
approx. 1/3ml twice a day. She has the occasional, very small seizure that
probably only my husband or myself would notice. A month ago she started
sleeping 9-10 hours a night, unbroken.
As you can imagine, this has
been absolutely life changing for all of us. We have been able to explore
normal lives and realise the potential in our child...I don't have a specific
dollar amount that Ava's prior medication regime was costing the government but
I would imagine (especially if you take into account surgeries, doctors and
therapies) that it was in the hundreds of thousands per year.
Reliance on unrefined cannabis
products in the illicit market
A significant problem for individuals currently using medicinal cannabis
is the fact that, as an unregulated and illicit activity, there is little
control over the quality or standardisation of the products being used. The
University of Sydney academics group noted in its submission:
Medicinal cannabis use is widespread in Australia despite the
prevailing regulatory framework. Vulnerable patients source cannabis
preparations from the black market. These preparations are unregulated with
potential for inappropriate cannabinoids for certain indications (e.g. high THC
for paediatric epilepsy), contamination with pesticides or heavy metals,
tinctures with no cannabinoids sold as medicine, and poor understanding of
appropriate dosing schedules.
Their submission confirmed that black market cannabis available in
New South Wales is not generally optimised for therapeutic applications:
In 2013, in conjunction with the NSW Police and the National
Drug and Alcohol Research Centre (NDARC), our group preformed the first ever
chemical analysis of street cannabis seized by the police at various sites in
NSW...Our results showed that typical street cannabis (more than 200 samples were
analysed) was high in THC and very low in the therapeutically useful, non
psychoactive cannabinoids such as CBD and THCV. This illustrates a major
potential problem with the current regulatory environment whereby person
seeking to use medicinal cannabis are likely to end up with illicitly obtained,
high THC preparations, that may be devoid of the phytocannabinoid ingredients
that would best treat their condition... At present, consumers have no ability
to determine the type or strength of cannabinoid products they are consuming,
and it remains illegal for analytical laboratories to even test these products.
These are major impediments to the safer use of medical cannabis, and may more
than likely be exacerbating the harms experienced by consumers.
Professor Iain McGregor of the University of Sydney expanded on this
argument in evidence to the committee:
[In the illicit market] there is no quality control. We have
had parents of epileptic children get in touch and say: 'Suddenly the new
tincture is not working. The old one was fine and controlled the seizures. Now
my child is fitting again with this new bottle that we got, and we don't know
why. Can you help? Can you tell us what has changed and why it is not working
anymore?' These are desperate people that should be helped.
Several patient groups that gave evidence also commented that concerns
about quality control were a significant issue for individuals seeking to use
cannabis products for therapeutic purposes.
These concerns were echoed in written submissions by other individuals currently
using medicinal cannabis.
Several submitters and witnesses expressed the view that a regulated
medicinal cannabis industry would be better than the current situation in which
many individuals access cannabis products illegally. The University of Sydney
academics group stated:
A regulated industry is far preferable to the existing
situation of consumers relying on unregulated and illegal products, no
authoritative consumer information from health professionals, and researchers
being restricted to pharmaceutical products – of which there remain a very limited
number of cannabinoids available from a small number of pharmaceutical
Difficulties associated with
getting TGA approval for cannabinoid products
Several submitters and witnesses commented on the process and
difficulties associated with gaining approval for a cannabis-based product
through the TGA. As noted in chapter 2, getting a product listed on the
Australian Therapeutic Goods Register (ARTG) involves a sponsoring organisation
presenting a dossier of evidence including clinical trial data to the TGA,
which then assesses the application in an iterative process that can take up to
a year to complete.
The TGA informed the committee that costs for an application for a new chemical
entity are around $250,000.
Emeritus Professor Laurence Mather noted that the herbal nature of the
cannabis plant means that it is difficult for pharmaceutical companies to gain
patent protection in relation to cannabis-derived products:
When used as a medicine, cannabis cannot be regarded as a
single drug, and therein lies an issue. Conventional regulatory bodies have no
framework for examination and approval of potentially variable mixes of drugs.
Conventional pharmaceutical companies have little to gain from investing in
natural products that cannot be patented or bear an illegal drug level.
When questioned on why more companies were not sponsoring cannabis‑based
products for registration with the TGA, Dr Lisa Studdert of the TGA agreed that
patent protection is an issue:
[T]he economics of medicine registration are such that
companies need some patent protection to recoup costs over a period of time. We
know that many of the development costs of new medicines vary but they can be
in the hundreds of thousands if not up to billions of dollars.
Professor Philip Morris of the Royal Australian and New Zealand College
of Physicians agreed that:
with cannabis...I do not think there is any big commercial
organisation that will be coming forward to sponsor this drug's application,
and we will have to think about ways of having the drug's pros and cons
presented to the TGA so that it can be assessed in that way.
Associate Professor Lintzeris observed that the relatively small
pharmaceuticals market in Australia is another factor that means companies are
unlikely to invest significantly in getting new cannabinoid medications listed
through the TGA.
Professor Hall stated that, in additional to regulatory barriers,
pharmaceutical companies have not developed new cannabinoids or methods of
delivering them because 'it is costly to
develop and test new cannabinoids and difficult to recoup these costs when the
conditions for which they may be medically used are uncommon'.
Difficulties associated with conducting
research into medicinal cannabis products
Several of the academic groups in Australia conducting research into
medicinal cannabis noted that undertaking research in this area is extremely
difficult. The University of Sydney academics group submission stated:
Over the past decade there has been immense international
growth in this area of research as the significance of the endocannabinoid
system in human health and disease becomes increasingly apparent. Despite this,
we conduct our research in a tight regulatory environment that makes sourcing,
holding and administering cannabinoids extremely difficult and expensive.
Cannabinoid preparations typically have to be imported from the USA or Europe
at great expense, and with time consuming paperwork and processes imposed by
the TGA and state regulatory authorities. This is despite the fact that the
vast majority of cannabinoids we research have no psychoactive or addictive
properties in humans.
Dr Alexander Wodak of the Australian Drug Law Reform Initiative (ADLRI) commented
that research restrictions have been problematic overseas as well as in
In the United States cannabis is still on schedule 1, which
means it is as dangerous as heroin and more dangerous than cocaine, which is on
schedule 2. That gives you an idea of how serious the obstacles are. But
getting funding, getting approval from an ethics committee and, most
importantly of all, getting supplies of lawful medicinal cannabis in Australia,
the United States and many other countries at the moment is virtually
Professor Iain McGregor, an academic at the University of Sydney,
elaborated on the practical challenges associated with conducting cannabinoid
research in Australia:
We are involved in everything from cellular studies through
animal studies through to clinical trials, and all we encounter along the way
is hurdles imposed by state and federal legislation. For example, I am
interested in the mechanism whereby CBD affects epilepsy, but to get CBD I have
to fill in dozens of forms, deal with New South Wales Health, deal with the TGA
and often wait six to 12 months and spend thousands of euros to bring that into
Australia. Yet the industrial hemp manufacturers that are currently present in
New South Wales could easily extract CBD from their plants and give it to me
for research purposes.
