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Current drug policy in Australia fails to adequately support pregnant women’s health care, which exacerbates the gender health gap. Prompt and meaningful changes are urgently needed alongside a renewed commitment to integrated, woman-centred care for pregnant women.
Regulatory and legislative policy barriers are compromising equitable access to prescription medications during pregnancy for women in Australia, as underscored by a recent review examining the structure of drug policy in Australia and its alignment with the needs of expectant mothers.
The narrative review, led by researchers from the University of Technology Sydney, emphasises the urgent need for systemic changes to remedy the deeply ingrained barriers that hinder equitable medication access. The researchers advocate for prioritisation of integrated, woman-centred maternity care, which includes safe and equitable access to medications required during pregnancy. This could be achieved through strengthened collaboration across all sectors and stakeholders to facilitate evidence-informed decision making.
A major barrier to equitable medication access for all women is the frequent exclusion of pregnant women from clinical trials. This stifles the generation of crucial efficacy and safety data to support optimal medication use. This exclusion is perpetuated by the lack of industry incentives for investment in maternal health and stringent medicolegal risk management strategies, which were developed in response to historical catastrophic impacts of some medication use in pregnancy. There is concern, however, that this risk management approach has gone too far.
The review calls for a paradigm shift away from the deeply entrenched societal expectation to shield pregnant women from clinical research, to promoting their safety and wellbeing through the generation of knowledge that is derived from involvement in clinical studies.
Inadequate data hinder fair and appropriate medication use during pregnancy
Despite a high prevalence of, and a recognised need for, prescription medication use during pregnancy, there remains a persistent lack of data to support their safe, effective, and efficient use in this setting. These critical evidence gaps are the result of a complex interplay between a variety of factors, including a stringent regulatory environment influenced by prior drug-related catastrophes from medications such as thalidomide and diethylstilbestrol. Furthermore, these events have augmented fear and hesitation in women, prescribers, industry representatives, research ethics committees, and insurers alike. In contrast, one might argue that the devastating consequences that can ensue from medication use in pregnancy should serve as a critical reminder as to why we do need robust safety assessments in this medically complex population.
The enduring scarcity of data on medication use in pregnancy is undoubtedly a complex issue. Although incremental changes are essential first steps, they have not yet served as sufficient stimuli to bring about meaningful changes to address the status of pregnant women as “therapeutic orphans”. Despite federal policy reform in the United States (ie, amendment of the Common Rule to remove pregnant women from the definition of vulnerable populations), other barriers to inclusion persist (eg, insurance hurdles, lack of economic incentives for investment) and remain sufficient to stifle adequate investment in this area. This was exemplified by the widespread exclusion of pregnant women from initial COVID-19 vaccine and treatment studies, despite knowledge that pregnant women with COVID-19 were at heightened risk of admission to intensive care and mechanical ventilation. Some have argued that such exclusion led to preventable harms.
What barriers do Australian drug policies present?
Drug policy in Australia includes a myriad of different regulatory and legislative instruments covering experimental policies and processes, licencing and funding arrangements, and health service provider regulations. These structures protect the general population, and do not commonly encompass the needs of marginalised populations. Alternative pathways and incentives have been developed to meet the pharmacotherapeutic needs of specific marginalised populations, such as paediatric patients and individuals with rare diseases. Nevertheless, after decades of acknowledgement, pregnant women remain relegated to “therapeutic orphan” status.
Intentions to improve the integration of pregnant women into clinical trials face numerous barriers including concerns over fetal health risks, fear of litigation, insurance challenges, and regulatory and ethics application complexities. The deeply entrenched social norm of excluding pregnant women from clinical studies poses a significant barrier to medication access, further exacerbating additional restrictions within Australia’s legislative and regulatory frameworks.
Within medication licensing frameworks, there is often limited clinical trial data to adequately support pregnancy-specific indications. Recently, the Therapeutic Goods Administration has renewed efforts to promote the repurposing of medicines. This includes stimulating approval of new therapeutic uses for existing medicines in obstetrics; aiming to circumvent some of the regulatory and economic barriers associated with approval of a new indication. Nonetheless, medication sponsors retain the authority to assign overly stringent pregnancy safety classifications, which are seldom reassessed when real-world evidence becomes available and which are known to impede safe and effective medicine use.
Funding decisions, guided by economic evaluations, aim to facilitate equitable access to necessary medications. However, a paucity of clinical trial data in pregnant populations impedes efficiency assessments. Additionally, incorporating evidence for pregnant populations also poses challenges, such as evaluating quality of life in pregnant women and deciding whether or how to incorporate health outcomes for the developing fetus.
Inequities in medication access are further exacerbated by complex health service provider regulations and the influence of socioeconomic disparities. Although some policy changes have fostered better integration of woman-centred maternity care services (eg, case load midwifery), significant gaps remain across all domains of policy and Australia’s progress continues to lag far behind international progress.
Opportunities for change
Addressing the current inequities that pregnant women experience in access to necessary medicines requires complex systems-level changes (top-down) and patient and health-practitioner-led strategies (bottom-up). These start by incentivising industry investment in maternal health, facilitating the inclusion of pregnant women in clinical trials, and enhancing access to data to conduct post-marketing surveillance studies.
Health care providers play a crucial role in advocating for policy reforms to meet the needs of pregnant women, through prioritisation of integrated, woman-centred health care and overcoming regulatory barriers. We can forge towards a better future where all women receive access to safe, effective, and affordable medications.
Hannah Jackson is a PhD candidate and research assistant at the University of Technology Sydney, focusing on research that explores the complexities surrounding cost implications and equity concerns associated with medication use during pregnancy.
Associate Professor Luke Grzeskowiak is a practising clinical pharmacist and practitioner Fellow in the College of Medicine and Public Health at Flinders University and the South Australian Health and Medical Research Institute with expertise in quality use of medicines in pregnancy and lactation.
Professor Emily Callander is professor of health economics and head of discipline, health services management at the University of Technology Sydney. She has expertise in economic evaluation and indirect cost measurement.
The statements or opinions expressed in this article reflect the views of the authors and do not necessarily represent the official policy of the AMA, the MJA or InSight+ unless so stated.
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As always, medication choice needs to balance risk vs benefit. We have to use antibiotics and antiemetics when the risks of infection or dehydration are worse than the potential risks of the medications to foetal development.
When the Thalidomide tragedy occurred, the entire science of teratogenesis was very poorly developed. I agree with the authors that there is a risk from swinging too far the other way.