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Research Note Access To Medicinal Cannabis Bill 2015

Executive Summary

On 8 December 2015, the Andrews Government introduced the Access to Medicinal Cannabis Bill 2015 to the Legislative Assembly, thereby becoming the first Australian government to introduce a Bill to legalise medicinal cannabis through establishing a state-based medicinal cannabis scheme. The Bill provides for cultivation, manufacture and distribution of medicinal cannabis products in Victoria.

The Bill follows a pre-election commitment in August 2014 by the then Opposition Leader Daniel Andrews to pursue legalisation of medicinal cannabis. After the state election in November 2014, the Andrews Government asked the Victorian Law Reform Commission (VLRC) to review law reform options to enable access to medicinal cannabis for patients in exceptional circumstances. This Bill responds to recommendations in the VLRC's report.

Under the proposed scheme, cultivators would be licensed by the Department of Economic Development, Jobs, Transport and Resources to grow cannabis for medical and research purposes. The Department of Health and Human Services would be responsible for overseeing the manufacture of medicinal cannabis products, authorisations for patients and practitioners, research and clinical guidance. Children with severe epilepsy would be the first to access Victorian-grown medicinal cannabis from 2017, with provisions for further patient eligibility to be established in regulations. Cooperation with the Commonwealth would also be necessary, in order to fulfil Australia's obligations under international agreements on narcotic drug control.

This Research Note provides background on the issue of medicinal cannabis, including recent policy developments, an overview of medicinal cannabis and research into its efficacy, and an outline of the VLRC's recommendations in their 2015 Medicinal Cannabis report. The Bill's major provisions are discussed, as well as comments by interested parties, plus an overview of access to medicinal cannabis in interstate and international jurisdictions.

Introduction

On 8 December 2015, the Andrews Government introduced the Access to Medicinal Cannabis Bill 2015 to the Legislative Assembly. In doing so, the Victoria Government became the first Australian government to introduce a Bill to legalise medicinal cannabis through a state-based scheme. The Bill establishes a medicinal cannabis scheme in Victoria, including the cultivation, manufacture and distribution of medicinal cannabis products.

The Andrews Government intends that children with severe epilepsy would be the first patients to access the medicinal cannabis scheme from 2017.[footnote 1] In her Second Reading Speech, the Minister for Health, the Hon. Jill Hennessy highlighted the conflict faced by families who seek to treat their epileptic children with medicinal cannabis despite it being illegal:

Too many parents are turning to the black market out of desperation to obtain medicinal cannabis to alleviate their pain and suffering … The law needs to change, because families should not have to make the choice between obeying the law and treating their children.[footnote 2]

The Bill enables the Victorian government to prescribe other eligible patient groups to access medicinal cannabis products on a date to be proclaimed ('most likely in 2018').[footnote 3] In line with an election commitment and recommendations of the Victorian Law Reform Commission (VLRC), it is intended that medicinal cannabis products would not be made available in a form that could be smoked. The Bill also does not remove the prohibition on cannabis used for non-medicinal purposes. The Health Minister stated that 'the Access to Medicinal Cannabis Bill will relieve people's suffering and change lives across this state.'[footnote 4]

Background

This section provides background information on the medicinal cannabis debate, including recent policy developments. An overview of what medicinal cannabis is, as well as research into its efficacy and side effects, is also included. The Background section concludes with an outline of the recommendations by the VLRC in their Medicinal Cannabis report, tabled in Parliament on 6 October 2015.

Policy developments

Debate on the legalisation of medicinal cannabis was stimulated over the past few years by several personal accounts of patients with severe conditions who found relief by using medicinal cannabis. From 2014, media attention was drawn to the case of Dan Haslam, a 25 year old man in NSW who used medicinal cannabis to alleviate nausea and vomiting from chemotherapy. His mother Lucy became a key campaigner for access to medicinal cannabis. Dan Haslam's story had a significant impact on NSW Premier Mike Baird, who credited Haslam with changing his views on medicinal cannabis. The NSW Premier announced trials into medicinal cannabis from mid-2015 and Victoria, Queensland and Tasmania have subsequently joined NSW in these trials. [footnote 5]

In Victoria, media coverage highlighted the story of Cooper Wallace, a four-year-old boy with disabilities and epilepsy whose quality of life was improved through treatment with medicinal cannabis. His mother Cassie Batten was arrested in 2014 after admitting on television that she administered medicinal cannabis to her son. Police later dropped charges against Batten on advice from the Office of Public Prosecutions.[footnote 6] The then Opposition Leader Daniel Andrews met with the family and in August 2014, he pledged to pursue legislative reforms to legalise medicinal cannabis if elected at the November state election that year.[footnote 7]

The then Victorian Coalition Government responded to the ongoing debate by announcing plans to amend the law to facilitate clinical trials into medicinal cannabis.[footnote 8] They subsequently introduced the Drugs, Poisons and Controlled Substances Amendment (Clinical Trials) Bill 2014, however this Bill lapsed when the 57th Parliament expired in November 2014.[footnote 9] The Coalition Government had also indicated an intention to establish an expert advisory committee of clinical and regulatory experts to investigate the related clinical and ethical issues.[footnote 10]

After Labor's state election win, the now Premier Daniel Andrews announced on 19 December 2014 that the VLRC had been asked to conduct a review into law reform options to enable legal access to medicinal cannabis for people in exceptional circumstances.[footnote 11] The VLRC was due to report by the end of August 2015, and the Government planned to introduce legislation to Parliament by the end of 2015.[footnote 12]

The VLRC's final report, Medicinal Cannabis, was delivered to the Attorney-General by 31 August 2015 and tabled in Parliament on 6 October 2015.[footnote 13] The Government announced that they fully accepted 40 of the VLRC's 42 recommendations, with two accepted in principle. Following the VLRC's recommendations, the Government pledged to create a medicinal cannabis scheme in Victoria, including a system for licensing cultivators and the establishment of an Office of Medicinal Cannabis within the Department of Health and Human Services to oversee manufacture, dispensing, research and clinical guidance.[footnote 14]

The Government declined, however, to implement the VLRC's recommendation for broader patient eligibility in the initial stages, which included access to medicinal cannabis for patients with conditions such as multiple sclerosis, pain from cancer or HIV/AIDS, severe nausea or wasting from cancer or HIV/AIDS and chronic pain. Instead, the Government intends to limit access to one patient group in the first instance — children with severe epilepsy — citing difficulties in establishing the appropriate scale and quality of cultivation and manufacture to address all conditions in the short term.[footnote 15] Eligibility may be broadened to further patient groups on the advice of an Independent Medical Advisory Committee, which the Government aims to establish in line with another VLRC recommendation.[footnote 16]

The VLRC report also underlined the need for cooperation with the Commonwealth, and the Victorian Government committed to working with the Federal Government to enable legal access to medicinal cannabis.[footnote 17]

There have also been developments at the federal level. On 17 October 2015, Federal Health Minister Sussan Ley announced plans to amend the Narcotics Drugs Act 1967 (Cth) to allow for controlled cultivation of cannabis for medical and scientific purposes, and a Commonwealth licensing scheme for suppliers. States and territories would be required to introduce equivalent legislation in order for cultivation to proceed, allowing the states and territories to licence growers in their own jurisdiction. The legislation would also ensure that the regulation of new medicinal products would continue to be the responsibility of the Therapeutic Goods Administration (TGA).[footnote 18]

In December 2015, however, the Federal Health Minster announced that the Federal Government had decided to introduce legislation for a single national scheme for growers in all states and territories. The legislation would be introduced in Federal Parliament's first sitting fortnight of 2016.[footnote 19]

While this proposed national cultivation scheme developed at the federal level, the Andrews Government continued to put forward a Victorian scheme based on the VLRC's recommendations by introducing the Access to Medicinal Cannabis Bill 2015 during the last sitting week of Victorian Parliament for 2015.

Aside from the Access to Medicinal Cannabis Bill, Premier Daniel Andrews and Health Minister Jill Hennessy provided further details on Victoria's involvement in clinical trials of medicinal cannabis products. On 3 February 2016, they announced that the Austin Hospital will be part of an international clinical trial of a synthetic form of a cannabis compound cannabidiol (CBD) in the treatment of childhood epilepsy.[footnote 20] The trials will be open to a small group of children with severe epilepsy and will commence this year.[footnote 21]

Medicinal cannabis

Cannabis is a generic term for drugs made from any of the genus cannabis plants, including Cannabis Sativa and Cannabis Indica. Drugs derived from cannabis are usually produced in three main forms: marijuana (dried leaves and flowering tops of the plants), hashish (cannabis resin) and cannabis oil.

When consumed, cannabis can result in users experiencing an alteration in mood and a feeling of 'high'. The psychotropic and psychoactive effects of cannabis were grounds for the inclusion of cannabis as a controlled drug in the United Nations Single Convention on Narcotic Drugs in 1961. Cannabis is an illicit drug in Australia under Commonwealth and state laws, and is the most widely used illicit drug in Australia.[footnote 22]

Cannabis consists of over 400 chemical substances, and over 60 of these are cannabinoids. When ingested, cannabinoids activate the cannabinoid receptors in the body, producing a range of effects on movement, appetite, emotion, memory and cognitive functions.[footnote 23]

Principal cannabinoids with therapeutic potential in the cannabis plant are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC produces the psychoactive effects of cannabis, but can also have therapeutic effects on reducing pain, nausea and vomiting, and stimulating appetite. CBD is non-psychoactive and may reduce the unwanted psychoactive effects of THC.[footnote 24] CBD is being investigated in the treatment of various conditions, including epilepsy, schizophrenia and other psychotic disorders, type II diabetes, inflammatory bowel disease, gliomas and drug dependency.[footnote 25]

The combination and strength of cannabinoids in cannabis plants can vary depending on plant strain and conditions of growth and storage, as well as chemical contamination (eg. from pesticides, heavy metals, fungus and mould).[footnote 26]

Cannabinoids can be manufactured in pharmaceutical laboratories as pharmaceutical drugs. Three pharmaceutical cannabinoids are dronabinol, nabilone and nabiximols. Dronabinol is a synthetic THC which has been approved for the treatment of nausea and vomiting in chemotherapy patients, as well as AIDS related weight loss. Nabilone is a synthetic analogue of THC, licensed for use in treating chemotherapy-induced nausea and vomiting. Nabiximols (trade name Sativex) is a 1:1 ratio of THC and CBD from cannabis plants, approved to treat spasticity in patients with multiple sclerosis. Dronabinol and nabilone have been granted approval for use in the United States of America, Canada and the United Kingdom, but have not been marketed in Australia. Nabiximols (Sativex) has been approved to treat spasticity for patients with multiple sclerosis in Canada, the United Kingdom, Spain, New Zealand, and in Australia as a controlled drug available on prescription for multiple sclerosis patients.[footnote 27]

Characteristics of medicinal cannabis

The Drug Policy Modelling Program at the University of New South Wales stated that medicinal cannabis products can be categorised by how their production is regulated:

§ pharmaceutical cannabis products – these products have been approved by conventional regulators such as the TGA and include the nabiximols (Sativex) and synthetic cannabinoids

§ controlled and standardised herbal cannabis – these have standardised levels of cannabinoids and have been tested to be free of harmful adulterants (eg. products made in the Netherlands by Bedrocan BV)

§ unregulated illegal herbal cannabis – this is any cannabis products bought on the black market, generally with unknown concentrations of cannabinoids and potentially harmful contaminants.[footnote 28]

Administration of cannabis

Cannabis can be administered in a number of ways. Smoking (via 'joints' or water pipes) offers a rapid effect and allows patients to self-titrate (measure their own dosage), but has been linked to health risks including cardiovascular and respiratory disease and cancer. Inhalation through a vaporiser also offers a rapid effect, allows for self-titration and may avoid the health risks of smoking. Ingestion via food or drink has a slower effect, is more difficult to self-titrate and not suitable for patients with nausea and vomiting. Taking cannabis in oral capsules has a slower effect and swallowing may be problematic for patients with nausea and vomiting. Cannabis can be applied to the skin as a cream or taken orally in tincture form, where liquid drops are placed under the tongue. Cannabis can also be taken in oral spray form (such as the nabiximols 'Sativex'), which is considered by some to be the best form for controlled dosage – it has a slower effect yet avoids the unwanted feeling of 'high', and is suitable for patients with nausea and vomiting.[footnote 29]

Efficacy of medicinal cannabis

There is an expanding body of evidence on the efficacy of cannabis for certain medical conditions.[footnote 30] However, some commentators have questioned the quality of the research currently available.[footnote 31] Evidence for the potential of cannabis in the treatment of various conditions is outlined below.

