Journal List > PLoS One > PMC9651563
Abstract
Background
Patient interest in the use of cannabis-based medicines (CBMs) has increased in Australia. While recent policy and legislative changes have enabled health practitioners to prescribe CBMs for their patients, many patients still struggle to access CBMs. This paper employed a thematic analysis to submissions made to a 2019 Australian government inquiry into current barriers of patient access to medical cannabis.
Methods
We identified 121 submissions from patients or family members (n = 63), government bodies (n = 5), non-government organisations (i.e., professional health bodies, charities, consumer organisations or advocacy groups; n = 25), medical cannabis and pharmaceutical industry (n = 16), and individual health professionals, academics, or research centres (n = 12). Data were coded using NVivo 12 software and thematically analysed. The findings were presented narratively using a modified Levesque’s patient-centred access to care framework which includes: i) appropriateness; ii) availability and geographic accessibility; iii) acceptability; and iv) affordability.
Results
Submissions from government agencies and professional health bodies consistently supported maintaining the current regulatory frameworks and access pathways, whereas an overwhelming majority of patients, advocacy groups and the medical cannabis industry described the current regulatory and access models as ‘not fit for purpose’. These differing views seem to arise from divergent persepctives on (i) what and how much evidence is needed for policy and practice, and (ii) how patients should be given access to medical cannabis products amidst empirical uncertainty. Notwithstanding these differences, there were commonalities among some stakeholders regarding the various supply, regulatory, legislative, financial, and dispensing challenges that hindered timely access to CBMs.
Conclusions
Progress in addressing the fundamental barriers that determine if and how a patient accesses and uses CBMs needs i) a ‘system-level’ reform that gives due consideration to the geographic disparity in access to prescribers and medical cannabis, and ii) reframing societal and health professional’s views of CBMs by decoupling recreational vs medical cannabis.
Introduction
Community interest in the use of cannabis for therapeutic purposes has increased within Australia and internationally [1, 2]. The rapid growth in national demand for access to cannabis for therapeutic use has largely been driven by patient or consumer advocacy groups, increased media attention, and a growing yet still incomplete body of research examining cannabis’ treatment efficacy [1]. Legislative changes at the level of Australian state and federal government have occurred over the past decade to legalise the use of medical cannabis, and to regulate its prescribing and distribution. In 2014, the state of New South Wales legalised prescription access to medical cannabis on compassionate grounds to individuals with terminal illnesses [3], and in 2016 Victoria legalised medical cannabis with no constraints [4]. The most significant legislative changes followed, when in late 2016, the Australian Federal government amended the Narcotics Drug Act (1967) to enable the cultivation, production, and manufacture of medical cannabis [5, 6].
Alongside these legislative changes, Australia (like many other jurisdictions worldwide) has witnessed an increase in patient demand for access to medicinal cannabis and renewed scientific interest in its therapeutic use. A preliminary search of Australian New Zealand Clinical Trials Registry showed that, as of December 2021, over 50 observational and randomised controlled trials (RCTs) of medicinal cannabis products for various indications have been registered. While research into the use of medicinal cannabis products continues, Australian policy and legislative changes have enabled health practitioners to prescribe medicinal cannabis to their patients typically before products have satisfied the standards of quality, safety, and efficacy required for registration by the Therapeutic Goods Administration (TGA). Despite the availability of numerous unapproved medicinal cannabis products for prescription by health practitioners [7], currently only two medicinal cannabis products are listed on the Australia Register of Therapeutic Goods (ARTG)—Sativex® (nabiximols) and Epidyolex® (cannabidiol (CBD) 100 mg/mL) [8]. In the case of unapproved medical cannabis products, clinicians need to apply to TGA via the Special Access Scheme (SAS) Category A notification pathway, SAS Category B application pathway, or as an Authorised Prescriber (AP; requiring jurisdictional and/or TGA pathways). SAS Category A is a notification pathway that may be used by a prescribing registered health practitioner (including nurse practitioner) to access unapproved therapeutic products including medical cannabis via importation for patients defined as seriously ill. SAS-B is an access pathway through which a registered health practitioner applies to the TGA for approval to prescribe an unapproved medical cannabis product for a patient under their care [1]. In the case of Authorised Prescribers, approval may be granted to access an unregistered product under the ‘established history of use pathway’ for up to 5 years, pending the endorsement of this timeframe, or the ‘standard pathway’ requiring approval from a human research ethics committee or endorsement by specialist college (accurate as of November 2021; [9]).
Reflective of the complexity of accessing unapproved products, in November 2019, the Australian Senate referred an inquiry to the Senate Community Affairs References Committee into current barriers to patient access to medical cannabis in Australia [10]. This review was established in response to anecdotal evidence that patients continued to report various difficulties in accessing medical cannabis since its legalisation [10]. During the inquiry, the committee called for public submissions to inform current barriers to accessing medical cannabis across the supply chain. During 69 days of consultation in 2020, multiple stakeholders, including patients, clinicians, and organisations, submitted their perspectives relating to the terms of reference. The recommendations from the Committee’s report highlighted key priority areas in refining and expanding Australia’s regulatory processes. A significant and ongoing challenge for the sector is how to draw forward a unified strategic approach to medical cannabis access from the various, sometimes divergent, stakeholder perspectives. Determining key similarities and differences in stakeholder views, priorities, and preferences, is needed to balance inclusive and equitable access to medical cannabis with safety and regulatory requirements. Despite the rich and descriptive accounts provided through the inquiry, how the views of different stakeholders, including the public health community in Australia, have framed the medical cannabis-related policy debate has not been systematically explored. Using the submissions from stakeholders, this study aimed to (1) identify the views of multiple stakeholders regarding medical cannabis; (2) identify the policy frameworks and preferred regulatory options recommended by stakeholders, and identify the associated discourses used to describe them; and (3) elucidate the ways in which scientific evidence about medical cannabis has been framed to justify the proposed regulatory frameworks and changes relative to medical cannabis access.
Methods
Data sources
In December 2019, the Senate Community Affairs References Committee invited the public and interested organisations to make submissions to an inquiry into the current barriers to patient access to medical cannabis in Australia. The terms of reference sought comment across major areas of Australian’s medical cannabis landscape, including:
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The appropriateness of Australia’s regulatory frameworks for medical cannabis products, inter-state differences in interpretation and access, and comparison to international best practice models;
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Regulatory barriers to accessing medical cannabis (including those in rural and remote areas), and its impact on the mental and physical wellbeing of patients;
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Financial barriers and the suitability of the Pharmaceutical Benefits Scheme (PBS) for subsidising patient access to medical cannabis; and
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Information sources for health professionals, availability of and need for education and training.
The Inquiry received 146 submissions from government and non-government organisations, professional health bodies, health charities, advocacy groups, medical cannabis industry and members of the public (S1 File). The Standing Committee also conducted a public hearing in January 2020, the transcripts of which were later published. This study analysed both written submissions and, where submission authors participated in a public hearing, the relevant section of the transcript from the hearing.
Data extraction and analytical framework
Data relating to barriers to and solutions for patients accessing medical cannabis, and arguments made for and against adopting specific regulatory approaches, were coded using NVivo version 12 software (QSR International Pty Ltd, Melbourne, Australia), then thematically analysed using the Framework Method [11]. The Framework Method, originally developed in the 1980s by the UK National Centre for Social Research, is a type of thematic analysis which involves developing a matrix of structured thematic categories into which the data is coded and analysed either by case (in this case individual submissions) and by code (i.e., a descriptive or conceptual label is assigned to excerpts of the submissions in the coding process). This method of thematic analysis was chosen for this study as it enables analytical themes to be developed both from the inquiry’s terms of references and from the narratives of individual submissions.
The analysis included five steps. Firstly, a team of researchers (DE, LG, and MG), all from different research fields, read through a randomly selected subset of submissions and transcripts from the public hearing (five submissions each). These submissions were then used to identify common themes and come up with initial coding framework (step 2). Following this, the whole team met to discuss key emerging themes and develop, revise, and refine an initial coding framework (step 3). The initial analytical framework and pre-specified codes generated through independent coding, discussion and consensus were found to be similar to the patient-centred access to care framework previously developed by Levesque et al. [12]. Thus, data from all submissions was extracted (by one author–DE) and coded using Levesque’s framework which includes the following dimensions or themes (step 4): (1) appropriateness; (2) availability and geographic accessibility; (3) acceptability; and (4) affordability. Appropriateness refers to the suitability of current regulatory frameworks and access pathways for medical cannabis and the extent to which patient needs for access were met by these frameworks. Data relating to the impact of patient location (according to state or territory and rural or remote areas) has on access to prescribing health professionals and/or medical cannabis products were coded under “availability and geographic accessibility”. The “acceptability” code relates to the cultural, ethical, and social factors that determine health professionals’ preparedness to prescribe medical cannabis and for patient use for therapeutic purposes. These factors are underpinned by complex social constructs that include patient stigma associated with cannabis use, attitudes of consumers and health professionals towards medical cannabis, and the current regulatory frameworks. The “affordability” refers to costs associated with medical cannabis and ability to pay according to income. Thematic analysis was then conducted on the coded data, guided primarily by our research objectives (i.e., explore views of multiple stakeholders regarding medical cannabis, and recommended regulatory and policy options to improve access) and by emergent themes generated inductively from the data [13] (step 5).
Results
Sample overview and stakeholder categories
A total of 121 submissions were included in the analysis: 63 from patients or family members, 5 from government bodies, 25 from non-government organisations (i.e., professional health bodies, charities, consumer organisations or advocacy groups), 16 from medical cannabis and pharmaceutical industry, and 12 from individual health professionals, academics, or research centres (Table 1). Submissions were also supplemented with interview transcripts from the public hearing. We excluded confidential (not publicly available) submissions (n = 21) and supplementary attachments (n = 4). The website link to the original submissions publicly available on the Australian government parliament website are provided in S1 File.
Table 1
Stakeholder group | N (%) |
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Governmental organisations | 5 |
Non-governmental organisations | |
Professional health bodies | 7 |
Health charities, patient and consumer advocacy groups | 18 |
Pharmaceutical and medicinal cannabis industry | 16 |
Member of the public | |
Health professionals, academics, or research centres | 12 |
Patients and caregivers | 63 |
Use of and access to medical cannabis
Submissions from multiple stakeholders into the barriers for access to medical cannabis in Australia contained a range of arguments for and against various regulatory and access frameworks for medical cannabis. Submissions from professional health bodies, health charities and government agencies consistently supported maintaining the current regulatory frameworks and access pathways. Conversely, submissions from patients, patient advocacy groups, and the medical cannabis industry tended to describe the current regulatory and access models as ‘not fit for purpose’. Given the nature of the inquiry, there were instances of submissions that predominately centered on advocacy for increased access and easing of costs and other regulatory burdens for patients. Some of these included proposed amendments to regulation and justification for these recommendations. However, analysis in this study focussed more on the thematic debates emerging within the discourse and their implications for the national framework. These negotiations seem to arise from divergent persepctives on (i) what and how much evidence is needed for policy and practice, and (ii) how patients should be given access to medical cannabis products amidst empirical uncertainty.
