Cannabis and its medicinal uses
The cannabis plant is an annual hemp plant that grows in many temperate
and tropical zones of the world including Australia.
Cannabis has a long history of being used as a herbal remedy, while hemp
obtained from the cannabis plant is used in an industrial setting with various
applications including cloth and twine. While there are many recognised strains
of the cannabis plant that have been developed through selective breeding, Cannabis
sativa is the primary strain of relevance.
The cannabis plant contains numerous different chemical compounds, many
of which are classified as cannabinoids. Cannabis sativa contains
more than 100 different cannabinoids, as well as roughly 300 non‑cannabinoid
A submission to the inquiry from Dr David Allsop, Clinical Associate
Professor Nick Lintzeris, Associate Professor Jonathon Arnold and
Professor Iain McGregor, all associated with cannabinoid research at
the University of Sydney (referred to in this report as the University of
Sydney academics group) explained that cannabinoid science is a rapidly
Cannabinoid science is one of the fastest moving frontiers in
pharmacology and is poised for a period of great scientific and medical discovery
in coming years. This is based on our relatively new understanding of the endocannabinoid
system of the brain and body. Endocannabinoids are cannabis-like signalling
molecules that play a role in nearly every physiological process that is known
to mankind. Endocannabinoids act through cannabinoid CB1 and CB2 receptors to
influence appetite, cognitive function, pain, anxiety, immune function, bone
growth and tumour proliferation. The development of medicines that modulate
these processes has remarkable potential to influence human disease and
The two most well-understood cannabinoids are delta-9-tetrahydrocannabinol
(THC) and cannabidiol (CBD). Emeritus Professor David Penington AC explained the
roles of these two compounds:
The most potent cannabinoid in its influence on mood
(relaxation and euphoria) is [THC]. The effect of high dosage is termed "stoned"
in the vernacular. It also has significant analgesic effects. Over the past 10‑15 years,
marijuana has been bred to produce a high content of this product to serve the
market demand for its effects. This is derived particularly from the
reproductive seed and adjacent leaves of the plant This type of product is
colloquially termed skunk. It acts on the endogenous CB1 and CB2 receptors, the
former being widely represented in the brain. CB2 on the other hand is wieldy
distributed in body tissues and cells, responding to the body's own
endo-cannabinoids influencing immunity and inflammation.
The second most extensively studied component has been
cannabidiol (CBD) which counteracts, to a significant extent, the excitatory
effects of THC mediated through its influence on excitation of the body's
endogenous cannabinoid receptors CB1and CB2, substantially modifying the
effects of stimulation by THC. It derives especially from the stalk of the
leaves and is commonly contained in the marketed product of hash or hashish. It
has strong anti-emetic and analgesic effects and may also have anti‑inflammatory
effects. It is reported to improve symptoms of developing psychosis. There is
much recent research in this field.
The University of Sydney academics group noted that, in addition to THC,
at least 10 of the other cannabinoids present in the cannabis plant are
currently under investigation as showing promise for potential therapeutic
Submitter views on the indications
for which medicinal cannabis may be used
Submitters and witnesses to the inquiry expressed a range of views on
the efficacy of cannabis products in medicinal settings, and the current state
of the scientific literature in relation to medicinal cannabis.
Emeritus Professor Laurence Mather, a chemical and clinical
pharmacologist with four decades of academic research experience in the
disciplines of anaesthesia and pain medicine, including cannabinoid research,
provided a summary of the known and possible uses for cannabis and preparations
thereof, as reported in peer-reviewed scientific literature, as follows:
Historically recognized uses for
management of migraine pain;
management of painful cramps of dysmenorrhoea;
glaucoma treatment (temporary relief);
epilepsy treatment (and possible treatment for intractable
seizures, for example in paediatric Dravet syndrome);
bronchodilation (associated with asthma treatment);
Agreed and prospective uses for
control of refractory nausea and vomiting (for example from
appetite stimulation (for example in patients with HIV-related or
cancer‑related wasting syndrome);
control of muscle spasticity (for example from multiple sclerosis
or spinal cord injury);
pain management (analgesia, especially from neuropathic pain, and
as an anti‑inflammatory agent);
anti-convulsant effects (for example in patients with epilepsy);
Under investigation for cannabinoid
Anti-tumorigenic uses and direct (local) anticancer treatments;
endocrine-metabolic modification (for example in diabetes);
treatment of post-traumatic stress syndrome;
delaying progression of neurodegenerative conditions (for example
Alzheimer's disease); and
treatment of various forms of inflammatory bowel disease.
