Medicinal Cannabis: Report (html)

9. Conclusion

9.1 The Commission has been told that reform to Victoria’s laws to allow people to be treated with medicinal cannabis in exceptional circumstances is both overdue and premature. It is said to be overdue by those in the community who are already using it to relieve the symptoms of a broad range of medical conditions, some of which are severely disabling and others of which are causing high levels of pain and suffering. It is said to be premature by those who caution against providing access to an otherwise illegal drug before conventional and reliable clinical evidence of its efficacy in treating specific conditions, and its side effects, is comprehensively available.

9.2 In this report, the Commission has favoured an evidence-based approach to determining the exceptional circumstances in which medicinal cannabis would be made available, but for compassionate reasons one that extends in limited circumstances beyond the exacting clinical standards that apply to the scheduling of prescription medicines. The recommended eligibility criteria encompass severe conditions and symptoms regarding which there are multiple examples of significant improvement after patients have begun using cannabis, and where returning to prescription medicines presents an unacceptable risk to their health and quality of life.

9.3 Thus, the Commission’s recommendations endeavour to balance evidence of efficacy with knowledge of potential risks of side effects and abuse. The recommendations incorporate extension of compassion to take account of the suffering arising from certain medical conditions and to be responsive to the wishes of patients and their carers in respect of conditions that impact upon them in often extreme ways.

9.4 The Commission’s recommendations give weight to research assessments of the efficacy of medicinal cannabis but accord less significance to assertions and anecdotes. They are framed on the basis of the legitimacy of the current preclusion of recreational use of cannabis and identify major deficits in the option of a grow your own scheme which bypasses medical practitioners and is substantially unregulated and unmonitored. The Commission’s recommended approach looks to integrate medicinal cannabis within the pharmacopoeia available to medical practitioners. It recognises that medicinal cannabis is not a panacea; it is simply another pharmacological option with great promise in some contexts and which is the subject of strong levels of confidence in some sectors within the community. It has the potential to play a constructive role in the management of some conditions and the alleviation of pain and suffering.

9.5 These aspects of the Commission’s recommendations are a matter of compromise. They endorse and support a system of testing medications that protects the community against foreseeable risks posed by untested preparations that have the potential to have a range of adverse consequences for patients. In addition, they make only a modest and controlled inroad upon the criminal status of using, possessing, cultivating and trafficking in cannabis. In this regard, it is acknowledged that many cannabis users, including some who use it for medicinal purposes, will be deeply disappointed with the approach that the Commission has taken; they will continue to use cannabis covertly and illegally without the involvement of medical practitioners.

9.6 However, it is the Commission’s view that it is important for a medicinal cannabis scheme to be significantly weighted in favour of strong evidence bases; any other approach is unlikely to secure the confidence and endorsement of the medical profession. International experience has shown that, without the support of a significant percentage of medical practitioners, any medicinal cannabis scheme will face significant hurdles as a public health measure.

9.7 Australia’s medical practitioners are not ideologically averse to the development of new medical options or to employment of innovative measures in difficult clinical scenarios where there is a high level of suffering by their patients and those who care for them and about them. However, for the present they are divided on the question of whether medicinal cannabis is a proper alternative to orthodox prescription medications. They are reticent about the provision of any medicinal cannabis products that have not been approved by the Therapeutic Goods Administration. In addition, they have little knowledge about the therapeutic properties of medicinal cannabis in its various forms and strengths, and do not have experience in administering it or supervising its effects.

9.8 In order to elicit the confidence of the medical profession in a reform to the law so as to permit access to cannabis for medicinal purposes, it is prudent to adopt a graduated and conservative approach to making it legally available and to ensure that medical practitioners (and pharmacists) are assisted to provide the information necessary for patients to provide informed consent. This means that under the Commission’s recommended option medicinal cannabis would not be legally available for patients with some conditions and that there would be regulatory oversight of the growing, manufacturing, authorising and dispensing of medicinal cannabis. These measures are proposed as means to provide reassurance to medical practitioners, pharmacists and the general community alike about what is a novel medico-legal step for Victoria.

9.9 Meanwhile, clinical evidence concerning the medical use of cannabis is growing, as are medical breakthroughs in preventing and treating many of the diseases for which prescription medicines are only part of the therapeutic answer. Experience in participating in a medicinal cannabis scheme is likely to provide an additional option for treating patients with serious conditions, to enrich the medical profession’s understanding about the use and effects of medicinal cannabis, and to address the wishes of a significant cohort of patients. The Commission considers it essential that the eligibility criteria—and the scheme itself—are reviewed and modified as more and better evidence of the efficacy, potential and side effects of cannabis becomes available.

9.10 The legislative basis for a Victorian medicinal cannabis scheme should rest upon regulatory objectives that would improve patients’ quality of life through appropriate treatment without unreasonably inflating their expectations of positive therapeutic effects or exposing them to undue risks. It needs to minimise any adverse consequences that may arise from departing from the national frameworks for controlling narcotic drugs and regulating therapeutic goods.

9.11 The Commission has considered the options proposed in submissions and consultations and has concluded that an approach based on the existing regulation of the cultivation of alkaloid poppies, the production of poppy straw, and the delivery of opioid replacement therapy would be most likely to achieve the regulatory objectives. This approach utilises well-trodden and familiar regulatory paths and thus does not involve the creation of a plethora of new bodies to enable regulatory oversight. It is likely to generate a consistent availability of high quality medicinal cannabis whose properties are known. In addition, it should enable medical practitioners to titrate the strengths and monitor the effects in their patients of active constituents such as THC and CBD. This will constitute a very significant safeguard against risks and side effects from the use of cannabis for medicinal purposes.

9.12 The way in which the Commission has structured its proposed scheme enables Australia to satisfy its international obligations and requires only a modest set of enabling steps by the Commonwealth in a collaborative partnership with Victoria. The initiative that is recommended preserves the integrity of Australia’s therapeutic regulatory framework but caters compassionately and humanely to the needs of a vulnerable group of patients whose suffering has been documented in Chapter 2 of this report.

9.13 The cost of establishing and operating a scheme that provides a limited number of people affordable access to a prohibited substance is likely to be significant, although levels of uptake of the scheme cannot be forecast with accuracy at this stage. Thus the scheme needs to be carefully designed and well managed to ensure that the cost is not disproportionate to its advantages and that it is efficiently run. The opportunity exists to reduce the unsatisfactory incidence of resort to illegal medicinal cannabis of uncertain quality and strength and that does not incorporate medical oversight.

9.14 The potential outcome of the scheme recommended by the Commission is the relief of high levels of suffering and avoidance of the pressures and stigma that currently attach to illegal procurement for therapeutic purposes of a drug principally used recreationally for its euphoriant effects. It will enable a drug with significant medicinal potential to be used in properly and safely controlled circumstances under the supervision of medical practitioners, thereby maximising its efficacy as a treatment and guarding against potentially adverse side effects.