Introduction
3.1
Access to medicinal cannabis is subject to the same access pathways as all other medicines in Australia: a combination of Commonwealth, state and territory legislation and regulations which relate to both how approved and unapproved medicines are prescribed and dispensed by health professionals to their patients.
3.2
As described in Chapter 1, medicinal cannabis, included in Schedules 4 and 8 of the Uniform Scheduling of Medicines and Poisons (Poisons Standard), requires a prescription from a health professional to access in all states and territories. All medicinal cannabis products, except for nabiximols (Sativex), also require some prescribing approval from the Therapeutic Goods Administration (TGA), as they are not currently approved medicines included in the Australian Register of Therapeutic Goods (ARTG).
3.3
As outlined in Chapter 1, the Therapeutic Goods Act 1989 (TG Act) provides a number of mechanisms to enable access to unapproved therapeutic goods. For unapproved medicinal cannabis products, these pathways include:
Special Access Scheme (SAS);
Authorised Prescriber (AP) scheme; and
access via clinical trials.
3.4
Access through each of these pathways also requires varying levels of state or territory approval, as summarised in Table 1.1.
3.5
This chapter examines the various pathways through which medicinal cannabis is accessed in Australia and the hurdles which they present to patients.
3.6
It also considers some of the regulatory pathways for medicinal cannabis prescription and access in other countries, and how models such as these could improve access in Australia.
Special Access Scheme
3.7
The SAS, which is managed by the TGA, is designed to provide prescribers with a pathway to prescribe unapproved medicines for individual patients on a case-by-case basis in 'exceptional clinical circumstances'.
3.8
There are two SAS categories relevant to medicinal cannabis, as defined in Chapter 1:
SAS Category A (SAS-A), a notification pathway for health professionals who prescribe an unapproved medicine to a seriously ill patient; and
SAS Category B (SAS-B), an application pathway for health professionals who wish to prescribe an unapproved medicine to a patient who does not meet SAS-A requirements.
3.9
A third SAS category, Category C (SAS-C), is a notification pathway for certain therapeutic goods with an established history of use. Medicines which can be accessed through SAS-C are specified in a list with their indications and the type of health practitioner authorised to supply them. Medicinal cannabis, in any form, is not a medicine currently specified for SAS-C.
3.10
Evidence received by the committee indicates that health practitioners are generally supportive of the SAS, in particular SAS-B, as the appropriate access pathway for medicinal cannabis, viewing it as a necessary clinical safeguard to ensure appropriate prescribing.
Use of SAS-A
3.11
There appeared to be some confusion from submitters as to whether medicinal cannabis could in fact be accessed through SAS-A.
3.12
This confusion has occurred in part due to the attempt by the Commonwealth Government to restrict the use of the SAS–A, both in their initial Narcotic Drugs Amendment Act 2016 legalising medicinal cannabis and in a further legislative instrument which was disallowed by the Senate in 2017.
3.13
Due to SAS-A access to medicinal cannabis being secured by the Senate, over 360 notifications have been received by the TGA under SAS-A.
Recent increase in SAS-B applications
3.14
As noted in Chapter 1, in 2018 the Commonwealth, states and territories (except Tasmania) streamlined access to medicinal cannabis products through the introduction of the TGA's SAS online system. Through this system, a single application can be lodged by a medical practitioner for both SAS-B and any relevant state or territory approvals.
3.15
The Department of Health (Department) submitted that:
Use of this online system reduces administrative burden on health practitioners and provide users with additional ability to manage their SAS applications and notifications.
3.16
The Department noted that there had been 'excellent uptake' of the online system, with 91 per cent of all medicinal cannabis applications and notifications in 2019 submitted through the online system.
3.17
The Lambert Initiative for Cannabinoid Therapeutics (Lambert Initiative) described that the introduction of the online system for applications has been a 'key facilitator' for improving access to medicinal cannabis in recent years. Submitters noted positive aspects of the SAS online system which have facilitated this improved access, including:
the speed of approval, with a TGA service standard of 48-hour turn-around of applications made through the system, and a median approval time of just over one day; and
the ability to make applications to the Commonwealth and to the relevant state or territory, if required, in a single form.
3.18
One patient described her positive experience of accessing medicinal cannabis through the SAS-B pathway:
I thought the process was straightforward and worked quite well. The TGA approvals occurred in a reasonable time frame and subsequent modifications to my prescription were processed without issues.
3.19
Improvements in access are also evidenced in the significant increase in the number of SAS-B applications for medicinal cannabis following the introduction of the online portal in late July 2018 (see Figure 3.1).
3.20
In 2019, the approximately 25 000 medicinal cannabis applications made through SAS-B represented one quarter of the total SAS-B applications made to the TGA – a significant proportion.
3.21
It is important to note that the high number of SAS-B applications for medicinal cannabis does not directly correlate to the number of individual applicants accessing medicinal cannabis through this pathway, as the figure does include multiple applications for some patients. The TGA told the committee that over 19 000 patients had been granted access to medicinal cannabis through the SAS and Authorised Prescriber pathways combined.
3.22
As will be discussed in Chapter 5, there is also likely to be a considerable cohort of individuals using illicit cannabis products to self-medicate who are not captured by the TGA statistics.
Concerns about using the SAS-B pathway
3.23
While submitters and witnesses acknowledged that the new online system had streamlined some aspects of the SAS-B application and approval process, many still described the process as inadequate, time-consuming, unnecessarily complicated and a deterrent for health professionals wishing to prescribe medicinal cannabis to their patients.