The role of evidence in informing policy and clinical practice: Why, what, and how much?
What counts as evidence?
The analysis of the submissions and public hearing transcripts revealed a divergent viewpoint among stakeholders on the level and credibility of evidence that is needed to support changing and/or maintaining the current regulatory framework regarding medical cannabis. Submissions from government agencies and public health communities (professional health bodies and charities) discussed the importance of evidence-based policy making and asserted that their policy positions are based on the latest scientific evidence. They tended to suggest that there is a paucity of current clinical evidence in terms of the safety and efficacy of medical cannabis (see Submissions 2, 8, 119, 129), and highlighted that further research is required to ensure future recommendations around the use of and access to medical cannabis is evidence based. This included the need for well-designed clinical trials with longer-term follow-up periods.
“There are very few well designed clinical trials using medicinal cannabis resulting in limited evidence for its use in successfully treating different medical conditions, or on effective forms and dosages.” (Northern Territory Government, Submission 2; page 2)
“The development of a sound evidence base remains a critical enabler to ensure safe and effective use of medicinal cannabis in chronic pain and requires further research and investment.” (Pain Australia, Submission 129; page 6)
Submissions from the health and medical field raised concern about approaches that introduced medical cannabis as a theraeputic option without considering the lack of clinical evidence on safety and efficacy, and other best practice treatment and management.
“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.” (Professor James Angus, Chair of the Australian Advisory Council on the Medicinal Use of Cannabis’ Submission 53; page 2)
Another finding was the inconsistent use of anecdotal evidence. Submissions from the health and medical professions which prioritised clinical evidence contrasted strongly against consumer and patient accounts. For example, the Australian Medical Association reported in their submission that some of their members were reluctant to prescribe medical cannabis because of the concern that it was introduced “based on anecdote and public opinion with the expectation that the science to catch up in due course” (Australian Medical Association, Submission 24; page 5). In contrast, patients, patient or consumer advocacy groups, and the medical cannabis industry described personal experiences of using medical cannabis within the therapeutic context (i.e., anecdotal evidence) to support a more permeable regulatory model. While the need to incorporate patients’ preferences into medical decision making has been highlighted by various stakeholders as a key component of patient-centred care, this has not been translated to decisions around access to and use of medical cannabis. For example, some patients, families, and caregivers reported using medical cannabis due to the significant financial distress, poor symptom control or intolerable adverse effects from conventional therapies (e.g., opioid dependence). One patient described medical cannabis as “a gateway out of the hopelessness of opioid dependence… alcoholism and addiction to prescription benzos” (Submission 132, page 1). Yet, what patients described as their lived experiences was considered by many stakeholders as ‘anecdotal’ evidence, and it was argued that they should not be taken into consideration in the policy making process.
“What patients are reporting ‘anecdotally’ is their lived experience. I think it more sensible in the complex space of medicinal cannabis to instead consider a ‘risk vs benefits’ approach and to make care related decisions accordingly because regardless of political and medical opinions, thousands of Australian patients are using cannabis medically and illegally.” (Individual; Submission 65; page 4).
Patient access amidst empirical uncertainty
Whilst the need for high quality evidence on the safety and efficacy of medical cannabis products was widely acknowledged, there was a shared sense of recognition by stakeholders that there needs to be a way for medical cannabis to be managed and accessible to patients (even if conditionally) within the therapeutic context. However, stakeholders were largely divided when it came to how patients should be given access to medical cannabis products, particularly given the growing yet still incomplete evidence. The view of some professional health bodies and government agencies was that medical cannabis products should be reserved as ‘treatment of last resort’ to a subset of patients with life-limiting illness.
“Despite the lack of a current evidence-base, medicinal cannabis may be considered an option of last resort for chronic pain management where a range of other therapies have been exhausted.” Pain Australia, Submission 129, page 6
Again, clinical and governmental perspectives were not typically reflective of the views of patients and patient or consumer advocacy groups who regarded cannabis-based medicines as ‘first resort rather than a last resort’ (e.g., Submission 136, page 2) and advocated for expedited access while Therapeutic Goods Administration registration is pending. This regulatory and access preference for patients using medical cannabis was reflected for conditions ranging from life threatening illness such as cancer to illnesses such as anxiety or short-term or chronic insomnia.
In addition, the ways in which stakeholders have defined and framed ‘therapeutic use of cannabis’ (also referred to in the submissions as ‘cannabis-based medicines’ or ‘medicinal cannabis’) seemed to have influenced their policy or practice recommendations. Submissions from some pharmaceutical industry entities with a commercial interest in the therapeutic use of particular products of cannabis (e.g., cannabis products registered in ARTG) have framed ‘medicinal cannabis’ as consumer products that lacked sufficient empirical evidence to be considered an approved medicine.
“Non-regulatory approved cannabis-based products (“medicinal cannabis”) lack all or many of the important characteristics of an approved medicine, including stability, batch to batch consistency and label accuracy, and therefore the evidence base of these individual products is limited” (GW Pharmaceuticals, Submission 119; page 10).
On the other hand, this submission framed ‘cannabis-based medicines’ as high quality, regulatory-approved ‘pharmaceutical’ grade products, and as such these products cannot be equated with or replaced by ‘medicinal cannabis’ products via product substitution. The reasoning provided for this was that ‘not all products can be expected to have the same safety profile, therefore the safety data from one product cannot be extrapolated to another’ (GW Pharmaceuticals, Submission 119; page 10). However, this notion was seen unfavourably by many patients and advocacy groups. Patients discussed that such framing stemmed from and largely shaped by the government’s preconceived ‘anti-cannabis’ ideology, the financial conflict of interest between pharmaceutical and medicinal cannabis industry, and Australia’s ‘pharmaceutical lobbying culture’ (see Submission 91; page 9).
“I believe it is mostly born out of ignorance, kickbacks from Big Pharma and personal belief systems which hinder an evidenced based approach to the application of Medicinal Cannabis in the area of medicine and in other allied health areas.” (Individual; submission 65; page 2).
Barriers to and solutions for addressing medical cannabis access
A significant proportion of patients noted that they had experienced obstacles in accessing medical cannabis products, and many stakeholders discussed various supply, regulatory, legislative, financial, and dispensing challenges that hindered timely access to medical cannabis products. Using Levesque’s modified patient-centred access to healthcare framework [12], we categorised these access issues and recommended solutions into i) appropriateness, ii) availability and geographic accessibility, iii) affordability, and iv) acceptability.
“Not fit for purpose”: Appropriateness of the current model in meeting patients’ needs
Appropriateness of current regulatory frameworks and its responsiveness to the evolving medical cannabis market has been extensively discussed by stakeholders. While the current access schemes were considered by government agencies and professional health bodies as best-practice frameworks to ensure patient safety and informed prescribing decisions, many stakeholders including patients, patient advocacy groups and medical cannabis industries were concerned about the responsiveness of these frameworks to the evolving medical cannabis market, in terms of the diversity of patients and product preferences. The current access pathways were described by these latter groups as ‘too convoluted, complex and barrier forming’, and were thought to have put undue financial and psychological burden for people with low socio-economic status, older people reliant on pensions/disability allowances and those who live in rural and remote areas.
“No patient can find anything praiseworthy in a scheme that is deliberately crafted to present a daunting minefield of barriers impossible to negotiate, and, for the accepted few, culminating in an extortionately priced limited-range product so dilute and watered-down as to be next to useless.” (Individual; Submission 100; page 1).
In addition to the reference to regulatory hurdles above, stakeholders regularly raised recurrent practical challenges associated with each of the access pathways. Submissions from patients, advocacy groups and the medical cannabis industry reiterated that one of the main frustrations associated with SAS-B scheme was the arduous and time-consuming process that health professionals have to go through for writing a prescription. These includes familiarising with the scheme, collating necessary evidence and clinical justification, and completing the actual application. When discussing these limitations of the SAS-B access scheme, submissions from multiple stakeholders noted the scheme’s inflexibility to accommodate the unique features of medical cannabis products and need for reapplications (where a specific product formulation was not effective or not available) was attributed to further strain placed on patients by exposing them to unnecessary delays and financial stress (e.g., see Submission 15, 22).
It was indicated that the use of an AP scheme by prescribers had been limited mainly due to the challenges of getting approval from a human research ethics committee or endorsement from a specialist college (e.g., see Submission 6; 25). This is further complicated by the fact that none of the main professional Australian health bodies, including the Royal Australian College of General Practice or the Royal Australian and New Zealand College of Psychiatrists, endorse applications for authorised prescription of medical cannabis.
“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.” (Epilepsy Australia, Submission 22; page. 7).
Driving and medical cannabis: A legal quandary
Under the current Australian drug driving policy, driving while having detectable levels of tetrahydrocannabinol (THC; dronabinol) in the body is considered an offence, and patients may be subject to prosecution, fines, and loss of licence [14, 15]. The current drug driving policy as it relates to legally prescribed cannabis was considered by many stakeholders as a significant barrier to legitimate patient access to medical cannabis, especially to patients in rural and remote locations.
“Patients who have a prescription may not want to fill it, because they have a job in which they have to drive every day and they would be at risk of prosecution for doing something which they took steps to do lawfully.” Dr Nicoletti, Committee Hansard, page. 17.
Stakeholders put forward various policy solutions, ranging from exemption from prosecution for patients prescribed cannabis for therapeutic purposes to changing drug testing policy from a ’zero-tolerance’ towards one that reflect the level of impairment.
Illicit markets and self-cultivation
A significant proportion of patients who made submissions reported that they resorted to illicit markets (also referred to as ’black’, ’grey’ or ’green’ market) to source their medical cannabis products, or reported self-producing medical cannabis for personal use, often without a license to produce medicinal cannabis for that purpose (see submissions 4, 6, 13, 29, 44, 80, 91, 110). The main reasons specified for resorting to illegal access routes included: the complexity of the legal access system; the ‘unjust’ regulatory restriction imposed on patients to utilise only medical cannabis products currently available on the market, which are perceived to be ‘ineffective’ and/or expensive; and the onerous process required to switch between products.
“There is no doubt Australia has restricted cannabis and cannabis product access to the point where the current model actually drives patients to the alternative market and self-supply. If the current model was in place to protect patients self-evidently it has been an abject failure.” (Individual; Submission 80; page 5).
