Medicinal Cannabis: Report (html)

Executive summary

Introduction

1 This report completes the Victorian Law Reform Commission’s review of law reform options that would allow people in Victoria to be treated with medicinal cannabis in exceptional circumstances. The Victorian Government has made clear its intention to change the law to this effect, and the Commission has explored how it could be done, in accordance with terms of reference provided by the Attorney-General on 19 December 2014.

2 The terms of reference call for the Commission not only to review how Victorian legislation could be amended, but also to consider its interaction with Commonwealth law and functions and international conventions. In addition, they extend to an examination of how a medicinal cannabis scheme could operate. The Commission was asked to examine prescribing practices, eligibility criteria, the role of doctors, the regulation of manufacture and distribution, and which forms of medicinal cannabis should be permitted.

3 The Commission published an issues paper in March 2015, based on its analysis of the current law and research into the use of cannabis for medicinal purposes overseas, and called for submissions. It then held a series of consultations in Melbourne and regional centres with members of the public, health and legal professionals and government officials. It consulted by telephone with regulators and others involved with medicinal cannabis schemes in other countries and, as required by the terms of reference, convened panels of medical and regulatory experts.

4 The Commission’s conclusions are summarised below and its 42 recommendations are listed at page xxxiv–xl.

Medicinal cannabis

Definition

5 In the broadest sense of the term, ‘medicinal cannabis’ is cannabis used for medicinal purposes, namely to cure or relieve the symptoms of medical conditions. The purpose for which it is used distinguishes ‘medicinal cannabis’ from cannabis utilised as food or as a recreational drug.

6 Between 80 and 100 cannabinoids and some 300 non-cannabinoid chemicals are produced by the cannabis plant. The cannabinoids that have been discovered to have therapeutic properties are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), although claims in this regard have also been made in relation to a number of other cannabinoids. THC is best known for its psychoactive, euphoriant qualities but has also been identified to have anti-emetic, analgesic, anti-inflammatory and anti-oxidant properties. To a certain degree CBD moderates the effects of THC, and is being researched for its potential to treat epilepsy, schizophrenia and other psychotic disorders, type II diabetes, inflammatory bowel disease, gliomas and drug dependency, among other conditions. A range of other non-psychoactive cannabinoids are also showing promise for the treatment of a range of diseases.

7 There are three main types of Cannabis—Sativa, Indica and Ruderalis—and multiple strains within each type. Many more strains have been produced through cross-cultivation. The different strains contain varying amounts of cannabinoids and therefore can have different effects on the user. When consumed, certain cannabinoids found in the cannabis plant are understood to lock onto specific receptor sites in the body that interact with the endocannabinoid system. Non-cannabinoid chemicals such as terpenes are also claimed to contribute to the medicinal effects of cannabis.

8 The effect on the user depends not only on the strain and chemical composition of the cannabis but also on the form and the method of its application. Cannabis that is used for medicinal purposes takes a variety of forms and is administered in a number of ways. Medicinal cannabis schemes in other countries make the following forms available, in different combinations and on different terms and conditions:

• the dried flowering tops of the cannabis plant, taken through being smoked, vaporised or infused in tea

• cannabis resin, collected and compressed from the flowering tops

• infused cannabis products, such as alcohol-based tinctures, edible oils infused with cannabis and products made from these, creams and suppositories

• extracts of cannabis, containing concentrated extracts of cannabinoids, taken orally, topically or by vaporisation

• raw, undried cannabis leaves, consumed as a food.

9 Some of these forms and delivery methods are employed by recreational users as well.

10 In submissions and consultations, and indeed worldwide, the term ‘medicinal cannabis’ is variously interpreted, from a limited definition requiring specific medical intervention to a wide definition comprehending therapeutic use by non-qualified persons. As the terms of reference do not define the term ‘medicinal cannabis’, the Commission has adopted a broad approach in consideration of the issues, and which leads, for the reasons stated in this report, to the Commission’s recommendations.

11 The Commission uses the term ‘medicinal cannabis’ to refer to products containing cannabinoids that are derived from the cannabis plant by any process whatsoever—including drying, infusing and extracting—and which are consumed with the intention of achieving a therapeutic effect, namely curing or remediating the symptoms of medical conditions. While it includes pharmaceutical grade products that are extracted from the cannabis plant, for the purposes of this report medicinal cannabis is not taken to refer to synthetic pharmaceutical products that mimic the effects of cannabinoids in the body.

How medicinal cannabis is used in Victoria

12 A broad range of Victorians use medicinal cannabis for a variety of conditions and symptoms, notwithstanding its prohibition under Victorian and Commonwealth law.

13 The Commission heard compelling stories about the dramatic improvements to their health that some cannabis users have experienced. Many spoke of the ways in which cannabis had enabled them to stop using pharmaceutical drugs with serious side effects, or to ‘get their lives back’. People without experience of medicinal cannabis told the Commission about the desperation they felt in experiencing, or watching a loved one experience, the pain and suffering of a chronic illness, and expressed sincere hope that cannabis might be effective for them and made legally available.

14 The majority of medicinal cannabis users and their relatives who spoke to the Commission said they obtained it (at varying cost) from people who specialise in the unlawful cultivation and refining of cannabis for therapeutic purposes—in Victoria and interstate. Indeed, several such producers attended the Commission’s consultations and some made written submissions. They conveyed a detailed knowledge of the cannabis plant, its varieties and refined versions, and expressed strong views about its potential therapeutic applications. In addition, an expansive submission on behalf of the ‘cannabis community’ of Victoria provided an account of illicit medicinal cannabis production and use in Victoria.^[1] Users who presently access cannabis for medicinal purposes receive significant advice and guidance from their suppliers, including instructions on strains, dosage and indications.