3.24
A patient told the committee:
As a patient, I feel our current regulatory regime through the TGA SAS … is extremely inappropriate. It's stressful, tediously slow, very very expensive … I approached 9 Doctors to get a prescription. … Finally I found a clinic which has allowed access, but only with great financial costs. And delays. And excuses.
3.25
In a survey of patients conducted by the Lambert Initiative shortly after the introduction of the SAS online system, 91 per cent of respondents thought that the current regulatory model for accessing medicinal cannabis did not work well and 87 per cent expressed a view that it is extremely difficult for patients to negotiate. However, this survey has not been repeated since the wider uptake of the system.
3.26
The readiness of health professionals to use the SAS-B application pathway has been raised as a key barrier to access for many patients, with LeafCann Group summarising that the efficacy of the SAS:
… is limited by the health professionals prepared to prescribe medicinal cannabis and negotiate the online application process.
3.27
As outlined in Chapter 2, many of the key issues affecting health professionals' willingness to use SAS-B are education-based barriers.
3.28
United in Compassion submitted that the SAS-B process can require 'a significant element' of research from patients and their carers because of health professionals' 'lack of motivation and knowledge' of the pathway.
Time pressures on health professionals
3.29
A significant concern appears to be the time pressures that the SAS-B pathway places on health professionals, both the time it takes to acquire the knowledge to use SAS-B and the time it takes to complete an application.
3.30
The National Institute of Complementary Medicine Health Research Institute submitted that the 'extensive amount of time' required for health professionals to gain an understanding of the SAS-B process and system:
…may not suit the time poor nature of busy medical clinicians, with many simply too busy to engage in the process and/or referring patients to speciality cannabis clinics.
3.31
Submitters and witnesses described that the SAS-B application can take 20 to 45 minutes to complete, much longer than a standard consultation time for a general practitioner.
Treatment of last resort
3.32
The TGA's SAS guidance document for health practitioners and sponsors, which outlines the requirements for SAS-B applications, states that:
It is expected that the prescribing health practitioner will have considered all appropriate treatment options that are included on the ARTG and available in Australia prior to considering accessing an unapproved good under the SAS for their patient(s).
3.33
The Department submitted that it is intended that a SAS-B applicant prescriber consider available treatments and must 'provide a suitable clinical justification' for using medicinal cannabis, 'including reasons why products included in the ARTG are not suitable for treatment of the patient'.
3.34
Evidence received by the committee suggests that there is significant confusion amongst health professionals, patients and advocates about what constitutes the consideration of all appropriate treatment options prior to accessing medicinal cannabis through the SAS-B pathway, and how this information should be included in a SAS-B application.
3.35
Mills Oakley submitted that, by their understanding of the guideline, SAS applications require 'evidence that all other ARTG-entered treatment options have been tried and have failed'.
3.36
This view was shared by Dr Christina Xinos, Medical Director at Canopy Growth Australia:
In the Special Access Scheme, to use an unregistered product the guidelines suggest that you have to have tried every registered medication first … And, when a patient is applying for the unregistered medicine, the doctor has to list, in the clinical justification, every single medicine that the patient has tried, explain why they think medicinal cannabis is going to work and attach clinical papers or other justification as to why they feel it's appropriate. It's part of the TGA guidelines.
3.37
A health professional described that completing the SAS-B paperwork with this level of detail:
… to prescribe this treatment to a single patient (one who could afford it) would require at least four hours of my time.
3.38
However, the TGA told the committee that the SAS-B form does not require a significant level of detail from an applicant.
3.39
The TGA provided the committee with a copy of the two-page SAS-B application form, as well as a de-identified copy of a typical completed SAS-B application for medicinal cannabis, to demonstrate the detail required in the clinical justification part of the form.
Requirements for reapplications
3.40
The other main frustration with the SAS-B process raised by submitters was the requirement for reapplications where a product was not available or not effective for the patient, or when an approval had expired.
3.41
Under SAS-B, an applicant applies for approval for one formulation of a medicine only. Unlike single-molecule medicines, which are likely to have limited available formulations, medicinal cannabis is available in a wide range of formulations which health professionals may wish to prescribe for a wide range of indications.
3.42
If the formulation a health professional receives SAS-B approval for is unavailable, or the approved product does not have the clinical benefit hoped for, the approval process has to be repeated for a new product. Dr Teresa Nicoletti, a lawyer and scientist with expertise in medicinal cannabis regulation, explained that:
This can be as simple as starting with, say, a 20:1 CBD product and finding out that, instead, you need a 15:1 product or you need a higher dose or you need an oil instead of a capsule. Each of those are separate and distinct goods which require a separate application.
3.43
Shortage of supply can also lead to reapplications, as one patient told the committee:
In the short time I have been a Medical Cannabis patient I have had to have my doctor approve me via the TGA for a number of products due to shortage of supply, this has caused delays to my access to the medicine.
3.44
There are some measures in place to streamline the online reapplication process, including that the application form can be 'cloned' or copied to reduce administrative burden of filling out the entire form again. However depending on the circumstances of the initial application, a health professional may still need to have further consultation with a patient to undergo the reapplication process when a product is unavailable.
3.45
Practitioners are also generally granted a 12-month approval for SAS-B applications from both the TGA and the relevant state or territory authority to reduce the need to re-apply regularly.
