What follows is a sketch based on the verbatim transcription by Hansard of the day’s proceedings. For a far more in-depth and detailed understanding of what occurred, reading the document in full is recommended. It can be downloaded here.
Compelling as any courtroom drama, the for and against camps of the Regulator of Medicinal Cannabis Bill fired their opening salvos in Canberra on 30th March 2015.
The arguments were straightforward enough – what did witnesses (and sometimes the Tribunal) think of the idea that a new, single-purpose, stand-alone Regulator should be created to look after everything medical cannabis? Nationwide, from cultivation through to consumption, the entire works, just as the Bill had intended.
Cannabis and nothing else that is, since the drug, perhaps unlike anything on the face of the earth, is a very special plant indeed and needs to be treated as such. It deserves a fully legislated-for, duly sanctioned and fully authorised judicial contraption all of its own to make sure it gets treated right. Like a demanding and rambunctious teen it is different; people just don’t understand it. Only those specially appointed from among the cognoscente could possibly do that – which is kind of a valid point.
One of the tribunal thought so anyway – but then you’d expect as much from the RMC Bill’s principal architect.
For among the three taking evidence, representing the Senate’s Legal and Constitutional Affairs Legislation Committee tasked with investigating all this, was Richard Di Natale. The Green Party Leader had sponsored the proposed legislation which, if enacted, would have led to an entirely different legal and regulatory landscape than that which is today known but not necessarily loved by medical cannabis enthusiasts throughout the whole of Australia.
First to go head-to-head with the Senator for Victoria – himself a qualified medic – was a Dr Maureen Mitchell on behalf of the Australian and New Zealand Society of Palliative Medicine, and she clearly had different designs to those of the politician.
Dr Mitchell was, she said ‘keen to ensure treatment regimes are supported by good quality evidence,’ by implication suggesting a lack of it in the case of medicinal cannabis and overlooking the fact the Hearings had presumably been set up to gather it. ANZPM was, she told the Tribunal, ‘concerned this bill enables a proposed therapeutic agent, medicinal cannabis, to bypass TGA scrutiny and expose the public to unnecessary harm,‘ which, she believed, might occur due to lack of research.
Hang on though – weren’t ANZPM members notorious for the liberal use of opioids in their line of work?
Unlike those drugs, no deaths had ever been recorded as a direct result of cannabis use lobbed Sen Di Natale, to find himself warned by the Chair he was there to ask questions not hold a debate with the witness.
But Dr Mitchell remained resolute. ‘We do not use the raw opium poppy. We do not give the patients the raw plant; we give them a very standardised, well-researched product. This is where our argument is,’ she countered. ‘The opioids we use are prepared in a formula so we know exactly what the dose is and exactly what the dosage regimes are. We do not supply them with the raw plant that has other impurities in it.’
That was her story and she was clearly going to be sticking to it. She and her organisation wanted to see the ‘development of therapeutic agents that are much more targeted,’ and supported study only ‘of the component drugs‘ in cannabis, prompting the Senator to point out a ‘strong body of evidence that demonstrates there are synergistic effects between the different compounds in it. That is, they act together and the sum of their actions is actually greater than the individual component effect,’ but still she would not have a bar, insisting ‘research is still in its infancy‘.
None of this stopped Dr Mitchell’s organisation giving the drug a starring role in its 2016 Conference but such was its position in 2015; one it turned out that was to be shared by a few – both in terms of new Regulator being proposed by the Bill and on medical cannabis generally. Not only should it ‘be held to the same standards of evidence, safety, quality and efficacy as any other therapeutic narcotic products,’ as the Australian Medical Association said in their Submission to the Inquiry, but the jury remained out on its effectiveness, awaiting more evidence which, they argued, currently did not exist.
Next up a duo from the Pharmacy Guild of Australia, like Dr Mitchell before them, staunch believers that ‘the Therapeutic Goods Administration as an existing regulatory body is the most appropriate framework‘ and thus too opposed to the Bill. ‘We do not believe that the creation of a new separate regulator to oversee a medicinal cannabis supply chain is required‘, the Guild’s Mr Todd told the bench, further opining ‘the TGA possess the necessary experience and expertise to regulate medicinal cannabis.’ So much for that then. Sen Di Natale was in for more of the same.
An interesting point was raised though when Mr Todd mentioned arrangements in place between the TGA and its counterparts overseas which mean drugs already approved by such bodies as the US Food and Drugs Administration don’t need to go through such a rigorous approvals process here. The only problem with that is cannabis itself. Though legal in nearly half of all US States, it remains strictly illegal at Federal level and – apart from just two registered synthetic cannabinoid drugs – most definitely not FDA approved. Little was said about other countries like Israel, Canada and Holland however, all of which have dedicated Government Offices or Schemes much as the Bill was suggesting.
