Medicinal Cannabis: Report (html)

3. Access to medicinal cannabis in ‘exceptional circumstances’

Introduction

3.1 Law reform to allow people to be treated with medicinal cannabis in exceptional circumstances needs to establish a way of distinguishing who is eligible and who is not. This chapter explores the concept of exceptional circumstances and how to convey it in legislation in the form of eligibility criteria. The criteria would be applicable to treatment with medicinal cannabis under any of the law reform options discussed in this report.^[1]

3.2 The conclusion reached is that the criteria should be based on two factors:

• evidence of the efficacy of cannabis in treating a medical condition

• the extent to which it is likely to improve the patient’s quality of life.

3.3 Compassion demands that individual suffering be taken into account, but not that clinical efficacy be ignored. With this perspective as a guide, a number of conditions and associated symptoms are identified and a set of criteria proposed.

3.4 Because a decision to use medicinal cannabis is a medical one, participation in the scheme should not be determined by statutory provisions alone. For the treatment to be truly ‘medical’ in nature, the supply and administration of medicinal cannabis must take place under medical supervision. The reasons for this are twofold. First, treatment with medicinal cannabis must be rational—that is, it must be made available only where there is a reasonable prospect that it will provide a benefit to the patient. Second, the use of medicinal cannabis must be appropriately supervised so that its use does not harm the patient or interfere with other treatments received. It needs to be integrated into the healthcare holistically provided to the patient.

3.5 At the same time, the requirements of medical supervision must not present an insurmountable barrier to patients who could be assisted by the use of medicinal cannabis; nor should it be intolerable to patients wishing a reasonable measure of autonomy in the treatment they receive or unacceptable to the medical practitioners asked to act as ‘gatekeepers’ to the scheme. The regulatory framework should put the eligibility criteria into operation by allowing access by patients who meet the criteria, preventing access by those who do not, and addressing the risks of dishonest and criminal conduct by those who seek to divert medicinal cannabis products to people who are ineligible to participate in the scheme. Similar regulatory challenges are encountered in administering the opioid replacement therapy program. This chapter sets out a system for regulating access to medicinal cannabis that is based on that scheme.

Exceptional circumstances

The idea of ‘exceptionality’

3.6 ‘Exceptional circumstances’ conveys the notion of a limited group of individuals whose experience differs substantially from the norm. The term suggests that there must be something identifiably, objectively different and unusual about the circumstances in which medicinal use of cannabis is authorised that make them exceptional.

3.7 The task for the Commission is to demarcate these cases from those that are not ‘exceptional’.^[2] They are not more worthy than other cases—rather, they are just far enough outside the usual experience to justify an exception being made.

3.8 The term ‘exceptional circumstances’ is found in a number of areas of Victorian law.^[3] It is frequently intended to convey a situation which is highly unusual, such that departure from the ordinary rules can be justified.^[4] Indeed, it conveys a situation where the exercise of discretion is compelled by considerations that are outside normal experience.^[5] While ‘exceptional circumstances’ is in some cases defined,^[6] courts and legislators have generally been reluctant to confine the application of the term to a rigid set of scenarios, reflecting the need for flexibility in compelling circumstances.^[7]

3.9 This approach reflects the function of ‘exceptional circumstances’ in the context of the Commission’s review: to distinguish those cases in which a departure from the ordinary rules can be justified.

3.10 The ordinary rules are that cannabis is a prohibited substance unless provided in a form that has been approved by the conventional processes for regulating therapeutic goods.^[8] The Attorney-General’s terms of reference imply that an alternative regulatory approach is to be considered where circumstances require that an exception be made. The alternative approach being contemplated for such circumstances is to take certain products outside of the conventional, evidence-driven approval and treatment framework.

3.11 The challenge is to identify those matters that justify exceptionality.

Compassion as a basis for action

3.12 In the Commission’s view, the common factor that justifies a different approach for a small group of patients is compassion^[9]—that is, empathy and an authentic desire to address another person’s suffering.^[10] This is reflected in the recommended regulatory objective which refers to ‘allowing compassionately for exceptional circumstances of medical need’.^[11]

3.13 Many submissions received by the Commission urge it to achieve a balance between the stern demands of conventional approval processes and the large number of reports and studies that have identified positive effects or potential from medicinal cannabis for patients with a variety of conditions. Some arguments were mounted from principle—identifying limitations of the research or medical practice—and others were generated by experience of the therapeutic assistance provided by medicinal cannabis. As discussed in Chapter 2, many people with a variety of painful and life-threatening conditions informed the Commission of assistance that they had derived from forms of medicinal cannabis that they had procured illegally.

3.14 Indeed, throughout the Commission’s consultations it was evident that a tension exists between those who advocate a rigid adherence to provision of medication only on the basis of research of the kind demanded for conventional medicines, with no exception being made for medicinal cannabis, and those whose approach is more liberal—influenced or even determined by anecdotal and experiential accounts of therapeutic efficacy, as well as by compassion. The Commission has received submissions at either end of this continuum and at many different points along it.

3.15 For cannabis to be included among the medicinal options available in Victoria, a compromise needs to be found between the extreme positions in order to cater to the present-day suffering of patients that is not being adequately alleviated by conventional forms of relief. It is evident that a tipping-point has been reached within the community which requires such a compromise to be brokered.

3.16 Laurence Mather and his co-authors argued in 2013 that compassion commands us to act, in spite of incomplete research:

A civilised and compassionate country that supports evidence-based medicine and policy should acknowledge that medicinal cannabis is acceptably effective and safe, and probably also cost-effective, especially when the costs of resource use and improvement to the lives and functionality of patients and carers are considered. There is certainly more to learn about medicinal cannabis, but we know more than enough to act now.^[12]

3.17 The exercise of compassion to mitigate the harshness of a wholly evidence-based approach has been urged or drawn upon regularly in respect of medicinal cannabis. For instance, this was the hallmark of the approach of a report in 2013 by a committee of the New South Wales Parliament which emphasised the promise of medicinal cannabis in treating a number of painful conditions that do not respond to existing treatment, and advocated a ‘compassionate approach’.^[13] In 2014, the Public Health Association of Australia similarly identified a ‘need for a compassionate regime whereby seriously and terminally ill individuals who have been appropriately authorised may possess and use cannabis without penalty’.^[14]

3.18 The medicinal cannabis community also draws on the concept of compassion,^[15] and clubs that have been established in Australia and internationally to supply medicinal cannabis call themselves ‘compassion clubs’.

3.19 In its submission to the Commission, in which it listed arguments for the legalisation of medicinal cannabis, the Macedon Ranges Group of Christian Business Men Australia gave primacy to compassion:

Compassion for children who suffer from frequent and highly debilitating seizures and also for cancer sufferers who are in constant, severe pain where the only known effective treatment has been presently illegal medicinal cannabis. Compassion is also warranted in regard to the agonising dilemma of parents of affected children as they must currently break the law or watch their children suffer and deteriorate mentally and physically.^[16]

3.20 The Commission endorses this approach. It is not an approach that renders irrelevant the state of research knowledge about the efficacy, safety and risks attaching to medicinal cannabis. However, it does mean that the strong feelings and hopes of patients, the potential of medicinal cannabis, and the proliferation of accounts about the apparent efficacy of medicinal cannabis for certain conditions should be taken into account in construing when it should be made available in ‘exceptional circumstances’.

3.21 The Commission’s incorporation of compassion as a relevant consideration for making medicinal cannabis available to some patients should not be mistaken for a suggestion that ‘compassion’ should explicitly be made the basis for eligibility under a Victorian medicinal cannabis scheme; this would fail to take account of other relevant considerations. As observed by AMA Victoria, ‘terminology or concepts such as ‘compassionate’ or ‘exceptional’ circumstances … are vague, subjective terms and are likely to lead to a lack of clarity in medical practice.’^[17] Rather, the exercise of compassion has influenced the Commission’s identification of certain exceptional circumstances for the present in which access to medicinal cannabis should be allowed. It is not a threshold for access, but informs how that threshold should be determined.

Eligibility criteria

Factors informing eligibility criteria

3.22 Determining when a patient should be eligible for medicinal cannabis under any Victorian scheme is not a mechanical or purely scientific exercise; it is an approach that should respond humanely and empathically to the experience of pain and suffering which is not being effectively remediated by conventional forms of relief (such as opiates, anti-spasticity, anti-emetic or anti-epileptic drugs). At the same time, it should not disregard the evidence regarding the potential utility of cannabis as a medicinal agent. It follows that the eligibility criteria must take account of the experience of particular conditions, and whether there is a reasonable potential for medicinal cannabis to assist, while also placing particular emphasis on patients’ (subjective) experience of suffering and their desire for another therapeutic option.

3.23 Thus, the Commission has had regard to several factors in developing eligibility criteria for access to medicinal cannabis:

• the state of the clinical literature in relation to the efficacy or potential efficacy of medicinal cannabis for particular medical conditions and symptoms, particularly in relation to the likelihood that cannabis will assist

• the seriousness of the medical conditions, including patients’ prognoses and the extent of the disability caused by their conditions

• the extent to which the symptoms of the conditions interfere with patients’ ability to derive enjoyment and fulfilment in their lives

• the extent to which cannabis can reasonably be anticipated to improve quality of life

• 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 patients with particular medical conditions.

3.24 While there must be evidence supporting the likely efficacy of cannabis for a particular medical condition, such evidence should not be the sole criterion applied. Compassion demands that the extent of suffering should be taken into account, and compared with the relief the patient might receive. The level of evidence required (regarding efficacy and side effects) should respond to the severity of the patient’s suffering and the availability of alternatives.

Methods of determining eligibility

3.25 Although a wide range of eligibility criteria are used for medicinal cannabis schemes in other countries, three main approaches can be identified:

• case-by-case decisions by a medical practitioner, who decides at their discretion whether a patient is eligible to be treated with medicinal cannabis

• case-by-case decisions by a panel or a government official, which decides whether a patient is eligible by referring to a general statutory test

• a categorical test.

Decision by medical practitioner

3.26 A number of submissions to the Commission put the view that eligibility should be determined by the patient’s medical practitioner, exercising unfettered discretion.^[18] The practitioner’s assessment would focus upon the condition and symptoms of the patient, but the decision about eligibility would be made by the practitioner independently, free of constraints imposed by statutory eligibility criteria.

3.27 This is the approach taken in the Netherlands. While the Office of Medicinal Cannabis suggests some conditions where there is strong evidence cannabis can assist, medical practitioners are free to prescribe cannabis for any indication.^[19] Toby Stewart called for this approach to be adopted in Victoria:

The law cannot and must not displace the judgement of doctors. If it does, doctors will become clerks who look up laws and dole out drugs for a profit. They will no longer have any ethical duty, no[r] any interest in the complex issues of suffering, dignity and death. It is not for the law to decide who uses what drug. It is for the law to decide which drugs doctors may prescribe to alleviate suffering, and which they may not. This issue for reform here is the treatment of a drug by the law. The issue is not the wholesale revision of medical professional competence, and the replacement of doctors by merry statute. We must let doctors continue to prescribe those drugs which are lawful, as they deem fit in their professional capacity. People will not accept a law that displaces doctors. It will be a farce, and a disgrace, to propose such a law.^[20]

3.28 Notwithstanding such concerns, the Commission does not consider that the task of determining whether a particular patient is eligible should be a task entirely for the medical practitioner. The Commission’s medical advisory committee strongly opposed a scheme where the determination was entirely left to medical practitioners. The committee stated that this would give medical practitioners excessive latitude and inadequate guidance to decide who should have access,^[21] with the risk of highly variable decision making. The conventional regulatory structure in Australia, the Therapeutic Goods Administration (TGA), limits the circumstances in which approved medicines can be prescribed, and practitioners’ professional obligations allow them to go outside these restrictions only in limited circumstances.

3.29 Furthermore, while all decisions about a patient’s treatment, including treatment with medicinal cannabis, should be made on a case-by-case basis, this approach does not provide a basis for determining which patient’s circumstances are exceptional. It provides no objective standard against which to assess who should have access to medicinal cannabis when it is to be available only in exceptional circumstances.

Decision by a panel or government official

3.30 Another means of implementing a case-by-case determination would be for a government official or panel of doctors to determine, on application, whether a patient is eligible to be treated with medicinal cannabis, according to some very general statutory test of eligibility relating to the individual’s circumstances. It was suggested at a public consultation that people other than doctors could be involved in the decision.^[22]

3.31 The Commission is unaware of a medicinal cannabis scheme that relies on this approach, but expects that it could work in a similar fashion to the Special Access Scheme, under which the Secretary of the Commonwealth Department of Health has the discretion to allow unapproved medicines to be imported for, or supplied to, a patient on a case-by-case basis.^[23] A similar approach is taken in countries like Germany to manage requests to import medicinal cannabis products.^[24]

3.32 In the Commission’s view, this approach is not desirable as a systematic means of controlling access in Victoria. It would create administrative costs for the Victorian Government and uncertainty within the medical profession about who is eligible. It could also generate administrative appeals and applications for judicial review of decisions not to approve access.^[25] Importantly, the time taken to process applications for access would delay the treatment of gravely ill (possibly terminally ill) people with products that might assist them.^[26]

Categorical test

3.33 An alternative approach is for categories of patients who are eligible to receive medicinal cannabis under the scheme to be set out in legislation. This would give clarity to medical practitioners and the public. It would also reduce the pressure placed on medical practitioners to provide access to medicinal cannabis to treat minor conditions, where patients’ symptomatology is not significant, or in other circumstances that clearly are not exceptional.^[27] For this reason, the Commission’s medical advisory committee expressed strong support for eligibility criteria which specifically identify the medical circumstances that qualify a person for access.

3.34 There are some drawbacks to adopting a categorical approach. JB, for instance, expressed concern about not taking account of the patient’s individual circumstances:

Deciding who should be allowed access to medicinal cannabis should be on a patient by patient basis. All cases treated on their merits and not an umbrella decision affecting all people with the same condition.^[28]

3.35 The Drug Policy Modelling Program cautioned against the possibility of creating a division between those deemed to be ‘deserving’ as against ‘undeserving’.^[29] Another contributor argued that list-based tests are ‘generally exclusionary rather than inclusionary’ and ‘contrary to the notions of a compassionate scheme. They are limited in their ability to alleviate suffering and exclude many people in need.’^[30] It was also suggested that a categorical approach would limit the ability of the scheme to keep pace with scientific developments.^[31]

3.36 Comments made in a confidential submission argued that many patient groups other than those which receive media attention could benefit from access to medicinal cannabis. It was said that using a test based on categories risks making the assessment of ‘exceptional circumstances’ more one of politics than clinical judgment.^[32]

3.37 Notwithstanding these reasoned objections, the Commission considers that a test which establishes eligibility for categories of patients would be far more workable than one that requires an independent decision to be made for each individual patient by a doctor, panel or government official. A common theme of comments made at advisory committee meetings and during consultations was that medical practitioners need clarity and certainty regarding when medicinal cannabis can be used. A categorical approach is the best way of achieving this.

3.38 Employing a categorical test does not mean that the patient’s individual circumstances are not taken into account. As discussed later in this chapter, the Commission considers that patients who meet the eligibility criteria would be treated with medicinal cannabis only after assessment by a medical practitioner. It is also acknowledged that patients with rare conditions may be marginalised by tests based on categories and that, as the clinical evidence base for the efficacy of medicinal cannabis changes, so too should the categories. Ways in which residual flexibility for patients with rare conditions could be incorporated into the scheme, and for the scheme to be responsive to developments in clinical knowledge, are also discussed later in this chapter.

Criteria

3.39 A categorical test of eligibility could be based on:

• medical conditions

• symptoms

• symptoms and conditions.

3.40 These are discussed in turn below.

Condition-based test

3.41 Some submissions argued that eligibility should be based on whether the patient suffers from a particular medical condition.^[33] For instance, Cancer Action Victoria argued that there should be access to medicinal cannabis for patients with a listed medical condition for which there is clinical knowledge about efficacy.^[34]

3.42 Some United States jurisdictions rely in whole or in part on lists of conditions to establish a patient’s eligibility for medicinal cannabis.^[35] For example, access to medicinal cannabis is available in Connecticut to patients with a ‘debilitating medical condition’, which includes ‘cancer, glaucoma, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, Parkinson’s disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, cachexia, wasting syndrome, Crohn’s disease, posttraumatic stress disorder’ or other conditions approved by the government.^[36]

3.43 There are difficulties with a condition-based test. As cannabis alleviates specific symptoms and does not treat the underlying disease, it could be inappropriate to base eligibility on a person’s condition alone. As Scott Hulley pointed out: ‘A condition with no symptoms is just a title/name’.^[37]

3.44 In particular, a definition that relies on a person’s condition alone would suggest a homogeneity of symptoms for each of the specified conditions which does not in fact exist. For example, not all multiple sclerosis patients suffer from intractable spasticity; likewise, not all HIV/AIDS patients experience wasting;^[38] and a percentage of patients who have chemotherapy do not experience serious nausea and vomiting. Similarly, not all patients with epilepsy have fits which cannot be adequately controlled by means other than medicinal cannabis.

3.45 This is important because, for instance, a patient with a recent diagnosis of multiple sclerosis may as yet be asymptomatic, such that it would be inappropriate for them to be prescribed medicinal cannabis to deal with spasticity and pain that they do not yet experience. In this regard, the Royal Australasian College of Physicians observed that:

Not all epilepsy variants are drug-resistant … In many cases of apparent drug-resistance, the epilepsy diagnosis is incorrect after further assessment or the medication chosen in the first two instances is inappropriate. … Furthermore, many patients regarded as drug-resistant may be appropriate candidates for potentially curative epilepsy surgery.^[39]

3.46 The Commission agrees with these concerns and considers that an eligibility test that required only that a person have a specified condition would capture individuals for whom medicinal cannabis would provide no medical benefit. It does not sufficiently satisfy the requirement for exceptionality.

