**9. Conclusions**

Australia spends in excess of \$20 billion annually on medicines. There is no doubt that this has resulted in significant health gains for individuals and populations, but it has also been accompanied by substantial harm and health care costs. Consequently, QUM and medicine safety were announced as Australia's 10th National Health Priority in 2019. Throughout this review, we highlighted the significant mismatch between Australia's annual multi-billion-dollar investment in medicines and our capability to deliver a comprehensive research program evaluating the health benefits and harms derived from this investment. We repeatedly highlighted the deficiencies in data access in Australia and how it lags behind most countries with mature publicly funded health care systems. We pointed to the need to establish centralised or distributed data assets operating under the Five Safes principles which would also support contemporary, collaborative, ethical and reproducible research and governmen<sup>t</sup> activity in population health. In the context of the COVID-19 pandemic, Australia has been notably absent in the global effort to better understand the real-world impact of repurposed or newly developed treatments to prevent and manage

COVID-19. The establishment of widely accessible national health data assets is now a matter of urgency. We urge decision makers to respond to this challenge.

**Supplementary Materials:** The following are available online at https://www.mdpi.com/1660-460 1/18/24/13345/s1, File S1: Studies included in this review assessing medicine exposure and outcomes using Pharmaceutical Benefits Scheme or Repatriation Pharmaceutical Benefits Scheme data.

**Author Contributions:** S.-A.P., N.P., D.H., C.M.V. and D.B.P. conceptualised this paper. J.d.O.C. and C.B. undertook the literature search and data extraction for the review of Australian studies leveraging PBS claims. N.P. and S.-A.P. worked with J.d.O.C. and C.B. to catalogue and interpret the literature. S.-A.P., N.P., J.d.O.C., H.Z., T.-L.L., C.E.-B., F.M.S., A.M., L.K.E., C.B., E.K., M.I., D.B.P., C.M.V. and D.H. contributed to the manuscript draft, reviewed and edited the manuscript and approved the final submitted version. All authors have read and agreed to the published version of the manuscript.

**Funding:** This review is supported by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Medicines Intelligence (GNT1196900); H.Z. is supported by a UNSW Scientia Fellowship; E.K. is supported by an NHMRC Emerging Leader Fellowship (APP1172978); C.B. is supported by an Australian Government Research Training Program Scholarship.

**Institutional Review Board Statement:** Not applicable.

**Informed Consent Statement:** Not applicable.

**Data Availability Statement:** Data sharing is not applicable to this article.

**Acknowledgments:** We would like to thank Barry Sandison for his insightful comments on this manuscript. This paper was written on behalf of the Centre of Research Excellence in Medicines Intelligence investigators; Chief investigators: Sallie-Anne Pearson, Nicole Pratt, Nicholas Buckley, David B. Preen, Louisa Degenhardt, Kees Van Gool, Claire M. Vajdic, Louisa Jorm, Andrew Wilson, David Henry; and Associate Investigators: Anne McKenzie, Christopher Etherton-Beer, Debra Rowett, Frank M. Sanfilippo, Helga Zoega, Julian Elliott, Sarah Lord, Timothy Dobbins, Tracey-Lea Laba, and Ximena Camacho.

**Conflicts of Interest:** C.E.B. is a member of the Pharmaceutical Benefits Advisory Committee (PBAC); S.P., N.P., T.L. and C.E.B. are members of the Drug-Utilization Sub-Committee of the PBAC; T.L. is a member of the Economics Sub-Committee of the PBAC; M.I. is a member of the Economics Sub-Committee of the MSAC; S.P. is a member of the National Data Advisory Council; C.M.V. is Deputy Chair of the NSW Population Health Service Research Ethics Committee; D.P. is a member of the Sax Institute Board. The views of authors expressed in this review article are their own and do not represent those of the aforementioned bodies. In 2020, the Centre for Big Data Research in Health received funding from AbbVie Australia to conduct post-market surveillance research. AbbVie did not have any knowledge of, or involvement in, this manuscript.
