History & Background

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Introduction

In late February 2016 the media both here and across the planet reported Australia had legalised ‘Medical Marijuana’.

What they were referring to was passage of the Narcotic Drugs Amendment Bill in the Australian Parliament, achieved in almost record time and with cross-party support, on 24th of that month.

But such headlines weren’t the entire story: the Bill did not exactly ‘legalise the use’ of medical cannabis or cannabis medicines at all; some products had – technically at any rate – been available all along via a couple of Government-run ‘Special Schemes’, discussed later on in this piece.  Indeed one of them – Sativex – had been formally approved & listed by the Government’s medical regulator.

What it did do was modify the existing Narcotic Drugs Act of 1967 so as to permit the lawful cultivation of cannabis for medicinal and research purposes here for the first time in over fifty years.

The new law and attendant regulatory changes kicked in on 1st November 2016 to further media attention.

It had all been a long time coming. For decades individuals and organisations in Australia and abroad had been hotly debating the matter – some wanting outright legalisation of the drug, others its use therapeutically and others still its ongoing prohibition.  A growing body of evidence however, mainly from overseas, began to suggest there were real medical benefits to be had from the plant or chemicals derived from it; a small number of medicines containing cannabinoids – the ‘active ingredients’ of cannabis – both synthetic and organically derived, were registered in the US and Great Britain; one of them, as we’ve said, was even registered here.

And cultivation of industrial hemp – once an Australian main-stay – had been gradually re-introduced from the late 1990s (though not for use as a foodstuff – something however the Government has been considering) after various legislative changes at State and Territory level – where ‘industrial hemp’ meant crops whose leaves or flowering heads did not exceed 1% THC – the ‘psychoactive’ cannabinoid found in some strains. On its medicinal properties, expert opinion was split – although, as we shall see, murmurings from a few corners of Government as far back as the early 1990s hinted the tide was beginning to turn – a little anyway – and that the same could be said for the mind of the general public.

By 2013 matters were reaching a head. This was in large part due to the work of New South Wales mother Lucy Haslam; her son Dan, who sadly died in early 2015 aged 25, had inoperable cancer and suffered badly from the effects of his chemotherapy. They discovered cannabis provided relief and, feeling aggrieved at finding themselves criminalised for using a treatment that was effective, Mrs Haslam and Dan began campaigning for changes in legislation. Things gathered momentum; finding support locally for what they were doing, first from their newspaper then the police and town mayor they eventually pulled on board NSW premier Mike Baird who wrote a Daily Telegraph article ‘How a young man changed my mind on cannabis’.  His government had previously ignored a Parliamentary Committee Report which spoke of the potential of medical cannabis but a year after Dan’s death – and huge national publicity – state regulations were amended so that patients could access the drug. Earlier, cash had also been earmarked for clinical trials.  Similarly, Victoria seemed to be edging its way towards ‘legalising’ medicinal use of the herb and then in 2014, at national level, the All Party Parliamentary Group for Drug Policy and Law Reform, having heard from Mrs Haslam, itself progressed the issue. Some months later, Green Party Leader, Senator Dr Richard Di Natale, along with co-sponsors Senators Ian Macdonald, Anne Urquhart and David Leyonhjelm from the Liberal, Labor and Liberal Democrat Parties respectively, introduced the Regulator of Medicinal Cannabis Bill 2014 to the Senate.

The 2016 Narcotic Drugs Amendment Bill was the Government’s eventual response; it involves politics at every level, pressure groups, many acronyms, profits from opium poppies and seven Public Inquiries.

The following article attempts to provide further historical background to that legislation and sketch some of the landscape around it. As with much else on this website, it should be seen as performing a signposting function directing the reader to the profusion of far more in-depth and detailed information available, much of which is superb both it quality and value. The discursive form we have chosen is in order to lend a framework to what would otherwise be merely a long list of links, floating without any context. And it is a long list; one we accommodate for quick reference and with brief explanations attached, within the various site sections.

Here though, we look briefly at some of the social, political and historical data at our disposal and the organisations behind it as well as the legal, regulatory and technical matters that do or will affect medicinal cannabis within Australia, pulling where necessary on sources from overseas. At highest level, the subject is comparatively simple, but drilling down we find this is far from the case even (or perhaps especially) at these early stages of what should become a long and compelling narrative. And because here, largely due to the way our government is structured, few things are ever simple – including the subject explored.

As a final note, some websites we’ve looked at use the terms ‘cannabis’, ‘hemp’ and ‘marijuana’ more or less interchangeably. We’ve stuck with the first – the plant’s botanical name – for the sake of clarity, unless referring specifically to, say, the modest but thriving industrial hemp businesses currently operating across the country, some of which may enter the field of medicinal cultivation.

Brief History – Licit/Illicit

It’s common enough knowledge cannabis has been used throughout history in many cultures for a variety of purposes, including medicinally, and the controversy surrounding it is a relatively recent phenomenon. A succinct but informative timeline from 2900 BCE to the present exploring such history appears on the American not-for-profit website Pro-Con.org which provides well-researched material giving the ‘for’ and ‘against’ positions on an array of controversial topics including cannabis & medicinal cannabis. There and elsewhere we feel enough ink has already been spilled to make further replication un-necessary.

The above having been said, reports of medicinal, industrial and recreational use of the herb in this country go back to the First Fleet; according to the Government of NSW ‘….plants were sent…by Sir Joseph Banks ….in the hope that the new colony might grow enough hemp to supply the British Navy with rope‘. Accounts differ as to how widespread the use of drug-cannabis was at this time – certainly hemp was widely grown for industrial purposes until the late 1930s – and as a medicine it was much respected and an ingredient in various patented remedies. Its therapeutic use was initially popularised in Europe (and hence later, Australia) by Dr William Brooke O’Shaughnessy, a physician and member of the Royal Society who worked for the East India Company and introduced the drug to Western medicine in 1841. A paper about him along with one of his own monographs ‘On the Preparations of the Indian Hemp or Gunjah’ are available for free download from the UIC website (for more on UIC see below).

Here, cannabis was also readily available in cigarette form under the name ‘Cigares de Joy’ until at least the 1920s and purportedly used as an asthma treatment. Generous amounts (dissolved in chloraform then topped up with morphine) were to be found in popular, freely available tinctures, in particular ‘Collis Brown’s Chloradyne‘ which were often given to children with apparently no ill-effects until well into the 20th Century. According to the writer John Jiggens, an authority on cannabis use in Australia, ‘attempts were made to prevent over-the-counter sale of Chlorodyne in the Australian state of Victoria in 1904, and were met with outrage.’ Some researchers (including Dr Jiggens himself) suggest cannabis had been – certainly in the late 19th and early 20th Centuries and even up until the 1960s – among the most widely used medicines in the land, helpful for ailments as diverse as migraine, nausea, chronic and acute pain including rheumatism as well as diarrhoea and convulsions. Queen Victoria was apparently often treated with it.

In 1925 however came the Geneva Convention on Opium and Other Drugs to which Australia was a signatory and which bracketed cannabis with narcotics such as heroin, morphine and cocaine leading to a ban on its importation in 1926. The the States and Territories gradually followed suit with their own legislation and in 1938, after a series of salacious (and false) articles in the ‘bushman’s newspaper’ Smith’s Weekly related to the politically motivated American Marihuana Tax Act of 1937 and hysteria incited by the 1936 movie ‘Reefer Madness‘ (these days a cult classic), the plant was declared a ‘noxious weed’.  The factors informing such views are historically interesting as this Huffington Post article outlines, but still it continued to be seen as a medicine though use of it in raw (or ‘crude’) form now required permission from then-regulatory body the Dangerous Drugs Authority. No such blessing was required for products like Choloradyne however and cultivation for personal use remained legal in Western Australia and Tasmania until 1950 and 1959 respectively . The situation remained  largely unchanged until the 1960s when, following ratification of the US-led 1961 Single Convention on Narcotic Drugs, which grouped cannabis cultivation with that of opium, the Commonwealth passed the 1967 Narcotic Drugs Act enabling the Government to meet its obligations under the Treaty, outlawing the drug altogether.

Further legislation among States and Territories – much of it relating to poisons – finally ended even (lawful) medicinal use; despite the fact the Convention allowed licences for treatment and research, it seemed by then the authorities felt no benefits were to be found.

