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Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.

Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs.

I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have. The legislation needs to be changed to give natural products a path to market.

Transcript

Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate? 

Senator McCarthy: I will refer to the department. 

Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements. 

Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers. 

Senator ROBERTS: Thank you. So there may be some hope. 

CHAIR: We will return to this after the break. 

Australia has the third highest rate of anti-depressant use in the western world. My question on the rate of anti-depressant use was clearly not one the Minister or the Department were expecting. To our health authorities, a positive outcome is getting a pharmaceutical product into someone’s body and calling the job done. Yet non-medical interventions for depression are available—exercise, social interactions and human touch (social dancing being a well-recognised therapy). These therapies are being ignored and high drug use celebrated. I believe this shows a pharmaceutical bias in the Health Department’s approach to depression. It feels like the Department of Health has become the Department of Pharmaceuticals.

Cannabis is used to treat depression overseas, yet this is not available in Australia in a practical way because no pharmaceutical company will sponsor a natural cannabis product. Why? Because the absence of a patent means they can’t get their money back on the cost of the application.

Transcript

Senator ROBERTS: Let’s move to antidepressants. Australia has an antidepressant use of 89 persons per 1,000. That’s the third-highest in the world, not far behind the highest, which is America at 110. The UK has less than we do: 71. Korea is the best at only 13. In other words, we have one of the highest rates of antidepressant use in the world. Isn’t this a failure of public health policy? We’re not treating these issues with a ‘Life. Be in it.’ campaign, knowing that exercise, dancing and group socialising all help with depression. We just write a script and call it done. Minister, what happened to preventive medicine—or is it now just about money for pharmaceutical companies?

Senator McCarthy: Again, your question is loaded with all sorts of accusations which I reject outright. We do our best to inform Australians of all things. In particular throughout COVID, we worked considerably hard to engage with communities remote and regional as well as across cities, so I reject the premise of your question.

Senator ROBERTS: This is not about COVID; this is about our remarkably high antidepressant use—close to the highest in the world.

Mr Comley: Professor Singer, would you like to make any comment on that as the Chief Medical Officer?

Prof. Singer: Clearly, there are different strategies used by different practitioners in relation to depression. A lot of the access to drugs depends on the access this is available as well as cultural factors. For example, you’ve commented that South Korea has a relatively low rate. I would expect that some of that would, in fact, relate to their cultural attitudes to the use of medication to treat depression as well as to attitudes around depression itself. I think one of the things that the use in Australia probably does indicate that people are prepared to be much more open about having depression and needing help. Clearly, prescriptions in some ways do reflect that issue.

Senator ROBERTS: Thank you.

Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.

Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs. I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have.

The legislation needs to be changed to give natural products a path to market.

Transcript

Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate? 

Senator McCarthy: I will refer to the department. 

Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements. 

Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers. 

Senator ROBERTS: Thank you. So there may be some hope. 

Proven over thousands of years and once America’s most prescribed medicine – until Pharma realised the profits it could make from patented products – medicinal cannabis has much to offer in terms of health and well-being. With 820 varieties growing in the Australian cultivar database, there’s a cannabis strain for many individual health conditions.

The Therapeutic Goods Authority (TGA) however, insists on tight control of the industry. This inevitably has enabled criminal gangs to provide much of the domestic medicinal supply, leaving the public vulnerable to potentially narcotics-laced products in the black market.

One Nation has advanced legislation to down-regulate medicinal cannabis so that any doctor can prescribe medicinal cannabis for any patient with a medical need and have that prescription filled by a chemist on the PBS. The goal here is to remove the industry’s criminal elements while providing the widest range of quality, whole-plant and natural cannabis for individual patient needs.

The TGA has authorised a range of cannabis products for prescription under its restrictive pathways program, yet there’s no reason not to offer these products in schedule 4, for any doctor to prescribe — truly safe and effective products that have already been prescribed successfully for many years.

By restricting these products using an approval system that has buried the TGA in paperwork they never check, the TGA is just looking out for the pharmaceutical industry and ignoring the needs of everyday Australians.

Transcript

As a servant to the many different people in our one Queensland community, I was pleased to accept an invitation from Isaac Balbin, founder of cannabis.org.au, to attend last Thursday’s national cannabis industry roundtable. What a pleasure it was meeting Isaac, Rhys and their team in Melbourne and speaking with other members of parliament who, like One Nation, believe medicinal cannabis is long overdue for sensible downregulation. Medicinal cannabis is marvellous. Proven over thousands of years, in the 1920s it was America’s most prescribed medicine before Big Pharma realised it could not make as much money from a natural plant. There are now 820 varieties—and growing—in the Australian cannabis cultivar database, many developed to suit specific health conditions or needs. 