Nor was the ghost of former PM Tony Abbot invoked, when he’d said the previous September ‘if a drug that’s proven to be safe abroad is needed here it should be available,’ perhaps because of his further observation that ‘the regulation of medicines is a thicket of complexity, bureaucracy and corporate and institutional self interest.’
As pharmacists, Mr Todd and his friend, a Mr Denis Leahy, had lots of thoughts about the Scheduling and Rescheduling of cannabis too. These matters, and the SUSMP – the Standard Uniform Scheduling of Medicines and Poisons which categorises all drugs and substances, is discussed in the ‘History & Background‘ section of this site, but the Guild reps were clearly enthused, arguing the plant and / or products made from it would be best placed in Schedule 8 so the authorities could keep an eye on it.
And although firmly of the belief the TGA offered the best mechanisms for regulating the weed and all to do with it, they acknowledged ‘registering a cannabis product through the TGA may be deemed a barrier to market entry‘ and so suggested the Administration might be good enough to make an exception for such medications. After all, the plant was impossible to patent so why would the drug firms invest? As Sen. Di Natale pointed out, ‘if you are not going to get a financial return on the product because you cannot patent it and you are competing against very cheap illicit products, there is no incentive for a drug company to bring this before the TGA, is there?‘
And round it went, the whole thing becoming tortuous, summed up neatly in an exchange between bench member and witnesses it’s worth reproducing in full:
Senator Di Natale: You suggested that the TGA is the right mechanism. We have the TGA in place. We have a drug debt we know is providing benefit to many people, and the clinical data is very clear for some conditions. Yet they cannot get access to it.
Mr Leahy: I think that is a question for the TGA when they appear.
Senator Di Natale: I have asked them this question, and their answer is, ‘While we wait for an application for a sponsor.’
Mr Leahy: In that case I think there is a need for more homework by the government of the day to see
whether the regulations that support this particular product need to have special consideration.
Senator Di Natale: That is what we have done. That is why we have come up with an independent
Mr Leahy: I think the cost of an independent regulator—as well as a whole variety of other reasons—would make it extremely difficult to manage the whole process.
Between them, the Pharmacy Guild of Australia and the Society of Palliative Medicine had summarised not only the main concerns of the medical cannabis sceptics but also the dilemma in which the drug now finds itself, given Senator Di Natale’s Bill was never passed into law. It is the TGA that now looks after things, together with States and Territories and the TGA’s new-born sister, the Office of Drug Control.
So how cannabis medications find their way through existing regulatory mazes – including the added tier of individual State or Territory bureaucracies – and onto the chemist shelves very much remains to be seen.
Lunch, after that, was probably welcomed by the Green Party’s Victorian Senator.
Reconvening, a contrasting tone would be set in the distinguished form of David Penington, the progressively-minded Emeritus Professor, doctor, academic and Vice-Chancellor after whom drug policy think tank the Penington Institute is named.
Unlike the preceding witnesses, his concerns lay with people using black market products and the fact many of such strains had been bred with deliberately high TCH levels – the plant’s psychoactive ingredient. Studies, he warned, linked high THC cannabis with psychosis. ‘On the other hand,’ he said, ‘if we are confident that we can provide a product which is safe then I think that we should move to make it available.’
Citing the Canadian experience he explained the predicament there: ‘The proposal of a national regulator that is before the Senate raises questions as to whether it is appropriate for the federal government to take responsibility for producing a product, which the Canadian government decided to do some 15 years ago.’
‘They’ve now bowed out of that … They were just contracting to a single company to produce a single product for use in Canada, and that has fallen by the wayside because that particular product did not meet all the needs of the people looking after the patients in need of pain relief and some other forms of relief, and it did nothing for the juvenile epilepsy problem, which is a very powerful and emotive issue‘.
What then might be the answer?
The situations in the ACT and Victoria were touched on since Victoria in particular seemed set to go its own way regardless of what Canberra did – and the danger of ‘a whole series of different processes in different states, which would be regrettable,’ with the additional problem that he ‘did not see the Therapeutic Goods Administration as having any experience of the kind that would be needed to handle such a complex issue‘.
But the Chair wanted to know ‘if you are going to regulate medicinal cannabis in Australia it will have to be self-funding. One of the questions that is exercising my mind is why set up a whole new bureaucracy to do that when we have the TGA there?‘
‘I do not think it would work,’ said Prof Penington, and this for a number of reasons.
What was needed he said, making way for the next witnesses, were ‘simple and workable outcomes rather than the risk of a cumbersome conflict between Commonwealth and states and between different states. We need to find a simple way to get ahead.’
