Cannabis Campaigners Smash Australian Trials and Pharmaceutical Influence
19 Dec 2016: Government (in)action on medical weed ‘unconscionable’
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.