“Black market Cannabis costs about $250 an ounce in Australia. Legal Cannabis for medical use in Australia costs $1300–1500 for the 1st month and $800 a month or more after that. With no subsidy it is hard for many to justify the legal route.” (Individual; Submission 91; page 11).
However, many patients who opted to source their cannabis from illicit markets felt that they had no other choice and yet, at the same time expressed concerns about the legal repercussions and safety issues associated with sourcing medical cannabis products from illicit markets (see submissions 4, 22, 36). The safety concern was also voiced by public health community, such as the Australasian College of Nutritional and Environmental Medicine, that such unregulated products could “contain contaminants such as heavy metals and pesticides, and that they may not contain the amount of active constituents they purport to.” (Australasian College of Nutritional and Environmental Medicine, Submission 29, page. 19). While a few submissions recommended amnesty be introduced for current users of illicit cannabis products for medical reasons (Medical Cannabis Users Association, Submission 9, p. 21; Submission 36, p. 10), others argued for broader decriminalisation of personal cannabis cultivation and use for medical purposes (Submission 6, pages 10–11; Submission 21, page 6; Submission 76, page 5; Submission 98,).
Availability and geographic accessibility
Urban–rural and inter-state disparity in access to prescribers and medical cannabis
Submissions from multiple stakeholders particularly patients, advocacy groups and patient representatives, discussed the challenges of accessing a health professional who is both willing and able (in terms of knowledge, time, and legal permission) to prescribe medical cannabis products in rural, regional, and remote locations (e.g., see submissions 15, 25, 35, 48, 116). Highlighting equity considerations, submissions often reiterated that the opportunity for a low-income person living in rural area to access a medical cannabis product cannot, and should not, be equated to the opportunity for another person–wealthier, living in urban area–due to differences in availability of ‘knowledgeable and willing’ prescribers (e.g., submissions 21, 37, 111). In these cases, it was noted that, even after managing to get a script for medical cannabis products, timely access in rural, regional and remote location were described as being severely limited due to inadequate availability of community pharmacies to source the prescribed medical cannabis product(s). The Medicinal Cannabis Users Association of Australia submission reported that ‘specialist’ consultation and monitoring fees are regularly applied at ‘cannabis clinics’, often resulting in patients being rarely reimbursed through appropriate channels such as Medicare or other Health Fund rebates (Submission 9; page 7).
“Lack of knowledgeable or willing prescribers in rural and remote Australia have led to Australian’s needing to travel to metropolitan areas to access either medical cannabis clinics or the few neurologists willing to prescribe medical cannabis. This has increased the financial burden on those families.” (Epilepsy Action Australia, Submission 22, page 10)
The inconsistencies in jurisdiction-specific requirements for prescribing and/or accessing medical cannabis products have also contributed to the disparity in access to medical cannabis products. United in Compassion suggested that the creation of a ’postcode lottery’, in which patients in certain States and locations have better access to medical cannabis than others have led to patients traveling and/or relocating to other States where medical cannabis is readily available, becoming ’cannabis refugees’ (Submission 7 page 4). Stakeholders recommended harmonising and streamlining the access pathways on a national level to allow each state and territory to process applications in an equitable manner, and “ensure that geographical location is not a barrier to access treatment” (Alcohol and Drug Foundation, Submission 26, page 3).
“There should be no barriers to people wanting to legally access medicinal cannabis, whether that results from where they live or their economic status and financial well-being. Equity of access should be a fundamental guiding principle of the Commonwealth’s policy settings and administrative arrangements for access to medicinal cannabis.” (Cancer Voices Australia, Submission 34, page 3)
Supply–demand mismatch
The severe supply shortage of Australian made products, along with the fact that imported medical cannabis are not subject to Good Manufacturing Practice requirements for equivalent quality, has led to an influx of overseas products that “may or may not be of an equivalent standard to those produced under Therapeutic Goods Administration oversight in Australia” (Entoura, Submission 25, page 4). The supply–demand mismatch is described in the submissions as being fuelled, partly, by such reliance of imported products, which comes with problems such as stock shortages and delayed access.
“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.” (Individual; Submission 48, page. 2).
“A strong domestic supply will remove the impact of a lack of commitment from, and changing priorities of, international suppliers who supply into Australia.” (Medicinal Cannabis Industry Australia, Submission 5, page. 5).
Epilepsy Action Australia reiterated the unique risks associated with sudden discontinuation of medical cannabis products when utilised as antiepileptic therapy due to supply issues as such disruptions in continuity of patient care places patients at “significant risk of status epilepticus and life-threatening seizures” (Epilepsy Action Australia, Submission 22, page. 10).
Affordability
Many patients referred to costs to access medical cannabis both in the process of obtaining health professional’s support for and prescription to access these products and in the ‘arduous’ process of obtaining a supply of prescribed medical cannabis product (e.g., see Submissions 65, 112; Committee Hansard page 2). These include costs associated with medical reviews and appointments, accessing prescribers and/or specialised cannabis access clinics, travel and accommodation costs for rural and remote patients, and cost of filling a prescription. Patients also reported being charged by their health professionals for initial appointments or specialist consultations and for the service of having their application completed (e.g., submission 45, 141). The requirement of repetitive GP visits for each prescription or product substitution and reliance on imported products (i.e., additional importation and delivery fees) were described as additional costs that create a barrier to access (e.g., Submissions 45, 70).
“These clinics are charging fees to put in an application to the TGA that attracts no fee. They are charging “Specialist” consultation rates and monitoring fees for which patients can rarely get a Medicare or Health Fund rebate.” (Medical Cannabis Users Assoc of Australia, Submission 9, page 7).
“It cost me $200 for my initial appointment, $59 for any subsequent scripts, $80 follow up appt, $59 whenever I have to adjust dose or product, which I was able to afford by making a debt with Centrelink [sic]” (Individual Submission 9, page. 8).
“At the higher end, the delivery fee may represent over 30% of the total cost of the order while some wholesalers may not charge a delivery fee if a large quantity of products is requested through a single order. Other wholesalers charge a Dangerous Drug (DD) handling fee to offset some of the costs associated with the special storage, delivery and inventory recording requirements of these products.” (Pharmaceutical Society of Australia, Submission 16, page. 6).
At the time this parliamentary inquiry was called (November 2019), nabiximols was the only medical cannabis product listed in Australian Register of Therapeutic Goods (ARTG), and there was no medical cannabis product included in the PBS. Nonetheless, submissions from different stakeholders tended to support the PBS as the most appropriate way to subsidise access to medical cannabis products (e.g., see Submissions 7, 15, 28; 29, 33, 35). Many patients, most of whom lives with chronic medical conditions and do not have a source of income other than pensions or disability allowances, reported that they often had to choose between paying for prescribed medical cannabis and other necessities such as food and rent due to the prohibitive cost of medical cannabis products.
“Every day we see patients crying out for cheaper or subsidised products.” (Medicinal Cannabis Industry Australia, Submission 5, page. 15)
“There is an overwhelming sense and expression of frustration and anger that there is a medicine that potentially can alleviate seizures that is only attainable by those who have the financial means to do so.” (Epilepsy Action Australia, submission 22, page 10)
The subsidisation of a health professional appointment through the introduction of a new Medicare Benefits Scheme (MBS) code that considers the longer consultation time required for patient workups and the submission of medicinal cannabis applications was recommended as a solution to alleviate the ‘exorbitant’ (see Submissions 8, 44, 81, 94) cost that patients would otherwise pay at cannabis access clinics (see Submission 21 page 22, and Submission 146 page 2). Some stakeholders discussed that although most States and territories have an established compassionate access scheme, it is often limited to only certain patient groups with certain conditions and pointed to the need for a Federal government compassionate subsidy scheme, as an alternative to PBS, to reduce the disparity and provide equitable access to all patients.
“A temporary subsidy [be] made available to people with epilepsy who are prescribed pharmaceutical grade cannabinoid-based medicines, until these medicines are listed on the ARTG and the PBS.” (Epilepsy Action Australia, Submission 22, page. 12)
However, such blanket government subsidy models were described by some as ’unnecessary and wasteful’ (Pharmacy Guild of Australia, Submission 27, page. 3; Clinical Oncology Society of Australia, Submission 124, page. 2.) and would potentially create a “precedent that may be used by advocates for the use of other unevaluated drugs to demand a similar subsidy from state and Federal governments solely because some patients claimed to benefit from using them” (Submission 68, pages 7–8.). A few submissions from patients and medicinal cannabis industry recommended that the cost of medical cannabis products could be subsidised through private health insurance, as with other non-PBS medicines (Medicinal Cannabis Industry Australia, Submission 5, page. 4; Individual Submission 61, page. 22), however, such arrangements would be applicable only for non-PBS medicines which have been approved and registered in the ARTG. The Australasian College of Nutritional and Environmental Medicine (ACNEM) recommended that down-scheduling of cannabidiol would reduce the cost for pharmacies (and thus for patients) as it removes the special storage, delivery and inventory recording requirements of medical cannabis products (ACNEM, Submission 29, page. 9.). The Department of Veterans Affairs (DVA) mentioned in their submissions that DVA subsidises most of the costs of medical cannabis (including consultations fees) for eligible veterans via the Repatriation Pharmaceutical Benefits Scheme, which does not have the same criteria as the PBS for listing medicines.
Acceptability
‘Pot doctors’ and ‘pot heads’: Stigma associated with medical cannabis
The stigma and prejudice associated with cannabis was described by stakeholders as the main challenge for health professionals to openly discuss and/or proactively prescribe medical cannabis products, and for patients to access and use these products (e.g., see Submissions 3, 6, 7, 22, 24, 26, 62).
“There is also the matter of stigma, again born out of ignorance and the assumption that anyone seeking to use Cannabis medically is a ‘druggie’.” (Individual; submission number 76, page 6)
Education and targeted public awareness campaigns for both healthcare consumers and professionals were also recommended as a solution to ‘demystify’ medical cannabis and the stigma associated with its use. In addition, providing best practice guidelines and continuous professional development courses for health professionals, revising of curriculum of medical, nursing and pharmacy schools to include endocannabinoid system, and setting up an independent national comprehensive education programme were discussed as potentials solution to the desire for further information on the use of, and access to medical cannabis products (e.g., see submissions 3, 7, 12, 25, 27, 33, 44)
“Health professionals need pragmatic clinical and practical guidance so that they are well equipped to deal with patient requests to access Medicinal Cannabis in a sensitive manner, drawing upon the evidence base.” (Individual; Submission number 27; page 1).