Multiple sclerosis (MS)

The VLRC stated that 'Although not conclusive, there is a reasonable level of research support for the effectiveness of cannabis in relieving pain and spasticity for those suffering multiple sclerosis'.[footnote 32]

Epilepsy

A Cochrane Review in 2014 found that 'no reliable conclusions' could yet be drawn regarding the efficacy of cannabinoids as treatment for epilepsy.[footnote 33] Also, a systematic review of the efficacy and safety of medicinal cannabis on neurological disorders, including epilepsy, published by the American Academy of Neurology in 2014 found that the efficacy of oral cannabinoids in epilepsy is unknown.[footnote 34] Epilepsy Australia takes a cautious approach, stating medicinal cannabis has potential in the treatment of epilepsy, however some of the current evidence is anecdotal.[footnote 35] New South Wales, Victoria and Queensland are to participate in trials of medicinal cannabis to treat epilepsy in 2016. The VLRC concludes that 'there is emerging research support for the effectiveness of cannabis in relieving the symptoms of epilepsy, especially for those with juvenile syndromes'.[footnote 36]

Chronic pain

The VLRC stated that there is moderate but emerging evidence to suggest that medicinal cannabis can help alleviate chronic pain. However the VLRC pointed out that medicinal cannabis should be viewed as part of a preferably multimodal strategy for a patient's chronic pain management.[footnote 37]

Cancer and HIV/AIDS

Evidence exists which suggests medicinal cannabis may be able to alleviate pain for patients with cancer and HIV/AIDS, though research is ongoing.[footnote 38] The VLRC stated that there is 'a modest level of research support' for the efficacy of medicinal cannabis in reducing nausea and vomiting caused by chemotherapy and wasting caused by HIV/AIDS. [footnote 39]

Overall, evidence for the efficacy of medicinal cannabis for these conditions is considered to be of 'moderate quality'.[footnote 40] Reasons for this include that existing research often relies on case studies, involves small numbers of patients, uses variable types of medicinal cannabis, and lacks rigorous controls and methodology.[footnote 41] However, the VLRC argued that there is cause for optimism regarding medicinal cannabis' therapeutic potential and further research will help clarify its efficacy and inform future debate.[footnote 42]

Side effects of medicinal cannabis

A range of side effects have been identified as linked to cannabis use, though the severity of these side effects has been disputed. Some commentators argue that the potential adverse health effects of cannabis are largely unknown due to lack of research and could be serious, especially for young people. On the other hand, a 2008 systematic review on medicinal cannabis use concluded that while short-term cannabis use did increase the risk of non-serious side effects, it did not increase the risk of serious side effects.[footnote 43]

The following side effects have been associated with cannabis use -

§ Respiratory effects – smoking cannabis can affect respiratory functioning and may have a carcinogenic effect.[footnote 44]

§ Psychotic effects – there is some research which suggests recreational cannabis use may be linked to psychoses, including precipitating and exacerbating schizophrenia. This may be attributed to the high-THC content of certain types of cannabis used by some recreational users. The proposed Victorian medicinal cannabis scheme would involve clinically monitored use of medicinal cannabis with very low or no THC content, so the risk of psychosis for patients is considered to be removed.[footnote 45]

§ Mood effects – Cannabis has been seen to cause adverse effects on mood in new recreational users, including making users anxious, depressed or paranoid. According to studies, these acute adverse reactions usually disappear after discontinuing use and are less common in regular users.[footnote 46] These adverse mood reactions have been noted in a small proportion of recreational users, and there is little data concerning such mood effects in the context of medicinal cannabis use.[footnote 47]

§ Impaired learning, memory and motivation – Some studies have found impairment of learning and memory, attention and other cognitive skills in chronic cannabis users, while other studies show no deterioration in cognitive performance. The potential effects of cannabis use on the developing brains of children is of particular concern, and therefore the VLRC recommends close monitoring of children in relation to medicinal cannabis.[footnote 48]

§ Dependency – Cannabis is not considered to be a highly addictive drug, though dependency and withdrawal can occur for a small percentage of users. The severity of cannabis withdrawal is described as similar to withdrawing from smoking tobacco.[footnote 49]

§ Cardiac effects – Cannabis use can cause tachycardia, which can heighten the risk of heart attack. Such cardiac effects only tend to be a problem in combination with existing cardiac risk factors such as arrhythmias or heart disease.[footnote 50]

§ Impaired concentration and psychomotor response – There is significant evidence showing that cannabis adversely affects concentration, slows response times and impairs psychomotor performance in general.[footnote 51] Those experiencing impairment often do not appreciate the severity of their impairment.[footnote 52] Impairment from cannabis use can be made worse when combined with alcohol.[footnote 53] Potential safety concerns have been raised about driving while under the influence of medicinal cannabis, as well as concerns over workplace safety.[footnote 54]

As with most prescribed medications, there are potential side effects associated with medicinal cannabis. These risks are thought to be limited, considering the proposed low THC content of medicinal cannabis. The VLRC believes that the risk of potential side effects can be managed through appropriate warnings, patient information and close monitoring of a patient's condition by medical practitioners. The side effects of medicinal cannabis use are not likely to be life-threatening, as long as misuse is avoided through appropriate medical supervision.[footnote 55]

Victorian Law Reform Commission recommendations

This section provides an overview of the recommendations made by the Victorian Law Reform Commission in their report on medicinal cannabis.

Attorney-General Martin Pakula asked the VLRC on 19 December 2014 to review options for legislative changes to allow people to be treated with medicinal cannabis in exceptional circumstances. The VLRC released an issues paper in March 2015, held nine public consultations in metropolitan and regional Victoria, and received 99 submissions.[footnote 56] The VLRC delivered their final report, Medicinal Cannabis by 31 August 2015, and the report was tabled in Parliament on 6 October 2015. The VLRC's report contained 42 recommendations on how the law may be changed in order to allow access to medicinal cannabis under certain circumstances.

Objectives of the law reform

The VLRC report made the point that allowing access to medicinal cannabis in exceptional circumstances conveys a policy intention, based on compassion, to depart from the usual strict criteria of evidence-based medicine.[footnote 57]

International obligations and Commonwealth collaboration

The VLRC report pointed out that Australia is signatory to three international agreements - the United Nation's Single Convention on Narcotic Drugs (1961), the United Nations Convention on Psychotropic Substances 1971and the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances 1988 - which restrict the cultivation, supply, possession and use of cannabis. The most significant agreement in relation to a Victorian medicinal cannabis scheme is the Single Convention on Narcotic Drugs (1961). Access to medicinal cannabis in Victoria would need to be consistent with obligations under articles 23 and 28 of the Single Convention on Narcotic Drugs (1961).[footnote 58] These articles include requirements for one or more government agencies to license cultivation and take physical possession of all crops. There are also reporting requirements to the International Narcotics Control Board.[footnote 59] To be compliant, the VLRC highlighted several ways in which Victorian and Commonwealth legislation would need to be amended to facilitate a medicinal cannabis scheme in Victoria:

§ A Victorian government agency must regulate cultivation, licence cultivators and take physical
possession of the crops;

§ Victoria would need to tell the Commonwealth Government the amount estimated to be used
each year; and

§ The Commonwealth would then need to report to the International Narcotics Control Board.[footnote 60]

The VLRC stated that the Commonwealth must remove production and distribution of medicinal cannabis products in Victoria from the reach of the Therapeutic Goods Act 1989 (Cth) and issue licenses to manufacture cannabis under the Narcotic Drugs Act 1967 (Cth).[footnote 61] Health Minister Jill Hennessy also stated that the Victorian Government would need permission from the Commonwealth Government to import cannabis seeds.[footnote 62]

Options for medicinal cannabis reform

The VLRC report canvassed several options for a medicinal cannabis scheme to be set up in Victoria:

§ Importation of cannabis products was discussed but ruled out as an option, as the supply may not be enough and may be in dried form, which is more likely to be smoked (a method not recommended by the VLRC).

§ Exemption from prosecution was not recommended, as this option would not solve the problem of supply, as cultivation and supply would remain unlawful.

§ A 'Grow your own' scheme was discussed, but was not recommended, due to quality and regulatory concerns, the possibility of misuse, the ability for crops to be smoked, and the fact that not all patients can grow their own cannabis or have someone else do it for them.

§ Regulated 'not-for-profit' production and distribution was considered but not recommended. The VLRC advised that medicinal cannabis should be treated like any other prescribed medication, not in a closed system which could re-inforce negative perceptions. This option was also not compliant with the Narcotic Drugs Convention rule which stipulates a government agency must take physical possession of the cannabis products.

§ Regulated distribution through dispensaries was discussed but not recommended. The report found that there is no need in Victoria to set up separate dispensaries to distribute medicinal cannabis products, unlike in the United States where not-for-profit dispensaries were needed in order to circumvent federal laws prohibiting pharmacies from selling cannabis products.

§ A government monopoly in cultivation and distribution was considered to be a good option, though the report highlighted concerns about over-reliance on a single supplier.

§ The establishment of multiple licensed producers was the VLRC's preferred option. Under this option, the Commonwealth must exempt manufacture and production of medicinal cannabis from regulation under the Therapeutic Goods Act and grant licences under the Narcotic Drugs Act 1967 (Cth). Similar to poppy farms, this option is consistent with obligations under the Narcotic Drugs Convention, is not dependent on a single source for cannabis cultivation, and is adaptable to law or policy changes.[footnote 63]

Therefore the VLRC report recommended that the model of multiple licensed producers be adopted for a Victorian medicinal cannabis scheme.

Cultivation

Under the VLRC's preferred model, cultivators would be licensed to grow cannabis and the licensing system would be based on arrangements for alkaloid poppy cultivators, as in Part IVB of the Drugs, Poisons and Controlled Substances Act 1981 (Vic). Medicinal cannabis cultivators would be granted a licence by the Secretary of the Department of Economic Development, Jobs, Transport and Resources. Cultivators could only sell to licensed manufacturers and would be required to have a contract with a licensed manufacturer at all times. Cultivators must also be of suitable character. The Chief of Police could oppose licensing decisions. Cultivators must deliver all medicinal cannabis grown to a licensed manufacturer or destroy it. The Secretary could suspend or cancel a licence, and applicants could appeal to the Victorian Civil and Administrative Tribunal (VCAT). Cultivators must also have a risk management plan.

A certain set of risks is involved in the cultivation of medicinal cannabis, and the VLRC proposed several risk management options (see Table 1).