Victorian MP David Limbrick made sensible comments about where the line between government regulation for the good of society and personal freedom should be—and it’s nowhere near where it is now. Legalise Cannabis Party MLC from Western Australia Sophia Moermond spoke to the need for some level of personal growth. While we may not agree on personal growing, there was so much commonality in views being expressed. I’m excited for the potential of the cannabis industry uniting behind a sensible cannabis downregulation. 

United Kingdom member of parliament Crispin Blunt updated us on how this is progressing better in the UK than here and provided a framework for evidence-based drug policy. Now, that’s an idea I can get behind: evidence based policy on medicine. 

One of Australia’s leading cannabis doctors, Dr Nic Guimmarra, Vice President of the Society of Cannabis Clinicians, raised his concerns that the current licensing schedule has led to a situation where some disreputable cannabis clinics are pushing patients through so quickly that the resulting prescription and instructions for use are counterproductive for the patient. It’s One Nation’s belief that the heavily regulated and restricted pathway system is burying the Therapeutic Goods Administration in paperwork that it’s not checking, causing suboptimal care and, likely, patient harm as conditions worsen instead of being treated. 

This is why One Nation advanced legislation to downregulate medicinal cannabis so that any doctor can prescribe medicinal cannabis for any patient with a medical need and have that prescription filled by a chemist on the PBS. Our legislation harmonises the THC level below which a planet is hemp, not cannabis, to one per cent. This aligns with changes made in all states. The bill further adds a level of THC and CBD below which a pharmacist could sell the product to an adult without prescription. 

I was pleased to hear Michael Balderstone, President of the Legalise Cannabis Party and a legend of the Australian cannabis industry, warn that new hybrid cannabis strains with THC of up to 35 per cent were a concern needing some regulation. Thirty-five per cent THC is insane. It would suit the treatment of chronic pain and palliative care and very little else. Michael called for some commercial growth activity as otherwise development of new strains will be compromised. This is the problem with free growing without a commercial option. The plant works best when the profile of THC, CBD, terpenes and flavonoids are set to the needs of a person with a specific health condition. Unlike pharmaceuticals, with natural plant cannabis, one size is not expected to fit all. For this development to continue, it needs a commercial market presence. Consensus in the industry may ultimately fall on some level of licensed free growing. One Nation will cross that bridge, in consultation with our members, when we get there. 

Last Thursday I heard an analogy for free growing. It was the belief that, just because people can brew their own beer, it doesn’t mean people will. In fact, almost nobody does, because people can readily buy what’s needed commercially. The challenge is to take out the industry’s criminal elements while providing the widest range of quality Australian whole-plant and natural medicinal cannabis at an affordable price. 

It’s a scandal that regulatory authorities insist on tight volume controls that enable criminal gangs to provide much of the domestic medicinal supply. These are gangs that lace cannabis with narcotics and then deliberately target kids at events like Schoolies. The TGA is driving practices hurtful and dangerous to children. It’s a scandal that the minister could downschedule cannabis today yet has not done so; scheduling is regulatory, not legislative. It’s a scandal that some in the cannabis industry, including pioneers, have developed their business under the current regulatory regime environment and see downscheduling as a threat to their nice little money-earners. 

There’s no reason the entire cannabis product offering that the TGA has authorised for prescription under their restrictive pathways program could not be offered in schedule 4, for any doctor to prescribe—products that have already been prescribed successfully and safely for many years. The minister could use a regulatory instrument to make it happen today, yet he will not, because predatory billionaire owners of pharmaceutical companies pull the strings in Canberra. Australians with a medical need for cannabis don’t get a look-in. This government is saying to everyday Australians, ‘Your needs don’t matter.’  

The TGA monitors impacts of cannabis and has found that medicinal cannabis has a lower adverse event rate than prescribed pharmaceuticals. Sensible downregulation will save lives. It will provide hundreds of tailored strains of medicinal cannabis designed to ease suffering and improve the health of our society, while taking the profit and control away from crime gangs. I look forward to working with cannabis.org.au to make this happen. 

I was very proud to introduce the Improving Access to Medicinal Cannabis Bill 2023. It has been too hard and too expensive for patients with severe conditions to access this drug.

One Nation’s will fix that for those in need of this amazing plant.

Since 2016 One Nation has campaigned for the step of allowing medicinal cannabis with a doctor’s prescription. Now in 2021, 184,000 applications have been approved.1,000 people a year have died from pharmaceutical painkiller overdoses. We can save more lives by making medicinal cannabis more available to those who need it. That is the next step One Nation is calling on the Government to take.

Transcript

Mr President

Since 2016 One Nation has been campaigning for natural, Australian, whole plant medical cannabis under doctor’s prescription, available through chemists on the Pharmaceutical Benefits Scheme.

So far in 2021 the TGA has approved 184,000 applications for medical cannabis – an exponential increase, with Queensland leading the way.

The world hasn’t ended. Nothing harmful happened.

People are being healed.

