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

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.

An Exploratory Bibliometric Analysis of African Pharmacovigilance Research Output Using SCOPUS

“…This possibly explains the small extent of African PV schemes in terms of therapeutic areas covered, the number of ICSRs submitted to VigiBase®, and the scope of PV activities [ 7 ]. Isah et al found that in addition to the significant donor funding, most African PV systems lack independence from regulatory agencies regarding operational and fiscal governance, limiting their operability [ 24 ]. The observed 2.1% African literature output mirrors the mere 0.88% African ICSR contribution to the global ADR database, VigiBase® [ 7 ] indicating the lack of investment in the field.…”

“…Several issues need to be addressed to redress the observed PV limitations in Africa. Firstly, firm regulatory policy and enforceable PV legislation need to be adopted to ensure adequate funding and authority to the local regulatory authorities (RAs) [ 24 , 26 ]. RAs and especially marketing authorization holders (MAHs) should be legally accountable for the provision of risk management plans for any registered medicine in Africa as occurs in ICH territories.…”