Chapter 2: Cannabis regulation in Australia

This chapter provides background information on the medicinal cannabis scheme that was introduced in 2016 into the ND Act. Six topics are covered:

• the elements of the cannabis plant, to inform an understanding of the elements regulated by the ND Act and those regulated, for example, by State and Territory industrial hemp laws
• examples of Australian laws that prohibit or regulate activities involving cannabis, with a focus on laws enacted prior to the commencement of the medicinal cannabis scheme in 2016
• Australian developments leading up to the creation of a medicinal cannabis scheme in 2016, and the main features of the new scheme
• the implementation and administration of the scheme within the department, and the role of the ODC within the department
• the pathways in the TG Act by which Australian patients can obtain access to medicinal cannabis products
• scheduling of controlled substances in Australian statutes.

The last two of those topics (patient access and scheduling) are not part of this Review. They are, however, an important adjunct to an objective of the ND Act of facilitating the supply of medicinal cannabis products to patients in Australia through authorised prescriber mechanisms. They will be noted in that context.

The cannabis plant [7] is an annual flowering plant that contains various components - roots, stem, leaves, flowering (or fruiting) tops and seeds. Resin can be extracted from the plant, principally from the flowers and adjacent leaves but also from other leaves and the stem.

The plant contains over 500 compounds (cannabinoids), including 120 phytocannabinoids. The two most important naturally occurring cannabinoids that have medicinal qualities are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is a psychotropic substance (or intoxicant); CBD is non-psychoactive.

THC and CBD are both derived from the flowering tops and resin of the plant. The cannabinoid concentration can vary across varieties or strains of the plant, with higher concentrations in the resin. Different concentrations of compounds can have different therapeutic benefits and psychoactive effects. The dried stem, leaves and seeds of the cannabis plant are almost devoid of psychoactive cannabinoids.

The cannabis flowering tops and resin can be administered in different ways, that include smoking or as a pharmaceutical or herbal preparation. Pharmaceutical preparations are mostly administered orally as capsules, tablets, and extracts or tinctures, but can be administered as a spray, ointment or by vaporisation.

Hemp is a cannabis plant that is bred to contain low (or zero) concentration of THC - that is, a cultivar, or specially cultivated plant. A hemp extract may have little or no psychoactive effect; a higher concentration of CBD in the plant may inhibit or counteract the psychoactive effects of THC. It is generally grown for industrial and horticultural uses. For example, the leaves and stem can be used as fibre, rope, fabric, insulation, and as a component of paper, fibreboard, plastic and compost; and the seeds can be used as a food ingredient, nutritional supplement or cosmetic.

Laws that regulate industrial hemp (also called low-THC hemp/cannabis) define the maximum THC content of the plant. A standard in many State and Territory laws in Australia is that the concentration of THC in the leaves and flowering heads must be no more than 1%[8], though the level is set lower in Victoria at 0.35%.[9]

Research is being conducted (increasingly) in Australia and internationally on the therapeutic benefits of cannabinoid medications. Some of the research is government sponsored. There was acceptance in Australia in adopting a medicinal cannabis scheme in 2016, that a case had been established for cannabis to be more readily available to Australian patients, potentially including those with conditions such as terminal cancer, multiple sclerosis, epileptic seizures, chemotherapy-induced nausea control and chronic pain management. Support has been expressed for research and clinical trials to be conducted on the therapeutic benefits for other conditions for which there is limited or no clinical evidence, such as depression, Alzheimer's disease, AIDS/HIV and post-traumatic stress disorder.

To explain the broader setting in which the medicinal cannabis scheme operates, this section gives examples of Australian laws that either prohibit or regulate activities involving cannabis. The laws referred to were mostly enacted prior to the creation of the Commonwealth scheme in 2016. The term 'cannabis' will be used, though many of the laws provide more specific definitions of the derivatives of the cannabis plant or the composition of the drug to which the law applies.

These examples of Australian laws are arranged in four groups that are broad generalisations - many laws fit in more than one group. The approach adopted in each Australian jurisdiction is that cannabis is treated as an illegal narcotic unless an activity such as possession, cultivation, manufacture or supply is authorised by another law.

