2.1 Readying the Materials

The first step of the READ approach to document analysis requires the researcher to establish the source, nature and number of the documents to be analysed.

On 14 November 2019, the Australian Senate referred an inquiry into MC access to the Senate Community Affairs References Committee, with a report expected by the 26 March 2020. A media release was issued on the 15 November 2019 publicizing the call for submissions stipulating these were to be received by the 17 January 2020 via an online submission site. An online guide suggested structuring submissions around the Terms of Reference for The Inquiry (available as Supporting Information). Authors could ask for their submissions to be confidential. No demographic details other than jurisdiction was recorded.

The Inquiry attracted 146 submissions from a diverse group of stakeholders. This study specifically analysed submissions from patients, highlighting the narratives of individuals who have accessed or have attempted to access legal or illicit MC (n = 45). Submissions from caregivers and family members were included (n = 17), providing a comprehensive view of the consumer experience at that time. For this analysis, submissions that did not address the Terms of Reference of The Inquiry and did not discuss barriers to access and usage were excluded (n = 2), resulting in a total of 60 submissions being considered for in-depth analysis.

2.2 Extracting Data

The second step of the READ process requires the researcher to determine what and how data are extracted from the documents and includes adopting a theoretical or conceptual framework as well as practical decisions on the coding software or processes. In this study, the analytical lens of consumer vulnerability (CV) was applied. CV is a concept that encapsulates the experiences of powerlessness and dependence consumers may face in a particular market due to various conditions or circumstances [11]. Models of CV typically aim to: (1) identify factors that contribute to or mitigate the experience of vulnerability within a market, (2) describe the experiences of CV and (3) illustrate the actions taken by consumers and other stakeholders to address CV [12-15]. Contributors (or antecedents) to CV span a broad range of factors including individual characteristics (e.g., age, socioeconomic status, illness); social expectations (e.g., norms, stereotypes); industry practices (e.g., pricing and marketing strategies, discrimination), as well as wider forces such as geographic location, legal and regulatory frameworks [16]. The current study provides a brief outline of individual characteristics to provide context but gives greater weight to those antecedents to which policy can be directed such as industry and policy features.

The critical components of the actual consumer experience of vulnerability are a lack of personal control in the market and the potential for consumer harm from market interaction [11, 13, 14]. Consumer and stakeholder responses to vulnerability in the marketplace are the final component of CV models [14].

Files of consumer submissions were imported into NVivo (version 1.5.2). Categories for coding were predefined according to the common elements of CV models (antecedents of CV, experience of vulnerability, responses to CV).

2.3 Analysing the Data

The third phase of the READ process requires authors to question both the data and the source. Methodology is established at this point.

Data were read with reference to a CV framework. The level of analysis within the framework where relevant include micro-level (i.e., subjective perspective), meso-level (i.e., transactional perspective) and macro-level (i.e., regulatory and industry) perspective. Tracts of text were coded and collated according to the predefined categories and level of analysis.

Previous studies have used frequency counts or some other quantitative method to aid analysis [17]. Quantitative cut-off points were used in the current study to gauge the strength of support amongst the 60 submissions for a theme within a CV component. Themes with recorded comments from at least 20% of viable consumer submissions were read closely and similarities and contradictions recorded. Key themes were those that referenced comments from at least 80% of consumer submissions.

The source of the documents was assessed for credibility. Submissions were highly subjective. Author agenda was apparent and included resolving MC access issues and reducing MC process and product costs among others. Submissions often included emotive accounts of illness, financial and psychological stress and criminal offences. Significant bias was apparent with most authors expressing strong beliefs in MC efficacy as a treatment for a wide range of conditions and symptoms despite a dearth of clinical evidence to support the claims.