Table 1. Risks associated with cultivation of medicinal cannabis and the regulatory responses proposed to control these risks

Risk

Regulatory Response

Diversion occurs because of

criminal intervention by third parties

(potentially causing risks to public

safety)

Risk management plan addresses facility security

measures, location, secrecy, surveillance

Diversion occurs because of

criminal conduct by employees or

contractors

Risk management plan addresses assessment,

training and supervision of employees and

contractors

Criminal record checks required for employees

Licence conditions require destruction of unused

cannabis

Diversion occurs because of criminal

conduct by managers/owners

Fit and proper person test before licence is

granted

Chief Commissioner of Police has veto power

Licence conditions require:

• that all cannabis cultivated is delivered to a

licensed manufacturer or destroyed

• that all unused cannabis is destroyed

Diversion occurs during transport

Risk management plan addresses how

transportation will be securely undertaken

Cannabis grown is of poor quality

Addressed through quality control regime

Source: Victorian Law Reform Commission (2015) Medicinal Cannabis: Report, Melbourne, VLRC, August, p. 154.

Manufacture

Manufacturers would be licensed to make medicinal cannabis products. The system would be similar to licensing manufacturers under Therapeutic Goods Act 1989 (Cth) and poppy straw processors under Drugs, Poisons and Controlled Substances Act 1981 (Vic). The Secretary of the Department of Health and Human Services would grant licences to manufacturers of medicinal cannabis products. Licencees must hold a manufacturing licence under the Narcotic Drugs Act 1967 (Cth) at all times. Manufacturers must also be of suitable character. The Chief of Police could oppose licensing decisions. Licensees must deliver all medicinal cannabis products to the Secretary within four months of the harvest date and destroy all unused material. The Secretary could suspend or cancel licences, and applicants could appeal to VCAT. Manufacturers must also have a risk management plan.

Manufacturing medicinal cannabis does involve certain risks, and the VLRC suggested strategies by which such risks could be controlled (see Table 2).

 

Table 2. Risks associated with manufacture of medicinal cannabis and the regulatory responses proposed to control these risks

Risk

Regulatory Response

Diversion occurs because of

criminal intervention by third parties

(potentially causing risks to public

safety)

Risk management plan addresses facility security

measures, location, secrecy, surveillance

Diversion occurs because of

criminal conduct by employees or

contractors

Risk management plan addresses assessment,

training and supervision of employees

Criminal record checks required for employees

Licence conditions require destruction of unused

cannabis

Diversion occurs because of criminal

conduct by managers/owners

Fit and proper person test before licence is

granted

Chief Commissioner of Police power to oppose

Licence conditions require:

• that all cannabis products are delivered to

the government or destroyed

• that all unused cannabis is destroyed

Diversion occurs during transport

Risk management plan addresses how

transportation will be securely undertaken

Cannabis products are of variable

quality

Manufacturing licences may only be granted

where applicant satisfies Secretary of capacity to

comply with production standards

Products are subjected to testing

Cannabis products contain unsafe

contaminants and harm public

health

Manufacturing licences may only be granted

where applicant satisfies Secretary of capacity to

comply with production standards

Products subject to testing for contaminants

Premises subject to inspections

Recall procedures in place

Source: Victorian Law Reform Commission (2015) Medicinal Cannabis: Report, Melbourne, VLRC, August, p. 160.

Distribution

The VLRC recommended that the Department of Health and Human Services be responsible for distributing medicinal cannabis products to pharmacies. Not all pharmacies would be involved in dispensing medicinal cannabis, only those who elect to be part of the scheme. Pharmacies must store medicinal cannabis according to the storage of a Schedule 8 or Schedule 9 poison. The Department of Health and Human Services should require pharmacists to notify them about the amount and type of products they dispense. The Secretary of the Department of Health and Human Services should also designate a price above which medicinal cannabis cannot be sold (incorporating pharmacy mark-ups). The rules on pharmacies would be modelled on those for opioids replacement therapy.[footnote 64]

The VLRC highlighted several risks relating to the distribution of medicinal cannabis, as well as ways in which these risks could be managed (see Table 3).

 

Table 3. Risks associated with distribution of medicinal cannabis to patients and the regulatory responses proposed to control these risks

Risk

Regulatory Response

Patients give or sell their authorised

supply to non-authorised users

Limited amounts may be dispensed

Patients use the same authority at

a number of pharmacies, obtaining

multiple quantities

Patients must attend a single pharmacy

designated by their doctor and follow a set process if they wish to transfer to another.

Patients obtain cannabis using forged

authorities

Communication encouraged between

pharmacists and medical practitioners

Forging an authority would be an offence

Pharmacists or pharmacy staff

misappropriate cannabis

Professional obligations on pharmacists and regulatory obligations on pharmacies

Record-keeping requirements for cannabis products

Theft of cannabis from pharmacies

through burglary

Secure storage requirements for cannabis products

Source: Victorian Law Reform Commission (2015) Medicinal Cannabis: Report, Melbourne, VLRC, August, p. 169.

Quality control

The VLRC report pointed out that currently only one pharmaceutical-grade cannabis product (Sativex) has been approved by the TGA but is not marketed in Australia. Therefore, in practical terms, it is not readily available in this country. The VLRC stated that requiring Victorian medicinal cannabis products to undergo approval by the TGA would 'reinforce the status quo and not result in additional approved products being made available to patients for a significant period of time'.[footnote 65]

The VLRC recommended an alternative regulatory structure be established in Victoria which does not involve similar obstacles to approval as prescription medicines, but does ensure the products are of good quality. The VLRC believes that medicinal cannabis products should be presented as 'a form of less refined herbal medicine', and that the regulatory scheme should provide for this.[footnote 66]

The report stated that it would not be feasible to make approval of medicinal cannabis dependent on the usual standards of proof that it is effective for particular indications. The VLRC pointed out that clinical trials are costly and time consuming, placing similar barriers to approval that already exist under the TGA, and would not help provide access to medicinal cannabis to patients in any meaningful way.[footnote 67]

Medical conditions

The conditions for which medicinal cannabis could be used would be prescribed by regulations. In the initial stages of the scheme, the VLRC report recommended that the conditions/symptoms include:

§ severe muscle spasms or severe pain associated with multiple sclerosis (MS);

§ severe pain associated with cancer, HIV, or AIDS;

§ severe nausea, vomiting or wasting associated with cancer or HIV/AIDS, or the treatment
thereof;

§ severe seizures from epileptic conditions where other treatments are not effective or have
intolerable side effects;

§ severe chronic pain where two specialists have stated that medicinal cannabis can provide better
pain management than other options; and

§ other conditions on a case by case basis.[footnote 68]

Authorisation

According to the VLRC's recommendations, specialist medical practitioners would determine the eligibility of patients. General practitioners would then have principal responsibility for monitoring efficacy and side effects. The Drugs, Poisons and Controlled Substances Act 1981 and regulations would need to be amended to make possession, administering, selling and supplying medicinal cannabis allowed for medical practitioners, registered nurses and pharmacists who participate in a medicinal cannabis scheme. [footnote 69]

The Secretary of the Department of Health and Human Services would need to provide training and information to medical practitioners, nurses, and other practitioners. The Department of Health and Human Services would be given the power to administer the scheme, and the authority to take possession of medicinal cannabis products, account to the Commonwealth for those products and arrange their transfer to pharmacies.[footnote 70]

Regulation

The VLRC recommended that cultivators should comply with Good Agricultural and Collection Practice.[footnote 71] Manufacturers should comply with PIC/S Guide to Good Manufacturing Practice for Medicinal Products.[footnote 72] The Department of Health and Human Services should decide which medicinal cannabis products may be manufactured and dispensed in Victoria.[footnote 73]

The VLRC report recommended that the Department of Health and Human Services should establish and publish a register of medicinal cannabis products approved for sale in Victoria, including:

§ the THC and CBD content as a percentage;

§ the formulation;

§ permitted ingredients;

§ the brand name under which it will be sold; and

§ label contents.[footnote 74]

The Department of Health and Human Services should have the power to authorise independent testing facilities in Victoria to test medicinal cannabis products. All products would be subject to testing for cannabinoid content and contaminants.[footnote 75]

The VLRC advised that medicinal cannabis products should:

§ not include products that can be smoked;

§ include a variety of delivery systems – tinctures/ oils / capsules / sprays and vaporisable liquids;

§ provide for variation in cannabinoid content; and

§ be kept under review depending on developments in technology and medical knowledge about
the medicinal use of cannabis and specific cannabinoids.[footnote 76]

Research and evaluation

The VLRC recommended enabling other patients to trial medicinal cannabis products, upon approval of the Department of Health and Human Services. They recommended that the Department work with the clinical research community to develop methods and protocols for collecting and sharing information about the incidence and outcomes of treatments in the Victorian scheme. Under the VLRC's proposed model, the Department of Health and Human Services should retain data from permit applications and dispensing authorisations to be compiled for evaluative purposes and non-identifying information to be made available for research. The Department should also conduct a privacy impact statement when designing data collection and management systems to safeguard the privacy of patients, carers, practitioners, pharmacists and other participants. The VLRC also recommended that the Minister for Health should arrange an independent evaluation to be undertaken by four years after commencement of the Act and report to Parliament.


The Bill

This section summarises the key provisions of the Bill. For an overview of the Bill in its entirety, readers are directed to the Explanatory Memorandum. As stated previously, the Bill is based on the VLRC's recommendations, as the Government fully accepted 40 of the VLRC's 42 recommendations, and accepted two in principle.[footnote 77]

Patient eligibility

In clause 3, the only specifically defined 'eligible patient' in the Bill is a child (under 18 years) who experiences severe epileptic seizures, where other treatment has not been effective or has created intolerable side effects, and who meets other prescribed criteria.[footnote 78] However, the definition of 'eligible patient' in the Bill leaves room for further conditions to be specified under regulations.[footnote 79]

Functions of Health Secretary

The functions of the Secretary of the Department of Health and Human Services (the 'Health Secretary') include overseeing the medicinal cannabis scheme and preparing and distributing educational materials on medicinal cannabis products (clause 9). The Health Secretary is also required to provide data to the Commonwealth, as requested, on cultivation, manufacture, sale or supply of cannabis. This reflects the need to collaborate with the Commonwealth in order to fulfil its reporting obligations to the Narcotics Control Board under the Single Convention on Narcotic Drugs (1961). The Health Secretary may also declare testing facilities for medicinal cannabis in the Government Gazette (clause 11).

Independent Medical Advisory Committee

The Health Minister may establish an Independent Medical Advisory Committee under clause 12. The matters on which the committee may advise the Minister can be set out by Ministerial Order in the Government Gazette and may include the types of medicinal cannabis products that should be approved and regulations to define patient eligibility.

Cultivation of medicinal cannabis

The Secretary of the Department of Economic Development, Jobs, Transport and Resources ('Resources Secretary') is authorised to obtain and cultivate cannabis in order to manufacture medicinal cannabis or for research purposes (clause 13). The Resources Secretary is able to enter into contacts with people who will perform the cultivation (clause 14). The Resources Secretary may supply cannabis to the Health Secretary (clause 13) and can enter into a contract to sell or supply cannabis to a licensed manufacturer (clause 16).

The Bill includes a provision for the Resources Secretary to apply for and hold a Commonwealth licence for the cultivation of cannabis (clause 17). The Commonwealth did not license cultivators of cannabis at the time of the Bill's introduction, however this provision reflects the Commonwealth Government's stated intention of introducing a national cultivation licensing scheme.

Manufacture of medicinal cannabis

The Health Secretary is authorised to obtain cannabis and cannabis extract from the Resources Secretary, or obtain or purchase cannabis from a licensed cultivator or other prescribed person/body, in order to manufacture medicinal cannabis products or for research purposes (clause 18). Other activities which the Health Secretary can undertake include packaging and transporting the medicinal cannabis products for sale or supply purposes, possessing and storing cannabis products and disposing of or destroying cannabis in a safe manner (clause 18).

The Health Secretary can enter into a contract with another person to perform the manufacturing activities (clause 19).