Evidence of efficacy

15 Cannabis has long been used by humans for therapeutic purposes, yet scientific knowledge about how it affects the body is relatively recent and incomplete. A substantial body of clinical evidence now exists in relation to the efficacy of certain forms of cannabis for particular medical conditions, although the evidence varies in its rigour. AMA Victoria acknowledges that there is ‘some evidence to suggest that cannabinoids are effective for the treatment of neuropathic pain, muscle spasticity for patients with [multiple sclerosis], and in controlling nausea for cancer patients’.^[2]

16 While this body of evidence is expanding, it is not yet of adequate quality for definitive statements to be made about the efficacy of cannabis in treating the range of conditions for which it is being used illicitly. A refrain of the credible scholarly literature is that further suitably controlled, high quality studies need to be undertaken in order to evaluate whether the claims, anecdotes and aspirations for the efficacy of medicinal cannabis can be justified.

17 Studies that are commonly cited in support of the efficacy of medicinal cannabis often rely on case reports, make claims arising from small patient cohorts, or lack controls and methodological rigour. Others are of limited utility because they were conducted on animals or cell lines, not humans. For the most part, systematic reviews and meta-analyses have offered only very qualified support or have identified potential, rather than actual, efficacy in medicinal cannabis.

18 Comparatively few research trials have been undertaken under close medical supervision where medicinal cannabis of known constituency was tested with double-blind techniques or effective placebo-controls. Few clinical trials have been conducted using cannabis oil, tinctures or other herbal preparations.

19 It seems likely that these deficits will be addressed in research currently underway or soon to commence. When these results become available, scientific discussion about the efficacy of medicinal cannabis will be significantly more sophisticated and informed than the discussions that can currently take place.

Side effects

20 A major reason why some within the medical profession have reservations about providing access to medicinal cannabis is the risk of adverse health effects. Some of these risks are known, and could be serious for some patients. Other risks, particularly in the long term, are unknown and this uncertainty would need to be factored into any decision by a patient or their carer to use it.

21 The following side effects have been identified, and are well described, but all are also disputed:

• Smoking cannabis, particularly in combination with tobacco, raises a risk of respiratory and potentially carcinogenic effects.

• Cannabis use is a risk factor for developing and exacerbating the symptoms of schizophrenia, and for the development of psychotic symptoms.

• Cannabis may have an adverse impact on the user’s mood, particularly if a new user, including by making them anxious, depressed or paranoid.

• Although cannabis is not highly addictive or habit-forming, the potential does exist for a small percentage of users, at least in the recreational context, to become dependent upon it to a point where they experience withdrawal symptoms for a time when they stop using.

• Heavy cannabis consumption is known to induce tachycardia, and can increase the risk of heart attack, notably for users with existing heart disease or arrhythmias (abnormal heart rhythm).

• Cannabis use during pregnancy has been found to be associated with a number of undesirable effects.

• Cannabis use is likely to impact adversely upon concentration, responsiveness to stimuli and psychomotor function.

22 Most studies on the adverse effects of cannabis have focused on unregulated, illegal cannabis used recreationally, rather than on a quality-controlled supply intended for medical use. A systematic review conducted in 2008 looking at the medical use of cannabinoids concluded that short-term use increased the risk of non-serious adverse events compared to a control group, but not the risk of serious adverse events. However, the authors concluded that further research was needed before long-term risks could be accurately characterised.^[3]

23 The point made by many submissions to the Commission is that the proven level of adverse effects, even from unmonitored recreational abuse of herbal cannabis, is of modest dimensions. Unlike the experience of opiate drug use, no deaths have been attributed to cannabis abuse. The Commission is of the view that, nevertheless, the risks—especially the long-term risks—and the concerns raised by the medical profession about them, should be acknowledged. Any Victorian medicinal cannabis scheme should be designed so as to permit the use of cannabis only under medical supervision, thereby enabling attentive and prompt responses to, and management of, any side effects that are identified to be emerging from its use.

Forms available under a medicinal cannabis scheme

24 As the effects of cannabis depend to some extent on the form in which it is administered, any Victorian medicinal cannabis scheme would need to make a variety of forms available. International experience shows that otherwise patients will rely on illicit supplies. The Commission considers that the range of products should be determined by the scheme regulator, be broad, and be responsive to changes in patient needs, research findings and product development.

25 However, the Commission recommends against patients being permitted to smoke medicinal cannabis. It is not persuaded by the submission made on behalf of the cannabis community of Victoria, which echoed the views of many who attended public consultations in presenting reasoned arguments for permitting smoking as an efficient, effective, practicable and accessible method of THC delivery.

26 Cannabis is commonly administered by smoking and is the preferred method for many users, notably when used for recreational purposes. It has been said, however, that fewer than half of the regular users of cannabis in Australia smoke it.^[4]

27 Although the findings are inconsistent, there has been some association between smoking and lung conditions and cancer risks that have not been observed for other modes of administration. There is also the possibility of accidental ingestion by third parties through passive smoking.

28 While noting these potential risks, the Commission’s primary concern is that providing smokable products as a medicine under a government scheme would be inconsistent with the public health policy to reduce smoking in the community. Over the past three decades governments have passed increasingly more restrictive laws aimed at protecting public health by prohibiting or discouraging smoking, while the not-for-profit sector has run extensive public health campaigns to the same end. A scheme that enabled people with severe medical conditions to smoke, for medical reasons, a substance that is illegal for others to use, would send a confused public health message and thereby undermine the achievements of the programs that discourage the general community from smoking.

29 Another key concern of the Commission is the impact that supplying dried cannabis under a medicinal cannabis scheme would have on the risk of diversion. Although there could be an illicit market for any product produced under the scheme—particularly a product with significant THC content—it is likely that the demand for dried cannabis would be strongest because of its popularity for recreational use. While probably more expensive, the licit product would have been produced under controlled conditions, free of contaminants.