Discussion
This thematic study examined the views and policy positions of multiple stakeholders regarding use of cannabis for therapeutic purposes, and barriers to and solutions for addressing medical cannabis access in Australia. It highlights the diverse and often conflicting stakeholder discourses around what should qualify as ‘evidence’, and what is safe and equitable in terms of the policy and practical frameworks for the therapeutic use of cannabis. As a morally and legally contested area, navigating the regulatory frameworks governing access to and use of cannabis-based medicines has proven to be a complex and multi-layered undertaking for end-users. In particular, the study describes the key points of tension in ‘system’ level medical cannabis policy and access. Findings from this study revealed that the view of government agencies and public health communities (professional health bodies and charities) in terms of the appropriateness of the current regulatory frameworks and access pathways are in strong contrast to and often incompatible with, the end-user expectations of patients, advocacy groups, and the medical cannabis industry. Submissions from government agencies and professional health bodies consistently supported maintaining the current regulatory frameworks and access pathways, whereas an overwhelming majority of patients, advocacy groups and medical cannabis industry described the current regulatory and access models as ‘not fit for purpose’. Our analysis revealed that these tensions were largely underpinned by empirical uncertainties and differing views on the acceptable level and credibility of evidence i.e., what, and how much evidence is needed for policy and practice. Notwithstanding these differing views, there were commonalities among some stakeholders in terms of the various supply, regulatory, legislative, financial, and dispensing challenges that hindered timely access to medical cannabis products.
There have been several regulatory shifts in relation to medical cannabis since 2016. In December 2020, Australia voted at the Commission on Narcotic Drugs for removal of cannabis and cannabis resin from Schedule IV of the Single Convention on Narcotic Drugs, 1961, and thereby recognising the use of cannabis for therapeutic purposes. Australia was one of only three countries to support all five recommendations submitted to vote by the World Health Organisation at the commission [16, 17]. Border controls for Delta-9-tetrahydrocannabinol (dronabinol) formulations have been maintained, consistent with the current Schedule 8 poison status of cannabis that was implemented in Australia in 2017 [18]. The SAS online portal system was made available in July 2018 facilitating a concurrent application to the Commonwealth and relevant State/Territory with the aim of streamlining the application process and reducing approval times from ‘several weeks to a maximum of 48 hours’ [19]. The most notable regulatory changes happened in response to issues raised in the 2019 Senate Inquiry. The Senate Community Affairs References Committee into current barriers to patient access to medicinal cannabis in Australia put forward 20 recommendations [19] including, among others
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Development and delivery of targeted education to health professionals, medical students, patients, and the public,
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Assessment of the need for establishing a new independent medical cannabis regulator, and a Commonwealth Compassionate Access Subsidy Scheme
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Amendment and/or clarification around the requirements of SAS-B and AP schemes, and
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Down-scheduling or de-scheduling of low dose cannabidiol.
The Australian Government published a response on the 4 March 2021 to the recommendations arising from the Senate Inquiry. Details on which recommendations were noted, accepted in part or in full, not accepted can be found at the department’s website [19]. The government have since made a series of reforms to the way medical cannabis is accessed via SAS-B and Authorised Prescriber schemes as well as provided tailored information for consumers, health professionals, sponsors and manufacturers. Another major regulatory change came into effect on 1 February 2021, when cannabidiol at a dose of 150 mg or less and meeting specific requirements was down-scheduled to be available over the counter [20], albeit no product has met requirements to be supplied in this manner yet. According to the Therapeutic Goods Administration Medicinal cannabis Special Access Scheme Category B dashboard data, there has been a surge in the number of SAS-B applications, increasing from 57,700 applications in 2020 to 111,500 in 2021 (as of November 2021) [21]. On the 22 November 2021, the Therapeutic Goods Administration implemented changes to the SAS and AP application pathways whereby applications are made by cannabinoid content categories. However, it is not yet apparent how bioequivalence will be determined in this instance. This number is expected to increase substantially given the recent changes to SAS-B application requirements.
Submissions to the Senate Inquiry revealed a broad range of factors that may contribute to inequity in patient access to medical cannabis, although it is worth noting that many of these factors also influence access to healthcare more broadly. These include: a lack of regulatory harmonisation across states and territories; medical practitioner workforce disparities and limited access to health professionals willing to prescribe cannabis medicines; inequalities relating to participation in clinical trials; public transport inequities; and costs associated with medical cannabis access. There is disparity in the number of SAS-B applications approved in each state and territory, where the number of applications approved in Queensland is almost twice that of New South Wales, well over double that of Victoria, and six times that of Western Australia [21]. Approvals for other states and territories of Australia including South Australia, Australian Capital Territory, Northern Territory, and Tasmania are negligible [21]. It is, however, important to note that the SAS B approval data represents the prescriber consulting location rather than the patient location. For example, a product may be prescribed following a telehealth consultation by a prescriber in one state for a patient residing in another state and the product can be shipped to patients from a dispensary located in a different state or territory. The low rate of applications from Australian Capital Territory is likely attributable to the state’s decriminalisation of cannabis for personal use since 31 January 2020 [22]. Currently, the majority of clinical trials that provide subsided medical cannabis to patients are centred around trials that are in the states of New South Wales, Queensland and Victoria [23]. Inequities are also compounded by the geographic location of cannabis clinics in these same states [24]. Disparities are no more evident than they are in Tasmania, which has the lowest number of approvals in Australia due to the latent introduction of legislation to allow both general practitioners and specialists to prescribe, requirement that both prescribers and dispensers need to be from Tasmania, and legislation that did not allow prescribers to access the national Therapeutic Goods Administration streamlined SAS-B portal for prescribing [25, 26] There are also issues around access in rural communities within each state and territory where limited and variable medical workforce supply in rural districts, poor access to community pharmacies to source the prescribed medical cannabis product(s), and conflicting opinions on current drug driving laws prohibiting driving [25]. These leads to heightened financial strain and required resources to access medical cannabis products in geographical locations that have lower socioeconomic status compared to urban areas.
Acceptability of medical cannabis to prescribers and the public has also been reported by diverse stakeholders as a major psychosocial factor that limits patient access to medical cannabis. Despite a growing interest in and awareness of its benefits, several stigmas remain attached to medical cannabis, such as its connections to cannabis more broadly, including negative perceptions as a recreational substance, illegality, and a potential vulnerability to or exacerbation of mental health concerns [27]. These stigmas prevent both consumers and clinicians from openly discussing and engaging with medical cannabis as a treatment possibility. Given that these stigmas toward therapeutic use of cannabis are mainly due to its connections to recreational cannabis, it may partially be addressed by decoupling recreational vs medical cannabis via increased education and public awareness campaigns, as recommended by the Senate Inquiry committee. While concerns regarding the acceptability of medical cannabis may equally be viewed as attempting to ensure patient safety, they conversely result in making access to medical cannabis more difficult for consumers. Evidence strongly suggests that the complex regulatory framework for accessing medical cannabis is contributing to some people choosing to access illicit cannabis products, which has its own quality and safety implications and legal repercussions.
The financial and temporal costs associated with accessing medical cannabis, incurred from accessing appointments and products, have increased exponentially and in many cases is viewed as prohibitive. Patients must pay for all medical cannabis products outright; except for Epidyolex® which was listed on the Pharmaceutical Benefits Scheme in May 2021 as a third line treatment for Dravet Syndrome [6, 28]. The prohibitive cost and complex regulatory landscape were indicated by consumers as main reasons to resort to illicit markets and/or self-cultivation for sourcing cannabis products for therapeutic purposes. Although the recommendation response report [19] details that ‘the Government does not support the provisions of amnesties for possession and/or cultivation of cannabis through illegal sources’, a considerable proportion of consumers reported having used illicit markets or self-cultivation routes to access their products. This was also reported in a national survey conducted in 2018–19, where more than 90% of respondents indicated they obtained their medical cannabis from ‘recreational dealers’, illicit medical cannabis suppliers, friends or family, or via self-cultivation [29].
Internationally, the question of how to regulate medical cannabis is a major source of debate in many countries and continues to divide the public health community. The laws and policy domains in the majority of countries are grounded in and shaped by the existing and historical cannabis regulation [30], making it difficult to draw credible comparisons across countries. Despite differences in their regulatory approaches to medical cannabis, majority of these countries agree on: i) the need for continued education for health practitioners, ii) addressing stigma, iii) involving patients and addressing patients’ concerns, and iv) improving the evidence base through real-world data collection.
The 2019–20 Senate Inquiry and transcripts from public hearings represent the most recent and comprehensive data from multiple stakeholders on use of, and access to medical cannabis in Australia. However, our study has some limitations. The major caveat with respect to the dataset is the fact that submissions to the inquiry were voluntary and that the data may not be nationally representative. Submissions by public health academics and researchers were made in their individual capacity and views of professional health bodies may not necessarily represent the views of all their members. It is also worth mentioning that it was unclear in the submissions whether respondents are of Aboriginal or Torres Strait Islander backgrounds. There is a need for more research to better understand the values and preferences of diverse communities. The dataset and findings from the analysis should be regarded as a snapshot in time, given the ever-changing regulatory landscape regarding medical cannabis. As discussed in detail, some of the ‘system-level’ access barriers have been resolved in the some of the reforms and regulatory changes that were instituted since the inquiry was held. Nevertheless, this analysis has provided an insight into the views of multiple stakeholders on use of medical cannabis and the Australian regulator approach, and achieving equitable access to these products.
Conclusions
Our analysis of Inquiry submissions revealed various regulatory, financial, psychological, supply and dispensing challenges with potential impact on timely access to medical cannabis products. While recent regulatory changes made by the jurisdictional and Federal government have been implemented with the intention of addressing perceived access barriers to medical cannabis, the Senate Inquiry highlighted broader access issues relevant to all medicines. One of the fundamental barriers that determine how and if a patient accesses medicines is the urban–rural disparity in access to healthcare. Furthermore, decoupling recreational vs medical cannabis and reframing societal and health professional’s views of medical cannabis are some of essential first steps to destigmatise and improve access to the therapeutic use of cannabis.
Supporting information
S1 File
List of stakeholders included in the analysis (n = 121).
(DOCX)
Data Availability
All underlying data used in this study is publicly available at Australian government parliament website, and can be accessed at https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Medicinalcannabis.
References
- PLoS One. 2022; 17(11): e0277355.
- Decision Letter 0
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Decision Letter 0
2 Sep 2022
PONE-D-22-15976From growers to patients: multi-stakeholder views on the use of, and access to medicinal cannabis in AustraliaPLOS ONE
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Reviewer #1: Overall a very good paper, providing interesting insights and perspectives into the Senate discussions and their outcome. I only missed some considerations of possible traditional and herbal medicine schemes that exist in the country or in states and territories, and may have been used as a point of comparison (see PP. 157-160 in WHO global report on traditional and complementary medicine 2019, https://www.who.int/publications/i/item/978924151536). A mention and brief discussion of the participation (or lack thereof) of aboriginal people would also have been welcomed.
