Alex Wodak. How should medicinal cannabis be provided lawfully in Australia?

May 29, 2015

Current Affairs

Ms Sussan Ley, the Federal Health Minister, recently acknowledged that medicinal cannabis was likely to proceed in Australia but advocated proceeding cautiously. A Private Members Bill is under consideration and seems to have strong support including backing from both sides of the aisle. So the question is now increasingly moving from ‘whether’ to ‘how’ to proceed with medicinal cannabis. 

Hippocrates said that doctors should ‘cure sometimes, treat often, and comfort always’. Medicinal cannabis is about the need for the health care system to try to ‘comfort always’. What should the lawful provision of medicinal cannabis in Australia hope to achieve?

First, medicines are expected to be effective. Medicinal cannabis usefully reduces distressing symptoms in a number of conditions when conventional medicines have proved ineffective and/or had unacceptable side effects. There is sufficient evidence of sufficient quality to conclude that medicinal cannabis is effective. Though conventional medicines may often be more effective, they don’t work often enough for medicinal cannabis to be a useful back up. This is the view of many experts and many highly regarded scientific organisations. However some experts and organisations have different views. Medicinal cannabis does not appear on current evidence to cure any condition. But some laboratory research suggests that cannabis may cure some conditions. A different conclusion could be justified in the future.

Second, we expect medicines to be safe. A recent review concluded that ‘97% of the adverse effects of medicinal cannabis in clinical trials were minor, with dizziness (20%) being the most common’. The prestigious US Institute of Medicine determined that the acute adverse effects of cannabinoids were ‘within the risks tolerated for many medications’.

Third, these days we increasingly insist that medicines are also cost-effective. There is little information about the cost-effectiveness of medicinal cannabis but it is likely to be cost effective. It may sometimes help to avoid expensive conventional medications or even shorten costly hospital stays.

And fourth, we would want to make sure that medicinal cannabis does not impair the integrity of Australia’s highly regarded pharmaceutical regulatory system (i.e. the Therapeutic Goods Administration).

As our politicians increasingly move from the ‘whether’ to the ‘how’ question, we should start thinking about the guiding principles for implementation.

A national approach is preferable to individual approaches from six states and two territories. So far we have had, or soon will have had, five parliamentary inquiries (Tasmania, NSW, Commonwealth, ACT, Victoria). Let’s hope that we can avoid a situation where residents of one jurisdiction where medicinal cannabis is not approved try to obtain what they desperately want from another state or territory where cannabis has been approved.

Regulated cannabis is always preferable to black market cannabis as it is virtually identical from one batch to the next, has known concentrations of the key psychoactive constituents and any chemical or microbiological contaminants will be below set safety limits. Currently an unknown but presumably large number of people, some for probably legitimate reasons, use unregulated cannabis they have cultivated or bought from the black market. Surely we can do better than that.

When deciding whether or not to start medicinal cannabis, the recreational use of the drug should be ignored. The ‘whether’ question should be decided only on the evidence of effectiveness and safety – and ideally also cost effectiveness. When considering ‘how’ medicinal cannabis should be provided, we cannot ignore the large unregulated market for recreational cannabis.

The introduction of an intervention not previously part of the official health care system should be slow and cautious. It is easier to liberalise a too-restrictive approach than restrict a too-liberal approach. Getting the balance right is important as the more restrictive the approach adopted, the larger the proportion of patients who will use unregulated supplies.

Any system for administering medicinal cannabis should be sufficiently flexible to allow for changes as knowledge increases over time.

Ill people who use medicinal cannabis and their carers and doctors should not have to worry about possible legal repercussions provided that they stay within unambiguous legal boundaries covering cultivation, purchase, possession, use and prescribing.

The system established for medicinal cannabis should identify approved medical conditions and may also need to identify required diagnostic criteria and criteria indicating sufficient severity. As knowledge of the benefits of medicinal cannabis is increasing rapidly, the approved medical conditions should be reviewed frequently. In some exceptional cases, where there is limited evidence there should also be scope for approving medicinal cannabis on compassionate grounds.

Decisions about medicinal cannabis for individual patients should be made by independent experts and not by Ministers, Department of Health officials or Members of Parliament.

Lawful cultivation by patients and/or their carers should be an option but not the only option as some will be unable or too ill to cultivate their own cannabis.

Most patients requiring medicinal cannabis are likely to have limited funds after some years of poor health, so affordability is an important consideration.

The least-worst way of ingestion at present is inhalation of cannabis vapor. A new pharmaceutical product (nabiximols, Sativex®), the next best option, is in Australia currently approved for only one condition, virtually unavailable and expensive. Older pharmaceutical preparations (Nabilone, Marinol), now obsolete, were too poorly and erratically absorbed to succeed commercially and are therefore unsuitable. Administration of cannabis by inhalation of smoke may sometimes have to be grudgingly tolerated, for example patients with a short life expectancy who have been happily smoking cannabis for some time. Liquid preparations will be needed for children.

Medicinal cannabis presents a number of challenges for policy makers but none are impossibly difficult. After all, medicinal cannabis is now available in about twenty other countries.

As Whitlam’s 1972 campaign slogan said ‘it’s time’.

Dr Alex Wodak AM, President, Australian Drug Law Reform Foundation

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