In relation to the current clinical trials in Australia of the nabiximols
Sativex, Associate Professor Lintzeris commented:
[I]t is a very long, difficult process to do this kind of
research and there is only one pharmaceutical company in the world from which
we can access these medications. So we are beholden to GW Pharmaceuticals'
board decisions. These are financial interests that they have, just like any
other drug company...In the studies that we are doing, GW Pharmaceuticals have
been supportive of us...We have estimated that the medication that
GW Pharmaceuticals will be providing us for the research [costs the
company] well in excess of half a million dollars...That is comparable to the
total grant we received from NHMRC to do this research. That really puts in
perspective just how expensive it is to do this kind of research and, at this
point in time, how beholden we are upon the drug company to provide us these
Professor McGregor noted that supply of cannabis for research purposes
at the current time is entirely dependent on overseas suppliers, stating that
researchers 'are really at their mercy with our clinical trials at the moment
because we have no local supply of cannabinoids'.
He also explained, however, that if regulatory restrictions were relaxed in
Australia it would be relatively straightforward for existing industrial hemp
producers to start growing cannabis strains for specific research purposes:
[T]here is quite a vibrant industrial hemp industry in
Australia...In discussions with industrial hemp manufacturers, I have said to
them, 'What would it take for you to switch over to different plants that will
express some of the therapeutically important cannabinoids and extract them?'
Basically, they could do that this year...[T]hey have more than 200 strains of
cannabis plants available that express different levels of these cannabinoids.
So, if we wanted to, say, have a plant that was very high in THCV that might be
good for obesity or diabetes, that is certainly doable within their existing
stocks and strains.
The committee received evidence from companies and individuals involved
in the production of industrial hemp in Australia, who confirmed that it would
be possible for existing growers to produce cannabis plants with specific
cannabinoid profiles, including low-THC strains, and controlled for
contaminants in order to advance the use of and research into medicinal
Inability for state and territory
governments to progress the issue
Several submitters and witnesses noted that state and territory
governments are currently unable to progress bringing medicinal cannabis inside
a legal regulatory framework, due to the Therapeutic Goods Act 1989 (TG
Act) 'covering the field' in relation to the regulation of cannabis as a
therapeutic good. The ADLRI stated:
All State or Territory based initiatives to allow, or trial,
medical cannabis come up against the jurisdictional supremacy of the
Commonwealth law, in particular the [TG Act].
The central problem is that the [TG Act] covers the field –
that is, the Commonwealth has sole jurisdiction for therapeutic goods and the
States have no (or very little) authority in this area. Further, the [TG Act]
applies to any substance that is marketed and/or traded as a therapeutic good.
Therefore, as soon as cannabis is provided as a therapeutic good, any affect of
State laws is overridden by the [TG Act]...Given this, it is essential that the
Commonwealth pass legislation allowing States to have self‑determination
over their medical cannabis policies. The simplest way for this to happen is
for legislation that clearly states that the [TG Act] does not apply to medical
Mr Ben Mostyn of the ADLRI expanded further on how this issue currently
plays out in New South Wales:
We have the perverse situation in New South Wales at the
moment where every party has expressed support for medical marijuana; there
seems to be very strong support in the community, where 75 or 80 per cent of
people do not want to see people who use medical marijuana facing prosecution;
and unfortunately the New South Wales parliament just seems to not have the
authority or the jurisdiction to do anything about it. Any attempt that they
make to try medical marijuana will have to be a very laissez-faire
trial...because it will have to try and completely avoid the [TG Act]. They will
have to be doing something completely outside that therapeutic framework.
Comments on the regulatory model proposed in the Bill
Many submitters and witnesses expressed support for the intention of the
Bill to provide a national framework for the regulation of medicinal cannabis
that facilitates the acceleration of research in this area and increases access
to medicinal cannabis products where these are show to be effective.
Broad comments on the regulatory
approach taken by the Bill
The evidence presented to the inquiry by submitters and witnesses, including
cannabis researchers and drug policy experts was that the two extremes in terms
of approaches to regulating medicinal cannabis are:
approaches which legalise or decriminalise medicinal cannabis,
providing high availability to patients but limited quality control and greater
risk of leakage into the illicit market; and
approaches which only allow for pharmaceutical-grade medicinal
cannabis products subject to stringent testing regimes, with supply being
Several submitters and witnesses commended the Bill's attempts to strike
a middle ground between these two extremes of regulation. For example,
Associate Professor Lintzeris commented:
This legislation, the way we see it, provides at least a
framework. It does not have all the answers on how we are going to do it but it
provides a framework and, importantly, it is somewhat independent of direct
government roles. It allows appropriate experts and community players to drive
this agenda moving forward. So we see it as striking a fairly useful and
important balance between those two competing poles of the debate.
Views on the necessity of a
Some stakeholders to the inquiry argued that the current system of
regulation in Australia is adequate and does not require significant change.
The Australian Medical Association (AMA), for example, argued that the necessity
for any medicinal cannabis products to be of pharmaceutical quality means that
an alternative scheme to regulate medicinal cannabis would be detrimental:
The public discourse on the use of medicinal cannabis for a
limited number of health conditions ignores the fact that consuming cannabis
for recreational purposes is harmful...This is why medicinal cannabis should be
subject to the [TG Act] and not regulated separately.
While this stance may be seen as conservative in the context
of the current debate on the merits of medicinal cannabis, it is critical that
medical practitioners have confidence in the integrity of the pharmaceutical
products that are available to treat patients. Similarly, all patients
including those being treated for terminal illness, must be confident in the
quality of the therapeutic products that are prescribed to them by their
treating medical practitioner.
The Australian and New Zealand Society for Palliative Medicine similarly
With patient safety paramount, Medicinal Cannabis use should
be evidence‑based and as a prescribed medication, regulators should
establish the use of pharmaceutical quality products only, which are managed in
the same way as other prescribed medications, via the existing mechanisms established
by the [TG Act].
Role of the proposed Regulator
versus the current role of the TGA
Discussion about whether a new standalone regulator for medicinal
cannabis was justified focussed on the question of whether the functions
proposed to be granted to the new Regulator could already be performed by the TGA.
'Duplication' of regulatory
functions with the TGA
Some submitters and witnesses argued that creating the proposed
regulator, as envisaged under the Bill, would generate a duplication of
regulatory functions with the TGA. The Pharmacy Guild of Australia argued that
the creation of a new regulator solely to regulate medicinal cannabis 'has the
potential to fragment the regulation of medicines in Australia as well as lead
to confusion and unnecessary duplication of regulatory processes'.
Medicines Australia agreed that a new regulator would 'introduce an additional
level of regulation that is unnecessary'.
Cancer Voices Australia stated its concern that the Bill would
circumvent and add complexity to the current process of listing and approving
medical drugs by the TGA.
Representatives from the TGA presented the view that the TGA would be
able to perform some but possibly not all of the functions proposed for the
Regulator to perform under the Bill. Dr Lisa Studdert of the Market
Authorisation Group within the TGA stated:
Certainly for the approval of a product for therapeutic use, [the
TGA does] have that expertise...there is a precedent with the product Sativex,
which is a cannabis based product which has been approved for market
registration in Australia. For that function there is the expertise, but I
think the scope of the bill and perhaps what is being anticipated goes much beyond
what is covered in the [TG Act].