Taking the stand next were two from Public Health Association of Australia, an organisation that had earlier back the Bill in its Submission to the Inquiry.
Michael Moore, the Association’s Chief Executive, former politician and and Adjunct Professor in Health Policy and Governance at the University of Canberra was at this time a busy man, readying himself to appear the following day before the ACT legislature, underway with its own Inquiry on the very same subject.
Taking a firm stand against the position of the Australia and New Zealand Society of Palliative Medicine Professor Moore believed strongly where palliative care and cannabis was concerned ‘there simply should be no penalty applied to those people or their carers. To us that is fairly straightforward.’
The challenge for his organisation he said, was how to go to the next stage, expressing his delight when the Regulator of Medicinal Cannabis Bill was tabled, ‘because we see that as an important solution with what is going on in the ACT and, indeed, in New South Wales on this issue,‘ and adding he considered cannabis ‘a herbal remedy,’ noting the TGA seprated medicines that way, though the line between ‘herb’ and ‘chemical’ was a fine one.
Mr David McDonald, a social scientist and a Fellow of the Public Health Association of Australia and Visiting Fellow at the National Centre for Epidemiology and Population Health at ANU said he was present to give a scientific perspective, drawing together the disciplines of ‘criminological thinking and public health thinking‘ and trying to cross-pollinate those. To him the new Bill facilitated ‘the sort of work that can be done at a state level‘ and provided a good framework for dovetailing of the separate responsibilities of the Commonwealth, particularly relating to the UN Convention on Drugs, because otherwise respective jurisdictions might end up with ‘models that were significantly different to each other.’
He thought too Australia could learn from ‘the terrible design and the terrible implementation of therapeutic cannabis in many jurisdictions in the USA, and see essentially what not to do.‘
Strains of the plant were discussed and Mr McDonald raised a concern of Professor Penington’s – that due to customer demand, high TCH to low CBD cultivars were now in preponderance. The Netherlands however had 20 years of experience growing more therapeutically useful varieties in conditions which made the end product safe, sterile and free of dangerous additives or pesticides, he said.
When asked whether the expensive drug Sativex – the only Government-approved cannabis medication in Australia – would come down in price he said he suspected not ‘because of the way drug companies operate,’ and said many people were currently using black market tinctures of cannabis.
Discussing these he said ‘when it comes to the tincture, the infusion in oil, the people are actually doing assays and they know what is in it. So they are selling it as high THC or high CBD, or a mixture. They are doing what drug companies would normally do. We have had a few of those people convicted and imprisoned, and they are doing what they consider is a compassionate public service.‘
Senator di Natale wondered if ‘a system where we could license growers, farmers, and ensure that there was a quality control framework to get can get a clear picture of the CBD-THC ratios of either the herbal plant product or the oils or tinctures’ could be done quite easily. To which the answer was yes.
Next on the stand would be the Government itself – a Health mandarin, Nathan Smyth, there to defend his Department’s critique of the Senate Bill in its Submission to the Inquiry and two colleagues from the oft-mentioned TGA, whose ears must have been burning throughout.
So it was a brave Professor Moore who concluded: ‘We really would like to see the TGA separated from this issue, because the cannabis issue, no matter how much we would like to see it as a health issue—is still a law enforcement issue. It is a still a drug of dependence issue. It has a range of other ramifications that our medicines generally do not have. Having it separated from the TGA certainly in the initial instance would, I think, be a very positive step.’
‘The Authorisation Division of the TGA is responsible for the approval for marketing in Australia of medicines and medical devices. We also handle the access for unapproved products through the Special Access Scheme and other similar mechanisms‘.
‘We are all surprised that the Therapeutic Goods Administration is universally loved. I was not aware of that before, said the Chair – but Hansard does not record irony.
Mr Smyth said: ‘We are aware of international models that use cannabis or cannabis derived products for medicinal purposes. But our understanding is that there is no current international model that features market authorisation for raw herbal cannabis from any national medicines regulator as such. The operation of those agencies or authorities is outside the national medicines regulator‘.
There is actually, in Israel but let’s not get all caught up.
‘The overarching principle for us is to ensure compliance with our obligations under the Single Convention and Article 23 of the Convention places quite strict and clear requirements on the cultivation or the use of cannabis as a potential product,’ he continued, laying the next major plank of the ‘against’ argument – that breaking the Convention would jeopardise Australia’s precious poppy industry – a definite no-no for a country whose Prime Minister enjoys deep financial ties to Glaxo-Smith-Kline, the pharmaceutical giant and major industry stakeholder. Putting it in black and white, it was, said Mr Smyth, for Government to decide ‘whether this is a product that is best regulated through the TGA or as a separate stand-alone body.’ A stand-alone body his boss Martin Bowles had already made clear would cause headaches in the area of compliance to the UN Convention.
