Understanding the Dynamics of More Restrictive Medicines Policy: A Case Study of Codeine Up-Scheduling in Australia

Background: There has been increasing concern over opioid-related harms across the world. In Australia in 2018, codeine-containing products were up-scheduled from over-the-counter access at pharmacies, to requiring a prescription. The drug regulator’s decision to up-schedule was contentious and widely debated, due to the potentially large impact on consumers and healthcare professionals. This study aimed to analyse influences on the codeine up-scheduling policy. Methods: This retrospective policy analysis used the Advocacy Coalition Framework (ACF) to understand how policy actors with shared beliefs formed adversarial coalitions to shape policy. Data were drawn from documents (regulator policy documents, public submissions, news reports, organisational media releases and position statements) and semi-structured interviews with 15 key policy actors. Codes were generated relating to policy processes and actor beliefs; broad themes included the role of health professionals, perceptions of opioids, impact on consumers, and the role of government in healthcare. Results: Two coalitions in this policy subsystem were identified: (1) supportive [with respect to the up-scheduling], and (2) opposing. The key evident beliefs of the supportive coalition were that the harms of codeine outweighed the benefits, and that government regulation was the best pathway for protecting consumers. The opposing coalition believed that the benefits of codeine accessible through pharmacists outweighed any harms, and consumers should manage their health without any more intervention than necessary. The policy decision reflected the influence of the supportive coalition, and this analysis highlighted the importance of their public health framing of the issue, the acceptability of their experts and supporting evidence, and the perceived legitimacy of the up-scheduling process. Conclusion: Understanding these coalitions, their beliefs, and how they are translated through existing policy processes and institutions provides insight for those interested in influencing future health policy. Specific lessons include the importance of strategic frames and advocacy, and engagement with formal policy processes.