Emeritus Professor Laurence Mather stated in his submission:
[H]aving studied a great deal of the relevant scientific and
medical peer‑reviewed published evidence about cannabis, I maintain that
this evidence inarguably demonstrates cannabis to be a useful medication, and
ought to be available to Australian patients in need. I thus maintain that the
evidential literature strongly supports appropriate changes to the law, at both
Federal and State levels, to enable cannabis and preparations thereof to be
reintroduced into the range of medicines available for the treatment of an
already identified number of medical conditions, with sufficient flexibility to
enable future uses.
Dr Alexander Wodak AM, who worked as director of the alcohol and drug
service at St Vincent's Hospital in Sydney for three decades, stated his view
that medicinal cannabis was useful in a range of circumstances:
[T]he evidence is clear that it is a useful medication. At
this stage of our knowledge it is probably only a second line medication; in
other words, the standard medicines should be used first, but they fail often
enough, leaving patients in considerable distress. That happens often enough to...justify
the use of medicinal cannabis for those patients. We are often talking about
very distressing symptoms in terminal conditions or serious medical conditions
that are limiting the quality and quantity of life.
Some other submitters and witnesses were more equivocal about the
potential of medicinal cannabis. For example, Professor Wayne Hall, Director of
the Centre for Youth Substance Abuse Research at the University of Queensland,
expressed the view that the current research indicated medicinal cannabis is
'at best, modestly effective for some purposes (for example vomiting and
nausea) and probably for others (for example chronic pain, depression,
Professor Hall stated:
An informed policy towards the medical use of cannabinoids
requires much better evidence than we currently have...we need clinical trials of
the safety and efficacy of CBD and other cannabinoids in treating intractable
epilepsy and chronic pain. Evidence from these trials is essential for rational
decisions to be made about the medical use of cannabinoids.
The Royal Australasian College of Physicians considered that 'while
medicinal marijuana shows some potential for certain patients, further research
is required to determine its efficacy and it should be subject to the same
scrutiny as any other medicine'.
Painaustralia expressed the view that, for individuals with chronic
non-cancer pain, there is little proven evidence for the effectiveness of
cannabinoids in helping patients, and that it did not endorse the use of
cannabinoids for this group of patients 'until such time as a clear therapeutic
role for [cannabinoids] is identified in the scientific literature'.
Associate Professor Lintzeris of the University of Sydney argued that a
balance must be struck when assessing the potential of medicinal cannabis:
there are a lot of claims and counterclaims about the role of
cannabinoids—that they will cure everything, on the one hand; there is a group
of advocates saying, "This is better than sliced bread and should be in
the drinking water" and, at the other extreme, we have got other people
who identify that the evidence is not there and we really should not be
progressing, it is too risky and, for a range of reasons, we do not want to go
down that track...It is a fine balance about how governments, professional
societies, regulators, consumer groups...keep abreast of the evidence and are
able to make sure that, where we know that there is a role for the cannabinoids
and they can be provided safely, those markets are then opened up, whilst not
necessarily promoting the use of cannabinoids where there is not evidence.
The 'ensemble' or 'entourage'
Some submissions to the inquiry noted that an active area of research in
cannabis science is the so-called 'ensemble' or 'entourage' effect, which
suggests that it is the effect of the various cannabinoids and terpinoids in
the cannabis plant working together, rather than the action of any single
cannabinoids present in the plant, that produce the most beneficial medicinal
Professor McGregor of the University of Sydney commented on this issue
in evidence to the committee:
The ensemble or entourage effect is much spoken about. It is
often people who want to defend smoked cannabis as the primary therapeutic who
say you are not going to get a therapeutic effect until you have 100
cannabinoids and 200 terpenoids all together in the one mix. The evidence is
actually not that strong. We have good evidence for CBD moderating some of the
psychosis-inducing effects of THC and some of the other adverse effects. We
have a little bit of work on THCV antagonising some of THC's effects. But what
we really need to do is to go back to basics with preclinical work looking at
these different ratios...and play with the different ratios using pure
cannabinoids and work out what is therapeutically best and see if an entourage
effect actually does exist.
Grades of medicinal cannabis
The National Drug and Alcohol Research Centre at the University of New
South Wales (NDARC) noted in its submission that there are three possible
grades of cannabis and cannabis products that are used in medicinal contexts,
namely pharmaceutical, medical-grade herbal and herbal, as follows.
Pharmaceutical grade products
NDARC described this class of products as 'a medical grade product with
standardised content of the active constituents, presented as a medication
(with standardised packaging, dosing and so on)'. NDARC noted that this is
effectively the same as for any pharmaceutical preparation that adheres to the
requirements of the Therapeutic Goods Administration (TGA), the agency that
oversees the registration of medications in Australia, and that most clinical
trials examining medicinal cannabis have been conducted with pharmaceutical
preparations, rather than with herbal cannabis.
