MTaPS Kenya Hosts IGAD/EAC Activities Close-Out Meeting

Addressing the health needs of populations requires them to have access to quality-assured, affordable, effective, and safe medical products and related services. These can only be ensured through strong pharmaceutical systems that regulate, supply, and promote appropriate use.

The US Agency for International Development (USAID) Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, through its Kenya team, collaborated with the East African Community (EAC) and Intergovernmental Authority of Development (IGAD) on activities geared toward supporting the medicines regulatory harmonization agenda of the two regional economic communities and USAID Kenya and East Africa (KEA) priorities. The focus was on regulatory systems strengthening (RSS), pharmacovigilance (PV), and local manufacturers’ adherence to good regulatory practices and requirements.

Since 2019 and with funding from USAID KEA, MTaPS has been supporting the medicines regulatory harmonization agenda and cross-border health by strengthening regulatory systems, PV, and compliance to good regulatory requirements and practices among local manufacturers in IGAD and EAC. On May 19, 2022, MTaPS held a close-out meeting for those EAC/IGAD activities. Representatives from USAID KEA, USAID Washington, IGAD Secretariat, Kenya Pharmacy and Poisons Board, MTaPS leadership, and country offices participated in the meeting.

MTaPS Director Francis Aboagye-Nyame gave a summary of the achievements of the program’s RSS work globally and within the African Medicines Regulatory Harmonization agenda, regional economic communities, and selected countries.

“MTaPS has supported the IGAD and EAC secretariats, respective member or partner states, and selected cross-border areas to establish pharmacovigilance systems to promote safety monitoring and surveillance. This support also included working with the Kenya Pharmacy and Poisons Board, the NEPAD Regional Center of Regulatory Excellence in Pharmacovigilance in Africa and lead NMRA for PV and PMS in IGAD and EAC regional economic communities (RECs) or regional intergovernmental organizations (RIGOs). By so doing MTaPS build the capacity of PPB, Kenya to better serve those two roles, and is working in selected individual countries within IGAD and EAC to implement other country-specific work plans.” – Francis Aboagye-Nyame, MTaPS Director

In her remarks, Ms. Wairimu Gakuo, Team Leader for Strategic Partnerships at USAID KEA, acknowledged the tremendous work done by MTaPS and the sustainability model of the implemented activities. She emphasized their impact on the regulatory environment within the two regional economic blocks.

“We have made great strides in both pharmacovigilance and post-market surveillance, co-creating activities with the Pharmacy and Poisons Board and supporting the countries in the IGAD and EAC region to strengthen their systems in these two areas. Through this collaboration, key milestones have been achieved to support medicines, regulation, and harmonization.”

Dr. Fatuma Adan, Head of Mission, Health and Social Development Department, IGAD secretariat, thanked USAID and MTaPS for their collaboration and work, especially toward the RSS, and their contribution to the goal of an African medicine agency. She asserted that regulatory harmonization has played a significant role in ensuring that those areas historically neglected or hard to reach are strengthened and populations in these areas have responsive health systems. The work done has helped to build capacity within the secretariat, which is now able to sustain the work. Nonetheless, more support is required to further strengthen the health system within the IGAD region.

Close-out presentation

Dr. Ndinda Kusu, MTaPS Kenya’s Country Project Director, gave a presentation of the project’s activities and achievements and highlighted the lessons learned and the path to sustainability model that has been put in place. Highlighted achievements included:

• Ensuring the functionality of governance structures for PV through the EAC/IGAD secretariats by having expert working groups
• Capacity building on PV for priority IGAD/MTaPS cross-border health facilities to enhance identification, monitoring, management, and reporting of adverse drug reactions
• Developing harmonization documents (e.g., compendium, PV curriculum, standard operating procedures) to enhance regulatory integration and systems strengthening
• Strengthening regulatory compliance for local manufacturers to ensure availability of good quality, safe, efficacious, and effective products
• Supporting the regional center of regulatory excellence and the national medicines regulatory authority for Kenya to operationalize a safety advisory committee to review and evaluate safety data for decision making

The presentation also laid out the lessons learned:

• Diversity among the states in IGAD and EAC called for adaptation of packages and activity implementation timelines
• The funding of the secretariats is essential for spurring activities planned in the region
• The project was unable to continue with EAC activities due to funding gaps
• Need to strengthen collaborative mechanisms among NMRAs and the pharmaceutical industry
• Teamwork and collaboration among manufacturers needs to be strengthened to minimize competition and push for a common agenda
• Country-level engagement at the NMRA level and related support is key for the harmonization agenda
• Support for regional activities needs to adapt to changing dynamics and the prevailing COVID-19 situation in countries

The MTaPS IGAD/EAC portfolio also generated some learning products, including two assessments on the status of pharmacovigilance systems in IGAD and Adherence to Good Regulatory Standards and Practices by Local Manufacturers in IGAD and EAC. The next steps include plans to publish the two assessments of PV systems in IGAD and the local manufacturer assessment.