Some of the key concerns raised throughout the inquiry related to the regulation, manufacture, sale and availability of medicinal cannabis products in Australia.
As outlined in Chapter 1, medicinal cannabis products in Australia are subject to all of the same requirements for production and sale as any other medicine under the Therapeutic Goods Act 1989 (TG Act) and related regulations.
Additionally, Australia is a party to the United Nations Single Convention on Narcotic Drugs (UN Single Convention) which currently lists cannabis in its prohibition schedule. This means that Australia also has certain requirements under international law in relation to the manufacture and distribution of medicinal cannabis.
The committee heard throughout the inquiry that medicinal cannabis does not neatly fit within the traditional frameworks for the approval and manufacture of therapeutic goods in Australia. Mr John Jackson, President of the Victorian Branch of the Pharmaceutical Society of Australia, told the committee that:
We are used to working with products that, by their nature, are standardised and able to be replicated, and consequently can be registered. The definition of medicinal cannabis arose in terms of a therapeutic use, without being clear as to exactly what the product would be.
This chapter first examines the pathways for therapeutic goods approval in Australia, and considers how changes to the scheduling, approval or registration of medicinal cannabis products could improve access for patients.
It then explores the current regulatory requirements for the domestic production of medicinal cannabis, the impact of these requirements on supply and availability, and broader concerns about stock and supply of medicinal cannabis products in Australia.
Regulating medicinal cannabis products
All therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA), as outlined in Chapter 1. When discussing the TGA regulation and approval of medicinal cannabis products, there are two key aspects to be considered:
the type and concentration of cannabinoids, for example cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), in the product and how this results in its scheduling under the Uniform Scheduling of Medicines and Poisons (Poisons Standard); and
whether the product has been approved and entered into the Australian Register of Therapeutic Goods (ARTG).
Scheduling in the Poisons Standard
As noted in Chapter 1, cannabis is currently included in three schedules of the Poisons Standard:
Schedule 4 – Prescription Only Medicine (S4). S4 includes CBD products containing at least 98 per cent CBD;
Schedule 8 – Controlled Substance (S8). S8 includes three manufactured medicines containing cannabis (nabiximols, nabilone and dronabinol), and cannabis and THC when prepared or packed for human therapeutic use in accordance with the Narcotic Drugs Act 1967 (ND Act) and the TG Act; and
Schedule 9 – Prohibited Substance (S9). S9 includes cannabis and THC for purposes other than those listed in S4 and S8.
As CBD products represent around one third of all medicinal cannabis products available for patient access in Australia, several submitters have suggested that moving CBD, particularly in lower doses, from S4 to Schedule 2 – Pharmacy Medicine (S2) or Schedule 3 – Pharmacist Only Medicine (S3) would increase patient access to these products by no longer requiring a prescription.
As noted in Chapter 3, some CBD products are already sold over-the-counter, without a prescription, in countries such as the United Kingdom, Canada and Switzerland.
LeafCann told the committee that down-scheduling CBD products to S3:
… would allow for faster access without having to get a script approved through SAS [Special Access Scheme] every time a patient wants to renew a prescription. Given the safety profile of CBD these products can be dispensed with confidence under the supervision of a pharmacist.
The Lambert Initiative for Cannabinoid Therapeutics (Lambert Initiative) agreed, suggesting that CBD products containing low to moderate doses be scheduled as S2 and S3 and noting that such a change:
… would remove the requirement of many patients to engage in difficult, expensive and time-consuming engagement with an (often reluctant) medical profession, allow the tens of thousands of Australians using illicitly procured THC-dominant cannabis for conditions such as anxiety and insomnia to trial quality assured CBD-only products for their condition, and bring our policy framework into alignment with some our closest international companions …
Epilepsy Action Australia proposed that a model of scheduling based on the concentration of CBD in the product could be introduced:
… with lower concentration medicines being classified as Schedule 2 Pharmacy Medicines; intermediate concentration medicines being classified as Schedule 3 Pharmacist Only Medicine; whilst higher concentrations remaining Schedule 4 Prescription Only Medicine.
