Cannabis Policy Car Crash

19 Dec 2016: Government (in)action on medical weed 'unconscionable'

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Australia’s move to legalise medicinal cannabis is already a huge failure critics of the scheme say.

The country’s Federal Government is on a collision course with would-be commercial producers and patient groups less than two months after the legislative and regulatory changes took effect that were intended to permit the plant’s cultivation and use for therapeutic purposes.

But campaigners and industry insiders claim the rules – which came into force on 1st November – have, if anything, made the plant harder to grow and medicine no easier to obtain.

Already one of the country’s biggest industrial hemp farmers, poised to enter the medical market with oil made from plant strains it has been breeding in Australia for fifteen years, has shifted operations to the US after finding itself blocked by the new regulations. One of its shareholders, millionaire philanthropist Barry Lambert who last year endowed Sydney University with $34 million for research into medical use of the herb, described the system as ‘unworkable’ and accused Australia of ‘not being serious’ on cannabis. ‘The chance for Australia to be smart and innovative has once again been thwarted by our government,’ Mr. Lambert said.

A patient advocacy group is petitioning Canberra because it says claims by the Government the drug had been legalised for medical use were ‘false and misleading,’ calling the idea that patients could go to their doctor and be prescribed it ‘political spin and propaganda’. Another group is understood to have raised similar concerns with Ministers also at national level.

Elsewhere, a clinic that had been growing plants to make extracts for children with intractable epilepsy has been raided and had its crop confiscated. The clinic says this could leave up to 1,800 people stranded without access to critical treatment.

But no licences have as yet been awarded by the Department of Health to grow plants or make products from them despite a queue of experienced firms – some listed on the Australian Stock Exchange – keen and ready to do so but prevented by bureaucratic restraints.

And last month one of the drug’s most emphatic and long-standing political champions, New South Wales Senator David Leyonhjelm, opposed final pieces of additional legislation that nailed the regulations in place accusing the government of ‘first giving birth to a new industry then immediately smothering it in red tape‘.

To make matters worse, legislation surrounding the drug – in some ways the opposite of what many campaigners had wanted – mean State and Territory laws bring an additional tier of beadledom, creating a postcode lottery in terms of potential availability. This is because patients wanting access to cannabis or doctors who wish to prescribe it must first obtain permission from the Federal Government’s national Regulator the Therapeutic Goods Administration and then from their State or Territory Health Department – with rules varying between jurisdictions. One of them – the Northern Territory’s – doesn’t grant any permission at all.

Taken together it looks like an impending debacle in the arena of public policy with an unwelcome PR dilemma. And the the Government is getting twitchy.

Last week it took the unusual step of publishing a rebuttal of a report (behind paywall) in the Australian Business Review after Mr Lambert’s company Ecofibre announced it was leaving Australia. ‘We have an Australian company, Australian seeds, Australian shareholders, but we have to go to America because of the legislation,’ Mr Lambert was quoted as saying.

What he was referring to were arrangements laid down by the Government’s recently-formed Office of Drug Control, set up to licence, regulate and monitor cannabis cultivation and product manufacture. The Regulations stipulate growers show they have a licenced manufacturer lined up to buy their crops while manufacturers themselves need to demonstrate they have a market with end users in mind – including customer details. Meanwhile, schemes governing access to cannabis only allow for existing compounds to be prescribed, thus causing a Catch 22: a manufacturer won’t be allowed to make something unless there’s a demonstrable market and the market cannot be demonstrated unless the manufacturer first has a commodity which could then – it follows – be prescribed. With supply and demand both of raw plant and end product so ludicrously played off against each other the situation is Kafkaesque; chicken and egg are somehow expected to materialise simultaneously – if they don’t, all concerned are left stymied. Mr Lambert’s chagrin therefore isn’t entirely unwarranted.

On top of this, Ecofibre say the plant strain they’ve successfully been growing for a decade and a half in the Hunter Valley, NSW, is perfect for making high CBD hemp oil for use as an epilepsy treatment but the government is preventing them from doing so. While authorities say the crop is fine for industrial purposes and contains only small traces of THC – the psychoactive ingredient of cannabis – it cannot be used to make medicine because open field growing conditions do not meet the ODC’s strict cultivation criteria. In practice this means the firm now exports Australian seeds to Kentucky in the US where they have legally grown and harvested 500 acres this year. Oils derived from the crop are then lawfully sold to the burgeoning American market and – it is hoped – some shipped back to Australia. But even on this the ODC isn’t happy, refusing to allow the oil into the country unless first approved for export by the US Drug Enforcement Agency. This, Ecofibre says, is unnecessary because the US 2014 Farm Bill enables MOU holders in Kentucky legally to export products made from the hemp plant – and round the argument goes.

