Journal Article

Pharmacovigilance Funding Landscape in Africa-A Survey

Tumwijukye, H, Opadeyi, A, Tanui, P, Harmark, L, Mmbaga, B, Smith, D, Isah, A, Sigonda, M N, Cobelens, F, Ayinbuomwan, S, Fimbo, A, Tiemersma, E

2022

Overview

Introduction: The growth of pharmacovigilance (PV) in resource limited settings (RLS) in Africa has been slow. It is yet to achieve the maturity required to ensure safety of medicines deployed in the setting. One of the key factors highlighted as hindering this growth is the inadequacy of funding [1,2]. Objective: This paper presents the result of a survey assessing the prevailing pharmacovigilance funding landscape in African countries, including factors hindering and measures likely to improve sustainable funding. Methods: A standardized questionnaire was developed in English with French and Portuguese translations and effectively distributed to 35 African countries during the period July 2020 to October 2021. The information sought related to features and operation of the PV system, sources of and factors impacting on PV funding. Suggestions were solicited in free text format on hindrances and measures to improve sustainable PV financing. The information was requested from the Head of the National Pharmacovigilance Centres (NPC). The data collected were handled qualitatively, analysed and presented descriptively. Values were expressed as range and median. A thematic synthesis was carried out to aggregate the free text responses. Results: The questionnaire was completed by NPCs in 24 African countries (response rate of 68.6%); with National Medicines Regulatory Agency (NMRA) and NPC in 22/24 (91.7%) and 20/24 (83.3%) countries respectively. Again, 20/24 (83.3%) countries are in the WHO Programme for International Monitoring (PIDM). Number of staff/NPC was 5 with staff ratio NPC:NMRA of 1:11. PV activities were funded mainly by Governments and donor agencies. The mode of support was by cash grants, technical and other logistics channeled mainly through the NMRA and Public Health Programmes (PHP). Few countries 9/23 (39.1%) had a clear budget line within government budgets and 85.7% had their funding linked to the NMRA. Factors identified as hindering PV funding included-lack of awareness of the importance of PV and poor prioritisation in the national scheme, unfavourable legal environment, non-generation of revenue, poor budgetary allocation, diversion of funds etc. Measures suggested to improve PV financing include adequate prioritisation and political goodwill, improved legal environment with increased annual budgetary allocation, revenue generating activities etc. Conclusion: In all, funding of pharmacovigilance in Africa is inadequate, seemingly arbitrary. lacking legislative provisions and tied to the NMRA with significant donor funding channelled through the NMRA and PHP. There is need for PV financing to be backed by statute which will ensure sustainable funding and implementation of measures likely to improve funding

• Publisher: Springer Nature B.V
• Subject: Budgets / Financing / Funding / Logistics / Medicine / Pharmacology / Pharmacovigilance / Public health / Questionnaires / Revenue / Surveys / Sustainability / Translations