Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries

Ambrose O Isah; Abimbola O Opadeyi; Henry Tumwijukye; Frank Cobelens; Diede Smith; Margareth Ndomondo-Sigonda; Linda Harmark; Paul Tanui; Edine Tiemersma; Blandina T Mmbaga; Gugu Mahlangu; Stephen A Ayinbuomwan; Rachida Soulaymani; Jayesh M Pandit

doi:10.1177/20420986231188836

Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries

Ther Adv Drug Saf. 2023 Jul 24:14:20420986231188836. doi: 10.1177/20420986231188836. eCollection 2023.

Authors

Affiliations

¹ Department of Clinical Pharmacology and Therapeutics, School of Medicine, College of Medical Sciences, University of Benin/University of Benin Teaching Hospital, Benin City, Edo State PMB 1154, Nigeria.
² Department of Clinical Pharmacology and Therapeutics, University of Benin/University of Benin Teaching Hospital, Benin City, Nigeria.
³ Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.
⁴ African Union Development Agency-New Partnership for Africa's Development (AUDA-NEPAD), Midrand, Johannesburg, South Africa.
⁵ Netherlands Pharmacovigilance Centre Lareb, Den Bosch, The Netherlands.
⁶ KNCV Tuberculosis Foundation, The Hague, The Netherlands.
⁷ KNCV of the Kilimanjaro Clinical Research Institute, Moshi, Tanzania.
⁸ Medicines Control Authority of Zimbabwe, Harare, Zimbabwe.
⁹ WHO Collaborating Centre for Strengthening Pharmacovigilance Practices, Centre.
¹⁰ Anti Poison et de Pharmacovigilance du Maroc, Rabat, Morocco.
¹¹ PV Expert, Kenya, Association of Pharmaceutical Industries (KAPI), Nairobi, Kenya.

Abstract

Background: An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used.

Objectives: The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa.

Methods/processes: The process of developing this framework entailed a review of PV financing in some developed economies, a landscape study of funding of PV in some African countries, an in-depth understanding of the PV system and the organisational structure and nexus between the regulatory agencies and National Pharmacovigilance Centre. Critical points for consideration included the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework. Consultative meetings, webinars and interviews with experts were carried out.

Results: The findings showed that most of the PV systems were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. A framework likely to ensure sustainable PV financing is suggested to capture all available sources of funding, mine the potential sources providing a sizeable pool of revenue to address its activities and enabling legal framework which will engender autonomy. Furthermore, it will address the nexus between the regulatory agencies and the PV outfits, thus enabling appropriate share of resources and blockage of diversions.

Conclusion: In all, addressing the various elements identified in this study and providing the legal provisions which guarantees some degree of autonomy will provide a sustainable mechanism for PV funding in the resource-limited setting of Africa.

Keywords: Africa; financial sustainability; funding; pharmacovigilance; resource-limited settings.

Plain language summary

Funding models for pharmacovigilance in resource-limited African countries An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings following their entry into the WHO Programme of International Drug Monitoring is the lack of adequate funds to establish a functional National Pharmacovigilance System. This article provides an overview of various potential sources of funds in these settings and how they can be harnessed to fund PV. We undertook a review of PV financing in developed settings and carried out a landscape study of funding of PV in some African countries, as well as having an in-depth understanding of the PV system and the organisational structure. The nexus between the regulatory agencies and National Pharmacovigilance Centre was noted. We took into account the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework for the different African countries. We also identified the prevalent and potential sources of funds for PV. Consultative meetings, webinars and interviews with experts in PV were carried out as well. We discovered that most of the PV facilities were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. We have now proposed funding models that may lead to increased revenue for PV in these countries as well as suggesting that a legal framework be provided to guarantee sustainability and address the nexus between the regulatory agencies and the PV outfits to ensure an appropriate share of resources and blocking diversions.