Up against so prominent a voice as Mr Lambert’s the Government was quick to hit back, issuing its press release within 24 hours of the Lambert story’s appearance. Titled ‘Correcting the record: Australian Financial Review story on medicinal cannabis‘, the statement claimed the ODC was already in the process of assessing medical cannabis licence applications and insisted an increasing number of requests for cannabis derived products had been received and approved – something patient organisations flatly refute.

One of them, the Queensland Medical Cannabis Advisory Group began a petition in November accusing the Government of ‘changing the goalposts’ in respect of who could or could not be prescribed the drug saying regulations placed it out of the reach of those needing it most. And campaigners have described the ‘legal vacuum’ that led to the late November raid on a ‘wellness clinic’ in Newcastle, NSW in which over 200 plants were seized and their owners left open to drug trafficking charges. The State has its own ‘Compassionate Use Scheme‘ which exempts some users from prosecution and a number had been obtaining it from the establishment. ‘It’s not much use if the (State) government allows people to use medicinal cannabis but then busts the people who are helping provide it,’ said a clinic representative. Another added ‘each of those plants has a child’s name on it and that child will now suffer greatly as a result of this ill-conceived action.’

These and other similar tales provide a litany of woes that have dogged Australia’s beleaguered ‘medical cannabis initiative’ since its inception early this year, including, lest it be overlooked, the fact that no allowances have been made for those found driving with the drug (lawfully) in their system. Impairment is not necessary for an offence to have taken place and cannabis, notoriously, can take days to exit the body while drug-driving is heavily punished.

Passage of the Narcotic Drugs Amendment Act last February should, in the words of Health Minister Susan Ley, have provided the ‘missing link’ that would enable States and Territories to ‘cultivate and supply cannabis for medicinal and scientific purposes.’ The ‘missing link’ she said then was ‘from farm to pharmacy,’ an effective enough soundbite though bearing little resemblance to fact. It was nevertheless seen as a promise by campaigners who are now feeling extremely short-changed.

Partly behind all this is the Government’s perhaps understandable preoccupation with the UN Single Convention on Drugs to which Australia is a signatory. The Treaty groups the plant with narcotics like cocaine and heroin but was written in 1961 before science began to realise the potential of cannabis after the discovery of the endocannabinoid system within the body. And it means the Government must tread very carefully; non-compliance could threaten Australia’s lucrative opium poppy trade which accounts for over 50% of the global market in raw product used to make drugs like morphine, codeine and other opiate-based medicines.

It was the Single Convention that led Ministers to reject earlier legislation – the Regulator of Medicinal Cannabis Bill – proposed by the Australian Green Party and moved by the Senate with cross-bench support in November 2014.

Had it been enacted, the Bill would have created a single purpose, national, stand-alone body responsible for overseeing everything medical cannabis and nothing but medical cannabis – a true link between farm and pharmacy like Minister Ley has described.

From 2013 many had been campaigning for precisely that and had gained overwhelming public support, evidenced in massive publicity and a 250,000-strong petition to the Australian Prime Minister Malcolm Turnbull. It placed the issue very much on the agenda for politicians quite literally left, right and centre. When the State of Victoria looked as though it would go it alone on the matter in 2015 the Federal Government was forced to act. There is little doubt had it done nothing Australia’s smallest but most densely populated state would have forged ahead and – arguably – put the country in breach of the Single Convention. Grass-roots activists and a number of big hitting medics and academics lobbied in favour of this specialist Regulator; the model wasn’t a novel one – at least three countries, Israel, Canada and Holland, have such dedicated organisations and they appear to be running well.

But the idea was doomed. In early 2015 a meticulous Public Inquiry into the proposed Bill by the Senate’s Legal and Constitutional Affairs Legislation Committee led to a recommendation it be enacted. But the Government chose not to listen. An election year was looming and clearly some action was called for. But instead of considering the views of experts and those in the front line who spelled out why cannabis is in some ways exceptional and, due to its complex chemistry, can’t be pigeonholed like other drugs, Ministers took the advice of their mandarins and more conservative, less knowledgeable elements within the healthcare professions. Between them these factions argued vehemently the Bill was unnecessary and potentially dangerous, that it broke with the Single Convention and that cannabis, far from being unique, should be viewed the same way as all other medicines.

So the Government did several things. First it placed responsibility for the drug not in the hands of any proposed new institution but rather within those of its existing medical regulator the aforementioned Therapeutic Goods Administration. And it did so regardless of strenuous and detailed explanations during the Inquiry as to why that institution had neither the expertise nor organisational apparatus to deal with a substance like cannabis – in fact, it was argued, the TGA would be supremely ill-equipped to do so for reasons that are not hard to grasp. The TGA, like its counterparts elsewhere in the world, can only evaluate and approve drugs using conventional regulatory standards – and cannabis just doesn’t fit them. 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). Cannabis itself therefore cannot be seen as a particular ‘drug’ in the way that say morphine or paracetamol can. Which is why, had politicians been really serious, creating a purpose-built agency outside the normal regulatory framework would have been as good a way as any to deal with what are, in fairness, some difficult issues.