3.46
However, this is not the experience of all patients. One patient described their experience of reapplications through a speciality medicinal cannabis clinic:
Third time ordering I was told by Cannvalate that my TGA approval was initially 3 months only and that if I wanted to continue to use the medication, I’d have to pay for another doctor consultation. I had to pay $80 again for 5 mins phone time with the Cannvalate doctor which would give me TGA approval for another year.
3.47
While not unique to the prescription of medicinal cannabis, the reapplication processes under SAS-B appear to be contributing to the costs and delays faced by patients seeking to access medicinal cannabis.
3.48
The broader issues around the interactions of supply and cost on access are discussed in greater detail in Chapters 4 and 5.
Is SAS-B fit for purpose?
3.49
Submitters noted that the SAS-B pathway was not necessarily designed for such a large volume of applications for a single class of medicine, on the scale seen for medicinal cannabis, as it is a system intended to be used only in 'exceptional clinical circumstances'.
3.50
United in Compassion submitted that the increasing number of applications received through SAS-B:
… is an indicator that the system is not fit for purpose, yet this is the main route for the majority of patients under a TGA administered model, clearly demonstrating that the majority of patients acquiring the medication via SAS B are not 'exceptional' but rather, represent common illnesses and conditions being approved in rapidly increasing numbers.
3.51
Indeed, evidence received from the TGA indicates that SAS-B was not anticipated to be the main pathway to access medicinal cannabis in Australia:
Originally it had been anticipated that individual practitioners who prescribed medicinal cannabis on a regular basis would seek to become authorised prescribers, so as to remove the necessity to apply for SAS B access for each prescription.
3.52
Dr Nicoletti also raised concerns about the suitability of the SAS-B pathway for medicinal cannabis as a class of drugs:
In relation to how the scheme was originally introduced, it was intended to be more applicable to conventional medicines where you have a synthetic mechanism that has a known pharmacological action and a single molecule that has a well-defined safety net because it's profiled and tends to be approved overseas but may not be approved in Australia. The scheme works well for those types of drugs. I don't think it works well for medicinal cannabis.
3.53
Ways in which the SAS-B pathway could be potentially adapted to be more suited to prescribing medicinal cannabis are discussed later in this chapter.
Authorised Prescriber scheme
3.54
As outlined in Chapter 1, the AP scheme is a kind of notification pathway for prescribing medicinal cannabis. Rather than requiring a patient-by-patient application to prescribe medicinal cannabis, as is required under SAS-B, an AP is approved to prescribe certain medicinal cannabis products for certain indications and is only required to report to the TGA every six months the number of patients to whom they have prescribed these products.
3.55
Although the AP scheme was anticipated by the TGA to be the main pathway through which regular prescribers of medicinal cannabis would seek access for their patients, as at 31 December 2019 only 74 medical practitioners had been granted authorisation, in only four states and for only a limited number of indications (see Table 3.1 below).
3.56
According to the Department, the majority of authorisations have been granted for management of cancer-related pain and/or symptoms.
3.57
These authorisations have amounted to at least 655 notified prescriptions of medicinal cannabis in total, a significantly lower number of prescriptions than seen through SAS-B.
Table 3.1: Authorised Prescribers of medicinal cannabis, as at 31 December 2019
|
|
|
|
|
|
New South Wales
|
31
|
Cancer pain and symptom management
|
81
|
|
Chronic non-cancer pain
|
|
Intractable epilepsy
|
|
Refractory epilepsy/paediatric refractory epilepsy
|
|
Queensland
|
18
|
Refractory paediatric epilepsy
|
87
|
|
Cancer pain and symptom management
|
|
Chronic non-cancer pain
|
|
Palliative care management
|
|
Victoria
|
21
|
Cancer pain and symptom management
|
58
|
|
Chronic non-cancer pain
|
|
Compassionate access to medicinal cannabis (small group of children with very severe intractable epilepsy)
|
|
Continuation of Compassionate Access Paediatric Scheme Pilot trial for young people with Refractory Anxiety disorders
|
|
Severe refractory epilepsy
|
|
Patient meets the inclusion criteria and are approved by an independent panel of the Office of Medicinal Cannabis, Department of Health and Human Services Victoria
|
|
Western Australia
|
4
|
Cancer pain and symptom management
|
53
|
Source: Adapted from Department of Health, Submission 10, pp. 21–22.
3.58
The low number of health professionals seeking to become APs has been attributed to a number of factors, including:
the limitation of an AP to only prescribe specific medicinal cannabis products for the certain indications for which they are approved;
problems in getting authorisation, including the time taken to undertake the requisite research for the application and difficulties in then gaining appropriate ethics approvals or specialist endorsements; and
the need to still apply for state and territory authority, in some circumstances, in order to prescribe Schedule 8 products.
3.59
The Department told the committee that, as a result of these factors and the comparative ease of use and flexibility of the SAS-B online portal, prescribers had reported that they do not see a significant benefit undergoing the authorisation process.
3.60
AusCann noted that the time taken to complete an AP application, in addition to the wait required for consideration by an ethics committee and then the TGA, can limit a health professional's responsiveness to their patient's needs.
3.61
Epilepsy Action Australia further submitted that:
Medical Practitioners have stated that they maintain greater clinical freedom in selecting the most appropriate medication for their patients from a wider range of products and cost points by choosing not to become Authorised Prescribers.