30 In addition, the Commission was told that, to continue to enforce the prohibition on recreational use, law enforcement agencies would need to be able to distinguish between licit and illicit cannabis, and this would be extremely difficult if licit dried cannabis were made available under the scheme.

Eligibility under a medicinal cannabis scheme

Identifying people in ‘exceptional circumstances’

31 In developing eligibility criteria for access to medicinal cannabis, the Commission was guided by the policy intention, conveyed in the terms of reference, that the scheme should be limited to people in exceptional circumstances. The following factors were taken into account:

• the state of the clinical literature in relation to the efficacy or potential efficacy of medicinal cannabis for the condition suffered by the patient, particularly in relation to the potential for cannabis to provide therapeutic assistance

• the extent to which medicinal cannabis is likely to improve the patient’s quality of life

• the seriousness of the medical condition, including the patient’s prognosis and the extent of their disability

• the extent to which the symptoms of the condition interfere with the patient’s ability to function

• the availability of standard treatments that may assist, how effective they are and what side effects they cause or may cause

• the state of the clinical literature in relation to the risks or potential risks posed by medicinal cannabis for the patient.

Criteria based on conditions and symptoms

32 The Commission recommends that a patient’s eligibility to receive medicinal cannabis should rely on a combination of symptoms and the condition which gives rise to the symptoms. The conditions should be ones for which there is a reasonable measure of research support in respect of efficacy, or in respect of which the research is weaker but the circumstances of the category of patient are particularly compelling.

33 The Commission has identified a set of conditions and symptoms as the basis for initially making medicinal cannabis available:

• severe muscle spasms or severe pain resulting from multiple sclerosis

• severe pain arising from cancer, HIV or AIDS

• severe nausea, severe vomiting or severe wasting resulting from cancer, HIV or AIDS (or the treatment thereof)

• severe seizures resulting from epileptic conditions where other treatment options have not proved effective or have generated side effects which are intolerable for the patient

• severe chronic pain where, in the view of two specialist medical practitioners, medicinal cannabis may in all the circumstances provide superior pain management by contrast with other options.

34 The basis for these categories and the way they are formulated is the body of research as to their efficacy, the compassionate circumstances attaching to the distressing circumstances of the categories of patients, and the control of risks and options that is addressed by the formulations proposed. The proposals are structured to provide access for a number of different categories of patients in controlled circumstances that minimise the potential for abuse of the scheme and optimise the prospect of participation by medical practitioners.

35 The Commission suggests this list as a basis for further discussion between the government, the medical community and patients. This is particularly important as the research base is constantly changing.

36 The criteria would be set out in regulations, which could be revised from time to time on the advice of an independent advisory committee constituted by the Minister for Health. In addition, the Secretary of the Department of Health and Human Services, or a suitably qualified committee, would have the discretion to permit access, on a case-by-case basis, for patients who do not meet the criteria in rare and special cases.

Authorising patients to have access to medicinal cannabis

37 A decision that a patient should be treated with medicinal cannabis is not a legal decision: it is a medical decision. The Commission proposes that access to medicinal cannabis by patients who meet the eligibility criteria would be authorised by specialist medical practitioners. However, the patient’s general practitioner would be responsible for the patient’s ongoing treatment, between visits to the specialist, and for monitoring its efficacy and any side effects.

38 The specialist medical practitioner, and subsequently the general practitioner, would issue an authorisation that is similar to a prescription. The use of language relating to prescriptions is avoided because the circumstances in which medical practitioners would be facilitating medicinal cannabis being made available, and monitoring its use, would be different to some degree from the circumstances attaching to medication that they prescribe in the orthodox way.

39 The legal arrangements would be modelled on those that apply to the opioid replacement therapy program, under which methadone and other restricted drugs are made available to patients. Accordingly, the specialist medical practitioner would need to seek a permit from the Secretary of the Department of Health and Human Services before authorising a patient to use medicinal cannabis. The permit would be valid for 12 months.

40 In applying for the permit, the specialist medical practitioner would state that, among other things, the patient’s condition and associated symptoms meet the eligibility criteria, it is appropriate in all the circumstances that the patient be treated with medicinal cannabis, and the patient has been informed that its efficacy and side effects have not been tested by the Therapeutic Goods Administration.

41 Although the permit requirement and the authorisation process to some degree constitute an impediment to access, they are necessary to enable treatment with medicinal cannabis in the community to be effectively monitored. Importantly, they ensure that a medical practitioner with the necessary expertise in the condition or symptom for which the patient would be using medicinal cannabis is consulted and is enabled to make the relevant medical decisions.

Options for changes to the law

Regulatory objectives

42 Drawing from the terms of reference and comments in submissions, the Commission has identified objectives that should be relevant to any law reform that allows people to use medicinal cannabis in exceptional circumstances. It referred to these objectives when reviewing the options for law reform and recommends that any Victorian medicinal cannabis scheme be designed so as to be compatible with them.

• Allow compassionately for exceptional circumstances of medical need

If the strict criteria of evidence-based medicine that normally apply to prescription medications were applied to cannabis, there would be negligible scope for medicinal cannabis products to be made available in Victoria today. Allowing medicinal cannabis to be used in exceptional circumstances conveys a policy intention, based on compassion, to depart from the stringency of the usual rules.

• Integrate the use of medicinal cannabis products into the patient’s medical treatment

Integrating the use of medicinal cannabis into the patient’s medical regime characterises the reform as a health initiative. It enables medicinal cannabis to be integrated as but one of a variety of therapeutic options to meet a patient’s needs. It also recognises that a scheme that allows medicinal cannabis to be used in exceptional circumstances would apply only to patients with severe illnesses and debilitating symptoms and a substantial medical history.

• Ensure that patients are informed of clinical uncertainty about the safety and efficacy of medicinal cannabis products they use

Patients who use medicinal cannabis products—or carers who make decisions on their behalf—must be informed about the risks, and the current limits of clinical knowledge about its efficacy and effects, including those which are long-term.