Professor Laurence Mather, a renowned specialist who has long studied cannabis points to a monograph in the British Pharmaceutical Codex of 1949 as a defining moment when the drug fell from favour. It stated ‘Cannabis is too unreliable in action to be of value in therapeutics as a cerebral sedative or narcotic…‘ and that statement ‘contained the beginnings of the scientific argument for the demise of cannabis pharmacotherapy that was completed politically for reasons that were neither medical nor scientific,’ Professor Mather says.

The drug was yet further restricted internationally by two later UN agreements, the Convention on Psychotropic Substances (1971) and the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988) each of which loosely coincides with differing phases of the ongoing international ‘War on Drugs‘. It’s in part due to these Treaties, particularly the Single Convention, that the Government found itself with such a headache with cannabis regulation, something we explore further on.

From the late 1920s until the present therefore, the history of cannabis use in Australia – any cannabis use – is one of partial or complete prohibition and the attendant criminalisation of users regardless of motive. An in-depth look at such matters is beyond the scope of this website, which is focused solely on the plant’s therapeutic aspects, though it is all but impossible to avoid the wider discussion completely since until recently no legal distinction was made between cannabis for recreational purposes and those for medicinal use. The story of its legal position – both current and in the past – is of course reflective of our Federal system, with relevant legislation found at Commonwealth, State and Territory levels but as the Parliament of New South Wales again puts it: ‘This network of laws is complex, sometimes overlapping and not always consistent. A common feature, however, is that cannabis is regarded as a proscribed substance in every jurisdiction,’ (see also ‘States and Territories’ section of this website).

Nimbin & underground

Definitely relevant however is the story of the ‘alternative’ community at Nimbin, itself in New South Wales, the village’s growth out of the Commonwealth Government-backed Aquarius Festival in the early 1970s together with the work of Australian therapeutic cannabis pioneers in the region. One of them in particular, Tony Bower, is well known for the production and manufacture of his cannabis-derived ‘Mullaways‘ liquid which he plans to register as an authorised medicine in Australia as soon as he can. Mr Bower has previously been the focus of police attention and would distribute his product – said to be helpful for various conditions –  free from the back of a van on production of a doctor’s certificate. A more detailed account of this and the red tape involved in his trying to register the medicine as far back as 2008 appeared in the Saturday paper in May 2014.

Others too have had high-profiles in the space, not least Andrew Kavasilas and Dr Andrew Katelaris.

The former, a prominent industrial hemp advocate was the cannabis campaigning Hemp Party’s Northern Territory Senatorial Candidate and author of the 2004 book, ‘Medical uses of cannabis : Information for Medical Practitioners‘ (which appears to be out of print but is available to read at the National Library of Australia in Canberra). He has long argued the plant’s value as a food-stuff  and once owned a cafe in Nimbin. The second, Dr Katelaris (sometimes  referred to by the media as ‘Dr Pot’) – a controversial figure in Australia and overseas – has been helping treat people with the drug for over a decade and a half and was struck off the Medical Register in 2005 for refusing to stop doing so.  More recently, Dr Katelaris found himself in a media storm over the death of an ovarian cancer patient and complications in another after treating the women with cannabis oil, an incident he says will not deter him.  And in early December 2016 – as this article was being written – the ‘Church of Ubuntu‘ in NSW, with which Dr Katelaris is heavily involved and which grows and dispenses medical cannabis to nearly 2000 people round Australia, was raided by State Police.

Extensive collections of talks and interviews from all three men on the subject of hemp, cannabis generally and the medical variety in particular are available on YouTube (Dr Katelaris here, Mr Kavasilas here and Mr Bower here) and since each has tirelessly campaigned and advocated within the field over many years no discussion, however cursory, would be complete without their names being mentioned.

From the 1970s then, residents of Nimbin – described by Hemp Party President Michael Balderstone as ‘a refugee camp from the War on Drugs‘ – defied the law, openly growing and consuming the plant with varying degrees of police intervention. The village and its activities play a legendary part in Australian counter-culture and, where medicinal cannabis is concerned, emerges in the 1990s through to today as an influential force through Bower, Kavasalis’, and Katerlaris’s work (see also the ‘People‘ section of the site).

For readers with a broader interest in this and other areas of underground folklore a plethora of information from a wide variety of sources is readily available online – the simple Google search term ‘Cannabis Australia‘ throws up over 17 million results and an excellent general account of Australian cannabis use can be found in the book ‘Marijuana Australia’ by the aforementioned John Jiggens or in his free-to download (and unput-downable) PhD Thesis of 2004 ‘Marijuana Australiana: Cannabis Use, Popular Culture, and the Americanisation of Drugs Policy‘.  And film-maker  Richard Baron also successfully crowed-funded a full-length documentary of the same name (preview via last link) featured in the Byron Bay Film Festival in October 2016 to an approving press.

Some relevant organisations

Scores of newspaper articles, books and papers both official and un-official in nature and NGOs like the Australian Drug Law Reform Foundation and Drug Policy Australia among the pro-cannabis camp, offer news, opinion and studies on the subject with stances inclined toward liberalisation. Some of Australia’s smaller political parties too favour blanket legalisation, in particular Drug Law Reform Australia, the above-mentioned Hemp (Help End Marijuana Prohibition) Party the Sex Party (the last two forming an alliance in the 2016 elections) and the Pirate Party to name four of these (and, as we have said, it was the Green Party whose leader and Senator, Dr Richard Di Natale got the medicinal cannabis ball rolling, at least legally speaking, with cross-party support for his Bill from Senate colleagues).

Anti-cannabis organisations – Drug Free Australia and the National Cannabis Prevention and Information Centre (NCPIC) for instance – provide, not unexpectedly, far less enthusiastic material, though NCPIC is the more nuanced and its website an excellent reference point.  In November 2016 however the Centre announced it was to close due to the withdrawal of Federal cash.  But the Government also funds a number of other organisations and projects concerned with drug education and harm minimisation which are discussed later on, while some health institutions such as the Australian Medical Association, the various Royal Colleges and the Pharmacy Guild of Australia have taken such a conservative stance on medicinal cannabis – the cause of much heated debate and a matter we explore in some detail in this section of the site.  The Public Health Association, Australia’s peak NGO has however taken a more progressive position, saying in 2015 the Government was ‘out of step’ and calling for the removal of penalties for possession of cannabis for medicinal use.

Advocacy / Pressure Groups & Others

In the area of medicinal cannabis specifically, perhaps its leading and best-known proponent is the advocacy group United in Compassion (UIC), founded by Lucy Haslam mentioned earlier, in memory of Dan her late son. Mrs Haslam’s work, and that of her organisation, includes a petition to the Australian Prime Minister and Minister for Health of well over a quarter of a million signatories on the Change.org website.  This prompted a response from Health Minister Susan Ley describing new ‘landmark legislation’ that would be the ‘missing piece’  for Australian patients, which turned out to be the the Narcotic Drugs Amendment Act.  Face-to-face meetings with politicians and government officials, media appearances – including the creation of various websites and running two major symposia featuring senior clinicians and experts from across the world (presentations from which are available on UIC’s website – including slides – or their YouTube Channel) represent still more of the organisation’s achievements. Completing the picture was the announcement in April 2016 that Australia’s first medicinal cannabis farm, named after Dan Haslam, had been opened in New South Wales by then-acting-Prime Minister Barnaby Joyce who had himself made a U-turn on the matter. ‘The farm is the latest step in a concerted plan by Ms Haslam to allow people compassionate access to the drug, which she had to buy illegally for her own son to relieve his pain while being treated for bowel cancer,‘ an ABC report explained at the time.

UIC also houses and works with another, separate organisation – the Australian Medical Cannabis Observatory, a project run by healthcare providers, scientists, academics and other professionals exploring hard clinical, scientific and pharmacological aspects of the drug thus growing the body of learned work and enquiry around it. The Observatory is currently running a survey among patients and adheres to the ‘Open Science‘ ethic of encouraging free access to research and (suitably anonymised) data. Th Observatory also has links with the Australian Drug Observatory at the Australian National University, headed by emergency trauma doctor David Caldicott, a vocal UIC supporter.

