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Our primary mission is advocating for patient access to Full Spectrum herbal medicinal Cannabis extracts and dried herb Cannabis in a manner which is safe, effective, affordable, equitable and favourable for patients, for the dignified relief of suffering.
UIC suggests a definition of MC that can, we hope be agreed on by everyone. This has been written by Professor Mark Ware, a world authority on the subject and a guest at the 2019 UIC Symposium. Mark’s definition is to be found in the Encyclopaedia Britannica, arguably the most trusted source of general knowledge in the English language, so hopefully will not prove controversial.
The full version of Dr Ware’s definition can be found here
For the purposes of our own wepage however, the salient and defining paragraph is this one, which describes MC as:
‘….the use of cannabis under ongoing medical supervision, with an established diagnosis of the target symptom-disease complex. Herbal cannabis is used in conjunction with, or in consideration of, other pharmacological and nonpharmacological approaches and with the goal of reaching prespecified treatment outcomes.’
This, Dr Ware asserts, is because ‘there is no inherent difference between herbal cannabis used recreationally and that used medically’ whilst going on to imply a distinction between ‘medicinal cannabis’ per se and the ‘several pharmaceutical drugs based on cannabis, in purified and standardized form, (that) have been made available for medical use.’.
Though later in his Britannica article Dr Ware does add that cannabis ‘…developed for medical use…..(is) grown under carefully controlled conditions, and the drug is standardised’ he also insists that it ceases to be ‘medical’ if used outside of a clinical environment:
‘Cannabis that is used in an unsupervised manner is not considered medical cannabis. The same is true for cannabis that is authorised by a physician who has not adequately evaluated the patient, who does not prescribe the cannabis as part of a wider care model, or who does not monitor the patient for subjective and objective outcomes or adverse events.’
Such a distinction between herbal / whole plant cannabis and ‘pharmaceutical drugs based on cannabis’ is particularly important however since some in the medical Establishment and certain researchers believe only isolated cannabinoids delivered as pharmaceutical medicines are the only acceptable form cannabis products should take thus make efforts to conflate such drugs with the term ‘medicinal cannabis.’
An Assessment of the Current State of Play in Respect of MC in Australia
The Need for Information and Education About Cannabis and Cannabis Products for Medical Use
The purpose of this page is to explain, as concisely and clearly as possible, where UIC stands on a variety of cannabis-related issues, what the organisation stands for more generally as well as why such positions have been adopted.
Based on these, UIC will continue to develop a Programme of Work with the purpose of effecting the aims of our Mission Statement. Equally, we will be open to supporting and / or endorsing and / or collaborating with any organisation, individual or project we feel helps move the agenda towards this just as we will oppose and call out those we believe are obstructing it.
Some of our perspectives and viewpoints have emerged from an assessment of Australia’s current medicinal cannabis ‘framework’ carried out in the creation of our Public Submission to the Review of the 2016 Amendments to the Narcotic Drugs Act 1967. The Review is a statutorily mandated process evaluating outcomes resulting from the 2016 legislation and is due to report at latest by the end of October 2019.
The Submission – which can be downloaded in full here – is a ‘Foundational Document’ for UIC in that it lays out our thoughts, views and criticisms of Australia’s current legislation and regulation in respect of this medicine as well as suggesting a definition of MC (see above) that can, we hope be agreed on by all. It further presents a number of suggestions and demands we believe necessary to improved patient access and the enabling of development of a domestic cannabis industry.
A summary of points and information raised in the document are as follows:
UIC’s focus is, and has consistently been through the lens we feel all discussion about medicinal cannabis must necessarily be viewed: the fact that, currently, hundreds of thousands of sick Australians needing this medicine are accessing black market products of unknown provenance and completely without medical supervision, criminalising themselves in the process. This potentially unsafe and grossly unsatisfactory state of affairs represents – presumably – the exact opposite of what Governments and medical professionals would have wished to accomplish yet has become exactly the position in which Australia now finds itself, largely as a result of the 2016 legislation.
Failing or refusing to acknowledge this reality and its significance is to overlook arguably the single most important facet of the matter at hand – the context of things as they actually are. Without a full appreciation and recognition of these as the circumstances in which Australia’s current MC ‘framework’ currently operates is to render such a discussion meaningless.
Two key documents inform the Amendments to the Narcotic Drugs Act 2016 – the Government’s own Explanatory Memorandum of the legislation (this is what lawmakers use as a briefing before they vote on a Bill) and a Regulation Impact Statement undertaken in 2015 which itself became incorporated into the Explanatory Memorandum.