• Ensure that medicinal cannabis products are of reliable quality and known composition

Any regulation would provide a level of quality assurance that illicit production cannot guarantee, but the scheme would need to do more than this. It should impose standards that provide medical practitioners and their patients with confidence about the potency and contents of the products being administered.

• Foster, and be responsive to, clinical research and developments in technology

Any medicinal cannabis scheme established in Victoria would need to remain current as scientific knowledge, medical practices and technology continue to evolve.

• Preserve the prohibition of unlawful trafficking, cultivation, supply and use of cannabis

The proposed legislative reform would need to reinforce ongoing prohibitions on the trafficking, cultivation, possession and use of cannabis. The reform would not allow everyone who currently uses cannabis, or wants to use it, to do so legally.

• Provide an equitable and accessible scheme

Any scheme would need to provide the necessary amount of regulation to achieve its objectives while not becoming so complex, burdensome or expensive that it deters those on whom its success depends, and those it is intended to benefit, from participating.

Identifying the options

43 The Commission examined the current law to identify the options for reform. Few options could be introduced by Victorian legislation alone. Almost all would require the agreement or support of the Commonwealth Government. All need to be considered in view of Australia’s international obligations.

44 The Drugs, Poisons and Controlled Substances Act 1981 (Vic) could be amended to modify existing prohibitions on the trafficking, cultivation, possession and use of cannabis, but this would be only a partial measure.

45 The importation, manufacture and sale of cannabis products for medicinal purposes is regulated by Commonwealth law. A Victorian scheme for patients to be dispensed medicinal cannabis products of known and stable composition and quality by pharmacists could be established only in collaboration with the Commonwealth Government.

46 Commonwealth law and policy on the regulation of cannabis is guided by Australia’s international obligations under the Single Convention on Narcotic Drugs 1961 and related treaties. These instruments require governments to impose controls on the amount of cannabis produced, the circumstances in which it is produced, and the purposes for which it is made available.

47 As with all international conventions to which Australia is a party, the obligations imposed by the Single Convention on Narcotic Drugs are not incorporated directly into domestic law unless given effect to by statute. Not all the obligations imposed on Australia have been incorporated into Australian law. However, Australia is a party to the Convention, which carries with it distinct obligations of significance. Further, if Australia failed to fulfil the obligations under the Convention to which Australia has agreed, Australia may be subject to international criticism and sanction for failing to implement the Convention’s obligations.

48 Reporting on 11 August 2015 on a Bill to create a Commonwealth medicinal cannabis scheme, the Senate Legal and Constitutional Affairs Legislation Committee recommended that the Bill be amended to ensure that ‘medicinal cannabis products can be made available in Australia consistent with Australia’s international obligations, including under Articles 23 and 28 of the Single Convention on Narcotic Drugs 1961.’^[5]

49 The Commission therefore considers that a Victorian medicinal cannabis scheme should be framed in accordance with the specific requirements and policy objectives of the Convention.

Review of the options

50 The Commission has identified and formed views on several options for law reform, as summarised below:

• Importation: Victoria could import cannabis for the purposes of a medicinal cannabis scheme by special arrangement under Commonwealth law.

• Exemption from prosecution: eligible patients and their carers could be authorised to possess small quantities of cannabis for the patient’s use.

• ‘Grow your own’: eligible patients and their carers could be authorised to cultivate cannabis plants for the patient’s use.

• Regulated not-for-profit production and distribution: not-for-profit cooperatives could be licensed to cultivate, manufacture and distribute medicinal cannabis products among their members, all of whom would need to be eligible patients and their carers.

• Regulated distribution through dispensaries: medicinal cannabis products could be distributed through single-purpose dispensaries.

• A government-enforced monopoly: Victoria could authorise or license a single entity to cultivate and manufacture cannabis for distribution to patients through pharmacies.

• Licensed producers: Victoria could issue multiple licences to cultivators and manufacturers to produce medicinal cannabis products for distribution to patients through pharmacies.

51 To create a legally stable scheme, all of the options for producing and distributing medicinal cannabis in Victoria would be contingent on the Commonwealth cooperating in either or both of the following ways:

• removing the production and distribution of medicinal cannabis products under the Victorian scheme from the reach of the Therapeutic Goods Act 1989 (Cth)

• issuing a licence to manufacture cannabis under the Narcotics Drugs Act 1967 (Cth).

52 Most of these options would also generate obligations under the Single Convention on Narcotic Drugs. If Victoria were to regulate the cultivation of cannabis for medicinal purposes (as opposed to merely decriminalising its cultivation for personal use in small amounts), Australia’s international obligations would require it to license the cultivators and take physical possession of the cannabis crops. It would also need to inform the Commonwealth about the amount of cannabis that it estimates would be used for medicinal purposes each year, so that the Commonwealth in turn could report to the International Narcotics Control Board.

Importation

53 Currently, cannabis can be imported under Commonwealth law and policy only if approved on a case-by-case basis by the Secretary of the Commonwealth Department of Health, exercising powers under the Therapeutic Goods Act and the Customs Act 1901 (Cth). The Law Institute of Victoria proposed that the Commonwealth provide special access for state governments to import products for the purpose of their medicinal cannabis schemes. This would not require legislative reform, though, if ongoing, it could be desirable to have the security of a statutory avenue of access.

54 The appeal of this option is that it could reduce the cost to Victoria of administering a medicinal cannabis scheme while providing access to products that have been produced under regulated conditions. However, it does not appear feasible in the current international environment.

55 The only country that exports medicinal cannabis products is the Netherlands, and the total amount that the Dutch government permits to be exported each year is very low. Moreover, the products are only in the dried plant form that is supplied domestically and are able to be smoked. If imported to Victoria, it would need to be transformed into other forms by a manufacturer whose activities were regulated under Commonwealth and Victorian laws.