The first group of laws to note are those that treat cannabis as an illegal narcotic or illicit substance. Following are some examples:[10]

• Criminal Code Act 1995 (Cth): Cannabis is in a scheduled list of 'Controlled drugs' and 'Controlled plants'.[11] The Criminal Code Act 1995 (Cth) contains many separate offences that make it illegal to traffic, import, export, manufacture, cultivate or possess a controlled drug or plant, unless justified or excused under another law.[12]
• Crimes (Traffic in Narcotics and Psychotropic Substances) Act 1990 (Cth): Cannabis is in a scheduled list of 'Narcotic Drugs'.[13] It is an offence under the Crimes (Traffic in Narcotics and Psychotropic Substances) Act 1990 (Cth) to deal in one of those drugs on board an Australian aircraft or ship or in another country that has similar laws to Australia.
• Drug Misuse and Trafficking Act 1985 (NSW): This Act prohibits the cultivation, manufacture, supply, possession and use of various drugs including cannabis.
• Criminal Code 2002 (ACT): The focus of the offence provisions of this Act is upon 'Serious Drug Offences', such as cultivation and manufacture of commercial quantities of controlled drugs (including cannabis), drug trafficking and selling drugs to children.
• Transport Operations (Road Use Management) Act 1995 (Qld): It is an offence under this Act to drive a motor vehicle while under the influence of a drug (such as cannabis) or while a drug is present in blood or saliva.[14]

A qualification on those examples is that the penalty attached to a specific offence will generally vary according to the quantity of drug involved. A common example is that simple possession of a small quantity of cannabis may attract either a warning, referral to a diversion or drug treatment program, or a low fine or penalty notice that if paid does not result in a recorded conviction.

The next group to note are the Australian laws that regulate supply or access to cannabis as a therapeutic medicine. Some examples:

• Therapeutic Goods Act 1989 (Cth): This Act imposes controls on the quality, safety and efficacy of therapeutic substances that are used in or exported from Australia. Two important elements of the Act are the ARTG which is a register of 'approved' medicines that can be supplied in Australia; and the Poisons Standard[15] which classifies drugs and poisons in schedules, as recommendations for adoption by States and Territories. One cannabis product is registered in the ARTG; cannabis is listed in Schedule 8 of the Poisons Standard as a 'Controlled Drug'; and cannabidiol is listed in Schedule 4 of the Standard as a 'Prescription Only Medicine'.
• Customs Act 1901 (Cth): Cannabis is listed in both the Customs (Prohibited Imports) Regulations 1956 and the Customs (Prohibited Exports) Regulations 1958 as a drug that cannot be imported to or exported from Australia without a licence and permit under those Regulations.[16]
• Drugs, Poison and Controlled Substances Act 1981 (Vic): This Act establishes a comprehensive framework applying to medicines and poisons, in line with the Schedules in the Poisons Standard. Activities that are controlled include possession, manufacture, storage, supply, labelling, packaging, medical prescription and pharmacy dispensing.
• Controlled Substances Act 1984 (SA): This Act is a public health and safety Act that applies to medicines, poisons and prohibited substances (including cannabis) that are used in health care, industry, agriculture or in the home, and the Act controls activities such as manufacture, sale, supply and possession.

A third group of laws comprises the Acts in two States that aimed to establish a comprehensive framework for regulating the supply of medicinal cannabis to patients. Both Acts were enacted prior to the establishment of the Commonwealth medicinal cannabis scheme in 2016, but neither Act was implemented following the Commonwealth development:

• Access to Medicinal Cannabis Act 2016 (Vic): The Act was designed to enable Victorian patients to access medicinal cannabis in exceptional circumstances. Allied provisions in the Act dealt with cultivation and manufacture of medicinal cannabis products, research and supply. The Victorian Government announced in 2018 that it would not implement a stand-alone regulatory scheme following Commonwealth action to licence cultivation and manufacture.[17] It is understood that the Victorian Act may be repealed.
• Public Health (Medicinal Cannabis) Act 2016 (Qld): This was an analogous Act to the Victorian Act and laid down a comprehensive framework describing eligible prescribers, patients and medicinal cannabis products. The Queensland Act was repealed from 1 July 2019[18], to be replaced by a new scheme under the Medicines and Poisons Bill 2019 (Qld). The Bill is intended to make it easier for patients and doctors to access medicinal cannabis, including prescription of medicinal cannabis by non-specialist medical practitioners.[19]

A fourth group of laws are those relating to industrial hemp:

• Industrial Hemp Act 2015 (Tas): A licence can be granted under this Act to authorise cultivation, supply, manufacture or research involving industrial hemp for non-therapeutic purposes. This can include use in textiles, paper and building materials (for hemp fibre and pulp) and cosmetics and food (for hemp seed and oil). Industrial hemp is classified under the Act as cannabis that contains less than 1% THC.
• Acts in other jurisdictions that deal exclusively with industrial hemp are the Hemp Industry Act 2008 (NSW), Industrial Hemp Act 2017 (SA), Industrial Hemp Act 2004 (WA) and Hemp Fibre Industry Facilitation Act 2004 (ACT).[20]

One other important framework item to note is the National Drug Strategy 2017-2026. This is endorsed by the Ministerial Drug and Alcohol Forum. The Strategy lays down a national framework to minimise the harm associated with drug use, including both illicit and pharmaceutical drugs. Cannabis is listed as a priority substance in the Strategy.