A provision also enables the Health Secretary to apply for and hold a Commonwealth licence for the manufacture of cannabis products (clause 22). Under section 15(1) of the Narcotic Drugs Act 1967(Cth), cannabis can only be manufactured in Australia with a licence issued by the Commonwealth Minister of Health.[footnote 80]

Cultivation licences

Part 5 of the Bill sets out provisions relating to cannabis cultivation licences. Responsibility for issuing cultivation licences falls to the Resources Secretary. Provisions include that the Chief Commissioner of Police must support the licence application, that the applicant and each of their associates is a fit and proper person and have not been found guilty of a serious offence in Victoria or elsewhere within 10 years before the application is made, and that the premises for the cultivation are suitable (clause 21).

The Resources Secretary may also consider 'suitability matters' (clause 31(2)(a)). Suitability matters are defined in clause 5 and include whether the person applying for cultivation or manufacturing licence is of good repute, has a history of non-compliance with relevant legislation[footnote 81] or licences for cultivation or manufacturing, and has a sound financial background and appropriate current finances. The Resources Secretary could also consider any offence the applicant has committed in the 10 years prior to the application (clause 31(2)(b)).

A cultivation licence lasts for three years (clause 32).

Clause 35 stipulates that a licensed cultivator must issue an identification certificate to each employee and specifies the information that this certificate must contain. A breach of this requirement may result in a penalty of 60 penalty units.[footnote 82]

The Resources Secretary may also place conditions on the cultivation licence, or amend, renew, suspend or cancel a cultivation licence (see clauses 33, 34, 36-43).

Manufacturing licences

Provisions on manufacturing licences are set out in Part 6 of the Bill. Licensed manufacturers are authorised to obtain or purchase cannabis or cannabis extract from the Resources Secretary or a licensed cultivator to manufacture medicinal cannabis products and undertake research. They are able to possess, package, store and transport cannabis for the purposes of their licence. However, manufacturers are not allowed to obtain or purchase cannabis seed (clauses 44, 45).

The Health Secretary is responsible for granting manufacturing licences. As is the case with cultivation licences, the Chief Commissioner of Victoria Police must approve the applicant for a manufacturing licence, the applicant and each of their associates must be a fit and proper person and have not been found guilty of a serious offence in Victoria or elsewhere within 10 years before the application is made, and the premises is suitable for manufacturing (clause 52).

The Health Secretary may also consider 'suitability matters' (clause 52(2)(a)).[footnote 83] The Health Secretary could also consider any offence the applicant has committed in the 10 years prior to the application (clause 52(2)(b)).

A manufacturing licence lasts for three years (clause 53).

As is the case with licensed cultivators, a licensed manufacturer is also required to issue an identification certificate to each employee. Clause 56 specifies the information that this certificate must contain. A breach of this requirement may result in a penalty of 60 penalty units.

The Health Secretary may also place conditions on the manufacturing licence, or amend, renew, suspend or cancel a manufacturing licence (see clauses 54, 58-63).

Contracts between cultivators and manufacturers

Part 7 provides that a licensed cultivator or manufacturer can apply to the Health Secretary to register a contract between cultivator and manufacturer. The Health Secretary must keep a contracts register and notify the Resources Secretary.

Health Secretary's functions - obtaining, purchasing, registering, selling and supplying medicinal cannabis products

The Health Secretary can obtain or purchase medicinal cannabis products from a licensed manufacturer (clause 69). The Health Secretary is also responsible for approving that a medicinal cannabis product is of sufficient standard and quality to be suitable for patients (clause 70). Under clause 71, the Health Secretary must keep a publicly accessible register of approved medicinal cannabis products.

The Health Secretary is then authorised to sell or supply the medicinal cannabis products to a pharmacist. In turn, the pharmacist is authorised to obtain or purchase, possess, store, sell, supply and transport any approved medicinal cannabis products (clause 72).

A maximum price at which a pharmacist can sell the medicinal cannabis products may be set by the Health Secretary in a notice in the Government Gazette (clause 73). The Health Secretary can also direct the pharmacist in the way they sell or supply the medicinal cannabis products.

The Health Secretary can also sell or supply medicinal cannabis to authorised researchers (clause 75).

Practitioner medicinal cannabis authorisations

The Bill sets out the authorisations that medical practitioners may apply for with regard to medicinal cannabis in Part 9. There are three different types of 'practitioner medicinal cannabis authorisations' — for eligible patients, for research purposes or for exceptional circumstances. These authorisations enable the specialist or registered medical practitioners specified to issue a patient medicinal cannabis authorisation to the patient or participant, and to supply the approved medicinal cannabis product by the issue of that patient authorisation. For research purposes, further provisions for practitioners to possess, store, transport and perform other activities also apply (clause 77).

Clauses 78 and 79 set out how a specialist medical practitioner can apply for a practitioner medicinal cannabis authorisation for eligible patients and for research purposes. A registered medical practitioner (not necessarily a specialist) can apply for practitioner medicinal cannabis authorisation in exceptional circumstances, for situations when compassionate access is sought for a patient who does not meet the eligibility criteria (clause 80).

Under clause 81(2)(ii), the patient must ordinarily reside in Victoria in order for a practitioner medicinal cannabis authorisation to be granted.

Responsibility for granting practitioner medicinal cannabis authorisations falls to the Health Secretary, who must also keep a register of these authorisations (clauses 81 and 83). The Health Secretary may also amend, suspend or cancel practitioner medicinal cannabis authorisations (clauses 84 and 85).

Patient medicinal cannabis access authorisations

The Bill sets out provisions regarding patient medicinal cannabis access authorisations in Part 10. These authorisations allow patients to obtain, possess, store and use medicinal cannabis products. A registered medical practitioner who is specified on a practitioner medicinal cannabis authorisation can issue a patient medicinal cannabis access authorisation to a specified patient.

A pharmacist can sell, supply or transport medicinal cannabis products to a patient with a patient medicinal cannabis access authorisation, or an authorised person acting on the patient's behalf (clause 88).

Other people such as the registered medical practitioners, treating medical practitioners, the carer, parent or guardian of the patient or participant also have authority to possess, use and administer medicinal cannabis (clause 90).

Review of decisions relating to licences

A person can apply to VCAT to review decisions by the Resources Secretary or Health Secretary regarding cultivation or manufacturing licences (clause 91).

Protected information

Division 2 of Part 11 includes provisions for VCAT procedures where there may be protected information.

Offences

The Bill creates a number of new offences, which are outlined in Part 12. These offences include:

§ a medicinal cannabis licensee must report amendment or cancellation of registered contract
within three days (100 penalty units[footnote 84]);

§ a licensed manufacturer must report amendment or cancellation of Commonwealth license
within ten days (100 penalty units);

§ a medicinal cannabis licensee must report certain events, including change of details, insolvency,
bankruptcy or the licensee or associate being found guilty of an offence in Victoria or another
jurisdiction, within seven days (100 penalty units);

§ a medicinal cannabis licensee must report prescribed events within seven days (100 penalty
units);

§ a medicinal cannabis licensee must surrender a suspended or cancelled licence within 14 days
(20 penalty units);

§ a medicinal cannabis licensee must not contravene the licence (minor condition – 20 penalty
units, otherwise 100 penalty units or 12 months imprisonment, or both);

§ a medicinal cannabis licensee must prohibit access to licensed premises (100 penalty units);

§ an employee must carry an employee identification certificate (60 penalty units) and produce it
on request of a medicinal cannabis inspector (60 penalty units);

§ a medicinal cannabis licensee must not employ a disqualified person[footnote 85] (60 penalty units);

§ a disqualified person must not accept employment by a medicinal cannabis licensee[footnote 86]
(60 penalty units);

§ a medicinal cannabis licensee must ensure employees do not contravene the licence or
provisions of the Act (60 penalty units);

§ a medicinal cannabis licensee has criminal liability for failure to exercise due diligence (penalty
not exceeding the maximum penalty that applies to the offence committed by the employee);

§ a medicinal cannabis inspector must not be hindered or obstructed (100 penalty units);

§ a person must not fail to comply with any direction, requirement or order of a medicinal
cannabis inspector (100 penalty units); and

§ a person must not sell or supply medicinal cannabis which does not comply with the prescribed
labelling, container, storage, packaging or advertising requirements (if any) (20 penalty units).

Medicinal cannabis inspectors - enforcement powers

Cultivation inspectors

Division 1 of Part 13 of the Bill sets out the powers of cultivation inspectors. The Resources Secretary authorises cultivation inspectors. General powers of the cultivation inspector include the power to enter and inspect premises of cultivation licence, examine cannabis, intercept and inspect any vehicle or machine in connection with the cannabis cultivation, require documentation, take soil samples and remove cannabis specimens (clause 113).

If the inspector does take a sample, they must divide the sample into three parts and give one part to the cultivation licensee and one part to a medicinal cannabis testing facility, and retain one part untouched (clause 113(4)).

Manufacturing inspectors

The Health Secretary authorises manufacturing inspectors (clause 114). Manufacturing inspectors have similar powers to cultivation inspectors, one of the differences being that they do not take samples of soil. They make take samples of cannabis or cannabis extract and must divide any such samples into three parts, as detailed above under cultivation inspectors.

Medicinal cannabis inspectors - powers and procedures

Specific provisions apply in cases where a medicinal cannabis inspector seizes a document, takes a sample, removes a specimen, or seizes cannabis (Part 13, Division 3).

Powers of Secretaries - seized cannabis

Division 4 of Part 13 provides for the powers of the Resources Secretary and the Health Secretary with regard to cannabis which has been seized. Processes may include disposing of the seized cannabis, returning it, or retaining it as evidence in legal proceedings, as appropriate.

General

Part 14 outlines general provisions including authorisations for medicinal cannabis testing facilities. Under clause 135, the Health Minister must put in motion an independent review of the Act by the fourth anniversary of the commencement of this clause.

The Governor in Council may make regulations on many different aspects of the medicinal cannabis access scheme. Regulations may include:

§ prescribing quality standards for cultivation, manufacturing or approved medicinal cannabis
products;

§ prescribing cultivation and manufacturing licence conditions;

§ prescribing forms;

§ regulating premises, vehicle and machinery connected with cultivation, manufacturing or
destruction of cannabis;

§ regulating transport of medicinal cannabis products;

§ security and signage requirements;

§ the manner in which inspections are undertaken;

§ record-keeping requirements;

§ the sale, supply, storage and security of medicinal cannabis products;

§ preventing misuse of medicinal cannabis;

§ regulating the advertising of medicinal cannabis;

§ the colouring of medicinal cannabis products;

§ regulating the sale of medicinal cannabis;

§ specifying the packaging and containers for medicinal cannabis products;

§ labelling medicinal cannabis products;

§ specifying the persons or classes of persons authorised to purchase, obtain, possess, use or
administer medicinal cannabis products; and,

§ the administration and use of approved medicinal cannabis products (clause 136).

Amendment of the Drugs, Poisons and Controlled Substances Act 1981

The Bill makes a number of amendments to the Drugs, Poisons and Controlled Substances Act 1981 (Part 15 of the Bill). Amendments include provisions regarding:

§ definitions relating to medicinal cannabis products, licensing and authorisation;

§ persons authorised to possess poisons or controlled substances;

§ wholesale manufacture, sale or supply of poisons or controlled substances;

§ labelling offences;

§ sale of substances in unauthorised containers;

§ administration of drugs of dependence in aged care services;

§ inspections of premises;

§ duties of officers regarding seized substances;

§ drug trafficking;

§ supply of drug of dependence to a child;

§ possession of drug making equipment, chemicals, documents or instructions;

§ cultivation of narcotic plants;

§ possession of a drug of dependence;

§ introducing a drug of dependence into the body of another person;

§ use of a drug of dependence;

§ forging prescriptions;

§ obtaining drugs of dependence by false representation; and,

§ lists of licences and permits.

The Bill also inserts a new section 129A into the Drugs, Poisons and Controlled Substances Act 1981 which details the regulations regarding medicinal cannabis that may be made by the Governor in Council.

