The Battle Continues

21st June 2017: Tensions rise in struggle for medical pot, Government becoming 'outrageous'

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You would need to have been on another planet if you missed last Tuesday’s Senate vote (13th June) – the press and TV were over the thing like a rash.

We’re talking, it goes without saying, of the Disallowance Motion which overturned regulations former Health Minister Sussan Ley had popped in sub rosa last year designed to prevent the terminally ill from obtaining cannabis through a fast-track prescription pathway called SAS Category A (SAS-A).

As this site and others put it at the time, ‘campaigners and advocacy groups were celebrating’ at what by anyone’s standards was rather a startling win. It had come after Tasmanian Senator Jacqui Lambie and the Greens’ Richard Di Natale made use of a procedural technicality to get the Motion debated a second time after it fell in the Upper House a month earlier. But are the bunting and party balloons out too soon we are wondering? Can gravely sick patients now really obtain such medicine through the process as the Senators had deemed that they should – assuming that doctors will use it?

Certainly Health Minister Greg Hunt was quick off the mark to condemn the vote’s outcome, calling it ‘reckless,’ claiming ‘lives were at risk’ and adding ominously, ‘we cannot accept this, and I have asked the TGA for advice.’

What will happen next exactly seems to be a case of ‘wait and see’. For a start – and as we predicted the day the Motion was passed – both the AMA and RACGP were quick to denounce what had happened. You’d think the Upper House had elected to place bongs and free bags of weed in every doctors’ surgery and hospital waiting room the way they were carrying on. Both presidents of both organisations said they were disappointed and said they were worried the drug could be ‘diverted’ into the ‘general community’. RACGP head Bastien Seidel thought it brought ‘politics into healthcare’ and muttered something about the change undermining ‘the reporting and monitoring processes to the detriment of patients and their doctors.’ Never mind the ‘change’ he was referring to simply restored to his members a route that was previously available, never mind the RACGP has by its own admission long been busying itself trying to replace the AMA as the ‘political voice of GPs’ as Australian Doctor magazine reported in July 2015.

And in a manoeuvre than isn’t far short of a scandal, the TGA hastily wrote to existing importers of cannabis products to tell them their goods – the ones that are ready and waiting in the country – could not be dispensed using Category A.

Dear Importers,’ began the letter, from the Office of Drug Control’s Darren Jones, ‘You may be aware that on Tuesday 13th June 2017, the Australian Senate voted to disallow an amendment to the Therapeutic Goods Regulations 1990 which subsequently now allows access to medicinal cannabis products under the Special Access Scheme Category – A (SAS-A).

However, you should be aware that condition 1 of your import permit limits supply of medicinal cannabis products to those patients approved under Special Access Scheme Category – B (SAS-B), to authorised prescribers or through clinical trials.

In line with Australian Government policy, condition 1 will be maintained on all bulk imports of unregistered medicinal cannabis products.

Supply of medicinal cannabis products imported by you may only be for:

  • – SAS-B
  • – Authorised Prescriber Scheme    
  • – Clinical trials

Please note, it is a breach of your permit and licence conditions if you supply any imported medicinal cannabis product to a patient under SAS-A.

You will be advised if there are any changes to Government policy on this matter.’

Which is a rather strange thing to do if, as both Greg Hunt and his bureaucrats had insisted, there was real concern that by relaxing the rules around Category A ‘suitcases full of deadly fungus- and cyanide-contaminated unregulated marijuana’ (we paraphrase, but only a bit) would inevitably flood into the country.

Neither had the TGA, at time of writing (Tuesday 20th June) updated its website to indicate anything other than cannabis could not be obtained through the Category – the page in question still saying ‘Please note, SAS Category A is not an available access pathway for medicinal cannabis products and Schedule 9 medicines’.

ODC, the Authority’s smaller sibling however did act, sending the below email to interested parties and flagging up what appear to be hastily convened and dodgy-looking ‘information and consultation sessions’ in Brisbane and Adelaide in July. We say ‘dodgy’ because of the organisation’s inexplicable offer of private, one to one meetings with cannabis growing and manufacturing licence holders and applicants to discuss ‘commercially confidential information’ such individuals ‘may not wish to raise in the public meeting.’ The reader may make of this what they will.

