Medicinal Cannabis: Report (html)

1. Introduction

Terms of reference

1.1 On 19 December 2014, the Attorney-General, the Hon. Martin Pakula, MP, asked the Victorian Law Reform Commission, under section 5(1)(a) of the Victorian Law Reform Commission Act 2000 (Vic), to review and report by 31 August 2015 on options for changes to Victorian law to allow people to be treated with medicinal cannabis in exceptional circumstances. The terms of reference appear at page ix.

1.2 The Victorian Government is committed to enabling the lawful use of cannabis for medicinal purposes in exceptional circumstances.^[1] The terms of reference do not invite the Commission’s views on this policy, nor on the separate question of whether the prohibition on the cultivation, production, supply and use of cannabis should be fully lifted. Accordingly, the Commission makes no comment on these matters.

The Commission’s process

1.3 The Government appointed Dr Ian Freckelton QC as a Commissioner to lead the reference, with effect from 27 January 2015 to 31 August 2015.

1.4 The Chair of the Commission exercised his powers under section 13(1)(b) of the Victorian Law Reform Commission Act to constitute a Division to guide and oversee the conduct of the reference. All members of the Commission joined him on the Division.

1.5 The terms of reference ask the Commission to appoint expert panels specifically to examine prescribing practices and the regulation of the manufacture and distribution of medicinal cannabis. Committees of experts have often assisted the Commission in identifying issues and exploring options for reform, though they are not involved in developing or voting on the Commission’s recommendations. They are a valuable source of advice and the Commission appreciates the time and expertise that the members contribute.

1.6 Consequently, two advisory committees were formed for the medicinal cannabis reference:

• a medical advisory committee, comprising experts in the therapeutic use of cannabis and current clinical research in the area

• a regulation advisory committee, comprising experts in effective regulation and the operation of current law and overseas reforms.

1.7 The committees met separately in April 2015, and together in May 2015. The members are listed at Appendix A.

1.8 The Commission’s usual practice when conducting reviews of this type is to release a comprehensive consultation paper after initial discussions with stakeholders. In view of the short time line for this reference, the Commission published an issues paper^[2] before beginning the consultations. The issues paper provided background information and asked questions about issues arising from the terms of reference.

1.9 The issues paper was published on 17 March 2015. The Commission initially sought written submissions in response to the questions by 20 April 2015, to assist in planning the consultations, but continued to receive them until the end of July.

1.10 Ninety-nine submissions were received and are listed at Appendix B. The Commission also received many comments and further information informally from interested members of the public.

1.11 Formal consultations, led by the Commission Chair and Dr Freckelton, were held in Melbourne and eight regional centres in May and June 2015. In each location, members of the public were invited to attend an open meeting to express their views. Private meetings were also held with individual members of the public, legal practitioners and health professionals.

1.12 Over the course of the reference, the Commission consulted many other people in Victoria and overseas, including government officials involved in implementing medicinal cannabis programs. The consultations are listed at Appendix C.

1.13 The Commission records its appreciation for the substantial contribution made to its work by everyone who put forward their ideas and insights.

The Commission’s approach

Scope of the reference

1.14 The Victorian Government has made a public commitment to introduce legislation that will enable cannabis to be used for medicinal purposes in exceptional circumstances. Announcing the reference to the Commission, the Premier said: ‘We’ll get the advice not on if we should do it, but how we should do it’.^[3] The government aims to present a bill to Parliament by the end of 2015.^[4]

1.15 The terms of reference convey a policy intention that people will be allowed to be treated with medicinal cannabis only in exceptional circumstances, and that cannabis will be legalised only for that purpose. Growing, supplying, possessing and using cannabis for other purposes will remain illegal.

1.16 Arguments against this policy were made in some submissions and during consultations, but the Commission did not enter the debate. The scope of the review is determined by the terms of reference and the Commission has confined its investigations, comments and recommendations accordingly.

Focus of inquiry

1.17 The Commission discerned two fundamental lines of inquiry from the terms of reference:

• What should the ‘exceptional circumstances’ be?

• How can the law be amended to enable people who are allowed to be treated with medicinal cannabis to obtain it, while preventing unauthorised use?

Exceptional circumstances

1.18 The question of who should be eligible to be treated with medicinal cannabis under a scheme that permits it in ‘exceptional circumstances’ is a health issue. The starting point for the Commission in pursuing this aspect of the reference was to consider the results of clinical research into the efficacy of cannabis in treating different medical conditions and symptoms, as well as the evidence for risks and side effects.^[5]

1.19 The Commission also took account of the growing amount of material from other sources suggesting that cannabis can be as effective as, and the side effects less problematic than, opiate forms of analgesia and other pharmaceutical products. This includes less rigorous scientific research, substantial anecdotal evidence, testimonials, and surveys. The reliability of the claims varies, as does their evidentiary value for the purpose of developing eligibility criteria for a Victorian medicinal cannabis scheme.

1.20 There have been marked improvements in the quality of life of some severely ill Victorians after being treated with cannabis, with noticeably better results than prescription medicines had been able to achieve. The Commission met a number of these patients and their families, and many others in Victoria and interstate provided written submissions about their experiences. Their experiences provide compelling examples of the limits of prescription medicines in treating their conditions and of a groundswell of support for exploration of an alternative therapeutic option such as medicinal cannabis.

1.21 The Commission’s conclusions are discussed in Chapter 3 of this report.

Law reform options

1.22 In addressing the question of how the law could enable eligible patients to be treated with medicinal cannabis, the Commission determined whether the responsibility to regulate each step of the supply chain falls within Victoria’s jurisdiction, the Commonwealth’s jurisdiction, or both.^[6] It then explored the scope for Victoria to introduce reforms either with or without the assistance of the Commonwealth.

1.23 This analysis was set out in the issues paper and the Commission sought submissions on how the supply and distribution of medicinal cannabis in Victoria should be regulated. The views of the regulation advisory committee were sought, and the Commission also looked to the approaches taken in other countries.