The first cannabis product has now been approved for supply under the Pharmaceutical Benefits Scheme for Dravet’s syndrome. It’s an extract not whole plant, yet at least it’s a natural product.

One Nation worked with the Government to introduce new cannabis licensing for export producers in 2019 that’s been largely responsible for the increase.

At the time the cannabis community did not understand why One Nation was celebrating regulation changes that provide companies with the certainty needed to enter export markets.

We’re now seeing the benefit of One Nation’s advocacy. Businesses expanded production for export and have been able to supply some of that product into the Australian prescription market.

This caused prices to fall and increased the range of available options, quality and availability.

In a Senate speech in 2019 I quoted a Roy Morgan survey that found medical cannabis could help one million Australians a year. That’s looking accurate.

Most of the growth in medical cannabis has come from pain relief, just one of the many uses for medical cannabis.

In 2019, 1000 Australians died of overdoses from prescription pain killers.

No-one’s ever died from prescription medical cannabis. There are more lives to be saved here moving patients from fatal narcotic drugs to medical cannabis.

I urge the Government to widen approved use of medical cannabis to include epilepsy and chemotherapy support, amongst others.

Our people, our community and our nation deserve improved access to medical cannabis.

Hemp is a variety of cannabis that does not contain high levels of the psychoactive compound called THC, also referred to as marijuana. The war on THC has caused hemp to be stigmatised without reason.
Hemp is a modern commercial crop for use in paper, fabrics, natural pharmaceuticals, and, as Senator Whish-Wilson pointed out, in food.

What I would like to add to the debate is to point out that hemp is a fast-growing crop, which makes it suitable for opportunistic planting after rain. Used in rotation with grain crops, hemp can condition the soil and improve yields across the planting cycle.

Hemp is deeply rooted, which remediates soil and provides a crop to stabilise and protect topsoil in areas where erosion can be a problem. Hemp is being trialled as a forage crop in Tassie. Those are going to be healthy, happy cows. I urge all Australian farmers to take another look at hemp and join a world market expected to be valued at about $50 billion by 2026.

Transcript

Thank you, Madam Acting Deputy President. As a servant to the people of Queensland and Australia, I’m delighted to say that this bill holds enormous promise. For far too long, cannabis and hemp have been suppressed for reasons that have everything to do with established interests, and nothing to do with the merits of the plant.

That has hurt people for years and is hurting hundreds of thousands of people now. This bill addresses one area that has been holding back the Australian cannabis and hemp industry. Currently, there is no formal system for providing approvals for the export of medical cannabis and hemp.

The approval must apply, the producer, sorry, must apply to the minister for an ad-hoc approval. While approvals have been granted, the volumes are a fraction of the potential that this crop offers. The Export Control Act, 2020 came in this year and it allows the minister to make rules that govern the issue of exports certificates.

If a substance is on the list, rules are issued to regulate the export of that substance. Now cannabis and hemp were not originally included in that bill. This amendment corrects that. Cannabis and hemp growers and manufacturers can now have certainty about the rules for export.

Every grower is on the same footing. All who meet the rules can get an export licence and sell the product into the world market, and what a market that is? The cannabis and hemp market in Australia is expected to grow to a billion dollars in just four years and double that to $2 billion by 2028.

And at that time, our near neighbours in Asia, in the Asian market will exceed $10 billion. This is a wonderful opportunity, the start of a wonderful opportunity. Australia’s reputation as a high quality, safe supplier of food and medicine will help our producers take a significant share of that huge market.

And I must compliment the government’s decision to require all cannabis producers to follow the International Safety and Quality Standard known as the GMP, good manufacturing practise. Quality processing has been instrumental in growing our reputation for trusted product and that means a lot to people overseas and in Australia.

Internationally, the world market for cannabis and hemp is expected to reach $50 billion by 2030. Some of this growth is from the trend to legalise recreational cannabis, which I need to make clear, One Nation does not support.

We do support natural, Australian whole plant medical cannabis by way of doctor’s prescription to any person with a medical need, supplied by a pharmacist, subsidised on the PBS. I note that the government is also looking to reschedule low THC cannabis into schedule three as an over-the-counter, chemist-only medication.

One Nation supports that reschedule. We have long pushed for this. The Liberal government talks about market efficiency but in the cannabis market, we have nothing but over-regulation and disincentives to enter the market. This bill will help but there is much, much more to be done.

I draw the government’s attention to the review of the Narcotic Drugs act conducted by Professor McMillan, which reported almost 12 months ago, July 2019. Professor McMillan made 26 recommendations to improve the commercial efficiency of the cannabis market in Australia.

None, none of those recommendations have currently been implemented. Many of those recommendations dovetail nicely with the intent of the Export Control Legislation Amendment to develop an Australian export industry for cannabis and hemp.