Some comments:
P.1: “Community interest in the use of cannabis for medicinal purposes has increased within Australia and internationally [1, 2]. The rapid growth in national demand for access to cannabis for therapeutic use has largely been driven by…”
I would suggest to harmonize the language you use elsewhere in the article, and general use: “therapeutic” or “medical” to be applied to purposes (therapeutic purposes, therapeutic use…), and the word “medicinal” to the plant (medicinal plants; medicinal cannabis). To match this, the sentence could therefore read as follows:
“Community interest in the use of cannabis for *therapeutic* purposes has increased within Australia and internationally [1, 2]. The rapid growth in national demand for access to *medicinal* cannabis for *such* use has largely been driven by…”
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P.1: “consumer advocacy groups”
Consider “patient advocacy groups” or “patient or consumer advocacy groups”
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P. 1, § 2: “(like many international jurisdictions)”
Consider: “(like many other jurisdictions internationally)” or “(like many other jurisdictions worldwide)”
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P. 4, in the sentence “Between 17 January 2020 and 26 March 2020, multiple stakeholders, including consumers, clinicians, and organisations, submitted their perspectives relating to the terms of reference.”
Consider using “patients” instead of “consumers” – Note: this is valid elsewhere, throughout the text of the manuscript.
I would also recommend replacing “Between 17 January 2020 and 26 March 2020” by “During a XX-days consultation in 2020”. My assumption is that such level of precision is not required in the introduction; however, the mention of exact dates in the “Data sources” part of the “Methods” section where other dates (e.g. December 2019; January 2020) are mentioned, may make more sense.
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P. 3 or 4:
It may be relevant to mention that Australia was one of the three countries that voter in favour of all the recommendations of the World Health Organization related to medicinal cannabis, in December 2020. See table p.7 in: History, science, and politics of international cannabis scheduling, 2015–2021 https://ssrn.com/abstract=3932639.
Explanations of vote pp. 17-18 in: https://www.unodc.org/documents/commissions/CND/CND_Sessions/CND_63Reconvened/ECN72020_CRP24_V2007524.pdf
Following the vote, Australian representatives declared: “we must be prepared to listen to expert scientific and medical advice and keep the scheduling of controlled substances up to date and in line with community expectations” and that “Australia will continue to advocate for greater access to controlled medicines for those in need” https://www.unodc.org/documents/commissions/CND/CND_Sessions/CND_64/Statements/13April/Australia.pdf
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P. 5: “government and non-government organisations, peak health bodies, health charities, advocacy groups, medicinal cannabis industry and members of the public”
I have some issues with the classification of stakeholders presented here. And, although the manuscript points at the Supplementary File 1, there is no further explanation of which stakeholder was classified in which particular category, and the reasons for it. In my understanding, the list could be reduced to three classes: “government organisation”, “non-government organisation” (which includes de facto “health charities, advocacy groups, medicinal cannabis industry” -unsure about “peak health bodies”) and “members of the public” (i.e. individuals).
I am not sure of what “peak health bodies” refer to, although I understand I may not be familiar with this terminology. There are some examples throughout the text which help get an idea, but it would be interesting to explain more clearly whether these include also public or semi-public health monitoring agencies, institutions, and other public health organisms of a public-interest character, or if it refers only to private health stakeholders, consortia, or colleges?
I would also have appreciated a clarification of the criteria used to distinguish between “advocacy groups” and “health charities” –my understanding is that many of those labelled as one group could fall under the other, and vice-versa. E.g.: are “Drug Free Queensland” and “Medical Cannabis Users Assocation of Tasmania” advocacy groups, health charities… or both?
Finally, it may also have been beneficial to screen “members of the public” (1) to distinguish healthcare professionals or patients, for instance, from other interested parties (2) for possible affiliation to non-governmental organisations and/or possible corporate interest.
In addition to clarifications on P.5 (maybe a small table describing characteristics of the different classes of stakeholders), an idea could be to present the information in Supplementary File 1 as a table, with a first column listing stakeholders, and added columns with precisions about the class applied by the authors to each particular respondent, and other comments or information related. –in a way that matches the information presented in the first paragraph of the “Results” section.
P. 6 mentions the presence of “a link to included documents” in the Supplementary File, but there was no link(s). It may be interesting to provide URLs to the submissions, if available.
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P. 6: “Submissions were also supplemented with interview transcripts from the public hearing (Table 1).”
No Table 1 in the manuscript I have been given access to.
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P. 7: “Submissions from the health and medical field” is followed by a quote from GW pharmaceutical, supporting the exact type of products that this company is commercialising. Tis does not seem to be just any submission from simply “the health and medical field”, but from a multinational corporate firm with interest in preserving market shares. This should be acknowledged, notably in the context of the two only cannabis-based medicines listed on the ARTG, whiich are mentioned P. 3, are owned and commercialised by that particular company. This seems to need acknowledgement as well.
This is echoed on P. 9, where the sentence “Submissions from some pharmaceutical industry entities with an interest in the therapeutic use of cannabis have framed ‘medicinal cannabis’ as consumer products that lacked sufficient empirical evidence to be considered an approved medicine.” could be more precise, for instance:
“Submissions from some pharmaceutical industry entities with *a commercial* interest in the therapeutic use of *particular products of*/*their products* cannabis have framed ‘medicinal cannabis’ as consumer products that lacked sufficient empirical evidence to be considered an approved medicine.”
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P. 8: “Whilst the need for high quality evidence on the safety and efficacy of medicinal cannabis products was widely acknowledged, there was a sense of recognition that there needs to be a way for medicinal cannabis to be managed and accessible to patients (even if conditionally) within the therapeutic context.”
Unclear sentence: was there a *shared* sense of recognition among all stakeholders or only some? It may need to be specified.
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P. 11 where “tetrahydrocannabinol (THC)” is mentioned, it could be sound to include the international nonproprietary name (INN) for delta-9-tetrahydrocannabinol, which is “dronabinol”. This would make sense, provided that the INN for Epidiolex® is used on P. 3 (INN cannabidiol) as well as the non-proprietary name for Sativex® (nabiximols) PP. 3 & 15.
See https://www.linkedin.com/pulse/dronabinol-your-cannabis-kenzi-riboulet-zemouli/ and P. 6 in: List of Proposed INNs No. 51, WHO Chronicle 38(2), 1984 https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl51.pdf?sfvrsn=3ded55af_9&download=true and P. 4 in: List of Recommended INNs No. 24, WHO Chronicle 38(6), 1984 https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/rl24.pdf?sfvrsn=99779214_6&download=true
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P. 11 “Under the current Australian drug driving policy, driving while having detectable levels of tetrahydrocannabinol (THC) in the body is considered an offence, and patients may be subject to prosecution, fines, and loss of licence.”
Source or reference needed.
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P. 11 “A significant proportion of patients who made submissions reported that they resorted to black market (also referred to as ‘black’, ‘grey’ or ‘green’ market) to source their medicinal cannabis products”
Consider: “they resorted to *the illicit* market (also referred to as ‘black’, ‘grey’, *’alternative’,* or ‘green’ market)”
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P. 11 ” reported self-producing medicinal cannabis for personal use, often without a license to produce medicinal cannabis (see submissions 13; 80, 91, 29; 4, 110, 44, 6).”
Consider ” reported self-producing medicinal cannabis for personal use, often without a license to *that purpose*”
Also consider ordering the submission numbers in ascending order, in this sentence and throughout the text.
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P. 12: “many patients who opted to self-medicate with illicit cannabis”
Self-medication is different than sourcing cannabis from the illicit market after being prescribed. Self-medication implies the absence of an external healthcare advice. I suggest replacing the terms ” who opted to self-medicate with illicit cannabis” with “who opted to source their cannabis from the illicit market”
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P. 12: “issues associated with sourcing medicinal cannabis products from the black market”
Consider relying on neutral language, except in quotations, i.e. using the terms “illicit market” instead of “black market” throughout the text (e.g. P. 20).
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PP. 13 & 14, sentences almost similar:
“The Medicinal Cannabis Users Association of Australia submission reported that where ‘cannabis clinics’ are available, often via telehealth consultation, they often charge “specialist” consultation rates and monitoring fees for which patients can rarely get a Medicare or Health Fund rebate (submission 9; page 7).”
““These clinics are charging fees to put in an application to the TGA that attracts no fee. They are charging “Specialist” consultation rates and monitoring fees for which patients can rarely get a Medicare or Health Fund rebate.” (Medical Cannabis Users Assoc of Australia, Submission 9, page 7).”
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P. 15: “At the time of this parliamentary inquiry (November 2019)”
I thought that it was between 17 January 2020 and 26 March 2020,?
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P. 15: “compassionate access schemes” –> “scheme”
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P. 18: “However, Australia did not vote for additional recommendations made by the World Health Organisation, including the removal of border controls for Delta-9-tetrahydrocannabinol formulations”
This is incorrect, or I did not properly understand the formulation.
A good article to understand the WHO recommendations is WHO’s first scientific review of medicinal Cannabis: from global struggle to patient implications https://www.emerald.com/insight/content/doi/10.1108/DHS-11-2021-0060/full/html
Australia voted in favour of all recommendations that were submitted to the vote, and was one of the few countries to do so. The recommendations that Australia did not vote in favour of were, in fact, not put on the ballot. See vote results here: “Report on the reconvened sixty-third session (2-4 December 2020), economic and social council official records, 2020 supplement no. 8A”, E/2020/28/Add.1, available at: undocs.org/E/2020/28/Add.1 and in https://ssrn.com/abstract=3932639
See also explanations of vote pp. 17-18 in: https://www.unodc.org/documents/commissions/CND/CND_Sessions/CND_63Reconvened/ECN72020_CRP24_V2007524.pdf where is is stated:
“Australia supported recommendation 5.1 which recogni zes that cannabis and cannabis resin are unlikely to produce ill-effects similar to other Schedule IV substances, and that some parties have enacted laws to enable the medical use of cannabis and cannabis resin.
− Australia considers this approach strikes an appropriate regulatory balance and simply recognizes that there is a legitimate medical use quite separate to the use of cannabis for research purposes.
Australia supported recommendation 5.2 and 5.3 Australia’s strong preference is for dronabinol, THC and its stereoisomers to be managed consistently with cannabis and cannabis resin under Schedule I of the 1961 Convention. This would remove ambiguity and complexity, especially as it applies to trade between member states.
Australia supported recommendation 5.4 which will improve consistency and remove ambiguity in the regulation of cannabis extracts and preparations.
Australia supported recommendation 5.5 on the basis that predominantly cannabidiol preparations with low concentrations delta-9 THC are of less risk of harm than those which contain greater than 0.2 per cent. This recommendation assists improving consistency and trade and reporting discrepancies.”