Ms Philippa Horner, Principal Legal Advisor at the TGA, continued:
[The TGA] really only gets involved in terms of
pharmaceuticals like Sativex in that bit about approving the medicine. Before
that and after that there are the customs prohibited imports regulations, which
determined whether drugs can come into Australia to be manufactured in
Australia, and there are then the states and territories who have all the rules
about what pharmacists and wholesalers can do with drugs that have got schedule
8 substances in them. So we are just a kind of slice of a whole system that is
set up already.
The Pharmacy Guild of Australia argued that any expanded regulatory
powers in relation to medicinal cannabis should be granted to the TGA through
amendments to the TG Act, rather than the creation of a new regulator:
[P]owers and responsibilities [relating to medicinal
cannabis] should be delegated to the relevant regulatory area within the
Therapeutic Goods Administration (TGA) and any required amendments to the law
should be made to the Therapmtic Goods Act 1989...[The TGA's] key roles
include classifying medicines based on their risk, implementing appropriate
regulatory controls for manufacturing of medicines and the monitoring of medicines
which includes a comprehensive adverse event reporting programme. Therefore,
the TGA is the most appropriate regulatory body to oversee the supply and
export of medical cannabis as they possess the necessary experience and
expertise in this area.
By contrast, Emeritus Professor David Penington expressed the view that
the TGA does not have the experience required to handle the complexities associated
with coordinating the issue of medicinal cannabis across Australia:
[T]he TGA traditionally has dealt with clear-cut proposals
which lead to drugs which can be commercialised and so on. It would not be a
body that would be able to liaise with other state health departments and the
like in the way that I believe is going to be essential to get effective control
of medical cannabis. The control will need to be at a state level with programs
that are flexible and can be adjusted as more knowledge emerges as to which
particular forms of disease would benefit from treatment. I think the TGA
wants clear-cut proposals that are all supported by factual evidence of trials
and the like. But it is not likely to be able to handle the complexities of
production of the appropriate cannabis product, nor is it likely to be in a
position to handle the liaison that will be needed between the various state
Professor Penington argued further that this national coordination would
require a body other than the TGA to implement, regardless of whether the
Regulator proposed by the Bill was to eventuate:
I think it is very important that there be tight
regulation—that is, regulation which needs to be implemented by the states, in
my view, rather than a national regulation. That regulation hopefully ought to
be consistent, so that even under COAG it is possible that you could have a
special group established that could handle these sorts of issues with the
Commonwealth agreeing to operate it. It may not have to be an agency comparable
to the TGA in any sense. But it may need to be an agency or committee or
structure that has the authority to coordinate activities for the various
programs that would be advised, medically as well as legally, on the sorts of
conditions that it is agreed should commonly be used and the sorts of ways in
which the new trials of emerging new things can be tested...I do not think [the
TGA] can be the body that will persuade the states to come together and have
sensible, ongoing agreement as to what are the conditions that should apply and
'Parallel' operation of the TGA and
Professor Wayne Hall expressed caution in relation to creating a
parallel system of regulation for one particular class of medicinal product:
I would be wary of creating special regulatory systems for
one drug. I think we should try and do what we can to deal with it within the
existing pharmaceutical structure. It might need bit of tweaking, but I think
creating a parallel system for distribution, a special access scheme, adds to
the expense. One could easily imagine other people coming along making similar
demands about other products that they want to see introduced in a medical
practice, so I think one has to worry about precedents.
Conversely, the Public Health Association of Australia stated:
PHAA fully supports the approach of having the Regulator
operate in parallel to the TGA. We note the intention to have its processes
align with the TGA insofar as that is appropriate, particularly as new
cannabis-based therapeutic products that meet TGA standards come onto the
The University of Sydney academics group stated its support for an
independent regulator being able to operate synergistically with the existing
We believe that a dedicated medical cannabis regulator can
coexist in parallel with the TGA's existing procedures and processes but provide
a much more lean, efficient and specialized approach to regulation. While there
is a role for medical cannabis products as identified in this bill, it does not
obviate the role of the TGA in the development of medical cannabinoids as
pharmaceutical products. Pure pharmaceutical grade products will be an
inevitable result of the current research trajectory in the medicinal
cannabinoid area and may be the most desirable end product for certain patient
populations. The new regulator can explore alternate yet parallel and
synergistic policy models for the regulation of research into medical cannabis
products, as well as their use.
Dr Wodak expressed the view that a dedicated regulator would allow the
difficult issues surrounding the regulation of medicinal cannabis to be worked
through and address concerns raised about the prospect of using cannabis
There are a lot of people in the community and in the
professions who would welcome [the introduction of medicinal cannabis], but there
are some people who are very nervous about that, and I think we should try to
allay their fears, and say that this is going to be done seriously and
properly. I think an office of medicinal cannabis would do that. It is a very
difficult area...and I think that having a dedicated office that does this and
does not do other things would allow them to focus and concentrate and sort out
some of the thorny issues.
Dr Wodak argued that a standalone regulator would be required for the
time being, but may later be able to be subsumed within the TGA as the science
of medicinal cannabis becomes better understood and the regulatory processes
for medicinal cannabis are firmly established.
Applications made both to the
Regulator and the TGA
The Bar Association of Queensland questioned whether the Bill would
result in 'forum shopping' from companies seeking to list medicinal cannabis
It appears from the [EM] to the Bill that pharmaceutical
companies will have a choice as to which regime they apply to for approval to
sell medicinal cannabis products.
It is unclear if two separate applications may be submitted
concurrently to these authorities (the TGA and the...Regulator). It is also
unclear if an application is rejected by one Regulator that fact and reasons
for that rejection are required to be disclosed to the other Regulator should
the company make a subsequent application pursuant to the alternative scheme.
This should be clarified.
The Pharmacy Guild noted that 'if the majority of companies elect to
have their products registered through the TGA, then the proposed new regulator
On the issue of the high costs of listing products through the TGA, the
Pharmacy Guild argued:
If the cost of registering a cannabis product through the TGA
is deemed to be a potential barrier to market entry, consideration should be
given to reducing the application fees for these types of products. This
approach will ultimately be a more efficient option than establishing a new
Application of the TG Act and
Narcotic Drugs Act 1967 to activities undertaken in accordance with the Bill
Evidence presented to the inquiry by the Department of Health
(department) and the TGA raised concerns that the system of regulation
envisaged under the Bill could create legal uncertainty in relation to whether
the TG Act would apply to activities purportedly taken in accordance with
the Bill in certain circumstances.
An opt in/opt out system?
The department questioned how the "opt in/opt out" system
proposed in the Bill might work, stating that it was unclear when the Bill
would apply versus the TG Act:
The...Bill appears to operate in parallel with the TG Act on
the basis of choice by a person to opt into the [Bill's] Scheme and opt out of
the TG Act scheme. The implication of the opting in and opting out mechanism
could be significant. This is particularly the case in relation to the
application of the TG Act, as the definitions of "medicinal cannabis"
and "medicinal use" are not clearly articulated in the [Bill] and it
is not clear how they would not be caught by the definition of
"therapeutic goods" in the TG Act. The complexity of this opting in
and opting out system can be confusing for the regulated persons, the regulator
and other agencies such as the TGA. Without a clear definition, it is not clear
to consumers, health professionals, the industry and the regulators which law
applies and what their legal obligations and responsibilities would be. It
would be difficult for the regulators to determine what their powers are and
whether they have the right to take regulatory action in relation to a
particular product or activity.