1.24 A number of options emerged from the consultations and submissions. They are discussed in Chapter 5 of this report.

Regulatory objectives

1.25 The Commission’s recommendations about options for legislative change—as well as the Government’s decisions about which changes to make and how to implement them—need to be guided by clear expectations about what the reforms are intended to achieve.

1.26 For this reason, the Commission identified objectives that would be relevant to any law reform that allows people to use medicinal cannabis in exceptional circumstances, and invited comments on them. They have been derived from the policy conveyed in the terms of reference.

Allow compassionately for exceptional circumstances of medical need

1.27 If the strict criteria of evidence-based medicine that normally apply to prescription medications were applied to cannabis products, there would be little scope for cannabis products to be prescribed in Victoria today.^[7] The medical profession is divided on the issue, but many practitioners consider it premature to change the law before more clinical evidence is available.^[8]

1.28 Allowing medicinal cannabis to be used in exceptional circumstances conveys an intention to depart from the rules that normally apply under the Commonwealth Therapeutic Goods Administration (TGA) scheme. It suggests that, in some cases, medicinal cannabis products should be able to be used even if their quality, safety and efficacy have not been verified to the same exacting standards as apply to prescription medications.

1.29 The basis for such a policy is compassion. There are numerous examples of cannabis being used in Australia and other countries by people for whom prescription medicines have been ineffective or have caused debilitating and serious side effects. The particularly compelling cases are those where there is such a marked improvement in the patient’s quality of life following treatment with medicinal cannabis—succeeding where prescription medications have failed—that the benefits are seen to outweigh the risks of unwanted side effects, including those which could emerge in the longer term.

1.30 Aaron Johnson, whose daughter suffers from Dravet syndrome,^[9] a rare form of epilepsy, described the conundrum facing the families of severely ill patients:

Too many parents like myself are in desperate circumstances, law abiding citizens with a[n] unconscionable choice to make, break the law or watch your child suffer or possibly die, wondering why a government with the power to make change has failed them.^[10]

1.31 AMA Victoria expressed concerns about terminology or concepts such as ‘compassionate’ or ‘exceptional’ circumstances, as they are ‘vague, subjective terms and are likely to lead to lack of clarity in medical practice’.^[11]

1.32 The Commission agrees that compassion should not be the criterion for determining whether a person is eligible to use medicinal cannabis under a Victorian scheme. For the purposes of framing amendments to the law, the term provides insufficient guidance for a decision maker when determining if a patient is eligible, and would create uncertainty for the patient about their legal entitlements. The regulatory objective underscores the desirability of taking a compassionate approach when identifying what the eligibility criteria should be.

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

1.33 Integrating the use of medicinal cannabis into the patient’s medical regime is a necessary objective of a medicinal cannabis scheme. It characterises the reform as a health initiative. It also recognises that a scheme that allows medicinal cannabis to be used in exceptional circumstances would apply to patients with severe illnesses and debilitating symptoms and a substantial medical history. A patient in such circumstances is highly likely to be under the care of a medical practitioner.

1.34 Those calling for reform commonly assume that any treatment with medicinal cannabis would be under the care of a medical practitioner, in the same way as conventional treatment.^[12]

1.35 AMA Victoria agrees that medical practitioners should have a ‘gatekeeper’ role that involves advising patients about the advantages, disadvantages and risks of treatment, but asserts that they are not currently equipped to do so:

AMA Victoria reiterates that medical practitioners are only able to conduct this crucial educational role as part of good medical practice, once conclusive clinical trials are conducted on the efficacy and side effects of medicinal cannabis.^[13]

1.36 Individual medical practitioners expressed divergent views. The Commission was told that doctors would not prescribe medicinal cannabis because there is insufficient evidence of its efficacy, no guidelines about its use, and no approved product available for sale in Australia.^[14] However, the view was also put that it would be better to supervise patients in using measured amounts of products of known quality and composition than have them experiment with illegal products without medical supervision. Concern was expressed that patients are declining conventional therapies because of the claims being made about cannabis.^[15]

1.37 Some submissions argued that medical supervision is unnecessary and unlikely to be forthcoming. Amanda Newell, for example, said in her submission that:

I personally don’t feel a GP is necessary. Colorado have a good thing going, Australia should take some advice from them. Otherwise, sell it over the counter at the chemist, similar to Codeine (that’s a far more dangerous and addictive drug than Cannabis though).^[16]

1.38 Matthew Pallett identified a need for guidance but said that this should come from outside the medical profession:

Nobody has ever died from using cannabis or whole plant cannabis extracts which have been around for a couple of centuries, even from uncontrolled illicit street supply. This indicates a need for use under medical supervision to be totally unnecessary but guidance for administration for inexperienced users by those experienced in the practices, would make reasonable sense in order to avoid unwanted side effects that can occur with incorrect strain choice.^[17]

1.39 Other submissions called for a broad range and variety of health and allied health practitioners to advise and monitor patients about their use of medicinal cannabis.^[18]

1.40 The question of who should be able to authorise medicinal cannabis treatment is discussed in Chapter 3. However, the objective of integrating the use of cannabis with the patient’s program of medical treatment extends beyond the ‘gatekeeper’ role. While no one may have died from cannabis, many have died from conditions that cannabis is being used to treat. A decision to use medicinal cannabis should not isolate the patient from broader medical care or undermine their other medical treatment. Rather, it should be integrated into broad medical management of the therapeutic needs of the patient.

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

1.41 Patients with access to licit medicinal cannabis products that have not been approved by the TGA could wrongly assume that their quality, safety and efficacy have been tested to the same standards as prescription medicines. If they have read information on the internet promoting the many therapeutic benefits attributed to cannabis use, they may have a false impression about the probative value of some of the claims.

1.42 Accordingly, the scheme would need to ensure that patients who use medicinal cannabis—or carers who make decisions on their behalf—know about the risks and the current limits of clinical knowledge about its efficacy and effects, including its long-term effects.