Mills Oakley and Bod Australia submitted that CBD-rich products which do not meet the 98 per cent CBD threshold but contain low THC and higher concentrations of non-psychoactive cannabinoids are still listed in S8, and that this would complicate their inclusion in lower schedules or as complementary medicines.
Bod Australia proposed that products such as these, containing less than 0.3 per cent THC, could be down-scheduled from S8 in line with other CBD products:
This should see these products available over the counter in pharmacies under Schedule 3 of the Poisons Standard and would remove the need for Special Access Scheme (SAS) prescribing, thereby reducing cost to the Government.
Bod Australia also recommended that products containing greater than 0.3 per cent of the psychoactive THC should continue to be regulated as a controlled drug.
The Department advised that the process for changing the scheduling of medicines in the Poison Standard entails the following:
any individual or organisation can apply to reschedule a particular substance, and the Department can also submit an application;
the Advisory Committee on Medicines Scheduling (ACMS) considers the application and public submissions relating to the application; and
the scheduling decision is made by a senior departmental medical officer, who is advised by ACMS.
The Department submitted that it is currently undertaking a safety review of CBD at lower doses, to determine whether 'relaxation of the scheduling status of low dose CBD (e.g. to over the counter) could be considered during 2020'.
At the public hearing in January, the TGA noted that the question of down-scheduling CBD would also possibly be put out for public consultation following this review:
But we're a couple of months away from that, and it would be an extensive public consultation because … there will be hundreds and hundreds of submissions with a wide diversity of views.
UN Single Convention and the Poisons Standard
Submitters and witnesses informed the committee about proposed changes to the scheduling of cannabis in the UN Single Convention, which would change Australia's international obligations in relation to the storage, manufacture and handling of certain medicinal cannabis products and may have an impact on their scheduling in the Poisons Standard.
Specifically, submitters raised the following changes which had been recommended by the World Health Organization's Expert Committee on Drug Dependence:
removing cannabis and cannabis resin from Schedule IV, the prohibition schedule;
adding certain products containing THC into Schedule III; and
removing (de-scheduling) CBD from the convention entirely.
These proposals were due to be considered in early March 2020 at the 63rd session of the United Nations Commission on Narcotic Drugs, but the vote was postponed until December 2020 'in order to clarify the implications and consequences of, as well as the reasoning for' the proposed scheduling changes.
The TGA clarified for the committee that any de-scheduling of CBD from the UN Single Convention would be unrelated to an Australian decision about down-scheduling CBD in the Poisons Standard:
So the United Nations Commission on Narcotic Drugs has this WHO recommendation to take cannabidiol out of the class of schedules … as drugs of dependence. … But that is about whether cannabidiol is or isn't a drug of dependence. … And while that may have implications for how hemp is handled that does not relate to whether scheduling, for example, low-dose cannabidiol products could be considered for over-the-counter use.
However, the Department noted that the down-scheduling of other cannabis products in the UN Single Convention could have an impact on the Poisons Standard, as the Scheduling Policy Framework for S8 and S9 makes reference to a drug's status in the Schedules of the UN Single Convention and the United Nations Convention on Psychotropic Substances.
Registration of medicinal cannabis products in the ARTG
One of the main barriers to accessing medicinal cannabis raised by submitters is the lack of medicinal cannabis products in the ARTG, with only nabiximols (Sativex) currently registered.
In Australia, all approved therapeutic goods are entered into the ARTG. Therapeutic goods entered in the ARTG can be lawfully supplied and do not require special approval from the TGA for their use. The Department submitted that:
… where it is anticipated that particular products will be used to a significant extent in the future, sponsors are encouraged to develop the data required for ... registration. Potential advantages of registration may include wider prescriber confidence in the quality, safety and efficacy of the product; availability at community pharmacies on a standard prescription; and the ability of the sponsor to apply for PBS [Pharmaceutical Benefits Scheme] subsidy for the product.
There are three categories of medicines in the ARTG – Listed, Assessed Listed and Registered – as outlined in Table 4.1. The categories determine the level of evaluation required before a product is included in the ARTG, as do the status of the product's ingredients either in the Poisons Standard or in Therapeutic Goods (Permissible Ingredients) Determination (the list of approved complementary medicine ingredients) and the indications for which the product is intended.