The TGA shared similar concerns. The TGA argued that, while licensees granted
authorisations under the Bill's schemes would be exempt from the operation of
the TG Act so long as they complied with their licence or authorisation,
any activity outside the scope of their license may then come under the
coverage of the TG Act. Ms Phillipa Horner, Principal Legal Advisor at the TGA,
The way we understand the bill works is that it fundamentally
says that if you are acting in a way that is compliant with a licence or
authorisation you have been given under this legislation then, for instance,
the [TG Act] does not apply...[W]here it becomes complicated is where
someone does something that is not in conformity with a licence—whether or not
it is a breached condition, it is an offence under this Act. Then every
provision of the [TG Act] would come into play, so that a person would be
committing an offence under the [TG Act] in relation to that. Until you know
whether someone has committed an offence you do not know whether you have got
jurisdiction to investigate them. So you might be in this rather difficult
position of purporting to use powers that you do not know you are able to use.
It is a bit of a catch-22 position, because...the provisions come in and out,
depending on whether you are compliant or not. It makes it quite difficult.
When asked whether this potential difficulty could be overcome, Ms Horner
I do not know that this would work in every situation, but
another way you might do it is to make it so the [TG Act] applies whether the
drug you are talking about is regulated under this Act or not; but that would [then]
require a whole suite of offences to be in [the Bill] when the person did not
The department argued in its submission that a similar issue would arise
in relation to the interaction between the Bill and the Narcotic Drugs Act,
whereby license holders under the Bill would be exempt from the operation of
the Narcotic Drugs Act when acting in accordance with that licence. However, where
a licensee is non‑compliant with licence conditions and the activity in
which a licensee is engaged is not accordance with the medicinal licence they
would be, based on the current wording of the Bill, subject to the Narcotic
Drugs Act again.
Accordingly, the department questioned whether under the Bill there
could be 'several offence provisions from different legislative schemes
potentially applying to the same activity', and concluded:
Further consideration should be given to the
interrelationship between the...Bill and the [Narcotic Drugs Act] and whether
there is value in dealing with the regulation of medicinal cannabis by
amendments to the [Narcotic Drugs Act] rather than creating a completely
separate and free‑standing regime. Building on the existing legislative
framework may assist in ensuring consistency, achieving clarity and avoiding
duplication of regulation due to several applicable laws.
Register of regulated medicinal
The TGA also questioned what would happen if the Regulator made a
decision to take a product off the proposed register of regulated medicinal
[I]f a drug were taken off the register...that would
immediately mean that everybody down the line who was using that drug would
immediately be committing offences under the therapeutic goods legislation and
probably under the state legislation as well—that means the people who had an
authorisation—because suddenly the drug is no longer the defined drug; it is a
drug that has been removed. I am not sure how that would work and whether
people would have an opportunity to appeal against that decision, but you can
imagine that could create a fair degree of legal uncertainty.
Interaction with other Commonwealth
The department also raised concerns about the Bill's interaction with
the Customs (Prohibited Imports) Regulations 1956 and Customs (Prohibited
Exports) Regulations 1958 (together the Customs regulations) and the Crimes
(Traffic in Narcotic Drugs and Psychotropic Substances) Act 1990.
The department highlighted that the Bill appears to overlap with some
aspects of the Customs regulations with regard to the importation and
exportation of cannabis and other cannabis products.
The department stated that the Bill 'does not appear to override the
prohibition on importation or exportation of cannabis products under the
customs legislation' and that '[f]urther consideration on the best way to
achieve consistency and avoid duplication between the...Bill and the customs
legislation with respect to import and export licences' would be required.
The department indicated that the Crimes (Traffic in Narcotic Drugs
and Psychotropic Substances) Act 1990, which contains offences relating to
the cultivation, import and export, and possession of controlled plants and
drugs including cannabis, may also interact with the operation of the Bill. The
department stated that further consideration needed to be given to whether
amendments to this Act are required in relation to the production of cannabis
for medicinal or experimental use sanctioned under the Bill.
Adherence to Australia's
international treaty obligations
Several submitters and witnesses commented on whether the functions and
powers of the proposed Regulator were sufficiently articulated in the Bill to
satisfy Australia's obligations under the Single Convention on Narcotics
Drugs (the Single Convention), the Convention on Psychotropic Substances
and the United Nations Convention Against Illicit Traffic in Narcotic Drugs
and Psychotropic Substances.
The Penington Institute noted that other signatories to the
international narcotics treaties have already approved the use of cannabis for
therapeutic purposes through various regulatory structures.
The department expressed the view that there are aspects of the Bill
'which may not adequately implement Australia's obligations under the drug
control conventions, in particular the Single Convention'. In particular,
the department argued that the Regulator's functions in relation to
fulfilling Australia's obligations under the Single Convention should be more
[C]lause 30 of [the Bill] provides that the Regulator has the
functions of the Agency referred to in Article 23 of the Single Convention.
However, [the Bill] does not specifically provide that the Regulator will be the
sole agency that can authorise and licence cultivation of cannabis plants in
Australia, nor that it is required to purchase and take physical possession of
cannabis crops, as required by Article 23.
Article 23 also requires that the Agency must have the
exclusive right of importing, exporting, wholesale trading and maintaining
stocks other than those held by manufacturers, of medicinal cannabis or
cannabis preparations. To ensure clarity of the functions of the Regulator and
to ensure that Australia meets its international obligations, it would be
preferable if the functions and powers of the proposed Regulator were drafted
in a way that more clearly conforms with all the requirements of Articles 28
and 23, rather than simply referencing relevant articles of the Single
Convention, and generally requiring that the scheme operate in accordance with
the Single Convention.
The department further argued that the ability for Australia to prevent
excess accumulation of cannabis and limit the total quantities of cannabis
manufactured in or imported to Australia, as required under the Single
Convention, may be compromised 'by the potential existence of more than one
agency under Commonwealth and State and Territory law that can grant
authorisations and licences with regard to dealings in cannabis'.
The department also noted that Australia is required under the Single
Convention to provide the United Nations International Narcotics Control Board
(INCB) by 30 June each year with statistical returns in relation to of
production, manufacture, consumption, stocks and seizures of narcotic drugs,
and stated that 'it is unclear from [the Bill] whether the Regulator would
be responsible for meeting these obligations' in relation to cannabis.
Application of the Bill to participating
states and territories
Another significant issue discussed throughout the inquiry was whether
the Bill would be able to improve the current arrangements between the
Commonwealth and states and territories in relation to the regulation of medicinal
Emeritus Professor Mather highlighted that several states are advancing
the regulation of medicinal cannabis, and that the existence of a single,
federal regulator as proposed under the Bill would be preferable to individual
states and territories advancing their own schemes:
Various of the state and territory governments are presently
examining the evidence concerning medicinal uses of cannabis, and how it should
be dealt with by legislation. This includes whether and how it should be
lawfully prescribed and dispensed as a pharmaceutical preparation, or at least
lawfully allowed to be used, with the patient and/or carer being responsible
for its acquisition and quality. However, it is proceeding in a state-by-state
or territory basis, with notable differences, and this will inevitably lead to
problems, unforeseen and otherwise.
How to permit and regulate cannabis and cannabis preparations
for medicinal use has been a major stumbling-block to present state and
territory governmental inquiries. If this Bill will allow a mechanism for the
Federal production, regulation and permission of cannabis use as a medicine,
including production and research, and to allow State and Territory governments
to adopt the code of regulation afforded Federally, then surely this seems a
beneficial way of precluding inharmonious local legislation and the errors of
the past. A nation-wide code seems both sensible and economical.