1.43 The Law Institute of Victoria pointed out that, as part of their duty of care, medical practitioners must provide their patients with information that will enable them to give their informed consent to medical treatment. This includes information about all material risks. A medical practitioner who fails to do so is exposed to civil liability for the outcome, even if the treatment was not negligent:

With the example of a medicinal cannabis product that is not regulated under the Commonwealth TGA, medical practitioners would arguably need to provide an appropriate disclaimer as to the limited therapeutic research and the limited evidence of efficacy. The patient would need to assume the risk. This is more complicated in the situation of minors and people who lack capacity to give informed consent and their ability to assume that risk.

As the efficacy of the medicinal cannabis (without an established therapeutic product in an appropriate registered form) is still unclear (on a clinically trialed basis), this may cast doubt that express consent from a decision maker was adequately informed.^[19]

1.44 Some medical practitioners have questioned how they could ensure that a patient gives informed consent to use medicinal cannabis when they themselves are unclear about the possible consequences of the decision.^[20] The Royal Australasian Society of Physicians has noted that the potential risks and benefits will be very different from one patient group to the next.^[21] The Commission expects that concerns of this nature could be addressed to some extent by training and guidelines that could be offered under a medicinal cannabis scheme. In addition, clinical trials that are underway or proposed in Australia and internationally will continue to enrich knowledge about the medicinal properties of cannabis.

1.45 It is nevertheless clear that any scheme introduced in Victoria would need to accommodate the uncertainties surrounding a decision to use a medicinal cannabis product that has not been tested to the standards required by the TGA for prescription medicines. Patients would need to be informed (preferably verbally and in writing in language they are likely to understand) that aspects of the treatment such as the dosage, the best form of administration, immediate and long-term side effects and interaction with other medications have not been established authoritatively by clinical trials, and would need to take responsibility for the decision to proceed with the treatment in view of the information with which they are provided.

1.46 The scheme would also need to support the development of expertise among medical practitioners in the use of cannabis for medicinal purposes, and to ensure that only those with appropriate training would assess whether it should be made available to their patients.

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

1.47 There are many reasons why products provided under a Victorian medicinal cannabis scheme would need to be of reliable quality and known composition:

• It is essential to patient safety.

• It would enable a doctor to titrate dosage and monitor dose-response effect.

• It would provide a superior product to what is available illegally.

• It would enable useful data to be collected on the efficacy and side effects when treating particular conditions and symptoms.

1.48 Any regulation would provide a level of quality assurance that illicit production cannot guarantee, but the scheme would need to impose standards that provide medical practitioners and their patients with certainty about the potency and contents of the products being administered.

1.49 A number of submissions pointed out the need to ensure that the products to which patients are given access are of reliable and verifiable composition.^[22] Many members of the public who told the Commission that they wish to be able to use cannabis legally said that their main concern is to have access to products of a consistently good quality. As Shirley Humphris argued in her submission: ‘We need a supply that is clean and grown under controlled conditions (street cannabis can be heavily laced with pesticide)’.^[23]

1.50 Possible approaches to regulating the quality of products are discussed in Chapter 7.

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

1.51 Any medicinal cannabis scheme established in Victoria would need to remain effective over time as scientific knowledge, medical practices and technology continue to evolve. Greater understanding about the therapeutic properties of cannabis could have an impact on the range of products made available in Victoria, the conditions under which they are provided, and the size and focus of the scheme. Accordingly, the scheme would need to keep pace with, and be responsive to, clinical research and developments in the medicinal cannabis industry.

1.52 Measures that would enable a Victorian medicinal cannabis scheme to be responsive to developments in clinical knowledge, and subject to ongoing monitoring and review, are discussed in Chapter 8.

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

1.53 The proposed legislative reform would need to reinforce ongoing prohibitions on the cultivation, supply and use of cannabis. The reform would not allow everyone who currently uses, or wants to use, cannabis to do so legally. It follows that the illicit market would continue to exist.

1.54 Depending on the features of the scheme that is established, it could create new opportunities for cannabis to be supplied and used illegally. For example, medicinal cannabis supplied under the scheme could be diverted to unauthorised users by:

• authorised patients who pass on some of their supply to others

• medical practitioners who enable access by patients who do not meet the eligibility criteria

• theft of cannabis seeds or plants under cultivation

• theft of medicinal cannabis products from distributors or patients.

1.55 Opinions vary on the impact that a Victorian medicinal cannabis scheme could have on the illicit market. Concerns that legitimising the use of cannabis for medicinal purposes ‘normalises’ recreational use among young people have not been supported by recent research findings.^[24] However, international experience has shown significant diversion of cannabis produced in ‘grow your own’ schemes to the illegal market where adequate controls are not in place.^[25]

1.56 The Law Institute of Victoria indicated that the risk of diversion is affected by the balance of supply and demand and this should be borne in mind when establishing the scheme.^[26] The Victorian Alcohol and Drug Association suggested that cannabis is so widely available and affordable illegally that legal products would have little street value.^[27] Dr Andrew Katelaris pointed out there is no risk of CBD-dominant cannabis products being diverted for recreational use because CBD has no psychotropic effect.^[28]

1.57 In addressing the risk of diversion, law enforcement authorities would need to be able to determine whether a person in possession of medicinal cannabis is authorised under the scheme and to distinguish between products that have been made available under the scheme and diverted to the illegal market and products that have been produced illegally. In addition, security measures appropriate to the assessment of the risk would need to be put in place at every step of the supply chain. Many submissions commented on the security risks and suggested how they could be managed.^[29] The Commission has taken such risks into account in developing its recommendations.

Provide an equitable and accessible scheme

1.58 This objective has been developed in response to comments that the Commission received on the issues paper, notably from the advisory committees.^[30] It recognises the need for the reform to create a scheme that provides 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.