Table 4.1: Categories and requirements in the Australian Register of Therapeutic Goods
Pre-market efficacy assessment
From list in Therapeutic Goods (Permissible Ingredients) Determination only
From list in Therapeutic Goods (Permissible Ingredients) Determination only
Ingredients assessed pre-market
From list in Therapeutic Goods (Permissible Indications) Determination only
Conditions assessed pre-market
Conditions assessed pre-market
Requires a prescription
Any prescription medicine is subject to the highest level of evaluation before being registered in the ARTG, requiring a sponsor of the product (usually a pharmaceutical company) to submit a dossier of evidence on the clinical efficacy, safety and manufacturing quality for evaluation by the TGA.
The Department anticipates that an ARTG registration application will soon be made for Epidiolex, a CBD-only medicine for patients with epilepsy. In late 2019, this product received a priority review determination, which provides for an expedited assessment, and an orphan drug designation, which allows for application and evaluation fees to be waived, in anticipation of an application.
There are also up to 20 commercial clinical trials for other medicinal cannabis products currently underway in Australia 'with the expectation that they will seek ARTG approval'.
Willingness to seek registration for medicinal cannabis
Submitters have raised concerns about the willingness of medicinal cannabis manufacturers to participate in the ARTG registration process for their products, in particular willingness to gather the large amount of clinical evidence required for an application.
FreshLeaf Analytics told the committee:
There is little commercial incentive for any company to invest in the kinds of clinical trials required … as their products are botanically derived generics and not protected by patent monopoly rights.
This issue was also raised by Mills Oakley, which told the committee that:
The investment into preparing such a dossier is prohibitive, running into tens of millions of dollars, and not commercially viable when it is weighed against the inability to obtain [intellectual property] protection and the difficulties in obtaining PBS listing.
In response to concerns that the medicinal cannabis industry does not have an interest in pursuing ARTG registration for products, the Department has made clear that it has 'no power to compel a sponsor to make a submission to the TGA for registration in the ARTG'.
However, Mrs Elizabeth de Somer, Chief Executive Officer of Medicines Australia, noted that the TGA has previously worked with the pharmaceutical industry to find a sponsor for products which were not commercially viable, citing the example of tamoxifen for the prevention of breast cancer:
… working with sponsors, the TGA was able to identify a sponsor that was willing to put in the effort for that expanded access to be made. I think that there is opportunity and willingness between sponsors and the TGA to find a solution that still reviews evidence, is still evidence based and puts some effort in capturing ongoing evidence as it emerges—so building that evidence base over time and making a decision based on what they have in front of them.
Changing the clinical trial evidence requirements of registration
Medicinal Cannabis Industry Australia (MCIA) and other submitters proposed that applications for ARTG registration of medicinal cannabis products should be allowed to include evidence from 'n-of-1' clinical trials, where the entire trial cohort is a single patient, to reduce the burden for sponsors in conducting large-scale trials.
The Medical Cannabis Council explained:
Results of n-of-1 studies can be collected and collated to provide scientific rationale for further controlled clinical trials for specific indications being implemented. … We therefore request that N-of-1 trials be … an optional source of evidence to enable medicinal cannabis companies to register their products in the ARTG. This would enable registration of products without the considerable burden of running large, expensive and challenging up-front controlled clinical trials.
However, other submitters were adamant that ARTG requirements should not be relaxed or changed for the registration of prescription medicinal cannabis products and that further clinical evaluation is required before these medicines are approved for use.
Professor James Angus, Chair of the Australian Advisory Council on the Medicinal Use of Cannabis, submitted that:
If the TGA moved to register cannabis products under our present state of knowledge of efficacy and safety it would set a precedent and potentially jeopardise the regulatory system as we know it. The gaps are substantial in current knowledge about the dose, delivery of different products, therapeutic use as add-on therapy or stand-alone therapy in the treatment of a broad spectrum of conditions and diseases. This poses an unacceptable risk in my view to changing the current requirements of registration that have a remarkable track record.