Medicines Australia agreed that the current federated model of
regulation is unsatisfactory, but did not support a new regulator as proposed
by the Bill:
[T]he foremost barrier that Medicines Australia members have
experienced in attempting to supply medicinal cannabis products in Australia
have arisen from state and territory poisons legislation. In particular,
differences in permit, prescription and risk-management plan requirements.
These issues would not be overcome by the introduction of the [Bill] without
appropriate changes to state and territory legislation...[T]he focus should be
placed on harmonising state and territory legislation, rather than introducing
a new level of national regulation, where appropriate and functional regulation
The National Centre for Education and Training on Addiction (NCETA)
cautioned that implementing a regulatory scheme in conjunction with
participating states and territories would be complex:
This will likely require States and Territories to amend
legislation and undertake activities on behalf of the Commonwealth. These
cooperative arrangements will be complex and will vary between jurisdictions
due to differences in jurisdictional...[law] enforcement approaches to illicit
cannabis [and regulatory] structures and approaches in place for Schedule 8
It will be important not to underestimate the complexities of
these legislative and regulative arrangements in establishing the Regulator.
The Law Institute of Victoria argued that it was unclear to what degree
states would be required to reform existing legislation to incorporate the
parallel system of regulation proposed by the Bill.
Comments from state and territory
The committee received submissions to the inquiry from both the
Victorian and ACT governments.
The Victorian Government confirmed its commitment to investigating
legislative reform options to allow people to be treated with medicinal
cannabis in exceptional circumstances, noting that 'the use of medicinal
cannabis is a matter of high sensitivity and complexity'.
It stated that the Victorian Law Reform Commission's (VLRC) final report into
these issues, due to be completed in August 2015, would inform its
deliberations on the matter of legislative reform in relation to medicinal
The Victorian Government is committed to working
collaboratively with the Commonwealth Government and other states and
territories, to share information on issues relating to the use of appropriate
therapeutic products derived from cannabis.
The Victorian Government will consider the recommendations made
by the VLRC before forming a final position on the proposed Regulator of
Medicinal Cannabis Bill 2014.
If the Regulator of Medicinal Cannabis Bill 2014 progresses,
the Victorian Government will seek to further engage with the Commonwealth
Government regarding issues raised in the Bill. In particular, consideration
will need to be given to the scope of the Regulator's proposed functions and
the interaction between the operation of Victoria's legislation and any new
proposed national regulatory framework.
The ACT Government stated its belief that a national approach to the
regulation of the medicinal use of cannabis is required, and expressed support
for the compassionate intent of the Bill.
It noted that if the ACT agreed to enter into an arrangement with the Commonwealth
to participate in the scheme, it would need to amend its laws relating to the
unlawful possession and administration of cannabis.
Appropriateness of the rule-making
power in the Bill
Several submitters and witnesses commented on the nature of the Bill as
a 'framework' piece of legislation, with many significant features of the
regulatory structure in relation to medicinal cannabis to be determined by
the Regulator through the proposed rule-making power.
Ms Phillipa Horner of the TGA suggested that the proposed broad
discretion of the Regulator to create rules relating to its operation is
[I]t is very unusual I think for an agency to be set up that
makes its own rules—and you can see a lot of the detail of this is going to be
in the rules—grants licences, enters into contracts with people in
licences...[a]nd then it presumably does some enforcement and presumably
prosecutes people if they breach. It also would then take things off the
register—it would take licences away. That is a pretty unusual kind of set up.
In relation to the rule-making power, the ACT Government submitted that
the absence of draft or indicative principles or processes for the development
of the rules 'creates uncertainty about the efficacy of the scheme to prevent
or minimise diversion and threats to public health and safety'.
It argued that consideration could be given to including principles in the Bill
to serve as a guide for the development of the rules, and that the rules should
be made by executive government rather than the Regulator.
The AGT Government further commented that, should the Bill be enacted,
it would 'be eager to participate in the development of the rules', with a view
to ensuring that the relevant issues and perspectives are satisfactorily
addressed and incorporated.
Some stakeholders expressed the view that the flexibility afforded by
the rule‑making power in the Bill was a positive feature. For example, Professor
Ritter of the NDARC stated:
[An] advantage, from my reading of this draft bill, is that
it has the capacity to be flexible and the regulator can then change over time.
One of the problems with public policy is that decisions get made and then
there is no ability to then change those decisions once one starts to see
either very positive consequences or unintended negative consequences. It seems
to me that there is the opportunity for enormous flexibility. If you look at
the United States experience, many of the states have changed and resharpened
some of their regulatory approaches over time. You really want to have that
ability, and I think the bill gives that.
Proposed register of medicinal
In relation to the Regulator's proposed role of approving and
registering medicinal cannabis products, various submitters and witnesses
argued that the Regulator would need to maintain similar standards in relation
to these products as apply to other medicines. For example, the Cancer Council
Australia & Clinical Oncology Society of Australia in a joint submission stated
that 'any product for medicinal purposes must be evaluated against objective
criteria to ensure a high standard of safety, efficacy and quality for a
particular use or uses'.
NCETA, which supported the creation of the Regulator, submitted that the
Regulator should maintain similar standards to the TGA in its decision-making
on medicinal cannabis products:
It will be critical to ensure that an appropriate level of
rigour is maintained in the Regulator's decisions concerning the ways in which
medicinal cannabis is made available and used. Given that pharmaceutical
companies will also be able to apply to the Therapeutic Goods Administration to
sell medicinal cannabis products under the TGA's legislation, it will be important
to ensure the new approval mechanisms established under the Bill are both
complementary to, and as rigorous as, those that currently apply to the TGA.
Any short cuts to obtaining regulatory approval should be avoided at all costs.
In arguing against the necessity for a new regulator, the AMA stated:
Medicinal cannabis should be held to the same standards of
evidence, safety, quality, and efficacy as other therapeutic narcotic products.
This will ensure that medicinal cannabis can be standardised and regulated in
its pharmaceutical preparations and administration, thereby reducing the harm
to potential users.
Process for the Regulator to
approve products as 'suitable for medicinal use'
Under paragraph 13(2)(b) of the Bill the Regulator would be required to
be 'satisfied that the cannabis product is suitable for medicinal use' in order
to include a cannabis product on the proposed register of medicinal cannabis
Cancer Council of Australia & Clinical Oncology Society of Australia
noted in a joint submission:
This subjective assessment does not acknowledge any process
undertaken by an applicant in seeking a product to be registered, including
responding to specific criteria such as clinical outcomes and patient safety.
The absence of a structure to objectively evaluate the application should also
be noted. A rigorous review process is critical, for example, the review of
therapeutic products prior to registration on the Australian Register of
Therapeutic Goods. In the context of the Bill this is essential as people will
be exposed to the product either through access (medicinal license) or research
(experimental license). Assessment determines whether any risks associated with
the product outweigh the benefit to the patient.
Painaustralia expressed the view that the proposed Regulator should
adhere to the principle that substances intended for therapeutic purposes be
fully characterised chemically, pharmacologically and toxicologically, and
argued that providing a clear definition of 'medicinal cannabis' in the
Bill would address this concern:
Painaustralia believes that in this context
"medicinal" should refer to cannabinoid preparations of sufficient
and consistent quality to be capable of being tested for efficacy and safety,
and calls for a specific definition of medicinal cannabis to be
incorporated into the Bill.