1.59 A concern frequently raised with the Commission is the importance of making the medicinal cannabis products that are sold under a Victorian scheme affordable for patients, particularly as many could be on low incomes because of disabilities stemming from their conditions.^[31]

1.60 Otherwise, as a submission made on behalf of cannabis users and advocates pointed out, patients could resort to using less expensive illicit products:

Patients’ access to cannabis under any regulated scheme is vital to its success. If patients are unable to practically access cannabis, they will not embrace the system and return to buying their medicine from the illicit market.^[32]

1.61 This has been the experience overseas. This has been an important issue in the various iterations of the Canadian medicinal cannabis scheme.^[33] In Italy, eligible patients were permitted in 2013 to access imported medicinal cannabis from the Netherlands. However, the imported cannabis was priced at ten times the cost of products purchased on the illicit market, at €38 per gram, or €1,000 per month for a typical patient. As a result, only a ‘few dozen’ Italian patients signed up for the program.^[34] Italy now produces its own medicinal cannabis.

1.62 In a number of jurisdictions, retail prices for medicinal cannabis are set by the government because of its involvement in the market. In the Netherlands, the Office of Medicinal Cannabis sells all the medicinal cannabis provided under the scheme. It sets the prices based on the net costs it incurs in purchasing, analysing, packaging and distributing the cannabis.^[35] The scheme is revenue-neutral.^[36]

1.63 Some states in the United States impose price controls by regulation rather than by government involvement in the distribution process. In Vermont, for instance, dispensaries are required to have ‘a sliding-scale fee system that takes into account a registered patient’s ability to pay’.^[37] In New York, the government will set the ‘per dose price’ at which medicinal cannabis may be sold.^[38] Prices are also controlled indirectly by the common requirement that distributors operate on a not-for-profit basis.

1.64 A view put forward in several submissions was that patients should be able to grow their own cannabis, to keep the costs affordable.^[39] This would be only a partial solution, because not all patients have the ability, inclination or resources to grow their own. They would be reliant on products that have been manufactured under regulation and sold for a higher price.

1.65 A number of factors other than the purchase price of the products would be likely to affect the accessibility of the scheme for patients. Patients may be unable or unwilling to participate if:

• The authorisation process is expensive, difficult or protracted.

• No local medical practitioners will supervise the treatment.

• There are extensive delays in meeting demand for the products.

• The monitoring and review obligations impose an unreasonable burden.

1.66 The obligations imposed by the scheme on other participants should also not be too onerous. Over-regulation of the cultivation and processing of cannabis, excessive licence fees, or duplication of regulation by Victoria and the Commonwealth would increase costs and act as a disincentive to potential licensees. If the qualifications or reporting requirements under the scheme are overly time-consuming, medical practitioners may choose not to be involved, or they may charge a higher fee to patients to recover their costs. Similarly, if the rules concerning distribution depart too much from existing practice and require new procedures and systems to be established, pharmacies may be reluctant to participate as well. Considerations such as these at any point of the process could affect the viability of the scheme.

1.67 The more efficient the design of any Victorian medicinal cannabis scheme, the lower would be the costs at each step of the supply chain. In turn, the extent to which the government may need to subsidise the purchase price of the products would be reduced. The Commission has been mindful of this consideration in evaluating the law reform options in this report.

Recommendation

1 Law reform to allow people to be treated with medicinal cannabis in exceptional circumstances should be designed so as to be compatible with the following objectives:

(bp) Allow compassionately for exceptional circumstances of medical need.

(bq) Integrate the use of medicinal cannabis products into the patient’s medical treatment.

(br) Ensure that patients are informed of clinical uncertainty about the safety and efficacy of medicinal cannabis products they use.

(bs) Ensure that medicinal cannabis products are of reliable quality and known composition.

(bt) Foster, and be responsive to, clinical research and developments in technology.

(bu) Preserve the prohibition of unlawful trafficking, cultivation, supply and use of cannabis.

(bv) Provide an equitable and accessible scheme.

Risks

1.75 The introduction of a scheme to allow Victorians to be treated with medicinal cannabis in exceptional circumstances would generate risks that need to be taken into account in considering the law reform options. The option preferred by the Commission has been developed with a view not only to the regulatory objectives but to the management of these risks.

1.76 There are hierarchies of risk at every level of any regulatory scheme. The Commission focused on those which are inherent to the proposed reform:

• Patient safety is compromised when using products that do not meet the safety, quality and efficacy standards that apply to prescription medicines under the national regime.

• There is uncertainty or controversy about the circumstances in which access to cannabis is permitted.

• Medicinal cannabis products are diverted to unauthorised users.

• There are excessive costs to government in establishing and operating a scheme outside the national framework for regulating therapeutic goods.

• Victoria does not secure the necessary support from the Commonwealth in establishing and operating an effective scheme.

1.77 The Commission discusses these risks throughout the report. Although they are relevant considerations in introducing the proposed reform, it is important to acknowledge that numerous other factors will inform the many decisions required in drafting legislative amendments and establishing and operating a medicinal cannabis scheme.

Expectations about implementation

1.78 The Commission’s approach to identifying and assessing the options for reform is underpinned by a number of expectations about the features of any medicinal scheme that may be established in Victoria. The discussion about the options in this report assumes that each would have these features.

A regulator

1.79 Responsibility for establishing and administering the scheme would reside within the portfolio of the Minister for Health. The Commission is aware that preparatory work is already underway within the Department of Health and Human Services, driven by a newly established medicinal cannabis taskforce, pending the completion of this reference.

1.80 Depending on the features of the scheme that is adopted, the Commission expects that the Secretary of the Department of Health and Human Services would be responsible for functions such as:

• establishing and maintaining records in relation to eligible patients and carers, and participating medical practitioners and pharmacists

• granting permits to medical practitioners

• creating and enforcing quality assurance standards

• controlling the manufacture and distribution of medicinal cannabis products

• providing data to the Commonwealth in order to meet international reporting obligations

• preparing guidelines and educational material for the public, medical practitioners and pharmacists.