The Australian Medical Association also made the point that clinical trials provide the sort of evidence that health professionals rely upon in making decisions to prescribe a medicine:
What GPs are asking for is an opportunity to be informed about exactly where the evidence is going. One of the reasons we're doing the clinical trials is to understand its efficacy and the actual formulations that are available and how they should be used.
A separate ARTG registration for medicinal cannabis
LeafCann and Entoura, two organisations from the medicinal cannabis industry, proposed that an additional category of 'AUST C' could be introduced into the ARTG specifically for the assessment and listing of medicinal cannabis products.
LeafCann submitted that:
This would be parallel to the “TGA Listed Assessed” (AUSTLA) category which is intermediate between TGA Listed (AUSTL) and TGA Registered (AUSTR) and would require a dossier of data that supports efficacy for particular indications, but not the same level of safety data as required for AUSTR, because of the inherent safety profile of cannabinoids.
Entoura described that an 'AUST C' category could require:
… a dossier of data supporting the efficacy for stated indications that would have minimum requirements of clinical studies, including the use of observational n=1 studies as supporting data. This category should be required to have specific Product Information (PI) and Consumer Medicines Information (CMI) available following the Black Triangle Scheme for new prescription medicines.
Regulating cannabinoids as complementary medicines
The Medical Cannabis Users Association of Australia and other submitters made the argument that cannabis, as a plant, is a 'herbal' medicine and therefore should be regulated as a complementary medicine.
The Medical Cannabis Users Association of Tasmania submitted that:
The prescription medicine system is suited towards single molecule synthetic products not multi molecule botanicals which are much better suited to the Complimentary Medicines category for herbal and natural products.
Australasian College of Nutritional and Environmental Medicine and other submitters recommended that non-psychotropic cannabinoids, in particular CBD, be removed from the Poisons Standard and be listed in the Therapeutic Goods (Permissible Ingredients) Determination instead. This would effectively grant them complementary medicine status and:
… would then open up access to patients, and it would also allow it to be prescribed by other qualified healthcare practitioners.
Including certain cannabinoids in the Therapeutic Goods (Permissible Ingredients) Determination would also allow medicinal cannabis products to be listed as AUST L or AUST L(A) in the ARTG and would remove the need for more detailed registration applications.
However, the inclusion of complementary medicine ingredients in this determination is still subject to TGA reviews for safety. Medicines Australia told the committee that:
It would be a decision of the [TGA] to determine … whether cannabinoids fit into that criteria.
Some witnesses disagreed with the proposal of treating medicinal cannabis as a complementary medicine. Mr Anthony Tassone, a member of the National Council of the Pharmacy Guild of Australia, warned that:
… if we classified [medicinal cannabis] products as a complementary or herbal medicine … and were only looking at quality and safety but not efficacy or effectiveness as we do for prescription medicines, we would be doing our patients a disservice.
Mr Jarrod McMaugh from the Pharmaceutical Society of Australia also reflected that the plant origin of medicinal cannabis products was not sufficient to class them as 'herbal' medicines:
… the scheduling processes are there to look at not just the safety of medicines but also the specific reason that we use a medicine … it's not just about, 'Well, it's from a plant; therefore, it's a herbal product,' otherwise we would have opiates and cocaine available that way—both are from plants.
The committee notes significant support from submitters and witnesses for cannabidiol-based products to be made available over-the-counter, either through down-scheduling in the Poisons Standard or by being regulated as complementary medicines. The committee also recognises that there are a wide range of views about whether cannabidiol and other non-psychotropic cannabinoids should be regulated as pharmaceutical or complementary medicines.
Allowing medicinal cannabis products containing low-dose cannabidiol with very low levels of psychoactive cannabinoids to be accessed over-the-counter would greatly increase the accessibility of these products for patients. It would also bring Australia in closer in line with models of access in countries such as the United Kingdom and Canada.
The committee also notes that the Therapeutic Goods Administration is currently undertaking a safety review of low-dose cannabidiol and anticipates that the question of de-scheduling or down-scheduling these substances may be put to public consultation in the near future.
However, the committee is unclear whether it is intended that this public consultation is to be part of the ordinary public consultation process in response to a specific scheduling application to the Advisory Committee on Medicines Scheduling, or if it is intended as a broader review by the TGA.