Consequential amendments

Consequential amendments apply to the following Acts:

§ Crimes Act 1958

§ Guardianship and Administration Act 1986

§ Health Records Act 2001

§ Mental Health Act 2014

§ Pharmacy Regulation Act 2010

§ Prevention of Cruelty to Animals Act 1986


Stakeholder and Community Views

This section outlines the comments of interested parties concerning medicinal cannabis, including surveys of community opinion, submissions to the VLRC's Medicinal Cannabis Issues Paper, and newspaper editorials.

Surveys

There appears to be significant community support for the medicinal use of cannabis.

According to a Roy Morgan telephone survey of 644 people on 20-22 October 2015, 91 per cent of respondents stated that the use of marijuana for medical purposes should be made legal.[footnote 87]

In May 2015, Palliative Care Australia published a survey of 1,000 people across Australia which found 67 per cent of respondents supported the use of medicinal cannabis. Support was highest among the elderly, with 72 per cent of 75-84 year olds stating they would vote to legalise medicinal cannabis, compared to 62 per cent of 18-24 year olds. Opposition to the use of medicinal cannabis was relatively low (9 per cent), but about a quarter (24 per cent) said they were not sure. [footnote 88]

A similar level of support for medicinal cannabis was found by a ReachTel survey of 3,431 Australian residents in 21 July 2014, with 65.9 per cent of respondents supporting the legalisation of cannabis for medical purposes. Respondents in the 51-65 year old age bracket showed the highest percentage of support (69.9 per cent).[footnote 89]

In the 2013 National Drug Strategy Household Survey by the Australian Institute of Health and Welfare, around 69 per cent of respondents supported a change in legislation permitting the use of marijuana for medical purposes, and 75 per cent of respondents were in favour of clinical trials into medical marijuana (see Table 4).[footnote 90]

Table 4: Support* for measures relating to cannabis use in medical settings, people aged 14 years or older, 2004 to 2013 (per cent)

Measure

2004

2007

2010

2013

A change in legislation permitting the use of marijuana

for medical purposes

67.5

68.6

68.8

69.1

A clinical trial for people to use marijuana to treat

medical conditions

73.5

73.6

74.0

74.7

* Support or strongly support (calculations based on those respondents who were informed enough to indicate their level of support). Source: Table 9.13, 2013 National Drug Strategy Household Survey.

VLRC submissions

The Victorian Law Reform Commission received 99 written submissions in response to their Issues Paper on Medicinal Cannabis, which was released in March 2015.[footnote 91] The following section outlines the submissions of several interested parties from the medical, legal, consumer and law enforcement sectors.

Australian Medical Association (Vic)

In their submission to the VLRC, the Victorian branch of the Australian Medical Association (AMA) expressed concern about departing from the principles of evidence-based medicine, even in exceptional circumstances. They advocated for further clinical trials to be undertaken before medicinal cannabis is made available for use.[footnote 92] The AMA (Vic) also preferred a coordinated national approach to regulation of medicinal cannabis, rather than regulation on a state-by-state basis.[footnote 93]

MS Australia and MS Research

MS Australia and MS Research Australia placed emphasis on proven treatments which have been approved by the TGA. They advocated for further clinical trials of medicinal cannabis, and currently prefer the pharmaceutical cannabis product 'Sativex' as an option in the treatment of multiple sclerosis.[footnote 94]

Law Institute of Victoria

In their submission to the VLRC, the Law Institute of Victoria (LIV) noted the need to collaborate with the Commonwealth in establishing a medicinal cannabis scheme in Victoria. As cultivation and manufacture of medicinal cannabis falls under three international agreements, there is potential for Commonwealth interference in a state-based scheme if there is no collaboration in some way.[footnote 95]

The LIV suggested a Special Access Scheme for the importation of already established medicinal cannabis products such as those available in the Netherlands (Bedrobinol, Bedrocan, Bediol and Bedica) as the best option in the first instance. These products are already regulated for quality and consistency, and using the special access scheme for such regulated therapeutic products may reduce difficulties between state and Commonwealth legislation. Importation could provide an initial pathway to access 'while the local market and regulatory framework is being established'.[footnote 96]

The LIV argued that medicinal cannabis differs from the poppy industry, as opiates are an established approved and regulated pharmaceutical product under the TGA, with an international market. By contrast, the LIV stated that it is not clear whether medicinal cannabis will be commercially viable as an industry, and whether medical practitioners and pharmaceutical companies will want to participate, considering the unavailability of clinical evidence of efficacy and potentially limited demand. While acknowledging that replicating a regulatory scheme similar to the opiate poppy industry may be an option for medicinal cannabis, the LIV points out that the lack of a federally approved and regulated product creates legal issues that were not applicable to the poppy industry.[footnote 97]

Australian Nursing and Midwifery Federation

The Australian Nursing and Midwifery Federation (ANMF) supported the legalisation of cannabis for the treatment of terminal and life-threatening illnesses and in palliative care. In addition, the ANMF supported appropriate regulation for sourcing, prescribing and administering medicinal cannabis.

The ANMF also argued that exhausting all other treatments should not be a necessary requirement in order to access medicinal cannabis, as this may prove too lengthy a process and prolong the suffering of patients.

The ANMF stated that they 'do not support that the quantum or quality of existing research should limit, delay or prohibit the legalisation of medicinal cannabis'.[footnote 98]

Victoria Police

As a law enforcement agency, Victoria Police did not see themselves as being in a position to recommend any model for decriminalisation, recognising that this is a decision for the legislature. In their submission to the VLRC, Victoria Police aimed to present certain parameters to be considered in legalising medicinal cannabis, in order to limit potential risks to public safety.

The Victoria Police emphasised the need to avoid diversion of cannabis to criminal groups and the risk to public safety. In particular, Victoria Police expressed concern about potential risks of medicinal cannabis in relation to road safety. In their submission, Victoria Police stated that 55,817 roadside drug tests were conducted by Victoria Police in 2014. Of these tests, 1,368 drivers tested positive for cannabis, either alone or with another illicit substance. Victoria Police stated that this means cannabis was present in 2.45 per cent of the roadside tests.[footnote 99]

Victoria Police offered several parameters to the VLRC for consideration:

§ any proposed scheme must be time limited;

§ crude cannabis must be excluded;

§ personal cultivation must be prohibited;

§ supply and distribution of medicinal cannabis must be strictly regulated;

§ there must be strict eligibility requirements for prescriptions;

§ registered medical professionals must be the prescribing authority;

§ any scheme must provide for a register of prescribers and patients;

§ legislative considerations should include provisions to manage possession of medicinal cannabis;
and

§ effects on road safety must be a paramount consideration.[footnote 100]

Victorian Alcohol and Drug Association

As the peak body for the Victorian alcohol and other drug sector, the Victorian Alcohol and Drug Association (VAADA) made a submission to the VLRC. Acknowledging the growing evidence for the efficacy of medicinal cannabis and the global trend towards legalising cannabis for medical purposes, VAADA supported access to medicinal cannabis scheme in Victoria for patients with specific conditions for which cannabis can bring relief.

VAADA noted that cannabis features significantly as both a principal and contributing substance to alcohol and other drugs (AOD) treatment services. As with other medications where dependence and misuse is possible, VAADA emphasised the need for safeguards when regulating medicinal cannabis. They suggest that this could involve ensuring that the composition of the substance is such that there is minimal recreational value to those who may consume it without a prescribed medical reason.

VAADA also argued that the risk of diversion is minimal. Cannabis is already the most accessible and affordable illicit drug in Australia, so it is unlikely that medicinal cannabis would have much 'street value' or result in significant increase in illicit use.[footnote 101]

With regard to acute drug toxicity mortality, VAADA compared cannabis to pharmaceutical opioids, which contributed to 185 deaths in 2014, or just less than half of all overdose related drug deaths in Victoria. By contrast, VAADA stated that the Victorian Coroner's Court has never named cannabis as a contributing substance in acute drug toxicity mortality.[footnote 102]

Cancer Action Victoria

Cancer Action Victoria (CAV) is a state-based consumer advocacy organisation which aims to improve the experience of Victorians affected by cancer. In their submission to the VLRC, CAV advocated for access to medicinal cannabis for patients with conditions where there is clinical knowledge to support the use of medicinal cannabis. They argued that cancer should be registered as one such condition. CAV disagreed with the view that medicinal cannabis should only be viewed as a treatment of last resort, arguing that medicinal cannabis should 'resume its place in the pharmacopoeia, to be used alone or in combination with other pharmaceuticals'. [footnote 103]

CAV expressed the view that medicinal cannabis should not be regulated under therapeutic goods legislation or narcotic drugs legislation, but regulated separately. The reason stated was that cannabis is not simply one drug but a complex combination of multiple chemical substances which may work best as an 'entourage'. In the form of pharmaceutical products such as Sativex or Dronabinol, CAV argues medicinal cannabis can be prohibitively expensive, as well as difficult to prepare and titrate.[footnote 104]

CAV advocate for all forms of medicinal cannabis to be made available to patients, including fresh, dried, cold extractions/concentrates and heated extractions/concentrates. They argue that patients with terminal cancer should be allowed to smoke medicinal cannabis, as the long-term risk of lung cancer is not relevant in these cases.[footnote 105]

Media editorials

Following the release of the VLRC's final report in October 2015, an editorial in The Age newspaper expressed support for the VLRC's recommendations, stating that the proposed scheme was 'pragmatic and properly balanced'.[footnote 106] While acknowledging that more evidence on the efficacy of cannabis is needed, The Age argued that there are good reasons to allow compassionate access to medicinal cannabis for patients with certain severe and chronic conditions.[footnote 107]

In a 2014 editorial, the Herald Sun expressed sympathy for patients who were suffering and faced difficulties accessing medicinal cannabis legally. The Herald Sun advocated for further trials to be done quickly so that the efficacy of medicinal cannabis could be assessed for the benefit of patients and their families.[footnote 108]

After the Federal Health Minister Sussan Ley's announcement in October 2015, an editorial in The Australian expressed support for the Federal Government's proposal to introduce a national cultivation scheme. The Australian viewed the decision as 'timely', stating that a national licensing system would be able to provide a quality-controlled and reliable supply of medicinal cannabis, giving 'peace of mind' to patients.[footnote 109]

Other Jurisdictions

This section provides information on developments to regulate access to medicinal cannabis in Australia and overseas.

Australia

At a Council of Australian Governments (COAG) Health Council meeting in October 2014, Commonwealth, state and territory health ministers discussed the issue of medicinal cannabis. While reinforcing their opposition to the recreational use of cannabis, ministers 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.'[footnote 110] This section discusses the initiatives involving medicinal cannabis announced by several Australian jurisdictions that are underway or about to commence.