Symptom-based test

3.47 Alternatively, a test for eligibility could be based on symptoms alone. In order to be eligible, a patient would need to have a designated level of symptoms, with no requirement that they be tied to a particular condition. In Maryland, for example, medicinal cannabis may be made available to patients who have a ‘chronic or debilitating disease’ that results in admission to palliative or hospice care or that produces ‘cachexia, anorexia or wasting syndrome, severe pain, severe nausea, seizures or severe or persistent muscle spasms’.^[40]

3.48 The Royal Australasian College of Physicians opposed a test based on symptoms alone:

A symptoms list alone is not appropriate to determine a person’s eligibility because symptoms can be common across multiple conditions. … For example, not all seizures are epileptic, some seizures are symptomatic of other remediable conditions such as alcohol abuse or electrolyte imbalance, therefore a thorough evaluation of the patient, condition and treatment options are required. … The situation for multiple sclerosis is similar.^[41]

3.49 In the Commission’s view, a definition which relies on symptoms alone would be undesirable. The mere existence of a symptom or symptoms, even if required to be ‘severe’, does not provide enough detail to determine whether medicinal cannabis would be of assistance. Further, it would not effectively ensure that medicinal cannabis was restricted only to patients in ‘exceptional circumstances’, as the symptoms for which medicinal cannabis has been found to assist include some that are commonly experienced by people without chronic illnesses (such as nausea). A qualification based on symptoms alone would not convey whether a patient’s state was serious and permanent.

3.50 For these reasons, a symptom-based test would afford doctors a substantial amount of latitude in authorising access to cannabis such that the scheme could become almost indistinguishable from one where eligibility is determined solely at their discretion. Criteria such as ‘severe pain’ or ‘severe nausea’ (wording used in other jurisdictions, either in isolation or in conjunction with a condition-based test) would require practitioners to engage in a subjective assessment while not conveying much about the therapeutic utility of cannabis in the particular case. UTT BioPharmaceuticals argued that this could lead to ‘exploitation and abuse of the system’.^[42]

Test based on conditions and symptoms

3.51 The third option is to adopt a test that makes eligibility contingent on the patient’s condition and the symptoms from which they suffer. Such a test could be structured in either of two ways:

• disjunctively, using separate lists of symptoms and conditions

• conjunctively, where eligibility is based on the patient having a combination of symptoms and conditions.

3.52 A significant number of American states use disjunctive eligibility criteria: that is, they contain both stand-alone symptoms and stand-alone conditions.^[43] For example, the Nevada statute defines a ‘chronic or debilitating medical condition’ as ‘acquired immune deficiency syndrome, cancer, or glaucoma’ or as ‘a medical condition or treatment for a medical condition that produces, for a specific patient, one or more of the following: cachexia, persistent muscle spasms, including, without limitation, spasms caused by multiple sclerosis, seizures, including, without limitation, seizures caused by epilepsy, severe nausea, or severe pain’.^[44] Patients under such a test can qualify for medicinal cannabis by having a specified condition or a specified symptom. The Commission’s view is that such a model incorporates the weakness of both types of test—it is overly broad in the same way as the condition- and symptom-based tests are.

3.53 The conjunctive option is the one preferred by the Commission. That test would require a patient to show that they have a particular symptom or symptoms and that they are afflicted by a given condition. For example, while severe nausea would not be enough on its own, it could make a patient eligible if it was the result of cancer or its treatment. A test of this kind was previously used in Canada,^[45] has been proposed in the Australian Capital Territory^[46] and is employed in some United States jurisdictions.^[47] A test of this kind was preferred by the medical advisory committee.^[48]

3.54 In the Commission’s view, a test which combines the requirements of a condition-based test and a symptom-based one addresses the shortcomings of each test. It ensures that the patient’s condition is serious and long-lasting, and that the symptoms experienced are of a sort likely to be relieved by medicinal cannabis.

3.55 An exception to this conclusion exists for chronic pain. As explained elsewhere in this report, chronic pain is difficult for clinicians to manage and can be caused by a variety of underlying disorders, if a cause can be identified at all. The management of pain varies for different individuals, and the success of a particular treatment will depend on individual circumstances besides the underlying condition. For these reasons, the discipline of pain medicine has shifted towards the management of pain, rather than the diagnosis of its cause.^[49] Given this landscape, should chronic pain be among the conditions for which medicinal cannabis is made available, it would not be possible or appropriate for the sufferer to also show they were affected by a particular condition or conditions. Chronic pain is considered in more detail below.

3.56 In addition, as set out below, particular considerations apply where medicinal cannabis, with its unresolved side-effect profile, is given to children. Thus, an additional requirement is proposed in respect of the provision of medicinal cannabis for epilepsy conditions, where many of the patients will be under-age.

Recommendation

2 Eligibility to be treated with medicinal cannabis in exceptional circumstances should be:

(dq) determined by the patient’s medical condition and symptoms arising from that condition or its treatment

(dr) specified in regulations.

Proposed conditions and symptoms

3.1 The Commission considers that, in determining the eligibility criteria, the conditions and symptoms selected should only be those for which there is a reasonable measure of research support in respect of efficacy or for which the research is weaker but the circumstances of the patient are particularly compelling. Conditions and their symptoms which meet these criteria are:

• 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 that 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 pain management that is superior to what can be provided by other options.

3.2 The Commission does not assert that this set of conditions and symptoms is objectively the only formulation available and suggests this list as a basis for further discussion between the government and the medical community. This is particularly important as the research base is rapidly changing and will continue to do so for some time.

Multiple sclerosis

3.3 There is a reasonable level of research support for the efficacy of medicinal cannabis products, most particularly Sativex, in the treatment of pain and spasticity relating to multiple sclerosis. There are also strong circumstantial reasons for allowing patients to be treated with medicinal cannabis under the scheme for this purpose.

3.4 The incidence and impact of the spasticity in multiple sclerosis were described in a submission from MS Australia and MS Research Australia:

Muscle spasticity is a significant problem for many people living with [multiple sclerosis], affecting over 80% during the course of the disease and negatively impacting mobility and personal independence. Spasticity can cause pain, sleep disturbance and reduced mobility. These symptoms can significantly limit a person’s quality of life as they have less energy, ability to complete everyday tasks and social activity. It can also lead to an increased reliance on carers and the health system if symptoms progress to a stage where mobility is significantly hampered or hospitalisation is required.^[50]

3.5 MS Australia and MS Research Australia observed that, to date, medications to treat spasticity for people with multiple sclerosis have not always been effective and can have ‘intolerable side effects’.^[51] The joint submission stated that this position was guided by a scientific evidence-based approach and advocated for a regulatory framework that would facilitate further clinical trials ‘to determine the components, dosage and frequency of cannabis-based products and their effectiveness in managing a range of symptoms for people living with chronic conditions like MS.’^[52]

3.6 The Royal Australasian College of Physicians told the Commission that: ‘Muscle spasticity is a significant problem for many people living with multiple sclerosis and therapeutic options are currently limited’. It stated that many multiple sclerosis specialists believe there is sufficient scientific evidence to develop guidelines to trial the medical prescription of cannabinoid products (Sativex) for the treatment of spasticity in some patients with multiple sclerosis.

3.7 Sativex has been approved for multiple sclerosis-associated spasticity in Canada, New Zealand, the United Kingdom, Austria, the Czech Republic, Denmark, Germany, Sweden, Israel, Italy and Spain. In Australia, it was registered in 2012 by the TGA as a treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy.^[53]

3.8 The Commission’s medical advisory committee informed the Commission that there is consensus that cannabis can be effective at treating spasticity where other treatments have failed. Not all patients experience spasticity, and for many patients conventional treatments (including pharmaceuticals and physiotherapy) can effectively control these symptoms. Members told the Commission that the symptoms of multiple sclerosis change over time, including the nature of the patient’s spasticity, and accordingly the response to cannabis would need to be carefully monitored by the treating doctor.^[54]

3.9 There is also some evidence that medicinal cannabis can help relieve pain associated with multiple sclerosis. Sativex has conditional approval in Canada as an adjunctive treatment for neuropathic pain in multiple sclerosis. This approval is said to reflect the ‘promising nature of the clinical evidence which must be confirmed with further studies’.^[55] The Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists conceded that a possible exception to its adverse position on the use of medicinal cannabis would be for the treatment of pain in multiple sclerosis.^[56]

3.10 The authors of a 2014 review on cannabinoids were guarded in their findings on both spasticity and pain. They concluded that:

… the effectiveness of cannabinoids for the treatment of muscle spasticity or neuropathic pain in multiple sclerosis is unclear and any benefit is likely to be modest, while mild to moderate adverse events are common and long term safety has not been established.^[57]

3.11 Some advisory committee members argued that, as Sativex is already approved for use in treating multiple sclerosis, there would be no advantage in making an alternative form of medicinal cannabis available.^[58]

3.12 Although Sativex is licensed for use in Australia, it is not sold in this country and, if it were, the cost would not be subsidised under the Pharmaceutical Benefits Scheme. Therefore, practically speaking, Sativex is available for very few patients, due to the high out-of-pocket cost and bureaucratic complexity associated with obtaining it.

3.13 On balance, the Commission’s view is that there are sound reasons to include multiple sclerosis patients suffering severe symptoms in a medicinal cannabis scheme. They are alone among the patient groups under consideration in that they have access to a cannabis-based drug that has been approved for use in their condition, but accessing this medicine is presently highly problematic. In addition, the evidence supporting the utility of cannabis for multiple sclerosis is among the strongest of all the groups considered here. Refusing this group access would be an unacceptable outcome, particularly given the limited treatment options otherwise available and the impact of spasticity on patients.^[59]

Control of pain for cancer and HIV/AIDS patients

3.14 Many submissions called for cannabis to be made available to alleviate pain associated with cancer and HIV/AIDS.^[60] Cancer Action Victoria argued that cancer should be incorporated on the list of medical conditions for which medicinal cannabis can be provided to patients.^[61]

3.15 Between 30 and 50 per cent of cancer patients experience pain, while 70 to 90 per cent of patients with advanced cancer suffer from pain.^[62] However, the causes are complex and the mechanisms differ from those that cause inflammatory or neuropathic pain. Opioids, including morphine and oxycodone, are currently the primary therapy used to relieve pain in cancer patients, but have many undesirable side effects, including constipation, sedation, respiratory depression and tolerance formation.^[63]

3.16 Cancer Council Victoria observed in its submission that a clinical trial is underway in Australia to determine the efficacy of administrating Sativex to relieve persistent chronic pain in patients with advanced cancer who have not responded to conventional medicines.^[64] It also conducted a survey of Cancer Council Victoria Clinical Network members, to gain insight into their attitudes and experiences regarding the current use of medicinal cannabis in cancer care and the proposed medicinal cannabis scheme. The members who responded said that pain management was the most common reason for patients using cannabis medicinally, followed by nausea, vomiting and weight loss management associated with their cancer treatment:

Although there is a level of skepticism about the effectiveness of medicinal cannabis, due to the current gaps in clinical evidence, many think that it should be an accepted part of standard medical care in the treatment of cancer-related symptoms. Some clinicians would be reluctant to prescribe medicinal cannabis, even if a scheme is introduced. Again, this is due in part to evidence gaps not only with regard to its effectiveness, but with respect to required dosing and administration routes. There was strong support for medicinal cannabis to be available to cancer patients only ‘when conventional treatments have been tried and failed’.^[65]

3.17 The Commission was told by the medical advisory committee that although cannabis would be used relatively rarely in pain management for terminally ill patients, it could be helpful for a small subset of such patients. It would be unlikely to be used as a first- or second-line treatment. Cannabis was said to be less effective than drugs administered through new ‘intrathecal’ delivery system (where analgesic drugs are administered through the spinal cord fluid).^[66]

3.18 As discussed in Chapter 2, there is limited research evidence that addresses the utility of cannabis to treat pain specifically caused by cancer. The Commission does not comment on whether the research conducted on chronic pain has application to pain caused by cancer. The Commission notes that Sativex has conditional approval in Canada as an adjunctive treatment for moderate to severe pain in patients with advanced cancer. This approval is said to reflect the ‘promising nature of the clinical evidence which must be confirmed with further studies’.^[67]

3.19 The research evidence is stronger regarding HIV/AIDS. Approximately 40 per cent of people living with HIV and being treated with antiretroviral medications experience the painful condition ‘HIV-associated sensory neuropathy’.^[68] There are few treatments available which are proven to relieve pain caused by this condition. Cannabis is among the few treatments which have been proven through randomised controlled trials.^[69]

3.20 There are other considerations that are strongly supportive of the provision of medicinal cannabis to people experiencing pain associated with cancer or HIV/AIDS. These conditions have the potential to diminish a person’s quality of life in a profound way, as conveyed by the submissions received by the Commission,^[70] and cannabis may provide a treatment option that offers relief from pain at a time when patients are in need of comfort. In addition, as these conditions are recommended below as legitimising access to cannabis for the treatment of nausea, vomiting and wasting, there seems little utility in preventing access to it for pain relief as well. Accordingly, the Commission’s view is that cannabis in medicinal forms should be available to patients suffering from cancer or HIV/AIDS and experiencing severe pain.

Relief from nausea, vomiting and wasting

3.21 Nausea and vomiting are common and distressing problems for cancer patients. Approximately 50 per cent of patients with cancer experience nausea or vomiting, either as a result of the cancer itself or its treatment. These symptoms have been summarised as follows:

Nausea and vomiting are common problems in cancer patients throughout the trajectory of their illness. Whether these patients are receiving high-dose cisplatin 1 [a chemotherapy drug] with the best available antiemetic therapy or are experiencing the advanced stages of cancer, approximately one half will experience nausea or vomiting, or both. The causes of these distressing symptoms are diverse, and they include medication, radiation therapy, and the effect of the cancer itself. … Although therapy that aims to correct the underlying cause is rational, for many patients, such an approach is not possible.^[71]

3.22 Both cancer and HIV/AIDS patients can experience wasting as a result of their disease. Depending on the type of cancer, 30 to 80 per cent of cancer patients experience weight loss, which can be as a result of the condition or its treatment.^[72] Severe wasting, known as cachexia, ‘adversely affects the patients’ ability to fight against infection and withstand treatment by chemotherapy and radiotherapy. As a result of all these negative effects, the body begins to waste away.’^[73] This is counter-therapeutic in every sense.

3.23 In its submission to the Commission, Cancer Council Victoria supported making medicinal cannabis available for nausea and vomiting where other treatments have failed, and observed there is evidence supporting its efficacy.^[74] Similarly the joint submission by the National Cancer Council and the Clinical Oncology Society of Australia to the Senate Legal and Constitutional Affairs Committee’s inquiry into the Regulator of Medicinal Cannabis Bill asserted there is evidence that medicinal cannabis could be useful for this purpose, and commented that: ‘Managing illness induced by chemotherapy, especially in patients with advanced cancer who have responded poorly to conventional relief options, is a significant problem for cancer patients and their doctors.’^[75]

3.24 In these circumstances, given the evidence for the effectiveness of medicinal cannabis in enhancing appetite and reducing nausea and wasting, the Commission is satisfied that in appropriate circumstances medicinal cannabis has a therapeutic role to play for this category of patient.

Epilepsy

3.25 The present state of research on the efficacy of cannabinoids (particularly cannabidiol) as a treatment for epilepsy does not yet allow firm conclusions to be drawn. The existing research lacks authoritativeness, and rigorous studies are only now starting to get underway, including in Australia, but there is emerging support for the efficacy of cannabis in relieving the symptoms of epilepsy, especially for those with juvenile syndromes.

3.26 The reality pointed out to the Commission in its consultative processes is that significant numbers of parents faced with epilepsy syndromes such as Dravet, Lennox-Gastaut and genetic forms of epilepsy such as CDKL5 are turning to cannabis in an attempt to address life-endangering seizures in their children, which can be hundreds daily and which may not be responsive to orthodox epilepsy medications. The Commission heard moving accounts from parents of children with such syndromes who maintained that various forms of medicinal cannabis had extremely positive effects on the experience of symptoms by their children.

3.27 While the clinical research on this application of cannabis does not itself provide a compelling basis for action, the other considerations affecting this patient group are overwhelming. The feature which sets this group apart from other conditions where research is lacking is the scale of the transformations anecdotally observed for epileptic patients treated with medicinal cannabis. It is true that the results seen by families have not been rigorously assessed, but anecdotally there are numerous children for whom medicinal cannabis has provided astonishing relief.

3.28 However, because both the risks associated with medicinal cannabis—particularly for children—and the benefits of treatment remain uncertain, at this stage treatment should be limited to only the most gravely ill sufferers of epilepsy, where other treatments have failed to bring the patient’s symptoms under control or have caused intolerable side effects. Thus, in respect of this category of patients, in part because of the unknown consequences of administration of medicinal cannabis over what may be an extended period of time to children with developing brains, the Commission is of the view that it is proper to require that other forms of treatment have been attempted and found ineffective before medicinal cannabis is used.

Chronic non-cancer pain

3.29 In 2015 the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists issued a formal position in relation to the use of cannabinoids for patients with chronic non-cancer pain, concluding that:

With the possible exception of pain and spasticity in multiple sclerosis, there is little evidence for the effectiveness of cannabinoids in chronic non-cancer pain situations, whether or not the pain attracts the descriptor ‘neuropathic’.^[76]

3.30 This statement does not apply to patients who are in palliative care.^[77]

3.31 A number of questions arise about:

• the capacity of medical practitioners to identify categories of patients within the chronic pain cohort effectively

• the role of patient-self-report of symptoms among sufferers of chronic pain

• the distinctions between patients who seek medicinal cannabis for a combination of psychotropic effects and pain relief, as against those for who seek it solely for its analgesic qualities

• whether the consequences of long-term provision of such medication are overall therapeutically advantageous.

3.32 In addition, it is apparent that modest numbers of United States and Canadian medical practitioners have been prepared to authorise/prescribe medicinal cannabis to patients with chronic pain,^[78] this in turn creating difficult pressures for practitioners and potentially distorting effects on the doctor–patient relationship.^[79] These matters need to be explored further by carefully constructed studies.