The committee recommends that the Therapeutic Goods Administration, as a matter of priority, conduct broad public consultation on the future scheduling of cannabidiol and other non-psychoactive cannabinoids.
This public consultation should be conducted with the aim of the Department of Health making an application to the Advisory Committee on Medicines Scheduling, if deemed appropriate, and should therefore consider:
the current inclusion of cannabidiol in the Uniform Scheduling of Medicines and Poisons (Poisons Standard) Schedule 4 – Prescription Only Medicine and other cannabinoids in Schedule 8 – Controlled Substance;
the suitability of down-scheduling these cannabinoids to Schedule 2 – Pharmacy Medicine and/or Schedule 3 – Pharmacist Only Medicine; and
the suitability of regulating these cannabinoids as complementary medicines, through removal from the Poisons Standard and inclusion in the Therapeutic Goods (Permissible Ingredients) Determination.
The committee is of the view that a safety review and public consultation process will provide the Therapeutic Goods Administration with the evidence required to determine the most appropriate pathway for the future regulation of cannabidiol and other non-psychoactive cannabinoids consistent with the requirements of safety and quality for all therapeutic goods in Australia.
The committee further recommends that, as soon as practicable after a safety review and public consultation process is completed, the Department of Health make any appropriate application to the Advisory Committee on Medicines Scheduling in relation to the down-scheduling or de-scheduling of cannabidiol and other non-psychoactive cannabinoids.
The committee also notes that the scheduling of cannabis and cannabis-related products in international drug control conventions may have flow-on effects for Australian regulations, both in relation to the scheduling of cannabis and for the production of medicinal cannabis products. These effects are considered in further detail below.
Medicinal cannabis supply in Australia
A common theme throughout the inquiry was the availability and supply of medicinal cannabis products in Australia, in particular products which have been cultivated and produced domestically.
It is estimated by the Department that only 10 per cent of medicinal cannabis products prescribed through the Special Access Scheme in 2019 were locally cultivated and manufactured.
Locally-manufactured medicinal cannabis products
Evidence to the committee suggests that the current low level of locally cultivated and manufactured medicinal cannabis products is due to the following factors:
the newness of the medicinal cannabis industry in Australia;
the licensing processes of the Office of Drug Control (ODC) under the ND Act and related regulations, which were outlined in Chapter 1; and
the costs and current inefficiencies of production.
An industry in infancy
Submitters noted that the medicinal cannabis industry in Australia is still 'in its infancy' and that this was a major factor in the low level of Australian product currently available.
While the ODC regulatory scheme for the cultivation, manufacture and production of medicinal cannabis was established in October 2016, the first licences were only granted in 2017. In 2018, Little Green Pharma, a company based in Western Australia, became the first company supply medicinal cannabis products locally grown and produced to Australian patients.
The Department commented that the medicinal cannabis industry's achievement of 'licensing, construction of facilities, production, manufacture and sale of a prescription medicine product' within less than two years was 'remarkable'.
FreshLeaf Analytics submitted that, although only two Australian companies have currently brought medicinal cannabis products to market, it is anticipated several more locally-cultivated products will become available early this year.
Officers from the Department explained that Australian companies are currently licenced to produce up to 35 000 kilograms of medicinal cannabis and that by the end of 2020 the market share of Australian products may be significantly higher, possibly up to half of the market, once more production is underway.
Licensing and the Office of Drug Control (ODC)
Overwhelmingly, submitters cited the key barrier to local medicinal cannabis supply being the significant delays experienced by applicants in receiving appropriate licences from the ODC.
As outlined in Chapter 1, there are currently three types of licences:
medicinal cannabis licence, authorising cultivation or production or both;
cannabis research licence, authorising a similar process for research purposes; and
manufacturing licence, authorising the manufacture of a drug or product.
It appears that delays in processing licences for cultivation, research, manufacturing and importation of medicinal cannabis products have been due to under-resourcing of the ODC.
The Department recognised that there have been some challenges for the ODC to process and issue licences:
Since the commencement of the Scheme in October 2016 there has been a significantly higher volume of licence applications than was forecast when the scheme was developed. This has created resourcing and processing challenges for ODC in administering the scheme.
