The following Submissions, seemingly more than all others, were to shape the Government’s thinking about medicinal cannabis and what it would do with ‘the problem’. All of the below felt Australia’s existing regulatory mechanisms would do perfectly well where the drug was concerned and that no new stand-alone, single-purpose regulator, as the Senate Bill was proposing, would be necessary.
Some in the medical professions held firmly that insufficient evidence existed for the drug’s beneficial use – and it is interesting to compare such views to those of the scores of individuals discussing their own direct experience with it (these are catalogued on the ‘Individuals in Favour of Bill’ page).
Or the views of the numerous clinical experts who also submitted to the Inquiry.
The Department of Health head too, Martin Bowles, expalained in no short measure how the proposed Senate Bill, which if enacted would create a new body to regulate medical cannabis, created numerous legal and regulatory headaches, as if these would prevent Ministers from acting had they the political will.
PainAustralia’s contribution proved especially contentious, prompting one of its board members – an ex-High Court Judge – to write separately pointing out he disagreed with the organisation’s stance.
But the views that are expressed in the following documents were by and large the views that prevailed – the Government rejected the recommendation of the Senate’s Legal and Constitutional Affairs Legislation Committee that the Bill be passed into law, instead opting to amend drugs legislation of the 1960s to allow medical cannabis to be grown under extremely strict regulation, and cannabis products to be accessed via already-existing Special Schemes subject to State and Territory rules.
Guild supports use of cannabis medical preparations after ‘appropriate consideration by Australia’s regulatory bodies.’ Does not support new Regulator, believes such powers should be ‘delegated to TGA’ (as occurred) and that consideration be given to reducing cost of registering new cannabis medicines. Suggests NHMRC (National Health and Medical Research Council) could develop clinical guidelines for health professionals to assist in determining suitability of medical cannabis among patients. 2 pages.
Government-funded peak organisation working for benefit of those involved with end-of-life care. Submission endorsed by Associate Professor Richard Chye, Emeritus Professor Ian Maddocks, Professor Jane Phillips, Professor Patsy Yates ‘modelled on the Australian Register of Therapeutic Goods.’ Also argues ‘at present there is not comprehensive evidence to address questions such as who may benefit from medicinal cannabis and derivatives; if there are ongoing and long-term benefits from continued use and what are the nature and impact of any adverse effects.
‘Medicinal cannabis is not the only measure available to provide comfort for people with a terminal illness. While there are many accounts in the medical and non-medical literature of the value of cannabis in symptom relief, there are also clinical trials that have found no superior benefit of cannabis over other available medications for symptoms such as nausea, pain or weight loss‘. 9 pages.
Industry body representing interests of Australian pharmaceutical businesses. Opposes new Regulator, believes existing mechanisms suffice. Also recommends ‘the focus should be placed on harmonising state and territory legislation‘ and argues ‘the foremost barrier that Medicines Australia members have experienced in attempting to supply medicinal cannabis products in Australia have arisen from state and territory poisons legislation. In particular, differences in permit, prescription and risk-management plan requirements’. Sent by Tim James, the organisation’s CEO, reported by the Sydney Morning Herald to have to have left the organisation ‘after a brief but turbulent tenure’. 2 pages.
College does not support Bill and ‘considers that while medicinal marijuana shows some potential for certain patients, further research is required to determine its efficacy and it should be subject to the same scrutiny as any other medicine. ‘ Believes TGA best mechanism for regulating medicinal cannabis and a new Regulator would duplicate effort. 2 pages.
Organisation supports scientific trials of medicinal cannabis but cites then-AMA Victoria President Dr Tony Bartone, as warning against legalising cannabis for medicinal use (he did not, rather, he warned against the raw plant for that purpose) and concerns over standardised quality. Also that ‘only fully-tested cannabis-based medicines should be permitted.‘ Concludes:’ACL also notes the AMA’s position statement on cannabis use, which gives a long list of adverse short-term and long-term side effects, including particularly egregious mental health outcomes. Schizophrenia and psychosis are highlighted as being linked to cannabis use. Although noting the ‘therapeutic potential’ of cannabis, AMA states its use is “still experimental”‘. 2 pages.
Not-for-profit society for medical practitioners providing care to those with a life threatening illness. Opposes new Regulator, supports an ‘evidence based approach to the use of medicinal cannabis as a pharmaceutical grade refined product with control mechanisms congruent with that of other medicinal drugs,administered via the Therapeutic Goods Association‘ and ‘Pharmaceutical data is necessary to support evidence-based medicine; variations in raw products impact on determination of best therapeutic outcomes.‘ Concerned about patient safety. 10 pages.