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P. 18: “no product has met requirements to be supplied in this manner [16]”
It is unclear if the reference mentioned related to the fact that no product has met requirements to be supplied in this manner. I would place the reference before the word “albeit”, and slightly edit the sentence so it reads:
“over the counter,[16] albeit no product has met requirements to be supplied in this manner *yet*.”
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P. 20: typo in “or by via self-cultivation”.
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I look very much forwards to reading an improved and final version of this article!
Thank you for your work.
Reviewer #2: A fascinating and well written article that qualitatively delves into over 120 submissions made by a variety of stakeholders to the 2019 Australian inquiry into barriers to patient access to medicinal cannabis. Using the modified Levesque patient-centred access to care framework, the authors examine these barriers from the perspective of appropriateness, availability and geographical accessibility, acceptability, and affordability. The analysis uncovers the tension and differences between government/professional and patient/advocacy stakeholders with regards to their perception of the current regulatory framework and the impact on access and use of medical cannabis. This manuscript provides a deep dive into the discourse surrounding access to medicinal cannabis in Australia and will be informative for other jurisdictions who have legalized/decriminalized access to medicinal cannabis.
There are a few issues that would warrant further consideration and elucidation:
• In the Introduction, a description of the SAS Category A and SAS-B pathways is presented – it is not clear if there is a distinction between “medical practitioners” and “registered health practitioners”. Given some jurisdictions allow other health professionals, such as nurse practitioners, to authorize/prescribe medical cannabis, it would be helpful to clarify if there is indeed a difference across these pathways re: type of health care professional.
• There is reference throughout the manuscript to “scientific evidence” and what type and how much evidence is perceived to be required by different stakeholders to support the prescription of medical cannabis. The role of patient preference/values and contextual factors, such as the risks of other pharmaceutical treatments (e.g., opioids) and resources, however, is not mentioned. Given these are hallmarks of evidence-based medicine, it would be worthwhile for a brief discussion about whether evidence-based medicine is a guiding principle across government, professional and charity groups, as well as among the patient/advocacy stakeholders.
• I was intrigued by the quote drawn from the health and medical field that suggested that “We firmly believe that patients deserve access to medicines of the highest quality – testing for both safety and efficacy in placebo-controlled, randomized clinical trials and licensed as medicines…”. This quote appears quite naïve of the reality of medical cannabis research with regards to limited funding as well as the challenges associated with conducting clinical trials on a plant-based medicine that is difficult standardize as well as blind subjects to due to its psychoactive effect. It also expresses a clear bias toward the medicalization of cannabis, assuming that medicinal cannabis should be developed into a pharmaceutical medicine that can be patented and licensed. I would encourage the authors to reflect further in the discussion on the tension that exists when these two different paradigms of therapies (plant vs. pharmaceutical) collide.
• The discussion would have benefitted from a brief discussion of other medical cannabis regulatory systems, including in Canada and the US, and whether the associated policies/processes would address some of the barriers expressed by stakeholders in Australia.
• Recommend that not only do medical and pharmacy schools need to include education on the ECS and medicinal cannabis, but also nursing schools as nurses are often tasked in clinical settings to assist patients in using medicinal cannabis. To do so, they require sufficient education about medicinal cannabis.
• In the Discussion, there is commentary regarding the acceptability of medical cannabis being viewed as an attempt to ensure patient safety; however, in restricting access and pushing patients towards the unregulated/illegal market, they are also placing them at risk through the use of an unregulated supply of cannabis as well as the risk of criminalization. Some discussion of this is required.
• The need to “decouple” medicinal cannabis from that used for recreational purposes is indeed important; however, it would be useful to suggest some strategies to do (i.e., education, public education, working with professional societies with stigmatizing policies).
Minor grammatical/writing issues:
• The term “peak health bodies” is unique to Australia and does not easily translate for readers from other countries. Please define when first used and provide an example.
• The word “neogitations” is spelled wrong on the 3rd line above the section entitled “The role of evidence in informing policy and clinical practice…”
• Remove “an” from the following sentence, “…and advocated for an expedited access while TGA registration is pending.”
• In the first sentence under “Supply – demand mismatch”, edit to read: “…Australian made products, along with the fact that imported medicinal cannabis…”
• Edit the following sentence in the discussion: “…cost that patients would otherwise pay at cannabis access clinics…”
• There are too many acronyms, particularly in the Discussion. Please consider keeping only a handful of them so the reader is not confused or searching for what they stand for throughout the manuscript.
• The sentence with “This ‘postcode’ lottery is evidence “ appears to be unfinished in the Discussion.
• The term “black market” has fallen out of favour; please consider using “unregulated” or “illegal” market instead.
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Reviewer #1: Yes: Kenzi Riboulet-Zemouli
Reviewer #2: No
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- PLoS One. 2022; 17(11): e0277355.
- Author response to Decision Letter 0
»
Author response to Decision Letter 0
14 Sep 2022
Reviewer 1:
Overall, a very good paper, providing interesting insights and perspectives into the Senate discussions and their outcome. I only missed some considerations of possible traditional and herbal medicine schemes that exist in the country or in states and territories and may have been used as a point of comparison (see PP. 157-160 in WHO global report on traditional and complementary medicine 2019, https://www.who.int/publications/i/item/978924151536). A mention and brief discussion of the participation (or lack thereof) of aboriginal people would also have been welcomed.
Thank you for this feedback. It was unclear in the submissions whether respondents are of Aboriginal or Torres Strait Islander backgrounds. We have indicated this as a limitation, and recommended for more research to better understand the values and preferences of diverse communities.
1. P.1: “Community interest in the use of cannabis for medicinal purposes has increased within Australia and internationally [1, 2]. The rapid growth in national demand for access to cannabis for therapeutic use has largely been driven by…”
I would suggest to harmonize the language you use elsewhere in the article, and general use: “therapeutic” or “medical” to be applied to purposes (therapeutic purposes, therapeutic use…), and the word “medicinal” to the plant (medicinal plants; medicinal cannabis). To match this, the sentence could therefore read as follows:
“Community interest in the use of cannabis for *therapeutic* purposes has increased within Australia and internationally [1, 2]. The rapid growth in national demand for access to *medicinal* cannabis for *such* use has largely been driven by…”
This has been changed (pg. 3 and pg. 18), text copied below:
Pg. 3: “Community interest in the use of cannabis for medicinal therapeutic purposes has increased within Australia and internationally [1, 2].”
Pg: 18: “…recognising the use of cannabis for medicinal therapeutic purposes.”
2. P.3: “Consumer advocacy groups” – consider “patient advocacy groups” or “patient or consumer advocacy groups”.
This has been changed (pg. 3 and pg. 9, text copied below):
“The rapid growth in national demand for access to cannabis for therapeutic use has largely been driven by patient or consumer advocacy groups…”
“Again, clinical and governmental perspectives were not typically reflective of the views of patients and patient or consumer advocacy groups…”
3. P. 3: “(like many international jurisdictions)” – consider “(like many other jurisdictions internationally)” or “(like many other jurisdictions worldwide)”.
This has been changed (pg. 3, text copied below):
“Alongside these legislative changes, Australia (like many other jurisdictions worldwide)…”
4. P. 4, In the sentence “Between 17 January 2020 and 26 March 2020, multiple stakeholders, including consumers, clinicians, and organisations, submitted their perspectives relating to the terms of reference”, consider using “patients” instead of “consumers” – Note: this is valid elsewhere, throughout the text of the manuscript. I would also recommend replacing “Between 17 January 2020 and 26 March 2020” by “During a XX-days consultation in 2020”. My assumption is that such level of precision is not required in the introduction; however, the mention of exact dates in the “Data sources” part of the “Methods” section where other dates (e.g. December 2019; January 2020) are mentioned, may make more sense.
This has been changed (pg. 4, text copied below):
“During 69 days of consultation in 2020, multiple stakeholders, including patients, clinicians, and organisations, submitted their perspectives relating to the terms of reference…”
5. P. 3 or 4: It may be relevant to mention that Australia was one of the three countries that voter in favour of all the recommendations of the World Health Organization related to medicinal cannabis, in December 2020. See table p.7 in: History, science, and politics of international cannabis scheduling, 2015–2021 https://ssrn.com/abstract=3932639. Explanations of vote pp. 17-18 in: https://www.unodc.org/documents/commissions/CND/CND_Sessions/CND_63Reconvened/ECN72020_CRP24_V2007524.pdf Following the vote, Australian representatives declared: “we must be prepared to listen to expert scientific and medical advice and keep the scheduling of controlled substances up to date and in line with community expectations” and that “Australia will continue to advocate for greater access to controlled medicines for those in need” https://www.unodc.org/documents/commissions/CND/CND_Sessions/CND_64/Statements/13April/Australia.pdf.
Thank you to the reviewer for this clarification. We have included this information as part of the discussion on regulatory changes. We have included the suggested citations. See the extract below.
p.g. 18 “In December 2020, Australia voted at the Commission on Narcotic Drugs for removal of cannabis and cannabis resin from Schedule IV of the Single Convention on Narcotic Drugs, 1961, and thereby recognising the use of cannabis for therapeutic purposes. Australia was one of only three countries to support all five recommendations submitted to vote by the World Health Organisation at the commission. Border controls for Delta-9-tetrahydrocannabinol (dronabinol) formulations have been maintained, consistent with the current Schedule 8 poison status of cannabis that was implemented in Australia in 2017 [14].”
6. P. 5: “government and non-government organisations, peak health bodies, health charities, advocacy groups, medicinal cannabis industry and members of the public”
I have some issues with the classification of stakeholders presented here. And, although the manuscript points at the Supplementary File 1, there is no further explanation of which stakeholder was classified in which particular category, and the reasons for it. In my understanding, the list could be reduced to three classes: “government organisation”, “non-government organisation” (which includes de facto “health charities, advocacy groups, medicinal cannabis industry” -unsure about “peak health bodies”) and “members of the public” (i.e. individuals).
I am not sure of what “peak health bodies” refer to, although I understand I may not be familiar with this terminology. There are some examples throughout the text which help get an idea, but it would be interesting to explain more clearly whether these include also public or semi-public health monitoring agencies, institutions, and other public health organisms of a public-interest character, or if it refers only to private health stakeholders, consortia, or colleges?
I would also have appreciated a clarification of the criteria used to distinguish between “advocacy groups” and “health charities” –my understanding is that many of those labelled as one group could fall under the other, and vice-versa. E.g.: are “Drug Free Queensland” and “Medical Cannabis Users Assocation of Tasmania” advocacy groups, health charities… or both?
Finally, it may also have been beneficial to screen “members of the public” (1) to distinguish healthcare professionals or patients, for instance, from other interested parties (2) for possible affiliation to non-governmental organisations and/or possible corporate interest.