1.81 The Secretary’s lawful functions may need to be amended accordingly^[40] and other government agencies may also need to be involved in regulating aspects of the scheme.^[41] In any event, the functions would be within the remit of existing government agencies and there are no compelling reasons to create an independent statutory authority for this purpose.^[42]

1.82 To the extent that there is a need for the Victorian Government to enter into contracts or own property, these powers could be exercised by an existing body corporate known as the ‘Secretary to the Department of Health and Human Services’.^[43] This body corporate and its predecessors have a long history of contracting and owning property for discharging various health-related functions.^[44]

1.83 The Commission also expects that, while the new regulatory powers would be formally reposed in the Secretary, in practice they would be exercised by, or on the advice of, a business unit within the Department of Health and Human Services. In this report, the Commission refers to this unit as the ‘Office of Medicinal Cannabis’.

An advisory body

1.84 The Commission has recommended above that one of the regulatory objectives of any medicinal cannabis scheme in Victoria should be to foster, and be responsive to, clinical research and advancements in technology. It was suggested to the Commission that the Government establish and use a panel of experts to guide it on the state of the science and how this should inform its decision making.^[45]

1.85 The Commission concurs with the thrust of these submissions. An Expert Advisory Committee on Medicinal Cannabis was established by the Department of Health and Human Services in 2014 and could form the basis of such an advisory body under a medicinal cannabis scheme.

1.86 Professor David Penington recommended the formation of a panel of patient advisors who are ‘knowledgeable about alternative products and methods of administration.’^[46] The Commission agrees that the Department of Health and Human Services should consult with patients and their carers about the operation of the scheme. However, while the panel proposed by Professor Penington could be useful, and community consultation is important, there may be better means of communicating with this disparate and widespread group of people.

Interim measures

1.87 There could be a considerable period of time between a decision being made by the Government about the type of scheme to introduce and the supply of medicinal cannabis products under the scheme. The duration would depend on how much of the supply chain is regulated by the scheme. In the meantime, it is reasonable to expect that the patients for whom the scheme is designed would continue to use, or could seek to use, illicit medicinal cannabis products.

1.88 Accordingly, the Commission acknowledges that the Government may consider introducing interim measures in anticipation of the scheme coming into operation. These could be introduced under interim legislation that is repealed upon the full scheme coming into effect. Such measures could include, for example, the establishment of a registration scheme for patients for whom specific services and authorisations could be created. The Commission makes no recommendations about any such measures as it would be beyond the scope of the terms of reference. However, the following observations are made for the Government’s information.

1.89 In considering which interim measures, if any, to introduce, it would be prudent to be guided by the regulatory objectives that the full scheme is intended to achieve. An interim measure should not permit activities which again would be prohibited under the scheme; if it did, the final scheme would be undermined by the interim scheme that preceded it.

1.90 The immediate priorities identified by patients and their families who spoke with the Commission about their current illicit use of cannabis for medicinal purposes, and who would be eligible to participate in the scheme if the recommended eligibility criteria were applied, are to be protected from prosecution and be able to find out the composition of the products they use.^[47]

1.91 A number of submissions, and comments made during consultations, called for an amnesty for patients and their suppliers.^[48] However, any ‘amnesty’ would need to take the form of an authorisation to conduct activities that are otherwise prohibited under the Drugs, Poisons and Controlled Substances Act 1981 (Vic).

1.92 Interim measures could authorise specific classes of people to possess or administer cannabis for medicinal purposes, including for example:

• patients and carers who have been registered for the purposes of the interim measures

• medical practitioners and nurses involved in their care

• employees of testing facilities for the purpose of implementing any interim measures allowing for medicinal products to be tested.

Concurrent developments

Rescheduling of cannabidiol

1.93 On 1 June 2015, the cannabinoid cannabidiol (CBD) was rescheduled to Schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons.^[49] This means that a medicine containing cannabidiol and two per cent or less of other cannabinoids may be made available by prescription throughout Australia, as long as it has first been approved by the TGA.^[50]

Clinical trials

1.94 A number of clinical trials of medicinal cannabis are underway or planned in Australia.

1.95 New South Wales, Queensland and Victoria are sponsoring three trials to explore the efficacy of cannabis and/or cannabis-derived products. Led by New South Wales, the first trial is of children with severe, drug-resistant epilepsy. It will involve up to 200 participants, from mid-2016. The Victorian Government aims for at least a quarter to be from Victoria. The results of the trial are expected in two to five years.^[51]

1.96 The other two trials are for adults. One will focus on relieving the pain symptoms of adults with terminal illness. The other will be for adults with chemotherapy-induced nausea and vomiting, where standard treatment is ineffective.

1.97 Following a donation of $33.7 million for medicinal cannabinoid research, the University of Sydney recently announced that it will conduct a multi-year program to build on existing expertise to ultimately produce cannabinoid-based medicines. A priority will be to understand the potential for CBD and other cannabinoids to treat paediatric epilepsy.^[52] The University of Sydney is also involved in the government-sponsored trials.

Regulator of Medicinal Cannabis Bill 2014 (Cth)

1.98 In November 2014, the Regulator of Medicinal Cannabis Bill 2014 (Cth) was introduced to the Senate as a Private Member’s Bill.^[53] The Bill establishes the Regulator of Medicinal Cannabis, an agency that would:

• approve medicinal cannabis products for inclusion in a register of regulated cannabis products^[54]

• make, and monitor compliance with, rules for licensing the production, use, experimental use and import and export of medicinal cannabis.^[55]

1.99 The proposed office of Regulator is designed to satisfy the requirements of the Single Convention on Narcotic Drugs regarding government supervision of licensed cannabis cultivation.^[56] The source of constitutional authority for the Bill is said to be the treaty implementation aspect of the external affairs power.^[57] The scheme would apply only in those states and territories that opt in.^[58]

1.100 On 12 February 2015, the Senate referred the Bill to the Senate Legal and Constitutional Affairs Legislation Committee for report by 21 April 2015. On 11 August 2015 the report was tabled, supporting ‘in principle, the access to products derived from cannabis for use in relation to particular medical conditions where the use of those products has been proven to be safe and effective.’ The committee recommended amendments to the Bill to address issues in relation to its interaction with the existing Commonwealth regulatory framework for medicinal products, including the Therapeutic Goods Act 1989 (Cth), the Narcotic Drugs Act 1967 (Cth) and relevant customs legislation. It also recommended amendments to the Bill to ensure compliance with Australia’s international obligations, including under articles 23 and 28 of the Single Convention on Narcotic Drugs 1961.^[59]

1.101 The Commission is aware of active discussion at the political level, and among government agencies, about the possible introduction of Commonwealth legislation. Although Commonwealth legislation could modify the design of a Victorian scheme, the discussion in this report would remain relevant.