3.33 The Commission considers that, while there are likely to be advantages for some patients who experience chronic pain from a variety of conditions in being treated with medicinal cannabis, as against opiate analgesia,^[80] further analysis needs to be undertaken before medicinal cannabis is made available as a first line or even an alternative form of treatment for patients who suffer or claim to suffer chronic symptoms of pain.

3.34 For this reason, the Commission does not propose that chronic pain be a qualifying condition or symptom on its own, and instead considers that additional conditions should be imposed in respect of it. Nor should particular underlying conditions be specified in the eligibility criteria.^[81]

3.35 This stance will be controversial but it is a considered position on the part of the Commission. While it is conceded that a number of studies have demonstrated therapeutic potential for medicinal cannabis for neuropathic pain, this therapeutic option remains contested within the medical profession.

3.36 Allowing patients suffering from chronic pain to be treated with medicinal cannabis gives rise to other issues not raised by the other conditions discussed:

• As the ‘chronic’ pain is a long-term phenomenon, there is the potential for any treatment option to be sustained. This raises the issue of risk in a way that is more problematic in light of the limited clinical and research knowledge than is the case when the measure is relatively short-term, such as in treating symptoms of a terminal illness, or in circumstances of acute clinical need, such as in treating wasting or refractory epileptic conditions.

• There is the potential for such conditions to be asserted by patients without medical practitioners being able effectively to evaluate the clinical accuracy of what is asserted. The blurring between asserted medical use of cannabis and recreational use, as arguably has occurred in jurisdictions such as California,^[82] should be avoided.

• There is the potential for medical practitioners to be placed under uncomfortable pressures to authorise medicinal cannabis in such situations based upon patients’ unverifiable self-reports of chronic pain. There is a serious risk that a problematic number of medical practitioners could decide not to participate in the scheme. This could undermine its viability.

3.37 Thus the Commission is of the view that, if medicinal cannabis is to be provided to alleviate chronic pain, it is appropriate that two specialists should be required to arrive at the determination. While this is an extra burden for a patient who may be desirous of being treated with medicinal cannabis, the Commission has determined that for the present this is a reasonable requirement in light of:

• the risk of abuse

• the fact that such pharmacotherapy may be long-term, with the ensuing risks

• the fact that there are a variety of non-pharmacological options for the management of pain.

3.38 The Commission has concluded, on advice from the medical advisory committee, that the patient’s chronic pain should not need to be refractory in the sense of its having failed to respond to other forms of analgesia. Rather, the decision in respect of the advisability of medicinal cannabis as against (or in conjunction with) other treatment options should be that of the specialists who are consulted.

3.39 The specialists’ evaluation of the patient’s suitability for treatment with medicinal cannabis would include the likelihood that the patient would respond beneficially, and also whether it is the best form of treatment for the patient’s pain. This would be likely to take into account whether other measures have already been employed but found unsatisfactory—for a variety of reasons. It is common for there to be a variety of approaches to managing pain, and for pharmacotherapy to be only one of several components in the attempt to manage a patient’s symptoms. It is the Commission’s view that medicinal cannabis should only be made available to patients with chronic pain (not caused by cancer, HIV/AIDS or multiple sclerosis) where two specialists conclude that it may in all the circumstances provide superior pain management by contrast with other options.

Other conditions

3.40 As described in Chapter 2, there is a range of other conditions where claims of efficacy are made or preliminary research exists. However, there is not yet a strong evidence base for the efficacy of medicinal cannabis. In particular, there is insufficient research at this stage to support allowing patients with any of the following conditions routine^[83] access to medicinal cannabis:

• spinal cord injury

• post-traumatic stress disorder

• schizophrenia

• treatment of cancer (as opposed to its symptoms)

• Tourette syndrome

• inflammatory disorders

• motor-neurone disease (also known as amyotrophic lateral sclerosis)

• glaucoma

• Parkinson’s disease

• inflammatory bowel disease (including Crohn’s disease)

• hepatitis C

• sleep disorders

• anxiety and depression.

3.41 In each of these cases, there is research which is promising, and future studies may produce evidence sufficient to support provision of medicinal cannabis to these patients. However, at present, the Commission considers the government should be cautious about enabling cannabis to be dispensed to these categories of patients.

3.42 While the Commission has adopted an approach which is not rigidly controlled by the outcomes of blinded, placebo-controlled trials, there is still a need to ensure that cannabis is supplied to patients on a rational basis^[84]—that is, where there is a base level of evidence suggesting that cannabis is likely to assist. In the case of the conditions listed above, for some there has been almost no controlled evidence collected and, for others, no human studies of any rigour have been performed. To allow access to cannabis on the basis of such limited evidence would lack a reasonable evidence base and would be speculative.

3.43 It is acknowledged thatthere is a degree of arbitrariness in selecting particular conditions as against others. Those selected by the Commission are in response to clinical scenarios of particular need and distress identified by written submissions and by persons whom the Commission has met during its consultative processes. In addition, each has been selected on the basis of credible evidence supporting the efficacy of cannabis, although the evidence is not at the highest level.. As discussed later in this chapter, the scheme should allow for the conditions that are included to be kept under review, and also provide for case-by-case exceptions.^[85]

Recommendations

3.44 In light of the above discussion, the Commission considers that, at the outset of a Victorian medicinal cannabis scheme, patients who have certain designated conditions and are experiencing serious symptoms from those conditions should be eligible to be treated with medicinal cannabis. Whether an individual patient should receive such treatment would be determined under procedures that are discussed later in this chapter.

Recommendation

3 Eligibility for any Victorian medicinal cannabis scheme should be based initially on the following conditions and corresponding symptoms:

(a) severe muscle spasms or severe pain resulting from multiple sclerosis

(b) severe pain arising from cancer, HIV or AIDS

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

(d) severe seizures resulting from epileptic conditions where other treatment options have not proved effective or have generated side effects that are intolerable for the patient

(e) severe chronic pain where, in the view of two specialist medical practitioners, medicinal cannabis may in all the circumstances provide pain management that is superior to what can be provided by other options.

Other considerations

‘Severe’ symptoms

3.1 The qualifying adjective ‘severe’ is employed in these recommendations to require a high level of experience of the relevant symptoms of a designated category of condition.^[86] This approach is adopted to communicate clearly that medicinal cannabis, like other medications such as opioid analgesics, should only be used when therapeutically necessary (namely to address a set of symptoms), rather than as a prophylactic or as a continuing therapeutic option if symptoms do not require it.

Medicinal cannabis as a ‘last resort’?

3.2 Some submissions called for medicinal cannabis to be used as a ‘last resort’—that is, after other conventional treatments have failed.^[87] A small majority of clinicians surveyed by Cancer Council Victoria considered that eligibility should be defined by whether conventional treatments had been tried and failed.^[88] Other submissions opposed making medicinal cannabis a last resort.^[89] Some said it should be a matter of personal choice,^[90] and that if it works patients should not be required to exhaust all other options before they can use it.^[91]

3.3 Professor David Penington noted that ‘failed’ is not a neatly defined term, and queried whether a treatment like morphine, which might be partially effective but cause a distressing addiction, would be considered to have ‘failed’.^[92] Similarly, others drew attention to the many who suffer from side effects or allergies, and queried whether this would be a ‘failure’ of the treatment.^[93] Along similar lines, Mullaways Medical Cannabis Pty Ltd asked, ‘how many years of failed conventional treatments, with all their side effects and cost, must a person with exceptional circumstances endure before they have a right to cannabis treatment?’^[94]

3.4 The Royal Australasian College of Physicians opposed making resistance to treatment a requirement of eligibility:

It is not appropriate that all reasonable conventional treatments have failed before a person is eligible to use medicinal cannabis; this is not a requirement for antiepileptic drug trials or for potentially curative epilepsy surgery.^[95]

3.5 The Australian Nursing and Midwifery Federation—Victorian Branch told the Commission that it opposed restricting medicinal cannabis to those people for whom other treatments had failed. It stated:

We are concerned that being required to meet this threshold may cause unnecessary delay in patients receiving effective treatment and result in prolonged and avoidable suffering. Additionally, it is unclear who would determine the length of time that would be required to decide that conventional treatments have failed and what criteria would be used to assess them as having failed. Alleviation of pain and the effective relief of adverse effects of treatment and symptoms of medical conditions should be provided in a timely way and not obstructed by a requirement to exhaust other treatment options.^[96]

3.6 The Commission acknowledges that, given the unproven, novel character of medicinal cannabis, it would be more appropriately used after proven, conventional treatments have been trialled. It would be very rare, for instance, for it to be an analgesic of first resort, and even rarer for it to be a therapeutic option on its own for the relief of chronic pain. In respect of other conditions, too, it is to be expected that other therapeutic options would first be tried for a patient.

3.7 However, the Commission does not recommend a rigid or statutory prerequisite of intractability or refractoriness of the condition to other forms of medication or medical intervention. The weighing of management options and combinations of treatment should be a matter for decision between a patient and their medical practitioner, as would ordinarily be the case. In addition, the Commission is concerned not to raise the bar too high for patients to be able to gain access to medicinal cannabis. This is justified by the fact that the known risks of medicinal cannabis are only moderate and, for the most part, should be able to be addressed by attentive monitoring and responsiveness by the patient’s treating doctor.

3.8 There are two partial exceptions to this. For the reasons set out above, the Commission considers that medicinal cannabis should only be able to be authorised for the treatment of epilepsy where other treatment options have not proved effective or have generated side effects that are intolerable for the patient. In respect of chronic pain, there should be a requirement that specialists conclude that medicinal cannabis may in all the circumstances provide pain management that is superior to what can be provided by other options.

Terminal illnesses

3.9 The Commission considered whether to provide a standalone category for the terminally ill to qualify for medicinal cannabis. The Royal Australasian College of Physicians stated in its submission:

In the case of terminally ill patients, the use of medicinal cannabis (if the patient wishes to trial its use) most likely holds limited potential for damage and can always be ceased if there is no useful response. The [Royal Australasian College of Physicians] acknowledges there are many anecdotes where the use of cannabinoids have greatly benefited terminal patients without the associated side effects that opioid use cause.^[97]

3.10 In some jurisdictions in the United States (such as the District of Columbia, Maryland, Montana, New Jersey and New Mexico) a patient can become eligible for medicinal cannabis solely because their condition is terminal or they are receiving palliative care.^[98] Such a test has also been mooted in the Australian Capital Territory^[99] and previously existed in Canada.^[100] Incorporating such a test into a Victorian scheme would mean that the terminally ill could qualify for medicinal cannabis whether or not they were otherwise eligible by virtue of their condition and symptoms.

3.11 The Commission’s advisory committees and people who attended a consultation in Shepparton opposed this approach as unnecessary.^[101] Participants felt that the terminally ill would largely be captured by the proposed condition- and symptom-based criteria in any event, and that it would be counterproductive to provide medicinal cannabis to patients if it was unlikely to assist them.^[102] AMA Victoria observed that disregarding potential risks and side effects ‘solely based on the patients’ end of life status, diminishes the value of the lives of the terminally ill.’^[103]

3.12 The Commission agrees that separate eligibility criteria for patients who suffer from terminal conditions would be undesirable. As for all other patients, there should be some prospect that cannabis can assist the patient’s specific symptoms, which is ensured by the condition- and symptom-based test recommended above. Any alteration in the assessment of risk to respond to the position of a terminally ill person (for example, a diminished regard to long-term risks) would be taken into account in the medical practitioner’s clinical judgment.

The need for caution

3.13 There are significant pragmatic advantages to taking a gradual, step-by-step approach to the introduction of medicinal cannabis in Victoria, given the current limited reliable research base for its introduction as a lawful therapeutic option. The limitations in the current research literature are discussed in Chapter 2.

3.14 Most importantly, such an approach would allow for prompt intervention to assist those whose suffering is particularly severe. It also recognises that what is proposed is a significant social change—the removal of a drug from illegal status and its absorption in certain circumstances into the orthodox pharmacopoeia.

3.15 It would also allow a change in culture to start in respect of the recognition and use of medicinal cannabis as a therapeutic option, starting with a limited number of conditions. This is the approach most likely to engender confidence among medical practitioners, an issue which experience in jurisdictions such as Canada has demonstrated is fundamental for the viability of a medicinal cannabis scheme.^[104] It keeps to a minimum the range of circumstances in which there is encroachment upon the paradigm of evidence-based medicine and thus preserves the standard of medicine based on high-level evidence in the form of double-blind, placebo-controlled trials as the principal determinant for the provision of treatment by contemporary medicine.

3.16 It would also allow for Victoria’s medicinal cannabis scheme to take advantage of fast-evolving global research into the efficacy and risks of medicinal cannabis, prior to extending it to a broader set of conditions.

3.17 More generally, it would allow for review of the medicinal cannabis scheme (recommended below after four years) to assess its success in all respects, including in relation to its effectiveness in alleviating suffering for the conditions initially designated.

3.18 Inevitably, this means that some people who want to obtain lawful access to medicinal cannabis will not be able to do so, at least for a time, but, on balance, the Commission considers that this is the best option to make the proposed scheme viable and to command community and professional confidence from the start.

3.19 In addition, it allows for development of the scheme in a way that protects against actual or potential abuses. The Commission has noted the profile of medicinal cannabis patients in jurisdictions where people who claim to suffer chronic pain can obtain access to medicinal cannabis. The statistical profiles of users suggest that these schemes may be serving more than the patient cohort with the greatest degree of suffering.^[105] It is clear that a disproportionate number of consumers of medical cannabis in the United States seek the medication for relief of chronic pain, as well as for relaxation, in respect of which other options have not proved palatable or effective. This is not necessarily clinically inappropriate but it does create a real potential for abuse of a scheme and for medical practitioners to be placed under difficult pressures to enable access to medicinal cannabis when their ability to evaluate need objectively is limited.

3.20 The opportunity exists for Victoria to introduce a scheme which minimises the potential for abuse that could bring it into disrepute and imperil its viability by making medical practitioners reluctant to authorise access to medicinal cannabis. This opportunity should be realised by a conservative introduction of conditions and criteria enabling patient access to medicinal cannabis.

Incorporating flexibility

Allowing for exceptional cases

3.21 The Commission was told, both in written submissions and at its consultations, of patients with rare conditions who believe they have received therapeutic benefit from medicinal cannabis or think they might do so.^[106] A number of submissions supported the notion of a mechanism for allowing people who would not otherwise be eligible to be treated with medicinal cannabis under the scheme to be treated with medicinal cannabis.^[107] However, there was limited support for such a provision in the Commission’s medical advisory committee.^[108]

3.22 Some submissions said that this should only occur in the context of a clinical trial.^[109] Others supported a provision under which access by people in exceptional cases could occur if a second practitioner endorsed the use.^[110]

3.23 The Commission is satisfied that it would be humane and reasonable to provide for a mechanism for a person outside the designated categories to request access to medicinal cannabis in exceptional circumstances. Applications would need to be supported by a specialist medical practitioner.

3.24 These matters could be considered by a committee, comprising medical experts who could advise on the appropriateness of cannabis for the particular condition. Such decision making would be analogous to the decisions made by the TGA in the context of the Special Access Scheme.^[111] The committee would undertake a similar inquiry to that undertaken by a Drug and Therapeutics Committee in determining whether to approve use of an unapproved drug,^[112] but determine whether to permit use by particular patients on a case-by-case basis.

Recommendation

4 The Secretary of the Department of Health and Human Services, or a committee constituted by the Secretary under delegation, should be given power to permit patients on a case-by-case basis to be treated with medicinal cannabis in exceptional circumstances that do not otherwise fall within the eligibility criteria of the scheme.

Flexibility for ongoing determination of eligibility

3.25 Ongoing clinical trials and research are likely to change the evidentiary landscape significantly with respect to both the efficacy and risks of medicinal cannabis. Within even five years there will be much better knowledge that could affect the evolution of the kind of medicinal cannabis scheme that is being recommended by the Commission.

3.26 It follows that a fundamental attribute of the proposed scheme should be flexibility to adapt to such developments in clinical knowledge. In particular, should evidence emerge regarding the conditions for which medicinal cannabis is likely to be effective, the eligibility criteria may need to be amended by the addition or removal of conditions or symptoms. This would mean amending the regulations that set out the criteria.

3.27 The Commission considers that an advisory body should be constituted to advise the Minister for Health about the operation of the scheme and, in particular, the ongoing suitability and effect of the eligibility criteria, including whether they need to be amended. It should have independence from the Minister for Health. This is important to maintain the confidence of the public and the medical profession by demonstrating that decisions which affect the scope and features of the scheme are informed by health practitioners and others with professional expertise in the efficacy of medicinal cannabis.

3.28 An advisory committee could be established in either of two ways:

• As a consultative council, by executive order of the minister using existing powers.^[113] No new legislation would be required. Under this option, the matters and functions of the council would be determined by the minister and specified in an Order.

• As a statutory body, akin to the advisory committees that advise the Secretary of the Commonwealth Department of Health on the scheduling of medicines and chemicals. The Secretary is obliged to have regard to any recommendations or advice of these advisory committees when exercising relevant scheduling powers.^[114] Regulations set out how the committees are constituted and how meetings are to be conducted..^[115]

3.29 The initiative to amend the eligibility criteria of the scheme, through regulation, should rest with the Minister for Health on the advice of the advisory body.

Recommendation

5 The Minister for Health should constitute an independent medical advisory committee on medicinal cannabis to provide ongoing advice about the conditions and corresponding symptoms on which eligibility to be treated with medicinal cannabis is based. Such advice should include reference to:

(a) the responsiveness by patients to medicinal cannabis provided under the scheme and any side effects experienced by them

(b) the state of the clinical literature in relation to the efficacy or potential efficacy of medicinal cannabis for particular medical conditions and symptoms

(c) the state of the clinical literature in relation to the risks or potential risks posed by medicinal cannabis for patients with particular medical conditions

(d) the seriousness of the medical conditions, including patients’ prognoses and the extent of the disability caused by their conditions

(e) the extent to which symptoms of the conditions interfere with patients’ ability to derive enjoyment and fulfilment in their lives

(f) the extent to which medicinal cannabis can reasonably be anticipated to improve patients’ quality of life

(g) the availability of standard treatments that may assist, how effective they are, and what side effects they cause.