Another significant group is the Medical Cannabis Users Association of Australia (MCUA), which, as the name suggests, provides a collective voice for those individuals who feel they benefit from therapeutic use of the drug. The Association, said to be 6,000 strong, has a thriving Facebook presence and lobbies government and the authorities on the subject – including medical practitioners – as well as sharing news, offering training and events and conducting informal research.  Sitting alongside it is Medical Cannabis Kids – set up on Facebook by Tasmanian mother and activist Nicole Cowles to raise awareness of the issue of children for whom the drug helps illnesses such as intractable epilepsy and other life-threatening conditions.  Ms Cowles was described by Tasmanian Senator Lisa Singh as ‘an inspiring advocate’ during the second reading of the Regulator of Medicinal Cannabis Bill in the Senate in 2014.

And another group still, Weeded Warrior, exists to help those from the forces with PTSD and other mental health problems caused by time spent in the militia.

Aside from these, a number of advocacy bodies representing healthcare consumers and / or those with particular illnesses or conditions have also made themselves heard on the matter, in relation to their specialised fields.  Submitting responses and / or giving evidence (not all sympathetic) to the Federal Government’s Public Inquiry into the Senate’s Regulator of Medicinal Cannabis Bill of 2014 (discussed below and in this section of the website) were Cancer Voices Australia (see Submission); Palliative Care Australia (see Submission); the Australian Federation of AIDS Organisations (see Submission); Epilepsy Action Australia (see Submission); Cancer Council Australia & the Clinical Oncology Society of Australia  (see joint Submission); the Australian and New Zealand Society of Palliative Medicine  (see Submission); MS Australia & MS Research Australia (see joint Submission) and Painaustralia (see Submission).

In addition, following passage of the Narcotic Drugs Amendment Bill further sundry entities concerned with the topic (including ourselves) have also appeared. Some of them, NGOs such as the newly-formed Australian Cannabis Industry Association serve to undertake political lobbying and promotion of the commercial interests of what may be a nascent though potentially sizeable market. Others are newly formed businesses (three of them already ASX listed) gearing themselves up for what’s being seen by some as the birth of a new industry.

Some of these organisations are catalogued in this section of this website but, important though many may be, clearly the final say on legal and regulatory issues relating to cannabis – medicinal and non-medicinal – rests with the Authorities: the Australian, State and Territory Governments and the numerous Departments, agencies and bodies they oversee. Most of the Parliaments each provide plentiful stocks of documentation, legislation, regulation and political debate much of which requires consideration; below we look at the Commonwealth picture while State and Territory matters are (mostly) dealt with in this section of the site.

Government & Legislation

When it comes to medicinal cannabis and where the Federal Government is concerned, things look complex and perhaps are, involving upwards of a score of committees, campaigns, strategies, organisations and institutions many of which, to a greater or lesser extent, already do, will or may impact on the drug’s cultivation and use.  Such a position might not have occurred if a new regulator had been created – with blanket national responsibility for all things medicinal cannabis from production through to registration of products and access by doctors and patients – as proposed by the Senate’s Regulator of Medicinal Cannabis Bill.  Instead though, Canberra did something else, deciding to use existing Government apparatus plus one newly formed regulator – the Office of Drug Control – to work in tandem with States and Territories on the matter, thus involving at least three separate entities in the process of getting the plant grown, seeing it through to the patient – and in turn creating a ‘post-code lottery’ in terms of availability.

A single-purpose regulator could and would have side-stepped all this, along with a vast amount of red tape. Arguments for and against establishing one were raised in all of the six Public Inquiries held between 2013 and 2015 by five of the States and at Federal level.  And to understand these is more fully to understand medical cannabis and the issues surrounding the herb; since within those Inquiries, perhaps more than anywhere else, the many often dramatically conflicting opinions and positions on the subject were voiced and so vividly defined.  For this reason we’ve explored in some detail the largest of them – the Commonwealth Government exercise carried out in early 2015 – in this section of the website.

As things now stand though, as we’ve said, existing Federal and State/Territory organisations, strategies and procedures (plus the ODC) remain the ones governing what Australia does with its weed.

It leaves something of a difficult situation though, because whilst the Government seems to have partially embraced the idea it’s at least possible cannabis may have some therapeutic value in certain circumstances, in all other respects the drug is completely illegal and balancing those two positions a sensitive political issue.

There have been complaints too the new legislation and concomitant regulations smother its production and use in red tape making access difficult and preclusively expensive.  And that means it’s possible many will continue to source the drug from the black market criminalising themselves in the process.

And all the time the herb enjoys such dual legal status it’s relevant to look not only at officialdom’s approach and position toward the medical product but also its stance on illicit drugs generally and cannabis in particular.  How it’s viewed and how the organisations and strategies involved approach the issue is based on a perception of the drug – deserved or otherwise – that is going to be hard to shake off; one that doubtless played a part in the debate that emerged during the aforementioned Public Inquiries, and set to continue long after.

Medical or otherwise, the Department of Health runs almost everything to do with drugs generally, obviously including cannabis. Under its auspices comes the Government’s National Drugs Campaign and the Department part-funds the Alcohol and Drug Foundation which runs ‘The Other Talk‘ website for young people and also administers (among others) the Australian Drug Information Network, itself also DoH-funded. Each organisation has a diversity of roles and objectives addressing a range of demographics mostly related to (usually illicit) drug awareness raising, harm minimisation and assisting and running projects including at local level. The Department of Health also pays for the National Drug Law Enforcement Fund (NDLERF), part of the Australian Institute of Criminology which researches areas involved with drug law enforcement.

As such these bodies have little to say about medicines per se, focusing entirely on the problematic and / or illegal uses of drugs.  They’re important though because they both inform and are informed by Australia’s National Drug Strategy (or NDS).  The Strategy, initiated at Commonwealth level in 1985 is intended as a joint effort between State and Territory governments and the non-government sector to implement the ‘three pillars of harm minimisation’ – demand reduction, supply reduction, and harm reduction.  The NDS is is the responsibility of the Intergovernmental Committee on Drugs (IGCD) which advises senior politicians (such as those on a further body called the Ministerial Council on Drug Strategy) about policy, as does another organisation – the Drug Advisory Council of Australia, representing the non-Government sector.  Though not immediately concerned with our area of interest, these entities are nevertheless part of a ‘big picture’ of the Government’s over all approach to drugs (medicines have their own National Strategy which is described further on). And since the legitimisation of cannabis for therapeutic purposes is at its earliest stages and the law does not extend to recreational use, the NDS and its various strands play a part in what is clearly a developing saga, especially, as we have said, if patients continue to source their medication outside of ‘legitimate’ channels.

In addition to the above, the Government also funds the National Drug and Alcohol Research Centre (NDARC) at the University of New South Wales, the Government’s main policy think-tank and on drug-related policy and long-time voice in the medical cannabis discussion (see paper ‘Framing the Regulatory Options‘).  The Centre also houses NCPIC – the National Cannabis Prevention and Information Centre mentioned previously and earmarked by the Government to close at the end of December 2016. (Interestingly, the University of New South Wales is also home to another organisation, the Australian Drug Law Reform Initiative comprised of UNSW academics from various disciplines including legal and social sciences together with some of the staff within NDARC. Describing itself as a ‘working group formed with the intent of pursuing a variety of pathways towards drug law reform, education and the achievement of social justice,’ a number of its members have not unexpectedly been vocal within the medical cannabis discussion).

Exploring though how (licit) medicinal cannabis will now find its way to the ‘legitimate’ Australian healthcare recipient following the legislative changes in 2016 is necessarily to consider the political, regulatory and (local, national and international) statutory positions that remain – as well as the bodies that implement and oversee them. All, to some degree or another, will, or already do, impact significantly on all aspects of the drug and those involved – and it isn’t a straightforward matter.

Moreover, as we’ve already pointed out, acquiring such medication will vary from State to State since the Government’s main regulator, the TGA (discussed below) together with the States and Territories will decide which patients (if any) are to be permitted access and how they can obtain it. Manufacture of cannabis products is regulated jointly by the Commonwealth and States & Territories.

The Federal Government says it consulted with its counterparts on the matter and continues to do so via some of the various intergovernmental bodies at its disposal, as well as inter-departmentally (the latter through SIDCINI -the Interdepartmental Committee on International Narcotic Issues).   In particular, the IGCD, mentioned earlier, COAG – the Council of Australian Governments and the Australian Health Ministers’ Advisory Council seem to have all been involved throughout. According to the Government’s own Explanatory Memorandum of the final legislation,  feedback was  provided but the fact remains, State and Territories are now at variance with one another so the picture relating to each is explored in this site section.