Access to cannabis products for therapeutic or medicinal purposes was possible prior to 2016, principally under the pathways in the TG Act (discussed below). The first approval granted through the Special Access Scheme (SAS) to import a medicinal cannabis product occurred as early as 1992. Cannabidiol was also re-classified by the TGA in the Poisons Standard in July 2015 from being a Schedule 9 'prohibited substance' to a Schedule 4 'prescription medicine'.

From 2016 onwards there was also the prospect of expanded access to medicinal cannabis products in Victoria and Queensland under new State Acts that year.[21] Related developments in some States were that penalties for possession of cannabis were downgraded or transformed. An example was the Terminal Illness Cannabis Scheme established in New South Wales in 2014 (later renamed the Medicinal Cannabis Compassionate Use Scheme), which enabled New South Wales police to exercise enforcement discretion in relation to the possession and use of cannabis products by certain terminally ill patients.

Prior to 2016 there was growing public discussion in Australia and other countries of proposals to provide easier patient access to cannabis for therapeutic purposes. A report of the Victorian Law Reform Commission in 2015 recommended legislative change to allow people to be treated with medicinal cannabis in exceptional circumstances.[22] The Commission's recommendations were largely accepted in the enactment the following year of the Access to Medicinal Cannabis Act 2016 (Vic).[23]

A legislative proposal introduced into the Australian Parliament in November 2014 by the Australian Greens with cross-party support was the Regulator of Medicinal Cannabis Bill 2014. A report on the Bill by the Senate Legal and Constitutional Affairs Legislation Committee in August 2015 did not recommend support of the Bill as drafted, nor the establishment of a free standing regulatory agency for medicinal cannabis, but expressed support in principle for legislative reform to enable patient access to cannabis products for use in treating particular medical conditions where the use of a product has been proven to be safe and effective.[24] The Senate Committee noted that many of the 261 submissions it received gave detailed individual patient accounts of their experience in using cannabis products (largely sourced illegally) to treat a variety of medical conditions.[25]

The Senate Committee also noted the strong popular support for medicinal use of cannabis that was reported in the Australian Institute of Health and Welfare 2013 National Drug Strategy Household Survey: 75 per cent of people supported clinical trials of cannabis products to treat medical conditions, and 69 per cent supported legislative reform to permit use of cannabis for medicinal purposes. The Senate Committee report summarised the evidence before the Senate Committee that pointed to difficulties posed by existing Australian laws in obtaining cannabinoid medications and conducting clinical research.[26]

A theme in the public debate in Australia at that time was that there was limited clear evidence from clinical trials and scientific research on the medicinal and therapeutic benefits of cannabinoid medications. There was acceptance nevertheless that a case had been established for cannabis to be more readily available to Australian patients, potentially including those with conditions such as terminal cancer, multiple sclerosis, epileptic seizures, chemotherapy-induced nausea control and chronic pain management.[27] There was concern also that the existing obstacles to cannabis supply meant that people may obtain cannabis of unknown composition through the black market without appropriate medical supervision.

The Minister announced on 17 October 2015 that it was the Government's intention to sponsor amendments to the ND Act to enable the cultivation of cannabis for medicinal and scientific purposes, consistently with Australia's international obligations relating to narcotic drugs. The proposed changes were enacted on 29 February 2016 and commenced operation on 29 October 2016.[28]

The lead-up to the 2016 amendments included extensive and targeted consultation with the States and Territories, including through the Intergovernmental Committee on Drugs. The consultation aimed to develop a 'nationally agreed approach' to the development of the new scheme.[29] This was seen to be important to ensure that patient access to cannabis-derived products for medicinal use was consistent around Australia, and that there were no regulatory gaps that could be exploited by organised criminal groups. Support for improved patient access to medicinal cannabis was expressed by professional and support bodies such as the Australian Medical Association, Royal College of Physicians, Multiple Sclerosis Australia, MS Research Australia and Palliative Care Australia.