3.62
For those health professionals who do chose to apply to become APs, the process can be long and laborious. Entoura, a supplier of medicinal cannabis products, provided the committee with a case study which demonstrates the typical experience of a health professional seeking to become an AP:
It should be noted that recently a GP received a letter from TGA suggesting that they apply to become an authorised prescriber of medicinal cannabis, based on their experience and the number of SAS B applications they had approved. To ensure all the required detail was included for the conditions and products this GP utilised, the application was 195 pages in length. Once this application was approved by TGA the GP needed to upload >70 inputs to the TGA online portal. This is a process that very few doctors are prepared to undertake and those that are prepared are not doing so without significant assistance and cost.
3.63
Another health professional, quoted by United in Compassion, found that her ethics application to prescribe five medicinal cannabis products for seven clinical indications 'stretched to 52 pages'.
3.64
There also appears to be some confusion among submitters and witnesses as to whether a single Authorised Prescriber application can include multiple products and indications for endorsement. Some submitters contended that a major barrier to health professionals pursuing AP status was a requirement to complete a separate application for each product and indication, although it appears this may only be required for seeking new and additional approvals after an initial application.
3.65
An application to become an AP must also receive either approval from a human research ethics committee (ethics committee) or endorsement from a specialist college to be considered by the TGA. This is not unique to medicinal cannabis, and is a requirement of any Authorised Prescriber approval for any medicine, biological or medical device.
3.66
No specialist colleges, such as the Royal Australian College of General Practice or the Royal Australian and New Zealand College of Psychiatrists, are currently endorsing applications for authorised prescription of medicinal cannabis. The TGA told the committee that the hope had been for specialist colleges to endorse their members' applications, however:
Those colleges … have taken the view that they don't have the resources and they don't really have a research ethics role. We can't force them to do it, so sadly they are not doing it at the moment.
3.67
To further complicate matters, the National Institute of Integrative Medicine ethics committee appears to currently be the only ethics committee with a process in place to consider applications for authorised prescribing of medicinal cannabis outside of clinical trials.
3.68
At the public hearing, the committee questioned whether the AP scheme could be adapted to allow a practitioner to become an AP after completing an accredited education course, instead of requiring the current model of approval or endorsement. The TGA informed the committee that a change to section 19 of the TG Act would be needed to make such an adaptation.
Clinical trials
3.69
The third recognised legal pathway for accessing medicinal cannabis in Australia is through clinical trials. The TGA regulates the use of medicinal cannabis for clinical trials through its Clinical Trial Notification scheme, outlined in Chapter 1.
3.70
As of 31 December 2019, the TGA had received 61 notifications of clinical trials using unapproved medicinal cannabis in Australia. However, as the TGA does not hold data on the number of patients in these clinical trials, it is unclear how many individuals are accessing medicinal cannabis in this way.
3.71
The Medical Cannabis Users Association of Australia submitted that it was not aware of any of its 18 500 members accessing medicinal cannabis through an official clinical trial.
3.72
Additionally, as with the AP scheme, access to medicinal cannabis through clinical trials is currently limited to only some jurisdictions: there are currently no notifications of clinical trial sites in the Northern Territory or Tasmania. The Northern Territory Government submission noted that there may be opportunities in the future for the territory to 'partner with health services in other jurisdictions to participate in clinical trials'.
3.73
Adjunct Professor John Skerritt from the TGA told the committee that these kinds of cross-jurisdictional partnerships could be used to increase access to medicinal cannabis clinical trials both in regional areas and in states without current trial locations. He also described that regional access to clinical trials is an ongoing issue for other medicines, such as cancer treatments, not just medicinal cannabis, and told the committee that:
The government has brought in a measure to encourage clinical trials—I'm now talking more broadly on clinical trials—in rural and remote areas, but it has been an ongoing challenge globally as far as access to clinical trials once you're outside major cities.
3.74
Some of the broader concerns about geographical differences in access are discussed later this chapter.
3.75
Issues relating to the outputs of clinical trials, and their role in the approval of therapeutic goods, are explored in Chapter 4.
Alternatives proposed to the current TGA pathways
3.76
Due to their concerns about the suitability of the current TGA access pathways for medicinal cannabis, witnesses and submitters have suggested a number of ways in which these pathways could be adjusted to improve health professional engagement and patient access.
Proposal for an independent regulatory framework
3.77
Some submitters expressed the view that the current regulatory framework is not suited for medicinal cannabis and called for the introduction of an independent regulator of medicinal cannabis.
3.78
For example, Lucy Haslam from United in Compassion told the committee:
I firmly believe we've chosen the wrong regulatory framework. It's so broken I think even fixing it is going to be difficult. I think we need a new system. I think we need to go back to the beginning and back to what was recommended originally by the Senate inquiry in Canberra in 2014, 2015.
3.79
Witnesses from key patient and research advocacy bodies Epilepsy Australia, Multiple Sclerosis Australia and Multiple Sclerosis Research Australia, all also backed an Independent Regulator for medicinal cannabis products.
3.80
Ms Carol Ireland, Chief Executive Officer and Managing Director, Epilepsy Action Australia said:
I spoke at the 2014 Senate inquiry and strongly supported the establishment of a regulator. My view hasn't changed. I think there has been progress and lots of effort to make the existing system work. There has been improvement, but we still overwhelmingly hear about the barriers and the difficulties. I think we're trying to force a square peg into a round hole.
3.81
Mr Giles, National Policy Officer, Multiple Sclerosis Australia said:
From MS Australia's point of view, I would say that if in setting up the independent regulator it speeds up access but still ensures that there are safe, affordable products available to people in the MS community then, yes, we'd be up for it.