Producing such Statements as these are standard (and compulsory) in Government whenever significant regulatory developments are planned and discussed within Cabinet – and is a process overseen by the ‘Office of Best Practice Regulation’ (OBPR) which sits in the Department of the Prime Minister and Cabinet.
As one would expect from an organisation tasked with administering Regulatory Impact Analysis requirements, the OBPR has its own handbook – the ‘Best Practice Regulation Handbook’ – which sets out the standards and demands placed on Government Departments where the framing of regulation and assessment of its impacts are concerned. Meet those requirements (per the Handbook) and a Department will have achieved the expected Best Practice; failure to do so means it will not.
Unfortunately, the Regulation Impact Statement for Medicinal Cannabis did not meet those standards, (a majority of such Statements do) with the OBPR commenting that:
‘The Office…assessed the RIS prepared by the Department Health as compliant with the Government’s requirements but not best practice. To achieve best practice more detailed analysis of the practical impacts of the measure and more extensive consultation was required.’
It was this failure, at this early stage we argue that led to the disaster which followed.
Failure of the Department of Health’s Regulation Impact Statement to meet the Standards of Best Practice as stipulated by Office of Best Practice Regulation within the Department of the Prime Minister and Cabinet meant that in effect, other than keeping Australia compliant with the UN Single Convention on Narcotic Drugs (considered important to protect the coutry’s lucrative poppy straw trade) no policy objectives were identified in terms of what the 2016 legislation was supposed to achieve. That means no targets were set, no real explanation as to its actual purposes or intent were provided, no goals or end states described. So when – in October 2018 – the time came for the legislation to be reviewed (a process mandated in law) no benchmarks existed against which its failure or success could be measured.
With no real policy objectives stated or clearly identified, the 2016 legislation also ignored expert advice provided by a year-long Public Inquiry into a previous Bill, the Regulator of Medicinal Cannabis Bill, which would have created a stand-alone MC Regulator outside of the Therapeutic Goods Act 1989. following in the footsteps of every other country operating a functional medicinal cannabis framework. In doing so, cannabis was thus placed in the hands of the Therapeutic Goods Administration – an organisation created to regulate conventional medicines.
The TGA and its recent (2015) offspring the Office of Drug Control have in place (quite correctly) various standards relating to the cultivation and production of cannabis and cannabis medicines whether originating in Australia or overseas. Hence imports and (so far mostly theoretical) locally sourced goods alike must be grown using Good Agricultural Practices (standards laid out by the Food and Agricultural Organization of the United Nations), Good Manufacturing Practice (as stipulated by the PIC/S Guide to GMP) as well as the Therapeutic Goods Orders #93 & #100 – the TGA’s ‘Standard for Medicinal Cannabis’ – and ‘Microbiological Standards for Medicines’ respectively.
To the extent that every cannabis product available here must comply with these standards, they can clearly be said, in one sense, to be ‘approved for use in Australia’ yet none (save for Sativex, already mentioned) has been evaluated for inclusion on the Australian Register of Therapeutic Goods (ARTG) which lists products that can be legally supplied in this country. Thus, in an equally substantive and highly consequential way, are these medicines simultaneously ‘unapproved for use in Australia’, leaving them, as we’ve already argued, in an incoherent state of ‘regulatory limbo’ – quite literally, simultaneously ‘approved unapproved medicines’. This, UIC finds to be nonsenical, particularly in light of the fact that the TGA’s normal ‘approvals process’ for conventional medcines is unsuitable for cannabis and many cannabis products which means they’re destined to remain ‘approved unapproved medicines’ forever.
Because cannabis and cannabis products are unapproved (yet simultaneously in some respects also ‘approved’ – see above) for use in Australia the only real pathway available to acesssing these medicines is the TGA’s Special Access Scheme.
The SAS, according to the TGA website, was created ‘for health practitioners who wish to access therapeutic goods that are not in the Australian Register of Therapeutic Goods (ARTG) and are not otherwise exempt from being in the ARTG’. The SAS means doctors must apply to the TGA to prescribe certain medicines which must then be approved by bureacrats.
This however – and in the TGA’s own words – is pathway designed and intended only ‘for exceptional clinical circumstances’.
As an organisation advocating for medical cannabis, UIC is acutely aware that there are currently many thousands of individuals using the drug solely for medical purposes across Australia (and millions doing so worldwide). Whilst it remains true almost all domestic users are obliged to source their medicines from the illicit market for use without clinical supervision (including of children with complex conditions, often rare forms of intractable epilepsy) it cannot realistically be argued these circumstances are remotely ‘exceptional’. This situation of course remains true regardless of the extent to which politicians, bureaucrats and elements within the medical profession would like to believe or insist otherwise. The reality is that cannabis is widely used and its use (as a medicine) is growing in both popularity and ubiquity.
