Masterarbeit
Strategies and Measures to Prevent Substandard and Falsified Medicinal Products in Sub-Saharan Africa ***
Dr. Anissa Boucherot (2025)
Summary
Language: English (British)
Substandard and falsified (SF) medicinal products pose a significant threat to regions where regulatory oversight is weak. WHO reported up to 116 000 deaths due to SF Antimalarial medicines in Sub-Sahara-countries in 2017. The fight against SF medicinal products is crucial and requires a multifaceted approach, involving stronger regulatory frameworks, addressing the security gaps along the supply chain of medicinal products, and responding faster to increased demand for essential medicines. This thesis provides an overview of strategies and associated measures to achieve the prevention of SF medicinal products in the Sub-Saharan region as listed:
- Reducing weaknesses in regulation of medicinal products:
- Strengthening regulatory frameworks through harmonisation and collaboration: e.g. AMRH, ZAZIBONA, MEDISAFE-project, AMA treaty (28 ratification out from 55 countries)
- Enabling upgrade to WHO maturity level 3 for stable regulatory environment
- Responding to demand for essential medicinal products through local productions:
- Increasing local production through cooperation and supporting start-up platforms: PAHO-Africa-CDC; Platform for Harmonized African Health Products Manufacturing (PHAHM), African Pharmaceutical Technology Foundation (APTF), African Pooled Procurement Mechanism (APPM), technology transfer through “Access to medicines” initiative
- Supporting local manufacturers to obtain GMP-certification and produce medicinal products in quality standard, supported by e.g. Medicines for Malaria Venture (MMV)
- Addressing gaps in security along the supply chain of medicinal products:
- Implementation of Verification system “TRVST” for donated medicinal products supply chain; Verification system based on Blockchain technology (in Nigeria for example)
- Application of field detection systems (e.g. GPHF-Minilab, IR-scanner)
- Talent development to address shortages of required workforce:
- Pharmacometrics Africa-platform: training for “Clinical Assessors within African Regulatory Agencies”; EAC Regional Centre of Excellence for Vaccines, Immunisation and Health Supply Chain Management (EAC RCE-VIHSCM): “Global Standards for Traceability of Health Products and Technologies” training.
Nevertheless, future surveys should explore the experiences of the Sub-Saharan countries with traceability systems for medicinal products. Further, the impact of regulatory reforms and workforce training should be assessed after a period of time. Research is also needed to understand consumer behaviour and drivers behind the demand for SF medicinal products.
Finally, addressing the challenge of SF medicinal products will require sustained commitment from the African governments and support from international organisations, the pharmaceutical industry and local communities. Only continued efforts and targeted investment in the health system can reduce the prevalence of SF medicinal products. These SF medicines contribute to increased morbidity and mortality and delay efforts to eradicate diseases. The resulting risk of drug resistance due to SF medicinal products is not limited to Sub-Saharan countries. It is also a global health challenge due to changing weather patterns that lead to mosquito-borne diseases spraying into new regions (dengue virus in Western-Europe in 2023).
Pages: 62