3.82
This was echoed by Dr Luker, Research Development Coordinator, Multiple Sclerosis Research Australia, who said:
MS Research Australia completely agrees with both MS Australia and Epilepsy Action. As long as it speeds everything, it's still clinically proven and there is quality assurance, then I completely agree.
3.83
Dr Teresa Nicoletti, Partner, Mills Oakley; Director, Medical Cannabis Council; and Member, Australian Lawyers Alliance, agreed that creating an Independent Regulator would solve the problems in the current system:
…why would you try and adapt a scheme that has, for the last 30 or 40 years, been focused on conventional medicines and try and adapt that scheme to fit what is a very different group of medicines? I don’t understand why there should be any resistance to a separate regulator to deal with this type of product.
3.84
Several submitters referred to the Regulator of Medicinal Cannabis Bill 2014, a private senator's bill which proposed the establishment of such a body.
3.85
The bill was subject to an inquiry by the Senate Legal and Constitutional Affairs Legislation Committee in 2015, and lapsed at the end of the 44th Parliament without passing either house.
3.86
United in Compassion noted that the proposal of an independent regulatory body was 'accepted and widely supported across the political spectrum' as the best regulatory framework for Australia, particularly due to the 'complex nature of the cannabis plant and the many cannabinoids and chemical compounds it contains'.
3.87
However, some submitters did not share this view and maintained that the TGA and Office of Drug Control (ODC) are the appropriate bodies to regulate medicinal cannabis products, although some refinements to their processes may be required.
3.88
Mr Anthony Tassone from the Pharmacy Guild of Australia told the committee:
… we support the medicinal use of cannabis preparations following appropriate consideration and assessment. To that end, we believe the Therapeutic Goods Administration, the TGA, as the existing regulatory body, is the most appropriate framework for this to occur, and therefore do not believe that the creation of a new separate regulator to oversee the medicinal cannabis supply chain is required.
3.89
The Medicinal Cannabis Industry Australia observed:
… the regulation of medicinal cannabis under a dual ODC/TGA framework assists to provide confidence to doctors and the healthcare sector along with acceptance of medicinal cannabis as a ‘medicine’. Thus, MCIA supports improving the current system rather than introducing a new regulatory framework.
3.90
Cann Group also submitted that:
Australia’s regulatory regime for the manufacture and supply of therapeutic goods … is among the best practice models in the world. As a result, Australia enjoys a reputation of manufacturing therapeutic goods to the highest standard of quality, complemented with a well-established system of prescribing and dispensing drugs (both registered and unregistered) in a safe and responsible manner.
Committee view
3.91
It is clear that there remains strong support from many stakeholders for an independent regulator for medicinal cannabis, in line with the 2014 private senator's bill. They believe this would address many of the access issues associated with the current system of regulation through the TGA.
3.92
Many patient groups have identified problems accessing medicinal cannabis as a result of the current regulatory processes through the TGA. This report will consider these barriers in detail and should they fail to be addressed within the course of 12 months following the release of this report, then the government should move to consider an independent regulator for medicinal cannabis.
3.93
Any new regulator should be designed by experts, to provide the appropriate level of regulation for this discrete class of therapeutic products. The regulator would ensure safety, efficacy and consistency of product, while ensuring that doctors can prescribe medicinal cannabis to patients as seamlessly as they currently prescribe other common pharmaceutical products.
3.94
The committee recommends that, if after 12 months from the tabling of this report the Commonwealth Government through the Therapeutic Goods Administration has failed to address the barriers to appropriate, regulated patient access to medicinal cannabis in Australia, a new Independent Regulator be considered, using the Regulator of Medicinal Cannabis Bill 2014 as a basis.
Notification pathways
3.95
Some submitters proposed that a notification pathway be introduced, whereby health professionals notify the TGA of their intention to prescribe medicinal cannabis to a patient without needing to first seek approval. For example, AusCann submitted that:
A move to a framework based primarily on a notification process, with the responsibility of prescription firmly placed on the prescriber … would decrease resource requirements of the TGA. It also enables flexibility of treatment options for the doctor, with the patient benefiting from a timely and individualised treatment approach.
3.96
Canopy Growth suggested to the committee that medicinal cannabis products for certain indications should be included in the SAS-C list, as this notification pathway does not require the 'lengthy process' of clinical justification. This proposal was supported by the Medicinal Cannabis Industry Association, which agreed that using the SAS-C notification pathway would 'accelerate access' for patients.
3.97
However, the TGA raised concerns about the suitability of SAS-C for medicinal cannabis:
Generally, the other Special Access Scheme drugs, such as those on Special Access Scheme C, have a long history. They might have been in the German and French markets for 20 years and the Australian market's too small. … With medicinal cannabis, we actually don't have that. With those particular products we don't have that history of use anywhere in the world, regarding evidence of quality, safety and efficacy in the long run, so there are additional unknowns with medicinal cannabis compared even with many of the other drugs on the Special Access Scheme.
3.98
The SAS-C list also does not contain medicines from Schedules 8 of the Poisons Standard, which would currently limit its potential utility for medicinal cannabis products other than CBD.
Approval pathways
3.99
Some submitters have proposed that the SAS-B and AP pathways be streamlined to allow for approvals of medicinal cannabis as a class of drug and/or for a particular indication, rather than on a product-by-product basis.