Medical-grade herbal products
NDARC stated that the second form of cannabis for medicinal use is
herbal cannabis that is produced and processed in controlled and standardised
conditions, and as such is described as 'medical-grade herbal cannabis':
This means that its cultivation has to be standardised to
produce stable levels of cannabinoids (THC and CBD), and the product has to be
free of any harmful adulterants. The Dutch licensed grower "Bedrocan"
provides an example of this type of process.
Illicit or unrefined herbal
In addition to pharmaceutical preparations and medical-grade herbal
cannabis, the final grade of product is regular herbal cannabis, available
through the illicit market:
[This cannabis] has an unknown and potentially unstable
content of THC, CBD, and of other active constituents is a third option. It may
have adulterants and moulds as a result of improper air circulation and drying,
heavy metals taken up from the soil and air, and pesticides or other chemical
residues from pest protection and fertilisation.
Types of medicinal cannabis
products and routes of administration
Submitters to the inquiry noted that, other than smoking cannabis,
medicinal cannabis preparations come in a variety of forms, including:
oral administration of pills (for pharmaceutical preparations);
tinctures and ointments;
ingestion of oils derived from cannabis plants; and
vaporisation of the herbal product.
Difficulties associated with using
cannabis as medicine
Submitters and witnesses noted several difficulties associated with
using cannabis as a medicinal treatment, namely that: as a plant-based remedy,
cannabis does not readily fit into the pharmaceutical model of medication that
is predominant in Australia; and the proven harms associated with cannabis
usage is an additional complication when assessing its potential therapeutic
Emeritus Professor Mather noted that the composition of cannabis makes
it more complicated to use in medical contexts:
Apart from its regulation according to international treaties
and consequent Australian laws, the most serious complication affecting the use
of cannabis as medicine lies in its composition, or rather the uncertainty in
its composition. Unless selectively modified, cannabis is a variable mixture of
natural products, and not a single substance for which purity and strength can
be ascertained or be regulated by the operation of the Therapeutic Goods
Harms associated with cannabis use
Submitters and witnesses to the inquiry noted that cannabis is a
substance that can cause significant harm, and that examinations of the
medicinal uses of cannabis products must be viewed in this light. Emeritus
Professor Penington identified that cannabis with high THC content has been
clearly linked to the precipitation of psychotic symptoms, and that further,
cannabis use has been shown to have a negative effect on brain development in
users aged between 15 and 25 years.
The Royal Australian & New Zealand College of Psychiatrists stated
that caution must be exercised in relation to medicinal cannabis, as cannabis
'is a substance that may cause significant psychiatric morbidity and can alter
the trajectory of an individual's mental illness for the worse'.
Submitters noted that the act of smoking the cannabis plant poses clear
health risks, and may be a risk factor in the development of respiratory
diseases and some cancers.
Associate Professor Lintzeris noted that the issues of medical
substances also being harmful in some circumstances is not unique to cannabis:
Cannabinoids are like any other drug: used well, used
correctly, they can have some therapeutic benefits; used poorly, used
incorrectly, they are associated with harms. Cannabis is not unique in that.
Most of our medications, even penicillin—if you give it to the wrong person,
people die from adverse reactions to penicillin. So this is not an unusual
balance that governments and regulators need to get right.
Effects on other public health
Professor Allison Ritter from the NDARC informed the committee
that comparisons between states in the US with and without medicinal
cannabis laws showed emerging trends in terms of corollary effects on other
public health issues. These include a lowering of alcohol consumption and a
significant reduction in opioid overdose fatalities in states where medicinal
cannabis was available.
Emeritus Professor Mather also commented on the issue of a
reduction in opiate overdoses in these jurisdictions:
One paper suggested that in patients prescribed chronic doses
of opioids for persistent conditions such as chronic pain there was in the
order of 25 per cent fewer opioid related deaths in jurisdictions where
cannabis was available. I think another paper reported 10 per cent.
Nonetheless, whether it is 10 per cent, 25 per cent or some other percentage,
cannabis is a relatively fail-safe medicine. The nonsteroidals that might be
used in those patients can cause kidney damage and liver damage. The opioids
that might be used can stop breathing and cause death that way. Cannabis is not
known to cause fatalities.
Popular support for the use of
cannabis for medicinal purposes in Australia
The Australian Institute of Health and Welfare noted in its submission
that data from the 2013 National Drug Strategy Household Survey shows
widespread support for the use of medicinal cannabis in Australia, including:
75 per cent of people aged 14 or over would support a clinical
trial of cannabis to treat medical conditions; and
69 per cent of people would also support a change to the
legislation permitting the use of cannabis for medicinal purposes.
NDARC noted in its submission that this level of support in Australia
has been consistent for over a decade.
Existing regulation of cannabis products in Australia
At the present time cannabis and cannabis products are regulated in
Australia through a combination of Commonwealth and state-based legislation.