As we have already said, the February 2016 Narcotic Drugs Amendment Bill set out to provide for the (heavily and carefully) regulated cultivation of the herb for medicinal (and scientific) purposes and was successor to the original Regulator of Medicinal Cannabis Bill.  The latter was read and moved by the Senate in November 2014 and surprised pundits because of the extent of its cross-bench support – and led to dire warnings of ‘regulatory nightmares’.  It had proposed to establish a new Government entity – the ‘Regulator of Medicinal Cannabis’ – to create and ensure compliance of special rules, applied via licensing, that would control everything related to the drug’s medicinal use, from planting through to prescription. Its reason was simple – to ensure Australia could continue to meet its Treaty-bound obligations under the 1961 Single Convention on Narcotic Drugs whilst allowing the local cultivation of raw cannabis crop readily available for the medical and scientific markets, including for export. And in doing so it would by-pass existing Commonwealth regulations and regulatory bodies (which are discussed later on in this piece).

In February 2015 the Senate sent this Bill for consideration to its Legal and Constitutional Affairs Legislation Committee, which, after some shenanigans, said it would give its final report in the following October after holding a Public Inquiry. Over two hundred and fifty responses were received, many of them highly significant and detailed from various experts, peak bodies and other organisations with an interest within the field; both the submissions themselves and ensuing public hearings that took place at the end of March /beginning of April the same year are explored in this section of the website.

Following this consultation, the Senate Committee did indeed report back that October with a five-chapter, 98 page-long document which included six main recommendations – including that the Bill should be enacted – as well as raising and highlighting what were, and remain, many of the major issues that have traditionally plagued cannabis use as a medicine.  Richard Di Natale, the Bill’s sponsor described them at the time as ‘minor concerns but some would be its undoing. Not least among them was the fact that, as a plant, cannabis cannot be seen as a single drug.  Its active ingredients, which run to three figures, are argued to work as an ‘entourage‘ (i.e. to interact and harmonise with one another to provide the best benefit). And this, unfortunately, makes it difficult (maybe impossible) for the drug – at least its raw form – to meet conventional regulatory standards of examination and evaluation since no framework exists for such investigations. And for the same reason, as the Committee Report put it: ‘…the herbal nature of the cannabis plant means that it is difficult for pharmaceutical companies to gain patent in relation to cannabis-derived products.’  

Such a situation immediately creates an impasse since many within the debate insist, like the Australian Medical Association, that ‘medical cannabis should be held to the same standards of evidence, safety, quality and efficacy as any other therapeutic narcotic products,’ as that organisation said in its Submission during the consultative process.

The Report also described how local cultivation of cannabis would be useful for research purposes since obtaining it was, at the time, extremely expensive and difficult as well as pointing out the Bill’s initial aim of ‘striking a balance’ between ‘high availability but limited quality control’ of medicinal cannabis to patients and their access only to ‘pharmaceutical-grade medicinal cannabis products subject to stringent testing regimes, with supply being tightly controlled.’

This issue of the type of availability, seen in the context of difficulties examining drug-cannabis scientifically within a regulatory framework led some expert witnesses in the March/April public hearings (as well as within various public submissions) to differ. The question was, could – or should – a new, single-purpose Regulatory body be created to deal with cannabis and cannabis alone (as the Bill was proposing) or would existing, perhaps modified, mechanisms do just as well?

Arguments on both sides, which are many and various, can be found in the Senate Report we refer to as well as the public hearing reports and the relevant public submissions – and are significant because they demarcate still-existing ‘battle lines’ over how, why and by whom medicinal cannabis can and ought to be used, as do points raised in the section of the Report dealing with an ‘Authorised Patients and Carers Scheme’ also proposed by the Bill.

In any case these, together with the fact the proposed Regulator would have been expected to create its own rules within what was merely a ‘framework’ piece of legislation led the Senate Committee to recommend, among other things the Bill be amended ‘to address issues raised about its interaction with the existing Commonwealth regulatory framework for medicinal products.’  And the Department of Health had also raised concerns over how it would affect Australia’s treaty obligations where the Single Convention was concerned – a an extremely big deal indeed, as we shall shortly see…

The result, for good or for ill, was the Narcotic Drugs Amendment Bill, announced and given its first reading the same month the Senate Committee published its Report. An overview of the second, new Bill is given in its own Explanatory Memorandum, this one a hefty 104 pages, and a document critical to understanding fully the Bill’s implications. In essence though, the Government had decided to green light the cultivation of crops for medical and scientific purposes but in accordance not with new legislation and a new Regulator but within an existing Act – the Therapeutic Goods Act of 1989, applied by the powerful and many-faceted Therapeutic Goods Administration, or TGA. And in order to facilitate this as well as adhere to the Single Convention on Drugs the Government did in fact set up a new body, the Office of Drug Control (ODC) launched in anticipation of and just nine days before passage of the Amendment Bill in February 2016.

This new organisation would be creating regulations too, not related to use or prescriptions for cannabis (as a stand-alone Regulator would have) – that role would fall to the TGA – but instead in regard to its import and cultivation and, in tandem with States and Territories, the manufacture of cannabis-based products. The possibility of cultivating the herb for export had it seems been abandoned, for the time being at least, and for reasons that aren’t entirely clear but which are tied to the UN Single Convention. South Australia has however indicated it plans to lobby the Commonwealth on the matter and at least one firm, AusCann, which had planned to export to Canada, has made  a number of abortive attempts to grow plants for use outside Australia.

The Office of Drug Control meanwhile was also put in charge of administering the existing Narcotic Drugs Act of 1967 as well as parts of the Customs Prohibited Imports and Exports Regulations where drugs were concerned.

Hence between them, at Federal level, the TGA and the ODC would be – and are – the two principal agencies calling the regulatory if not policy shots on medicinal cannabis with certain other responsibilities left to the States and Territories.

In order to grasp the roles and obligations of the TGA and ODC as well as some of the stumbling blocks faced by stakeholders in the medical cannabis panorama – including those within Government – it’s probably useful to sketch where these and a number of other relevant organisations sit within the huge machinery of State.  Its cogs often (though not always) move at what can sometimes seem a frustratingly unhurried pace; slow they may be but turning they constantly are, so it’s important to remain ever alert for life-signs within this vast apparatus.

As has been noted several times, a bespoke ‘Regulator of Medicinal Cannabis’ would largely have bypassed the Government’s existing arrangements – and valid arguments exist for and against the creation of such a body. As things stand however, as we shall see, not only have the TGA and ODC’s roles become pivotal, position statements the Government made in the course of 2016 as well as the Explanatory Memorandum referred to above mean a large part of its other paraphernalia needs to be considered when reflecting on the status and future of the herb therapeutically.

Medicines Policy & QUM

Astride everything, as we know, is the Government’s Department of Health and its over-arching National Medicines Policy – in its entirety a complicated jigsaw comprising a swathe of different bodies, agencies, regulations, guidelines and processes, each, either now or in the future, playing a part, great or small, in the business of medicinal cannabis.

At top level then, the Policy’s aims (though not always achieved) are, not unexpectedly, the provision of ‘quality, cost-effective care responsive to people’s needs, incentives for preventive health, cost effective care and better value for money’ and all this while ‘retaining the benefit of universal access to basic health services through Medicare’.

Unsurprisingly, no mention of any specific product or treatment is made in the Policy but the significance of its numerous components is plain from its four main areas of focus, these being to ensure Australians have access to medicines they need ‘at an affordable cost to themselves and the community’; ensuring medicines meet ‘appropriate standards of quality, safety and efficacy’; ensuring they (the medicines) are usedjudiciously, appropriately, safely and efficaciously‘; and ‘maintaining a responsible and viable medicines industry‘. Each is area explored in greater depth within the Policy document itself but their significance should be apparent since medicinal cannabis and/or cannabis products will surely need to satisfy Government objectives if they’re ever to mutate into registered products or win the confidence many within the medical professions.  (Likewise however, the Government should equally be able to be called on to deliver such outcomes when it comes to accessing product).