3.100
A carer who had experienced both the Canadian and Australian medicinal cannabis access schemes told the committee that the approval of medicinal cannabis as a broad class of product with a daily dosage limit, rather than a specific product, had a significant advantage when products were not available for her son:
… [In Canada] it was very easy to switch to an alternative product … without any paperwork or applications because the doctor had recommended a daily authorised limit of cannabis that could be consumed for the patient …
3.101
Epilepsy Action Australia proposed that APs should be able to be endorsed to prescribe medicinal cannabis as a class of drug to a particular cohort of patients.
3.102
Noting that many health professionals do not have an interest in pursuing the AP pathway, MedReleaf Australia instead suggested a modified SAS scheme, which could involve a health professional seeking approval for the general supply of medicinal cannabis to a single patient for a single indication, and that the health professional could then send a regular report to the TGA outlining the products prescribed under that approval.
Committee view
3.103
The committee recognises that while medicinal cannabis remains a largely unapproved class of drugs there is a role for the TGA in approving its prescription through the established pathways for unapproved drugs.
3.104
Health practitioners' limited knowledge of the Special Access Scheme and Authorised Prescriber pathways and requirements appears to be hindering access to medicinal cannabis for many patients and, as discussed in Chapter 2, the information currently provided on the TGA's website in relation to these pathways does not appear to be meeting the needs of practitioners who wish to use them.
3.105
The committee recommends that the Therapeutic Goods Administration review and improve its online resources for health professionals relating to the regulations and processes for prescribing medicinal cannabis through the Special Access Scheme and Authorised Prescriber pathways.
3.106
The committee is aware that practitioners would benefit from greater clarity about the exact requirements for applications under the SAS-B pathway, particularly relating to the use of medicinal cannabis as a 'last line' therapy after consideration of approved medicines. The current popular understanding of these requirements appears to be leading to a large amount of work and a significant time commitment for already time-poor practitioners and does not reflect the expectations of the TGA.
3.107
The committee recommends that the Therapeutic Goods Administration immediately clarify the clinical justification requirements of Special Access Scheme Category B in its instructions to prescribers.
3.108
The committee recognises that another frustration for health professionals applying for SAS-B approval for their patients is the requirement to reapply when the approved medicinal cannabis product is not available or does not have the desired clinical benefit. If they were to seek SAS-B approval for multiple products at once, or for medicinal cannabis as a broader class of drug, this would remove some of the need for reapplications, reduce the time required to fill out forms and wait for approvals, and allow them to be more responsive to the needs of their patients.
3.109
The committee recommends that the Department of Health make amendments to the Special Access Scheme Category B pathway to allow for approval of:
multiple medicinal cannabis products in a single application; and/or
medicinal cannabis as a class of drug for the treatment of a patient for a particular indication.
3.110
It is clear from the evidence received by the committee that the Authorised Prescriber pathway has not been as well-utilised for medicinal cannabis as originally anticipated.
3.111
The low uptake of the Authorised Prescriber pathway appears to stem chiefly from the difficulties health professionals face in seeking approval from ethics committees or endorsement from specialist colleges for their applications, and the inflexibility of being approved for only certain products. By comparison, in most jurisdictions, the SAS-B pathway does not require any additional expert endorsement or approval and provides health professionals with the flexibility to change products as needed for their patient.
3.112
However, the committee received insufficient evidence as to whether these difficulties are unique to medicinal cannabis or reflect broader inflexibilities in the Authorised Prescriber scheme.
3.113
The committee recommends that the Department of Health modify the operation of the Authorised Prescriber scheme for health professionals seeking to prescribe medicinal cannabis to ensure that:
completion of an accredited medicinal cannabis course be a requirement to obtain Authorised Prescriber status;
relevant specialist colleges be resourced to grant Authorised Prescriber status to their members;
the pathway to authorised prescriber status through the National Institute of Integrative Medicine be clarified and communicated to doctors; and
authority be granted to prescribe all medicinal cannabis products, rather than on a product-by-product basis.
Jurisdiction-specific regulatory requirements
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Australian states and territories have regulatory responsibility for controlling medicines within their jurisdiction in accordance with their own drug and poison regulations. Although the Commonwealth administers the Poisons Standard to promote a uniform approach to the regulation of medicines, the ultimate responsibility for deciding how medicines are prescribed and dispensed rests with states and territories.
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In relation to medicinal cannabis, jurisdiction-specific regulatory requirements for prescribing fall into one of two categories:
General requirements relating to the prescription of any Schedule 8 (Controlled Substance) medicine in that jurisdiction, such as rules around the duration of a prescription, or prescribing to children or people with a history of drug addiction.
Specific requirements relating to the prescription of medicinal cannabis, such as requiring a specific permit to prescribe a cannabis-based Schedule 8 drug, or rules relating to which patients and indications are eligible to be prescribed medicinal cannabis.
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Before the introduction of the TGA online application system, many patients and health professionals found the process for seeking Commonwealth and jurisdiction-specific approvals for medicinal cannabis to be slow and inconsistent, resulting in a major barrier to access.
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As previously discussed, the introduction of the online system, combined with a series of regulatory improvements in 2018 and 2019 in several jurisdictions to reduce the number of additional requirements, appears to have addressed many of the complexities around this approval process. Dr Nicoletti told the committee that:
The streamlining has had a major positive effect on removing a lot of that state layer of regulation. … I applaud the government for taking the steps needed to remove that state layer of regulation.