Australia's obligations under international narcotics treaties also impact on the
control of cannabis in Australia.
International obligations in
relation to cannabis plants and cannabis products
Australia is a party to three international agreements which impact on
the regulation of cannabis for medicinal purposes, namely:
the Single Convention on Narcotic Drugs (1961) (the Single
Convention), which specifies the obligations of signatory states for narcotic
drugs listed in schedules annexed to the Convention (including cannabis);
the Convention on Psychotropic Substances (1971); and
the United Nations Convention Against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances (1988), which aims to promote
cooperation between parties to address various aspects of illicit traffic in
narcotic drugs and psychotropic substances.
The Department of Health noted in its submission that the Commonwealth
is responsible for the implementation of Australia's treaty obligations:
The Commonwealth is responsible for the implementation of
international agreements that it enters into and generally has the power to
make legislation to implement Australia's treaty obligations. Accordingly, the
Commonwealth is responsible for ensuring that any Commonwealth, State or
Territory medicinal cannabis scheme is consistent with Australia's treaty
obligations under the three drug control conventions[.]
Relevant obligations under the
Under Article 30 of the Single Convention, controls on the production of
opium poppy contained in Article 23 of that convention also apply to any
permitted cultivation of cannabis plants. Under Article 23, State Parties must
establish and maintain a government agency with responsibilities to:
designate the areas in which cultivation is permitted;
grant licenses for cultivation;
purchase and take physical possession of crops produced by
hold the exclusive right of importing, exporting, wholesale
trading and maintaining stocks other than those held by manufacturers, of
medicinal cannabis or cannabis preparations.
Article 28 of the Single Convention requires State Parties to adopt such
measures as may be necessary to prevent the misuse of, and illicit traffic in,
the leaves of the cannabis plant.
Under Paragraph 3 of Article 29 and paragraph 2(a) of Article 30 of the
Single Convention, Australia is required to prevent the accumulation, in the
possession of drug manufacturers, traders, distributors, state enterprises or
duly authorised persons, of quantities of drugs in excess of those required for
the normal conduct of business having regard to the prevailing conditions.
Commonwealth legislation governing
A number of Commonwealth laws impact on the cultivation, production and
usage of cannabis and cannabis products in Australia, as follows:
the availability of cannabis as a therapeutic substance is
regulated under the Therapeutic Goods Act 1989 (TG Act);
the manufacture of narcotic drugs including cannabis is
controlled under the Narcotic Drugs Act 1967 (Narcotic Drugs Act);
the import and export of cannabis into and out of Australia is
regulated under the Customs Act 1901 (Customs Act) and the Customs
(Prohibited Imports) Regulations 1956 and Customs (Prohibited Exports)
Regulations 1958 (Customs Regulations); and
offences relating to the cultivation, import and export,
possession of controlled plants and drugs (including cannabis) are found in the
Crimes (Traffic in Narcotic Drugs and Psychotropic Substances) Act 1990
as well as Part 9.1 of the Criminal Code Act 1995 (Criminal Code).
Authorised cultivation and
production under the Narcotic Drugs Act
The Department of Health provided a synopsis of the Narcotic Drugs Act
in its submission:
The Narcotic Drugs Act 1967 (ND Act) regulates the manufacture
of all narcotic drugs under the requirements of the Single Convention through a
similar licence and permit regime. The ND Act provides a mechanism to ensure
the manufacture of all narcotics is in accordance with global licit demand, and
to enable Australia to meet its set reporting obligations. A licence and permit
to manufacture may be granted if a prospective manufacturer is able to provide
the required information on the quantity of narcotic material to be
manufactured and the premises on which it is being manufactured, to a delegate
of the Minister for Health. The current manufacturing licensing and permit
regime takes into consideration the State legislative framework in relation to
the manufacture of narcotic drugs from opium poppy straws.
Officials from the TGA and the Department of Health confirmed that, in
relation to the cultivation of poppy straw in Australia for manufacture into
medicinal products, state legislation governs the cultivation of poppy straw,
while both the TGA and state governments play interrelated roles in relation to
the manufacture of poppy straw into final products.
It was also noted that the Commonwealth and state and territory
governments are currently in the process of negotiating a new national
agreement in relation to the cultivation of opium poppies in Australia.
Commonwealth restrictions on the
importing and exporting of cannabis
The import and export of cannabis into and out of Australia is regulated
under the Customs Act and Customs Regulations.
Under section 51A of the Customs Act, 'border controlled' drugs and
plants (including cannabis) are taken to be prohibited imports. A system of
licences and permissions in relation to the importation of prohibited goods is
established under the Customs Regulations. The Department of Health
[A] person wishing to import a drug must apply in writing for
both a licence and a permit from the Secretary of the Department of Health.
