Posted by Amy Sarcevic on 15 June 2026
Improving the accessibility of drugs for pregnant women
Reproductive-age women make up a significant portion of the population, yet they are often excluded from clinical trials for pharmaceuticals, including those targeting common pregnancy-related conditions. Dr. Nisha Khot, Vice President of RANZCOG and Clinical Director of Obstetrics and Gynaecology at Peninsula Health, believes this must change.
Dr. Khot highlights that much of the existing data on drug safety and efficacy for pregnant women comes from incidental cases where women consumed medications before realizing they were pregnant. This creates two key challenges:
- Lack of Empirical Data: These data points lack the rigor of randomized control trials, leaving many drugs labeled as "probably safe" for pregnancy.
- Drug Discontinuations: When manufacturers modify drugs, older varieties with pregnancy safety approval are often discontinued, leaving newer versions untested for pregnant women.
The Case of Pre-Eclampsia
This issue is particularly problematic for women with pre-eclampsia, a condition affecting 5-8% of pregnancies. Treatment relies on general blood pressure medications, which are not specifically designed for pregnancy and are often used "off-label."
"There are only three or four drugs available for severe hypertension in pregnancy, and they are decades old. Research has advanced significantly, but pregnant women don’t have access to these newer, better options," Dr. Khot said.
A Multi-Pronged Solution
Dr. Khot suggests a multi-faceted approach to address these challenges:
- Building Awareness: Educating manufacturers about the demand for pregnancy-safe drugs.
- Advocating for Inclusion in Trials: Ensuring pregnant women are included in clinical trials to provide robust data on drug safety and efficacy.
- Government Incentives: If pharmaceutical companies lack financial motivation, governments should step in to provide incentives or requisition drugs to meet the needs of pregnant women.
"It’s not good enough to exclude women from trials because of perceived challenges. We are 50% of the population and deserve equal access to safe, effective medications," Dr. Khot emphasized.
Gaps in PBS and Manufacturer Provisions
Dr. Khot also highlights gaps in the Pharmaceutical Benefits Scheme (PBS) and manufacturer provisions that disproportionately affect women:
- Non-Hormonal IUDs: These are not PBS-listed because they are classified as devices, leaving women to pay out-of-pocket despite their long-standing availability.
- HRT Patches: The discontinuation of hormone replacement therapy patches has left menopausal women without effective solutions, as cheaper alternatives dominate the market.
"These gaps in access are unacceptable and highlight inequities in healthcare for women," Dr. Khot said.
Signs of Progress
There are encouraging signs of change. RANZCOG recently convened a medicines roundtable with manufacturers, the TGA, PBS, and clinicians to address these issues. Dr. Khot noted that manufacturers expressed a commitment to ensuring their drugs remain accessible to pregnant women.
Additionally, multiple organizations are advocating for the inclusion of pregnant women in medical research, though Dr. Khot believes more work is needed.
"I’m looking forward to continuing this discussion with the sector," she said.
Join the Debate
Dr. Nisha Khot will present her insights at the upcoming Obstetric Medico-Legal Congress, hosted by Informa Connect. The event will take place on 16-17 September at the Crown Conference Centre Melbourne.
About Dr. Nisha Khot
Dr. Nisha Khot is the Vice President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and Clinical Director of Obstetrics and Gynaecology at Peninsula Health in Melbourne. She co-chairs the Living Evidence for Australian Pregnancy and Postnatal Care Guidelines and serves as Board Chair of the Multicultural Centre for Women’s Health. Dr. Khot is a passionate advocate for gender equity and diversity in healthcare leadership.