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However there are concerns that, despite process improvements, inconsistencies in jurisdiction-specific requirements for prescribing are resulting in ongoing inequitable patient access to medicinal cannabis.
The 'postcode lottery'
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The inequitable access to medicinal cannabis across jurisdictions has been described by United in Compassion, among others, as the 'postcode lottery', whereby patients in certain locations can access medicinal cannabis, while patients in others, such as in Tasmania or in rural and remote communities, are almost completely unable to do so.
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Several submitters described how this 'postcode lottery' is forcing some patients to travel or relocate to other regions or jurisdictions, or even overseas, in order to access medicinal cannabis.
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The Australian Pain Management Association submitted that 20 per cent of surveyed medicinal cannabis users had to travel outside of their local area to find a health professional willing to prescribe.
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One patient told the committee:
I rang around until I found Dr X in Baulkham Hills. I required a referral which I was lucky enough to get from one of my open-minded doctors … As there were no local certified GPs I had to travel 120 km to see Dr X. Public transport would have been very difficult.
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The key 'postcode lottery' issue faced by patients is whether they can see a health professional who is both willing and able to prescribe medicinal cannabis to them.
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Following changes in 2018 and 2019, Tasmania is now the only jurisdiction which requires a specialist prescription in all circumstances; however some states still require specialist consultation or support for particular patient groups.
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A requirement for specialist approval of a medicinal cannabis prescription can impact on the ability of GPs to make appropriate clinical choices for their patients, and can increase patients' costs in accessing medicinal cannabis.
Rural and regional Australia
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The role of GPs as the primary prescribers of medicinal cannabis is especially significant for patients in rural and remote areas, who have limited access to a range of health professionals in general, let alone access to specialists.
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Patients in rural and remote areas have reported difficulties if their local health professional is unwilling to consider prescribing medicinal cannabis or does not have sufficient knowledge of medicinal cannabis, particularly if they are unable to meet the costs of travelling into cities to access health services.
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The time pressures on rural GPs were also cited, with the family member of one patient noting:
Living in a rural area does impact your ability to access Medicinal Cannabis. GP’s are overworked everywhere (and in rural areas I feel even more so) you can wait 2 weeks for a doctor’s appointment. I had to wait 6 weeks just to get a flu shot! … most simply don’t have the time (nor the adequate knowledge) to prescribe Medicinal Cannabis …
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To address some of these issues of access, some submitters recommended that all jurisdictions consider extending medicinal cannabis prescribing rights to nurse practitioners, particularly in rural and remote communities.
Tasmania – the odd state out
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Overwhelming, the most serious concerns about jurisdiction-level differences in medicinal cannabis prescribing were raised in relation to Tasmania.
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Tasmania is the only jurisdiction which has not agreed to participate in the SAS online system and the ordinary access pathways used by other states and territories. Instead, Tasmania administers a medical cannabis Controlled Access Scheme (CAS) which applies to all unapproved Schedule 4 and 8 medicinal cannabis products.
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Under the CAS, any patient seeking to access medicinal cannabis must be referred to a specialist, who must then make an application to the Tasmanian Department of Health for assessment by a multidisciplinary expert panel of clinicians. If the prescription is authorised, the medicinal cannabis product must then be dispensed through a Tasmanian hospital pharmacy. The scheme is fully funded, and patients who do receive access pay only the equivalent of their applicable Pharmaceutical Benefits Scheme patient co-payment.
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The number of patients who have accessed medicinal cannabis in Tasmania through the CAS is very low, apparently no more than 17 patients in total.
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While some submitters praised the fact that the CAS subsidises the cost of accessing medicinal cannabis to some patients, it was a widely held view that not allowing Tasmanian patients to access medicinal cannabis outside of the CAS is putting them at a significant disadvantage compared to the rest of the country.
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A key recommendation to the committee was that GPs in Tasmania should be permitted to prescribe medicinal cannabis, in line with other jurisdictions.
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Tasmanian patients and carers also described their experience with the CAS, explaining the frustrations in waiting to see a specialist, only to then have a specialist's application to prescribe medicinal cannabis rejected by the CAS panel. Ms Lyn Cleaver, the parent of a man with severe refractory epilepsy, told the committee:
[The application] came back that, in order for Jeremy to be eligible for the state's controlled access scheme, he must try and fail all conventional anticonvulsant drugs. At the time we started cannabis we were already being told that the neurologist had nothing to prescribe, that he'd emptied his toolbox. So, that the panel should determine that Jeremy should try these other drugs didn't seem acceptable and didn't seem right.
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The Department explained that the Tasmanian Government had made a sovereign choice not to take part in the streamlined access process agreed by the COAG Health Ministers in April 2018 and is within its legal rights to determine how medicinal cannabis is prescribed in that state. The Department assured the committee that that the federal Minister for Health has committed to continue to raise the issue of medicinal cannabis access in Tasmania 'at every opportunity he has'.
Need for harmonisation
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Witnesses and submitters expressed a strong support for continued harmonisation of jurisdiction-specific regulatory requirements to further streamline the process of medicinal cannabis prescribing approval in Australia and to reduce inequities of access.
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Medicinal Cannabis Industry Australia recommended that the COAG Health Council Ministers remove any remaining jurisdiction-based replications of the TGA approval process and any processes specific only to medicinal cannabis, making the point that:
The unregistered medicine aspect is under the remit of the TGA, and existing processes around prescription and narcotic management at the State level are well established.
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Other medicinal cannabis organisations have called for all jurisdiction-specific approvals for medicinal cannabis to be abolished entirely, although such a change would also require COAG agreement.