The report calls for a reduction in the onerous conditions being applied to the industry and to people who work in it. These restrictions are an unnecessary and costly barrier to efficient quality production. They’re holding our farmers back, they’re holding everyone in the supply chain back and holding customers back.

Professor McMillan has recommended that a single licence be issued for all or some of cultivation, production, manufacture and research. This is instead of the individual licences currently being required at each step. The report also suggested licences be valid for five years rather than 12 months.

Now most exported cannabis and hemp is value added, allowing one producer to now grow, process, manufacturer and research new products and a five year licence guarantees the security of their investment, which improves the return of their investment.

By encouraging vertical integration, our producers can benefit from multiple profit centres and insulate against fluctuations in one area of this emerging market. Export opportunities will be enhanced by a wider range of products offered for sale. Volume and diversity resulting from export markets will benefit domestic patients as well.

So let me explain. Currently medical cannabis is prohibitively expensive. This is in part due to the high administrative, regulatory and security costs imposed on each stage of the process from cultivating or importing through to selling the product to a patient.

This high cost is spread across low volumes because of restricted access making each prescription too expensive for patients to afford. And that creates an ongoing cycle of high prices and low affordability leading to low volume which leads to high prices. It’s a vicious cycle.

This bill represents a way out of that self-defeating cycle by allowing for the current small domestic demand to be met from high volume, low cost export production. Medical cannabis is best used when the plant has been processed as little as possible. It is a wonderful natural product.

Conversion into vaping solutions, patches, topicals and capsules does not disturb the compound profile of the plant. It is a wonderful product. Since medical cannabis has been legal for many years in well, most nations on the planet, we are seeing an explosion in new hybridised varieties of medical strains of cannabis.

I’ve seen some of them myself. These have been developed to provide an optimum profile for a specific medical condition. This wonderful plant, and it has many varieties can be tailored to specific needs of patients. And there are many patients in desperate need of this.

Hundreds of different varieties are now available to the world market, hundreds. The more of these varieties that can be grown in Australia to support export demand, the greater the variety that will be available to supply domestic patients. People can have this marvelous natural plant tailored to suit their specific medical needs.

With a professional, efficient, and profitable export industry, Australian patients will be able to access the exact cannabis profile for their particular health condition at much reduced prices, much greater value. So as a senator from Queensland, I’m excited that we have a growing centre for cannabis excellence in Southport.

Our beautiful climate is perfectly suited to growing hemp for food, textiles, cosmetics, oil, building products, and so much more. Queensland will be on the forefront of this multi billion dollar export industry for both hemp and cannabis.

One Nation’s policy of restoring property rights for farmers and building more dams will deliver to our farmers the capacity to grow Australia’s agricultural capacity through hemp and cannabis. Before closing, I want to reiterate what our party leader, Senator Hanson said and express my thanks to Senator Coleman from the Liberal Party and Senator Kitching from the Labor Party.

It was them who made it possible because Senator Hansen and some of our staff have been pushing for this for years vigorously and it’s wonderful to see this step. Tiny though it is, it is a wonderful step. So thank you. In closing, may I suggest that the success of this bill will depend upon what the export rules for cannabis are.

To date, rules on medical cannabis and hemp have been so damn onerous. People were left wondering if the government was fair dinkum about a plant that has so many proven applications, and so many successful runs on the board overseas.

We look forward to the government proving through fair and effective regulation, that they are indeed genuine about implementing this bill’s attention, thank you.

One Nation has worked with the Government to pass legislation through the Senate to remove a major stumbling block that will expand the medical cannabis and hemp markets.

Senator Roberts said, “This is a game changer for the medical cannabis and hemp industries.”

The Certification of Narcotic Exports bill replaces the ad hoc approvals for exports with a streamlined process giving certainty to medical cannabis and hemp growers and manufacturers.

One Nation supports natural, whole plant medical cannabis via doctor’s prescription for a medical need, issued from a chemist and on the PBS, but does not support recreational use of cannabis.

“It is a lifeline for thousands of people currently forced to use illegal medical cannabis at high prices, as affordable legal cannabis is hard to obtain,” added Senator Roberts.

The bill will lead to a quick expansion of Australian production for export, which will bring about a greater range and lower prices for Australian patients.

Senator Roberts stated, “Export volumes assist local companies to grow plants with a wider range of profiles, allowing a patient to receive cannabis developed for their specific medical condition.”

“Australia has a unique competitive advantage with perfect climate, existing transport infrastructure and the international standard of Good Manufacturing Practice already in place.”

“Queensland is at the forefront of this multi-billion dollar export industry with a manufacturing facility at Southport, and expected growth to $1 billion over next four years.”

Hemp is known for its strength, durability and versatility, has wide application and its market growth looks promising. One Nation calls on the government to honour the intentions of this legislation and put in place export rules for cannabis that facilitate growers and manufacturers accessing export market.