Exemption from prosecution

56 Patients who have been authorised to be treated with medicinal cannabis could be made exempt from criminal prosecution for use or possession of the amount they need. The Drugs, Poisons and Controlled Substances Act could be amended to create an exception to the offences of possessing or using a drug of dependence for small amounts of dried cannabis or cannabis extract where a person is an authorised medicinal cannabis user.

57 The exception would extend to the patient’s carers, to allow them to possess the cannabis that the patient may lawfully use. It would also require an additional exception to be made to the offence of introducing a drug of dependence into the body of another person.

58 This option would protect patients and their carers from the risk of being prosecuted, and the associated uncertainty and stress. It may be useful as an interim measure, pending the establishment of a regulated supply of medicinal cannabis products under a government scheme. If it were introduced as an intermediate step, the Commission considers that it should apply only to those patients who would be eligible to participate in the fully operational scheme.

59 However, the Commission does not support this option. It is similar to a scheme in New South Wales to which there has been a muted response from patients, few of whom have participated. It fails to provide access to a safe and reliable supply of medicinal cannabis products. Thus, it would not integrate medicinal cannabis effectively into a health regime: doctors would authorise patient access to cannabis, but would not have any mechanism for controlling or supervising use. The products available to the patient would not necessarily be therapeutically appropriate, as they could have unknown or inappropriate THC/CBD levels and contain unsafe contaminants.

60 Because the cultivation and supply of cannabis would remain unlawful, any person selling cannabis to an authorised patient or their carer would still be committing an offence. The legislative change would only assist users willing to purchase cannabis that has been grown and supplied illegally. This in turn would strengthen the illicit market.

‘Grow your own’

61 A large number of people who made submissions and attended consultations argued for a ‘grow your own’ scheme. Eligible patients could be licensed by the government to cultivate a designated number of cannabis plants at home for medicinal purposes and would be able to nominate carers to assist them. The patients and carers would be responsible for manufacturing the raw cannabis into a form appropriate for the patient to use.

62 Victoria’s Drugs, Poisons and Controlled Substances Act could be amended to provide that a licensed patient who operates within the conditions of the licence would not be engaging in the unauthorised trafficking, cultivation, possession or use of a drug of dependence within the meaning of the Act. The legislation would also need to permit the patient to possess the necessary substances, materials and equipment at their residential address for this purpose.

63 A grow your own scheme was recommended in 2000 by a New South Wales Working Party on the Use of Cannabis for Medical Purposes. More recently, it was proposed by a Bill that was introduced into the New South Wales Parliament in 2014 and lapsed during 2015, and a draft Bill that is currently under consideration by a committee of the Legislative Assembly of the Australian Capital Territory.

64 This option could provide eligible patients with a readily available and inexpensive supply of cannabis. They would have control over their dosage, frequency of use and form of administration. They would no longer need to rely on the illicit market for the purchase of prepared cannabis (provided they were able and inclined to grow their own) and they would be aware of the conditions in which the cannabis is grown and processed.

65 Medical and regulatory experts overwhelmingly rejected this option when discussed at consultations, as did a significant number of patients and their families who want medicinal cannabis to be made available in the same way as prescription medication. The Commission shares their concerns. A grow your own scheme would not provide all eligible patients with access to medicinal cannabis because it would exclude those who do not have the resources, skills and ability to grow their own plants or have them grown on their behalf. It would not ensure that the patient’s cannabis use is integrated with their other medical treatment because their medical practitioner would not know of, or be able to monitor, what they were using or the effects. A patient using home-grown cannabis may not be using a product of sufficient quality or consistent composition because of the significant variability caused by different cannabis strains and growing conditions, which only sophisticated growing operations are able fully to control.

66 As noted above, the Commission considers that the products that are made available under any medicinal cannabis scheme should not be able to be smoked. A grow your own scheme would bolster the production of dried plant products, as this is cheaper and easier than producing refined products and preferred by many users. There would also be a substantial diversion risk, as there would be no distinction between licit and illicit dried plant products and the limits on production and distribution would be very difficult to enforce. This would undermine efforts to preserve the continuing prohibition of unlawful trafficking, cultivation, possession and use. A study of Canada’s scheme in 2012 estimated that 36 per cent of personal cultivation licences were subject to ‘misuse’, defined as the sale of cannabis grown under such a licence to the illicit market. It would also generate the potential for both collateral criminal conduct and a risk of house fires and toxicity within domestic environments.

67 This option would not ease the regulatory burden and the related costs to the Victorian Government, compared to the other options, because an alternative scheme would still need to be introduced to produce medicinal cannabis products for patients who are unable—or do not wish—to be responsible for producing their own medicine.

Regulated not-for-profit production and distribution

68 Some submissions advocated the creation of regulated not-for-profit cooperatives, collectives or clubs which would arrange for the collective cultivation and manufacture of medicinal cannabis products for distribution to their members. Membership would be confined to authorised patients and their carers. The entity could engage contractors or rely on its members to grow the plants and manufacture the products.

69 Under current law, the Commonwealth would regulate the manufacture and distribution of therapeutic goods by any such entities. However, there is some scope for Victoria to legislate in this area. While the Commonwealth has direct jurisdiction over incorporated entities, its power to regulate unincorporated associations involved in manufacturing and distributing therapeutic goods is determined by Victorian legislation. The Commonwealth Therapeutic Goods Act applies to them by operation of the Therapeutic Goods (Victoria) Act 2010 (Vic). To resume jurisdiction over unincorporated associations for the purposes of this option, Victoria could amend the Therapeutic Goods (Victoria) Act to exclude the operation of the Commonwealth law for the purposes of the production and distribution of medicinal cannabis by authorised unincorporated associations.

70 The authorised entities would still need to obtain a manufacturing licence from the Commonwealth under the Narcotic Drugs Act.