Strongly opposes idea of new Regulator which it says will duplicate TGA work. Raises concerns about doctor/patient relationship, recognises its position could be seen as ‘conservative.’ Raises issue of ‘negative effects of use of cannabis on mental health’. The Therapeutic Goods Act and the Narcotic Drugs Act ‘already adequately provide for the regulation of therapeutic narcotics’. 2 pages.
Authors Debra Cerasa, CEO MS Australia; Dr Matthew Miles, CEO MS Research Australia. MS Australia (MSA) is the national peak body for people living with multiple sclerosis Australia and MS Research Australia the largest not-for-profit organisation dedicated to funding and coordinating MS research in this country. Organisations say they ‘support any proven treatment that has been deemed safe by the Therapeutic Goods Administration and that helps to minimise the impact of the disease and allow people with MS to live more fulfilling lives,’ adding ‘robust and reliable evidence is needed to determine the possible benefits and risks of cannabis for managing symptoms of chronic illnesses such as MS‘. Say would welcome availability of Sativex – the only approved cannabis-based medicine in Australia – subsidised through PBS. 5 pages.
A ‘national Christian voice – promoting true family values for the benefit of all Australians.’ Says ‘allegedly “overwhelming” proof (of benefits of medicinal cannabis) has not convinced professional medical associations‘ and heavily cites Dr Tony Bartone of AMA (mentioned above) who is sceptical (or ‘conservative’) and President of the Royal Australasian College of Physicians (RACP) Professor Nicholas Talley who urged proceeding with caution until further clinical trials had taken place. Others cited are Professor Wayne Hall (‘First, we need clinical trials of the safety and efficacy of CBD and other cannabinoids in treating intractable epilepsy and chronic pain. Evidence from these trials is essential for rational decisions to be made about the medical use of cannabinoids,’) and Dr John Whitehall, Professor of Paediatrics at the University of Western Sydney who discusses process of evaluating medical value of a substance. Opposes idea of new Regulator saying ‘the purpose of the Therapeutic Goods Administration (TGA) is to protect the Australian public from medicines with doubtful benefits and unacceptable risks‘ and says TGA-approved cannabis products are already available. Discusses US experience of medicinal cannabis which it says has lead to abuse because of poorly worded laws and mentions opposition from US medical associations. Provides numerous references and concludes: ‘Since the Regulator of Medicinal Cannabis Bill 2014 would bypass the Therapeutic Goods Administration, which already assesses the safety and efficacy of medicines, the Bill should be rejected‘. 11 pages.
Australia was the first country in the world to develop a national framework strategy for the treatment and management of pain and this organisation was founded in 2011 to implement that Strategy. It was also partly the subject of a submission (see Number 71) from board member the Hon. David Ipp expressing the fact he did not support PainAustralia’s view on the matter, and was critical of it. Founding partners are the Australian Pain Society (APS) and the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists (FPM, ANZCA).Organisation says is ‘supportive of clinically sound, appropriately regulated use of medicinal cannabinoids in situations of palliative care‘. Calls for clinical trials, and ‘does not endorse the use of cannabinoids for people with chronic non-cancer pain until such time as a clear role for them is identified in the scientific literature‘. Also calls for clear definition of medical cannabis. Gives position of Faculty of Pain Medicine which is, among other things that it considers use of cannabinoids as medicine is ‘based more on anecdote than on sound clinical science and practice‘. Contrast with Submission 169, Submission 93, Submission 99, Submission 103, Submission 132 and others (see ‘Individuals In Favour of Senate Bill page). 5 pages.
Author is Martin Bowles, Department Secretary (most senior official within Department). Points out cannabis is a tightly controlled narcotic and that there is already a system in place for regulating access to medicinal narcotic drugs dependent on a combination of Commonwealth, State & territory laws. Also that the current system relies on ‘a significant number of agencies’ (including Customs & Border Protection, his own Department, State & Federal Police, the Attorney General’s Department, Department Foreign Affairs) and the ‘complexity and interrelationships’ of the issues these bodies administer needs to be taken into consideration in the effective implementation of the proposed regulatory frameworks‘. Argues the Bill would set up new system that would ‘cut across and replicate’ the existing one and leaves ‘a number of legal and practical issues unidentified and / or unresolved‘ leading to problems. Discusses in some detail: Therapeutic Goods Act 1989; international obligations; Customs Regulations, Narcotic Drugs Act 1967; Crimes (Traffic in Narcotic and Psychotropic Substances) Act 1990 and the impact the Bill would have on these. Makes comments about other considerations and concludes ‘it is the view of the Department further detailed consideration of the interrelationships of these laws is required‘ which he says would ensure new legislation is ‘coherent, clear and workable‘ and believes existing Bill would requires ‘substantial revision and reconsideration‘ to address the issues raised by the Department. 5 pages.