Of apparently equal concern was the definition of medicinal cannabis, which would determine whether it would go through normal TGA approval channels. The TGA’s expertise lay with products like Sativex but ‘the scope of the Bill and perhaps what is being anticipated goes much beyond what is covered in the Therapeutic Goods Act‘.
Not any more it doesn’t. The Sponsors should have known by this stage it was pretty well game over.
Much chewing of fat about what the Bill had to say about a number of other matters and the legal complications that would arise helped drive a further stake into the legislation.
Would the proposed Regulator be purchasing the drugs from the growers, as it would need to if it planned to comply with the Convention? Because ‘The Therapeutic Goods Administration really only gets involved in terms of pharmaceuticals like Sativex in the bit about approving the medicine. Before that and after that there are the Customs Prohibited Imports Regulations and there are then the States and Territories who have all the rules about what pharmacists and wholesalers can do with drugs that have got Schedule 8 substances in them‘.
All that to think about, all those hurdles to jump.
Sen. Di Natale seemed to be getting frustrated: ‘We have got widespread use of a product for therapeutic purposes. We have got a product that is being used that is of unknown quantity and unknown purity. We have clinical evidence that supports its use for a narrow range of indications and there is promising evidence for other potential indications, and we have got you guys, who are the regulators, who approve medicines, and we have not got those two things coming together.’
What about poppies, then? How does Australia conduct itself there?
An exchange only possible between a politician and three senior civil servants followed, worthy of an Ocker Jim Hacker and an ever-constructive Sir Humphrey plus a back-up of two. It led nowhere; the Senator was crimping once more:
‘It is a unique circumstance, isn’t it, in that we have a product that is covered by the Single Convention; we have a product where there is widespread use within the community, where there is emerging evidence for effectiveness; and the TGA is not really set up to be able to deal with those conflicting issues, is it?’
‘I think that one of the problems with the TGA is that the way they have operated with medicines is, as Dr Studdert said: a dossier, a firm evidence base and very clearly defined doses for clear indications. And what you are getting out there in the community with some of the potential use is varying product, unknown quality, unknown quantity and administration by various kinds of different means, and that inherently creates a difficulty for the way that the TGA register therapeutic goods’, said Mr Smyth – helpful enough but apparently missing the point because – Sen Di Natale again:
‘Part of the aim of this bill is to try and streamline that as much as we can and to deal with some of those issues that you’ve addressed, simply because the way the TGA currently operates is not suited to what is going on within the community in terms of the use and so on‘.
But what about the various approvals processes? What about recalls? What about if something goes wrong?
Is it possible, wondered Sen. Di Natale, ‘some of these functions might be able to be performed by the TGA, should they be approved by another Regulator?’
His Regulator, that be, natch – but the idea didn’t get far.
The matter of cost then arose – registering a med with the TGA will set you back over $250,000 plus an annual charge of $4K, so not really the cheapest of hobbies.
The Chair obviously had a brainwave though:
‘If I came to you with a handful of marijuana and said, ‘Here’s a certificate to show that is 50-50 THC and CBD can you register it for me? You would first say: ‘Give us your $250,000.’
Dr Stoddert of the TGA was quite brazen: ‘I would say, ‘Money up front; otherwise we don’t pass go.’ On behalf of the TGA, I would want to see the evidence you have that shows you can consistently produce a medicinal form of that leaf product with that formulation of 50-50 and then the clinical evidence that supports that formulation having therapeutic effect.‘
Well, you would, wouldn’t you.
More talk ensued, but in the end – as succinctly put by the Chair – it came down to this.
Nowhere in the world could the TGA do what was envisaged by the Bill. The proposed Regulator couldn’t do what was proposed by the Bill either, because of Regulations implemented for the most part by the TGA.
Wrapping up, the bench went fishing. Did the estimable Health Dept. representatives think it (the Bill) was a good idea?
No comment was the reply – ‘it’s an opinion, we’re not going there.’
‘Perhaps rather than an opinion, if we wanted to make medicinal cannabis available to people, would this Bill allow that to happen in a reasonably straightforward way?‘
Erm….if Parliament wanted it, that is?
‘I will just comment without saying it is good, bad or anything’, said the TGA’s legal advisor. ‘It’s difficult to know.’
The Bill left too many questions unanswered, too many loose ends untied. Which could have let the Regulatory tail have a wag of the Policy dog.
That, money and the Single Convention would, in the end, be its undoing.
‘It’s not easy, is it?’ said the Chair, declaring the Hearing adjourned.