71 To create the scheme, Victoria could amend the Drugs, Poisons and Controlled Substances Act to provide for licences to be issued either to a cooperative (to produce medicinal cannabis products for its members), or to a person nominated by the cooperative (to cultivate a certain amount of cannabis, or produce products, as determined by the cooperative and approved by the government).

72 The licensees would need to comply with detailed rules, which could be a combination of licence conditions, statutory provisions and regulations, to ensure that the products are of good quality and are provided only to authorised patients.

73 Proponents of this option said that it would reduce the demand for illicit cannabis and provide hubs for treatment outside the conventional medical system. A submission made on behalf of the cannabis community of Victoria put forward a detailed proposal, based on the British Columbia Compassion Club, in which the cooperative would operate a closed system encompassing all steps of the production and supply of the product as well as patient care.

74 The Commission does not consider that this option is suited to Victoria. It was told on several occasions that patients and their families would like medicinal cannabis to be treated as much as possible like conventional medications. Having medicinal cannabis cultivated by and for closed communities of users could reinforce negative perceptions about using it, perpetuate doubts about its efficacy, and undermine efforts to encourage communication between patients and their medical practitioners. It would significantly exclude the participation of medical practitioners in monitoring the effectiveness of the medicinal cannabis and taking suitable measures to address any risks or side effects.

75 The Commission also notes that this option would provide little, if any, opportunity for the government to take possession of the medicinal cannabis before it is distributed to patients, as required by the Single Convention on Narcotic Drugs. This would make the system legally unstable and could deter the Commonwealth from agreeing to issue the manufacturing licences on which the scheme would depend.

Regulated distribution through dispensaries

76 Several submissions suggested that medicinal cannabis products could be distributed through dispensaries. Dispensaries have been established in a number of jurisdictions overseas as outlets for producers of medicinal cannabis products or in connection with a clinic that specialises in the use of those products.

77 This option could provide for the distribution of products by a publicly funded or commercial entity that has manufactured the products under licence, as an alternative to distribution through pharmacies. Again, as with the previous option, the government would be unable to meet the obligation under the Single Convention on Narcotic Drugs to take possession of the medicinal cannabis before it is distributed.

78 As the distribution of medicinal cannabis products is regulated under the Therapeutic Goods Act, Commonwealth support would be needed. This could take the form of an exemption under that Act to enable Victoria to regulate the distribution of medicinal cannabis products by entities that are licensed to do so under Victorian legislation.

79 The Drugs, Poisons and Controlled Substances Act could be amended to provide for a licence to be issued to an entity to distribute medicinal cannabis products. The amount and content of the associated rules would depend on the entity, but probably would be directed to the risk of diversion to the illicit market.

80 The form and function of medicinal cannabis dispensaries that operate overseas vary. The common elements are that they supply only cannabis products and usually offer the customer a variety of products, information about the characteristics and effects of each, and advice about which could be most suitable in treating their condition.

81 The Commission does not consider this option appropriate for a Victorian medicinal cannabis scheme. Unlike the United States, where not-for-profit dispensaries have been established under state medicinal cannabis schemes because federal government law effectively prevents the sale of cannabis by pharmacies, there is no regulatory incentive in Victoria to find an alternative to existing retail outlets.

A government monopoly

82 Under this option, a single entity with the necessary ability and capacity would cultivate and distribute cannabis and deliver it to the government, for distribution through pharmacies. The entity could be a government agency or government-owned corporation, a university or research institute, or a privately owned corporation.

83 It appears that Commonwealth support would be needed for each of these options, with the possible exception being an agency or statutory authority that does not generate revenue. The entity would need to be licensed under the Narcotic Drugs Act. In addition, an exemption from regulation under the Therapeutic Goods Act would be necessary.

84 The option could be established in either of two ways. The Drugs, Poisons and Controlled Substances Act could be amended to permit a specified government-funded or -owned entity to cultivate and manufacture cannabis for medicinal purposes and exempt it from Part V of the Act (concerning offences relating to drugs of dependence). Alternatively, the Act could be amended to provide for the Secretary of the Department of Human Services and Health to issue a licence to cultivate and manufacture cannabis products for delivery to the government. The government could then grant the licence to a suitable entity.

85 Because only one producer would ever be involved, the scheme would not involve a substantial regulatory burden. It would create a simple mechanism that is substantially compliant with international law and allow for an experienced entity to start producing cannabis medicines relatively quickly.

86 The government would have to identify a suitable producer that could consistently produce enough cannabis of sufficient quality to satisfy the requirements of a Victorian medicinal cannabis scheme. The scheme would turn on the capacity of that single producer to manage risks and to supply enough product without subcontracting its functions to other cultivators and manufacturers. If a suitable entity could be identified, this option could be an intermediate step in establishing a scheme that is sustainable in the long term. However, on balance it is not recommended.

Multiple licensed producers

87 Support was expressed in several submissions for a scheme based on the current arrangements for the cultivation of alkaloid poppies and the production of poppy straw under the Drugs, Poisons and Controlled Substances Act. On this model, the government would license multiple private cultivators and manufacturers to produce cannabis products for supply through pharmacies.

88 New provisions would be inserted into the Drugs, Poisons and Controlled Substances Act authorising various dealings that are currently illegal. Commonwealth support would be needed, exempting the manufacture and production of medicinal cannabis from regulation under the Therapeutic Goods Act and granting licences under the Narcotic Drugs Act.

89 This option would allow cultivators and manufacturers to be assessed against statutory criteria and be subject to other controls derived from Victoria’s poppy scheme. The government would be able to exercise the degree of regulatory control required by the Single Convention on Narcotic Drugs. In addition, the scheme would be adaptable to any changes to law or policy, either in Victoria or at the Commonwealth level, which could affect the reach or focus of the scheme. It would not be dependent upon a single source of supply, which can be a logistical vulnerability.