Authorisation of treatment

Overview of proposed procedure

3.1 A decision that an individual patient is treated with medicinal cannabis is a medical one. While the recommended eligibility criteria would establish at law who may participate in the scheme, the question of whether medicinal cannabis is an appropriate form of treatment for each eligible patient needs to be determined by a medical practitioner. Further, in line with the recommended regulatory objectives, the use of medicinal cannabis should be under medical supervision.

3.2 Thus, the regulatory framework for any Victorian medicinal cannabis scheme needs to enable medical practitioners to authorise the medicinal cannabis products to be dispensed to those of their patients who meet the eligibility criteria and for whom it is appropriate in all the circumstances that they receive this form of treatment.

3.3 It was proposed to the Commission that the opioid replacement therapy program and procedures for providing access to Schedule 8 medicines provide useful models on which to base the regulatory framework for dispensing medicinal cannabis.^[116] These mechanisms are an established means of allowing certain categories of patients to have access to strictly controlled medicines.

3.4 There is merit in building on existing practices while accommodating the different objectives and risks in providing access to medicinal cannabis. The remainder of this chapter sets out a procedure for authorising the supply of medicinal cannabis to patients, under medical supervision. In summary, it comprises the following features:

• A medical practitioner who specialises in the medical condition on which their patient’s eligibility is based applies to the Department of Health and Human Services for a permit to issue an Authority to Dispense Medicinal Cannabis.

• The application for the permit conveys the specialist medical practitioner’s opinion that the patient is eligible to participate in the scheme and it is appropriate in all the circumstances that they be treated with medicinal cannabis. It would also certify that the patient has been informed that the product has not been approved by the TGA, the approved alternatives, and the risks, potential benefits and side effects.

• On obtaining the permit, the specialist medical practitioner issues an Authority to Dispense Medicinal Cannabis which, like a prescription, authorises a pharmacist to dispense the medicinal cannabis. The pharmacist is identified on the permit and on the Authority to Dispense.

Residence requirement

3.5 The Commission considers that only patients ordinarily resident in Victoria should be able to obtain medicinal cannabis under any Victorian scheme.^[117] If residents of other states or territories were eligible to access medicinal cannabis, they would be exposed to prosecution under their local laws if they took it back to their home jurisdiction, and the Victorian community would bear the additional costs of supporting a much larger patient population.^[118] The Law Institute of Victoria highlighted this as an issue:

Access to the regulated scheme in Victoria should be restricted to permanent Victorian residents and the drug may only be used when within Victorian borders. This would prevent issues with medical ‘tourism’ and the conflict with criminal sanctions in other jurisdictions.^[119]

3.6 Because the Victorian scheme would be departing from the national therapeutic goods framework, it would not be lawful to possess medicinal cannabis products sold in Victoria in other states and territories of Australia unless reciprocal laws were passed. In addition, pharmacies outside Victoria would be unable to supply the product specified.^[120]

3.7 It would be undesirable for non-residents to travel to Victoria, obtain medicinal cannabis, then return to a part of Australia where the product is unlawful and cannot be purchased as they would therefore be unlikely to receive medical supervision. In some circumstances they would be liable to be prosecuted for use and possession of the drug. For similar reasons, patients who are authorised to obtain medicinal cannabis in Victoria should be warned not to take the product interstate or overseas.

Recommendation

6 Any medicinal cannabis scheme in Victoria should be applicable only to persons who ordinarily reside in Victoria.

Which practitioners?

3.8 Registered health practitioners in Australia have diverse areas of expertise, ranging across the many facets of healthcare.^[121] Several categories of health practitioners have the capacity to prescribe medicines,^[122] and many have a range of sub-specialities.^[123]

3.9 In the issues paper, the Commission sought feedback on who should have the authority to assess whether a patient is an appropriate candidate to be treated with medicinal cannabis.^[124]

Health practitioners other than medical practitioners

3.10 Several submissions endorsed the involvement of registered health practitioners other than medical practitioners.^[125] The Cannabis Policy Project recommended that a broad range of practitioners be considered, arguing that the inclusion of nurse practitioners in the Canadian scheme ‘speaks to a continuing problem of accessibility to the program whilst doctors are the only gatekeepers’.^[126]

3.11 Cannabis Science Australia Ltd suggested that non-medically trained practitioners could effectively authorise treatment, under supervision.^[127] Other submissions endorsed including health practitioners with prescribing entitlements.^[128]

3.12 Some submissions called for naturopaths to be involved.^[129] Naturopaths are not legally registered health professionals in Victoria^[130] and have no prescribing entitlements. In this regard, Victoria Police submitted that:

It would be inappropriate for practitioners, such as alternative therapists who are not authorised to prescribe scheduled medicines, to be authorised to prescribe medicinal cannabis.^[131]

3.13 The majority of submissions and other comments made to the Commission on this issue recommended that only medical practitioners, or a subset thereof, be able to authorise treatment with medicinal cannabis.^[132] It was submitted that involving other types of health practitioners would be too broad.^[133] In endorsing this approach, Cheryl Wright stated:

It should not be made difficult or impossible for patients to access medical cannabis, but it also needs to be monitored by practitioners who know what they’re doing.^[134]

3.14 The Commission agrees. Only registered medical practitioners should be able to authorise access to medicinal cannabis. Given that eligibility would be confined to people with severe conditions and symptoms, the ability to authorise should be confined to medical practitioners.^[135]

Which medical practitioners?

3.15 The Commission heard from many sources that only specialist medical practitioners^[136] should be able to authorise access to medicinal cannabis.^[137] Others opposed confining authorisation powers to specialists.^[138] The debate primarily came down to a question of access against control and expertise.

3.16 The question of access raises issues such as cost, waiting times and the need to travel to a metropolitan centre. Few specialists routinely travel to regional centres, meaning that significant time and expense can be associated with arranging to see one.^[139] Jeni Martin submitted that confining authorisation powers to specialists would ‘impact heavily on invalid pensioners and people in rural and remote areas’.^[140]

3.17 On the other hand, it was observed that ‘telemedicine’ has made it easier for people in the regions to access specialists.^[141] Mullaways Medical Cannabis Pty Ltd stated that, even though specialists are seen infrequently, most people in exceptional circumstances ‘have a team of doctors overseeing their treatment’.^[142]

3.18 Some on the Commission’s medical advisory committee raised concern about the pressure that could be placed on general practitioners by their patients.^[143] Equally, it was submitted that permitting only specialists to authorise would create a bottleneck, leading to long waiting lists.^[144]

3.19 The need for expertise in treating the patient’s condition suggests that it should be specialists who can authorise access. The Royal Australasian College of Physicians recommended that only specialist medical practitioners in relation to the condition that cannabis is intended to treat^[145] should be able to authorise access. For example, paediatric neurologists would authorise for paediatric epilepsy, while adult neurologists would authorise for multiple sclerosis:

This restriction is proposed because… there is a long list of proposed conditions for which medicinal cannabis has been suggested. This would avoid a sudden influx of prescriptions that may be otherwise inappropriate and prior to other treatment options being explored.

3.20 Professor David Penington, on the other hand, drew attention to palliative care, where services are increasingly being offered at the primary care level, with more patients seeking to die at home. In these circumstances, he submitted, it would be appropriate for general practitioners to be able to authorise access.^[146]

Commission’s conclusion

3.21 The Commission considers that access to cannabis should be able to be authorised only by specialist medical practitioners.^[147] It acknowledges that this significantly limits access, particularly in regional areas, but considers that this compromise is necessary to ensure expertise, especially in the early phases of the scheme.

3.22 The experience of other jurisdictions has shown the dangers of making the power to authorise too wide. In Arizona, the ‘vast majority’ of patient certifications have come from naturopaths, even though there are ten times as many medical doctors in the state. Arizona’s Director of Health Services reportedly said that ‘not all naturopaths are writing certifications, but a handful of them are clearly in the certification business’.^[148] In Colorado as at 2012, more than two per cent of the state’s population had received a medicinal cannabis recommendation and 49 per cent of medicinal cannabis recommendations had been issued by only 15 medical practitioners.^[149]

3.23 One of the recommended regulatory objectives of any Victorian medicinal cannabis scheme is to ‘integrate the use of medicinal cannabis products into the patient’s medical treatment’,^[150] which requires that the use is under medical supervision. At the outset of the scheme, it is important that focus is directed to developing and sharing knowledge about the effects of treatment with medicinal cannabis for patients with the medical conditions covered by the scheme. As specialists are better placed to review evidence and conduct research in their area of speciality, it would be more appropriate to place this responsibility with them. The Commission also notes concerns about the extent to which authorisation decisions could be influenced by the ideological views of the practitioner, and this would be easier to identify and contain where a smaller number of practitioners are involved.

Which specialists?

3.24 Some medicinal cannabis schemes in other jurisdictions require a practitioner who authorises access to have a pre-existing relationship with the patient. AMA Victoria opposed this approach, noting that ‘it is becoming increasingly uncommon for a person to have a long-standing physician-patient relationship with a specific medical practitioner’.^[151]

3.25 Another submission, from an individual, also opposed requiring a pre-existing relationship:

I currently must wait anywhere between 2–3 months to access my treating specialists. If an established relationship with such a physician is required (as is required in some overseas jurisdictions) before access is granted to a patient, it could realistically take patients like myself, 12 months or more, before they were able to have access to medicinal cannabis. ^[152]

3.26 The Commission agrees and does not propose that the authorising specialist be required to have an existing relationship with the patient, although it notes that in many instances the authorising specialist will be the patient’s treating specialist practitioner.

3.27 The precise categories of specialists would require consultation between government and medical professionals. However, the Commission notes that the following categories may be appropriate:

Involving general practitioners

3.28 Monitoring a patient’s use of medicinal cannabis is essential to ensure that their treatment is safe and medically appropriate, and in particular that dosages are correct and that adverse effects (including, potentially, the development of dependence or the experience of side effects) are monitored and suitably addressed. In the Commission’s view, return visits to a medical practitioner should be required at regular intervals—say, three monthly—to ensure continuing monitoring and care.

3.29 The Commission has noted that permitting only specialists to authorise treatment with medicinal cannabis would limit the accessibility of the scheme. The access considerations raised earlier apply to an even greater degree for this aspect of the scheme, such that making the specialist responsible for monitoring would compound the accessibility issues further. Therefore, the Commission considers that this supervisory role should be the principal responsibility of general practitioners; of course, it would generally be shared with the treating specialist practitioner.

3.30 To address this, some of those consulted by the Commission proposed that treatment with medicinal cannabis could be authorised at first by a specialist and then be supervised by a general practitioner.^[153] The general practitioner would supervise the patient’s use and response, but would be unable to authorise access. It was suggested that general practitioners would not need cannabis training, and that they could obtain sufficient guidance from the authorising specialist.^[154]

3.31 The Commission endorses this approach as one which strikes an appropriate balance between access and expertise. It is suggested that a person could be authorised by their specialist for a set period (say, 12 months), with continuing access contingent on their returning at set intervals (say, every three months) to a nominated general practitioner. The implementation of this aspect of the scheme should be careful to avoid a situation in which practitioners mechanically continue treatment without considering the patient’s response.

3.32 At the conclusion of the period of authorisation, it would be standard (and necessary) practice for the general practitioner to report back to the authorising specialist regarding patient outcomes, adverse effects, dosage control and similar. The Commission considers that this need not be the subject of a specific recommendation.

3.33 General practitioners who are to be involved in the monitoring of a patient’s use of medicinal cannabis would need to obtain satisfactory knowledge with respect to medicinal cannabis, as they would with respect to any new drug which they prescribe or whose effects they need to monitor.

Recommendation

7 Specialist medical practitioners should determine which eligible patients should receive treatment with medicinal cannabis, while general practitioners should have principal responsibility for monitoring the efficacy and side effects of the treatment.

Practitioner’s role

Authorisation models

3.34 A number of models for the type of authorisation system Victoria should adopt were proposed to the Commission and identified in the systems that exist overseas. The two most common models about which submissions were received were the certification and prescription models.

3.35 Under a ‘certification’ model,^[155] a medical practitioner has no role other than to certify that a patient has at least one of the eligible conditions and/or symptoms. No product or dose is specified by the practitioner and, accordingly, patients may purchase whatever they wish, subject to any statutory purchase limits. Importantly, the certification decision does not require the practitioner to make an assessment of whether cannabis would be appropriate for the particular patient, including by considering the benefits and risks for them; rather, their role is merely to confirm the patient’s diagnosis.

3.36 A ‘prescription’ model,^[156] by contrast, involves a medical practitioner prescribing a particular form of cannabis, as they would for any other medicine. The practitioner specifies the product, dosage and frequency of administration, in the form of a ‘written direction… to a pharmacist for preparing and dispensing a drug’.^[157] Practitioners are required to make an assessment of whether cannabis would be beneficial for the patient, having regard to its risks and benefits, and can decline to prescribe if they feel medicinal cannabis would be inappropriate.

3.37 The chief differences between these approaches are the depth of assessment of the patient’s circumstances made by the medical practitioner, and whether the practitioner is asked to specify the product the patient should receive.

3.38 Many submissions suggested there would be difficulties implementing the ‘prescription’ model without an approved product standardised in the usual way.^[158] One member of the Commission’s medical advisory committee stated that, on the basis of the evidence currently available, they would not prescribe it.^[159] The Royal Australasian College of Physicians made this point clearly:

It is unacceptable for a doctor to be asked to authorise a patient’s use of or prescribe a substance of unknown composition and uncertain clinical effects.^[160]

3.39 Professor David Penington also thought that adopting the prescription model presented difficulties:

Use of a herbal product without the usual rigorous trials with testing of outcomes, dose and side effects would be unlikely to be acceptable to medical practitioners for ‘prescription’.^[161]

3.40 A number of other submissions advanced a certification model as their preferred option.^[162] That is, they proposed that the practitioner’s role be limited to confirming the patient’s diagnosis, and not extend any further.^[163] The Royal Australasian College of Physicians was among those seeking a ‘certification’ model:

In the absence of a reliable supply of cannabis products of known and certified composition, the doctor’s responsibilities must be confined to certification of a person’s eligibility … and the monitoring of drug interactions and adverse effects.^[164]

3.41 Consistently with his reservations regarding prescriptions, Professor Penington also suggested that certification would be a more appropriate role for medical practitioners:

Fears over medico-legal hazards in prescribing a herbal remedy can be overcome if effective regulation of the products is established, and the role of the medical practitioner is that of certifying, with the patient’s agreement, the nature of the patient’s clinical condition, in relation to those uses approved by legislation. The legislation could require this as a condition to register as a medicinal cannabis user. The relationship between doctor and patient would not be disturbed with the doctor free to give advice at any stage.^[165]

3.42 Shirley Humphris echoed these views:

A doctor maybe would not exactly prescribe cannabis in the usual way (doctors may fear potential litigation for ‘prescribing’ an untested product with unknown dosage) but rather certify the illness or symptoms. It would then be legal to have the discussion with the doctor re risks and benefits without fear of being informed on. Importantly the doctor would be able to run tests to monitor the effect cannabis may be having on existing meds (it is known … the concentration of some epilepsy meds are affected by cannabis).^[166]

3.43 A number of other submissions advocated for the prescription model, supporting the maintenance of discretion for medical practitioners.^[167] Jeni Martin stated, ‘[w]e need to trust that our medical professionals are generally conservative & unlikely to prescribe or recommend medicinal cannabis without adequate reasons.’^[168]

The preferred authorisation model

3.44 The system of authorisation should be acceptable to the medical profession. The effective participation of medical practitioners is a key to the success of any medicinal cannabis scheme.^[169] The fact that medical practitioners were not comfortable with their role as gate-keepers in Canada has led to a number of the problems in consolidating the operation of the scheme in that country.^[170]

3.45 The Commission acknowledges that there are significant difficulties associated with asking medical practitioners to ‘prescribe’ medicinal cannabis. If Victoria were to make available medicinal cannabis products that are quality-controlled and standardised for cannabinoid content, they would not be in the nature of medicines ‘approved’ by the TGA^[171] and thus medical practitioners would not have the usual level of information to decide whether prescription was warranted and what product and dose should be prescribed.

3.46 Prescription-type models have given rise to objections from the medical profession in other jurisdictions. In opposing the shift from a ‘certification’ model to an ‘authorisation’ model, the College of Family Physicians of Canada stated:

In our view, Health Canada places physicians in an unfair, untenable and to a certain extent unethical position by requiring them to prescribe cannabis in order for patients to obtain it legally. If the patient suffers a cannabis-related harm, physicians can be held liable, just as they are with other prescribed medications. Physicians cannot be expected to prescribe a drug without the safeguards in place as for other medications—solid evidence supporting the effectiveness and safety of the medication, and a clear set of indications, dosing guidelines and precautions.^[172]

3.47 The ‘certification’ model has a range of drawbacks, however. In merely certifying a patient’s diagnosis, the medical practitioner does not consider whether there are any particular features of the patient (such as history of drug dependency, poor cardiovascular health or a strong family history of psychosis) which might make cannabis inappropriate for them. It also ordinarily does not involve the practitioner in the selection of an appropriate formulation or strength, leaving the patient to determine this for themselves.^[173] This is problematic for patients, with some of those currently using cannabis telling the Commission they did not believe patients should be left to work out the best product on their own.^[174]

3.48 The Commission considers that, notwithstanding the discomfort of many members of the medical profession with the ‘prescription’ model, a scheme which does not involve the medical practitioner in a consideration of the risks and benefits for the particular patient would be an intolerable policy outcome. Patients should not be left to determine, on their own, whether medicinal cannabis is appropriate for them, and what form of it they should obtain.