The key features of the 2016 amendments are explained in later chapters of this report, but in summary:

• Cannabis cultivation and production for medicinal purposes and research would be controlled through a licence and permit system. This would enable the Commonwealth to control the number and types of cannabis plants that would be cultivated and the size of cannabis crops, ensure that licence/permit holders would comply with regulatory requirements, and enable the Commonwealth to meet its reporting obligations under the Single Convention.
• The existing licence and permit system in the ND Act relating to the manufacture of drugs was updated to mirror the new licence and permit system for cultivation and production.
• An applicant for a medicinal cannabis licence/permit must demonstrate that a supply arrangement exists with a licensed manufacturer, and the licensed manufacturer must demonstrate an authorised supply chain to a patient. These requirements would align production and supply with legitimate demand.
• The separate system of research licences and permits would enable expert research into such matters as growing conditions, strain selection and cannabis yields.
• Regulatory objectives relating to the security of cannabis crops, control of cannabis yields and minimisation of criminal risks would be achieved through licensing conditions, monitoring and inspections, regulatory directions and infringement notices, and offence and penalty provisions.
• Internal review and external appeal opportunities would be available to aggrieved applicants and licence holders.
• The ND Act would not override State and Territory laws except to the extent that any such law was inconsistent with the licensing and permit provisions of the ND Act or would prevent a Commonwealth licence holder acting under their ND Act licence or permit. The State/Territory laws that would continue to operate included laws dealing with medicines, industrial hemp, land use, and cannabis possession and supply.

In the Second Reading Speech for the 2016 amendments the Minister described it as a national licensing system to ensure that a safe, legal and sustainable supply of cannabis-derived products would be available to patients - a 'farm to pharmacy' cannabis supply chain.[30] The licensing and permit controls and regulatory requirements were said to strike 'the right balance between patient access, community protection and our international obligations'[31]. It was also a cooperative scheme that relied on the continuing operation of State and Territory legislation on many aspects of patient access and control of criminal risks.

Further changes were made to the ND Act later in 2016.[32] The amendments dealt with matters such as the protection of sensitive law enforcement information when an adverse decision is being reviewed, the grounds for refusal and revocation of licences and permits, and the scope of the regulation making power.

Another relevant legislative change in February 2018 was the amendment of the Customs (Prohibited Exports) Regulations 1958 to permit the export for therapeutic use of certain cannabis products cultivated or manufactured in Australia.[33] A department guidance document explained at the time that the purpose in allowing export was 'to allow for the Australian industry to expand and improve supply of medicinal cannabis within Australia'[34]. The product to be exported must comply with several requirements administered by both the ODC and the TGA, including an ODC assessment that the export would not occur to the detriment of supply to Australian patients.

Office of Drug Control

The ND Act vests functions and powers in the Secretary of the Department of Health (as the Secretary of the Department with portfolio responsibility for administering the National Health Act 1953).[35] The Secretary may delegate any power or function to any person, including (with State or Territory agreement) an officer or employee of a State or Territory agency.[36]

In recognition of the considerable work that would be required to implement and administer the medicinal cannabis scheme, the ODC was established in 2016 within the Department of Health, with two sections. An existing section, the Drug Control Section (DCS), retained its role of regulating the manufacture and import/export of narcotic drugs including cannabis, and fulfilling Australia's reporting obligations under the international drug conventions; and a new section, the Medicinal Cannabis Section (MCS), would regulate cannabis cultivation and production.

The ODC is part of the Health Products Regulation Group in the department. The ODC received additional staff funding from the Australian Government in November 2018 in response to the greater-than expected workload generated by the scheme.

The ODC is broadly responsible for regulating and providing advice to the Australian Government on the import, export and manufacture of controlled drugs to support Australia's obligations under the Single Convention. A specific role of the ODC is to administer the regulatory framework for the cultivation and manufacture of medicinal cannabis in Australia, through licensing and permit decisions and undertaking compliance and enforcement activities. The ODC's responsibilities include monitoring stock levels to ensure that manufactured quantities of medicinal cannabis products are consistent with domestic requirements and export commitments, engaging in cross-jurisdictional liaison to reduce the risk of illegal diversion of cannabis products, and fulfilling Australia's reporting obligations to the INCB.

Since the commencement of the medicinal cannabis scheme the ODC (at 30 June 2019) had received 246 applications for medicinal cannabis, cannabis research and manufacture licences. The ODC had granted 63 licences:

• 24 Medicinal Cannabis Licences - authorising the cultivation and production of cannabis for commercial use as a therapeutic product
• 16 Cannabis Research Licences - authorising the cultivation and production of medicinal cannabis for non-human research purposes
• 23 Manufacture Licences -authorising the manufacture of drugs (including medicinal cannabis products that are drugs) for therapeutic use.

Thirty three permits had been granted to permit cultivation by medicinal cannabis and cannabis research licence holders.

Licence holders can voluntarily elect to have their name published on the ODC website. Twenty licence holders were listed in June 2019.

There are no limits on the number of medicinal cannabis licences and permits that can be granted. The licensing and permit scheme is premised on a market-based approach to licensing. The expectation is that the market will indirectly determine the number of licences and permits that will be current at any time: limited demand for the supply of medicinal cannabis products is expected to cause a decrease in the number of licence and permit applications, and a high market demand may correspondingly cause an increase in applications.