90 This is the Commission’s preferred option and it recommends that it be adopted as the model for a Victorian medicinal cannabis scheme.

Regulation of manufacture and distribution

91 The terms of reference require the Commission to examine the regulation of medicinal cannabis manufacture and distribution, including which forms of cannabis should be permitted for use. The Commission has developed detailed proposals that are based on the current arrangements for the cultivation of alkaloid poppies, the production of poppy straw and the manufacture of therapeutic goods.

92 New frameworks would be required to regulate activities connected with the production of medicinal cannabis in Victoria. A new framework would be required for cultivation because this activity is currently not allowed. A new framework would be required for product manufacture and approval because these activities are presently regulated by the Commonwealth. Importantly, though, the scale of the new regulation required turns on any agreement reached between Victoria and the Commonwealth, and the extent to which this results in a transfer of regulatory responsibility to Victoria.

93 In designing proposals for the regulation of the medicinal cannabis supply chain, the Commission has given priority to:

• integrating legislative changes with existing provisions wherever possible

• using familiar regulatory tools

• imposing the least regulatory burden necessary to achieve the scheme objectives

• allowing flexibility to the regulator to manage risks

• having regard to the requirements of the Single Convention on Narcotic Drugs.

Cultivation

94 All cannabis cultivated in Victoria would be cultivated under licence. Licences to cultivate would be granted by the Secretary of the Department of Economic Development, Jobs, Transport and Resources. Recipients could be either individuals or corporations. The Department would be responsible for monitoring and enforcing compliance with the licence conditions and the risk management plan.

95 The licensing scheme would be set out in the Drugs, Poisons and Controlled Substances Act in similar terms to the provisions allowing for licensing of alkaloid poppy cultivators.

96 Cultivators would be permitted to sell only to licensed manufacturers, and would be required to have a contract with a licensed manufacturer at all times.

Manufacture

97 Like cultivators, manufacturers of cannabis products would be required to hold licences issued by the State of Victoria. Licences to manufacture refined cannabis products would be granted by the Secretary of the Department of Health and Human Services. Recipients could be either individuals or corporations.

98 The arrangements would be modelled on those for the manufacturing of therapeutic goods under Commonwealth legislation.

Distribution

99 It is proposed that distribution be coordinated by a government agency, as required by the Single Convention on Narcotic Drugs, particularly Articles 23 and 28. In order to comply with the Single Convention, licensed manufacturers would need to deliver all of the medicinal cannabis products they make to the Victorian Government, specifically the Secretary of the Department of Health and Human Services.

100 The Secretary would be responsible for the distribution of medicinal cannabis products to pharmacies. Patients would be dispensed medicinal products by a local pharmacy that has opted into the scheme.

101 The rules imposed on pharmacies and pharmacy departments regarding the distribution of cannabis would be modelled on the program for opioid replacement therapy.

Quality control

102 Only one pharmaceutical-grade cannabis extract (Sativex) has been approved for sale by the Therapeutic Goods Administration but it is not marketed in Australia and therefore, to all practical intents and purposes, is not available. This means that no medicinal cannabis products have been marketed or manufactured to this point in Victoria.

103 A Victorian scheme that requires medicinal cannabis products to be approved by the Therapeutic Goods Administration would reinforce the status quo and not result in any additional approved products being made available to patients for a significant period of time. It follows that, if the quality of medicinal cannabis products is to be ensured, an alternative regulatory structure needs to be established.

104 The alternative structure must sensibly be one which does not create the same or similar hurdles to approval as those that apply to prescription medicines but does take a cautious approach to ensuring that the products supplied are of good quality.

105 For the separate character of the Victorian products to be preserved, and the pre-eminence of conventional approval to be maintained, it is important that the character of the products be distinctive. That is, the government should not endorse these products as replacements for conventional pharmaceuticals. Therefore, it is the Commission’s view that medicinal cannabis products should be presented to patients as a form of less refined herbal medicine and that this be provided for by the regulatory structure.

106 The Victorian scheme should ensure that medicinal cannabis products produced under the scheme are free of unsafe components and are of known and stable composition. However, it would not be feasible or desirable for the scheme to make approval of a particular medicinal cannabis product contingent on proof (whether to conventional standards or otherwise) that the product is effective to treat a given indication. Clinical trials are costly and time-consuming to run, and placing similar barriers to product approval as already exist under the Therapeutic Goods Administration would not facilitate access to medicinal cannabis in any meaningful way.

Controlling risks

107 A Victorian medicinal cannabis scheme could be the first of its kind in Australia. A drug that would remain illegal for all other purposes in Victoria would be made legal, in controlled circumstances, for a limited group of people. The products would be new and the size of the patient group is initially difficult to predict. International experience in introducing medicinal cannabis schemes indicates that the regulatory scheme could need to be modified, possibly substantially, within a few years in response to unpredicted outcomes. For this reason, the Commission considers it prudent for the government to take a measured approach to the reforms and draw upon existing models that work in comparable contexts.

108 The Commission has identified a number of risks that are inherent to the proposal to make medicinal cannabis available to people in exceptional circumstances. It has taken them into account when formulating the regulatory objectives, the recommendations and the detailed proposals.

Patient safety

109 A risk to patient safety could arise from providing access to products that have not been required to meet the safety, quality and efficacy standards that apply to prescription medicines. The regulatory objectives address this risk by identifying the need to ensure that:

• Patients are informed of clinical uncertainty about the safety and efficacy of medicinal cannabis products they use.

• Medicinal cannabis products are of reliable quality and known composition.

• The use of medicinal cannabis products is incorporated into the patient’s medical treatment.

