Assuring the Quality of Essential Medicines Procured with Donor Funds

Moore, Thomas ; Lee, David ; Konduri, Niranjan ; Kasonde, Lombe

World Bank, Washington, DC

关键词: ACCOUNTING;    ACTIVE INGREDIENTS;    AID;    AIDS PREVENTION;    AIDS RELIEF;   

RP-ID  :  70853

学科分类：社会科学、人文和艺术（综合）

来源: World Bank Open Knowledge Repository

【 摘 要 】

The donor community spends millions ofdollars annually on procuring essential medicines as part ofdevelopment assistance for health. Defining and enforcingquality standards for these medicines continues to provechallenging as this involves complex regulatory processes.While developed countries with stringent regulatoryauthorities in place have the capacity to comply with strictregulatory requirements, the essential medicines procuredfor developing countries are either not available indeveloped country markets, or are not the most competitivelypriced medicines internationally. Donors have therefore beenforced to independently develop systems to purchase atlowest feasible cost, essential medicines for the developingworld without compromising quality. Through a desk reviewand consultation with key stakeholders, this paper compilesdata on various approaches used by international agenciesand donor bodies to improve the quality of essentialmedicines they procure, beyond the World Health Organization(WHO) prequalification of medicines program and the globalfund expert review panel, which focus only on medicines fortreating HIV/AIDS, tuberculosis, and malaria. This paperadditionally explores pragmatic options for a harmonizedapproach to ensuring the quality of medicines procured withdonor funds. Based on the observed limitations of existingapproaches, this paper considers a risk-based approachinitiated by WHO, through which medicines in the WHO modellist of essential medicines are classified according to riskcategories (high, medium, and low). In the long run, thegoal of international donor aid is to build the capacity ofdeveloping countries to take the lead in assuring the healthof their citizens. Effective harmonization, coordination,and optimal leveraging of existing approaches may helpnational regulatory authorities to strengthen their owncapacity to better control their markets, includingregistering products according to stringent standards,improving domestic manufacturing where applicable, andenhancing post-marketing surveillance.