While there is no direct limit on licences or permits, a Party to the Single Convention is required to report each year to the INCB on the quantity of drugs the Party intends to cultivate, manufacture, import and export.[37] A limit is set by the INCB, and it can call on a Party to adopt remedial measures to ensure that the provisions of the Convention are observed.[38]

Other government bodies

Other regulatory and advisory bodies within or supported by the department also play a role in relation to medicinal cannabis.

The TGA is also part of Health Products Regulation Group in the department. The TGA administers the TG Act, which embraces Good Manufacturing Practice (GMP) requirements for narcotics, the ARTG for registered and listed medicines, the Poisons Standard as a scheduling recommendation to the States and Territories, the Special Access Scheme (SAS), the Authorised Prescriber Scheme and the Personal Importation Scheme.

The department provides administrative support to the Australian Advisory Council on the Medicinal Use of Cannabis. The Australian Advisory Council comprises 16 members appointed by the Minister to provide advice to the Minister on the implementation and operation of the medicinal cannabis scheme. The members of the Australian Advisory Council are drawn from the Australian Government, the professions and the community, and have expertise in the fields of cancer, epilepsy, palliative care, toxicology, law, pharmacology, law enforcement and botany. It was envisaged that the Australian Advisory Council would operate for two years until February 2019, but the Minister has extended its term for another two years.

The Medicinal Cannabis Access Working Group, the Cultivation and Production Working Group and the Law Enforcement Working Group are intergovernmental working groups comprising representatives from all Australian governments. These groups share information from each jurisdiction on administrative, policy and legislative changes relevant to their remit.

Commonwealth law provides five main pathways through which a medicinal cannabis product can be lawfully supplied to a patient under the TG Act.[39]

First, any medicine that is included in the ARTG can (in accordance with State or Territory law) be prescribed by a medical practitioner for a patient and dispensed through standard pharmacy procedures. Inclusion in the ARTG is done by the TGA following evaluation of the quality, safety and efficacy of the medicine.[40] A registered medicine that is included in the ARTG can be a subsidised medicine under the Pharmaceutical Benefits Scheme (PBS).

The only product containing cannabinoids that is included in the ARTG is 'SATIVEX® (Nabiximols) (Sativex), It was registered in November 2012. Sativex contains a 1:1 ratio of THC and CBD, extracted from botanical medicinal cannabis. It is an oral spray that is indicated as a treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis. Sativex is not currently a PBS medicine.

Second, a medical practitioner who is an Authorised Prescriber under the TG Act may prescribe a specified medicinal cannabis product for a class of patients in their immediate care for approved indications.[41] The practitioner has to report six monthly to the TGA on the number of patients who are newly prescribed the medicinal cannabis product in the six monthly period and the number of patients continuing on the product.

The prescribed product may be locally manufactured or imported; if the latter, an import permit must be obtained by the importer of the product who may import bulk product that is held for supply.[42]

The conditions to be an Authorised Prescriber are that the medical practitioner is engaged in clinical practice, has the approval of an ethics committee or endorsement from an appropriate specialist college to prescribe the cannabis product, and the product is prescribed for a person suffering a life-threatening or serious illness or condition. At 30 April 2019 there were 57 Authorised Prescribers.

Third, Special Access Scheme Category A (SAS A) is a notification pathway that allows a medical practitioner to access and prescribe a medicinal cannabis product for a patient who is seriously ill.[43] Only a notification to the TGA is required before prescribing the relevant good, and not an application. The main requirement for this access pathway is that the patient is seriously ill, which is defined to mean the patient has a condition from which death is reasonably likely to occur within a matter of months, or premature death is reasonably likely to occur in the absence of early treatment.

A medicinal cannabis product cannot be manufactured domestically for supply directly through the SAS A pathway, as this is not listed in s 11K of the ND Act as a permitted use of a manufactured drug. Consequently, in practice, drugs that can supplied under SAS A are those either imported by a doctor or pharmacy or manufactured in Australia under a GMP licence using cannabis or cannabis extract starting material that has been imported.

Fourth, Special Access Scheme Category B (SAS B) is an application pathway through which a registered health practitioner may apply to the TGA for approval to prescribe a medicinal cannabis product for a patient.[44] The application must outline the patient diagnosis, the clinical justification for use of a product that is not included in the ARTG, and the proposed course of treatment.

Fifth, a person may access medicinal cannabis by participating in a clinical trial approved by an appropriate Human Research Ethics Committee and formally notified to the TGA.[45]

The great majority of medicinal cannabis products supplied to Australian patients through these pathways were imported. The first domestically produced product became available in August/September 2018 and only in small volumes.