Commonwealth

The Regulator of Medicinal Cannabis Bill was introduced by Greens Senator Richard Di Natale in November 2014. The Bill proposed a national regulator body that would be responsible for formulating rules for licensing of growers of cannabis for medical use, the manufacturing of approved cannabis products and the supply of regulated medicinal products to authorised patients. The Bill also proposed a register for medicinal cannabis products that would be separate from the Therapeutic Goods Act 1989. In setting up the Regulator, the Bill would meet Australia's obligations under the Single Convention on Narcotic Drugs 1961 (Single Convention) which requires a state signatory to control and monitor the production of controlled substances for medical and scientific purposes.[footnote 111]

The Bill was referred to the Senate Legal and Constitutional Affairs Legislation Committee, which reported in August 2015.[footnote 112] While the committee was broadly supportive of the use of proven safe and effective cannabis derived products for particular medical conditions, it raised concerns about the Bill's interaction with the existing regulatory framework for medicinal products, including the Therapeutic Goods Act and the Narcotic Drugs Act 1967. The Committee also raised concerns that the functions of the Regulator were not as clearly stated as it needed to be to meet the requirements of the Single Convention. It asked that the Bill be amended so as to avoid possible 'duplication, contradiction and uncertainty'.[footnote 113]

The Committee recommended Commonwealth consultation with states and territories to avoid any contradiction with state and territory regimes, and confusion for patients accessing the medicinal cannabis scheme. It stated that this would also help ensure that such a scheme would comply with Australia's international obligations under the Single Convention.[footnote 114]

On 12 October 2015, Senator Di Natale indicated that the Bill to create the national regulator was anticipated to be put to a Senate vote in November 2015.[footnote 115] On October 17 Federal Health Minister Sussan Ley, announced the government's plans to amend the Narcotics Drugs Actto allow for controlled cultivation of cannabis for medical and scientific purposes, and a Commonwealth licensing scheme for suppliers. States and territories would be required to introduce equivalent legislation in order for cultivation to proceed — essentially allowing for the states and territories to license growers in their own jurisdiction. The legislation would also ensure regulation of new medicinal products would continue to reside with the TGA.[footnote 116]

In December 2015, however, Health Minster Ley announced that the federal government had decided to introduce legislation for a single national scheme for growers in all states and territories. The legislation would be introduced in Parliament's first sitting fortnight of 2016.[footnote 117]

New South Wales

Premier Michael Baird announced on 16 September 2014 that a clinical trial into the use of cannabis to treat terminally ill patients would take place in New South Wales.[footnote 118] The trial would be devised by a working party, which would report back at the end of 2014. This follows an earlier announcement by Nationals MP Kevin Anderson that he would introduce a private member's Bill to legalise cannabis for medical use.[footnote 119]

In December 2014, Premier Baird announced the commitment of $9 million over the next five years for three clinical trials of medicinal cannabis. The clinical trials were to explore the use of cannabis and cannabis products for adults with advanced cancer; children with severe paediatric epilepsy; and cancer patients suffering chemotherapy-induced nausea.[footnote 120]

Extra funding of $12 million over four years was allocated to the new Centre for Medicinal Cannabis Research and Innovation in June 2015. The centre — which would establish a research network, provide grants, support stakeholders, and educate the public — would also monitor and report on progress and findings of the clinical trials.[footnote 121]

In October 2015, the New South Wales Government signed a memorandum of understanding (MOU) with UK based GW Pharmaceuticals. The MOU allows for NSW children suffering from severe childhood epilepsy to participate in clinical trials for a cannabinoid product containing cannabidivarin (CBDV) – a world first for such a trial. $3.5m was allocated to the Sydney Children's Hospital Network to lead the trial. The MOU also provides for compassionate access to a secure supply of the GW product, Epidolex, from early 2016 for children suffering severe childhood epilepsy and who are not participating in clinical trials, as well as further clinical trials of the product in children with treatment-resistant epilepsy.[footnote 122]

Separate from the clinical trials, the Terminal Illness Cannabis Scheme (TICS) formalised existing NSW Police discretion in not bringing charges of possession to terminally ill patients who use cannabis to alleviate their symptoms, and carers who assist them.[footnote 123] TICS is a registration scheme for NSW residents over the age of 18 years who have a terminal illness, and requires certification by a medical practitioner involved in the ongoing care of the patient in question. Registered adults are allowed to be in possession of specified maximum amounts of cannabis leaf, oil or resin.[footnote 124]

Australian Capital Territory

Chief Minister Katy Gallagher made a request in October 2014 for the ACT to be involved in the New South Wales clinical trial of medical cannabis.[footnote 125] Ms Gallagher had expressed a preference for a nationally coordinated response and wrote to federal Health Minister Peter Dutton in August 2014 proposing an Australia-wide clinical trial.[footnote 126]

Draft legislation sponsored by Greens Minister Shane Rattenbury in August 2014 was considered by a committee of the ACT Legislative Assembly. The proposed legislation would allow terminally and chronically ill patients in Canberra to grow and use cannabis to manage their pain and symptoms after applying for and receiving approval from the ACT Chief Health Officer.[footnote 127]

The report, tabled in the Legislative Assembly on 13 August 2015, recommended the ACT government work with other state and territory governments on a national medical cannabis scheme, while rejecting Mr Rattenbury's Bill. [footnote 128] The committee called on the federal government to improve access to synthetic cannabinoids – listing Sativex and Marinol (dronabinol) on the national Pharmaceutical Benefits Scheme – and for changes to laws concerning further clinical trials of cannabis.[footnote 129] Encouraged by the developments in medicinal cannabis laws in Victoria, Mr Rattenbury stated he would be introducing a private members' bill if no progress was made in the ACT by mid-2016.[footnote 130]

Queensland

In April 2015, Queensland Premier Annastacia Palaszczuk announced that trials of the use of medicinal cannabis would be established in Queensland in conjunction with New South Wales.[footnote 131] In August 2015, Health Minister Cameron Dick ordered that clinical trials for children with epilepsy commence in 2016,[footnote 132] with an announcement in October 2015 that Brisbane's Lady Cilento Children's Hospital would host the $3million trial site. The Minister also flagged the legalisation of the use of the synthetic cannabinoid Sativex for adults with multiple sclerosis.[footnote 133]

Tasmania

A committee of the Tasmanian Legislative Council established in July 2014 conducted an inquiry into the possible legalisation of cannabis for medical use in Tasmania.[footnote 134] The committee tabled its Interim Report in November 2014, and decided to conclude its inquiry in March 2015 in light of the introduction of the Senate Regulator of Medicinal Cannabis Bill 2014 and establishment of clinical trials in New South Wales.[footnote 135] Of its six recommendations, including a legislative framework for use and cultivation of medicinal cannabis, the government supported cooperation with mainland states in research, including clinical trials.[footnote 136]

In December 2015, the Tasmanian government signed a memorandum of understanding with New South Wales following a decision to participate in the New South Wales medicinal cannabis clinical trials. The MOU covers clinical trials, research, and cultivation of cannabis for medical and scientific purposes.[footnote 137]

International jurisdictions

The approach of international jurisdictions to medicinal cannabis schemes varies markedly in the way they regulate the legal access of patients to cannabis products. An analysis of medicinal cannabis laws divides the medicinal cannabis regimes in overseas jurisdictions into three general models: the 'prescription model' of the Netherlands; the 'statutory exemption model' of Canada and some states in the United Sates; and the 'defence model' employed by some states of the United States which recognises the defence of 'medical necessity' as applied to medical use of cannabis.[footnote 138] This section discusses some of the features of the medicinal cannabis access schemes in the Netherlands, Canada, the US and Israel.

Jurisdictions also regulate the form in which medicinal cannabis can be used. The Netherlands does not permit the sale of cannabis oil, edible or other infused products, while four types of medicinal cannabis are available in the form of dried plant material.[footnote 139] Until June 2015, this was also the case in Canada until a Supreme Court determination in R v Smith 2015 SCC 34found that restricting medical access to cannabis in its dried form infringed a person's right under section 7 of the Canadian Charter of Rights and Freedoms.[footnote 140] Supplies in alternative forms such as cannabis oil were, up to then, obtained through a process facilitated by 'compassion clubs'.[footnote 141] Israel also limits the availability of derivatives to cannabis oil and dried plant material (which can be smoked or packaged inside gel capsules). Some states in the US only permit forms of cannabis that cannot be smoked – infusions such as oils and foods – and forms which can be vaporised, while New York specifically prohibits smoking as a method of delivery.[footnote 142]

Netherlands

The Netherlands regime allows doctors complete discretion in determining the conditions and circumstances of patients that will benefit from treatment with medicinal cannabis. Additionally the Opium Act, amended in 2003, allows pharmacies to provide cannabis legally to patients on a doctor's prescription. The cultivation of the plant by a single state-licensed supplier (Bedrocan BV) is tightly regulated to ensure consistency in a standardised product with stated THC and CBD content – allowing doctors to determine appropriate dosage, and patients to control effects and use.[footnote 143]

Canada

The Canadian medicinal cannabis regulation has evolved through litigation in the higher courts where patients' rights to 'liberty and security' have been tested. Statutory exemption was created initially when an Ontario Court of Appeal case found that the prohibition of cultivation and possession of cannabis under the Controlled Drugs and Substance Act 1996 was unconstitutional as it did not provide an acceptable exemption for medical use. The Marihuana Medical Access Regulations 2001 provided statutory exemption from criminal prosecution for patients who, on application to the Minister of Health, obtained an 'authorization to possess'. Applications required a declaration from the applicant's medical practitioner stating the medical condition, symptoms, maximum quantities of dried marihuana to be authorised, the method of delivery, and that other conventional treatments had been considered or tried and proven to be ineffective or inappropriate. At that time, authorized patients could obtain a legal supply of medicinal cannabis from Health Canada, personal production for own use, or production by a designated person.[footnote 144]

When in 2012, the Marihuana Medical Access Program that administered the scheme, found that statistics revealed more than half those holding 'authorization to possess' also held 'personal-use production' licences, there were concerns that the system was open to abuse. In 2013, the Marihuana for Medical Purposes Regulations (MMPR) came into force, placing the production and supply of medicinal cannabis in the hands of licenced commercial producers only. Personal and designated person production was to end with the expiry of licences on 31 March 2014. However, due to interlocutory injunctions granted in the courts,[footnote 145] some licences may extend beyond that date.[footnote 146]

While the procedures for prospective medicinal cannabis users remain largely the same under the new MMPR scheme where patients consult with their doctors, applications to the Minister (that is, registration with the government) is no longer required.[footnote 147] Patients are issued with a standard form 'medical document' – similar to a typical prescription – allowing access to specified strain and quantities from a single licensed producer of their choice. The conditions for which a doctor can support the medical use of cannabis are no longer restricted, and less information is required.[footnote 148] According to Dr Ian Freckleton QC, former Specialist Commissioner to the VLRC's investigation into medicinal cannabis, the Canadian Medical Association and College of Family Physicians of Canada have raised concerns about pressures being placed on them to prescribe medical marijuana given insufficient supporting evidence on clinical risks and benefits and the absence of 'regulatory oversight'.[footnote 149] Nurse practitioners authorised to write prescriptions can also authorise patient access to medicinal cannabis.[footnote 150]

United States of America

States are limited in the design of their medicinal cannabis access schemes given that federal law prohibits doctors and pharmacies from prescribing and selling cannabis.[footnote 151] While federal law is clear on its prohibition of marijuana as enshrined in the Controlled Substances Act 1970, guidance issued by the Department of Justice in 2009 sought to address the issue of medical use of marijuana by advising federal prosecutors to limit the pursuit of individuals who do not violate state medical marijuana laws. This was couched in the following terms:

prosecution of individuals with cancer or other serious illnesses who use marijuana as part of a recommended treatment regimen consistent with applicable state law, or those caregivers in clear and unambiguous compliance with existing state law who provide individuals with marijuana, is unlikely to be an efficient use of limited federal resources.[footnote 152]

The memorandum strongly warned against state laws violating federal laws – priorities of which were enumerated in a 2013 memorandum – and reiterated federal authority to intervene and enforce federal law.[footnote 153]

Various legislative permutations allowing for access and supply of marijuana for medical purposes have evolved to accommodate federal restrictions. Twenty-three states and the District of Columbia have legislated to legalise 'comprehensive' medical marijuana and cannabis programs. Comprehensive programs provide protection from state-level criminal prosecutions, access through home cultivation or dispensaries, allow for a variety of strains, and allow smoking or vaporization of marijuana products, plant material or extracts.[footnote 154] All states require that qualifying patients are certified by a physician as having a medical condition that would benefit from the medical use of marijuana.[footnote 155] Most states specify conditions (eg. cancer, HIV/AIDS, glaucoma) or symptoms, with options for the state's departments of health to expand the list. With the exception of Maine and California, patient registration is mandatory, and qualifying patients are issued with identification cards by the state agency that maintains the confidential register. Nineteen states provide for dispensaries and all states specify possession limits.[footnote 156]