A central plank in the National Policy is the Quality Use of Medicines (QUM) Strategy whose goal it is to ‘make the best possible use of medicines to improve health outcomes for all Australians‘. With this in mind no leap of logic is necessary to see how ‘quality of use’ may also be a key factor in determining the ‘hows, whens and whys’ of medical cannabis, making this a document of especial significance. Indeed, since ‘QUM’ must necessarily seek and include input from all involved – from the manufacturer, retailer, health provider and Government through to the healthcare recipient – a need for co-operation and discourse is evident, particularly when new drugs, products or treatments make an appearance on the horizon.

The QUM Strategy comes under the auspices of the Pharmaceutical Health and Rational Use of Medicines Committee (or PHARM) a ‘multi-disciplinary’ body responsible for the Strategy’s implementation and for advising the Minister on matters relating to QUM. Other organisations are involved in this too, including the all-important Therapeutic Goods Administration. Each warrants mention, but as we know, it’s the TGA that sits at the epicentre of our ongoing saga.

TGA & Others

Its many limbs exist to regulate and govern just about all things available in Australia that can be described as ‘therapeutic’ (plus a few others as well) including their supply, import, export, manufacturing and advertising. From prescription drugs through to medical equipment and over-the-counter products it’s the TGA’s job to monitor and supervise them. The Administration itself is part of an over all body within the Department of Health called the Health Products Regulation Group which also comprises that other body tasked with looking after the introduction of medicinal cannabis, the newly-convened Office of Drug Control mentioned earlier. This is important because it’s the Regulation Group itself which has been responsible for drawing up rules and liaising with interested parties about issues to do with the herb. The Group also includes the Office of the Gene Technology Regulator which may be relevant if genetically modified cannabis or cannabis products enter the scene; as Drug Policy Australia has already pointed outthe Cannabis Australia is allowing to be imported for the first time includes GMO Cannabis‘ and ‘…there is a real danger GMO will take over as the dominant cannabis stock‘.

A dedicated web page explains the TGA’s structure in full, which includes another important component, the Medicines Regulation Division (MRD) which, via its Prescription Medicines Authorisation Branch oversees applications – such as that of Tony Bower and his product Mullaways – to register and supply all (or just about all) new medications. The MRD is additionally responsible for ‘Pharmacovigilance‘ (making sure products are of the requisite quality – i.e. what it says on the tin – and that no adverse effects are discovered) as well as a Scientific Evaluation Branch which reviews and appraises relevant scientific research, including, one must assume, clinical and other trials current or in the future around medicinal cannabis.

Significantly, the Administration is also responsible for this country’s ‘Poison Standard’ – in full the Standard Uniform Scheduling of Medicines and Poisons (or SUSMP) – a segmented (or ‘Scheduled’) list numbered 1- 10, indexing (and thus cementing in law) the supposed degree of toxicity of all substances considered dangerous (and / or of medical benefit). Within the TGA, SUSMP is run by two committees – the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) which sometimes work jointly.  Until recently almost all cannabis and cannabis-related compounds sat firmly within Schedule 9 – i.e. were ‘Prohibited Substances’, with a few listed as 8 – ‘Controlled Substances’. In January 2016 however the ACMS disclosed it was to re-categorise the drug as a Schedule 8 in keeping with legislative changes and, and as is usual with modifications like this, held a public consultation (submissions to which are here) eventuating in a complex-sounding announcement the following August that cannabis items were essentially to be moved from 9 to 8, the changes taking effect on 1st November.  Cannabidiol, or CBD, the non-psychoactive component of the plant used by many to combat seizures was placed into Schedule 4 (uncontrolled but prescribed drugs) – a step forward at least, but of little real help since no CBD medications are registered in Australia and are thus hard to come by, even from overseas.  Running out is a fear that haunts many carers.

And unfortunately, and because this is Australia, the matter doesn’t quite end there because States and Territories also have their own poisons regulations, which although based on the Federal Government’s Standard, still require adjusting (or not) to accommodate cannabis.  States and Territories are therefore discussed in this section of the website.

Another crucial list – the Australian Register of Therapeutic Goods (ARTG)  -where Tony Bower hopes to register Mullaways – also falls within the TGA’s bailiwick and specifies which medicines can by law be supplied in this country. The Register is governed by the Therapeutic Goods Regulations of 1990, (applied using SUSMP) and aside it an onerous ‘Prescription Medicines Registration Process‘ which any future products falling under the Regulations (such as Mullaways) must undergo before being included on the Register. This is is a drawn out and costly business (over $230,000, and taking more than a year last time we looked) which involves initial sponsorship of the drug plus an application and then evaluation by the Authority’s Prescription Medicines Authorisation Branch, itself housing five clinical units.  Registration is an absolute requirement for products containing substances in Schedule 4, 8 or 9 of the Poisons Standard – into which cannabis obviously falls, and herein lies the drug’s problem as we touched on above.

Most conventional medicines are developed using a single compound aimed at performing a single task and this is how they’re evaluated.  Cannabis though is different. The plant contains hundreds of chemicals which, although in theory could be isolated and tested individually or even in small groups for specific complaints, doing so would result in its supposed ‘entourage effect‘ being eliminated. Moreover, since the drug is now being discussed in relation to a wide variety of medical uses, trying to narrow down exactly which of its many substances is useful for precisely which condition – or conditions – would be extremely difficult. Add to this the fact that the whole plant cannot be patented (though it is being attempted) and developing drugs based on only one or a few of its ingredients for a particular purpose and thus for limited use, and you begin to see why this isn’t an attractive proposition for many in the pharmaceutical industry.

Yet this is exactly the process those in what might be termed the medical and scientific ‘Establishment’ insist cannabis and / or cannabis derivatives must undergo, otherwise, they say, the product cannot be deemed safe or well-tested and doctors would be loathe to prescribe it.  They believe it should not, in other words, be thought of or treated differently from any other drug and hold discussions about it like this one within their learned journals.

The Government has said it wants to ‘encourage’ the registration of medical cannabis products and in fact reforms to quicken the process for a number of medicines with ‘new approval pathways’ (i.e fast-tracking drugs approved overseas) were announced in September 2016. But in the case of cannabis the Department of Health also acknowledges the problems that exist in this area and that such registrations are likely to be some way off so it won’t make things easier in this drug’s specific case.

The Narcotic Drug Amendment Bill ‘will not not necessarily bring a medicinal cannabis product to registration on the Australian Register of Therapeutic Goods (ARTG), in the short or medium term, but will facilitate further clinical trials that may support such a registration in the future. Cannabis material cultivated and manufactured in Australia would be able to be used to conduct clinical trials and develop therapeutic products to be used in accordance with the Therapeutic Goods Act,’ says the Bill’s previously mentioned Explanatory Memorandum (p.11), doubtless to the annoyance of those wishing to see the immediate supply of medicinal herb/herb products to patients in need of the drug.

And in terms of those patients, last but by no means least, it’s also TGA that’s responsible – at least in part – for what it calls ‘pathways’ to accessing cannabis medicines. In fact it’s responsible for granting (or refusing) access to all unapproved (i.e. unregistered) drugs (including cannabis products) which can under certain circumstances, be obtained via its ‘Special Schemes’.

The Government has identified two of these in particular – the Administration’s ‘Special Access Scheme‘ and ‘Authorised Prescribers Scheme‘ – as the means by which patients and doctors can obtain such products.  And these routes can be complicated.  The Special Access Scheme, intended for individual cases, divides patients into two categories (‘A’ and ‘B’) depending on their condition. ‘Any unapproved therapeutic good can potentially be supplied via the SAS,‘ says the TGA unless it’s forbidden by State or Territory law (Sativex, which we mentioned at the beginning is an example of this).  Which means permission is needed from both the TGA and State or Territory Governments before it can be provided to patients. And as each State and Territory varies in its approach to the drug (as we discuss in this site section) who will able to get it and for what will depend upon where they live.  Local variations also apply to the Authorised Prescribers Scheme, but this is intended for doctors wishing to prescribe the same (unregistered) medicine to a number of different patients with similar medical conditions. Queensland’s Medical Cannabis Advisory Group – an advocacy body and self-help group based in that State – has an extremely useful guide to all this and in late 2016 launched a petition on Change.org after the Government ‘moved the goalposts’ on patient Categories, in effect making it impossible for terminally ill patients to access the drug as a matter of urgency.