7. In addition to clarifications on P.5 (maybe a small table describing characteristics of the different classes of stakeholders), an idea could be to present the information in Supplementary File 1 as a table, with a first column listing stakeholders, and added columns with precisions about the class applied by the authors to each particular respondent, and other comments or information related. –in a way that matches the information presented in the first paragraph of the “Results” section.
8. P. 6 mentions the presence of “a link to included documents” in the Supplementary File, but there was no link(s). It may be interesting to provide URLs to the submissions, if available. Also, “Submissions were also supplemented with interview transcripts from the public hearing (Table 1).” – no Table 1 in the manuscript I have been given access to.
Thank you. We have now included i) table 1 describing characteristics of the different classes of stakeholders, and ii) a supplementary table with list of included submissions and category of stakeholders. We have also included a link to website link to the original submissions publicly available on the Australian government parliament website
9. P. 7: “Submissions from the health and medical field” is followed by a quote from GW pharmaceutical, supporting the exact type of products that this company is commercialising. Tis does not seem to be just any submission from simply “the health and medical field”, but from a multinational corporate firm with interest in preserving market shares. This should be acknowledged, notably in the context of the two only cannabis-based medicines listed on the ARTG, whiich are mentioned P. 3, are owned and commercialised by that particular company. This seems to need acknowledgement as well. This is echoed on P. 9, where the sentence “Submissions from some pharmaceutical industry entities with an interest in the therapeutic use of cannabis have framed ‘medicinal cannabis’ as consumer products that lacked sufficient empirical evidence to be considered an approved medicine.” could be more precise, for instance:
“Submissions from some pharmaceutical industry entities with *a commercial* interest in the therapeutic use of *particular products of*/*their products* cannabis have framed ‘medicinal cannabis’ as consumer products that lacked sufficient empirical evidence to be considered an approved medicine.”
We echo the reviewer’s comment that a submission from cannabis/pharmaceutical industry do not necessarily reflect the views of “health and medical field”. We have therefore replaced the quote from GQ Pharmaceuticals to a representative quote from a health and medical profession. See the quote below.
“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.” (Professor James Angus, Chair of the Australian Advisory Council on the Medicinal Use of Cannabis’ Submission 53; page 2)
We have also made the recommended changes as “Submissions from some pharmaceutical industry entities with a commercial interest in the therapeutic use of particular products of cannabis (e.g., cannabis products registered in ARTG) have framed ‘medicinal cannabis’ as consumer products that lacked sufficient empirical evidence to be considered an approved medicine.”
10. P. 8: “Whilst the need for high quality evidence on the safety and efficacy of medicinal cannabis products was widely acknowledged, there was a sense of recognition that there needs to be a way for medicinal cannabis to be managed and accessible to patients (even if conditionally) within the therapeutic context.” – unclear sentence: was there a *shared* sense of recognition among all stakeholders or only some? It may need to be specified.
This has been clarified (pg. 8, text copied below):
“…there was a shared sense of recognition by stakeholders that there needs to be a way for medicinal cannabis to be managed and accessible to patients (even if conditionally)…”
11. P. 11 where “tetrahydrocannabinol (THC)” is mentioned, it could be sound to include the international nonproprietary name (INN) for delta-9-tetrahydrocannabinol, which is “dronabinol”. This would make sense, provided that the INN for Epidiolex® is used on P. 3 (INN cannabidiol) as well as the non-proprietary name for Sativex® (nabiximols) PP. 3 & 15. See https://www.linkedin.com/pulse/dronabinol-your-cannabis-kenzi-riboulet-zemouli/ and P. 6 in: List of Proposed INNs No. 51, WHO Chronicle 38(2), 1984 https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl51.pdf?sfvrsn=3ded55af_9&download=true and P. 4 in: List of Recommended INNs No. 24, WHO Chronicle 38(6), 1984 https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/rl24.pdf?sfvrsn=99779214_6&download=true
This has been included (pg. 11 and pg. 18, text copied below):
“… detectable levels of tetrahydrocannabinol (THC; dronabinol) in the body…”
“… border controls for Delta-9-tetrahydrocannabinol (dronabinol) formulations…”
12. P. 11 “Under the current Australian drug driving policy, driving while having detectable levels of tetrahydrocannabinol (THC) in the body is considered an offence, and patients may be subject to prosecution, fines, and loss of licence.”
Source or reference needed.
We have included the following references.
• Perkins D, Brophy H, McGregor IS, O’Brien P, Quilter J, McNamara L, Sarris J, Stevenson M, Gleeson P, Sinclair J, Dietze P. Medicinal cannabis and driving: the intersection of health and road safety policy. Int J Drug Policy. 2021 Nov;97:103307
• Alcohol and Drug Foundation. Medical Cannabis and Driving in Australia. 2022
13. P. 11 “A significant proportion of patients who made submissions reported that they resorted to black market (also referred to as ‘black’, ‘grey’ or ‘green’ market) to source their medicinal cannabis products” – consider: “they resorted to *the illicit* market (also referred to as ‘black’, ‘grey’, *’alternative’,* or ‘green’ market)”
This has been changed (pg. 11, text copied below):
“A significant proportion of patients who made submissions reported that they resorted to illicit markets (also referred to as ‘black’, ‘grey’ or ‘green’ market) to source their medicinal cannabis products…”
14. P. 11 ” reported self-producing medicinal cannabis for personal use, often without a license to produce medicinal cannabis (see submissions 13; 80, 91, 29; 4, 110, 44, 6)” – consider ” reported self-producing medicinal cannabis for personal use, often without a license to *that purpose*”. Also consider ordering the submission numbers in ascending order, in this sentence and throughout the text.
This has been changed (pg. 11, text copied below). Submission numbers have now been placed in ascending order where appropriate throughout the article.
“…reported self-producing medicinal cannabis for personal use, often without a license to produce medicinal cannabis for that purpose (see submissions 4, 6, 13, 29, 44, 80, 91, 110).”
15. P. 12: “many patients who opted to self-medicate with illicit cannabis” – self-medication is different than sourcing cannabis from the illicit market after being prescribed. Self-medication implies the absence of an external healthcare advice. I suggest replacing the terms ” who opted to self-medicate with illicit cannabis” with “who opted to source their cannabis from the illicit market”
This has been changed (pg. 12, text copied below):
“However, many patients who opted to source their cannabis from illicit markets felt that they had no other choice…”
16. P. 12: “issues associated with sourcing medicinal cannabis products from the black market”
Consider relying on neutral language, except in quotations, i.e. using the terms “illicit market” instead of “black market” throughout the text (e.g. P. 20).
This has been corrected throughout the article.
17. PP. 13 & 14, sentences almost similar: “The Medicinal Cannabis Users Association of Australia submission reported that where ‘cannabis clinics’ are available, often via telehealth consultation, they often charge “specialist” consultation rates and monitoring fees for which patients can rarely get a Medicare or Health Fund rebate (submission 9; page 7).”, and “These clinics are charging fees to put in an application to the TGA that attracts no fee. They are charging “Specialist” consultation rates and monitoring fees for which patients can rarely get a Medicare or Health Fund rebate.” (Medical Cannabis Users Assoc of Australia, Submission 9, page 7).”
To remove ambiguity, the first sentence on Page 13 has been rephrased (pg. 13, text copied below). The sentence on Page 14 has not been changed as this is a quote from a submission.
“The Medicinal Cannabis Users Association of Australia submission reported that ‘specialist’ consultation and monitoring fees are regularly applied at ‘cannabis clinics’, often resulting in patients being rarely reimbursed through appropriate channels such as Medicare or other Health Fund rebates (Submission 9; page 7)”.
18. P. 15: “At the time of this parliamentary inquiry (November 2019)” – I thought that it was between 17 January 2020 and 26 March 2020?
This has been rephrased (pg. 15, text copied below):
“At the time this parliamentary inquiry was called (November 2019)…”
19. P. 15: “compassionate access schemes” –> “scheme”
This has been changed (pg. 15, text copied below):
“…have an established compassionate access scheme…”
20. P. 18: “However, Australia did not vote for additional recommendations made by the World Health Organisation, including the removal of border controls for Delta-9-tetrahydrocannabinol formulations”
This is incorrect, or I did not properly understand the formulation.
A good article to understand the WHO recommendations is WHO’s first scientific review of medicinal Cannabis: from global struggle to patient implications https://www.emerald.com/insight/content/doi/10.1108/DHS-11-2021-0060/full/html
Australia voted in favour of all recommendations that were submitted to the vote, and was one of the few countries to do so. The recommendations that Australia did not vote in favour of were, in fact, not put on the ballot. See vote results here: “Report on the reconvened sixty-third session (2-4 December 2020), economic and social council official records, 2020 supplement no. 8A”, E/2020/28/Add.1, available at: undocs.org/E/2020/28/Add.1 and in https://ssrn.com/abstract=3932639. See also explanations of vote pp. 17-18 in: https://www.unodc.org/documents/commissions/CND/CND_Sessions/CND_63Reconvened/ECN72020_CRP24_V2007524.pdf where is stated:
“Australia supported recommendation 5.1 which recognizes that cannabis and cannabis resin are unlikely to produce ill-effects similar to other Schedule IV substances, and that some parties have enacted laws to enable the medical use of cannabis and cannabis resin.
− Australia considers this approach strikes an appropriate regulatory balance and simply recognizes that there is a legitimate medical use quite separate to the use of cannabis for research purposes.
Australia supported recommendation 5.2 and 5.3 Australia’s strong preference is for dronabinol, THC and its stereoisomers to be managed consistently with cannabis and cannabis resin under Schedule I of the 1961 Convention. This would remove ambiguity and complexity, especially as it applies to trade between member states.
Australia supported recommendation 5.4 which will improve consistency and remove ambiguity in the regulation of cannabis extracts and preparations.
Australia supported recommendation 5.5 on the basis that predominantly cannabidiol preparations with low concentrations delta-9 THC are of less risk of harm than those which contain greater than 0.2 per cent. This recommendation assists improving consistency and trade and reporting discrepancies.”
Thank you to the reviewer for this clarification. We have reviewed the reference provided and update the manuscript to read as follows:
p.g. 18 “In December 2020, Australia voted at the Commission on Narcotic Drugs for removal of cannabis and cannabis resin from Schedule IV of the Single Convention on Narcotic Drugs, 1961, and thereby recognising the use of cannabis for therapeutic purposes. Australia was one of only three countries to support all five recommendations submitted to vote by the World Health Organisation at the commission (ref). Border controls for Delta-9-tetrahydrocannabinol (dronabinol) formulations have been maintained, consistent with the current Schedule 8 poison status of cannabis that was implemented in Australia in 2017 [14].”
21. P. 18: “no product has met requirements to be supplied in this manner [16]”. It is unclear if the reference mentioned related to the fact that no product has met requirements to be supplied in this manner. I would place the reference before the word “albeit”, and slightly edit the sentence so it reads: “over the counter,[16] albeit no product has met requirements to be supplied in this manner *yet*.”