Dear stakeholder,’ the missive began, ‘this email is to inform you that a number of changes have been made to the Office of Drug Control website following the recent Senate decision to disallow the Therapeutic Goods and Other Legislation (Narcotic Drugs) Regulation 2016.

These updates have been made to provide clarity around what this decision means for importing medicinal cannabis products through the Special Access Scheme Category A and the effect on the domestic cultivation and manufacture of medicinal cannabis products.

The following pages may be of interest to you:

· Import and export of medicinal cannabis products

· News item – Supply of medicinal cannabis products under the Narcotic Drugs Act 1967

· News item – Medicinal cannabis products: Special Access Scheme Category A [No link provided]

· News item – Industry information and consultation sessions on medicinal cannabis (Brisbane and Adelaide)

If you have any further questions please email mcs@health.gov.au.

Regards,

Office of Drug Control

State and Territory legislation and regulation could itself too prove problematic – the Queensland Medical Cannabis Advisory Group has warned ‘Doctors and pharmacists need to check with their state or territory health department about whether there are any requirements they need to comply with under state laws.’

So for the moment, with some barricades already erected and ‘things’ obviously happening behind the scenes, nobody quite knows if and how Category A is likely to work until the process is tested by medics willing to face the ire both of the TGA and their professional bodies.

But even if it does start to tick over smoothly, the scheme is limited to imported products only – Section 11K of the Narcotic Drugs Amendment Act stipulates that domestically-grown products cannot, unless legislation is tweaked, be obtained through the pathway.

Amidst the furore that accompanied events in the Senate was to be found a commentary from within the bowels of Mills Oakley – a corporate law firm specialising, among other things, in advising those wishing to enter this country’s fledgling pot industry. As such the company is an outfit all too familiar with the minefield of legislation that surrounds cultivating the stuff or producing products made from it.

But Mills Oakley it turns out are quite unlike many of the would-be growers and licence holders that might have required their assistance in the last year. Many of them ASX-listed, most, if not all of these newly-formed entities have been strangely silent about patient access and notably uncritical of a Government which has caused such a mess. Mills Oakley themselves however have been far less circumspect in their position, lambasting Canberra several times over in regard to SAS-A.

And last week, their lead Partner on cannabis and resident expert on the matter, Tereasa Nicoletti, raised quite an interesting point.

Writing on her company’s website, Dr Nicoletti seemed pleased that ‘patients suffering from terminal or life-threatening illnesses may again be able to access imported medicinal cannabis therapies without..extensive waiting times‘ but also mused, in her view ‘the real reason why Category A access to medicinal cannabis was stymied remains unknown.’

Perhaps the reasons might have seemed less opaque had she read an item a few weeks earlier from ABC Rural. Concerning a high-profile grower called MediPharm, headed by Queensland-based businessman Adam Benjamin, the ABC held its interview with Mr Benjamin in a coffee shop to prevent the reporter having sight of the ‘secret location’ at which the company’s crop had been planted.

And the MediPharm man said the following:

Medicinal cannabis oils in their pure forms,’ he said ‘cost around the same as gold, around about $US30,000 per kilo or litre, which sounds like a lot but that is a pure form.’

That, we suggest, is your reason – right there. Cannabis oil has a value comparable to gold.

What he forgot to say of course – and what should be evident to anyone reading his comment – is that gold, unlike cannabis oil, isn’t – last time we checked – something that can be easily enough obtained simply by planting and watering some seeds. And conversely, cannabis and derivative substances, are only of such absurdly high value if kept tightly and rigorously controlled. Imagine the effect on prices if the plant – which grows like, well…a weed – imagine if there were fields full of the stuff sprouting up (legally) all over the country.

‘Protecting domestic growers’ it so happens was another of the reasons Greg Hunt and his friends cited for their stance over Category A. The Disallowance Motion would, he said in a letter to cross-benchers prior to the original vote on May 11th, ‘put the new burgeoning Australian industry at significant disadvantage to international suppliers.’

The idea of adjusting things so the ‘new burgeoning industry’ could supply through the Category didn’t, needless to say, cross his mind – patient well-being and need forever overlooked in what is becoming an increasingly bitter and bloody battle between the authorities and those seeking to access the medicine.