2.4 Distiling the Findings

The final phase of the READ approach is to refine the findings, preserve particularly illustrative examples within the documents and express the results as a narrative that satisfies the aims of the research. Quotes were included in the narrative when they exemplified the theme being discussed. Submissions tended to be lengthy (between 1 and 26 pages) and quotes used were usually edited down for ease of reading. All attempts were made to capture the essence of the consumer's meaning in these edits and the interested reader is directed to the original, publicly available transcripts for the full context.

3.1 Antecedents to Vulnerability

CV in the MC marketplace largely stemmed from a confluence of meso- and macro-level features that created pressure on consumers predisposed to CV. A description of micro-, meso- and macro- antecedents follows, and a graphical presentation is provided in Figure 1.

3.2 Experiences of Vulnerability

CV is defined in terms of two key factors: a lack of personal control [11], and the potential for consumer harm [11, 13]. Figure 2 summarizes MC consumer experiences of CV.

Consumers who were approved for a MC prescription experienced harm in the form of financial stress. The unapproved and therefore unsubsidised status of MC meant consumers, the majority of which were receiving some form of government benefit, could not afford the therapy or the processes for procuring a prescription. One submission revealed that treatment costs, including initial appointments and associated application fees, MC therapies and the required follow-up appointments had depleted their retirement account.

3.3 Responses to Consumers Experiencing Vulnerability

This section details the micro- (consumer), meso- (transactional) and macro-(regulatory/industry) responses to CV. Figure 2 summarizes the responses to CV.

4.1 Primary Barriers to MC Access

As the gatekeepers to health care HPs were the foremost barrier to the provision of MC. Consumer descriptions of the attitudes and behaviours of HPs with regard to MC prescription are in contrast to the findings of two systematic reviews which found general support for the use of cannabinoid-based therapies amongst medical practitioners [32, 33], though this support was condition-specific in Australia [34]. Regardless, it was the nexus of HP reluctance, the costs of access to an unapproved therapy and the irregular supply of MC therapies that effectively created the MC service system failure that prompted The Inquiry.

4.2 Implications for Policy

Patients' primary need was to access affordable MC in a timely, reliable and uncomplicated manner. Patients also expressed a desire to be able to drive a vehicle while using MC containing THC and to legally cultivate cannabis for their own therapeutic use. We consider the policy implications of each of these needs and wants and discuss solutions already implemented by the Australian government as well as policy alternatives.

It is reasonable to assume that a healthy domestic MC cultivation and manufacturing industry would realize Australian patients' need to access a reliable supply of affordable MC therapies. Regulation changes designed to foster a domestic industry are being made incrementally [35], and other broad government industry initiatives will assist the government's goal of Australia becoming a major manufacturer of MC products [36, 37]. However, the Australian industry is yet to meet its domestic needs. In 2020, imported products supplied 90% of MC consumed in Australia [38]. Furthermore, the total quantity of domestically cultivated stock has been steadily decreasing since 2021 while the export of domestic MC stock has been increasing [39]. Conceivably, increasing government support of the domestic industry's export opportunities may help local companies increase production capacity and hasten economies of scale—ultimately allowing the industry to flourish and then reliably supply the domestic market.

Consumers believe the path to affordable MC lay with government subsidies. This scenario is unlikely. The Australian Government subsidizes the cost of approved medicines under the Pharmaceuticals Benefits Scheme (PBS). Just two MC therapies, Sativex (for symptoms of multiple sclerosis) and Epidyolex (to treat seizures) are approved though neither of these has been recommended for reimbursement under the PBS. Other countries with a prescription model of MC access offer examples of low-cost compassionate access for specific patients. The Named Patient Pharmaceutical Assessment Policy is the New Zealand government's process for funding unapproved treatments for individuals whose clinical circumstances are life-threatening or extremely severe [40]. In Italy, MC prescriptions originating from public health systems and for specific pathologies warrant significant government reimbursement [41, 42]. Payment relief for Australian patients, however, is likely to come from the private health insurance sector. Certain Australian private health insurers offer some form of coverage of unapproved therapies accessed via special pathways, and the Australian government subsidizes health insurance for low-income patients. In Europe, German and Czech patients rely on health insurance rebates to ameliorate the costs of MC.

