28th July 2017: Authorities put on defensive at last
The war over medical weed has entered a new phase with lawyers now taking up cases on behalf of patients unable to obtain the drug due to this country’s broken and unworkable system.
On the off-chance it passed anyone by, Australia’s experiment with cannabis is failing, and failing spectacularly. An insistence by the Federal Government nearly two years ago that the plant be forced into a pharmaceutical model of manufacture, approval and supply as applied to other, more conventional drugs has proven itself a disaster, leaving thousands of patients across the country bereft of a product many had campaigned for years for the right make use of and which Canberra had promised they could.
By its own admission, the Government’s medical regulator the TGA, charged with looking after all so-called ‘licit’ use of the plant, has allowed access to only handful of individuals and doctors authorised to prescribe it, nearly all of the latter in clinical trials. The unregulated market meanwhile has grown exponentially, meeting a pent-up but unsatisfied demand and leading to a series of high profile arrests involving some of those operating within it.
The result, unsurprisingly, has been massive unrest among patients and advocacy groups alike who feel betrayed by politicians they thought had been persuaded both by huge popular pressure and an almost year long Federal Public Inquiry which took place in 2015. Its findings were published in a lengthy report advising the Government against placing responsibility for cannabis with the TGA and instead recommending the creation of a stand-alone specialist Regulator as proposed by a Greens Senate Bill passed by the Upper House in November 2014.
But the LNP it turned out wasn’t listening, rejecting the idea out of hand and insisting the herb should be treated ‘like any other medicine’. Thus was it entrusted to the TGA’s tender care and made subject to a framework of regulation and approval many insist is ill-suited, sparking an angry revolt. Advocates and would-be patients say the application processes involved make it nearly impossible for them or their doctors to get hold of despite a victory in the Senate last month which saw the overturn of rules designed to prevent a notification (rather than approval) mechanism to allow fast-track access to such medicine for the terminally sick.
High profile raids and arrests of notable illicit suppliers meanwhile have fanned the flames further as has the antipathy of many in the medical establishment who argue ‘insufficient evidence’ exists in regard to the plant’s therapeutic value. This last many see as suggestive of Big Pharma at work in the shadows, thwarting moves toward relaxing the rules: in jurisdictions where the herb has been allowed significant drops in prescriptions for an array of other drugs have been noted, particularly opioids used in pain relief, so bottom lines are quite visibly at stake.
To exacerbate matters yet more, State and Territory legislation in addition to that at the Federal level has meant a piecemeal, un-coordinated and massively confusing extra tier of red tape and duplication. Here, quite often further approvals and specialist involvement are required before anyone can get near to the drug. The situation has led to a paltry handful of approvals in States like Queensland – which has granted just four – and NSW (eighteen) despite massive demand among patients and growing attestations worldwide of the benefits cannabis offers.
All in all then it’s a sorry state of affairs in which the TGA blames the States and healthcare professionals, the States blame the TGA while the healthcare professionals blame everyone else – and looks suspiciously like a deliberate ploy on the part of the authorities to keep the herb as far out of reach of sick Australians as possible. Particularly annoying, say advocates, is that such shenanigans are openly taking place while Governments maintain the pretence of having made cannabis easily available.
This roughly speaking, is the backdrop (further, more detailed commentary is here) to what has become an increasingly embittered struggle between those seeking a legal source of what for some is a life-saving drug and the forces bent on placing road blocks at every turn. The resultant showdown is presumably one the powers-that-be imagined either wouldn’t happen or would somehow just go away. But developments of late will haven given them cause to reconsider.
Remember Dr Nicoletti’s name – it’s integral to this story and one likely to occupy a prominent place in the annals of the medicinal cannabis struggle.
With a background in the pharmaceutical trade as well as assisting Canberra with aspects of drug regulation, Dr Nicoletti had early involvement in the Australian medicinal cannabis sector, helping a number of wannabe growers and manufacturers with the tribulations faced in their licensing applications. As such, she’s more familiar than most with the attendant legal and regulatory hurdles, clearance of which requires higher-than-average athleticism.
Dismayed by the bleak landscape of patient frustration and young lives at risk, Dr Nicoletti has made herself and a small team available on a pro bono basis to a handful of families desperate to find a legal supply of cannabis products but struggling to navigate the bureaucracy.
One of these, the Peek family in Queensland, has battled the State Health Department for more than two years with little or no success while trying to get suitable medicines for their nine year old little girl Suli, who has multiple neurological disorders and suffers intractable seizures. Like many others in a similar position, the Peeks have found that cannabis is the only medication able to improve Suli’s quality of life, and yet they have been forced into using the black market.
The legal position, the Peeks were led to believe, was that cannabis can only be prescribed by a specialist and only dispensed after that specialist’s prescription has been approved by the State’s Expert Advisory Panel.
Not so, said Dr Nicoletti, pointing out that nothing in the Queensland legislation says anything whatsoever about permissions from such a panel being necessary where a specialist prescribes to a patient like Suli.
Queensland Health conceded this point. Notification alone, within seven days of a prescription being issued, is all that’s actually required, though a specialist will still have to write it.