Draft Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 (ACT)

1.102 The Standing Committee on Health, Ageing, Community and Social Services of the Australian Capital Territory Legislative Assembly is also considering proposed medicinal cannabis legislation—the Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 (ACT). On behalf of the ACT Greens party, the Minister for Justice^[60] presented an exposure draft of the Bill and a discussion paper to the Legislative Assembly in August 2014. The exposure draft and paper were referred to the committee.^[61]

1.103 The purpose of the draft Bill is to set up a licensing system for patients to possess and grow their own cannabis for medicinal purposes if approved by the Chief Health Officer.^[62] Patients would be able to make one of three types of application:

• Category 1 application: for the mitigation of symptom(s) of a terminal illness^[63]

• Category 2 application: for the mitigation of one or more listed symptoms associated with a listed condition, set out in a table (such as severe pain associated with cancer)^[64]

• Category 3 application: for the mitigation of a symptom of any other medical condition or its treatment.^[65]

1.104 The application would have to be supported by a statement from a doctor, with increasingly stringent requirements according to the category of application.^[66] In all cases, the applicant would need to have tried or considered conventional treatment first.^[67] Once approved, a patient would be permitted to possess cannabis. An approval would essentially amount to a licence to possess and use cannabis.^[68]

1.105 The patient would also be permitted to seek a licence to cultivate cannabis either personally or on their behalf by a nominated carer. It would be valid for a limited time (no longer than a year) and would stipulate maximum possession amounts.^[69] In applying for a cultivation licence, the applicant would have to establish that they have appropriate security measures in place,^[70] and only one patient would be able to be associated with any given cultivation site.^[71] The scheme would be reviewed after five years by a multi-stakeholder committee.^[72]

1.106 At the time of writing, the committee was due to report by the last sitting day of August 2015.^[73] The outcome could also be affected by any decision by the Commonwealth to legislate in this area.

Tasmanian parliamentary inquiry

1.107 On 20 November 2014, Government Administration Committee ‘A’ of the Tasmanian Legislative Council released an interim report on the use of natural botanical medicinal cannabis flower and extracted cannabinoids for medicinal purposes. The interim report noted that many Tasmanians were already using cannabis medicinally and that the law did not provide protections for these users or those who supply them.

1.108 While acknowledging that more research was needed, the Committee recommended immediate legislative change, on compassionate grounds, to protect users of medicinal cannabis from criminal charges associated with possession and administration. It also recommended that the Tasmanian Government:

• develop a legislative framework to enable medicinal cannabis to be used under medical supervision, including the preparation, cultivation and supply of medicinal cannabis

• facilitate clinical research

• adopt a cooperative approach with other jurisdictions regarding legalisation of the prescription, administration, possession and cultivation of cannabis for medicinal use

• engage with companies with appropriate expertise and capacity to progress the cultivation, extraction and processing of cannabinoids within the existing and/or future regulatory framework.^[74]

1.109 The Tasmanian Government responded to the interim report by expressing its support for clinical trials and the potential use of medicinal cannabis in Tasmania, subject to a proper evidence-based approach, strong regulatory framework and appropriate approvals from national regulators.^[75] However, it rejected the Committee’s recommendation to legislate immediately to protect individuals who are using medicinal cannabis from criminal charges. The Police Commissioner had said that Tasmania Police would not criminally pursue terminally ill users of cannabis or people who had contributed to the inquiry.^[76] The Committee presented its final report to the Legislative Council on 21 April 2015.^[77] It said that continuing the inquiry in light of the introduction of the Regulator of Medicinal Cannabis Bill 2014 to the Senate and the New South Wales Government’s commitment to clinical trials may be duplicative and unnecessary. The interim report stands as the substance of the final report.^[78]

Norfolk Island licence to cultivate and export cannabis

1.110 In April 2015, the responsible minister announced that AusCann Group Holdings Pty Ltd had lodged an application for a licence to ‘import, export, plant, cultivate, tend or harvest and sell’ cannabis, for the purpose of establishing a medicinal cannabis industry on Norfolk Island.^[79] Norfolk Island legislation permits the Minister to grant such a licence under ‘such conditions as the Minister thinks appropriate’^[80] and the Administrator has the discretion to cancel it at any time.^[81]

1.111 In May 2015, it was reported that the licence had been granted. The AusCann Managing director revealed that the company aimed to produce high quality medicinal-grade cannabis for export to importers that were licensed in accordance with the Single Convention on Narcotic Drugs.^[82] It had an initial order from Canada for one tonne and aimed to provide ten tonnes in the future. The first crop was to be planted in November 2015, to be harvested in May or June 2016.^[83]

1.112 Since then, the legal and governance framework for Norfolk Island has changed. The form of self-government that was established by the Norfolk Island Act 1979 (Cth) has been abolished.^[84] The Legislative Assembly and Executive Council will be replaced from

1 July 2016 by a regional council that will provide local and municipal services. State-level services will be provided by the New South Wales Government, and the law of New South Wales will apply. In the meantime an advisory council has been established as an interim body and the statutory office of Administrator will continue.

1.113 Norfolk Island laws will stay in place until they are specifically replaced by New South Wales law.^[85]

Structure of this report

1.114 Any approach to determining the exceptional circumstances in which a person could lawfully use cannabis for medicinal purposes should be grounded in an understanding of its therapeutic benefits, efficacy, risks and dangers. Chapter 2 contains an overview of what cannabis is, how it is used, and what is currently known and claimed about its therapeutic properties.