The impact of the ODC receiving hundreds of applications for licences and permits has had a significant impact on the ability of researchers and industry alike to conduct their business.
For example, LeafCann, a medicinal cannabis manufacturer, submitted that the current ODC delays have caused the Australia medicinal cannabis industry to move 'at such a slow pace' that very few companies have been able to make finished products for domestic supply.
The Medical Cannabis Council explained that the ODC's approach to assessing applications as they are received has also contributed to this slow pace:
To date, the ODC has been processing separate licences on a strict queue basis, regardless of prior applications, incomplete applications or the quality of application. This has resulted, for example, in some applicants receiving their manufacturing licence but then having to wait 1-2 years for their cultivation licence to be issued … such delays have already been extremely costly for many of our members.
Peter Crock, Chairman of MCIA, also told the committee:
For those who are through the process and looking to operate under a permit, we've had delays in getting timely responses to permits which are the key to the production of product to take through the system.
Issues with cannabis research licence
The Lambert Initiative explained that, in their experience, the mechanics of obtaining their research licences were 'routine and perfunctory', but that:
… under-resourcing of the ODC has led to increased delays in processing these permits from 20 working days (the stated estimates for processing Import Permits in ODC communications) to approximately 7-8 weeks (being verbal estimates provided in November 2019).
Medicines Australia told the committee about the importance of streamlined regulation for importing products for use in clinical trials:
The regulatory framework for initiating clinical trials can be lengthy and onerous … and we have heard that there have been hold-ups to getting clinical trial materials through the border. It would be disappointing if clinical trials that were set up to examine medicinal cannabis were held up in accessing those products by barriers created by our borders. Accessible clinical trial products should be as streamlined, efficient and regulation free as possible.
Recommended way forward
In light of these concerns, submitters called for an increase in resourcing in both funding and staffing for the ODC to improve the speed of processing licences.
Submitters also noted the independent Review into the 2016 Medicinal Cannabis amendments to the Narcotic Drugs Act 1967 conducted by Professor John McMillan AO (McMillan review), tabled in September 2019, which recommended changes to reduce some of the regulatory burden on the ODC.
Significantly, one of the key recommendations was to establish a new licence structure for medicinal cannabis products, providing for the issue of a single licence to authorise all or some of cultivation, production, manufacture and research of such products.
Submitters supported the proposal for streamlining the licence process into a single licence model. MCIA told the committee that:
Improving and streamlining the existing legislation and operations of [the] Office of Drug Control will assist to facilitate patient access to timely, cost effective and quality Australian product.
The Minister for Health has committed to implementing all of the recommendations of the McMillan review.
As part of the process in developing the single licence model, the ODC published a consultation paper in December 2019 and conducted public consultation meetings in February 2020 following written submissions.
The Department submitted that amendments to the ND Act to make the necessary changes to implement this streamlined model would be introduced into parliament in 2020.
Cultivation and production efficiencies
Low-THC hemp – a strain of the Cannabis sativa plant species – can be grown in Australia for non-medicinal purposes under state licencing schemes.
Several submitters raised that a potential area for improvement in the efficiency and cost of medicinal cannabis production in Australia would be to allow these industrial hemp crops to become 'dual use' and harvested for cannabinoids such as CBD. The Australasian College of Nutritional and Environmental Medicine explained that most industrial hemp crops are used only for the fibre from the stalk of the plants, and that the buds and flowers could be used to extract CBD.
As Dr Les Baxter from Tasmanian Alkaloids explained, there is a significant potential in allowing the dual use of crops in this way:
If you assume that there's maybe two per cent CBD in the residual plant, you're talking about up to 200 tonnes of CBD [nationally] that is potentially there and currently not accessible to the pharmaceutical industry for extraction.
Dr Baxter further explained that hemp crops grown in Australia must be grown either for the purpose of industrial hemp or for medicinal cannabis, and are thus subject to either state/territory or Commonwealth law:
Currently, you have to nominate whether you're growing a crop for industrial hemp or medicinal cannabis. If you grow for industrial hemp, it's under state jurisdiction and you can't extract from it. If you want to grow it for extraction, it comes under medicinal cannabis legislation and that controls the way that it's grown. It has to be grown under the Commonwealth legislation and that limits what can be done.