It is not clear that [paragraph 13(2)(b)]...satisfies this
Bedrocan, a medicinal cannabis producer responsible for supplying
medicinal cannabis products in the Netherlands and Canada, commented that
scientific findings in relation to different strains of cannabis should
underpin listings by the Regulator:
[Under the Bill] it is not clear what scientific evidence may
be required to market specific cannabis products as effective for different
Claims are often made connecting certain cannabis strains
with specific indications. While anecdotal reports of patients are useful and
necessary, these claims are often not supported by scientific evidence. Such
claims become particularly problematic in referring to cannabis that is non‑standardized,
as a claim of efficacy may be made for products that are marketed under the
same name, but which may vary significantly in their chemical composition
The marketing of different strains of cannabis for specific
indications, without proper evidence to support those claims, may create
confusion among patients and doctors. Care should be taken that the evidence
required to make claims of efficacy of a medical product for a certain
indication should remain at a high level of quality.
Palliative Care Australia called for the Bill to provide further details
about the evidence that would be required by the Regulator in approving
In contrast to these stakeholders, the Cannabis Policy Project contended
that the current wording of paragraph 13(2)(b) 'gives the regulator the
option to place a very narrow definition on the suitability of a cannabis
product', and argued it is 'conceivable that as it currently reads the regulator
could refuse all products'.
Cost of medicinal cannabis products
Cancer Council Australia & Clinical Oncology Society of Australia
noted that the cost of medicinal cannabis products made available by the
Regulator may be an issue:
By not requiring registration by the TGA, a product cannot
apply to the Pharmaceutical Benefits Advisory Committee for reimbursement.
Therefore a product cannot be available to a patient at a reduced price.
Pricing of products on the register for regulated medicinal cannabis products
must be public and transparent with an aim to provide products at a reasonable
Mrs Joelle Neville, whose daughter is currently being treated with
high-CBD cannabis oil, expressed concern that pricing would need to be
considered in order to make medicinal cannabis products affordable:
[W]e are currently out of pocket about $6,000 a year. If we
got to the point where it was being grown in Australia being produced here I
would hope that that would bring the cost down slightly, but my fear is that if
it was regulated to such an extent that government needs to recoup that cost
somehow it would then become unviable for an average family to purchase. That
is certainly a concern at the moment for most families. I know many families
that would like to be on hemp oil, or cannabis oil, but financially it is not
available to them, which leads, unfortunately, to shopping around on the
Medicinal cannabis licensing scheme
Some submitters commented on the processes proposed to be undertaken by
the Regulator when granting licenses. NCETA expressed the view that ensuring
the integrity of the licensing scheme proposed under the Bill would be of
The Regulator will...have an important role in ensuring that
only fit and proper individuals are involved in the production, distribution
and dispensing of medicinal cannabis. This will involve ensuring that
appropriate probity checks are undertaken to ensure that those involved in the
industry have no significant relevant criminal history or links to organised
On the issue of the criminal history of licensees, Palliative Care
Australia opined that the Bill should clarify whether a person with previous
convictions around cultivating or supplying cannabis would be able to gain a
licence to cultivate or manufacture medicinal cannabis under the proposed
medicinal cannabis licensing scheme.
Cancer Council Australia & Clinical Oncology Society of Australia
stated that the Bill was not clear about how a license application would be made
and assessed, including against what selection criteria a license application would
be evaluated, and recommended:
Specific application processes, conditions of a license and
the obligations of a license holder for each area of approval (e.g. distribution,
cultivation etc.) must be clear and transparent to the applicant and general
public. It is essential that post license monitoring and reporting be enforced
especially the licensee's responsibility to report any adverse events.
Authorised patients and carers
Several issues were raised in relation to the proposed authorised
patients and carers scheme, including:
processes for determining what kinds of medical conditions would
qualify patients to access the scheme;
the requirement under the Bill for access to the scheme to be
subject to the prescription of a medical professional;
implications for prescribing medical professionals, including
liability issues; and
means of ensuring that authorised patients and carers are
sufficiently protected from law enforcement activities.
Determining access to the scheme
for different conditions
Stakeholders to the inquiry presented varying views about how the
Regulator should determine which patients, or classes of patients, should
qualify for access to regulated medicinal cannabis products.
Emeritus Professor David Penington argued that the legislation should allow
for the listing of recipient groups in line with emerging research and clinical
Legislation will need to designate processes for approval of
further recipient groups, which will no doubt emerge. It is suggested that the
initial categories of pain in cancer, nausea and distress with cancer
chemotherapy, painful neurological conditions and refractory juvenile epilepsy
also provide for further categories when strongly recommended by two or more
recognised specialists with a commitment to data collection and reporting or
formal clinical trials.
Professor Wayne Hall argued that the government should not be involved
in supplying medicinal cannabis to patients outside of the context of clinical
If that were to happen, I think it would make clinical trials
harder to do because people could get the drug without participating in trials,
and we are talking about relatively small numbers of some of these cases, which
would make it difficult to recruit patients into trials. There are also equity
issues that are raised by governments supplying an unapproved, unevaluated
substance at substantial cost when the pharmaceutical regulatory process
decides not to fund drugs for which there is evidence of efficacy and safety
because they are too expensive.
Professor Hall stated that if medicinal cannabis was made available
outside of clinical trials, this 'should be for registered patients and for a
time limited period (e.g. 5 years) rather than an open ended commitment'. He
Governments should fund long term follow-up studies of
patients who use cannabis preparations and medical cannabinoids over periods of
years to assess: the risks of developing cannabis dependence; exacerbating
cardiovascular disease; precipitating psychotic disorders; and developing
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) was
concerned that, given the link between cannabis use and psychiatric illness in
some individuals, the Bill does not have a provision to identify patients who
have experienced negative psychiatric consequences as a result of cannabis use:
Without such a register, there would be the potential for
medical practitioners to prescribe something that - while it may be the
appropriate treatment for a medical concern - could have a significant
detrimental impact on a person's mental health and would not be in the best
interests of both patients and prescribers.
