Closing the gaps in the access to quality-assured medicines for global health: The case for oxytocin for postpartum haemorrhage.

Introduction: Access to quality-assured medicines remains unequal between high-income and low-income countries. To bridge this gap, product development and supply in low- and middle-income countries (LMICs) should follow World Health Organization (WHO)'s policies and recommendations whilst aligning with international standards.

Areas covered: We reviewed two cases on oxytocin access for postpartum hemorrhage (PPH), a condition that disproportionately affects mothers in low-income countries. The first case examines the challenges in ensuring quality-assured oxytocin injections in LMICs. International technical guidelines allow different storage conditions for oxytocin, which can cause confusion in countries with weak regulatory oversight. WHO and partners recommend a common storage and management of oxytocin to resolve this issue. The second case explores the design of clinical studies for inhaled oxytocin, a promising candidate for PPH aiming for rapid registration and inclusion in WHO's therapeutic recommendations. Aligning scientific, regulatory, and WHO policy requirements early in the development process can expedite access to new effective medicines in LMICs, and we described the potential clinical challenges in meeting this.

Expert opinion: Robust partnerships between stakeholders, to streamline medicine development and regulatory approval, are essential to close access gaps and ultimately prevent unnecessary deaths due to PPH in LMICs.