QUAMED, Brussels, Belgium.
Public Health Department, Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium.
Bull World Health Organ. 2020 Jun 1;98(6):413-419. doi: 10.2471/BLT.19.233882. Epub 2020 Apr 7.
To 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.
We 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.
Most 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.
We 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.
了解一些中小规模组织对世界卫生组织(WHO)药品预认证计划的看法,明确组织的未满足需求。
我们于 2018 年对 15 家比利时和非比利时中小规模组织的 17 名代表进行了一项探索性、定性研究,这些组织在中低收入国家从事人道主义、发展或公共项目的药品采购工作。我们采用半结构化访谈的方式,了解受访者在采购药品时使用世卫组织预认证指南的看法和经验。我们确定了一些新出现的主题,并就世卫组织预认证团队的活动提出了建议。
大多数受访者建议扩大预认证范围,纳入基本抗生素,特别是儿科制剂;以及胰岛素、抗高血压药和癌症治疗药物。受访者担心市场上 WHO 预认证药品的供应不规律,有时预认证产品的价格过高。小组织尤其难以谈判小批量采购。从事初级卫生保健和医院工作的组织很少参考预认证清单。
我们建议扩大 WHO 预认证产品范围,纳入基本抗生素和治疗非传染性疾病的药物。WHO 预认证团队可以要求预认证制造商公开其授权分销商的详细信息,并促进所有捐助者的质量保证政策的协调统一。对分销商和采购机构进行预认证可以帮助建立更透明和严格的机制。我们敦促世卫组织会员国和供资方继续支持世卫组织预认证团队,这对于实现全民健康覆盖仍然很重要。