Cannabis is included in Schedule 4 of the Customs [Regulations], which includes
drugs in Schedules I and II of the Single Convention (as well as those with
additional controls in Schedule IV). Permits for import of Schedule 4 drugs
must specify the quantity of the drug planned for import in order to estimate
the total amount of that drug authorised for import into Australia that year.
The amount approved for import is reported annually by the Department of Health
to the [International Narcotics Control Board].
Scheduling of cannabis and cannabis
products under the TG Act
The TG Act provides for a national system of controls relating to
therapeutic goods in Australia. Additionally, it provides a framework for the states
and territories to adopt a uniform approach to control the availability and
accessibility, and ensure the safe handling, of poisons in Australia.
The TG Act requires that therapeutic goods that are intended to be
supplied in Australia (whether produced in Australia or elsewhere), exported
from Australia, and imported into Australia, be entered in the Australian
Register of Therapeutic Goods (ARTG) (unless the goods are exempt from that
requirement or are otherwise approved or authorised under other provisions of
the TG Act).
Therapeutic goods (include medicines) are goods that generally are
presented, or for any other reason are likely to be taken for therapeutic use.
The definition of 'therapeutic use' under the TG Act includes use in or in
connection with preventing, diagnosing, curing or alleviating a disease,
ailment, defect or injury in persons, and influencing, inhibiting, or modifying
a physiological process in persons.
In addition to the ARTG, the TG Act also provides for the creation and
maintenance of a Poisons Standard, under which substances are classified into
schedules according to their assessed purpose of use, toxicity, safety in use
and potential for abuse. The scheduling classification sets the level of
control on the availability of poisons, which is then implemented through
relevant state and territory legislation.
Cannabis is currently listed as a Schedule 9 Prohibited Substance under
the Poisons Schedule.
Schedule 9 substances are those assessed as substances which may be abused or
misused, the manufacture, possession, sale or use of which 'should be prohibited by law except when
required for medical or scientific research, or for analytical, teaching or
training purposes with approval of Commonwealth and/or State or Territory
An exception to this scheduling is made for processed hemp fibre containing 0.1
per cent or less THC content.
Dr Lisa Studdert of the Markets Authorisation Group at the TGA,
explained in evidence to the committee the general process for applying to have
a product listed through the TGA:
[A] company would invest in the development of a dossier for
registration purposes. That would involve clinical trial data—usually phase 1,
2 and 3—other evidence around the pharmacokinetics, the toxicology and a range
of other chemical and ingredient-related information that would make up a
complete dossier. That is submitted to the TGA. The costs for an application
for a new chemical entity are around $250,000. The process is then undertaken
at TGA to review that, and that involves a range of evaluators reflecting the
nature of the data—clinical delegates, toxicologists, pharmacologists, other
experts as needed and appropriate to the particular application. The time for
reviewing that application varies but our statutory requirement is to do that
within 255 working days—around a year.
Dr Studdert continued:
Through that process there are interactions with the company,
that we refer to as the "sponsor"; it is not always a commercial
company, and that would be in response to specific questions the evaluators may
have around the data. So it is an iterative process, it is intensive, and it is
pretty standard around the world that regulators have a process similar to
that. We have an advisory committee on prescription medicines that will review
many applications and provide advice to the delegate in response to specific
questions. That comes close to the end of the process and then the delegate
makes a decision. If that is a positive decision within a few weeks it is
entered onto the Australian Register of Therapeutic Goods.
Listing of nabiximols and current
clinical trials of Sativex®
One cannabis-derived product, nabiximols, is currently listed as a
Schedule 8 Controlled Drug under the Poisons Standard.
This product is an oral mucosal spray marketed under the brand name Sativex®, and
was registered in Australia for symptom improvement in patients with moderate
to severe spasticity due to multiple sclerosis.
Palliative Care Australia noted that phase three clinical trials into
the use of Sativex for pain relief in cancer patients, involving 300 patients
in Australia and a number of other countries, are currently in progress.
Associate Professor Lintzeris informed the committee that clinical trials
into the effectiveness of the nabixomols cannabinoid medication Sativex, have been ongoing in
Australia since 2012, with funding assistance from the National Health and
Medical Research Council.
Professor Wayne Hall of the University of Queensland noted in relation
to the use of Sativex to assist Multiple Sclerosis patients:
The evidence on Sativex has not convinced regulatory
authorities in Australia to support its medical use in MS. [In 2013 the] TGA
only approved Sativex in MS patients who failed to respond to other treatments
and who showed a clinical response within 2 weeks of initiating treatment. The
Australian Pharmaceutical Benefits Advisory Committee (PBAC) decided against
publicly subsidising Sativex for MS patients. It concluded that the modest
clinical benefits and serious adverse side effects did not justify taxpayers
paying the manufacturer's asking price.