Only the first pathway provides access to a registered medicine in the ARTG - that is, a medicine registered in the ARTG after evaluation by the TGA (currently Sativex is the only such medicine). Therapeutic goods, including medicinal cannabis products, that are not included in the ARTG can be accessed through the other four main pathways. The TGA advises that 'it is expected that medical practitioners (prescribers) will have considered all clinically appropriate treatment options that are included in the ARTG before applying to access an unapproved medicinal cannabis product under the SAS'.[46]

All therapeutic goods that are supplied in Australia or imported or exported must conform to applicable standards.[47] The principal standard applying with respect to medicinal cannabis products is Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 (TGO 93).[48] TGO 93 imposes controls to ensure that the quality of the medicinal cannabis and ingredients used in the manufacture is of an acceptable standard and safe for consumers. A medicinal cannabis product manufacturer or supplier is required to declare that the product conforms to TGO 93. This requirement applies also to medicinal cannabis products a medical practitioner may prescribe through the Authorised Prescriber or Special Access Schemes, and in clinical trials. Evaluation of a medicine to be listed in the ARTG looks more rigorously at the quality, safety and efficacy of the product.

There are no definitive figures on the number of patients currently being supplied with medicinal cannabis in Australia through these authorised pathways. The number of patients currently using medicinal cannabis in Australia is not clear, although the following figures are indicative:

• At 31 May 2019, the TGA had approved over 7,700 applications for the supply in Australia of unregistered medicinal cannabis products under SAS B.[49] The large majority of approvals have occurred since 2016. The number of SAS B approvals has risen sharply over the past year: the number of monthly approvals between May 2018 to May 2019 has been 132, 146, 188, 229, 237, 331, 567, 490, 671, 738, 1041, 1110 and 1374. These numbers may include repeat applications for the same patient, as SAS applications contain de-identified information.
• At 17 May 2019, 135 notifications had been made to the TGA under SAS A - an increase from 45 notifications five months earlier in December 2018.
• Over 500 patients have received medicinal cannabis products through the Authorised Prescriber scheme. Hundreds of patients have also been prescribed Sativex.

A final point to note about patient pathways is that access to both the registered and unregistered medicinal cannabis products - the latter including through the Authorised Prescriber and Special Access Schemes - can require approval within the relevant State or Territory. This is to comply with State and Territory drugs and poisons legislation.

The Commonwealth, States and Territories have worked to streamline access to medicinal cannabis products by agreeing to a TGA portal through which a single application can be lodged by a medical practitioner for Commonwealth and State/Territory approval where required. The protocol is that the evaluation of an application will be completed and the applicant notified within two days of all required information being received. Tasmania does not participate in this procedure, requiring separate applications to the Commonwealth and to the Tasmanian Department of Health and Human Services.

A common feature of the legal instruments (laws and conventions) that regulate controlled substances such as narcotic drugs, medicines and poisons is that the instruments list the substances to which they apply in multiple schedules. The level of control of a substance will vary according to the schedule it is in.

Instruments that are discussed in this report that adopt scheduling are the Single Convention, the Poisons Standard, the Customs Import and Export Regulations, and the Criminal Code Act 1995 (Cth). The main point to be noted at this stage is that there are differences between those instruments in Schedule classification/definition and numbering. In part that is because the scheduling in each instrument is set in a different context or for a different purpose. For example, the Single Convention establishes an international framework for narcotic drugs to be available for the relief of pain and suffering, while coordinating international measures against abuse of narcotic drugs; and the Poisons Standard sets a domestic framework for the availability of medicines and drugs.

The Single Convention contains four Schedules and specifies different controls to be applied to the narcotic drugs in each Schedule. Schedule I lists cannabis, cannabis resin and extracts and tinctures of cannabis. Schedule IV lists cannabis and cannabis resin. Higher standards of control apply to Schedule IV drugs. There is further discussion of the Single Convention in Chapter 3.

The Poisons Standard includes (as a schedule) the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). The SUSMP in turn contains Schedules that state the level of control to be exercised over the availability of the medicines and poisons in each Schedule. The Schedules embody the decisions of the Secretary of the Department of Health (or delegates) regarding the classification of poisons. The Schedule classifications are a recommendation to be given legal effect by the Australian States and Territories in legislation that regulates medicines and poisons and their availability to the public.[50] The objective of the SUSMP is to promote a uniform approach throughout Australia to the availability, accessibility and safe handling of medicines and poisons. (In this Report, a reference to the Poisons Standard should be read as being a reference to the SUSMP.)