These limitations on the cultivation of cannabis are also related to Australia's obligations under the UN Single Convention. MCIA explained that:
Under international law under the single convention, you cannot use a hemp crop for the extraction of cannabinoids. That's overarching.
Some submitters described that the interaction between state/territory and Commonwealth licencing for industrial hemp and medicinal cannabis was confusing and burdensome for producers, and that the costs of growing the same crop for different purposes were vastly different. Dr Teresa Nicoletti described that:
A company that has a hemp licence can grow industrial hemp, broadacre. … You may need some security fencing, but it's just two- or three-metre-high fencing to comply with local requirements. If that same crop is used for medicinal purposes, you can spend $10 million to $20 million constructing a secure facility that regulates that product as a medicinal cannabis product.
The committee notes that the McMillan review considered the issues surrounding hemp cultivation and supply in relation to the ND Act, the UN Single Convention and the consequences for the production of industrial hemp. While that review noted that deeper consideration of these issues were outside of its scope, it summarised that:
Australian law and the Single Convention are framed on the understanding that the rigorous requirements of the Convention do not apply to non-narcotic substances that are derived from the cannabis plant if used for industrial and horticultural purposes and not for medicinal or scientific purposes. That understanding is broadly reflected in Australian laws that differentiate between cultivation and manufacture of cannabis products to which the ND Act applies, and low-THC hemp production that is regulated by State and Territory laws.
The McMillan review noted that a new Single Licence Model could:
… enable fresh consideration of regulatory options for ensuring effective alignment and integration of ND Act licensing and State and Territory regulation, particularly of industrial/low-THC hemp.
General concerns about stock and supply
Due to the currently limited production of Australian medicinal cannabis products, there has been a reliance on imported products to meet the needs of patients and researchers.
The current reliance on overseas products has been cited by submitters as a major contributor to cost, as will be discussed in detail in Chapter 5.
Submitters have also raised concerns about the quality of these imported medicinal cannabis products, as well as issues relating to stock shortages and the time taken to import products, which are discussed below.
Quality of medicinal cannabis products
All unapproved medicinal cannabis products imported into, supplied and manufactured in Australia are required to meet the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017, commonly referred to as TGO 93.
Entoura and other submitters have raised concerns that medicinal cannabis products being imported into Australia – either for approved or illicit use – may not be meeting the standard set in TGO 93:
The delays experienced in the licence approvals for Australian manufacturers has led to an influx of imported medicinal cannabis products that may or may not be of an equivalent standard to those produced under TGA oversight in Australia.
However, as the Australasian College of Nutritional and Environmental Medicine noted, proving compliance with TGO 93 may not be straightforward for international manufacturers:
For Australian MC companies importing from the US and Canada, it is particularly problematic as many laboratories in those countries do not test all of the items required under TGO93 and for particular items, may use a different standard (eg. a different cut-off level for presence of a particular heavy metal).
Other submitters raised concerns that imported products are not required to be compliant with the TGA's Good Manufacturing Practice (GMP) requirements, which are principles and procedures for manufacturers of medicines in Australia.
The TGA's guidance on this matter notes that that imported medicinal cannabis products not on the ARTG and intended to be used through appropriate access pathways do not require GMP clearance, but:
… the medicinal cannabis product must be manufactured in accordance with an acceptable manufacturing standard. … The countries that demonstrate compliance [with guiding principles for an acceptable standard] currently include Canada, Germany, the Netherlands, Switzerland and Israel.
Little Green Pharma submitted that:
… it is a point of concern that imported medicinal cannabis products and active pharmaceutical ingredients (APIs) are not automatically subject to GMP-equivalent quality requirements, as are all other medicinal products imported from these jurisdictions.
AusCann Group noted that a lack of GMP requirement for imported product also impacts upon the competitiveness of the Australian industry and proposed that the principles of GMP become a requirement for imported medicinal cannabis products:
It is critical that imported products are required to meet the same standards as domestically produced products to ensure a level playing field. Active monitoring of imported (and domestic) products is essential, coupled with appropriate action against a Sponsor supplying non-compliant products.