State and territory regulation
Enforcement of drug laws in Australia occurs through individual states
and territories, and legislation in each Australian jurisdiction treats 'minor'
cannabis offences differently. Three jurisdictions (the Australian Capital
Territory, South Australia and the Northern Territory) have decriminalised
minor cannabis offences, with possession of limited amounts of cannabis being
subject to civil fines rather than criminal penalties. In the other states,
diversion programs are generally offered for first-time offenders before
criminal sanctions are imposed. A summary of the treatment of cannabis
possession under state and territory laws in Australia is provided in
Table 2.1 – Treatment
of minor cannabis offences in Australian jurisdictions
Treatment of minor cannabis offences
The ACT introduced a civil penalty system for the possession
of 'small amounts' of cannabis in 1993. If someone is caught with up to two
non-hydroponic cannabis plants, or up to 25 grams of marijuana (cannabis
plant material), they receive a $100 fine with 60 days to expiate (pay the
fine) instead of a criminal charge. Instead of paying the fine, the person
may choose to attend a drug assessment and treatment program.
In 1987, South Australia was the first state to decriminalise
minor cannabis offences. The possession of up to 100 grams of marijuana, 20
grams of hash, one non-hydroponic plant or cannabis smoking equipment leads
to a fine from $50 to $150 with 60 days to expiate.
Since 1996, adults found in possession of up to 50 grams of
marijuana, one gram of hash oil, 10 grams of hash or cannabis seed, or two
non-hydroponic plants can be fined $200 with 28 days to expiate rather than
face a criminal charge.
New South Wales
If someone is caught with up to 15 grams of cannabis, they
may receive a 'caution' from the police officer, which includes information
about the harms associated with cannabis use and a number to call for
drug-related information or referral. Only two cautions are allowed to be
given to the same person before criminal charges are laid.
A police officer may give someone a caution and offer them
the opportunity to attend a cannabis education program if they are caught
with no more than 50 grams of cannabis. Like NSW, only two cautions are
allowed to be given to the one person.
Someone found in the possession of up to 50 grams of cannabis
can be given a caution up to three times in ten years. For the first caution,
information and referral is provided. A brief intervention is given with the
second caution. On the third and final caution, the offender must be assessed
for drug dependence and attend either a brief intervention or treatment
Police officers in Queensland offer someone the option of
diversion, rather than prosecution, if they are found in possession of up to
50 grams of cannabis. The diversion includes a mandatory assessment and
brief intervention program. Only one offer of diversion is allowed per person.
Individuals in possession of not more than 10 grams of
harvested cannabis and/or a used smoking implement who have no prior cannabis
offences will be required to attend a Cannabis Intervention Session within 28
days or receive a cannabis conviction for the offence. All cannabis
cultivation offences will attract a criminal conviction.
State and territory initiatives relating to medicinal cannabis
Several jurisdictions in Australia have announced initiatives relating
to medicinal cannabis that are currently in progress or scheduled to commence
in the near future.
Council of Australian Governments
agreement on medicinal cannabis
At a meeting of the Council of Australian Governments (COAG) Health
Council on 10 October 2014, Commonwealth, state and territory health ministers
discussed the issue of medicinal cannabis and 'agreed to work collaboratively
to share knowledge and information on issues relating to the use of appropriate
therapeutic products derived from cannabis for medicinal purposes'.
New South Wales Terminal Illness
The NSW government announced in September 2014 that it was issuing new
guidelines for NSW police that would enable officers to exercise discretion not
to charge terminally ill adults who use cannabis to alleviate their symptoms,
or their carers.
Under the Terminal Illness Cannabis Scheme, NSW residents over the age
of 18 who have a terminal illness (as certified by a medical practitioner
involved in their ongoing care) may apply to be registered for the scheme, and
may additionally nominate up to three individuals to be registered as carers.
Registered individuals may then possess and administer cannabis leaf, oil and
resin, up to specified maximum amounts, without being cautioned or charged by
Professor Ritter, Director of the Drug Policy Modelling Program at
the NDARC, stated that, as at the end of March 2015, around 20
individuals had been granted exemptions under this scheme.
New South Wales clinical trials for
the medical use of cannabis
Also in September 2014, the NSW government announced that it would be
initiating clinical trials for medical cannabis in NSW for patients suffering
from debilitating or terminal illness.
These trials were to be undertaken with up to $9 million in funding
provided over five years by the NSW government.
In December 2014 it was announced that a clinical trial of cannabis
derived products would be established for children with severe, drug-resistant
epilepsy, through a partnership with the Sydney Children's Hospitals Network.
It is expected that this trial will start enrolling patients in 2016, with
results available 'within two to five years'.