Thus, regardless of how much the Government and elements within the medical profession wish to view and proclaim use of MC products as appropriate only for these ‘exceptional clinical circumstances’ the truth of the matter is that they are clearly and obviously far from it – as vast and growing data from across the globe increasingly illustrate. Any ‘pathway’ to a legal MC supply therefore that is for use only in these ‘exceptional circumstances’ is, we believe, inherently and, by definition, unfit for purpose, made worse by the Department of Health’s own admission (in the 2016 Narcotic Drugs Act Amendments) that use of the SAS is a ‘cumbersome and costly exercise.’
At around the same time the Amendments to the Narcotic Drugs Act passed into law in 2016 ‘cannabis’ was rescheduled (and later further adjusted) in the SUSMP, Australia’s Poison Standard, bringing CBD products of high (98%) purity into Schedule 4 of the Standard (‘Prescription Only Medicines’) and those containing THC or any other cannabinoid into Schedule 8 (‘Controlled Substances’ – requiring State authorisation for use). Non-medical – i.e. unregulated cannabis products – remained within Schedule 9 (‘Prohibited Substances’).
This Scheduling in turn meant that State approval was required in addition to TGA approval – and most states have their own regulation or even legislation in respect of medicinal cannabis, usually involving the blessing of specialist doctors. The result has been a patchwork of rules and processes varying between States which has had the net effect of interfering with the normal doctor/patient relationship while creating a ‘postcode lottery’ throughout the country. UIC has heard of cases of families moving from one State to another or even emigrating overseas in order to access life-saving cannabis or cannabis products while an absurd assumption has been made that medical ‘specialists’ are better qualified to prescribe and have a greater understanding of medicinal cannabis than do normal GPs. Former RAGP President Dr Bastian Seidel described the entire ‘system’ as a ‘basket case.’
Since cannabis and cannabis products remain ‘unapproved’ (though still in some respects ‘approved’) medicines in Australia, thus not on this country’s Australian Register of Therapeutic Goods (ARTG) they cannot be considered for inclusion within the PBS – the Pharmaceutical Benefits Scheme – which is how medicine are subsidised. This has put legal cannabis products out of the reach of many patients even where and when a prescription/approval might be available.
A further effect of the 2016 legislation has been to prevent lawful suppliers from ‘marketing’ (in other words providing information about) their goods to the public and doctors alike.
Subject to other legislation and the Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG), the TGA makes the position explicitly clear on its website:
‘The advertising of prescription only medicines (including medicinal cannabis preparations) to the public is prohibited.
Prescription medicines not included on the ARTG are considered unapproved therapeutic goods and cannot be advertised in Australia to consumers or health professionals.
Medicines accessed through the approved therapeutic goods pathways generally are, or are likely to meet the requirements for scheduling as, prescription medicines. In any case, such goods cannot be advertised to consumers.’
Since doing so is unlawful under both civil and criminal law, instead, healthcare practitioners interested in prescribing MC and cannabis products must first find a supplier’s identity (provided on the ODC website) then contact the business directly before particulars may be finally provided.
This obstacle to knowledge flowing between doctors and MC suppliers, at a time when medical education is desperately needed in this sphere is unacceptable. UIC is contacted on a regular basis by medicos seeking product details where the sharing and dissemination of such information should clearly be permissible for the cannabis Industry itself. The current position therefore represents a highly inadequate and haphazard means for clinicians to acquire what is often critically important data and information enabling practitioners to assess whether MC or cannabis products may be suitable (or otherwise) for their patients.
While demand for cannabis and cannabis products is huge, the creation of a scenario in which such demand is not matched by the ability to access the medicine more readily the market has become badly distorted. Development of a local cannabis industry – which would have the effect of decreasing prices – is hamstrung because of a seemingly modest demand while the growth of ‘specialist clinics’ (their ‘expertise’ not in cannabis medicine itself but negotiating the bureaucracy involved in accessing it) is ensured.
These establishments in turn prescribe imported products sold at grossly inflated prices placing them well out of reach of most patients so that, three years after the NDA Amendments were enacted, almost the only products currently available (in so far as they are available at all) are those obtained from overseas, mainly Canada.
The cost of these imported medicines – in all but one State (Tasmania, which we have discussed) is borne by the patient – which we find equally untenable.
