Abstract
Structural factors that contribute to health disparities (e.g., population-level policies, cultural norms) impact the distribution of resources in society and can affect medication accessibility; even in high-income countries like Australia. Industry practices and regulatory approaches (e.g., a conservative approach to testing medicines in pregnant women) influence the availability of safety and efficacy data necessary for the licencing and funding of prescription medications used during pregnancy. Consequently, pregnant women may be prescribed medications outside of regulatory or funder-approved indications, posing risks for both prescribers and pregnant women and potentially compromising equitable access to medications. This review examines the regulatory and legislative structural factors that contribute to health disparities and perpetuate the deeply ingrained social norm that we should be protecting pregnant women from clinical research rather than safeguarding them through such research. Addressing these challenges requires a renewed commitment to integrated, woman-centred maternal healthcare and strengthened collaboration across all sectors. FUNDING: Australian Government Research Training Program Stipend from the University of Technology Sydney, National Health and Medical Research Council (NHMRC) Fellowship, Channel 7 Children's Research Foundation Fellowship (CRF-210323).