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To facilitate further regulatory harmonisation between the Commonwealth, states and territories, the Royal Australian College of General Practitioners and other submitters have proposed that a national framework for medicinal cannabis access be developed.
International jurisdictions and their access models
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Throughout the inquiry, submitters and witnesses have drawn international examples of medicinal cannabis regulation to the attention of the committee. The NSW Nurses and Midwives' Association told the committee:
Australia must draw on the lessons learned internationally, and aim for implementation of a best practice model of care – one that prioritises patients' needs foremost.
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Most countries which allow patients to access medicinal cannabis products are similar to Australia, in that they require a doctor's prescription and/or a government approval, but some have taken different and less restrictive approaches to access.
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In several countries, including the United Kingdom and Switzerland, CBD-only products are able to be sold over-the-counter and therefore do not need any prescription or approval for purchase.
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Other countries, such as Germany and Israel, have chosen to regulate medicinal cannabis through specialised medicinal cannabis agencies, outside of their normal medicine regulation pathways.
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Some jurisdictions, including several US states, Canada and the Netherlands, have also legalised access to recreational cannabis, meaning that patients can choose to self-medicate with cannabis products without any interaction with a health professional. However, recreational cannabis legalisation has had some unintended impacts on the manufacture of medicinal cannabis in some areas, with submitters noting that:
Cannabis legalisation has not served medical cannabis patients well in Canada or the USA. It has removed incentives for cannabis growers and processors to produce medical cannabis products because their largest profits come from daily cannabis users who account for 80% of their business. Legalisation has also removed incentives for the industry to fund controlled clinical research into the safety and effectiveness of cannabis based medicines. It has also not increased researchers’ access to medical cannabis products for investigator-initiated clinical trials.
The Canadian model
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Patients have been able to access medicinal cannabis in Canada since 2001, although the scope of the initial scheme was limited and only 7900 patients registered in the first 13 years. Regulations were introduced in 2016 to allow registered patients, authorised by health professionals, to produce their own cannabis for medicinal purposes. These regulations were repealed in October 2018, when Canada passed the Cannabis Act which made cannabis legal for recreational purposes and changed the rules for access to medicinal cannabis products. The number of registered medicinal cannabis patients in Canada plateaued at around 370 000 in 2019 following the availability of recreational cannabis.
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Submitters and witnesses particularly favoured the current Canadian model of cannabis regulation which, in addition to providing access to approved cannabis medicines through usual drug regulation pathways and cannabis for recreational use, allows individual patients to be authorised by a prescriber to legally purchase cannabis products from a licensed seller or produce their own supply in a larger-than-recreational quantity.
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This model effectively allows individuals to access a range of unregistered cannabis products without requiring a prescription. These unregistered cannabis products are not subject to any pre-market review for quality, safety or efficacy, and cannot be sold as health products making any claims of health benefits.
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The health professional authorisation required to access unregistered cannabis products for medicinal purposes is not a prescription; instead, the two-page form is used by health professionals to indicate their support for a patient using cannabis for medical purposes. This authorisation specifies a quantity of cannabis and duration of use, for no more than one year. The patient then registers either with Health Canada to produce their own cannabis, or with a licensed seller to purchase product from them.
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Individuals can also access approved CBD health products over-the-counter, and approved prescription cannabis medicines (i.e. nabiximols) with a prescription from their health professional. These products are subject to pre-market review for quality, safety and efficacy in accordance with traditional therapeutic goods regulations in Canada.
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While the federal Canadian government oversees most aspects of medicinal cannabis production and distribution, each province and territory still has its own rules relating to cannabis more broadly, including possession limits and minimum age for access. These provincial rules also relate to the operation of licensed sellers, also known as dispensaries, which are responsible for selling cannabis products for medical and non-medical uses which have not been registered as health products.
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Witnesses and submitters have proposed that a similar model, where authorised patients can access a legal dispensary to select the medicinal cannabis products (including whole plant and CBD-only products) which meet their needs, be adopted in Australia.
Committee view
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The committee acknowledges that harmonisation of Commonwealth, state and territory legislation and regulations for medicinal cannabis is an ongoing task and supports a streamlined regulatory framework which reduces duplication across jurisdictions. The committee is aware of the significant role which the COAG Health Council has played in this regulatory harmonisation to date.
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The committee recognises that further harmonisation of jurisdiction-based legislation is still required to make the rules around patient access to medicinal cannabis more consistent across Australia.
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The committee recommends that the COAG Health Council develop a National Framework for Medicinal Cannabis Access to set out goals for further harmonisation of Commonwealth, state and territory legislation to ensure that there are appropriate, clear and consistent regulatory pathways for accessing medicinal cannabis in Australian into the future.
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Despite the significant strides made in harmonisation in the past few years, Tasmania remains the odd state out. The committee has serious concerns about the low number of patients who have been able to access medicinal cannabis in Tasmania and the very strict requirements around prescribing, which are not at all in line with other jurisdictions.
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The committee recommends that the Tasmanian Government immediately join all other jurisdictions in participating in the Therapeutic Goods Administration's single national online application pathway for accessing unregistered medicinal cannabis and reducing state-based requirements for medicinal cannabis approval.
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The committee notes the international models of access to medicinal cannabis raised by submitters. The proposal to introduce some of these international models in Australia, such as rescheduling CBD-only products to sell them over-the-counter, are discussed further in Chapter 4.