But the politicians – senior ones at any rate – did not feel so inclined.

Amending existing drugs legislation to allow for the plant’s cultivation they then set about its rescheduling within the national Poisons Standard, changing it from a Schedule 9 (‘Prohibited’) substance to a Schedule 8 (‘Controlled’) one. At the same time the Office of Drug Control was established to take, as we’ve said, responsibility for the licensing end of things and middle-ranking officials with no expertise in the subject quickly got to work creating the regulations that have caused so much affront. Patient access would be dependent on ‘Special Schemes’ already in use at the TGA through which, under certain circumstances doctors can prescribe and patients may obtain (at their own expense) products unapproved in Australia. But these too were tweaked to make cannabis more difficult to obtain than any other supposedly lawful drug. The Government meanwhile continues to claim ‘the benefits and risks of medicinal cannabis have not been adequately characterised‘ – a position at odds with the evidence which led to the law being – theoretically – relaxed in the first place. And it contrasts markedly with Ms Ley’s pledge to to make the TGA Schemes work effectively:

The steps we take in health must always be with the patients in mind and this is very much a measure for the patients…. their advice, their input, their passion and their advocacy has brought this to our attention,‘ she told Parliament the day the law was amended.

Throughout the entire saga no medical cannabis users were consulted even as the Government reneged on yet another of its commitments – the creation of an Expert Advisory Council to provide guidance on what is by anyone’s reckoning a complex and difficult landscape. Bulldozing ahead, unaided, with such a poorly designed system was bound to cause discontent.

The result has been chaos and a barely concealed antipathy toward not only the Turnbull Government but the bureaucrats in its employ. Advocacy groups like the now pre-eminent United in Compassion, which led the charge to get the law changed and became, in the process, the biggest organisation of its kind in Australia, reports scores of calls from bewildered medics and patients alike no better off than they were prior to the legislative changes. Some campaigners believe the difficulties have actually increased the black market in medical cannabis.

What might occur next is a matter for speculation; in the words of one Ecofibre executive ‘the draconian measures being put in place do not in any way support patients’ rights to access this medication and equally make it unviable for producers and manufacturers’.

But perhaps that was always the plan. Such exquisitely awful policy and regulatory design flaws as these and apparent changes of heart are otherwise inexplicable.

26 thoughts on “Cannabis Policy Car Crash”

  1. This is shocking news. I thought the matter had been successfully resolved. What can we, the ordinary person, do to help?
    Chris

  2. The way I see it, the only reason it has got to this stage is due to public pressure and the overwhelming evidence showing its health benefits. Else they would have kept this natural, God created plant forever stained by the Pharma backed regulators. Very hard to believe that the sole purpose of governments is to provide services, NOT to continually meddle in the people’s free choices.

  3. This article describes the current Prohibition Style Access Scheme very well. As a pharmacist there is already enough oversight in schedule 8 prescriptions without adding multiple layers above it. The current regulations are not in the public interest and need to be scrapped

  4. my 8 year old daughter has an undetermined complex neurological disorder and refractory epilepsy, she is in palliative care and has been using mc for over 18 months now and all medical avenues have been exhausted. cannabis oil wont cure her nothing will but it gives her the best quality of life possible. state and federal govts. should all hang their heads in shame as the regulations they impose make it impossible to access mc especially here in qld. it is all in my opinion a smoke screen as they dont seem to realy want to help the sick and suffering, sadly i dont think my daughter will get to see it legalised and will die a criminal

  5. Barry, I was so pleased when I saw your commitment to cannabis. I was just an interested bystander, but now my husband has mesothelioma (asbestos disease) & with his pain getting worse I would love to ease his symptoms. So I am devastated by this govt. Keep up the fight. Gaye Barbour.

  6. Well said, great to have the complexities and spin unravelled. Too true will Gov releasing self congratulatory PR, people are suffering and dying. There needs to be urgent access and education, especially around the scientific facts, cannabis is safer and more effective than modern medicine for many disabling and deadly conditions, it’s just the chemical companies sponsor the government and they can’t actually upset them by letting a popular alternative be freely available. If people were the first priority there would be cannabis in every ambulance, and ED like the epi-pen, status epilepticus is no less dangerous than anaphylaxis…and that’s just one therapeutic benefit they are failing to provide to the sick..

  7. The Constitution clearly states that the Federal Gov has no say over agriculture so how the hell can they make laws restricting access to produce.