3.49 In the Commission’s view, a patient’s treating medical practitioner should be required to consider, for the patient before them, whether cannabis would be an appropriate treatment, having regard to the considerations that would usually inform their clinical decision making. This reinforces the notion, expressed above, that a medicinal cannabis scheme should be centred on treatment by a medical practitioner. It is also consistent with the requirement under international law that drugs such as cannabis be used in a ‘rational’ way.^[175]

3.50 Consequently, the Commission considers that, when deciding whether to authorise a patient to access medicinal cannabis, a medical practitioner should be required to make the same assessment as would be made for prescription medicines.^[176] This would include a consideration of:

• the likely benefits for the patient,

• the patient’s risk factors and the significance of those risks for the particular patient

• the availability of other treatments the patient has not yet tried

• whether there is a likelihood of abuse.

3.51 In addition, the medical practitioner should select the product and dosage the patient will receive. While the products would not be approved by the TGA, a Victorian scheme could limit and standardise the range of products available, giving practitioners confidence, as in the Netherlands, in the products they prescribe.^[177] In the Commission’s view, such an approach is essential to fulfilling the regulatory objective of integrating medicinal cannabis into the patient’s medical treatment.

3.52 It is inevitable that some practitioners would hesitate at the outset to make decisions under this model in the absence of an approved product. However, analogous decisions are often made by medical practitioners in the context of off-label prescribing; by extension, they can be made in the context of medicinal cannabis. As the scheme evolves, and more information about dosage and effect is assembled and made available through continuing medical education programs, medical practitioners’ knowledge and experience will grow. This is reflected in the Canadian experience. At the start of the Canadian medicinal cannabis program, the number of practitioners signing authorisations was very small, while today significant numbers are involved in the scheme.^[178] Practitioners are also reportedly growing in their acceptance of the scheme, with professional networks and training programs becoming more established.^[179]

Similarity to off-label and unlicensed prescribing

3.53 Medicinal cannabis products supplied under a Victorian scheme may have not been approved by the TGA, and this would place medical practitioners in the difficult position of dealing with substances for which dosages and reactions are not clearly quantified by virtue of research conducted methodically under controlled circumstances on human subjects with a variety of different conditions. However, models for this type of prescribing can be found in ‘off-label’ and ‘unlicensed’ prescribing.

3.54 Off-label prescribing involves the provision of approved drugs in situations^[180] for which they are not approved.^[181] Unlicensed prescribing, on the other hand, involves the provision of drugs not approved for any indication. Off-label prescribing is widespread, particularly in areas such as paediatrics, oncology, psychiatry and palliative care.^[182]

3.55 Joe Collier explains the ‘clinical and ethical dilemmas’ associated with off-label and unlicensed prescriptions:

The licensing arrangements ensure a rigorous assessment of each medicine, using volumes of data … on the efficacy and safety of the product when used for a given indication. Tight controls are set on the quality of the product, and when it is given according to the recommendations in the [product information] the authority calculates that it is more likely to improve patient wellbeing than do harm. … When a medicine is prescribed outside of these arrangements, this support is absent and treatment tends to be based more on assumptions and extrapolations.^[183]

3.56 Guidelines issued by the Council of Therapeutics Advisory Groups in 2013 state that off-label prescribing should ordinarily only be considered where all other options, including medicines approved by the TGA, are unavailable, exhausted, not tolerated or unsuitable.^[184] They instruct practitioners that, if there is high-quality evidence to support a proposed use, off-label use is generally appropriate but if only lesser quality evidence exists and the potential benefits appear greater than the potential harms, use should be confined to exceptional cases or be allowed conditionally, subject to review. If there is no evidence at all, use should be confined to a clinical trial.^[185]

3.57 In this regard, the Royal Australasian College of Physicians drew a link between unapproved but standardised cannabis products and clinical trials:

If a reliable and legal supply of a purified form of medicinal cannabis is established in Victoria, but an absence of trial data concerning efficacy, safety and dosing information persists, the doctor’s role in prescribing medicinal cannabis should be as per the conduct of a clinical trial.^[186]

3.58 The essential difference between a decision to prescribe a medicine off-label and the decision to prescribe in an approved way is that a practitioner must exercise greater judgment about whether a use is appropriate for the patient when prescribing off-label. In the case of unapproved medicines sought to be accessed through the Special Access Scheme, a similar judgment is required, but the ultimate decision maker is the TGA. These decisions are much more guided and constrained where a medicine is prescribed within the scope of its approval, where the risks and benefits have been assessed in advance by the TGA.

Children and vulnerable patients

3.59 By adopting usual practices for the authorisation of medicines, there would be no need to adopt special rules for the eligibility of children and other vulnerable patients—medical practitioners would apply the same considerations as they would for other types of medicines. As the Royal Australasian College of Physicians submitted, for such patients, provided the practitioner ensures there is a medical need for the prescription and it is in the patient’s best interests, the same considerations should apply as for any other treatment.^[187]

Acknowledging difference

3.60 In acknowledgement of the fact that medicinal cannabis remains of a fundamentally different nature to other medications ordinarily supplied on prescription—in particular, that the products made available under a Victorian scheme would not have received TGA approval—the Commission considers that a different name should be used for the document that authorises medicinal cannabis to be dispensed to a patient. It suggests that it be referred to as an ‘Authority to Dispense’.

Patient education and monitoring

3.61 There are a number of reasons why that the use of medicinal cannabis by patients should be closely supervised by a medical practitioner. These include:

• Potential psychiatric and other harms associated with cannabis, including the development of dependence or psychosis, should be monitored by an independent expert.

• Cannabis has the potential to interact with other medications.^[188]

• Dose-response effect should be reviewed regularly to ensure that the form of administration, type of medicinal cannabis and quantity of active constituents can be titrated and adjusted to achieve optimally beneficial effect.

• Patients should be encouraged not to cease other necessary medications.

• Cannabis should be used as only one part of treatment provided by medical practitioners to patients for serious conditions from which they suffer.

3.62 Submissions called for medical practitioners to play a role in educating and assisting patients. JB, for instance, stated that practitioners should:

provide educational material to a patient outlining the benefits, advantages, disadvantages, side effects (if any), dosages, follow up appointments to ascertain the benefits and progress of the patient after commencing medicinal cannabis^[189]

3.63 The Commission agrees with these comments and emphasises that monitoring by a medical practitioner of the authorised use of cannabis for medicinal purposes is essential, whichever model of authorisation is adopted.

Legal procedures

3.64 The above passages considered the substantive obligations which should be imposed on medical practitioners in connection with authorising use of medicinal cannabis. This section will consider how those obligations should be reflected in law.

Permit requirement

3.65 In the Commission’s view, the legal arrangements for patient authorisation should be modelled on the permit requirement for prescription of opioid replacement therapy.^[190] A specialist medical practitioner who wishes to authorise medicinal cannabis to be dispensed should first seek a permit from the Secretary of the Department of Health and Human Services. A permit would have to be sought in all cases.^[191]

3.66 The Secretary of the Department of Health and Human Services should have discretion to decline to issue a permit where the patient is identified as having diverted their supply of medicinal cannabis to an unauthorised person or deceived their medical practitioner concerning their eligibility. As medicinal cannabis would be supplied under the scheme to gravely ill people, this would not be appropriate as a general rule, but a discretionary power to refuse may be appropriate in particular cases.^[192] The Secretary should also have discretion to refuse in other scenarios, such as where false or misleading information has been supplied in seeking a permit^[193] or where another practitioner has already been issued a permit in respect of that patient.

3.67 Because each permit application would be associated with a particular patient and a particular medical practitioner, the system would allow the Department to supervise patients and authorising practitioners. There would need to be a means for pharmacists dispensing medicinal cannabis to confirm that a permit has been granted for a patient. For consistency with other permits, appeal rights should be created for persons affected by permit refusal.^[194]

3.68 Regulations would control the content of the permit application form, thereby enabling the Secretary to collect data regarding the use of medicinal cannabis.^[195] The permit itself would contain specified information, including:

• the duration of the permit, not to exceed 12 months

• the name and address of the patient

• the name of the general practitioner or clinic with principal responsibility for monitoring the efficacy and side effects of the treatment

• the pharmacy at which the patient or carer will obtain medicinal cannabis

• the names of any carers who will collect or administer the medicinal cannabis.

3.69 Following the issue of a permit to the specialist medical practitioner, an ‘Authority to Dispense’ could be issued in accordance with the permit. This document would perform the same function as a prescription, in that it would authorise a pharmacist at the nominated pharmacy to dispense a stated product and amount of medicinal cannabis to the patient or their nominated carer.

3.70 After the initial Authority to Dispense is made by the specialist, Authorities to Dispense would generally be given by the patient’s general practitioner. This means that patients would need to consult their general practitioner periodically in order to continue the treatment, so that the general practitioner can monitor relevant symptoms. For this reason it is important for the general practitioner to be able to amend the product or dosage.

3.71 It should be noted that, under the opioid replacement therapy permit schemes, many aspects of prescribing and approval practices are set out in departmental policies.^[196] This approach could be replicated for medicinal cannabis, so that the requirement for the applicant to be a specialist, refusal of permits, prescribing practices and so on can be governed more flexibly than if these matters were specified in legislation.

Recommendations

8 A specialist medical practitioner who is registered with the Medical Board of Australia within a prescribed category for the medical condition on which their patient’s eligibility is based should be able to apply to the Secretary of the Department of Health and Human Services for a permit to issue an Authority to Dispense Medicinal Cannabis in respect of that patient. The application should state that:

(a) The patient’s condition and associated symptoms meet the eligibility criteria of the scheme.

(b) It is appropriate in all the circumstances that the patient be treated with medicinal cannabis.

(c) The patient has been informed and accepts that the medicinal cannabis product they will receive will not have been tested for efficacy and side effects by the Therapeutic Goods Administration, and has been informed of other treatments which have been so tested, along with the risks, potential benefits and side effects, including long-term effects, of each.

(d) The patient has been informed that information about their treatment will be collected and used for scheme evaluation and research purposes.

9 The Secretary of the Department of Health and Human Services should have the power to issue a permit to a specialist medical practitioner if satisfied that:

(a) The specialist medical practitioner is registered as a specialist with the Medical Board of Australia within a prescribed category for the medical condition on which patient eligibility is based.

(b) The patient ordinarily resides in Victoria.

(c) There is not an unacceptable risk that the patient will abuse the terms of the permit.

Permit delegation

3.1 As noted above, while the initial power to authorise a patient to be treated with medicinal cannabis should rest with a specialist medical practitioner, supervision of the patient ought to be the role of approved general practitioners. The permit system could also be used to implement this. Under the existing permit system for Schedule 8 opioid replacement therapy drugs, medical practitioners can delegate to another practitioner at the same practice, who can prescribe to existing patients during times when they are absent. A similar approach could be taken for medicinal cannabis. While the permit would be sought by the authorising specialist medical practitioner, that practitioner could delegate to a general practitioner or clinic named on the permit to continue treatment with medicinal cannabis.

3.2 Authorities to Dispense medicinal cannabis would only authorise a set number of months’ worth of medicinal cannabis to be dispensed. In order to continue receiving medicinal cannabis, a patient would need to return regularly to their general practitioner to obtain a further Authority to Dispense. The general practitioner should have the ability to select the product to be dispensed, and should not be constrained to select the product originally identified by the specialist. As with prescriptions, the Authority to Dispense would specify how much could be purchased and how often.

Recommendations

10 A valid permit should entitle the specialist medical practitioner, or a general practitioner identified on the permit, to issue an Authority to Dispense Medicinal Cannabis. An Authority to Dispense Medicinal Cannabis would:

(a) authorise a pharmacy or pharmacy department identified on the permit to dispense medicinal cannabis in accordance with specified instructions

(b) enable no more than three months’ supply of the medicinal cannabis products to be dispensed to the patient or carer at a time.

11 The permit issued to a specialist medical practitioner by the Secretary of the Department of Health and Human Services should specify:

(a) the duration of the permit, not to exceed 12 months

(b) the name and address of the patient

(c) the name of the general practitioner or clinic with principal responsibility for monitoring the efficacy and side effects of the treatment

(d) the pharmacy at which the patient or carer will obtain medicinal cannabis

(e) the names of any carers who will collect or administer the medicinal cannabis.

12 An Authority to Dispense Medicinal Cannabis issued by a specialist medical practitioner or a general practitioner should specify:

(a) the product and dosage

(b) the name and address of the patient

(c) the pharmacy at which the patient or carer will be dispensed medicinal cannabis

(d) the names of any carers who may collect or administer the medicinal cannabis.

Informed consent

3.1 The likelihood that medicinal cannabis provided under a Victorian scheme would not have been approved in a conventional fashion (namely by the TGA) raises some risks of an uncertain level for patients. There is a need for medical practitioners to ensure that, in light of this uncertainty, they pay particular attention to obtaining properly informed consent from the patient prior to authorising the dispensing of medicinal cannabis.

3.2 The TGA’s ‘authorised prescriber’ scheme, which allows medical practitioners to seek approval to supply individual patients with unapproved goods (such as those which are used in a clinical trial or have been withdrawn from the Australian market) recommends that patients be specifically informed of the following matters before giving consent to treatment:

• that the product is not approved (that is, registered or listed) in Australia

• the possible benefits of treatment and any risks and side effects that are known

• the possibility of unknown risks and late side effects

• any alternative treatments using approved products which are available.^[197]

3.3 The Commission considers that a similar set of matters should be required to be part of the discussion between practitioner and patient in obtaining informed consent to treatment with medicinal cannabis. Importantly, this means that the patient assumes the risks associated with using a drug that is unapproved, but only in circumstances where they have been supplied with a sufficient level of information that they are able to do so in an informed way. The Department of Health and Human Services may wish to consider developing a standard patient consent form, similar to that used in clinical trials.^[198]

Liability and indemnity

3.4 Medical practitioners involved in a Victorian medicinal cannabis scheme may be concerned that, in authorising unapproved medicinal cannabis products, they could be liable civilly or professionally for consequences flowing from that decision, particularly where the available information regarding the efficacy and side effects of medicinal cannabis is comparatively limited. A medical practitioner may face legal consequences if they fail to inform a patient of a risk which they knew would be significant to the patient.

3.5 In Rogers v Whitaker, the High Court held that a medical practitioner has a duty to warn a patient of any ‘material’ risks inherent in a proposed treatment. A risk would be ‘material’ if, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to it if warned of its existence, or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it.^[199] However, liability in negligence will only be established if it can be proven that, had they been informed of the particular risk, the patient would not have proceeded to obtain the treatment.^[200]

3.6 This analysis can become more complicated where a treatment is experimental, or little is known about its risks and efficacy. A practitioner would be obliged to give a patient a balanced overview of the evidence regarding such matters and, where little is known, to indicate this.^[201] Medical practitioners also have a duty to stay informed regarding developments in the literature where experimental treatments are involved.^[202] Ultimately though, the decision whether to consent to treatment, once properly advised, resides with the patient.^[203]

3.7 In addition to civil liability, failure to obtain informed consent can give rise to breaches of a medical practitioner’s professional obligations.^[204] This requirement is, at heart, about ensuring that the treatment undertaken by the patient is entirely voluntary.^[205] National guidelines state that a patient’s informed consent must be obtained before treatment is administered, and specify the matters that must be brought to a patient’s attention.^[206]

3.8 In Canada, medical practitioners are required to make an individualised assessment of whether cannabis would be appropriate for the specific patient (although this assessment falls short of a prescription^[207]). The Canadian Medical Protective Association, which is the main insurer of the Canadian medical profession, advises that practitioners:

should not feel obligated to complete the medical document for medical marijuana if they are unfamiliar with its treatment or use, or if they feel it is medically inappropriate for a patient. Physicians who choose to complete a medical document should rely on sound medical judgment and comply with their College’s relevant guideline or policy.’^[208]

3.9 Notably, too, practitioners have the advantage of a comprehensive document issued by Health Canada.^[209]

3.10 The Commission was told by advisory committee members that providers of medical indemnity insurance in Australia may refuse to provide cover for medical practitioners’ activities in connection with approving access to medicinal cannabis, or may impose an increased premium if such cover is desired.^[210] This would be an unfortunate response, if it occurred.

3.11 The Commission notes that, although medicinal cannabis products would be in the nature of unapproved drugs, existing indemnity insurance policies do not automatically exclude such drugs from the scope of their coverage, and frequently include cover for practitioners taking part in clinical trials.

3.12 In other contexts, medical practitioners are afforded immunity under certain statutory schemes, primarily when conducting drug and forensic tests (provided they act properly or in good faith).^[211] The Commission notes that it would be open to the Victorian Government to provide medical practitioners (both the original specialist and the supervising general practitioner) with an indemnity or immunity in respect of their decisions on medicinal cannabis.

Patients’ rights and obligations

3.13 Patients for whom an Authority to Dispense has been issued should have certain rights under the scheme. They would be authorised to possess and use medicinal cannabis products obtained from a pharmacy in accordance with the Authority to Dispense.

3.14 It would remain illegal for non-authorised persons to possess medicinal cannabis, and a patient who supplied medicinal cannabis to anyone other than an authorised professional or their nominated carer would engage in trafficking, giving rise to an offence under the Drugs, Poisons and Controlled Substances Act 1981 (Vic).^[212] Likewise, a carer who supplied cannabis to an unauthorised person would also engage in trafficking for the purposes of the legislation.

3.15 The legislation should also ensure that relevant offences in the Drugs, Poisons and Controlled Substances Act 1981 are expanded to capture the following conduct:

• fraudulently obtaining or granting an Authority to Dispense^[213]

• representations that a product is a lawfully produced medicinal cannabis product despite it not having been manufactured under the scheme^[214]

• allowing an ineligible patient to access medicinal cannabis.

3.16 Appendix D sets out in detail other conduct which the legislation should ensure is captured by new or existing offences.

Recommendation

13 New offences should be created, or existing offences expanded, proscribing dishonest conduct in relation to obtaining a permit or issuing or obtaining an Authority to Dispense Medicinal Cannabis.