1.115 The Commission’s conclusions and recommendations about the eligibility criteria for a scheme that allows for people to be treated with medicinal cannabis in exceptional circumstances are explained in Chapter 3. Discussion then turns to who could authorise an individual patient’s access to medicinal cannabis and the possible regulatory mechanisms involved.

1.116 The legislation that controls access to cannabis is discussed in Chapter 4. The Drugs, Poisons and Controlled Substances Act 1981 (Vic) and the Therapeutic Goods (Victoria) Act 2010 (Vic) and associated regulations constitute Victoria’s contribution to national legislative frameworks that control narcotic drugs and ensure the quality, safety and efficacy of therapeutic goods.

1.117 Chapter 5 sets out the options for reform. The range of proposals put to the Commission is discussed. Some are not feasible because they are legally unstable or otherwise undesirable when considered in view of the regulatory objectives. An option that is feasible and most likely to achieve the regulatory objectives is identified and recommended. It is adopted as a model in the following chapters. Chapter 6 contains details of how medicinal cannabis products could be manufactured, supplied and distributed in Victoria under the recommended option.

1.118 Under the recommended option for the supply of medicinal cannabis products the Victorian Government would regulate the quality and type of products available. Ways in which this could be done are discussed in Chapter 7.

1.119 Any medicinal cannabis scheme introduced in Victoria could be the first of its kind in Australia, and would be implemented at a time when information about, attitudes toward and controls on the use of cannabis for medicinal purposes are changing rapidly.

Chapter 8 discusses possible measures for ensuring that the operation of the scheme contributes to research and is subject to ongoing monitoring and review.

1.120 Chapter 9 concludes the report.

1. ‘Victorian Government Moves Ahead with Plans to Legalise Medical Marijuana’, ABC (online), 19 December 2014 <http://www.abc.net.au/news/>.

   ↑

2. Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015).

   ↑

3. ‘Victorian Government Moves Ahead with Plans to Legalise Medical Marijuana’, ABC (online), 19 December 2014 <http://www.abc.net.au/news/>.

   ↑

4. Vanessa Desloires, ‘Premier Daniel Andrews Hope to Have Bill on Legalising Medical Marijuana Before Parliament Before End of Next Year’, The Age (Online), 19 December 2014 <http://www.theage.com.au/victoria/>.

   ↑

5. A comprehensive overview of the current state of clinical research was included in the issues paper and has not been replicated in this report. See Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015).

   ↑

6. Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015) Ch 4.

   ↑

7. Michael Vagg, ‘Is the Medical Marijuana Debate Even Worth Having?’ The Conversation (16 February 2015) <http://theconversation.com>.

   ↑

8. Advisory committee (Meeting 1); Submissions 27, 38, 40, 42, 47, 48; Consultation 16.

   ↑

9. Also known as severe myoclonic epilepsy of infancy, a rare and catastrophic form of intractable epilepsy that begins in infancy.

   ↑

10. Submission 33. See Appendix B for list of submissions.

    ↑

11. Submission 38.

    ↑

12. Submissions 2, 8, 42, 53, 56, 67; Consultation 13. See Appendix C for list of consultations.

    ↑

13. Submission 38.

    ↑

14. Advisory committee (Meeting 3); Consultations 8, 16.

    ↑

15. Advisory committee (Meeting 1).

    ↑

16. Submission 16.

    ↑

17. Submission 59.

    ↑

18. Submissions 1, 10, 84, 91, 95; Consultation 3.

    ↑

19. Submission 63.

    ↑

20. Submission 38; Advisory committee (Meeting 3).

    ↑

21. Submission 52.

    ↑

22. Submissions 22, 25, 35, 57, 60, 61, 69, 71.

    ↑

23. Submission 49.

    ↑

24. Deborah S Hasin et al, ‘Medical Marijuana Laws and Adolescent Marijuana Use in the USA from 1991 to 2014: Results from Annual, Repeated Cross-sectional Surveys’ (2015) 2 The Lancet Psychiatry 601.

    ↑

25. Submissions 37, 61, 74. Gerald Caplan, ‘Medical Marijuana: A Study of Unintended Consequences’ (2012) 43 McGeorge Law Review 127. Delsys Research Group, Cost-Benefit Analysis of Regulatory Changes for Access to Marihuana for Medical Purposes, Final Report (2012). Yu-Wei Luke Chu, ‘The Effects of Medical Marijuana Laws on Illegal Marijuana Use’ (2014) 38 Journal of Health Economics 43.

    ↑

26. Submission 63.

    ↑

27. Submission 46.

    ↑

28. Submission 30.

    ↑

29. Submissions 21, 23, 26, 29, 40, 42, 44, 58.

    ↑

30. Advisory committee (Meetings 1 and 2).

    ↑

31. Advisory committee (Meetings 1 and 2); Consultations 2, 4, 5, 6, 8, 23, 24, 26.

    ↑

32. Submission 95.

    ↑

33. Submission 95. See also Ian Freckelton, ‘Medicinal Cannabis Law Reform: Lessons from Canadian Litigation’ (2015) 22 Journal of Law and Medicine 719.

    ↑

34. Steve Scherer, ‘To Grow Cheap Marijuana, Italy Calls in the Army’, Reuters (online), 12 October 2014 <http://www.reuters.com>.

    ↑

35. Consultation 28.

    ↑

36. Ibid.

    ↑

37. 18 Vt Stat Ann § 4474e(b)(2).

    ↑

38. NY Public Health Law § 3366-D.

    ↑

39. Submissions 6, 23, 53, 95.

    ↑

40. The Secretary’s functions are set out in the Public Health and Wellbeing Act 2008 (Vic) s 17 and can be expanded by regulation: s 17(1)(c). Alternatively, new provisions could be added to the Act.

    ↑

41. The Commission expects that the Secretary of the Department of Economic Development, Jobs, Transport and Resources would regulate any cultivation of cannabis for medicinal purposes by licensed entities: see Chapter 6.