Nor could some of the growers it seems be less patient-centric than the Minister: ‘I was lobbied by a local producer, or an intending local producer, of cannabidiol,’ said Senator David Leyonhjelm, a long-time proponent of pot. ‘The gist of the lobbying or the gist of the message that was presented to me was they did not want the regulation to be disallowed because it would facilitate the entry of cannabidiol by import and that, as a consequence, they would be uncompetitive.’

Interesting the organisation or individual concerned did not lobby lobby for a relaxation of SAS-A so that domestic businesses would be able to supply through it but rather against the the pathway’s use altogether. So much for those whose lives depend on such medicines right now; so much for what campaigners had fought for.

Leyonhjelm was speaking at a much-reported on but little-analysed Senate Estimates Committee Hearing some weeks back, where he, Richard Di Natale and others had the chance to grill Professor John Skerritt, Head of the TGA’s Health Products Regulation Group and his sidekick beta-male Bill Turner from the Office of Drug Control.

Hansard’s report of the Hearing – or at least the relevant section – is certainly worth reading in full*. Much of it – for all the world like a script lifted straight out of ‘Yes Minister’ – is so grotesquely absurd it’s difficult to believe that fact, rather than whimsical fancy, is what one is looking at here – and Skerritt’s description of events on 11th May is beyond priceless. Hilarious – if there weren’t lives at stake: real people, real misery met by the buffoonery and arrogance of those who think (wrongly) they know what they’re doing.                              (* For those interested, we’ve extracted the segment in question which you can download as a PDF here).

Of particular note – and as mentioned earlier – was Professor Skerritt’s deplorable scaremongering that the relaxing of Category A would lead, somehow to ‘dangerous’, ‘unregulated’ and ‘contaminated’ cananbis products freely entering Australia.

He citied, as an example of what might occur, an instance in California some months ago where, ‘one and possibly a second’ death was recorded after patients were exposed to fungus on the medical weed they’d been using. For a start, it was only one, (though two people did have the ‘rare fungal infection’) but what he omitted to say was that those involved were so badly immune-compromised the merest infection with anything could have been easily fatal. Or that the cause of the infections was only probably – but not definitely – picked up from their pot.

Skerritt then went on to discuss how – in his words – ‘in Canada, some bright spark decided to use a fungicide that is used for lettuce on medicinal cannabis.’

You might say, ‘So what?‘ he went on. ‘People do not smoke lettuce — well, most people don’t. When the fungicide on the cannabis is heated, smoked or vaporised, it breaks down and turns into cyanide. Some millions of dollars of medicinal cannabis had to be recalled and destroyed in Canada when this was discovered.’

He might as well have added (but strangely didn’t) that a fairly substantial batch of bacterially contaminated bud was also recalled in Canada some while back – by Tilray, one of the few companies allowed and encouraged to import and store product in this country.

In any case, for all the $ billions now spent on ‘marijuana’ – medical or otherwise – in the Americas by probably millions of people, cases such as these are pretty rare, as Skerritt would have known only to well.

No, his real concern was – and now very much remains – the loss of control over cannabis use of Category A entails. Being a system of notification rather than an approvals procedure, it is now in theory possible, subject to State law, for a doctor merely to let the TGA know (s)he is prescribing the drug and then order its import it without need for further permissions.

While paint was drying on the upset the Senate vote caused, several other ‘happenings’ took place, each of relevance to the state of play in regard to the cannabis struggle.

One day after the vote, prominent campaigner Michael Lambert – described by the Telegraph as ‘a martyr’ – had a long-awaited day in court following his arrest in 2015 for possession, and the outcome was an absolute fudge.

Finding Michael guilty but refusing to record a conviction, Magistrate Bruce Williams – by all accounts a man of considerable sympathy – said he ‘couldn’t set a moral policy’, according to reports in the press. Which is another way of saying the setting of precedent by finding the defendant anything other was above and beyond his pay-grade. Michael walked free but was put on a Section 10 bond while all other charges were dropped.

Waiting in the wings though is another case which looks set to become yet more explosive – that of Andrew ‘Dr Pot’ Katelaris, the maverick disqualified medic and cannabis champion who’s been researching the plant and treating people with it for decades.

