Consumer perspectives of accelerated access to medicines: a qualitative study.

PURPOSE: In this study, the authors aimed to explore consumer perspectives on accelerated access to medicines. The authors were particularly interested in how they balance competing considerations of safety, efficacy, equity and access; whether and how their views change when there are different levels of uncertainty surrounding the safety and efficacy of new medicines; and the procedures that they think should be used to make decisions about accelerated access to new medicines. DESIGN/METHODOLOGY/APPROACH: This was an exploratory qualitative study. Thirteen semi-structured interviews with patient advocates and two focus groups with patients were conducted and analysed thematically. Interviews and focus groups were audio recorded and transcribed verbatim. Data were analysed through inductive thematic analysis.
FINDINGS: Participants outlined a range of justifications for accelerated access, including addressing unmet medical needs and encouraging further research and development. However, they were also cognisant of the potential risks and viewed ongoing data collection, disinvestment and market withdrawal as ways to address these. They also emphasised the importance of transparent decisions being made by people with relevant expertise, based on a thorough consideration of scientific evidence and stakeholder perspectives. ORIGINALITY/VALUE: This is the first study to comprehensively explore Australian consumers' views of accelerated access to medicines. The results suggest that consumers want timely access to new medicines, but not at the expense of safety, efficacy, equity and sustainability. While accelerated access programs are likely to be welcomed by consumers, they must be fully informed of their conditions and limitations, and robust post-market data surveillance must be implemented and enforced to protect the interests of both individual patients and the broader community. © Emerald Publishing Limited.