    ↑

42. Victorian Public Sector Commission, Legal Form and Governance Arrangements for Public Entities: Guidelines (May 2013) [3.2].

    ↑

43. Under the Public Health and Wellbeing Act 2008 (Vic) s 16, the ‘Secretary to the Department of Health’ is established as a body corporate, which is capable of owning property and doing all other acts which may be done by body corporate. By force of the current Administrative Arrangements Order (No 219) 2014, the ‘Secretary to the Department of Health’ is to be read as the ‘Secretary to the Department of Health and Human Services’: Victoria, Government Gazette, No S 460, 24 December 2014, Table 2, Item 22.

    ↑

44. See Victoria, Parliamentary Debates, Legislative Assembly, 10 March 2010, 748 (Daniel Andrews, Minister for Health).

    ↑

45. Submission 60 proposes that an expert committee be used to review proposals to conduct clinical trials; Submission 61 suggests establishing an ‘indication committee’ to establish eligibility criteria, and an ‘exemption committee’ to consider special cases of eligibility.

    ↑

46. Submission 24.

    ↑

47. Consultations 2, 4, 6, 13.

    ↑

48. Submissions 35, 43, 64, 71, 89, 95; Consultations 2, 5, 6, 9, 24, 26.

    ↑

49. Therapeutic Goods Administration (Advisory Committee on Medicines Scheduling), Final Decisions and Reasons for Decisions by Delegates of the Secretary to the Department of Health (19 March 2015) 56–60.

    ↑

50. Approval of medicines by the Therapeutic Goods Administration, the operation of the Standard for the Uniform Scheduling of Medicines and Poisons and the consequences of rescheduling CBD are discussed further in Chapter 4.

    ↑

51. Premier of Victoria, ‘Victoria to Participate in Medicinal Cannabis Trials’ (Media Release, 19 April 2015) <http://www.premier.vic.gov.au/victoria-to-participate-in-medicinal-cannabis-trials>.

    ↑

52. The University of Sydney, ‘Lambert Donation Puts Australia at Forefront of Medicinal Cannabinoid Research’ (Media Release, 12 June 2015) <http://sydney.edu.au/news/>.

    ↑

53. Commonwealth, Parliamentary Debates, Senate, 27 November 2014, 9506 (Richard Di Natale). See rule 6.6.1.

    ↑

54. Regulator of Medicinal Cannabis Bill 2014 (Cth) pt 2.

    ↑

55. Ibid cl 12.

    ↑

56. Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cth) 1. The Single Convention on Narcotic Drugs 1961 is discussed in Chapter 4.

    ↑

57. Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cth) 2.

    ↑

58. Regulator of Medicinal Cannabis Bill 2014 (Cth).

    ↑

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

    ↑

60. Shane Rattenbury MLA.

    ↑

61. Australian Capital Territory, Parliamentary Debates, Legislative Assembly, 7 August 2014, 2154 (Shane Rattenbury).

    ↑

62. Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 (ACT) cl 14.

    ↑

63. Ibid cl 7(3).

    ↑

64. Ibid cl 7(4).

    ↑

65. Ibid cl 7(5).

    ↑

66. Ibid cl 8–9.

    ↑

67. Ibid cl 8(2)–(3).

    ↑

68. Ibid cl 14.

    ↑

69. Ibid cl 16–22.

    ↑

70. Ibid cl 18(3)(d).

    ↑

71. Ibid cl 18(3)(e).

    ↑

72. Ibid cl 25.

    ↑

73. Standing Committee on Health, Ageing, Community and Social Services, ACT Legislative Assembly (2015) <http://www.parliament.act.gov>.

    ↑

74. Legislative Council Government Administration Committee ‘A’, Parliament of Tasmania, Interim Report on Legalised Medicinal Cannabis (2014) 7.

    ↑

75. Michael Ferguson, ‘Interim Report on Medicinal Cannabis’ (Media Release, 20 November 2014) <http://www.premier.tas.gov.au/releases/interim_report_on_medicinal_cannabis>.

    ↑

76. Ibid.

    ↑

77. Legislative Council Government Administration Committee ‘A’, Parliament of Tasmania, Final Report on Legalised Medicinal Cannabis (2015).

    ↑

78. Ibid 1.

    ↑

79. Robin Adams, Minister for Cultural Heritage and Community Services, ‘A Medicinal Cannabis Industry for Norfolk Island’ (Press Release,

    24 April 2015).

    ↑

80. Dangerous Drugs Act 1927 (NI) s 7A.

    ↑

81. Dangerous Drugs Act 1927 (NI) s 13. The Administrator exercised this power to cancel a licence issued under s 7A to Tasman Health Cannabinoids (NI) Pty Ltd (Tascann) in 2014 after identifying a need for the social, economic and environmental impacts to be properly assessed and for the community to be adequately consulted. He also expressed doubt that the licence adequately addressed international obligations regarding the cultivation and trade of illicit drugs and noted that it had been issued without consulting the relevant federal authorities: Gary Hardgrave, Administrator, Australian Territory of Norfolk Island, ‘Tasman Health Cannabis Licence Cancelled’ (‘Non Daun’taun (Government News from Kingston), 14 August 2014) <http://norfolkonlinenews.com>.

    ↑

82. ‘Firm to export medical cannabis’, Sky News (online), 20 May 2015 <http//www.skynews.com.au/news/national/>.

    ↑

83. 3AW, ‘Medical Marijuana Grown on Norfolk Island’, 20 May 2015 <http://www.3aw.com.au>.

    ↑

84. Norfolk Island Legislation Amendment Act 2015 (Cth).

    ↑

85. Department of Infrastructure and Regional Development, Australian Government, Fact Sheet: Answers to Your Questions from the Information Sessions (May 2015) <http://regional.gov.au/territories/norfolk_island/fact-sheets/Norfolk-Island-reforms-answers-from-info-sessions.aspx>.

    ↑