To help defend and justify its position on medicinal cannabis the TGA enlisted the services of a carefully selected group of academics, clinicians and public health ‘experts’ almost all with known prohibitionist stances on the plant and antagonistic toward its use as a medicine. Many of the same individuals have either built their careers demonising the drug or have received drug company funding or both. They were set to work producing documentation (‘Systematic Reviews’ and ‘Clinical Guidance Documents’ which supported the position taken by opponents of MC that ‘not enough evidence’ exists as to its safety and efficacy. Their publication prompted one eminent medico(Associate Professor David Caldicott of the Australian National University to criticise this work publicly. The week the ‘Guidance Documents’ mentioned above were released Dr Caldicott noted:
‘In just a decade’s time, they (the Guidances) will be mocked as an example of the abuse of science. (They are) political, designed to arrive at conclusions that suit parties other than patients. The sad reality is these documents …will do next to nothing to change the status quo – an illicit market of uncertain provenance, accessed by desperate people. They don’t tally with the experience of tens of thousands in Australia – millions worldwide – and so will simply be ignored, even by doctors who choose to educate themselves, overseas and online, about the ‘actual’ pros & cons of medicinal cannabis.’
For policy-writers, drug companies and the medical ‘establishment’ the only acceptable form of evidence is that of the Randomised Controlled Trial (RCT) – the ‘Gold Standard’ of ‘Evidence Based Medicine’.
On this matter, UIC accepts the relative paucity of RCT data where MC is concerned – the result of decades of complete prohibition – although the UK’s Centre for Medical Cannabis reports over 700 RCTs investigating the medical benefits of various cannabis products have been published in the last 10 years.
However to be thoroughgoing and truly disinterested when considering the matter of evidence, UIC believes investigators and Review authors should and must consider a wide range of evidence in the course of their work, not just Randomised Trials.
Disregarding huge demographic (or ‘Real World’) data however (involving millions of people using the medicine with remarkable degrees of success) along with countless clinically conducted observational studies, prescribing know-how and scholarship on the part of innumerable clinicians worldwide is certain to be partial at best and unscientific and dishonest at worst.
Numbers of approvals for cannabis and cannabis products are deeply unimpressive when compared to those overseas. As an indication consider Canada with c. 320,000 patients, The Netherlands with c. 40,000 patients, Germany (which legalised the drug for medical use a year later than Australia) also with c. 40 – 50,000 patients and Israel just slightly lower. What all of these jurisdictions have in common are regulatory models established to deal with cannabis outside of those used for conventional medicines.
About UIC
Executive Summary
Section One: Overview
1.1 The Review & Legislation
1.2 Overlooking Actual Reality: Illicit vs Licit Medicinal Cannabis Use in Australia
1.3 In Brief: Why the Amendments to the Narcotic Drugs Act Have Failed To Deliver A Successful Medicinal Cannabis Framework
Section Two: Definition: What is (and is not) ‘Medicinal Cannabis’?
Section Three: In Detail: Why the current Framework has failed and will continue to fail
3.1 Background to the Narcotic Drugs Act Amendments 2016
3.1.1 Two Different Bills – 2015/16
3.1.2 Public Inquiry – Regulator of Medicinal Cannabis Bill 3.1.4 Government Response
3.2 Initial evaluation process of possible outcomes of the 2016 legislative changes did not meet the Government’s Regulation Best Practice Guidelines
