Barriers and solutions to accessing essential breast cancer medicines in low resource settings – a mixed-methods study to investigate the pharmaceutical, economic, and policy challenges within the Zimbabwean context

Background: Zimbabwe faces significant challenges in accessing essential cancer medicines amid economic, healthcare infrastructure, and treatment cost difficulties. Breast cancer is the second most common cancer among Zimbabwean women, with a high mortality rate exacerbated by a lack of awareness, limited access to healthcare, and unaffordable treatment.

Aims: This research aims to explore and describe the causes of obstacles to accessing essential breast cancer medicines in Zimbabwe and make recommendations to address them, focusing on pharmaceutical policies, health system characteristics, and broader economic and policy factors. This aligns with progress towards universal health coverage strategic goal 3.8.

Objectives: The study will be conducted in 3 phases with the following six objectives: Phase 1 - (i) Identify regulatory challenges and (ii) barriers to accessing essential breast cancer medicines. Phase 2 - (iii) Identify health system related factors, (iv) evaluate economic, trade-related obstacles impacting affordability and availability of these medicines. Phase 3 - (v) Assess performance of the pharmaceutical system in ensuring access to essential breast cancer medicines and (vi) propose solutions.

Methods and Analysis: A mixed-methods approach will be used across the phases: (i) Scoping review using the Arksey and O'Malley framework and Covidence (2025) data management tool to systematically review and synthesize existing literature on the barriers to accessing essential breast cancer medicines; (ii) Policy analysis of policies impacting access to essential breast cancer medicines using a policy checklist by (Katrina Perehudoff et al., 2018), (iii) A quantitative cross-sectional survey on breast cancer medicine availability and affordability using WHO/HAI (WHO and Health Action International) methodology, (iv) a stakeholder engagement using semi-structured interviews with thematic analysis using N-VIVO (version 15) to gain perspective on health system characteristics; (v) an assessment of the pharmaceutical system's performance using a framework for qualitative evaluation of access to medicines by Joosse et al. (2024), with in-depth discussion and probing of how functional processes operate and impact access.

Ethical considerations: Ethical clearance will be sought from relevant committees and boards, and written informed consent will be obtained from participants in semi-structured interviews and surveys. The study will adhere to ethical guidelines to ensure the confidentiality and protection of participants' rights.