Necessity for a doctor's
As noted in chapter 3, under subclause 19(2) of the Bill, the proposed authorised
patients and carers scheme (to be established by the rules) must stipulate that
authorisations to patients or carers must only be given on request by a medical
Submitters and witnesses commented on how 'medical practitioner' should
be defined for these purposes, with the main three options being considered to
allowing all doctors and some allied health professionals (for
example, physiotherapists or occupational therapists) to prescribe medicinal
allowing all doctors to prescribe (but excluding allied health
allowing only some doctors to prescribe through a registered
Dr Alex Wodak suggested that all doctors should be given the ability to
prescribe medicinal cannabis under the scheme, but that allied health
professionals should be excluded from the initial scope of the authorisation
Professor Ritter from the NDARC considered that it would be appropriate
to allow health professionals other than doctors to prescribe products under
the scheme, as long as they had access to appropriate accreditation, training
Issues for prescribing medical
The AMA did not support the establishment of an authorised patients and
carers scheme as proposed by the Bill, nor the requirement that a medical
practitioner should be required for a patient authorisation:
[T]he requirement that patients and their carers be
authorised to use medicinal cannabis at the request of their medical
practitioner, is problematic. This may see undue pressure being put upon
doctors to support applications for authorisation, purely as a means of access
to cannabis products. There is a risk that if a doctor does not support a
patient's application for authorisation it may undermine the doctor/patient
RANZCP noted that the issue of individuals seeking cannabis for
non-medical reasons was an issue that needed to be considered:
It is the experience of many psychiatrists that patients who
express a wish to obtain cannabis lawfully are motivated more by experience of
its 'recreational' use than by reputed target symptoms that they may have, or
claim to have. The alleged benefits of cannabis (some of them unproven) have
been widely promulgated, and for doctors, the problems of assessment and
control will probably be comparable to those associated with the prescription
Professor Philip Morris, of the Royal Australasian College of Physicians
(RACP), claimed that doctors would be unwilling to prescribe medicinal cannabis
products unless those products had been assessed to the standards required by
regulators such as the TGA:
You are going to be asking doctors to prescribe this
medication for certain conditions. Once you start doing that, the physicians
that are doing this need to know that the medication has been appropriately
approved and that the pros and cons and the safety versus effectiveness in that
particular condition have been assessed adequately. Anything less than that
means that basically you are using a form of regulation which does not meet the
usual medical standards. Now, if you are going to have medication or the thing
prescribed by people other than doctors, then perhaps you could use a different
standard. If you are going to ask doctors to be responsible for patients and to
prescribe medication, then you need to go through the TGA experience.
The Australian and New Zealand Society for Palliative Medicine (ANZSPM)
queried what would occur in the event that one only practitioner operating as
part of a treatment team obtained a licence to be able to prescribe medicinal
Issues of ongoing supply may be problematic. Should one
clinician within a palliative care service decide to support the use of
cannabis and apply for a licence, there would need to be consideration by the
greater team as to issues of responsibility for ongoing care and support,
particularly at times of recreational leave for the licensee, etc. This adds
another level of complexity to patient care when one clinician holds the
licence but is not available to care for the client.
Exposure to liability for
prescribing medical practitioners
The ANZSPM raised concerns relating to the potential liability of
medical practitioners licensed to prescribe medicinal cannabis products:
The medico-legal ramifications with being responsible for the
outcomes associated with the use of this drug, particularly if there are
breaches of the rules such as drug diversion, may also be of great concern to
many ANZSPM members.
The Regulator would be yet another body which doctors, who
apply for a licence, will be answerable to, with possible serious legal
ramifications if breaches occur.
It is not known how Medical Indemnity Societies will support
clinical members if there are legal implications arising, especially as the use
of these drugs is not supported by good practice guidelines within a medical
The RACP echoed these concerns, arguing that the authorised patients and
carers scheme as currently proposed offers medical practitioners insufficient
protection from liability.
Education for prescribing medical
Several submitters and witnesses discussed the need for education in
relation to medicinal cannabis for prescribing medical practitioners. NCETA
argued that clear guidelines would need to be developed for doctors:
If medical practitioners are to have a role in prescribing
cannabis it will be crucial that they have access to evidence informed
guidelines about its appropriate medicinal uses. Such guidelines will need to
be developed in consultation with relevant medical colleges and experts and
supported by an extensive educational program to support practitioners in their
ANZSPM expressed similar views:
Expanded teaching of health professionals who will be dealing
with patients that have access to the drug will need to be considered. Patients
are not isolated to one health professional (the licencee), and general
education will be required to enable pharmacists, nursing staff and medical
practitioners who have clinical responsibilities of patients using the
medicinal cannabis, to ensure ongoing safety and good clinical practice. This
will be important particularly for Palliative Care and Mental Health
Specialists where many of the drugs used for symptom control have additive
properties to the effects of cannabis.
The ANZSPM stated that if the Bill was passed, health professionals would
need guidance on the use of medicinal cannabis in practice, and argued that
such guidelines would need to consider 'assessment criteria for prescribing,
monitoring patient response, monitoring any potential misuse and for
identifying possible drug interactions' as well as the relevant licensing
Palliative Care Australia noted that some medical bodies have developed
guidelines for the use of medical cannabis, including in countries such as
Canada where mechanisms for the use of medical cannabis have been introduced.
It argued that these guidelines may be worth considering by the Regulator in
the development of guidance materials for Australia.
The Pharmacy Guild suggested that, rather than a new regulator providing
standards and guidelines in relation to medicinal cannabis:
The National Health and Medical Research Council (NHMRC) could...develop
clinical guidelines to assist health professionals in determining the
suitability of medicinal cannabis treatment for individual patients as well as
ongoing management of symptoms and side effects.
Ensuring protection for authorised
ADLRI stated that practical safeguards would be needed to ensure that
authorised patients and carers were not unwittingly targeted by state and
territory law enforcement:
Whilst a class of people will be created who are free from
prosecution, it may be hard to ensure this freedom is absolute. There may be a
need for strong policy to be drafted for State police forces giving direction
on how to deal with people found with cannabis, who claim to be authorised
under the Commonwealth scheme to use medical cannabis.
ADLRI noted that while various options could be considered to help
identify authorised patients and carers, including a patient register or a card
system, none of these options were ideal:
Although a card may be issued to people within the defined
class, this is no guarantee that such people will be safe from search, arrest,
and detention. A registry may need to be created that Police can check before
arresting people, however significant thought will have to be given to how such
a registry is constructed and maintained to avoid concerns about accuracy and
Epilepsy Action Australia expressed concern that authorised persons
carrying regulated medicinal cannabis products may not be protected whilst
transiting through or temporarily visiting any Australian states and
territories not participating in the scheme implemented by the Bill.
The Bar Association of Queensland argued that it should be made clear
that medicinal use of approved cannabis products by registered patients is a
complete defence against any criminal charges relating to the possession or use
of those products in participating states and territories.
Experimental cannabis licensing
Many submitters and witnesses expressed support for the intention of
increasing access to cannabis for research and experimental purposes in
Australia, in order to establish a broader evidence base in relation to the
efficacy of medical cannabis.
The University of Sydney academics joint submission, which highlighted
the difficulties in obtaining cannabis strains for research purposes in
Australia, expressed strong support for the Bill's intention to allow for
cultivation of cannabis for research purposes:
[The Bill's] proposed mandate of setting up a system for the
cultivation and production of cannabis for medical use and research in
Australia, based on the Tasmanian poppy industry for opioids, would greatly
accelerate basic, clinical and translational research in the cannabinoid area.
This not only has the potential to facilitate access to medicinal cannabinoids
for the research and broader community, but also may help position Australia as
a global leader in the fast moving area of cannabinoid therapeutics... As we
develop a greater understanding of the role of different "big 10"
cannabinoids (e.g. CBD, THCV) for different medical indications (e.g.
epilepsy, chronic pain, neurodegenerative conditions, PTSD, obesity, cancer),
we will need to grow strains of cannabis that maximize the content of these
cannabinoids to facilitate therapeutic efficacy and the extraction and
purification of these compounds for high quality medications.
Emeritus Professor Mather lauded the inclusion of the proposed
experimental cannabis licensing scheme in the Bill as a means of furthering
research and development activities in the field of cannabis science.
NCETA agreed, stating that by enhancing access to cannabis for research
purposes, the proposed regulatory arrangements would assist researchers address
a number of knowledge gaps concerning the potential role of medicinal cannabis.