Seventeen states recently enacted 'limited access medical marijuana laws'. These states allow only the use of marijuana or marijuana products from certain strains that are low in THC and, additionally, have high concentrations of cannabidiol (CBD) in certain limited conditions or as a legal defence. The states limited access regimes specify the products be used in research (clinical trials) or treatment of specific medical disorders, such as intractable epilepsy or seizures. Provisions are also made for use by minors.[footnote 157]

Some states have special legislative provisions for 'affirmative defence' which protects patients from conviction – where medical necessity can be used as a defence – but not enforcement (arrest). Legal protection is contingent on enrolment in the state patient register. Apart from the complexities presented by the state of the US medical marijuana programs it is also worth noting that many schemes have only very recently been introduced, with various features still to be enacted or tested. For example, the limited access regime to be introduced in Idaho was vetoed by its Governor in April 2015.[footnote 158]

Israel

In Israel, the use of cannabis for medical purposes is limited to patients suffering from a specified list of conditions. Cannabis is available to all within the category of the terminally ill and those undergoing chemotherapy. In cases such as cancer, or where symptoms are sufficiently severe, such as Parkinson's disease, multiple sclerosis and neuropathic pain, patients must have had failed to respond to conventional or alternative treatments.[footnote 159] The list of eligible conditions can be expanded and timeframes for delivery of cannabis for each type of condition is also specified. For example requests for cannabis for terminally ill patients must be processed within 48 hours. Medical practitioners have to be authorized by the government to permit the use of cannabis by patients for medical purposes.[footnote 160]

 

Research & Inquiries Service

Research Notes are produced by the Parliamentary Library's Research & Inquiries service. They provide analysis on selected components of new Bills and topical issues in response to, and in anticipation of, the needs of Members of the Victorian Parliament.

This research publication is current as at the time of printing. It should not be considered a complete guide to the particular subject or legislation covered. While it is intended that all information provided is accurate, it does not represent professional legal opinion. Any views expressed are those of the author(s).

Some hyperlinks may only be accessible on the Parliament of Victoria's intranet. All links are current and available as at the time of publication.

Authors

Alice Jonas & Marianne Aroozoo

Research & Inquiries

Victorian Parliamentary Library & Information Service

Department of Parliamentary Services

 


[footnote 1] D. Andrews, Premier (2015) Medicinal Cannabis to be Legalised in Victoria, media release, 6 October.

[footnote 2] J. Hennessey, Minister for Health (2015) Second Reading Speech: Access to Medicinal Cannabis Bill 2015, Debates, Victoria, Legislative Assembly, 10 December, p. 5528.

[footnote 3] ibid.

[footnote 4] ibid.

[footnote 5] M. Baird (2015) 'How a young man changed my mind on marijuana', Daily Telegraph, 28 July, p. 13; D. Andrews, Premier (2015) Victoria to Participate in Medicinal Cannabis Trial, media release, 19 April. See also D. Andrews, Premier (2016) Australian First Clinical Trial For Kids With Epilepsy Starts in Victoria, media release, 3 February; R. Spooner & J. Medew (2016) 'Victorian children with epilepsy to take part in medical marijuana trial', The Age, 3 February.

[footnote 6] V. Desloires & L. Battersby (2014) 'Victoria to legalise medicinal cannabis', The Age, 19 December.

[footnote 7] H. Cook (2014) 'Labor will pursue cannabis reform', The Age, 25 August, p. 3.

[footnote 8] D. Davis, Minister for Health (2014) Coalition Government to Enable Cannabis Trials, media release, 28 August.

[footnote 9] For further information on the Drugs, Poisons and Controlled Substances Amendment (Clinical Trials) Bill 2014, see also A. Jonas (2014) Drugs, Poisons and Controlled Substances Amendment (Clinical Trials) Bill 2014, Research Brief, Parliamentary Library & Information Service, October.

[footnote 10] D. Davis, Minister for Health (2014) op. cit.

[footnote 11] Desloires & Battersby (2014) op. cit.

[footnote 12] ibid.

[footnote 13] Victorian Law Reform Commission (2015) Medicinal Cannabis: Report, Melbourne, VLRC, August.

[footnote 14] D. Andrews, Premier (2015) Medicinal Cannabis to be Legalised in Victoria, op. cit.

[footnote 15] J. Hennessy, Minister for Health (2015) 3AW Mornings, radio interview, 7 October.

[footnote 16] D. Andrews, Premier (2015) Medicinal Cannabis to be Legalised in Victoria, op. cit.

[footnote 17] ibid. For more information on the VLRC report, see the 'VLRC Recommendations' section of this Research Note.

[footnote 18] P. Riordan (2015) 'Turnbull government moves to allow states to legalise medicinal cannabis', Australian Financial Review, 17 October, p. 7.

[footnote 19] J. Lee (2015) 'National scheme to regulate medicinal cannabis growers', The Age, 2 December.

[footnote 20] D. Andrews, Premier (2016) Australian First Clinical Trial For Kids With Epilepsy Starts in Victoria, op. cit.

[footnote 21] ibid.; Spooner & Medew (2016) 'Victorian children with epilepsy to take part in medical marijuana trial', op. cit..

[footnote 22] General Purpose Standing Committee No. 4 (2013) The Use of Cannabis for Medical Purposes, final report, New South Wales, Parliament, Legislative Council, 15 May, p. 3.

[footnote 23] ibid, p. 4.

[footnote 24] ibid., pp. 3-4. Other compounds in cannabis plants may also have therapeutic properties. Researchers at the University of Sydney have identified what they call the 'big 10' non-psychoactive and non-addictive cannabinoids that show potential for medicinal use. See VLRC (2015) Medicinal Cannabis: Report, op. cit., p. 22

[footnote 25] VLRC (2015) Medicinal Cannabis: Report, op. cit., pp. xvi-xvii.

[footnote 26] General Purpose Standing Committee No. 4 (2013) op. cit., p. 4..

[footnote 27] ibid., pp. 4-5.

[footnote 28] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. 21.

[footnote 29] General Purpose Standing Committee No. 4 (2013) op. cit, pp. 5-6.

[footnote 30] VLRC (2015) Medicinal Cannabis: Report, op. cit., pp. 32-3.

[footnote 31] ibid., p. 33.

[footnote 32] ibid., p. 34.

[footnote 33] D. Gloss & B. Vickrey (2014) 'Cannabinoids for Epilepsy (Review)', Cochrane Database of Systematic Reviews, 3.

[footnote 34] B. Koppel et. al. (2014) 'Systematic Review: Efficacy and Safety of Medical Marijuana in Selected Neurological Disorders: Report of the Guideline Subcommittee of the American Academy of Neurology', Neurology, 82, pp. 1556-1563.

[footnote 35] Epilepsy Australia (2014) "Medical Marijuana" in the Treatment of Epilepsy, 30 October, Epilepsy Australia website.

[footnote 36] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. 36.

[footnote 37] ibid., p. 38.

[footnote 38]ibid., p. 39. See M. Tramer et. al. (2001) 'Cannabinoids for control of chemotherapy induced nausea and vomiting: quantitative systematic review', British Medical Journal, 323, pp. 1-8; J. Kramer (2015) 'Medical marijuana for cancer', CA: A Cancer Journal for Clinicians, 65, pp. 109-122.

[footnote 39] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. 40.

[footnote 40] ibid., p. 44.

[footnote 41] ibid.

[footnote 42] ibid., p. 45.

[footnote 43] T. Wang et. al. (2008) 'Adverse effects of medical cannabinoids: a systematic review', Canadian Medical Association Journal, 178, pp. 1669-1678.

[footnote 44] M. Ware & V. Tawfik (2005) 'Safety issues concerning the medical use of cannabis and cannabinoids', Pain Research

and Management, 10, pp. 31A, 32A.

[footnote 45] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. 47.

[footnote 46] M. Ware & V. Tawfik (2005) op. cit., pp 31A, 32A-33A. See also Institute of Medicine (1999) Marijuana and Medicine, Washington D.C, National Academy Press, p. 84.

[footnote 47] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. 47.

[footnote 48] ibid., pp. 47-48.

[footnote 49] National Cannabis Prevention and Information Centre (2011) 'Cannabis Withdrawal', 1 November, NCPIC website.

[footnote 50] M. Ware & V. Tawfik (2005) op. cit., p. 33A.

[footnote 51] For example, see R. Sewell, J. Poling & M. Soluoglu (2009) 'The effect of cannabis compared with alcohol on driving', American Journal of Addiction, 18(3), pp. 185-193; P. Armentano (2012) 'Cannabis and psychomotor performance: a rational review of the evidence and implications for public policy', Drug Testing and Analysis, 5, pp. 52-56.

[footnote 52] See A. Menetrey et. al. (2005) 'Assessment of driving capability through the use of clinical and psychomotor tests in relation to blood cannabinoids levels following oral administration of 20mg dronabinol or of a cannabis decoction made with 20 or 60mg delta9-THC', Journal of Analytical Toxicology, 29, p. 327.

[footnote 53] See L. Downey et. al. (2013) 'The effects of cannabis and alcohol in simulated driving: influences of dose and experience', Accident Analysis and Prevention, 50, p. 879; R. Sewell, J. Poling & M. Soluoglu (2009) op. cit.

[footnote 54] See J. Phillips, M. Holland & D. Baldwin (2015) 'Marijuana in the workplace: guidance for occupational health

professionals and employers: joint guidance statement of the American Association of Occupational Health Nurses and the American College of Occupational and Environmental Medicine', Journal of Occupational and Environmental Medicine, 57, p. 459.

[footnote 55] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. 50.

[footnote 56] Some of these submissions are discussed in the 'Stakeholder and Community Views' section of this Research Note.

[footnote 57] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. xxii.

[footnote 58] United Nations Office on Drugs and Crime (2013) The International Drug Control Conventions, United Nations, New York, pp 43-44, 47.

[footnote 59] See Articles 19 and 20 of the Single Convention on Narcotic Drugs 1961, as in ibid., pp. 38-41

[footnote 60] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. xxv.

[footnote 61] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. xxiv.

[footnote 62] J. Hennessy, Minister for Health (2015) 3AW Mornings, radio interview, 7 October.

[footnote 63] VLRC (2015) Medicinal Cannabis: Report, op. cit., pp. xxiv-xxix.

[footnote 64] See Department of Health and Human Services, Victoria (2015) 'Pharmacotherapy (opioids replacement therapy)', Health.vic website.

[footnote 65] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. xxx.

[footnote 66] ibid.

[footnote 67] ibid., p.xxxi.

[footnote 68] ibid., pp. xxxiv-xxxv.

[footnote 69] ibid., pp. xxxv-xxxvi

[footnote 70] ibid., pp. xxxvi-xxxvii.

[footnote 71] The VLRC report states that the standards most relevant to the production of botanical medicines are those produced by

the European Medicines Agency and the World Health Organisation (VLRC (2015) Medicinal Cannabis: Report, op. cit., p. 180). See European Medicines Agency (2006) Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin, (EMEA/HMPC/246816/2005) [footnote 2.2], EMA website; World Health Organisation (2003) WHO Guidelines On Good Agricultural and Collection Practices (GACP) for Medicinal Plants, Essential Medicines and Health Products Information Portal.

[footnote 72] Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) (2009)Guide to Good Manufacturing Practice for Medicinal Products, Therapeutic Good Administration website.

[footnote 73] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. xxxix.

[footnote 74] ibid., p. xxxix.

[footnote 75] ibid., p. xxxix-xl.

[footnote 76] VLRC (2015) Medicinal Cannabis: Report, op. cit., p. xl.