It was also announced that two further trials are being investigated,
with NSW Health stating that it will 'work with the research community to
assess interest in proceeding with trials' in the areas of:
adults with terminal illness, focusing on improving quality of
life, and symptoms such as pain, nausea and vomiting; and
adults with chemotherapy-induced nausea and vomiting, where
standard treatment is ineffective.
In April 2015, it was announced that the Queensland and Victorian state
governments had agreed to take part in the clinical trials being conducted in NSW,
allowing patients from those states to apply to be part of the upcoming trials.
Victorian Government commitment to
legalising medicinal cannabis
In December 2014, the Victorian Government announced its intention to
legalise medical cannabis for individuals with terminal illnesses or
and referred the matter of options for implementing this proposed reform to the Victorian
Law Reform Commission (VLRC).
The VLRC published an issues paper on medicinal cannabis on 17 March 2015,
stating that the two primary lines of inquiry being pursued by the VLRC were:
how to define the exceptional circumstances in which a person
should be allowed to be treated with medicinal cannabis; and
how the law could be amended to enable an authorised person to
receive the treatment they need while continuing to prevent unauthorised access
in other circumstances by other persons.
The VLRC issues paper came to the conclusion that:
A comprehensive medicinal cannabis scheme could be introduced
in Victoria, although it would rely on collaboration with the Commonwealth,
which has a broad role in regulating the importation, manufacture and
distribution of pharmaceutical goods in Australia. A more limited scheme could
be introduced by Victoria acting alone.
Community consultations relating to the issues paper were scheduled to
continue until the end of May 2015, with the VLRC scheduled to produce a final
report to the Victorian Government by the end of August 2015.
Regulatory approaches to medical cannabis in international jurisdictions
The VLRC's Medicinal Cannabis: Issues Paper (issues paper) notes
that a number of jurisdictions permit the use of cannabis for medicinal
purposes in some form, including Canada, the Czech Republic, Finland, Germany,
Israel, Italy, the Netherlands and 23 states of the United States of America
(US). The issues paper states that:
A further 12 US states...permit use of low-THC, high-CBD
cannabis, in some cases for research and trials only...In addition, Uruguay and
the US states of Alaska, Colorado, Oregon and Washington have legalised
cannabis for recreational use.
The issues paper provides a comprehensive analysis of the means employed
by different jurisdictions to regulate the use, manufacture and distribution of
cannabis products, making particular reference to the nature and form of
authorised cannabis products, the class of person who can legally access
cannabis products and the role of health practitioners in accessing cannabis
NDARC explained that the legislative basis for the availability of
medicinal cannabis in international jurisdictions:
...ranges from simple removal of criminal sanctions for
patients whose medical doctor has recommended the use of cannabis, to
state-level provisions of medicinal-grade herbal cannabis or pharmaceutical
preparations obtained by the patient from a pharmacy with a doctor´s prescription...[The]
variety of approaches offer different advantages and limitations in terms of treatment
availability, product quality and its adherence to medicinal product standards,
as well as in their overlap with the recreational market, and adherence to the
international treaties...They also differ in the range of supply options.
NDARC identified two scales, the form of patient authorisation and the
source of supply, which it used to examine the available regulatory options for
A table providing an overview of the pros and cons of currently deployed modes
of patient access and supply of medicinal cannabis across the globe as
submitted by NDARC is included at Appendix 3 to this report.
To better understand the range of international models currently used,
examples are briefly discussed below of legislative models where supply is less
regulated (California), where supply is more regulated (Washington) and where
supply is highly regulated (the Netherlands).
The Californian approach
In 1996, California voters passed Proposition 215, the Compassionate
Use Act of 1996, making it the first US state to allow for the medical use
Proposition 215 was supported by Senate Bill 420 which amended the Health and
Safety Code of California to require the California Department of Public Health
to oversee the creation of the medical marijuana program (MMP).
The MMP adopted a medical marijuana identification card (MMIC) to give
registered patients and caregivers access to a card, valid for one year, that
provides the holder with immunity from prosecution for possession of up to 8
ounces (approximately 228 grams) of dried marijuana and up to 6 mature or 12
immature marijuana plants.
Where a patient has been diagnosed as suffering from a prescribed serious
medical condition, he or she may approach his or her medical practitioner for a
recommendation. The diagnosis and the recommendation that the use of medical
marijuana would be appropriate for the patient must be documented in the
patient's medical records.
The patient may then enrol in the MMP at the county (local government) level by
providing a copy of the recommendation, proof of identity and residency, and by
paying the requisite fees.
A patient may also apply for a supplementary card for a primary caregiver, that
is, a person who is consistently responsible for the housing, health, or safety
of a qualified patient.
A minor (under 18 years of age) may apply as a patient or caregiver
under certain conditions. Minors may apply for themselves as qualified patients
if they are lawfully emancipated or have declared self-sufficiency status. If a
minor has not declared self‑sufficient status or is not emancipated, the relevant
local government must contact the minor's parent, legal guardian, or person
with legal authority to make medical decisions for the minor.
