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

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.

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Table 1. Stakeholders included in the analysis, n = 121.

https://doi.org/10.1371/journal.pone.0277355.t001

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

• Development and delivery of targeted education to health professionals, medical students, patients, and the public,
• Assessment of the need for establishing a new independent medical cannabis regulator, and a Commonwealth Compassionate Access Subsidy Scheme
• Amendment and/or clarification around the requirements of SAS-B and AP schemes, and
• 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