25 June 2018, Addis Ababa (Ethiopia): Launching a five-day meeting this morning, the Intergovernmental Authority on Development (IGAD) took key steps to strengthening pharmacovigilance and post-marketing surveillance systems for medicines marketed in Djibouti, Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda; with specific attention to cross-border points.
Four key outputs aimed at expanding access to quality-assured medicines in IGAD member states are expected by the close of the week:
- Establishment of a Regional Expert Working Group on Pharmacovigilance & Post-Marketing Surveillance.
- Recommendations for a regional cross-border pharmacovigilance system.
- Recommendations for implementation of a regional post-marketing surveillance strategy and related guidelines.
- A regional protocol for studying the prevalence of substandard and falsified medicines at selected IGAD cross-border sites, targeting products used in maternal & child health, family planning, tuberculosis, and HIV & AIDS programs.
Participants in the meeting include representatives from medicines regulatory authorities in IGAD countries as well as technical assistance experts from the Promoting the Quality of Medicines (PQM) program, which is financed by the U.S. Agency for International Development and implemented by the United States Pharmacopeia. IGAD is partnering with the PQM program for technical support in recognition of its global experience in strengthening medicines quality assurance systems.
The meeting is being chaired by Ato Yehelu Denekew, Director General of the Ethiopian Food, Medicines, and Healthcare Administration & Control Authority (EFMHACA). Inaugurating the proceedings this morning, Dr. Denekew emphasized that unregulated substandard and falsified medicines circulating in IGAD member states are, “…a serious public health threat which, if not prevented and controlled, will undermine confidence in public healthcare systems and programs.” He then added, “As chair of IGAD, Ethiopia supports efforts to study the prevalence of substandard and falsified medicines in cross-border areas. This will help the region develop necessary regulatory actions and interventions to control this problem.”
Fatuma Adan, Senior Regional Program Coordinator in IGAD’s Health & Social Development Division, called on the participants to review and finalize draft terms of reference for a Regional Expert Working Group on Pharmacovigilance & Post-Marketing Surveillance and submit such to the heads of the National Medicines Regulatory Authorities (NMRAs) for ratification and approval.
Timothy Nwogu, PQM Principal Program Manager, remarked that approaching pharmacovigilance and post-marketing surveillance from a regional perspective is more than a question of cooperation. “IGAD is fostering harmonization, and moving towards work-sharing and principles of mutual reliance,” he specified.
Paul Tanui of the New Economic Partnership for Africa Development (NEPAD) and Appollo Muhairwe of the World Bank also spoke at the opening ceremony to express support for the initiative.