Consequential changes

3.17 The impact of medicinal cannabis on driving would need to be considered. It is an offence to be in control of a vehicle while under the influence of a drug of dependence or with any concentration of THC in blood or saliva.^[215] The evidence strongly suggests that THC impairs a person’s ability to drive.^[216] While some jurisdictions overseas have set the prescribed concentration of THC above zero,^[217] the Commission does not recommend that this occur in Victoria. Accordingly, there would be a need to warn patients upon receipt of medicinal cannabis that their use of any THC-containing products could make them unable to drive.^[218] Similar warnings should be included regarding the dangers of operating heavy machinery, aircraft, vessels and so on.^[219]

3.18 The Commission heard from people who have been adversely affected by workplace drug-testing following the use of cannabis, or feared they would be.^[220] Some overseas jurisdictions have introduced laws to protect lawful medicinal cannabis users from workplace discrimination as a result of their use of cannabis.^[221] The Commission notes that Victorian anti-discrimination laws do not presently explicitly prevent discrimination on the basis of medical treatment.^[222] Action taken as a result of workplace testing is primarily a private matter between an employer and employee, and employees would be protected from unreasonable actions by unfair dismissal laws,^[223] so the Commission does not recommend any changes to the law in this regard.

Other participants

3.19 It would not be sufficient to authorise patients alone to possess and use medicinal cannabis. Many patients, including children and the physically infirm, may be unable to travel to collect medicinal cannabis or to administer it to themselves, and would rely on others to do it for them. The scheme would need to ensure that it does not criminalise the actions of such people by failing to recognise their role and cater properly to it.

3.20 The legislation should therefore authorise nominated carers^[224] to possess medicinal cannabis, in the form and up to the amount the patient could possess themselves.^[225] Carers would also need to be authorised to administer the medicinal cannabis to the patient.^[226] The carer would not be authorised to use the medicinal cannabis themselves.^[227] The scheme should have a mechanism through which professionals, such as in-home carers and workers at palliative care facilities or nursing homes can also act as carers.

Recommendation

14 The Drugs, Poisons and Controlled Substances Act 1981 (Vic), and the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) should be amended to allow patients and carers nominated in a valid Authority to Dispense Medicinal Cannabis, as appropriate, to obtain, possess and use the medicinal cannabis products designated in the Authority.

3.21 The legislation would also need to ensure that registered medical practitioners, pharmacists, nurses and nurse practitioners were authorised to possess, supply and/or administer medicinal cannabis products.^[228] This would be unnecessary if medicinal cannabis products were treated as Schedule 9 Poisons under the legislation. However, as explained below, a new category of substance would need to be created for medicinal cannabis products, meaning that cannabis-specific authorisation provisions would be required.

Recommendation

15 The Drugs, Poisons and Controlled Substances Act 1981 (Vic), and the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) should be amended to allow medical practitioners, registered nurses and pharmacists who participate in any Victorian medicinal cannabis scheme to obtain, have in their possession, administer, sell and supply medicinal cannabis products, as appropriate, for the purposes of the scheme.

A new category of poison

3.22 Because ‘Schedule 9 poison’ is defined in the Drugs, Poisons and Controlled Substances Act by reference to the Standard for the Uniform Scheduling of Poisons (SUSMP),^[229] the existing rules regarding Schedule 9 poisons would continue to apply to cannabis and cannabis products under a Victorian scheme unless cannabis is moved to another Schedule in the SUSMP. This could cause practical difficulties regarding the storage and dispensing of cannabis.

3.23 This problem is best solved by removing authorised cannabis products from the definition of a ‘Schedule 9 Poison’ for the purposes of the Drugs and Controlled Substances Act and the Regulations. Instead, a new class of poison would be introduced into the Act: ‘medicinal cannabis’. Cannabis products created under the scheme would be treated as ‘medicinal cannabis’ when used lawfully, and as a drug of dependence when used unlawfully. ‘Medicinal cannabis’ would then be used throughout the Act and the Regulations to authorise certain persons to deal in medicinal cannabis. The Commission has identified the necessary changes in Appendix D.

Implementation issues

Practitioner training

3.24 Medical practitioners would need education and resources on the evidence supporting the use of cannabis, its pharmacology, adverse effects and so on. Knowledge of these matters is limited among medical practitioners at present due to the limited trial data available and a lack of experience with cannabis. Comments were made in several submissions and at consultations about the need for suitable training to be made available to medical practitioners.^[230] Cancer Council Victoria stated that ‘[a]ny change to legislation should coincide with educational support to health professionals’.^[231] A respondent to Cancer Council Victoria’s clinician survey stated:

Although my knowledge is increasing, I do not feel I have an adequate understanding of the clinical use of cannabis or its derivatives. I don’t think that until I have some degree of clinical experience I can identify suitable patients.^[232]

3.25 Many in the cannabis community argued that medical practitioners have little understanding of concepts such as the endocannabinoid system.^[233] Matthew Pallett’s views were typical of those received by the Commission on this point:

As there are no registered medical professionals within Australia with training in the application of cannabinoid medicines or the endocannabinoid system no meaningful ‘medical oversight’ is possible in Australia at present. … the endocannabinoid system is NOT taught in medical or nursing schools at Australia and doctors therefore have little to no knowledge of this system.^[234]

Should training be mandatory?

3.26 One means of ensuring that only appropriately trained practitioners are able to participate in the scheme would be to restrict the participation of practitioners to those who have completed relevant training. This approach is adopted in some United States jurisdictions.^[235]

3.27 Dr David Bearman identified a training requirement as a way to ‘marginalize those physicians who might wish to practice a form of minimalist medicine in making recommendations and/or writing prescriptions for the medicinal use of cannabis’. He suggested that:

You can do this by requiring any physician who makes twenty-five (25) or more cannabis prescriptions a year to be certified. Such certification could include having attended a certain amount of category I CME say twenty hours, passing a test and practicing an acceptable standard of medicine.^[236]

3.28 The Australian Lawful Use of Cannabis Alliance proposed a register of qualified practitioners:

Victoria should establish a register of healthcare practitioners who intend to provide medical cannabis treatments. Entry on this Register should have, as a pre-requisite, the annual completion of a continuing professional education program specifically related to cannabis medicine and/or cannabis medical treatment options.^[237]

3.29 Such an approach is also used in the context of opioid replacement therapy.^[238] Medical practitioners generally may only prescribe opioid replacement therapy drugs, such as methadone, if they have been appropriately trained and are presently approved by the Department of Health and Human Services.^[239] The approval system aims to ensure that prescribing practitioners are familiar with the principles of opioid replacement therapy and prescribing policies.^[240] A similar scheme could be adopted in order to oversee medical practitioners involved in authorising access to medicinal cannabis.

3.30 The approval system is also used in the context of opioid replacement therapy to manage the number of patients per doctor. That is, a medical practitioner’s approval sets a maximum for the number of concurrent treatment permits the practitioner may hold. The maximum can be increased at the practitioner’s request. This system could similarly be used in a medicinal cannabis scheme to limit the pressure on doctors by placing a cap on the number of patients permitted to be treated with medicinal cannabis under their care at any given time.

3.31 It is important that the Department encourage medical practitioners to access appropriate training on medicinal cannabis, and it may be constructive for the Department itself to provide information and training in respect of such matters, as in Canada. However, requiring practitioners to be approved by the Department, and making the completion of training a condition of approval, would be excessive and would unduly limit the number of practitioners able to authorise treatment with medicinal cannabis. The number of specialists registered in the specialisations that are relevant to the conditions that determine eligibility is relatively small, and imposing an approval requirement may restrict this further. If this requirement were imposed on the supervising general practitioners as well, patients could be unable to continue treatment with their regular general practitioner, potentially disrupting their existing medical care.

3.32 Further, the risks attached to opioid replacement therapy that the approval system is designed to control would be largely absent from a medicinal cannabis scheme. One key imperative behind the use of approvals in the opioid replacement therapy scheme is the desire to prevent ‘doctor shopping’ by enabling departmental supervision of prescribing patterns. This risk would be significantly reduced in the proposed medicinal cannabis scheme, as only certain specialists would be permitted to authorise access. Further, the risks associated with overuse of cannabis are not of the same scale as for opioid replacement drugs: a fatal overdose of methadone and like products can occur if a patient takes only a few times the daily dose, while a fatal overdose from the use of cannabis has not been recorded. For these reasons, the Commission does not consider that the medical practitioners involved in the scheme should be limited to those who have been approved by the Department on the basis of having completed mandatory training.

3.33 The Commission agrees that specialists involved in the medicinal cannabis scheme should be encouraged to undertake training on the medicinal use of cannabis prior to becoming involved in the authorisation decision. However, undertaking training should be voluntary.

Provision of training

3.34 The Commission considers that the Department of Health and Human Services should have a role in addressing the need for practitioners to receive education and support. Examples of how this could be done include:

• offering training courses

• preparing guidelines to assist medical practitioners to determine when treatment with medicinal cannabis is appropriate

• making available detailed information on products, their formulation and pharmacology.

3.35 In Canada, Health Canada co-ordinated the collation and publication of clinical data on the efficacy and side effects of cannabis, which is disseminated to the profession to guide and inform them on appropriate uses, dosing and monitoring.^[241] This comprehensive document covers all aspects of cannabis use, and sets out the clinical evidence and pharmacology with extensive reference to research.

3.36 The Commission understands, however, that, while detailed, the document is not seen as particularly useful as a practical guide. In part to remedy this, at least one guidance document has been produced that, in addition to setting out the clinical evidence, sets out consequential recommendations, giving clearer guidance to practitioners about when treatment with medicinal cannabis is appropriate.^[242]

3.37 The Department of Health and Human Services would also need to play an active role in communicating product information to practitioners. Because the Secretary would be the sole supplier of medicinal cannabis products,^[243] the Department should be regarded as responsible for conveying information about product content and administration. The Department would also need to collate any reports of adverse events relating to particular products and find ways of conveying this information to practitioners.

Recommendation

16 The Secretary of the Department of Health and Human Services should provide suitable training and information materials to medical practitioners, pharmacists, patients and others with responsibilities under the scheme.

Role of professional associations

3.38 In Canada the professional associations and Canadian regulations do not direct practitioners on how the decisions should be made in relation to authorisation of use of medicinal cannabis, but guidance has been issued by the Canadian Medical Association and provincial colleges.^[244] The Canadian Medical Association advises practitioners they should not feel obligated to authorise medicinal cannabis for a patient if they feel it is medically inappropriate.^[245] It also recommends to practitioners that, among other things:

• they consider authorising cannabis only after conventional therapies have proven ineffective, until there is compelling evidence of its efficacy and safety for specific indications

• they assess the patient’s medical history, conduct a physical examination and assess for the risk of addiction and diversion, using available clinical support tools and tests

• they reassess the patient on a regular basis to establish the effectiveness of the medicinal cannabis in treating the medical condition for which it was authorised, as well as to assess possible addiction and diversion, and support maintenance, adjustment or discontinuation of treatment.^[246]

3.39 In addition, the College of Family Physicians of Canada recently issued Preliminary Guidance: Authorizing Dried Cannabis for Chronic Pain or Anxiety, a detailed document that advises practitioners on:

• what is known about the potential harms and benefits of cannabis use in various populations and for treating different conditions, with a focus on pain and anxiety

• regulations and suggested best practices to follow before authorising and continuing a patient’s access to cannabis

• tools to use when screening patients for misuse or addiction risk

• information about the strains available from licensed producers

• calculations for dosing.^[247]

3.40 Among other guidance, the College sets out a number of categories of patient for whom it considers dried cannabis is ‘not appropriate’, including those who are under the age of 25; have a personal history or a strong family history of psychosis; have a cannabis use disorder or a substance use disorder; have cardiovascular disease; have respiratory disease; or are pregnant or breastfeeding.^[248]

3.41 The Commission notes these developments and observes that professional colleges would have an important role to play in guiding and informing decision making by Victorian medical practitioners.^[249]

Data collection, monitoring and evaluation

3.42 Through use of a permit system, a Victorian scheme could facilitate the collection of data regarding the use of medicinal cannabis. The system could also incorporate reporting requirements, whereby medical practitioners supply information to the Department on results achieved with medicinal cannabis. The data collected by medical practitioners and passed on to the Department would need to be the minimum required and not be unduly burdensome.

3.43 In determining the data to be collected under the scheme, consideration should be given to how it could usefully assist in evaluating whether the scheme is meeting its regulatory objectives and in contributing to research data about the use of cannabis for medicinal purposes.

3.44 The collection of data regarding patient health and treatment raises privacy concerns. Proposed data collection methods should be subject to a privacy impact assessment before implementation, and have appropriate safeguards built in, in consultation with the Commissioner for Privacy and Data Protection and the Health Services Commissioner.

Is a register of patients necessary?

3.45 Many submissions touched upon the idea of creating a ‘register’ of patients who have been authorised to access medicinal cannabis in Victoria.^[250] Registration would be a prerequisite for patients being treated with medicinal cannabis under the scheme.

3.46 Victoria Police suggested that a central registry of patients could be useful as a means of monitoring the scheme:

In the interests of conducting a fully informed trial of medicinal cannabis, Victoria Police recommends that consideration be given to maintaining a register of prescribers and patients in relation to medicinal cannabis. The purpose of the register would be to track and record the number and types of prescriptions made, and the conditions/symptoms for which cannabis is prescribed.^[251]

3.47 The data collection benefits of registration were also remarked on by Mullaways Medical Cannabis Pty Ltd:

A Medical Cannabis Card would… record the amount of Cannabis/Cannabinoid medicine prescribed and the outcomes of the treatment. This will allow a big data analysis of the results which medical professionals can use to achieve the best outcome for the patient.^[252]

3.48 The Commission considers it likely that the Department of Health and Human Services would create, or be able to generate, records of patients who participate in the scheme. This has parallels in respect of dependence-forming drugs (such as opiates) supplied to drug-dependent persons.^[253] The process of issuing a permit on the application of a specialist medical practitioner for each patient would generate a significant amount of data, which would be supplemented by records of medicinal cannabis products that are dispensed pursuant to those permits. It should be noted that the Office would be bound by the privacy and access provisions in the Health Records Act 2001 (Vic).^[254]

3.49 While some overseas jurisdictions do not maintain records of medicinal cannabis patients,^[255] the Commission considers that this should be an integral component of the Victorian scheme. Without it, the government would have no way of monitoring the conditions for which cannabis is being authorised, no way of contacting patients regarding their interest in clinical trials, and no way of supervising the medical practitioners involved in authorising access. This would severely compromise the integrity of the scheme, its ability to support research, and the capacity to review the scheme after a suitable period of time. It would also create the potential for abuse of the scheme.

3.50 However, the Commission does not consider it necessary to require patients to register with the Department or to be issued with identification cards, as occurs in some other countries that have medicinal cannabis schemes.^[256] It is not required for access to other controlled therapeutic goods and there are no features of the proposed medicinal cannabis scheme that would make it necessary for government or helpful for the patient.

1. See Chapter 5.

   ↑

2. A number of submissions opposed this exercise altogether. Heather Marie Gladman, Australian HEMP Party summarised the views of a number of people who communicated with the Commission: ‘It should be available to everyone who needs it … All cannabis use is medical’: Submission 10. Others called for cannabis to be legalised for all purposes. The Australian Lawful Use of Cannabis Alliance asked why, in view of its potential protective and preventative benefits, only the sick should have access to cannabis: Submission 35. The Commission notes these objections but is confined to examine only those matters raised by the terms of reference.

   ↑

3. As Hedigan J said in Kent v Wilson [2000] VSC 98, [20]: ‘The courts have frequently been obliged to consider the meaning of the phrase “exceptional circumstances” in a variety of contexts, perhaps most commonly in connexion with the granting of bail in murder cases and the taking of appeals out of time.’

   ↑

4. See Charter of Human Rights and Responsibilities Act 2006 (Vic) s 31 (regarding when an human rights override declaration will be made); Children, Youth and Families Act 2005 (Vic) s 345 (regarding when a child can be prosecuted otherwise than on summons); Serious Sex Offenders (Detention and Supervision) Act 2009 (Vic) s 183 (regarding when a court can authorise publication of information regarding an application for a sex offender’s continued detention or supervision); Sentencing Act 1991 (Vic) ss 48O, 69W, 154 (regarding when a community correction order, fines work order or community work permit can be suspended by the Secretary to the Department of Justice); Road Safety Act 1986 (Vic) ss 51(12) and (12A) (regarding where a judge can cancel an immediate driver’s licence suspension imposed on a person found drink driving).

   ↑

5. Redlich JA said that for something to amount to ‘exceptional circumstances’, it must be ‘clearly unusual or quite special or distinctly out of the ordinary’. He said it is not enough to find something which ‘falls within the range of normally anticipated consequences, behaviours or exigencies’: R v Ioannou (2007) 17 VR 563, 568. But, depending on the context, something does not have to be ‘beyond reasonable expectation or contemplation’ in order to be exceptional. Lord Bingham of Cornhill CJ understood the phrase in a similar way: ‘We must construe “exceptional” as an ordinary, familiar English adjective and not as a term of art. It describes a circumstance which is such as to form an exception, which is out of the ordinary course, or unusual, or special, or uncommon. To be exceptional a circumstance need not be unique, or unprecedented, or very rare; but it cannot be one that is regularly, or routinely, or normally encountered’: R v Kelly [2000] 1 QB 198, 208.

   ↑

6. See, eg, Road Safety Act 1986 (Vic) s 90L(4).

   ↑

7. In Kent v Wilson [2000] VSC 98, Hedigan J stated at [22]: ‘Courts have been both slow and cautious about essaying definitions of phrases of this kind, leaving the content of the meaning to be filled by the ad hoc examination of the individual cases. Each case must be judged on its own merits, and it would be wrong and undesirable to attempt to define in the abstract what are the relevant factors’.

   ↑

8. That is, only where a particular form is moved to a different schedule of the SUSMP and approved for inclusion on the Australian Register of Therapeutic Goods: see Chapter 4.

   ↑

9. Etymologically, suffering with another. See generally Michelle Brenner, Conversations on Compassion (Create Space, 2015).

