Ethical, regulatory and market related aspects of deploying Triple Artemisinin-Based Combination Therapies for malaria treatment in Africa

Introduction: Artemisinin-based Combination Therapies (ACTs) are failing in Southeast Asia. Recently artemisinin resistance was reported from Rwanda and Uganda. It is paramount to protect ACTs from falling to resistance in Africa. Triple artemisinin-based combination therapies (TACTs) are being developed as a possible solution. TACTs have the potential to benefit the larger community and future patients by mitigating the risk of drug resistance. This study explored views of stakeholders on key ethical, regulatory and market-related issues that should be considered in the potential introduction of TACTs in Africa.  

Methods: We employed qualitative research methods involving in-depth interviews and focus group discussions (FGDs) with relevant stakeholders. We used a multiple case design, that allowed investigating country-specific contexts, while enabling extraction of overarching themes. Respondents at different levels of the innovation system of antimalarial therapies in Nigeria and Burkina Faso were identified and invited to participate in interviews and FGDs. We divided the key actor groups into three overarching categories to facilitate data analysis: policy makers, suppliers, and end-users. Transcripts were uploaded to NVivo12 Pro software and subjected to a process of coding. 

Result: Stakeholders’ views were varied. Some indicated that the successful deployment and uptake of TACTs is dependent on TACTs being better than ACTs, with minimal side effects and burdens, and support by the WHO and international funders.  At the country level, slow regulatory and implementation procedures were identified as potential barriers towards rapid TACTs deployment. Integrating TACTs in public sector distribution channels was considered relatively straightforward. More challenges were expected for integrating TACTs in private sector distribution channels, which are characterized by patient demand and profit. 

Conclusion: Market prospects of TACTs in Nigeria and Burkina Faso will depend on demonstrating the added value of TACTs over ACTs, advocacy by WHO and ensuring financial and regulatory arrangements are in place.  Anticipating and addressing potential ethical and market-related issues of deploying TACTs by, early engagement of stakeholders will be strategic to the potential deployment of TACTs in Africa.