Abstract
ObjectiveTo obtain the perspectives of some small- and medium-sized organizations on the World Health Organization (WHO) prequalification programme for medicines and to ascertain organizations’ unmet needs.MethodsWe conducted an exploratory, qualitative study in 2018 among 17 representatives of 15 small- and medium-sized Belgian and non-Belgian organizations who purchase medicines for humanitarian, development or public programmes in low- and middle-income countries. We used semi-structured interviews to obtain respondents’ views and experiences of using WHO prequalification guidance when procuring medicines. We identified emerging themes and formulated recommendations about the activities of the WHO Prequalification Team.FindingsMost respondents suggested expanding prequalification to essential antibiotics, particularly paediatric formulations; and insulin, antihypertensives and cancer treatments. Respondents were concerned about irregular availability of WHO-prequalified medicines in the marketplace and sometimes high prices of prequalified products. Small organizations, in particular, had difficulties negotiating low-volume purchases. Organizations working in primary health care and hospitals seldom referred to the prequalified lists.ConclusionWe recommend that the WHO-prequalified products be expanded to include essential antibiotics and medicines for noncommunicable diseases. The WHO Prequalification Team could require prequalified manufacturers to make publicly available the details of their authorized distributors and facilitate a process of harmonization of quality assurance policies across all donors. Prequalification of distributors and procurement agencies could help create more transparent and stringent mechanisms. We urge WHO Member States and funders to sustain support for the WHO Prequalification Team, which remains important for the fulfilment of universal health coverage.
Highlights
A key element of achieving universal health coverage in target 3.8 of the sustainable development goals is “access to safe, effective, quality and affordable essential medicines and vaccines for all.” Ensuring the quality of medicines is a moral imperative for any concerned stakeholder,[1] and failure to do so may have major public health and economic consequences
The majority had previous relevant experience in procurement of medicines and all participants had some degree of responsibility for quality assurance of purchased medicines
To address current trends in global health, invitations for expression of interest for World Health Organization (WHO)-prequalified products could be issued for essential antibiotics and medicines for noncommunicable diseases
Summary
A key element of achieving universal health coverage in target 3.8 of the sustainable development goals is “access to safe, effective, quality and affordable essential medicines and vaccines for all.” Ensuring the quality of medicines is a moral imperative for any concerned stakeholder,[1] and failure to do so may have major public health and economic consequences. Ensuring the quality of medicines is a moral imperative for any concerned stakeholder,[1] and failure to do so may have major public health and economic consequences. The globalization of production and distribution, coupled with the weakness of national medicines regulatory authorities in many low- and middle-income countries, makes it difficult to thoroughly assess the quality of medicines available in the global market.[2] Most national medicines regulatory authorities in low- and middle-income countries lack the human and financial resources and infrastructure to assess the efficacy, safety and quality of medical products submitted for marketing authorization or to maintain adequate postmarketing surveillance. Low- and middle-income countries are at-risk of having poor-quality medicines that weaken their health systems and erode trust.[5,6,7,8,9,10] Based on a literature review of papers that reported on field studies or surveys of the quality of medicines, WHO has estimated that about 10.5% of medicines in low- and middle-income countries are substandard or falsified (that is, 1166 of 11 156 tested samples in low-income countries and 3906 of 35 884 samples in middle-income countries).[11]
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