The whole regulatory picture of medicinal cannabis is provided on a TGA webpage, published when the new legislation and rules kicked in on November 1st 2016.  And it makes clear: ‘Patients will only be able to access medicinal cannabis if they live in a state or territory where it is not a prohibited substance; obtain a prescription from an appropriate medical practitioner, who obtains permission from the state or territory (and) the TGA to obtain a specific medicinal cannabis product.‘   In one sense, the new legislation changed nothing since this had been the case for some time – though action over the last few years by some of the States and Territories altered the picture somewhat.

In addition, the cost of products obtained via these Special Schemes needs to be met in full by the patient or patient’s carer and could be preclusively expensive. United in Compassion founder Lucy Haslam told the Canberra Times in September 2016 the new industry could be ‘so wrapped up with red tape patients wouldn’t be able to access a legal supply at an affordable price‘.  As we have said, currently only one cannabinoid drug, Nabiximols (trade name Sativex) is listed on the ARTG exclusively for use among sufferers of Multiple Sclerosis. But Sativex could hitherto only be used in trials (one of them – for treating cannabis withdrawal among addicts) because of State and Territory legislation. Even if it does now become available though, the cost of using it has been estimated at up to $45,000 per year.  And that will need to be met by the patient because Sativex (or any other cannabis medicine) appears on yet another important list – this one outside of the TGA – called the PBS Schedule (discussed below) since it wasn’t felt to give value for money.

The two other canniboid drugs on the market, Dronabinol and Nabilone can also be obtained though the TGA Special Schemes but rarely are and in any case are now largely considered redundant.

The only other track available to those wishing to introduce a new prescription product into Australia is through the TGA’s Orphan Drug Designation.  Under this, in exceptional circumstances, the Authority waives product registration and evaluation fees in cases where it believes a drug’s benefit is of high value but where the manufacturer may not recover the costs of registering and marketing the treatment. It remains to be seen whether any cannabis product will ever undergo such a procedure as this.

The remaining two organisations forming pieces of the over all QUM Strategy are the Pharmaceutical Benefits Scheme, (or PBS – mentioned above) and the National Prescribing Service.

The former of two, the PBS, is run by the Pharmaceutical Benefits Advisory Committee, a Government-appointed body made up of health professionals, bean counters and consumer representatives and, under the Scheme’s auspices, maintains a list (or ‘Schedule’) of all medicines subsidised by the Government.

The Committee, which meets three times a year, can – and does – recommend new products for inclusion on the PBS Schedule and as the PBS website makes clear: ‘No new medicine can be listed unless the committee makes a positive recommendation.’ And, since no new medicine can even be considered if it’s not already on the ARTG, patients with chronic conditions will be unable to obtain Government-subsidised cannabis medications for the foreseeable future, ensuring the cost of what they consider a necessary, even life-saving treatment is likely to remain extremely high or unaffordable if obtained by legitimate means.

The final body involved with QUM is The National Prescribing Service (also known as NPSMedicineWise) – a not-for-profit QUANGO, working independently of Government and, according to its website, aiming to ‘improve the way health technologies, medicines and medical tests are prescribed and used’, essentially acting as an advisory body to further facilitate the Quality Use of Medicines. The organisation is home to various online publications for both consumers and health professionals but has been quiet on the matter of cannabis.

Setting the safety standards for Quality Use of Medicines is the Australian Commission on Safety and Quality in Healthcare which is also responsible for Australian Charter of Healthcare Rights making this another likely stake-holding body in the medical cannabis debate, though it too has not unexpectedly, given the situation described above, been quiet on the subject so far.

Office of Drug Control & Friends

Next to the TGA within the Health Products Regulation Group sits the Office of Drug Control (ODC) created, it seems, to deal with much of the donkey-work left in the wake of the Narcotic Drugs Amendment Act. The ODC is responsible for regulating the import, export and to some extent the manufacture of controlled drugs (including cannabis and its cultivation), and as we have said, it is this institution that will be issuing licences for growing of the medicinal crop and – with States and Territories – to manufacturers that need it to make products.

Both the Narcotic Drugs Amendment Act itself and the ODC made very clear from the start strict criteria (including financial and being a ‘fit and proper person’) would have to be met before licences were granted and at the end of October 2016, over eight months after the Act was passed, it released its full, final and detailed Regulations – the Narcotic Drugs Regulation 2016 – for those involved in the commercial cultivation and production of cannabis and cannabis products. And the Office was true to its word about their exacting nature as this article in Vice explains. It’s not cheap either, with cultivation licences and permits – both of which are needed – costing over $7,000 (at time of writing, November 2016). Inspections, which can be carried out any time, are estimated at a further $7,000 – details of all fees can be found here.

The ODC has published Guidelines about all of this, covering manufacturing licence applications,  how to complete application forms,  compliance, enforcement and inspections,  fees and charges,  record keeping and reporting (important to the Office because of Australia’s commitment to the UN Single Convention on Drugs),  security, and the much-talked-of  ‘fit and proper persons’ requirement of licence holders and their staff. The information is summarised here and in a document published by the ODC on 1st November 2016. Application forms for all licences and permits are on the ODC website too.

The organisation has said it believes two hectares of greenhouse space will be sufficient to meet Australia’s medicinal cannabis requirement, prompting the ABC to ask, in July 2016, ‘Will big pharma lock ‘mum and dad growers’ out of medical weed?‘  In September 2016 space needed was re-estimated at 1.3 hectares by consulting giant Deloitte in an important report for the Government – Modelling the Cost of Medicinal Cannabis which has significance because the Commonwealth is obliged to provide information about how much cannabis it plans to produce to the International Narcotics Control Board which oversees compliance with the UN Convention on Drugs. A White Paper produced by ASX-listed cannabis production company MGC Pharmaceuticals and the University of Sydney Business School had previously guessed the greenhouse space needed would be between 1.3 and 5.1 hectares.

Compliance with the UN Convention has always been central to the Australian Government’s plans for medicinal cannabis, which, as we have said, stipulates this country provide an annual estimate of its over all crop to the above-mentioned, Vienna-based International Narcotics Control Board (INCB) which monitors the global production, distribution and use of all legally produced substances named in the Single Convention. The Board also needs to be informed of cropping areas, cultivators and licensing agreements and one of its requirements is the accounting for and destruction of any excess stock that’s produced to avoid its ‘diversion’ to illicit markets. Keeping the INCB happy is one of the Government’s major objectives, and this is mainly because of its opium.

Quietly, over the last fifty years, Australia, via plantations in Tasmania and elsewhere, has become possibly the world’s biggest producer of licit ‘poppy straw’ – the base constituent of commercially produced drugs such as morphine, codeine and other similar opioid pharmaceuticals. And supplying over 50% of the global raw product, all in full compliance with the Single Convention, makes this big business indeed – worth around $300 million per year to the economy and one Canberra does not wish to see jeopardised.

But in 2015, as the Regulator of Medicinal Cannabis Bill was being considered, a real likelihood arose some States would push ahead with the legalisation of medical cannabis regardless of what the Commonwealth did which would place a question mark over its responsibilities to the INCB.

As the ‘Regulation Impact Statement‘ in the Narcotic Bill Amendment Act Explanatory Notes puts it (p.16), had the Government of Australia done nothing: ‘..the risk to Australia’s compliance with its international obligations would be extremely likely to be realised,’ giving rise to a possible ‘negative impact on Australia’s licit poppy market and consequently the global supply of licit opiates.’

Making sure such risks are avoided falls to the ODC so its stances both on the space it plans to allow for harvesting and the criteria for obtaining licences (the latter cemented in legislation) warrants a degree of sympathy. This is especially true since statements both from that Office, the TGA and the their shared parent, the Health Products Regulation Group reflect a Government policy of expecting demand for medicinal cannabis be driven by patients and doctors even as such access is determined jointly between the TGA and States and Territories.

