Challenges to pharmaceutical policymaking: lessons from Australia’s National Medicines Policy

Abstract

Objective: National medicines policies (NMPs) provide a means for governments to achieve their objectives in relation to pharmaceuticals and other medicines. This research aimed to identify challenges to implementing the objectives of the Australian NMP from the perspective of key stakeholders. Methods: In 2012 and 2103, we conducted 30 semi-structured interviews with stakeholders involved in the discovery, clinical testing, regulation and funding of medicines in Australia. We asked participants to describe their careers and to give their opinions on specific issues surrounding drug development, clinical research, regulation and subsidisation in Australia. Data were analysed using Morse’s outline of the cognitive basis of qualitative research and Charmaz’s outline of data analysis in grounded theory. The initial phase of “open coding”, revealed findings that could be mapped to three of the four objectives of the NMP. We then conducted “focused coding” for themes relevant to these objectives. Results: Participants identified many issues relevant to the ongoing evolution of the NMP, relating primarily to ongoing tensions between the commercial objective of ensuring a viable medicines industry, and the non-commercial objectives of ensuring that medicines are safe, effective and affordable. There were also a number of other challenges identified to the achievement of both the commercial and non-commercial objectives of the NMP. These included limits to government funding, globalisation, consumer advocacy, changing scientific paradigms and new information technologies. Conclusions: There are many issues that need to be addressed if policymakers are to achieve the best outcomes from the NMP. Tensions between the commercial and non-commercial objectives of the NMP suggest the need to ensure that one stakeholder group’s imperatives do not stifle those of other groups. At the same time, there are a number of emerging issues that are likely to concern all stakeholders equally, and these are both challenges and opportunities for new kinds of collaboration.