The Californian MMP is not authorised to provide information on the type
of marijuana that should be used, nor the means of acquiring the dried
marijuana, seeds or plants. It follows that the supply of the product is not
In 2010 Californian voters rejected Proposition 19, which would have
legalised various marijuana-related activities and allowed local governments to
regulate and tax these activities.
As at May 2015, three competing Bills were being considered by the Californian
legislature, two in the assembly and one in the senate, each attempting to create
a framework that would codify how medical marijuana is grown and sold in
The State of Washington approach
In 1998, the voters of the State of Washington approved Initiative
Measure No. 692, which changed public policy to permit the medical use of
marijuana. Since 1998, the concept of medicinal use of marijuana has been
clarified to better protect the welfare of patients, ensuring that they had
access to a safe, consistent and adequate source of marijuana. However,
although permitted possession amounts were defined by legislation, the
legislation did not provide protection from arrest. The legislation only
provided a patient with a defence at trial.
In 2012, voters passed Initiative Measure No. 502 which also resulted in
Chapter 314–55 of the Washington Administrative Code on marijuana licensing of
coming into effect. The initiative allows for the possession and use of
marijuana for recreational purposes. The recreational scheme runs parallel to
the medicinal marijuana scheme. The initiative decriminalises possession of
marijuana by a person of 21 years or older, up to the prescribed amounts 
and permits the sale of marijuana to individuals over the age of 21. An
individual may possess up to 1 ounce (28.5 grams) of dried marijuana, 16 ounces
(approximately 456 grams) of marijuana-infused product in solid form or 72
ounces (approximately 2.13 litres) of marijuana-infused product in liquid form.
The initiative only allows for private use of marijuana, making it unlawful to
open a package containing marijuana or consume the drug in view of the general
The regulatory scheme is administered by the state Liquor and Cannabis Board
(formerly the Liquor Control Board) and provides for strict regulation of the production,
processing, and distribution of marijuana. Under the initiative, marijuana is traceable
from seed to sale and may only be sold or grown under license. Marijuana must also
be tested for impurities and purchasers of marijuana must be informed of the
THC level in the marijuana.
In October 2013, the then Liquor Control Board adopted detailed rules
for implementing Initiative 502. These rules describe the marijuana license
qualifications and application process, application fees, marijuana packaging
and labelling restrictions, recordkeeping and security requirements for
marijuana facilities, and reasonable time, place, and manner advertising
restrictions. Under the rules, Washington State imposes an excise tax of 25% of
the selling price on each licenced marijuana sale, taxing each point of the
sales process: from producer to processor, from processor to retailer, and from
retailer to consumer.
On 24 April 2015, the Medical Marijuana Regulation, Second Substitute
Senate Bill 5052, Chapter 70 of 2015 (Cannabis Patient Protection Act 2015
or CPPA) was made law.
The CPPA was intended to shift the regulation of medicinal cannabis to fall
under the same regulations developed under Initiative Measure No. 502,
regulating the recreational cannabis market. The CPPA was also designed to ensure
that patients retain their ability to grow their own marijuana for their own
medical use and that patients have the ability to possess more
marijuana-infused products, useable marijuana, and marijuana concentrates than
what is available to a non-medical user. It further allows for medical‑specific
regulations to be adopted as needed, after consultation with the departments of
health and agriculture, so that safe handling practices and testing standards
for medical products meet or exceed those standards in use in the recreational
The Dutch approach
In the Netherlands, the production of medicinal cannabis is overseen by
the Bureau voor Medicinale Cannabis (the Office for Medicinal Cannabis
or OMC), which supervises both growers and distributors and guarantees the
quality of medicinal cannabis products sold in the Netherlands. The OMC also
has a monopoly on the import and/or export of medicinal cannabis and its
Cannabis is cultivated in the Netherlands by a single, state-licenced
supplier, Bedrocan BV, a limited liability company. Cultivation is strictly
controlled ensuring a highly standardised product with a consistent genetic profile.
To be sold in the Netherlands, medicinal cannabis must meet certain quality
criteria and must not contain any pesticides, heavy metals, fungi or bacteria.
To ensure quality control, an independent company contracted by the government
tests each batch of cannabis and provides a certificate of analysis, which is
made available for inspection by patients and doctors.
The OMC allows for selected varieties of cannabis to be purchased on
prescription through Dutch pharmacies, each with a different composition and
strength to best target the symptoms of the individual patient. Although the
method of administering the medicinal cannabis is not regulated, it is
recommended that the patient avoid smoking the medicinal cannabis, but instead
employ methods such as drinking a tea made from the cannabis or inhaling the
product through an inhaler.
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