In considering the entire matter of medical cannabis, including the case for a possible stand-alone Regulator, the Government also had to be mindful of other existing legislation and regulatory frameworks, as pointed out by Martin Bowles, head of the Department of Health, in his Submission to the Senate Inquiry.  In addition to the UN Single Convention, Mr Bowles identified four – the Therapeutic Goods Act 1989, the Narcotic Drugs Act 1967, the Crimes (Traffic in Narcotic Drugs & Psychotropic Substances) Act 1990 and the Customs (Prohibited Imports) Regulations 1956 / Customs (Prohibited Exports) Regulations 1958 – explaining in turn how each of these would impact on the proposed Bill.  He detailed how ‘a significant number of Commonwealth agencies‘ were involved in the policing of cannabis, saying the Bill as it stood posed legal problems and suggested it would create ‘significant difficulties’ in preventing drug being stockpiled or diverted to the black market.  And he called for  a ‘coherent, clear and workable’ legislative framework to be adopted which he believed the Bill failed to offer.  The outcome, as we know, was the Narcotic Drugs Amendment Act of 2016, the creation of the Office of Drug Control to oversee the Customs Regulations and the Commonwealth’s UN Convention obligations with other regulatory matters left to the TGA and States and Territories. The Crimes (Traffic in Narcotic Drugs & Psychotropic Substances) Act 1990 gets no mention in the Amendment Bill’s Explanatory Memorandum.

To complete the picture, two further pieces of legislation – the Narcotic Drugs Legislation Amendment Bill and the Narcotic Drugs (Licence Charges) Bill 2016 – came before the Australian Parliament in November 2016. Their purpose was to further amend the 1967 Narcotic Drugs Act so the Government could impose charges for cannabis licences and ‘protect sensitive law enforcement information’ about those applying for them as well as provide the Health Ministers with various regulatory powers.

Explanatory Memoranda for each of the Bills can be found here and here and although both were passed, in a Senate debate on the matter, Sen. David Leyonhjelm – one of the sponsors of the original Regulator of Medicinal Cannabis Bill – opposed this final move.  Accusing the Government of ‘suspending a natural justice hearing rule’, Sen. Leyonhjelm said the powers it was giving itself to gather information secretly about prospective licensees allowed the government to expand the definition of a law enforcement agency as well as the term ‘drug’ and said it was ‘as if the government just gave birth to an industry and then immediately smothered it in red tape.‘ A video of his speech on the matter is here.

In addition to the organisations, strategies and policies sketched above, a few other bodies are relevant within the sphere of medicinal cannabis. Informing matters relating to medical and drug-related research and health standards is the National Health and Medical Research Council (NHMRC), an expert advisory body to Government, the medical professions and other interested parties from both public and private sectors. Part of its responsibility is research funding, thus for example, it provides money to the National Drug and Alcohol Research Centre at the University of New South Wales mentioned earlier. The NHMRC is also, among other things, home to Australian Health Ethics Committee (AHEC) which, as per its name, issues guidelines on ethical issues relating to health, including issues relating to clinical trials, especially on humans and these too will obviously play a part in determining the progress and future of medical cannabis use and research in Australia.

A further relevant agency is the Government’s Institute of Health and Welfare which provides statistics about Australians’ health and well-being and which has successively published a number of widely referred-to reports about medicinal cannabis and its use; in particular its annual National Drug Strategy Household Survey  is often cited as an indicator of the breadth of support for use of the drug in this way.

Last but not least, and because, nationally-speaking, there’s now a blurring of what is and is not the exact legal status of at least some cannabis users, Australian Immigration and Border Protection as well as Federal and State and Territory Police Forces also find themselves stakeholders within the area.

 

While Border Protection will take its cue from the Office of Drug Control and so deal with relevant products accordingly, all the time the substance remains essentially illegal, for these organisations it’s safe to say it will probably be ‘business as usual’.  In terms of policing though, some exceptions exist – like that of NSW with its Compassionate Use Scheme for registered medical users (see NSW page of site). And it might also be noted that Health Minister Susan Ley is on record as having told States if they wish to decriminalise the substance, it’s ‘entirely a matter for them’. But, as The Conversation highlighted in February 2016, problems remain of ‘…the state/territory drug driving laws (which) enable police to perform roadside testing of oral fluid for THC (cannabis)‘, adding ‘no proof of driving impairment is required to support a conviction by the courts,’ and pointing out ‘penalties for convicted drivers in some jurisdictions are quite severe involving a fine of over $1,000 and a driving disqualification of six months. For elderly people from rural areas dying of cancer, these are very significant..(and there are) no plans to amend the drug driving laws for people lawfully taking medicinal cannabis under medical direction’.

More History

The closing decades of the 20th Century saw the suggestion of some convergence of thought between certain corners of government, a number within the medical profession and various individuals working outside of authority who’d long argued cannabis was therapeutically beneficial. For early and subsequent research into such uses though it’s necessary to look outside of Australia to countries where most of the investigatory work has occurred and where use of medicinal cannabis is, and has been permitted.  A database of hundreds of such studies is available from the International Association for Cannabinoid Medicines, an organisation founded in 2000 to ‘advance knowledge on cannabis, cannabinoids, the endocannabinoid system and related topics especially with regard to their therapeutic potential,’ and whose website is a treasure-trove of information, opinion and learning.

The database lists upwards of 90 studies between 1970 and 1989, some as a result of the outbreak of AIDS when sufferers in the US who’d previously used the drug recreationally detailed its efficacy to that country’s Institute of Medicine which published a favourable report in 1982 (original,in full, here).  In 1985 the first cannabis-related product to be licensed by the US Food and Drug Administration was Nabilone (trade name Cesamet) a synthetic derivative of the psychoactive cannabinoid THC prescribed to reduce nausea and vomiting from cancer chemotherapy. In the same year, the FDA approved a second drug, Marinol (generically known as Drobinal) for the same purpose and in 1992 it also approved its marketing for the treatment of weight loss in patients with AIDS. Here in Australia, some HIV patients were also given Dronabinol under the Special Access Scheme mentioned earlier and in 2010 Nabiximols (trade name Sativex), became the first actual cannabis-based (i.e. non-synthetic) drug in the world to gain Regulatory approval when it was licensed in the UK. As we’ve already said, Sativex is the only cannabis-related product currently listed on Australia’s Register of Therapeutic Goods.

Renewed interest in drug-cannabis however really began in 1964 when an important discovery was made by an Israeli organic chemist, Raphael Mechoulam who, with his colleague Yechiel Gaoni, managed to isolate and synthesise versions of the cannabinoid THC – tetrahydrocannabinol, the psychoactive component of cannabis – though the reasons for its effects were unknown and would remain so until the late 1980s.

Then, US research found the brain contained ‘receptors‘ – molecules found in cell membranes which allow specific substances – hormones for example, or in this case cannabinoids – to ‘bind’ themselves to the cell. Moreover, not only did these receptors turn out to be more abundant in the human brain and nervous system than any other, but the body itself produced its own cannabinoids which, when bound to the receptors, were heavily involved an array of vital physiological processes. All this became known as the endocannabinoid system and gave rise not only to increased interest in cannabis research but led to massive breakthroughs in neuroscience as a whole after receptors were successfully cloned in 1990 and 1993. A detailed story of the discovery of the endocannabinoid system and some of its implications can be found on the US-based O’Shaughnessy’s Online website – a highly-regarded information resource on medical cannabis.  The ABC too has reported on this with  story + short video published on 1st November 2016 which also described local research work and conditions cannabis might treat.

Also back here, in the early 1990s, the National Drug Strategy Committee, administrative arm of the previously-mentioned Ministerial Committee, convened a National Task Force on Cannabis requiring it to report on public attitudes toward the drug as well as explore the health and social aspects of its use. Four separate documents would be forthcoming dealing with a number of topics and from them would be drawn a National Statement on Cannabis forming part of a wider National Drug Strategic Plan for the years 1993-97.

Although conclusions were focused primarily on negative issues and therefore a policy of continued prohibition would follow, one of the reports, ‘The Health and Psychological Consequences of Cannabis Use‘ prepared by the Drug and Alcohol Research Centre mentioned earlier, included a chapter ‘The therapeutic effects of cannabinoids’ reviewing evidence on the treatment of various conditions using the drug. The diseases in question were glaucoma, neurological disorders, asthma, AIDS and the use of cannabinoids for pain relief and as an anti-emetic. Conclusions were favourable over all, and the authors suggested ‘further basic pharmacological and experimental investigation, and perhaps clinical research into their effectiveness‘.