   ↑

10. See Emma Seppala, ‘The Compassionate Mind’ (2013) 26(5) Association for Psychological Science Observer

    <https://www.psychologicalscience.org>.

    ↑

11. See Chapter 1.

    ↑

12. Laurence Mather et al, ‘(Re)introducing Medicinal Cannabis’ (2013) 199 Medical Journal of Australia 759, 761.

    ↑

13. General Purpose Standing Committee No 4, Legislative Council of the Parliament of New South Wales, The Use of Cannabis for Medical Purposes (2013).

    ↑

14. Public Health Association of Australia, Position Statement: Medicinal Cannabis in Australia <http://www.phaa.net.au/documents/item/365>.

    ↑

15. The theme of the 2014 conference of the Medical Cannabis Users Association in Tamworth was ‘United in Compassion’

    <http://www.unitedincompassion.com.au>.

    ↑

16. Submission 34. Christian Business Men Australia also provided the Commission with a copy of a petition they prepared, for presentation

    to Parliament, calling for a ‘Compassionate Use of Medical Cannabis Act’. See Appendix B for list of submissions.

    ↑

17. Submission 38. The Commission’s medical advisory committee concurred with this view.

    ↑

18. Submissions 7, 23, 55, 84. Submission 97 also supported retaining discretion for medical practitioners.

    ↑

19. Consultation 28.

    ↑

20. Submission 23.

    ↑

21. Advisory committee (Meeting 1).

    ↑

22. Consultation 3. See Appendix C for list of consultations.

    ↑

23. See Therapeutic Goods Administration, Access to Unapproved Therapeutic Goods via the Special Access Scheme (November 2009).

    ↑

24. Federal Institute for Drugs and Medical Devices (Germany), Glossary: Cannabis (2013) <http://www.bfarm.de>; Marco Evers and Laura Höflinger, ‘Legal Highs: Welcome to the Cannabis Revolution’ Australian Financial Review (originally Der Spiegel) (10 July 2015).

    ↑

25. Decisions to refuse applications under the Special Access Scheme can be appealed internally or to the Administrative Appeals Tribunal: Therapeutic Goods Act 1989 (Cth) s 60(1)(ca).

    ↑

26. A case-by-case assessment by a government official could, however, be a means of dealing with rare and unusual conditions.

    ↑

27. Concern about the pressure that could be placed on doctors was expressed by the advisory committee (Meeting 1) and at Consultation 26.

    ↑

28. Submission 11.

    ↑

29. Submission 21.

    ↑

30. Submission 43.

    ↑

31. Submission 43, 97.

    ↑

32. Submission 32.

    ↑

33. Submissions 24, 37, 72, 74.

    ↑

34. Submission 54.

    ↑

35. Illinois relies on a condition-based test: 410 Ill Comp Stat 130/10(h). In addition, the jurisdictions listed at n 44 below have listed conditions as part of their eligibility test.

    ↑

36. Conn Gen Stat § 21a-408(2).

    ↑

37. Submission 22.

    ↑

38. Consultation 1.

    ↑

39. Submission 52.

    ↑

40. Md Code Ann § 13-3307(c). The statute also allows for symptoms to be produced by the treatment of a condition, eg chemotherapy.

    ↑

41. Submission 52.

    ↑

42. Submission 60.

    ↑

43. Alaska (Alaska Stat § 17.37.070(4)); Arizona (Ariz Rev Stat Ann § 36-2801), Colorado (Colo Constitution Article XVIII); Delaware (16 Del Code Ann § 4902A); Hawaii (Haw Rev Stat § 329-121); Maine (22 Me Rev Stat § 2422); Michigan (Mich Comp Laws § 333.26423); Montana (Mont Code Ann § 50-46-302(2)); Nevada (Nev Rev Stat § 453A.050); New Mexico (although no symptoms are listed in the statute they have been added by rulemaking: NM Stat § 26-2B-3); Oregon (Or Rev Stat § 475.302(3)); Rhode Island (RI Gen Laws § 21-28.6-3); Vermont (18 Vt Stat Ann § 4472)

    ↑

44. Nev Rev Stat § 453A.050.

    ↑

45. Marihuana Medical Access Regulations, SOR/2001-227 sch 1.

    ↑

46. Exposure Draft of Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 (ACT) cl 7(4).

    ↑

47. In Massachusetts (listed eligible conditions must be ‘debilitating’ with debilitating defined by regulations to mean ‘causing weakness, cachexia, wasting syndrome, intractable pain, or nausea, or impairing strength or ability, and progressing to such an extent that one or more of a patient’s major life activities is substantially limited’: 2012 Mass Acts Ch 369, § 1(C) and 105 Mass Code Regs § 725.004); New Hampshire (NH Rev Stat Ann § 126-X:1(IX)); New York (NY Public Health Law § 3360(7)(a)). In some states, this type of test is only employed for some patients, while others can qualify solely on the basis of their condition: see Minnesota (where a cancer sufferer or terminally ill patient will only qualify if experiencing severe or chronic pain, nausea/severe vomiting, or cachexia/severe wasting: Minn Stat § 152.22(14)(1) and (9)); New Jersey (where cancer and HIV/AIDS suffers must be experiencing severe or chronic pain, severe nausea or vomiting, cachexia or wasting syndrome resulting from the disease or its treatment: NJ Stat Ann § C:24:6I-3).

    ↑

48. Advisory committee (Meetings 1 and 3).

    ↑

49. Australian and New Zealand College of Anaesthetists Faculty of Pain Medicine, ‘Statement on Patients’ Rights to Pain Management and Associated Responsibilities’ (Position Statement No 45, 2010) <http://www.fpm.anzca.edu.au>.

    ↑

50. Submission 25.

    ↑

51. These can include fatigue, dryness of the mouth, dizziness, nausea, sleepiness, cognitive impairment, liver toxicity and addiction: Therapeutic Goods Administration, Australian Public Assessment Report for Nabiximols (27 September 2013) 194.

    ↑

52. Submission 25.

    ↑

53. Pharmaceutical Benefits Advisory Committee, Public Summary Document: Nabiximols (July 2013) <http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2013-07/nabiximols>.

    ↑

54. This observation was echoed in the TGA’s initial assessment of Nabiximols, where the examiner stated ‘a 4 week trial seems likely to identify most eventual responders. Clinicians would only be justified in proceeding to long-term treatment if there was a clear improvement in spasticity’: Therapeutic Goods Administration, Australian Public Assessment Report for Nabiximols (27 September 2013) 108.

    ↑

55. Health Canada, Approval of Sativex with Conditions: Fact Sheet (13 April 2005) <http://www.hc-sc.gc.ca>.

    ↑

56. Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetics, ‘Statement on “Medicinal Cannabis” with Particular Reference to its Use in the Management of Patients with Chronic Non-Cancer Pain’ (2015).

    ↑

57. Michael Farrell, Rachelle Buchbinder and Wayne Hall. ‘Should Doctors Prescribe Cannabinoids’ (2014) 348 British Medical Journal g2737.

    ↑

58. Advisory committee (Meeting 1).

    ↑

59. In deciding to overturn the initial decision to refuse TGA approval to Nabiximols, the delegate of the minister used similar reasoning to conclude that Nabiximols should be allowed to be registered, notwithstanding disputes over its efficacy: ‘in view of the limited therapeutic options for treatment of spasticity in the proposed treatment population and the capacity to sufficiently mitigate the potential risks from Sativex … the Delegate of the Minister considers this response rate provides sufficient evidence of efficacy to approve the registration of Sativex.’ Therapeutic Goods Administration, Australian Public Assessment Report for Nabiximols (27 September 2013).

    ↑

60. Submissions 12, 24, 45, 60, 64, 70, 83. Consultations 2, 4.

    ↑

61. Submission 54.

    ↑

62. Submission 57.

    ↑

63. L J Kehl, ‘A Cannabinoid Agonist Differentially Attenuates Deep Tissue Hyperalgesia in Animal Models of Cancer and Inflammatory Muscle Pain’ (2003) 103 Pain 175.

    ↑

64. Submission 57.

    ↑

65. Submission 99.

    ↑

66. Advisory committee (Meeting 1).

    ↑

67. Health Canada, Authorization with Conditions of Sativex (1 August 2007) <http://www.hc-sc.gc.ca>.

    ↑

68. Tudor J C Phillips et al, ‘Pharmacological Treatment of Painful HIV-Associated Sensory Neuropathy: A Systematic Review and Meta-Analysis of Randomised Controlled Trials’ (2010) 5(12) PLOS ONE e14433.

    ↑

69. Ibid.

    ↑

70. See, eg, Submission 64.

    ↑

71. David Warr, ‘Chemotherapy- and Cancer-Related Nausea and Vomiting’ (2008) 15 Current Oncology S1.

    ↑

72. Submission 57; Raghu Dhanapal, T R Saraswathi and Rajkumar N Govind, ‘Cancer Cachexia’ (2011) 15 Journal of Oral and Maxillofacial Pathology 257.

    ↑

73. Raghu Dhanapal, T R Saraswathi and Rajkumar N Govind, ‘Cancer Cachexia’ (2011) 15 Journal of Oral and Maxillofacial Pathology 257

    ↑

74. Submission 57.

    ↑

75. Cancer Council Australia and Clinical Oncology Society of Australia, Submission 37 to the Senate Legal and Constitutional Affairs Legislation Committee, Parliament of Australia, Inquiry into the Regulator of Medicinal Cannabis Bill 2014, 2015, 4.

    ↑

76. Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetists, ‘Statement on “Medicinal Cannabis” with Particular Reference to its Use in the Management of Patients with Chronic Non-Cancer Pain’ (2015).

    ↑

77. Ibid.

    ↑

78. See, eg: Elin Kondrad and Alfred Reid, ‘Colorado Family Physicians’ Attitudes Toward Medical Marijuana’ (2013) 26 Journal of the American Board of Family Medicine 52, 52–53.

    ↑

79. Samuel Fair noted that: ‘A formidable concern is that undue pressure will be placed on doctors to use the treatment experimentally, if a patient does not receive a desired response from more conventional treatment. … The concern is that such pressure may pose a risk to the doctor/patient relationship’: Submission 40.

    ↑

80. As discussed in the issues paper, among the benefits is a reduced incidence of opioid overdose deaths: Marcus A Bachhuber et al, ‘Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999–2010’ (2014) 174 JAMA Internal Medicine 1668; Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015) [3.33].

    ↑

81. The Commission heard, for example, about fibromyalgia, complex regional pain syndrome and other conditions: Consultations 1, 7.

    ↑

82. See J Michael Bostwick, ‘Blurred Boundaries: The Therapeutics and Politics of Medical Marijuana’ (2012) 87 Mayo Clinic Proceedings 172.

    ↑

83. Some patients in these categories may be able to access medicinal cannabis by reason of their experience of chronic pain.

    ↑

84. In part because of international law requirements: see [4.10].

    ↑

85. Discussed at [3.121]–[3.129].

    ↑

86. See the spectrum of terms discussed in Humphries v Poljak [1992] 2 VR 129, 134: ‘slight’, ‘mild’, ‘moderate’, ‘significant’, ‘marked’, ‘serious’, ‘severe’.

    ↑

87. Submissions 1, 5, 20, 31, 42, 49, 48, 50, 61; Consultation 8.

    ↑

88. Submission 99.

    ↑

89. Submissions 12, 22, 29, 54 and 75, Consultation 1.

    ↑

90. Submissions 18, 35, 18, 74.

    ↑

91. Submission 12; Consultation 26.

    ↑

92. Submission 24.

    ↑

93. Submissions 2, 43.

    ↑

94. Submission 29.

    ↑

95. Submission 52.

    ↑

96. Submission 74.

    ↑

97. Submission 52.

    ↑

98. DC Code § 7-1671.01; Md Code §§ 13-3307(c) & 13-3301; Mont Code Ann § 50-46-302(2); NJ Stat § 24:6I-3 & 24:6I-5; NM Stat

    § 26-2B-3.

    ↑

99. Exposure Draft of Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 (ACT) cl 7.

    ↑

100. Medical Marihuana Access Regulations (Can) (SOR 2001/227) s 1(1) (definition of ‘category 1 symptom’).

     ↑

101. Advisory committee (Meeting 3), Consultation 26.

     ↑

102. Consultation 26.

     ↑

103. Submission 38.

     ↑

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

     ↑

105. In Rhode Island, for instance, a 2015 review identified that the most common reason for receiving medicinal cannabis was chronic pain management: N Zaller et al, ‘Profiles of Medicinal Cannabis Patients Attending Compassion Centers in Rhode Island’ (2015) 47 Journal of Psychoactive Drugs 18. This study is consistent with a study of 1,655 patients seen in medical marijuana specialty practices in California, where Proposition 215 has permitted cannabis for cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine or ‘any other illness for which marijuana provides relief’ since 1996. 73% of applicants seeking a recommendation were male and half of the applicants were under 35. 82.6% of applicants reported using medical marijuana for pain relief, 70.6% for improved sleep, and 55.6% for relaxation. Physicians’ diagnoses were consistent with high levels of diagnosis of low back pain, muscle spasm, arthritis and lumbar degenerative disc disease in applicants for medicinal cannabis entitlement: Helen Nurnberg, Beau Kilmer, Rosalie Licardo and James Burgdorf, ‘An Analysis of Applicants Presenting to a Medical Marijuana Specialty Practice in California’ (2011) 4 Journal of Drug Policy Analysis 1. Similarly, the 2014 annual report filed under the Arizona Medical Marijuana Act found that approximately 70% of those who received medical marijuana authorisations were male and ‘severe and chronic pain’ was either the sole debilitating condition (71%) or among the debilitating conditions (19.2%) reported by those who were authorised, while conditions such as those with cancer (2.7%) and seizures (1.0%) did not figure prominently: Arizona Department of Health Services, Arizona Medical Marijuana Act (AMMA) End of Year Report (2014) <http://www.azdhs.gov>. In Colorado, where patients have been able to receive medical marijuana since 2000, 93.1% of patients report the qualifying condition ‘severe pain’. The next most common conditions were muscle spasms (17.5%) and severe nausea (10.8%), followed by cancer (3.6%) and seizures (2.3%): Colorado Department of Public Health & Environment, Medical Marijuana Registry Program Statistics (30 June 2015) <https://www.colorado.gov>.

     ↑

106. Submissions 43, 68.

     ↑

107. Submissions 3, 4, 6, 11, 13, 18, 24, 29, 32, 45, 48, 61, 63.

     ↑

108. Advisory committee (Meeting 1).

     ↑

109. Submissions 7, 52.

     ↑

110. Submissions 7, 20, 32, 48.

     ↑

111. A scheme under which applications may be made to import or supply an unapproved therapeutic good. See Therapeutic Goods Administration, Access to Unapproved Therapeutic Goods via the Special Access Scheme (2009).

     ↑

112. See New South Wales Health, Role of Drug and Therapeutics Committee in the Evaluation and Approval of Medicines for Use in Public Hospitals (Policy Directive No PD2008_037).

     ↑

113. Contained in s 33 of the Public Health and Wellbeing Act 2008 (Vic).

     ↑

114. Therapeutic Goods Act 1989 (Cth) s 52E(3).

     ↑

115. Therapeutic Goods Regulations 1990 (Cth) Divs 3A and 3B.

     ↑

116. Advisory committee (Meeting 2); Submission 8; Consultations 2, 24.

     ↑

117. Cf Firearms Act 1996 (Vic) s 46A, Relationships Act 2008 (Vic) s 6, Legal Aid Act 1978 (Vic) s 24(5). The Department of Health and Human Services would determine what supporting evidence for a person’s residency should be required.

     ↑

118. The Royal Australasian College of Physicians made this observation in Submission 52.

     ↑

119. Submission 63.

     ↑

120. Submission 52.

     ↑

121. Including Chinese medicine practitioners, dentists, medical practitioners, nurses, occupational therapists, optometrists, osteopaths, pharmacists, physiotherapists, podiatrists and psychologists: see Health Practitioner Regulation National Law, s 4 (definition of ‘health profession’).

     ↑

122. Namely, medical practitioners, nurse practitioners, dentists, optometrists and certain podiatrists: Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) rr 8, 9, 10, 11 and 11A.

     ↑

123. For example, medical practitioners can be registered as general practitioners or specialists: Medical Board of Australia, Types of Medical Registration (25 August 2014) <http://www.medicalboard.gov.au>. Nurses can seek endorsements on their registration enabling them to perform a greater range of functions: Nursing and Midwifery Board of Australia, Registration & Endorsement (31 July 2015) <http://www.nursingmidwiferyboard.gov.au>.

     ↑

124. Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015) [7.53]–[7.57].

     ↑

125. Submissions 4, 11, 14, 16, 37.

     ↑

126. Submission 37.

     ↑

127. Submission 69.

     ↑

128. Submissions 47, 48, 75. For example, nurse practitioners in Victoria are able to prescribe certain medicines (not including any substance listed in Schedules 8 or 9): Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 13(1)(ba) and Minister for Health, ‘Approval under Section 14A’ in Victoria, Victoria Government Gazette, No G 39, 25 September 2014.

     ↑

129. Submission 4, Consultation 4, 7.

     ↑

130. Naturopaths are generally registered with a private professional association (for example, the Australian Naturopathic Practitioners Association Inc) but are not subject to any government registration: Better Health Channel, Naturopathy (January 2015) <http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Naturopathy?open>.

     ↑

131. Submission 44.

     ↑

132. Advisory committee (Meetings 1, 3); Submissions 1, 2, 3, 5, 6, 7, 18, 19, 20, 23, 24, 28, 29, 31, 32, 38, 39, 42, 44, 45, 49, 52, 54, 60, 61, 64, 67, 72, 74.

     ↑

133. Submission 23.

     ↑

134. Submission 2.

     ↑

135. Nurses and nurse practitioners should, however, be authorised to possess and administer medicinal cannabis products when authorised by a medical practitioner.