[footnote 77] D. Andrews, Premier (2015) Medicinal Cannabis to be Legalised in Victoria, op. cit. The Government decided against implementing the VLRC's recommendation of broader patient eligibility in the initial stages (see 'Medical conditions' on page 12 of this Research Note). Instead, the Government intends to limit access to one patient group in the first instance - children with severe epilepsy - citing difficulties in establishing an appropriate scale and quality of cultivation and manufacture to address all conditions in the short term. Eligibility may be broadened to further patient groups on the advice of an Independent Medical Advisory Committee, which the Government proposes to establish. (See also page 3 of this Research Note.)

[footnote 78] Access to Medicinal Cannabis Bill 2015, p. 3.

[footnote 79] Explanatory Memorandum, Access to Medicinal Cannabis Bill 2015, p. 2. See also footnote 77.

[footnote 80] Explanatory Memorandum, Access to Medicinal Cannabis Bill 2015, p. 5.

[footnote 81] The current Bill and related regulations or the Drugs, Poisons and Controlled Substances Act 1981(Vic) and related regulations.

[footnote 82] A penalty unit is $151.67, as of 1 July 2015.

[footnote 83] See definition of 'suitability matters' in the previous section on cultivation licenses.

[footnote 84] A penalty unit is $151.67, as of 1 July 2015.

[footnote 85] A disqualified person is someone under the age of 17 years who is not undertaking an apprenticeship or traineeship, or who has been found guilty of a serious offence in Victoria or another jurisdiction within the last 10 years, or has been found guilty of an offence against this Act in the last five years, or has been found guilty of an offence against a corresponding law in the last five years, or belongs to a prescribed class of persons (clause 105).

[footnote 86] See above.

[footnote 87] Roy Morgan (2015) 'A massive majority of Australians support the legalisation of medicinal marijuana', 26 October, Roy Morgan website.

[footnote 88] Palliative Care Australia (2015) Survey Signals Support for Medicinal Cannabis in Australia, media release, 24 May.

[footnote 89] ReachTel (2014) 7 News - National Poll - 21st July 2014, ReachTel website.

[footnote 90] Australian Institute of Health and Welfare (2014) National Drug Strategy Household Survey: detailed report 2013, AIHW,

p. 115. 'In 2013, 23,855 people aged 12 or older provided information on their drug use patterns, attitudes and behaviours … Most of the analyses are based on the population aged 14 or older (unless specified), as this allows consistent comparison with earlier survey results..' (p. 3) It is unclear how many of the 23,855 respondents were aged 14 years or older.

[footnote 91] Victorian Law Reform Commission (2015) Medical Cannabis: Issues Paper, Melbourne, VLRC, 17 March.

[footnote 92] Australian Medical Association (Vic) (2015) Submission to the Victorian Law Reform Commission, Medicinal Cannabis Issues Paper, April, Melbourne, VLRC. The Royal Australasian College of Physicians (RACP) expressed a similar view that further clinical trials were needed, see Royal Australasian College of Physicians (2015) Submission to the Victorian Law Reform Commission, Medicinal Cannabis Issues Paper, May, Melbourne, VLRC.

[footnote 93] Australian Medical Association (Vic) (2015) op. cit.

[footnote 94] MS Australia and MS Research Australia (2015) Submission to the Victorian Law Reform Commission, Medicinal Cannabis Issues Paper, April, Melbourne, VLRC.

[footnote 95] Law Institute of Victoria (2015) Submission to the Victorian Law Reform Commission, Medicinal Cannabis Issues Paper, May, Melbourne, VLRC, p. 4.

[footnote 96] ibid., p. 5.

[footnote 97] ibid., p. 2.

[footnote 98] Australian Nursing and Midwifery Federation (2015) Submission to the Victorian Law Reform Commission, Medicinal Cannabis Issues Paper, June, Melbourne, VLRC, p. 5.

[footnote 99] Victoria Police (2015) Submission to the Victorian Law Reform Commission, Medicinal Cannabis Issues Paper, April, Melbourne, VLRC, p. 4.

[footnote 100] ibid., pp. 5-8.

[footnote 101] Victorian Alcohol and Drug Association (2015) Submission to the Victorian Law Reform Commission, Medicinal Cannabis Issues Paper, April, Melbourne, VLRC, p. 2.

[footnote 102] ibid.

[footnote 103] Cancer Action Victoria (2015) Submission to the Victorian Law Reform Commission, Medicinal Cannabis Issues Paper, May, Melbourne, VLRC, p. 2.

[footnote 104] ibid., pp. 2-3.

[footnote 105] ibid., p. 5.

[footnote 106] (2015) 'It's high time medicinal cannabis was legal', The Age, 12 October, p. 18.

[footnote 107] ibid. See also (2014) 'Medical marijuana needs brave course', The Age, 31 August, p. 24.

[footnote 108] (2014) 'Time for new drugs debate', Herald Sun, 26 August, p. 20.

[footnote 109] (2015) 'Cannabis, farm to pharmacy', The Australian, 19 October, p. 11.

[footnote 110] Council of Australian Governments (COAG) Health Council (2014), 'COAG Health Council Communique', 10 October.

[footnote 111] VLRC (2015) Medical Cannabis: Issues Paper, op. cit., pp. 65-66.

[footnote 112] Legal and Constitutional Affairs Committee (2015) Regulator of Medicinal Cannabis Bill, Senate, Parliament of Australia, August.

[footnote 113] ibid., p. 72.

[footnote 114] ibid., p. 73.; Single Convention on Narcotic Drugs, 1961, United Nations Office on Drugs and Crime, Article 4, p. 4.

[footnote 115] J. Lee (2015) 'Legal cannabis for patients a step closer', Canberra Times, 13 October, p. 4.

[footnote 116]P. Riordan (2015) 'Turnbull government moves to allow states to legalise medicinal cannabis', Australian Financial Review, 17 October, p. 7.

[footnote 117] J. Lee (2015) 'National scheme to regulate medicinal cannabis growers', The Age, 2 December.

[footnote 118] S. Nicholls (2014) 'Medicinal cannabis clinical trial to begin in NSW', Sydney Morning Herald, 16 September.

[footnote 119] ibid.

[footnote 120]NSW Health (2015) 'Clinical trials of cannabis products', NSW Health website.

[footnote 121](2015) 'Funds for medical cannabis research', NSW Government, 15 June. Also in October 2015, the NSW Department of Primary Industries and the Centre for Medical Cannabis Research and Innovation began scouting for potential sites for the cultivation of cannabis for medical and scientific purposes, which could begin in early 2016. (2015) 'NSW exploring sites to grow medical cannabis', NSW Government website, 19 October.

[footnote 122] NSW Government (2015) 'World first for NSW medical cannabis trails for children with epilepsy', NSW Government website, 28 October.

[footnote 123] This initiative was flagged by NSW Premier Baird in September 2014 when announcing the clinical trials.

[footnote 124]NSW Government (date unknown) 'Terminal Illness Cannabis Scheme', NSW Government website.

[footnote 125] T. McIlroy (2014) 'ACT to join national medical cannabis trial', Canberra Times, 14 October.

[footnote 126] ibid.

[footnote 127] T. McIlroy (2015) 'Minister slams report on medical cannabis scheme', Canberra Times, 14 August, p. 1.

[footnote 128]Standing Committee on Health, Ageing, Community and Social Services (2015) 'Inquiry into the Exposure Draft of the Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 and Related Discussion Paper', ACT Legislative Assembly.

[footnote 129] T. McIlroy (2015) op. cit.

[footnote 130] T. McIlroy & J. Gordon (2015) 'Marijuana laws a step closer, says Rattenbury', Canberra Times, 7 October, p. 3.

[footnote 131] A. Palaszczuk (2015) 'Queensland to establish medicinal cannabis trial', media release, 19 April.

[footnote 132] K. Donaghey (2015) 'Cancer victims wait', Sunday Mail Brisbane, 23 August, p. 34.

[footnote 133] (2015) 'Medical cannabis trial', Shepparton News, 30 October, p. 21.

[footnote 134] Legislative Council Sessional Committee Government Administration A (2014) 'Legalised Medicinal Cannabis', Parliament of Tasmania website.

[footnote 135] Legislative Council Sessional Committee Government Administration A (2015) Legalised Medicinal Cannabis Final Report, media release, 26 March.

[footnote 136] Tasmanian Government (2015) Government response: report on legalised medicinal cannabis, Tasmanian Government website.

[footnote 137] B. Richards (2015) 'Tasmania to sign on to medicinal cannabis trials', The Mercury, 8 December.

[footnote 138]C. Martin (2014) 'Medical use of cannabis in Australia: "medical necessity" defences under current Australian law', Journal of Law and Medicine, 21(4), p. 890. See also VLRC (2015) Medicinal Cannabis: Issues Paper, op. cit., pp. 113-114.

[footnote 139] Martin (2014) op. cit., pp. 890-891.

[footnote 140] I. Freckleton (2015) 'Medical cannabis law reform: lessons from Canadian litigation (Editorial)', Journal of Law and Medicine, 22(4), pp. 735-736.

[footnote 141] VLRC (2015) Medicinal Cannabis: Issues Paper, op. cit., p. 113; M. Danielle-Smith (2014) 'Six-year-old medical marijuana use runs afoul of Health Canada rule', Ottawa Citizen (online), 14 July.

[footnote 142]VLRC (2015) Medicinal Cannabis: Issues Paper, op. cit., pp. 113, 114.

[footnote 143] ibid., p. 110.

[footnote 144] Martin (2014) op. cit., pp. 891-892.

[footnote 145] See discussion on Allard v The Queen [footnote 2014] FC 280 in Freckleton (2015) op. cit., p. 734; see also VLRC (2015) Medicinal Cannabis: Issues Paper, op. cit., n. 88, p.122.

[footnote 146] Health Canada (2014) 'Information for Law Enforcement', Health Canada website.

[footnote 147] Health Canada (2015) 'Procedures for Accessing Dried Marijuana for Medical Purposes under the Marihuana for Medical Purposes Regulations', Health Canada website.

[footnote 148] Martin (2014) op. cit., p. 893.

[footnote 149]Freckleton (2015) op. cit., p. 722; see L. Eggerton (2013) 'New medical marijuana regulations shift onus to doctors to prescribe', Canadian Medical Association Journal, pp. E553-E554.

[footnote 150] VLRC (2015) Medicinal Cannabis: Issues Paper, op. cit., p. 137.

[footnote 151] ibid., p. 142.

[footnote 152] D. Ogden, Deputy Attorney General (2009) 'Memorandum for selected United States Attorneys', U.S. Department of Justice, 19 October.

[footnote 153]L. Ching & J. Brannon (2014) Is The Grass Always Greener? An Updated Looked at Other State Medical Marijuana Programs, Legislative Reference Bureau of Hawaii report 1, pp. 53-54.

[footnote 154]National Conference of State Legislature (2016) 'State medical marijuana laws', NCSL website.

[footnote 155]Ching & Brannon (2014) op. cit., p. 8; NCSL (2016) ibid.; Marijuana Policy Project (2015) 'State by state medical marijuana laws', MPP website; Network of Public Health Law (2015) 'Table: State medical marijuana laws', NPHL website; ProCon (2016) "23 Legal medical marijuana states and DC', ProCon website

[footnote 156]Marijuana Policy Project (2014) 'Summary of Medical Marijuana Laws', MPP website

[footnote 157] NCSL (2016) op. cit.

[footnote 158] See the NCSL website for key aspects of state and D.C. medical marijuana laws

[footnote 159] VLRC (2015) Medicinal Cannabis: Issues Paper, op. cit., p. 116.

[footnote 160](2014) 'Israel: New directives on use of marijuana for medical purposes, Global Legal Monitor, Library of Congress, January 6. The January 2014 Directive added Post traumatic stress disorder (PTSD) to the list of qualifying conditions.