The joint submission from Cancer Council Australia & Clinical Oncology
Society of Australia noted that the Bill does not acknowledge any requirement
to comply with Australian guidelines or policies for proposing or conducting
research on humans, or mention the need to fulfil a formal assessment process
or seek authorisation from a Human Research Ethics Committee to commence
cannabis product research on humans.
The submission argued:
The Bill must promote research integrity and ethical
compliance within the conditions of granting an experimental medicinal cannabis
license. This must include: the Australian Code for the Responsible Conduct
of Research and the National Statement on Ethical Conduct in Human
Research, including approval from a Human Research Ethics Committee to
undertake the proposed research.
Composition of the Regulator and
Cancer Voices Australia supported the mandatory inclusion of a consumer
(patient) representative as part of the Regulator's membership.
This proposal was also suggested by the Public Health Association of Australia
in its submission.
Palliative Care Australia argued that the inclusion of palliative care
expertise in the composition of the Regulator was important, and stated that
strong medical representation would be important to ensure that issues such as
who may use medicinal cannabis, the impacts of long term use and the level of
use were addressed properly.
The department stated that the establishment of the Regulator as a
separate statutory entity with a CEO and staff 'is not in keeping with the
Government's policy on a smaller and more rational government'. Further:
[The Bill] also proposes that the CEO of the entity be the
Chair of the regulator. It is not clear whether there may be any potential
conflicts for a person to hold these dual statutory positions, [or] whether the
person would be entitled to remuneration for each role. Further consideration
should be given to whether existing government agencies could support the work
of the Chair and members of the regulator.
Appropriateness of the monitoring
and investigatory powers of the Regulator
ADLRI expressed concern about the monitoring and investigatory powers of
the Regulator proposed under the Bill:
While we accept the argument that law enforcement and the
public must be able to be confident about the security of the scheme, extending
these powers to a new office, the Regulator, with no experience in police
investigative powers may be ill-advised. The Committee must give serious
consideration to whether a new agency should be given police powers or whether
it is appropriate for police to monitor medical users.
The preferred approach is to confine the use of powers of
entry, search and seizure to police organisations that are trained and
experienced in exercising these powers and that have appropriate oversight and
accountability...It may be simpler for the office of the regulator to report
concerns to local Police. Creating another investigative force may lead to
over-policing of sick people.
Mr Ben Mostyn of the ADLRI suggested that local police may already have
adequate powers to deal with suppliers licensed by the Regulator who breach the
terms of their licence:
It would seem that...those monitoring and investigative powers [in
the Bill] may not be necessary in the sense that either people who are licensed
suppliers will be supplying it in accordance with their licence or they will
not be...It would appear that, once they overstep the powers of the licence, they
would quite clearly then come within the jurisdiction of the local police
because they would be supplying cannabis without lawful authority. So it may be
simpler and preferable to just leave any of that unlawful supply to the current
systems in place.
Impact on state and territory law
Both the ACT Government and ADLRI expressed concern about the
implications of the Bill for state and territory law enforcement agencies. The
ACT Government argued that the Bill 'does not consider the impacts on law
Law enforcement agencies will be responsible for dealing with
instances involving the diversion of authorised medicinal cannabis products to
the illicit market, and to enforce other associated ACT legislation (for
example, the Road Transport (Alcohol and Drugs) Act 1977).
While the...Bill proposes to give the Regulator powers to
monitor compliance with the Act and the rules (including powers to investigate
breaches), there is no way to assess the possible impact on other law
Similarly, ADLRI acknowledged that the Bill could place state and territory
police in a difficult situation:
...because they are the ones who need to enforce the regular
cannabis laws whilst not overstepping the boundaries in any Commonwealth system.
Unfortunately...we can point to the problem, but we do not necessarily have the
Review of decisions by the
Administrative Appeals Tribunal
The TGA questioned whether the lack of definition of 'medicinal
cannabis' in the Bill may create a large number of applications for decisions
of the Regulator to be reviewed by the Administrative Appeals Tribunal (AAT):
In the AAT, any person with an interest in a decision can
come along and apply to have the decision overturned—not just the person who
has the licence. Whether that is going to result in thousands and thousands of
people wanting to go to the AAT, because either they have been refused an
authorisation or the drug that they were getting has been taken off the
register, will depend on how we define 'medicinal cannabis'. That is not very
clear, so it is a bit hard to know whether it is a practical problem or not...If
it mirrored the [TG Act], though perhaps not at the pharmaceutical level of
prescription medicines, then presumably the drugs you are talking about would
not be very many. But, if you are talking about a much wider group of drugs
that would be approved, then I suspect you would have some practical issues
about people wanting to appeal against any decisions about, or if any changes
were made to, accessibility.
Stakeholders raised several other issues relating to the impact of the
Bill that did not relate to its specific provisions, including resourcing,
reporting requirements and the need for community education.
Resourcing issues for the proposed
NCETA noted that in order to be effective, the Regulator would need to
be adequately resourced:
It will be necessary to financially compensate States and
Territories for activities related to the medicinal cannabis system. The
Regulator's activities and those to be undertaken by States and Territories
will need to be fully costed and appropriately resourced. Given that the Bill
contains no appropriation, funds will need to be allocated by the Parliament
for this purpose. Failure to ensure full and sufficient funding to the
Regulator will result in regulatory gaps and inconsistency in approaches as are
currently seen the regulation of Schedule 8 drugs across jurisdictions.
The NSW Bar Association argued that it would also be important that
adequate resources were devoted to law enforcement in order to prevent the
diversion of 'licit' cannabis to the illicit market.
Reporting requirements of the
The Cannabis Policy Project noted that there are currently no reporting
requirements imposed on the Regulator, and that in order to enhance
transparency and good governance, the Regulator should be required to provide
an annual report to Parliament detailing its activities and decisions.
The need for community education
and measures to prevent 'commercialisation'
NCETA argued that, should the Regulator be established as proposed by
the Bill, community education in relation to the changes would be important:
The introduction of arrangements such as those outlined in
the Bill will also require an extensive community education process. In particular,
the introduction of medical cannabis should not come at the expense of cannabis
coming to be regarded as a harmless, natural product. The adverse effects of
cannabis use have been well documented...Any move to enhance the medicinal use of
cannabis should not leave the broader community with the impression that
cannabis use (particularly smoking) is a health promoting activity or not
associated with a range of potential significant risks.
A joint submission from Australian Federation of AIDS Organisations, the
National Association of People With HIV Australia, ACON and Positive Life NSW
also highlighted the importance of community education:
The provision of information and education to communities
that are likely to utilise and benefit from the medicinal use of cannabis would
also be valuable. This should include the engagement of community, service
providers and doctors to ensure that reliable information is available to
consumers and doctors.
The NSW Bar Association argued that if the Bill was successful in
increasing access to regulated medicinal cannabis products, measures would need
to be taken to prevent the commercialisation of the cannabis industry:
A concern often expressed is the potential for the
'commercialisation' of cannabis use that could flow from regulated availability
of medicinal cannabis (similar to the commercialisation of tobacco and
alcohol). If a regulatory scheme for medicinal cannabis was introduced, it
would be necessary to have very strict restrictions on advertising, to ensure
that some of the mistakes in America are not replicated here.
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