     ↑

136. Namely, medical practitioners registered under the Health Practitioner Regulation National Law in a specialty approved by the Australian Health Workforce Ministerial Council under s 13 that Law: see Health Practitioner Regulation National Law, s 4 (definitions of ‘specialist’

     and ‘recognised specialty’). A current list of the approved specialties is available on the Medical Board of Australia website:

     <http://www.medicalboard.gov.au>

     ↑

137. Advisory committee (Meeting 1); Submissions 31, 32, 42, 60.

     ↑

138. Submission 7.

     ↑

139. Consultations 23, 24.

     ↑

140. Submission 7. Submission 49 agreed with this concern as it relates to remote patients.

     ↑

141. Consultation 8.

     ↑

142. Submission 29.

     ↑

143. Advisory committee (Meeting 1).

     ↑

144. Advisory committee (Meeting 1).

     ↑

145. Analogously to high-cost cancer drugs, which may only be prescribed by oncologists. Commonwealth Department of Human Services, Education Guide—Efficient Funding of Chemotherapy, 11 March 2015 <http://www.humanservices.gov.au>.

     ↑

146. Submission 24.

     ↑

147. Cf Poisons Regulations 1965 (WA) rr 38C–38P. These provisions state that, in Western Australia, certain named substances (eg thalidomide) shall not be prescribed except by certain specialists (eg a physician or a dermatologist). Substances like these are restricted using the ‘warrant’ system in Victoria: Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) pt 2 div 9

     ↑

148. Owen Dyer, ‘The Growth of Medical Marijuana’ (2013) British Medical Journal 347:f4755.

     ↑

149. Elin Kondrad and Alfred Reid, ‘Colorado Family Physicians’ Attitudes Toward Medical Marijuana’ (2013) 26 Journal of the American Board of Family Medicine 52, 52–53.

     ↑

150. See [1.33]–[1.40].

     ↑

151. Submission 38.

     ↑

152. Submission 43.

     ↑

153. Advisory committee (Meeting 1); Submission 20.

     ↑

154. Advisory committee (Meeting 1).

     ↑

155. This is the model used in all United States jurisdictions where retail sales of medicinal cannabis are permitted, primarily because medical practitioners there are forbidden to prescribe cannabis, but permitted by their constitutional right to free speech to ‘recommend’ cannabis to patients: Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015) [6.103]. The previous Canadian model also used such a system: Marihuana Medical Access Regulations SOR/2001-227, s 6(1).

     ↑

156. This is the model used in the Netherlands: Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015) [6.101].

     ↑

157. Oxford Concise Medical Dictionary (9th ed, 2015) 612 (definition of ‘prescription’).

     ↑

158. Submissions 24, 49.

     ↑

159. Advisory committee (Meeting 3).

     ↑

160. Submission 52.

     ↑

161. Submission 24.

     ↑

162. Submissions 10, 24, 29, 30, 35, 37, 72.

     ↑

163. Heather Marie Gladman stated in Submission 10, for example, that the practitioner’s role should be limited to ‘[t]he ability to sign a form saying this person can use medicinal cannabis. That’s it.’

     ↑

164. Submission 52.

     ↑

165. Submission 24.

     ↑

166. Submission 49.

     ↑

167. Submissions 2, 23. Many called for the doctor’s role to be the same as for any other medicine: Submissions 9, 18, 28, 45.

     ↑

168. Submission 7.

     ↑

169. Submission 57.

     ↑

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

     ↑

171. See [4.64]–[4.65] and Chapter 7.

     ↑

172. The College of Family Physicians of Canada, ‘The College of Family Physicians of Canada Statement on Health Canada’s Proposed Changes to Medical Marijuana Regulations’ (Position Statement, February 2013).

     ↑

173. Under the system of licensed producers in Canada, medical practitioners do not specify the type of cannabis to be used on a patient’s ‘medical document’. In addition, licensed producers are prohibited by Health Canada from recommending strains to patients as the best for treating a particular condition. As a result, a set of cannabis ‘consultants’ have started operations in Canada, in part to give patients advice on strain selection and administration methods, in a context where the strains a patient can obtain are virtually unlimited: Consultation 20.

     ↑

174. Consultation 13.

     ↑

175. See [4.10].

     ↑

176. That is, whether a ‘therapeutic need’ exists for the medication: Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) reg 8.

     ↑

177. Consultation 28.

     ↑

178. Ian Freckelton, ‘Medicinal Cannabis Law Reform: Lessons from Canadian Litigation’ (2015) 22 Journal of Law and Medicine 721.

     ↑

179. Consultation 20.

     ↑

180. This could include prescribing an unapproved dose, for an unapproved indication, outside the approved age range or via an unapproved route: Council of Australian Therapeutics Advisory Groups, Rethinking Medicines Decision-Making in Public Hospitals: Guiding Principles for the Quality Use of Off-Label Medicines (November 2013) 4.

     ↑

181. Off-label prescribing is not prohibited under Commonwealth or Victorian law, but a sponsor is not permitted to promote the use of a drug in an unapproved way: Council of Australian Therapeutics Advisory Groups, Rethinking Medicines Decision-Making in Public Hospitals: Guiding Principles for the Quality Use of Off-Label Medicines (November 2013) 6.

     ↑

182. Council of Australian Therapeutics Advisory Groups, Rethinking Medicines Decision-Making in Public Hospitals: Guiding Principles for the Quality Use of Off-Label Medicines (November 2013) 6.

     ↑

183. Joe Collier, ‘Paediatric Prescribing: Using Unlicensed Drugs and Medicines Outside Their Licensed Indications’ (1999) 48 British Journal of Clinical Pharmacology 5, 6.

     ↑

184. Council of Australian Therapeutics Advisory Groups, Rethinking Medicines Decision-Making in Public Hospitals: Guiding Principles for the Quality Use of Off-Label Medicines (November 2013) 10.

     ↑

185. Ibid 9.

     ↑

186. Submission 52.

     ↑

187. Submission 52. The Royal Australian College of Physicians also observed that, for children, consent to be treated with medicinal cannabis would be a matter of parental responsibility, as set out in Re: Sean and Russell (Special Medical Procedures) [2010] FamCA 948, subject to whether the minor is capable of understanding the medical treatment proposed and of providing informed consent on their own behalf: Gillick v West Norfolk Area Health Authority [1986] AC 112.

     ↑

188. For example, there is research to suggest that cannabis may interact with Atazanavir, an antiretroviral drug commonly used in the treatment of HIV: Q Ma et al, ‘Tobacco and Marijuana Use Significantly Decrease Atazanavir (ATV) Trough Concentrations in HIV-Infected Individuals’, paper presented to the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, 15 September 2009, cited in ACON and others, Submission to NSW Legislative Council Inquiry into the Use of Cannabis for Medical Purposes (February 2013).

     ↑

189. Submission 11.

     ↑

190. See Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 34. The scheme for opioid replacement therapy is technically a subset of the Schedule 8 permit scheme.

     ↑

191. As for opioid replacement therapy. While opioid replacement drugs are Schedule 8 poisons, for which permits are only required in certain circumstances, they are always required if the patient is drug dependent, which opioid replacement therapy patients always are. See Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 34(1).

     ↑

192. By way of comparison, pharmacotherapy (eg methadone) can continue to access opioid replacement drugs even if they have diverted their medication to third parties.

     ↑

193. Cf Medical Marihuana Access Regulations (Can) (SOR 2001/227) s 12(1)(b).

     ↑

194. If a permit to prescribe is refused by the Secretary under the existing scheme for permits to prescribe Schedule 8 or Schedule 9 drugs, any person who feels aggrieved by such a decision may appeal the decision to the Magistrates’ Court within six months: Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 37.

     ↑

195. Cf Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 19 and sch 2 Form DP2A.

     ↑

196. For example, under the opioid replacement therapy program: Department of Health, Policy for Maintenance Pharmacotherapy for Opioid Dependence (2013).

     ↑

197. Therapeutic Goods Administration, Access to Unapproved Therapeutic Goods: Authorised Prescribers (October 2004) 12.

     ↑

198. See the various patient information and consent forms available at Department of Health, Clinical Trial Research: How to Make an HREC Application (24 June 2015) <http://www.health.vic.gov.au/clinicaltrials/application-instructions.htm>.

     ↑

199. (1992) 175 CLR 479, 490 (Mason CJ, Brennan, Dawson, Toohey and McHugh JJ).

     ↑

200. Rosenberg v Percival (2001) 205 CLR 434, 443 (McHugh J). The test in Australia is a subjective test of causation; that is, it relies on what the specific patient would have done, not a hypothetical reasonable patient.

     ↑

201. See Chiropractic Board of Australia v Hooper [2013] VCAT 878, [309]–[314].

     ↑

202. See South Eastern Sydney Area Health Service v King [2006] NSWCA 2, [71].

     ↑

203. See, eg, Rosenberg v Percival (2001) 205 CLR 434.

     ↑

204. Medical Board of Australia v Laska [2011] VCAT 1888 (finding that failure to obtain informed consent to a medical procedure amounted to professional misconduct for the purposes of the Health Professions Registration Act 2005 (Vic)).

     ↑

205. Cf Charter of Human Rights and Responsibilities Act 2006 (Vic) s 10(c), which establishes that every person has a right not to be subjected to medical treatment without his or her full, free and informed consent.

     ↑

206. Medical Board of Australia, Good Medical Practice: A Code of Conduct for Doctors in Australia (March 2014) [3.5].

     ↑

207. According to the Canadian Medical Protective Association, ‘the medical document issued by physicians is distinct from a prescription. Prescriptions are required to access drugs approved for use and regulated by Health Canada. Health Canada does not currently approve nor regulate medicinal marijuana. Therefore, the medical document provided by physicians to allow patients to access medical marijuana can only be considered to be analogous to a prescription in limited ways’: Canadian Medical Protective Association, Medical Marijuana: New Regulations, New College Guidance for Canadian Doctors (July 2015) <http://www.cmpa-acpm.ca>.

     ↑

208. Canadian Medical Protective Association, Medical Marijuana: New Regulations, New College Guidance for Canadian Doctors (July 2015) <http://www.cmpa-acpm.ca>.

     ↑

209. Health Canada, Information for Health Care Professionals: Cannabis (Marihuana, Marijuana) and the Cannabinoids (2013)

     <http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/marihuana/med/infoprof-eng.pdf>.

     ↑

210. Advisory committee (Meeting 3).

     ↑

211. Various legislation provides that ‘no action lies’ against a medical practitioner who administers a forensic test: see, eg, Crimes Act 1958 (Vic) s 464ZH (in respect of anything ‘properly and necessarily done’), Public Health and Wellbeing Act 2008 (Vic) s 142 (practitioner must act ‘in good faith and with reasonable care’), Road Safety Act 1986 (Vic) s 57(8) (in respect of anything done in accordance with the subject’s consent).

     ↑

212. Section 71AC.

     ↑

213. Cf Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 78, which applies to fraudulently obtaining a prescription.

     ↑

214. This may be covered under consumer protection laws.

     ↑

215. Road Safety Act 1986 (Vic) ss 49(1)(a), (ba), (bb), 4(1) (definitions of ‘prescribed illicit drug’ and ‘prescribed concentration of drugs’). While the legislation in fact prohibits driving with more than a ‘prescribed concentration’ of THC in blood or saliva, that concentration is set at zero.

     ↑

216. Submission 44; Rebecca Hartman and Marilyn Huestis, ‘Cannabis Effects on Driving Skills’ (2013) 59 Clinical Chemistry 478; Michael Lenné, Tom Triggs and Michael Regan, ‘Cannabis and Road Safety: A Review of Recent Epidemiological Driver Impairment, and Drug Screening Literature’ (Monash University Accident Research Centre Report No 231, 2004); Olaf Drummer et al, ‘The Involvement of Drugs in Drivers of Motor Vehicles Killed in Australian Road Traffic Crashes’ (2003) 943 Accident Analysis and Prevention 1; National Cannabis Prevention and Information Centre, Driving Under the Influence of Cannabis: A Brief Review of the Literature (2013) <http://www.ncpic.org.au>.

     ↑

217. Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015) [6.110]. Washington state, where cannabis has been legalised for recreational use, allows drivers to have up to 5 nanograms of THC per millilitre of blood: Washington Department of Licensing, Washington Driver Guide <http://www.dol.wa.gov> 5-5.

     ↑

218. As THC remains in a person’s system for a significant time after consumption, patients may need to abstain from driving for longer than if they had consumed alcohol. The Road Safety Act 1986 (Vic) offers a defence to people who are charged with the offence of driving a motor vehicle while impaired by a drug under s 49(1)(ba) if the drug they were impaired by was consumed in accordance with a medical practitioner’s advice, and they did not and could not reasonably have known that the drug would impair their driving: s 49(3B). This defence would not, therefore, apply to a person consuming medicinal cannabis that was appropriately labelled, and in any event does not apply to the offence of driving with more than the prescribed concentration of THC in saliva.

     ↑

219. See Marine (Drug, Alcohol and Pollution Control) Act 1988 (Vic) s 28(1)(ba) and (bb); Civil Aviation Act 1988 (Cth) s 36; Rail Safety (Local Operations) Act 2006 (Vic) pt 6 div 3. Drug tests conducted pursuant to a court order may also be affected: Consultation 24.

     ↑

220. Consultations 1, 7.

     ↑

221. Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015) [6.109].

     ↑

222. While the Equal Opportunity Act 2010 (Vic) prohibits discrimination on the basis of disability, disability is not defined by reference to loss or impairment of bodily functions, rather than by reference to the treatment of any such disorder: ss 6 and 4(1) (definition of ‘disability’).

     ↑

223. See Jim Nolan, ‘Employee Privacy in the Electronic Workplace Pt 2: Drug Testing, Out of Hours Conduct and References’ (2000) 7 Privacy Law & Policy Reporter 139.

     ↑

224. Nominated on the authority: see [3.197]. A definition of ‘carer’ can be found in the Carers Recognition Act 2012 (Vic) s 4.

     ↑

225. This could be achieved by an amendment to the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 5, which, among other things, authorises persons who have the care of or are assisting in the care of a patient authorised to possess a scheduled poison to do so themselves: item 7.

     ↑

226. This would otherwise be an offence under the Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 74. If the patient is a child, the offence of supplying a drug of dependence to a child may also apply: s 71B.

     ↑

227. This could be achieved by an amendment to the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 45, which states that a person must not administer or use a Schedule 4, 8 or 9 poison except in the treatment of the person for whom it was prescribed.

     ↑

228. Cf Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 13(1)(ba) and (bb) and Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 5(2). It is not necessary to specifically authorise medical practitioners and pharmacists as s 13(1)(a) already authorises them to possess, use, sell and supply drugs of dependence ‘in the lawful practice of [their] profession’, which would include medicinal cannabis products.

     ↑

229. Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 4 (definition of ‘Schedule 9 Poison’).

     ↑

230. Submissions 12, 35, 50, 69, 74; Consultation 1; advisory committee (Meeting 1).

     ↑

231. Submission 57.

     ↑

232. Submission 99.

     ↑

233. Submissions 12, 45

     ↑

234. Submission 59.

     ↑

235. Such as Maryland, Massachusetts, New Jersey and New York: Victorian Law Reform Commission, Medicinal Cannabis: Issues Paper (2015) [6.99].

     ↑

236. Submission 97.

     ↑

237. Submission 35.

     ↑

238. Opioid replacement therapy includes the provision of methadone and other drugs for the treatment of dependence on heroin or pharmaceutical opioids.

     ↑

239. Department of Health, Policy for Maintenance Pharmacotherapy for Opioid Dependence (2013) 13-14. Practitioners can prescribe combined buprenorphine/naloxone for up to five patients without being approved, but approval is required for all other types of pharmacotherapy.

     ↑

240. Department of Health, Policy for Maintenance Pharmacotherapy for Opioid Dependence (2013) 6, 13-14. The Department may withdraw approval for practitioners who do not comply with the requirements of the prescribing policy.

     ↑

241. Health Canada, Information for Health Care Professionals: Cannabis (Marihuana, Marijuana) and the Cannabinoids (February 2013).

     ↑

242. The College of Family Physicians of Canada, Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary Guidance (September 2014).

     ↑

243. See [6.68]–[6.72].

     ↑

244. Canadian Medical Association, CMA Statement Authorizing Marijuana for Medical Purposes (Update 2015) (2015); Canadian Medical Protective Association, Medical Marijuana: New Regulation, New College Guidelines for Canadian Doctors (document number W14-005-E, July 2015) <https://www.cmpa-acpm.ca>.

     ↑

245. Canadian Medical Protective Association, Medical Marijuana: New Regulation, New College Guidelines for Canadian Doctors (document number W14-005-E, July 2015) <https://www.cmpa-acpm.ca>.

     ↑

246. Canadian Medical Association, CMA Statement Authorizing Marijuana for Medical Purposes (Update 2015) (2015).

     ↑

247. College of Family Physicians of Canada, Preliminary Guidance: Authorizing Dried Cannabis for Chronic Pain or Anxiety (September 2014) 2.

     ↑

248. College of Family Physicians of Canada, Preliminary Guidance: Authorizing Dried Cannabis for Chronic Pain or Anxiety (September 2014) 3.

     ↑

249. This was broadly endorsed by the advisory committee (Meeting 1).

     ↑

250. Submissions 29, 44, 60, 64, 70.

     ↑

251. Submission 44.

     ↑

252. Submission 29.

     ↑

253. See Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 34B.

     ↑

254. Section 10 of the Health Records Act 2001 (Vic) provides that the legislation applies to the public sector.

     ↑

255. In the Netherlands, medical practitioners may prescribe cannabis to patients, who collect it from a pharmacy like any other prescription medicine. There is no central registry of patients. In Canada, patients who possess a medical document signed by an appropriate health practitioner are entitled to register with a ‘licensed producer’, who deals with them directly and does not supply their details to the government.

     ↑

256. This is necessary, for instance, where persons are permitted to have dried cannabis in their possession for medicinal purposes – they require to be able to prove straightforwardly to police enforcing the general law precluding cannabis use and possession that they are ‘entitled’ to use and possess the permitted amount.

     ↑