3.3 System ‘A Basket Case’ – RACGP President
3.4 Case Proven: ODC Internal Audit 2017
3.4.1 Findings of Audit, ODC Under-resourced etc.
3.4.2 ODC lacking objectives, leadership
3.4.3 Characteristics & Principles of Best Practice in Regulation
3.5 An ‘Approved Unapproved Medicine’: Australia’s current Framework consigns cannabis forever to ‘regulatory limbo’
3.5.1 How Cannabis Products Are Currently ‘Approved’
3.5.2 By Its Own Admission: How ‘Regulatory Limbo’ was planned from the start
3.5.3 The Australian Register of Therapeutic Goods: Of no use to cannabis or cannabis products 3.5.4 Opponents of MC shape policy and legislation
3.6 Legislation (2016) never intended to make MC readily available to sick Australians
3.7 Legislation (2016) enacted against the majority of expert advice after six Public Inquiries
3.8 Additional reasons current Framework unsuitable for Medicinal Cannabis: ‘Enourage Effect/Personalised Medicine
3.8.1 UIC’s Position on the above
3.9 Inadequate Pathways to accessing cannabis – the consequences of a failed MC programme
3.9.1 ‘Pathway’ One: ARTG
3.9.2 ‘Pathway’ Two: Special Access Scheme, ‘Record Approval Levels’ and use of an unsuitable system
3.9.2.1 Minimal approval levels compared to overseas jurisdictions
3.9.3 ‘Pathway’ Three: Authorised Prescribers (APs)
3.9.4 ‘Pathway’ Four: Clinical Trials 3.10 Consequences of the 2016 Legislation 3.10.1 Stifling of Domestic Cannabis Industry
3.10.2 Distortion of market/unaffordable prices
3.10.3 Causes black market to flourish
3.10.4 Prevents medical professionals accessing critical information
3.10.5 Cannabis & cannabis products impossible to subsidise for the less well off
3.10.6 Policy-writers and legislators misled?: A misunderstanding of ‘medicinal cannabis’ – why the Therapeutic Goods Act is an inappropriate mechanism for its regulation
Section 4 Review of the arguments, notes on evidence selection and privilege, further obstacles to availability of MC
4.1 Argument for separate Regulator made, won, then rejected
4.2 Minority against separate Regulator win policy battle
4.3 ‘Medicinal cannabis’ not to be made readily available
4.4 Results of the legislation
4.5 ‘Cherry-picking’ of ‘experts’ to assist & support Government position
4.7 The matter of ‘Acceptable Evidence’ & a note on Randomised Controlled Trials (RCTs)
4.7.1 All other evidence disregarded
4.7.2 UIC’s Position on the above
4.7.3 Hierarchy of Evidence: A possible solution
4.8 Poor/limited knowledge of cannabis & cannabis products & medicine among healthcare professionals
Section Five: Further Comments + Recommendations
5.1 In Summary
5.1.1 Moving forward – remedy needed at political level
5.1.2 Judiciary might solve the problem
5.2 Five Policy Objectives for the Future
5.3 Immediate Actions Required
Foreword / Note To Review Secretariat
This submission was, for the most part, authored in January 2019 before the Secretariat published it’s ‘Discussion Paper’ of the Review.
UIC notes the following remark within that Discussion Paper:
This Review is restricted to a review of the operation of the ND Act. It is not a review of cannabis regulation in Australia more broadly. Matters that do not fall directly within the scope of the review are the operation of Commonwealth, State and Territory laws dealing with:
This we believe to be nonsensical – and an attempt by officials to limit the damage and embarrassment such a Review Process may cause by casting light upon what has been, from the outset, disastrous legislation and execrable public policy causing untold damage to sick Australians.
One of the key documents we feel the Review will have need to consider is the Explanatory Memorandum of the Narcotic Drugs Act Amendments Bill which can be viewed here
As the Memorandum makes perfectly clear, the legislation in question was designed with all or most of the issues identified in the above bulleted list in mind, thus they absolutely do fall into purview and operation of the Narcotic Drugs Act Amendments of February 2106. To argue otherwise would, we feel, be tantamount to an admission that legislators were being misled when asked to consider and vote on the relevant Bill.
On this basis then, we trust every issue raised by this Submission will therefore receive due deliberation and consideration in the course of your duties.
United in Compassion
March 2019
With the above in mind, UIC therefore believes Australia’s current ‘framework’ for MC is unfit for purpose and that only significant legislative and/or regulatory reform – effected at the political level – will improve matters to any appropriate extent. Without such reform we feel Australian patients will continue to be betrayed and a domestic cannabis industry throttled almost at birth.
Our favoured solution would be a return to the original scheme proposed in 2014 – a separate ‘Regulator of Medicinal Cannabis’ operating outside of the Therapeutic Goods Act 1989 thus also outside of Therapeutic Goods Administration control and oversight. This is exactly the model employed in every jurisdiction where cannabis has genuinely been made available for medical use and we believe the only one which can and will properly guarantee genuine access to cannabis and cannabis products for patients. Such a scenario would additionally provide the only environment in which we believe a domestic cannabis industry will be able to flourish and supply medicines to sick Australians at affordable prices. This is because – as other jurisdictions have established – conventional medical Regulators such as our own Therapeutic Goods Administration are neither designed nor suited to dealing with medicinal cannabis.
As a starting point, the Submission (having argued that the 2016 legislation was created without any meaningful policy objectives in mind) calls for five such objectives to be set by any Government or Minister when considering how to improve Australia’s MC framework going forward.
It thus argues that, going forward Australian MC regulation should:
We moreover call for Governments in Australia immediately to:
While UIC will continue to lobby for a better alternative to what we feel is an irredeemably unworkable system broken beyond repair, we recognise other important work must continue.
Details of our current priories, target groups and planned activities were described in a Presentation Lucy Haslam gave at the CannaTech Sydney event in November 2018 which also emphasises the need for Australia’s commercial cannabis organisations to come fully on board with patient advocacy. The Presentation can be downloaded here:
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