Stock shortages and delayed access
Submitters and witnesses also described how the reliance on overseas product is contributing to issues of stock shortages and delayed access for patients.
One patient described the frustration of stock shortages and delays when trying to access medicinal cannabis through SAS-B, which can require reapplications if stock is not available:
This past month due to a change in script requiring another approval from the TGA, and the product having to be imported from Canada, I ran out and was left without cannabis oil for almost three weeks. When I did receive the two bottles I had ordered, the expiry date was within the next two months, meaning about half a bottle was due to expire before I would have been able to finish it.
Epilepsy Action Australia described the impact of stock delays from overseas on a patient's treatment, and how this can have serious impacts on their health:
There have been recent disruptions in supply of particular pharmaceutical grade cannabinoid-based medicines which have impacted our clients. This has been of particular concern and source of anxiety, especially when the person has experienced a significant reduction in seizure frequency and severity and weaned off all other conventional antiepileptic medications. The sudden cessation of any medicine used as an anticonvulsant places the individual at significant risk of status epilepticus and life-threatening seizures.
The Australian Centre for Cannabinoid Clinical and Research Excellence proposed that measures should be put in place 'to mitigate imported cannabis medicines shortages and improve continuity of patient care', noting that:
In the event of stock shortages for NSW patients, the NSW Cannabis Medicines Advisory Service has assisted health practitioners with sourcing alternative, similar products, however … there are no equivalent services in other states and territories.
The TGA explained that medicine shortage is 'one of the biggest threats we have to public health in Australia', but that reporting of shortages is only required for reportable, approved prescription medicines and not for unapproved medicinal cannabis products:
Because these are on the Special Access Scheme we lack the same powers we have for mandatory reporting of shortages. The Therapeutic Goods Act changed so … it was mandatory for companies to report shortages only of the registered TGA approved ones, so we don't have good visibility of shortages of these products. It's another reason why we want more of these to be on the [ARTG].
The committee is aware that as the Australian medicinal cannabis industry matures, more Australian-made products will become available to patients. The committee hopes that the availability of Australian products will reduce the current reliance on an overseas market, and will alleviate ongoing concerns about the quality and availability of imported medicinal cannabis products.
However, the growth in the production of Australian medicinal cannabis products is currently held up by inefficient licencing processes. This is causing significant delays in the cultivation, manufacturing and research of cannabis products.
The committee is pleased to see that the Australian Government has acknowledged the problems which exist in the Office of Drug Control's licencing processes and has committed to adopting all of the recommendations of the McMillan review through the introduction of new legislation this year. In particular, the committee is of the view that the introduction of a single licence model would address many of the inefficiencies and delays faced by the industry.
However, the committee is concerned that any streamlining and improvement to licencing and other processes as proposed by the McMillan review will only be as good as the resources to implement them. Currently, it is clear that the Office of Drug Control is seriously under-resourced to manage demand.
The committee recommends the Australian Government immediately review the resourcing and staffing levels of the Office of Drug Control to ensure licence applications are processed without delays.
The committee recognises that some of the frustrations expressed by the medicinal cannabis industry in the production of medicinal cannabis products relate to the restrictions on the cultivation of cannabis due to Australia's obligations under the United Nations Single Convention on Narcotic Drugs and the United Nations Convention on Psychotropic Substances.
Evidence suggests that changes to these international drug control conventions, as have been proposed by the World Health Organization Expert Committee on Drug Dependence, may have wide-reaching and positive impacts on the regulation of cannabis production, both for medicinal cannabis and industrial hemp, and flow-on effects for the Poisons Standard scheduling of cannabis containing psychoactive cannabinoids.
The committee recommends the Australian Government support the World Health Organization Expert Committee on Drug Dependence's recommendations for changes to the scheduling of cannabis and cannabis-related substances in international drug control conventions.
The committee recommends the Department of Health, through the Therapeutic Goods Administration and the Office of Drug Control, continue to monitor how any future changes to Australia's obligations under international drug control conventions can facilitate streamlining regulations relating to the scheduling, approval, manufacture and handling of cannabis.