Research & Overseas

Around this time we find a small number of Australian clinicians cited in various of the peak journals on the subject of its medicinal use and as already mentioned Dr Andrew Katelaris began experimenting with cannabis therapeutically. (Many of these papers are no longer easily available and we are currently attempting to obtain them for use on this site. If anyone can help their assistance would be greatly appreciated). In 1994 and 1998 the Ministerial Council on Drug Strategy commissioned reports (now also seemingly unavailable) similar to those carried out previously which returned with similar findings, though little or no action was taken.

In terms of scientific enquiry during this time however, it would be unfair not to point out significant research also indicated a relationship – and maybe or maybe not – even  a causal link – between cannabis use, especially if regular or heavy, and mental health problems such as anxiety and, as some argued, schizophrenia, particularly among young people. This is an area fraught with controversy not least because, as Professor Wayne Hall – an important voice in the cannabis/medical cannabis debate in Australia – and others pointed out over fifteen years ago in the British Medical Journal ‘Rational debate has often been obstructed because the media present a forced choice between two sets of views. One of these constructed views is that cannabis is harmless when used recreationally, is therapeutically useful, and hence should be legalised. The other is that recreational use is harmful to health and that cannabis should continue to be prohibited for recreational or therapeutic purposes,‘ an observation with which it’s hard to take issue.

On the other hand, for legal reasons cannabis has been difficult and expensive to source for clinical research and even then most resources have traditionally been allocated to studies on the negative effects of the drug.  A large proportion of evidence of its possible medical benefits has necessarily then been ‘anecdotal’.  Add this to the fact the herb has so many active ingredients rendering it generally unattractive to the pharmaceutical industry, it becomes easy to see why progress in its re-introduction to medicine or the pharmacopeia has been slow-going and difficult.

Nevertheless, research does exist, as the International Association for Cannabinoid Medicines website reveals, and a search on PubMed meanwhile, the US Institute of Health National Library of Medicine website – housing one of the world’s biggest databases of over 26 million medical citations – throws up over 20,000 results using the term ‘cannabinoid’.

Reviewing each one (even allowing for a majority to be considered outdated or of little relevance) would of course require huge endeavour; we mention them here to indicate the wealth of material that exists on the subject; a glance at the titles alone is itself a telling experience.

From around the year 2000 a number of Governments internationally looked seriously at making the plant legal for medical purposes (and a few its recreational use) so that today several are often referred to as exemplars in the continuing debate on the subject. The 1996 ‘Proposition 215‘ Campaign in California (to legalise use of marijuana for cancer, AIDS patients and others) is an obvious famous example of such a discourse and currently medical grade raw cannabis is available in nine countries (these being some states states within the US – where it remains illegal at Federal level; Canada; the Czech Republic; Denmark; Finland; Israel; The Netherlands and Uruguay).

Countries most often cited (because of the relative – though varied – maturity of their research programmes and/or regulatory systems and /or medicinal cannabis markets) are Canada, Israel, the Netherlands (each of which have official Medicinal Cannabis Programmes) and the USA, although the Wikipedia page ‘Legal and medical status of cannabis‘ provides some useful additional background on other jurisdictions as well as more general information.

In the countries we highlight however, accounts, State variations and legal opinion differ as to when therapeutic cannabis became permissible in the US and Israel but in Canada the drug was legalised for medicinal use in 2001. The Netherlands had long had a history of tolerance, but the Government opened an ‘Office of Medicinal Cannabis‘ in 2000 and three years later fully regulated prescription forms of the raw herb were available from pharmacists supplied by the firm ‘Bedrocan‘ working under licence for the Dutch Government. Bedrocan – which made a Submission and gave evidence to the Australian Government’s Public Inquiry mentioned earlier – also exports to other countries such as Finland, Denmark and the Czech Republic.

Additional information about each will be posted to this website since it is possible – even likely – Australia’s medicinal cannabis journey will mirror aspects of one or more of the models elsewhere or at least pull on some of its learning. Israel in particular is of interest because of its pioneering work using the drug for a variety of diverse conditions and with a variety of the plant’s strains;  over 20,000 people are currently being treated for illnesses such as Crohn’s Disease, Post-Traumatic Stress Disorder, pain relief and appetite stimulation. Its Government-licensed supplier Tikun Olam – the country’s largest – has a number of clinical research projects past and present available on its website and was one of the subjects of a documentary by Australian TV reporter Helen Kapalos. And, like Canada and The Netherlands, the country has its own Medical Cannabis Unit within its Department of Health.

Ms Kapalos gave up her Channel 7 anchorwoman job to self-finance the film – A Life Of Its Own, released in October 2016 – after being inspired by Dan and Lucy Haslam when filming the Sunday Night TV show in 2014 which catapaulted the Haslams into the spotlight. Mrs Haslam too would visit Israel with NSW Premier Mike Baird in April 2016 to look at the country’s medical cannabis technologies, said to be cutting-edge and making it a world market-leader.  (And she would also, after Dan’s death, feature in another TV documentary – ‘Doing It For Dan‘, an ABC ‘Australian Story’; all three films are well worth a watch, though while two are available on YouTube ‘A Life Of Its Own’ does need to be purchased from Ms Kapalos’ film distribution company).

Closer to home, until around 2013, moves toward and even discussion about legislating for medicinal cannabis were halting and – as to be expected from federated government – piecemeal in nature. In 1997 a World Health Organisation report, identified ‘a clear need for both epidemiological and applied research on cannabis and its derivatives‘ and indeed from 2000 various studies, papers and other reports on the issue materialised which obviously came to the attention of the authorities and cumulatively, can reasonably be said to have nudged lawmakers in the direction of relaxing matters in terms of cannabis use within medicine.

One of the most widely quoted of these is one from 2000, by the Working Party on the Use of Cannabis for Medical Purposes chaired by the aforementioned Professor Wayne Hall for the New South Wales Government, which recommended the State sanction research into medical cannabis products, a ‘compassionate’ scheme for appropriate patients and a trial-run of exempting individuals possessing, growing or using the herb for therapeutic purposes. But the report also concluded ‘crude cannabis cannot be prescribed and is unlikely to ever be prescribed in Australia’ and felt access to the drug should be given ‘only to patients with serious illnesses who may benefit from its medical use‘. None of the recommendations were acted upon but the document clearly had an effect since it remains among the most widely cited among subsequent State, Territory and Federal investigations of the matter. A decade and a half later Professor Hall would make a Submission and give expert evidence to the Federal Government during its Public Inquiry into the Regulator of Medicinal Cannabis Bill.

From then until around 2013 things seem to go fairly quiet in Australia on the medical cannabis front -the research database Australian Policy Online lists just three between 2005-2014.

But from then, after the Haslam family and others began their campaigns – stories the media found irresistible – a flurry of activity, some of which is described above and other aspects elsewhere in the site, led to the legislative changes of 2016, including the intervention of such figures as ex-Prime Minister Tony Abbot publicly stating he felt cannabis should require no further testing if already approved overseas.

A time-line describing all this is provided on the NCPIC website and the arguments that arose during the course of events are described there. They involve, on the one hand, those researchers, practitioners patients and patient carers, too numerous to name, for whom cannabis is a real medical option, tried and tested sufficiently to make it immediately (and fairly widely) available, and others for whom there are major doubts and the need for further research.

The situation as it stands (in December 2016) though is not ideal.  Already some, including philanthropist and businessman Barry Lambert who donated over $30 million to Sydney University for a centre for Cannabinoid Therapeutics (see NSW page)has slammed the Government for creating an ‘unworkable’ bureaucracy.  Having invested in industrial hemp grower Ecofibre, which had planned to grow cannabis for use in cases of intractable epilepsy, operations are being forced abroad. A report (behind Paywall) in the Australian Financial Review describes how ‘the regulations passed in October require that a grower must prove in advance that they have a specific manufacturer lined up who is supplying for specific approved users. But this is a  Catch 22 because it is almost impossible to get permission to use cannabis‘.

It added Mr Lambert was also unhappy because medicinal cannabis must be grown in costly high-security glasshouses and Ecofibre grows in broad field.

Added to Queensland Medical Cannabis Advisory Group’s complaints and petition about patient access and a picture begins to emerge.

This article can only scratch the surface of what is clearly a massive subject but improvements to it are welcome.  In the meantime we wait and watch for developments – some of which are likely to be hugely exciting – and will update the site accordingly.