Eligibility criteria

110 There is a risk that the circumstances in which treatment with medicinal cannabis is permitted are uncertain or controversial. The Commission’s recommendation that eligibility be based on specified conditions and symptoms would make the criteria clear to patients as well as to medical practitioners. It is likely that any criteria that confine the coverage of the scheme to people in exceptional circumstances would be criticised by people who use medicinal cannabis for non-qualifying conditions. However, the recommended eligibility criteria are based on the best available evidence of efficacy, and the Commission has also recommended that they be subject to change, on the advice of an expert committee, as more evidence becomes available.

Commonwealth support

111 The viability of a Victorian medicinal cannabis scheme could be compromised should the Commonwealth not work with Victoria. The Commission considers that the preferred option, a comprehensive government licensing scheme, would comply with the Single Convention on Narcotic Drugs, and therefore would be compatible with Commonwealth government policies to support international measures to inhibit trade in narcotic drugs. It is also adaptable should the Commonwealth introduce a national scheme that regulates some elements centrally.

Diversion risk

112 A medicinal cannabis scheme could create new opportunities for cannabis to be supplied and used illegally. The need to enforce ongoing prohibitions is reflected in the regulatory objectives and the Commission proposes security measures at each step of the supply chain. Law enforcement authorities would be assisted further by the Commission’s recommendations not to provide medicinal cannabis in smokable form, which is more popular among recreational users.

Costs to government

113 There is a risk of excessive cost to government in establishing and operating the scheme. Although the Commission was not requested to investigate, and has not investigated, the costs of the options, it appears financially prudent to build on existing infrastructure and capabilities. The detailed proposals on cultivation and manufacturing are drawn from the cultivation of alkaloid poppies and the regulation of therapeutic goods; the recommended approach to authorising the use of medicinal cannabis by patients follows the procedures for the opioid therapy replacement program. Using existing institutions and comparable regulatory methods should substantially reduce the time and expense of reform.

Concerns of the medical profession

114 Medical professional bodies and a number of members of the medical profession put forward the view, in submissions and at advisory committee meetings, that medicinal cannabis products should be made available to patients only if the products have satisfied the rigorous requirements of the Therapeutic Goods Administration. Although the opinions of individual practitioners vary, concern was expressed to the Commission about patients being treated with products that have not been subject to the approval processes that normally apply to medicines in Australia. These processes ensure that products are manufactured to high standards and have been comprehensively assessed for safety and therapeutic appropriateness for particular medical conditions. They also provide to the medical practitioner extensive information about a product’s efficacy, its side effects, the recommended dosage, and other details that enable the practitioner to make a sound and defensible professional judgment about whether to recommend the treatment to their patients. The practitioner can draw on this information in ensuring that patients give informed consent.

115 The argument that all medicinal cannabis products should be subject to approval by the Therapeutic Goods Administration is an argument for the status quo. There would be no need for a Victorian medicinal cannabis scheme. However, as reflected in the regulatory objectives, it is important that the concerns of medical practitioners about medicinal cannabis are addressed.

116 For this reason, the Commission has identified means of creating mechanisms, based on existing practices and procedures, which respond to the concern that the medicinal cannabis products made available under the scheme will not have received Therapeutic Goods Administration approval. The proposed eligibility criteria give weight to clinical research; access to medicinal cannabis by individual patients requires the authorisation of a specialist medicinal practitioner who has expertise in the relevant condition; a medical practitioner specifies the products and dosage; provision is made for the effects of the treatment to be monitored; and the products themselves are prepared under conditions that ensure that they are of consistent quality and composition.

117 Importantly, too, unlike the position in jurisdictions such as the United States and Canada, where there remains some amount of reservation among medical practitioners about medicinal cannabis, the Victorian scheme would not provide a grow your own scheme or involve dispensaries that operate wholly or substantially outside the health system. Nor would it include smoking of dried cannabis. Rather, it would provide for medicinal cannabis to be dispensed by pharmacists in orthodox therapeutic forms such as oils, tinctures and vaporisable liquids. It is proposed that the Secretary of the Department of Health and Human Services assist medical practitioners by providing product information about medicinal cannabis products, as well as training in their application.

118 Thus, what is proposed is that medicinal cannabis be a form of medication that constitutes one of the available forms of pharmacotherapy for a small number of conditions, in ways which substantially enable medical practitioners to titrate dosage and monitor positive and negative effects as they would for Therapeutic Goods Administration-approved medications. It is thus consistent with standard medical practice with other medications.

Review of scheme

119 The Commission considers that the scheme should be reviewed after four years. By that time, the international and national regulatory environment for the control of cannabis could have changed, and knowledge about the efficacy of medicinal cannabis could have moved far beyond the evidence base on which the scheme rests. The health and safety risks could be different and the regulatory objectives outdated.

120 The review should consider how well the scheme has met its objectives and evaluate whether it should continue in the same form.

Concluding observations

121 Medicinal cannabis is not a panacea. Research into its efficacy has a significant way to travel before definitive conclusions can be drawn about the extent to which it can contribute to the alleviation of suffering. However, what can be said is that it has therapeutic potential. It appears that this potential is starting to be realised in the lives of people with very serious medical conditions. It needs to be integrated under medical supervision into the various options for treatment and management of the care of people with serious conditions without raising inappropriate expectations.

122 The opportunity exists for a combined Commonwealth and Victorian initiative to relieve suffering and to improve the quality of life for a vulnerable cohort of people within the community.

123 The passage of time and the opportunity for further research, along with evaluation of the scheme proposed by the Commission, would allow rigorous review of the success of this initiative to determine whether the proposed innovation is worthy of consolidation, extension or amendment.

1. Submission 95. See Appendix B for list of submissions.

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2. Submission 38.

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3. Tongtong Wang et al, ‘Adverse Effects of Medical Cannabinoids: A Systematic Review’ (2008) 178 Canadian Medical Association Journal 1669.

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4. Submission 95.

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5. Senate Legal and Constitutional Affairs Legislation Committee, Parliament of Australia, Regulator of Medicinal Cannabis Bill 2014 (2015) [5.13].

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