There are nine active Schedules in the Poisons Standard - Pharmacy Medicine (Sch 2), Pharmacist Only Medicine (Sch 3), Prescription Only Medicine (Sch 4), Caution (Sch 5), Poison (Sch 6), Dangerous Poison (Sch 7), Controlled Drug (Sch 8), Prohibited Substance (Sch 9), and Substances of such danger to health as to warrant prohibition of sale, supply and use (Sch 10).

Schedule 8, which applies to drugs that should be available by prescription but subject to controls to reduce abuse, misuse and physical or psychological dependence, includes the following two items: 'Cannabis (including seeds, extracts, resin and the plant, and any part of the plant) when prepared or packed for human therapeutic use' in accordance with ND Act or TG Act requirements; and THC 'when extracted from cannabis for human therapeutic use' in accordance with ND Act or TG Act requirements. Cannabis was changed from a Schedule 9 drug to a Schedule 8 drug in November 2016.

CBD is listed in Schedule 4 of the Poisons Standard as a Prescription Only Medicine under the following description: 'Cannabidiol in preparation for therapeutic use where cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation; and any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2 per cent or less of the total cannabinoid content of the preparation'.

Cannabis is also listed in Schedule 9 as a prohibited substance, except as covered by Schedule 4 or 8, or as processed hemp fibre or hemp seed oil with a prescribed minimum THC content.

The Customs (Prohibited Imports) Regulations 1956 contains 15 schedules that list items that are prohibited for import or to which special import requirements and permissions apply. 'Drugs' are listed in Schedule 4, and include 'Cannabinoids', 'Cannabis' and 'Cannabis resin'. A Schedule 4 substance can only be imported by the holder of both a licence and a permit - which, in the case of drugs listed in Schedule I or II of the Single Convention, can only be granted in specified circumstances designed to ensure Australia's compliance with the Convention.[51]

The Customs (Prohibited Exports) Regulations 1958 adopts a similar approach. Schedule 8 of the eight schedules in the Customs (Prohibited Exports) Regulations 1958 applies to 'Drugs the exportation of which is prohibited if specified conditions, restrictions or requirements are not met'. 'Cannabis' and 'Cannabis resin' are listed in Schedule 8. Among the requirements to be met for export are that the exportation is by a licensed exporter and the export is for a purpose specified in the Customs (Prohibited Exports) Regulations 1958.[52]

The Criminal Code Regulations 2019, Schedule 1, lists 'Controlled drugs', 'Controlled plants' and the quantities that, for the purposes of the offence provisions in the Criminal Code Regulations 2019, are a 'Commercial quantity', a 'Marketable quantity' and a 'Trafficable quantity'. Among the drugs listed in Schedule 1 are 'Cannabis (in any form, including flowering or fruiting tops, leaves, seeds or stalks, but not including Cannabis fibre' and 'Cannabis resin'. Among the controlled plants listed in regulation 12 is 'any plant of the genus Cannabis'. The interaction of the Criminal Code and the ND Act is discussed in Chapter 4.