Katelaris was arrested after a raid on his home by militarised police on 30th May following a disgraceful segment about a child he was treating on the Sunday Night programme the previous weekend. In an interview on local radio station Bay FM the next day he said he intended to plead not guilty to all charges on the grounds of medical necessity and opt for a trial by jury.  With well over 90% of the public supporting the use of the drug and Katelaris capable of bringing both vast expertise and considerable self-gathered scientific evidence to the table there’s an excellent chance he could win – and if he does it would be, to say the least, of significance.

The point with such cases and others like them is one long understood by many campaigners and advocates, especially those facing court – and something that seems gradually clearer to judges.  It is that legal permission to do something – in these instances, providing a life-saving, albeit outlawed medication to sick people desperately needing it – is irrelevant to a discussion about whether, from a moral perspective, it’s the right thing to do. In other words, legislation in and of itself, can’t make something good into something bad, or something bad into something good – and where cannabis is concerned, most people agree the law clearly is not on the ‘right’ moral side.

Such thoughts are doubtless preoccupying members of advocacy organisation MCUA (Medical Cannabis Users Association) right now after its Secretary Deb Lynch was arrested Monday night (19th June) on various cannabis-related charges – a move that sent shock-waves throughout the group.

Court-house demonstrations are planned as well as a call for assistance with funds, whilst Deb herself has reacted defiantly, telling members on Facebook she had ‘been waiting for this ……bring it on,’ paving the way for yet another conspicuous legal encounter.

The entire hubbub now surrounding the plant serves as a remarkable backdrop to this years United in Compassion Medical Cannabis Symposium – the third such event of its kind – which takes place in Melbourne at the end of the week (23rd-25th June).

In the run-up, organiser and UIC Founder Lucy Haslam voiced her sternest criticism to date of the Government which has been getting things so terribly wrong.

Speaking on Sydney Talk Radio’s Alan Jones Show with Chris Smith on Tuesday morning (20th June) she told listeners ‘People are shaking their heads at the attitude of the Government. They’re feeling hopeless at the lack of care and compassion that’s being showed to them. I look back now and wonder if they (the Government) weren’t just doing this to shut us up…to get the monkey of their back and act like they’re doing something because they’re actually making it harder and harder.’

People have been ‘lied to’ over cannabis for decades she said, ‘it’s actually farcical the way we’ve all been deluded and mis-informed about it. The harms have been exaggerated, the benefits hidden from us.’

Her real anger though was reserved for Health Minister Greg Hunt and his cronies at the TGA – the former dubbed a ‘hypocrite’ – for closing the door on the possibility existing and approved imports being accessed under Category A.

‘It’s outrageous,’ she insisted, with Smith adding he thought Lucy should be Australian of the Year and accusing Hunt of now wanting to lock up dying patients and legal suppliers.

Just prior to the Symposium, the launch of a recently announced ‘Medical Cannabis Council‘ will take place, also in Melbourne. The Council says it wants to bea unifying voice for the medical cannabis industry in Australia, facilitating a framework of best practice and supporting the positioning of Australia as a world leader in research and production of safe, scientifically backed medical cannabis products.’

Among its aims are to ‘promote and enhance patient access to medical cannabis products and to provide relief and support for patients seeking access…including information, practical assistance and advocacy.’

Formed by entrepreneur Adam Miller, founder of the cannabis industry start-up organisation Budding Tech, the Council includes an impressive list of names from science, business and medicine, so the launch should be an intriguing event.

It’s an enterprise that could prove very useful – if those from the patient and advocacy community become involved. Feedback thus far though is one of caution, some campaigners fearing a ‘peak organisation for industry promoting a CBD-only agenda.’

As with many other things, time will have to be the judge, as it will with the present, ever more volatile cannabis situation as a whole.

It is to be hoped the forthcoming Symposium will help progress matters further than they currently are – a kind of no-man’s land between what patients want and are cheerfully (though illegally) obtaining and what the Government is prepared to allow.

 

 

 

1 thought on “The Battle Continues”

  1. Adam Benjamin from Medipharm at a pharmacist information session, like a carnie drumming up business; “Are we all here to make money?!” Actually, hell no.

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