Australian patients want uncomplicated access to MC. The pathways chosen to allow access to MC were originally established to provide patient access to unapproved therapies in extenuating circumstances. The large demand for MC put considerable pressure on these established but seldom used processes. Policy changes have since occurred, and patient authorisation procedures for MC have been simplified. Arguably, the greatest change has been the recognition of MC as a broad range of therapies. MC therapies are now categorised according to the ratio of the cannabinoids THC and CBD. MC therapies with limited psychotropic effect (i.e., CBD-dominant) are now included in an ‘established history of use’ pathway for specific conditions and patient approval processes have been simplified for authorised prescribers. Also, applications now refer to a category of MC rather than a named product, negating the requirement for additional applications if a product substitute in the same category is required. HPs must continue to justify the prescription of MC therapies with intoxicating levels of THC when applying for patient approval.

A segment of patients sought the legal ability to grow their own cannabis. Most submission authors clearly preferred to access legal MC but felt the barriers to access gave them no choice but to source unregulated product. A smaller number of respondents articulated a preference for unregulated product. Patient autonomy, ideas of natural versus chemical, and patient experience with recreational cannabis have previously been implicated in this preference [43, 44], and were noted during this analysis but were outside the scope of the study to consider any further. Australian jurisdictional governments have intermittently considered liberal cannabis laws. At the time of writing, households in the Australian Capital Territory were able to cultivate a small number of cannabis plants for their own use. Future research might consider the impacts of decriminalisation on the MC and illicit cannabis markets and the impacts of using home cultivated cannabis on patient health and wellbeing.

Consumers using THC-based MC need to drive, particularly those living in rural and regional areas of Australia. Restrictions on driving were a significant barrier to access with around a third of consumers voicing concerns. Patient-led suggestions for alternative drug driving laws include exemptions for patients with a MC card, patient discretion based on packaging warning labels and replacing zero tolerance laws with more lenient actions such as police field sobriety tests. There is a need for more research on dosage effect and impairment duration before alternative policies can be considered.

4.3 Contributions to CV Literature

This study's focus on response to CV contributes to CV scholarship. Previous research has likened vulnerability in the marketplace to powerlessness and dependence and a reduced capacity to act [11, 12, 15, 45]. The current study reveals ways in which consumers regain autonomy and power both within the market and outside of the market. The coping strategies used by patients, such as delaying prescription dispensing have previously been noted as a cost-saving measure [46]. Patient stockpiling behaviours to cope with therapy shortages is a recognised strategy, most recently observed during the COVID-19 pandemic [47]. Like past CV studies, consumers also coped by creating and accessing community member support [48, 49]. Not only were information and product shared, but the emotional support provided by members increased the psychological capacity to remain in the market. Community support also allowed consumers to exit the market and access new, albeit illicit markets.

Consumers psychologically adapted to their circumstances. The finding that conservative consumers educated themselves about MC to dispel psychological discomfort about cannabis-based therapies supports previous patient research that found changing ideologies came about by educating oneself about personal healthcare, leading to a feeling of personal responsibility thereby reducing the experience of vulnerability [50].

Consumers responded to their vulnerability by accessing new markets. The MC market is distinct in that an alternative market can be readily accessed by consumers denied access to a legal one [1]. Unregulated forms of MC were considered cheaper, easier to access and as effective as legal product, a view shared by patients in New Zealand [43]. In contrast, the perception that legal MC was more consistent or better in quality and safer than illicit forms was noted in American studies [51, 52], and documented in an Australian survey of MC users [8]. The message that MC is safer and more effective than recreational cannabis may be an effective public health message used to create behaviour change and move consumers from illicit to regulated MC.

4.4 Limitations of Study

This document analysis is limited by respondent self-selection into the submission process. Most consumers and their carers who provided submissions were facing the consequences of serious illness, thereby restricting the generalisability of the results.