• [7] Sources relied on for this description include State Government website material relating to hemp regulation, and the report of the World Health Organisation Expert Committee on Drug Dependence, Fortieth Report (2018), WHO Technical Report Series, No 1013.
• [8] Hemp Industry Act 2008 (NSW) s 3(1); Industrial Hemp Act 2015 (Tas) s 4; Industrial Hemp Act 2017 (SA) s 3; Industrial Hemp Act 2004 (WA) s 3; Hemp Fibre Industry Facilitation Act 2004 (ACT) Dictionary.
• [9] Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 61(1).
• [10] Generally, see Parliament of Australia, Law and Bills Digest Group, 'Illicit Drugs, their Use and the Law in Australia', Background Paper 12, 1996-97; and Senate Economic References Committee, Personal choice and community impacts, Interim report on the sale and use of marijuana and associated products (May 2016).
• [11] Criminal Code Regulations 2019 (Cth), Schedule 1
• [12] See Criminal Code 1995 (Cth), Chapter 9, Part 9.1.
• [13] Crimes (Traffic in Narcotics and Psychotropic Substances) Act 1990 (Cth), Schedule 2.
• [14] Transport Operations (Road Use Management) Act 1995 (Qld) s 80.
• [15] The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is scheduled to the current Poisons Standard (current Poisons Standard). The current Poisons Standard is a non-disallowable legislative instrument for the classification of medicines and poisons (see s 52A of the TG Act). Medicines and poisons are classified under the SUSMP into Schedules, which state the level of control which should be exercised over the availability of the medicines and poisons in each Schedule. This Report refers to the more commonly used term 'Poisons Standard'. These references should be read as being to the SUSMP or relevant Schedule thereof.
• [16] Respectively, regulation 5 and Schedule 4 of the Customs Import Regulations; and reg 10 and Schedule 8 of the Customs Export Regulations.
• [17] Media Release, 'Victorian Medicinal Cannabis Industry Powers Ahead, 17 January 2018: www.premier.vic.gov.au/wp-content/uploads/2018/01/180117-Victorian-Medi… - external site - pdf,566kb. As to the inoperative status of the Victorian Act, see also Victorian Department of Health and Human Services, Annual Report 2017-18, p 90 ('Timeliness').
• [18] Health and Other Legislation Amendment Act 2019 (Qld), s 57.
• [19] Medicines and Poisons Bill 2019 (Qld) - https://www.legislation.qld.gov.au/view/html/bill.first/bill-2018-004/lh - external site; See also statement from The Honourable Steven Miles, Minister for Health and Minister for Ambulance Services (Qld) - http://statements.qld.gov.au/Statement/2019/4/3/queensland-streamlines-… - external site.
• [20] The Northern Territory Government introduced a Hemp Industry Bill 2019 into the Legislative Assembly on 16 May 2019.
• [21] Access to Medicinal Cannabis Act 2016 (Vic); Public Health (Medicinal Cannabis) Act 2016 (Qld).
• [22] Victorian Law Reform Commission, Medicinal Cannabis, Report, August 2015.
• [23] As noted above at footnote 16, the Act has been inoperative following the establishment of a Commonwealth medicinal cannabis scheme in 2016.
• [24] Legal and Constitutional Legislation Committee, Regulator of Medicinal Cannabis Bill 2014 (August 2015), Recommendation 1, p vii.
• [25] Ibid, para 1.5.
• [26] Ibid, para 2.29, and paras 4.4-30.
• [27] See TGA, 'Medicinal cannabis - guidance documents' (May 2018): www.tga.gov.au/medicinal-cannabis-guidance-documents - external site
• [28] Narcotic Drug Amendment Act 2016 (Cth).
• [29] See Explanatory Memorandum, Narcotic Drugs Amendment Bill 2016, 'Sections. 5: Consultation' (p 14).
• [30] House of Representatives, Hansard, 10 February 2016 at p 1165.
• [31] Ibid, p 1166
• [32] Narcotic Drugs Legislation Amendment Act 2016 (Cth).
• [33] Narcotic Drugs Amendment (Cannabis) Regulations 2018. The precise scope of the export provisions is explained in Department of Health, 'Export of medicinal cannabis: Guidance for cultivators and manufacturers of medicinal cannabis' (April 2018).
• [34] Ibid at p 4.
• [35] ND Act, s 4(1) (definition of 'Secretary').
• [36] ND Act, s 25.
• [37] Single Convention, Articles 12-21.
• [38] Single Convention, Article 14.1(b).
• [39] It is also lawful to access a medicinal cannabis product as an extemporaneously compounded product or via the personal importation scheme. These pathways fall under the TG Act and the Therapeutic Goods Regulations 1990 (Cth) and are not considered further in this report.
• [40] Therapeutic goods supplied in Australia are required to be included in the Register or, if not, to be covered by an exemption, approval, or authority. Criminal offences apply if a person imports, exports, manufactures or supplies therapeutic goods in Australia that are not registered, listed, exempt or the subject of an approval or authority under the TG Act (see ss 19B of the TG Act).
• [41] TG Act, s 19(5),(6). Further guidance material in relation to Authorised Prescribers is available on the TGA website (https://www.tga.gov.au/book-page/legal-basis-scheme - external site) and (https://www.tga.gov.au/sites/default/files/authorised-prescriber-scheme… - external site - pdf,271kb).
• [42] Customs (Prohibited Imports) Regulations 1956 (Cth), reg 5.
• [43] TG Act, s 18(1); TG Regulations reg 12A. Further guidance material relating to the Special Access Scheme is available on the TGA website (https://www.tga.gov.au/form/special-access-scheme - external site) and (https://www.tga.gov.au/sites/default/files/special-access-scheme-guidan… - external site - pdf,334kb).
• [44] TG Act, s 19(1)(a).
• [45] See TG Act, s 19(1)(b); and https://www.tga.gov.au/clinical-trials - external site.
• [46] https://www.tga.gov.au/access-medicinal-cannabis-products-1 - external site.
• [47] TG Act, s 14.
• [48] TGO 93, determined under s 10 of the TG Act, constitutes a standard for medicinal cannabis products (see TGO 93, s 5).
• [49] https://www.tga.gov.au/access-medicinal-cannabis-products-1 - external site.
• [50] TGA Act, ss 4(1)(b), 52D.
• [51] Customs (Prohibited Imports) Regulations 1956, reg 5(10).
• [52] Customs (Prohibited Exports) Regulations 1958, reg 8(1).