  8. A well written article that has explained to me what a debacle the Australian government has created, once again.
    I had thought it was done and dusted so those people this drug could help would be able to access it legally, apparently not.
    I thought industries growing crops would get the help they need and be able to compete against the rest of the world with the Australian Government fully behind them, apparently not.
    We had a great opportunity, once again, to do something really good for our country, to show the rest of the world what a great country I think we are but once again, that has been wrecked by politicians with what seems to be their own self serving agendas.
    Instead of leading the way and lobbying to change the outdated UN Single Convention on Drugs, they’ve just stuck their heads in the sand, once again.
    When will we have politicians of caliber and intelligence leading this country?
    Perhaps pressure from the international community will embarrass the Australian Government into reassessing and changing the legislation.
    Maybe if someone close to Turnbull needed to use this drug to find relief from their symptoms, he would have done it right the first time.

  9. MY son (42 years old) has Early Onset Parkinson’s disease. I pray that medicinal cannabis product is made available to him soon as his medication isn’t working any more. I just hope the powers that be who make this product unavailable to people like my son realise what they’re doing and can sleep at night!!

  10. Likening this situation to computer copy protection…
    Legitimate users are hurt because of red tape in-effectively attempting to block the illegitimate…
    The worse bit is, I’ve seen some great supporters, who as of December, now reside in the US due to Australian law not progressing or back-pedalling.

  11. So it’s ok for opium poppy to be ‘field grown’ NATURALLY and sold for making medicine but for hemp it isn’t?! What utter hypocritical nonsense!

  12. After visiting growers and CO2 extractors in Kentucky, Colorado & California and looking at the first rate farming & extraction setups being conducted there it makes me sick to see just how inept our politicians are when dealing with the issues surrounding the growing, production and regulation of medical cannabis and the non-THC extracts that can be easily produced from this plant.

    Its about time that our Prime Minister pulled his head out of his behind and started listening to independant non-vested experts who are not aligned with Big-Pharma. There is so much potential for employment, export and easing real human suffering wth non-THC products, particularly when combined with other extracts, such as essential oils for both topical and internal use.

  13. Excellent inforamative article that has answered so many of my questions. I will gladly put my name to any petition that will help change these destructive laws in place now.

  14. If the people of Australia woke up to themselves and moved to have it legalized for all purposes, everyone both sick and well, could enjoy the benefits of one of the safest drugs on the planet. I’ve been waiting for the last 45 years, not that that minor issue impacted too much on my capacity to enjoy my favorite herb.

  15. The Fed Govt is obviouly not serious about making CBD available to cancer patients. They are a bunch of weak kneed clowns who are more interested in traveling around the country with their wives on their personal business and making taxpayers pay for the joy rides. Bunch of selfish time wasters.

  16. Mr Turnbull what happened to Australia being the Innovative Country? Ha ha what a joke.
    Yet again, all talk!!! When are we going to see some REAL action on this. Isn’t it time for you to do something constructive or have you already figured you won’t be in government after the next election?

  17. So ashamed to be part of a society that doesn’t act quickly in adopting evidence based proposals that will immediately reduce suffering.

  18. I must disagree with a number of comments suggesting the politicians need to wake up and listen to people.
    The politicians are very intelligent people and know exactly what they are doing!

  19. The really sad part about this is that we once had a Government who actually cared about us average people with average problems, his name was Kevin Rudd he would have made sure it got implemented with out all the BS redtape as he was the only leader of this country to have any compassion in his heart.
    I have got severe Insomnia, Depression, Chronic back pain just to mention a few, and the only thing that keeps me from going insane and murdering anyone who comes in my vicinity, or myself at times, is good old Cannabis.
    I have smoked cannabis for 32 years and I’m 47 at the moment, I have never had a car accident due to being intoxicated on cannabis so why is it treated the same as Alcohol and other more serious drugs like Ice which do impair a persons ability to drive a motor vehicle.
    Only time I have ever had a car accident is under the influence of Alcohol, and if a driver is under .05 he is good to go, but lord no should a driver who smoked some cannabis the night before or even 3 days before get pulled over, who is no longer under the influence of cannabis as the intoxication only lasts for 4-6 hours and lot less for some, still get charged and loses their licenses for 3 months automatically not to mention the enormous $FINE$, what a load of BS.
    Turnbull you puppet, get of your lazy ass and help us Australians who need this Drug for cancer relief, Epilepsy, pain relief, mental issues, and much much more.
    Stop licking the big pharma’s behinds and receiving hidden kickbacks, and do what’s RIGHT for Australians for once in your term as Prime Minister of Australia.

  20. Go underground. These pack of A-holes wouldn’t know if it was on fire. Utterly nauseating listening to the suited low-lifes argue over expenditure on travel and tours. Go underground and help the sick and dying regardless. Business as usual folks and remember them at the polling booth!

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