This has been changed (pg. 18, text copied below):
“…down-scheduled to be available over the counter [16], albeit no product has met requirements to be supplied in this manner yet.”
22. P. 20: typo in “or by via self-cultivation”.
This has been corrected (pg. 20, text copied below):
‘… or via self-cultivation.’
I look very much forward to reading an improved and final version of this article! Thank you for your work.
Thank you for this feedback.
Reviewer 2
A fascinating and well written article that qualitatively delves into over 120 submissions made by a variety of stakeholders to the 2019 Australian inquiry into barriers to patient access to medicinal cannabis. Using the modified Levesque patient-centred access to care framework, the authors examine these barriers from the perspective of appropriateness, availability and geographical accessibility, acceptability, and affordability. The analysis uncovers the tension and differences between government/professional and patient/advocacy stakeholders with regards to their perception of the current regulatory framework and the impact on access and use of medical cannabis. This manuscript provides a deep dive into the discourse surrounding access to medicinal cannabis in Australia and will be informative for other jurisdictions who have legalized/decriminalized access to medicinal cannabis.
Thank you for this feedback.
There are a few issues that would warrant further consideration and elucidation.
1. In the Introduction, a description of the SAS Category A and SAS-B pathways is presented – it is not clear if there is a distinction between “medical practitioners” and “registered health practitioners”. Given some jurisdictions allow other health professionals, such as nurse practitioners, to authorize/prescribe medical cannabis, it would be helpful to clarify if there is indeed a difference across these pathways re: type of health care professional.
The SAS allows prescribers (including nurse practitioners) to prescribe medicinal cannabis products for a single patient on a case-by-case basis. We have now clarified this in our revised manuscript. We have also replaced “medical practitioner” to “registered health practitioner” for consistency.
2. There is reference throughout the manuscript to “scientific evidence” and what type and how much evidence is perceived to be required by different stakeholders to support the prescription of medical cannabis. The role of patient preference/values and contextual factors, such as the risks of other pharmaceutical treatments (e.g., opioids) and resources, however, is not mentioned. Given these are hallmarks of evidence-based medicine, it would be worthwhile for a brief discussion about whether evidence-based medicine is a guiding principle across government, professional and charity groups, as well as among the patient/advocacy stakeholders.
We thank the reviewer for the comment. We have now revised the manuscript according to reviewer’s comment. see the text below.
“While the need to incorporate patients’ preferences into medical decision making has been highlighted by various stakeholders as a key component of patient-centred care, this has not been translated to decisions around access to and use of medical cannabis. For example, some patients, families, and caregivers reported using medical cannabis due to the significant financial distress, poor symptom control or intolerable adverse effects from conventional therapies (e.g., opioid dependence). One patient described medical cannabis as “a gateway out of the hopelessness of opioid dependence… alcoholism and addiction to prescription benzos”. Yet, what patients described as their lived experiences was considered by many stakeholders as ‘anecdotal’ evidence, and it was argued that they should not be taken into consideration in the policy making process.”
3. I was intrigued by the quote drawn from the health and medical field that suggested that “We firmly believe that patients deserve access to medicines of the highest quality – testing for both safety and efficacy in placebo-controlled, randomized clinical trials and licensed as medicines…”. This quote appears quite naïve of the reality of medical cannabis research with regards to limited funding as well as the challenges associated with conducting clinical trials on a plant-based medicine that is difficult standardize as well as blind subjects to due to its psychoactive effect. It also expresses a clear bias toward the medicalization of cannabis, assuming that medicinal cannabis should be developed into a pharmaceutical medicine that can be patented and licensed. I would encourage the authors to reflect further in the discussion on the tension that exists when these two different paradigms of therapies (plant vs. pharmaceutical) collide.
The specific quote “We firmly believe that patients deserve access to medicines of the highest quality – testing for both safety and efficacy in placebo-controlled, randomized clinical trials and licensed as medicines…” came from cannabis/pharmaceutical industry, and do not necessarily reflect the views of “health and medical field”. We have therefore replaced the quote from GQ Pharmaceuticals to a representative quote from a health and medical profession (as suggested by reviewer 1). The need for clear and convincing evidence from gold standard RCTs, and the difficulty of achieving such data is highlighted in the revised manuscript.
4. The discussion would have benefitted from a brief discussion of other medical cannabis regulatory systems, including in Canada and the US, and whether the associated policies/processes would address some of the barriers expressed by stakeholders in Australia.
Globally, the laws and policy domains in the majority of countries are grounded in and shaped by the existing and historical cannabis regulation making it difficult to draw credible comparisons across countries. However, we have tried to describe this, and identify areas commonalities across countries.
“Internationally, the question of how to regulate medical cannabis is a major source of debate in many countries and continues to divide the public health community. The laws and policy domains in the majority of countries are grounded in and shaped by the existing and historical cannabis regulation [30], making it difficult to draw credible comparisons across countries. Despite differences in their regulatory approaches to medical cannabis, majority of these countries agree on: i) the need for continued education for health practitioners, ii) addressing stigma, iii) involving patients and addressing patients’ concerns, and iv) improving the evidence base through real-world data collection.”
5. Recommend that not only do medical and pharmacy schools need to include education on the ECS and medicinal cannabis, but also nursing schools as nurses are often tasked in clinical settings to assist patients in using medicinal cannabis. To do so, they require sufficient education about medicinal cannabis.
This has been included (pg. 17, text copied below):
“…revising of curriculum of medical, nursing and pharmacy schools to include endocannabinoid system…”
6. In the Discussion, there is commentary regarding the acceptability of medical cannabis being viewed as an attempt to ensure patient safety; however, in restricting access and pushing patients towards the unregulated/illegal market, they are also placing them at risk through the use of an unregulated supply of cannabis as well as the risk of criminalization. Some discussion of this is required.
7. The need to “decouple” medicinal cannabis from that used for recreational purposes is indeed important; however, it would be useful to suggest some strategies to do (i.e., education, public education, working with professional societies with stigmatizing policies).
We have now addressed these comments as below.
“Given that these stigmas toward therapeutic use of cannabis are mainly due to its connections to recreational cannabis, it may partially be addressed by decoupling recreational vs medical cannabis via increased education and public awareness campaigns, as recommended by the Senate Inquiry committee. While concerns regarding the acceptability of medical cannabis may equally be viewed as attempting to ensure patient safety, they conversely result in making access to medical cannabis more difficult for consumers. Evidence strongly suggests that the complex regulatory framework for accessing medical cannabis is contributing to some people choosing to access illicit cannabis products, which has its own quality and safety implications and legal repercussions.”
Minor grammatical/writing issues:
8. The term “peak health bodies” is unique to Australia and does not easily translate for readers from other countries. Please define when first used and provide an example.
“Peak health body” is the term commonly used in Australia to refer to “professional health bodies” such as Australian Medical Association. In order to avoid confusion, we have replaced “peak” with “professional” throughout the manuscript.
9. The word “neogitations” is spelled wrong on the 3rd line above the section entitled “The role of evidence in informing policy and clinical practice…”
This has been corrected.
10. Remove “an” from the following sentence, “…and advocated for an expedited access while TGA registration is pending.”
This has been corrected.
11. In the first sentence under “Supply – demand mismatch”, edit to read: “…Australian made products, along with the fact that imported medicinal cannabis…”
This has been corrected.
12. Edit the following sentence in the discussion: “…cost that patients would otherwise pay at cannabis access clinics…”
This has been corrected.
13. There are too many acronyms, particularly in the Discussion. Please consider keeping only a handful of them so the reader is not confused or searching for what they stand for throughout the manuscript.
We have now reduced the number of acronyms throughout the manuscript.
14. The sentence with “This ‘postcode’ lottery is evidence “appears to be unfinished in the Discussion.
We have now deleted this incomplete sentence since it was a repetition.
15. The term “black market” has fallen out of favour; please consider using “unregulated” or “illegal” market instead.
This has been corrected throughout the article. Please refer to Comments 13 and 16 above from Reviewer 1.
Attachment
Submitted filename: Response to reviewer comments.docx
- PLoS One. 2022; 17(11): e0277355.
- Decision Letter 1
»
Decision Letter 1
26 Oct 2022
From growers to patients: multi-stakeholder views on the use of, and access to medicinal cannabis in Australia
PONE-D-22-15976R1
Dear Dr. Erku,
We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.
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David James Carter, PhD, LLM (Res), LLB (Hon I), BA
Academic Editor
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Additional Editor Comments (optional):
Thank you for your careful and considered response to reviewer feedback. I have reviewed both Reviewer 1 and Reviewer 2’s comments on your first revision and am happy that you have been able to respond to their feedback in a timely and careful manner.
I note that Reviewer 2 has provided a final comment regarding a typographical/consistency issue in their revision feedback. I believe that this can be addressed during the production and proof revision process and is not the basis for a minor revision decision at this point in time. However, those who manage the production workflow may set this to be a minor revision to facilitate that change should that be more efficient in terms of workflow.
The feedback which must be addressed in proofing stages is as follows: First paragraph on p. 6 – there is still reference to physicians that imply they are the sole prescribers of medical cannabis in Australia – please include NPs or make more generic. This again occurs on p. 11, 13, 15. Please ensure both physicians and NPs are acknowledged. Academic Editor comment: This should be managed during production processes. In this instance it would be suitable to simply refer to authorised prescribers/prescribers/registered health practitioners who are able to prescribe etc rather than simply a reference to NP and medical practitioners.
Reviewers’ comments:
Reviewer’s Responses to Questions
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Reviewer #1: All comments have been addressed
Reviewer #2: (No Response)
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Reviewer #1: Yes
Reviewer #2: Yes
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Reviewer #1: N/A
Reviewer #2: Yes
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Reviewer #1: Yes
Reviewer #2: Yes
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Reviewer #1: Yes
Reviewer #2: Yes
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6. Review Comments to the Author
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Reviewer #1: Many thanks, I appreciated the comments of the other reviewer and your smooth update of the manuscript taking comments from the two of us into account. Best wishes.
Reviewer #2: First paragraph on p. 6 – there is still reference to physicians that imply they are the sole prescribers of medical cannabis in Australia – please include NPs or make more generic. This again occurs on p. 11, 13, 15. Please ensure both physicians and NPs are acknowledged.
Otherwise, thank you for the careful consideration of the reviewers’ comments, the authors did an excellent job of addressing.
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Reviewer #1: No
Reviewer #2: No
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- PLoS One. 2022; 17(11): e0277355.
- Acceptance letter
»
Acceptance letter
3 Nov 2022
PONE-D-22-15976R1
From growers to patients: multi-stakeholder views on the use of, and access to medicinal cannabis in Australia
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