That in itself is a win, although the challenge isn’t over just yet – it remains to be seen whether the medic involved has to be Queensland-based or whether an out-of-State specialist would suffice. And this is important because many strongly suspect a push to deter so-called ‘patient class prescribers’ from recommending or using the drug, including those at Lady Cilento Children’s Hospital where Suli is a long-time patient.
On the matter of finding a prescriber for Suli, Dr Nicoletti’s intentions are clear: ‘If a doctor, a neurologist say, claims lack of evidence or excessive risk then I would say the most important evidence is that which is already in front of them – their patient who is already benefitting from cannabis. In fact, it’s the only evidence that’s relevant in the context of that patient because one of the most well known characteristics of this medicine is that what works wonderfully for one person may not work at all for another. It’s why n of 1 trials, tailored to the individual, are the only way forward with this. And doctors have just got to accept that. Failing to prescribe cannabis in cases such as Suli’s amounts to a failure to do the best for their patient. Seizures which could otherwise be prevented or reduced using the drug themselves cause enormous harm and I shall be pointing that out.’
Her intervention in Queensland has, on paper at least, already made it easier for patients there to access the medicine they need and establishing whether outside specialists can indeed prescribe is the logical next step. Failing that, she’ll be approaching the doctors directly.
NSW is now in Dr Nicoletti’s sights, with the legislation there likely to pose a greater challenge than in Queensland: ‘It’s more or less open to be used however the Health Department wants; all patients need to go through the State’s Advisory Panel which seems to be duplicating the Federal approval scheme and unnecessarily stifling access.’
She will however work through all States if necessary, seeing their involvement as standing in the way of the patient-clinician relationship.
‘And if they’re stalling, I’ll call them out on it‘, she says, while describing the headway in Queensland as ‘extraordinary’.
Likely to be on the offensive as well is prominent Tasmanian-based Human Rights advocate and lawyer Greg Barns who for some time has been talking of exploring the cannabis matter from a specifically human rights angle. Though difficult and complex, those in the know suspect such a move might have legs.
The ABC have much of this information already gathered (but not used) for a piece aired this week on the 7.30 Show as campaigners gear themselves up for another round in a struggle that’s looking likelier by the day to become an election issue come 2019 if problems aren’t faced – and dealt with – by then.
Meanwhile, a number of high-profile cases, this time on the defensive, are scheduled in the fairly near future and which the authorities are unlikely to relish.
Jenny Hallam, a supplier from Adelaide who gave her medicines away free, was raided early in the New Year and her arrest met with an outpouring of public disgust. Her day in court is in September – following several adjournments – when her support is expected to be large. Another campaigner, Deb Lynch, Secretary of the 15,000-strong Medical Cannabis Users Association, has a Hearing slated the same month in Brisbane – and she plans to plead not guilty due to medical necessity.
Such a defence looks likely to have merit too – a 2014 paper published in the Journal of Law & Medicine (JLM) by Charles Martin then of Queensland University goes to fascinating lengths to spell out why.
The paper, called ‘Medical use of cannabis in Australia: “Medical necessity” defences under current Australian law and avenues for reform‘*, though pre-dating the Narcotic Drugs Amendment Act of 2016, still contains key arguments relevant today. We’re grateful both to the author (ironically now employed by the Queensland Director of Public Prosecutions) and JLM publisher Thomson Reuters for allowing us to make the thing available; it is, we suggest, critical reading for anyone facing charges relating to medicinal weed. If the paper is correct – and there is little to suggest it is not – such individuals seemingly stand a good chance of arguing a successful defence if a number of criteria are met.
Which might prove of useful to another defendant – Dr Andrew ‘Pot’ Katelaris, a highly conspicuous figure busted the day after the Sunday Night TV show broadcast a highly sensationalised programme about his use of cannabis products on a young child caught in a tug-of-war between his parents and carers and State Family and Community Services. Katelaris too has vowed to plead medical necessity and opt for a trial by jury.
Whatever the outcome of these and other cases likely to be brought in the future, one thing is looking certain – that things can’t continue as they are. As Dr Nicoletti points out, cannabis medicine means individualised treatment, quite literally finding the right strain, administered in the right dose for the right patient – a process anathema to the TGA model. It also works best in its natural, botanical form, not the kinds of highly refined, factory-produced pharmaceutical products the Regulator is geared up to handle and which it would like to turn the herb into. The idea of a whole plant being approved and registered (and thus, potentially subsidised on Australia’s PBS) is currently unthinkable.
And the growers themselves are running scared. Though sizeable investors in the system as it is, and as such, almost by definition no great friend to patients or advocates, still they recognise the need for doctors who are willing to prescribe ‘or there won’t be an industry’ as one of them recently bemoaned.
The fact is though there probably will be, in time and after some bitter fights are won. But it won’t look much like it does at present and it won’t be keeping patients out. In the more immediate term, for those already invested, the consolation of a lucrative export market beckons as the Office of Drug Control is making clear. The Department recently asked for ‘feedback’ on such plans, as if admitting the domestic scene has stalled.
None of which is consolation for those needing the medication in Australia and every reason why campaigners are girding themselves to joust on – and likely turn the next few weeks into gripping ones where medicinal pot is concerned.
*The above-cited paper was first published by Thomson Reuters in the Journal of Law and Medicine 21 2014 – Author Charles Martin.
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