't Hoen Ellen F M, Hogerzeil Hans V, Quick Jonathan D, Sillo Hiiti B
Independent Consultant, Medicines Law and Policy, Paris, 75011, France.
University of Groningen, 9713 AV Groningen, The Netherlands.
J Public Health Policy. 2014 May;35(2):137-61. doi: 10.1057/jphp.2013.53. Epub 2014 Jan 16.
Problems with the quality of medicines abound in countries where regulatory and legal oversight are weak, where medicines are unaffordable to most, and where the official supply often fails to reach patients. Quality is important to ensure effective treatment, to maintain patient and health-care worker confidence in treatment, and to prevent the development of resistance. In 2001, the WHO established the Prequalification of Medicines Programme in response to the need to select good-quality medicines for UN procurement. Member States of the WHO had requested its assistance in assessing the quality of low-cost generic medicines that were becoming increasingly available especially in treatments for HIV/AIDS. From a public health perspective, WHO PQP's greatest achievement is improved quality of life-saving medicines used today by millions of people in developing countries. Prequalification has made it possible to believe that everyone in the world will have access to safe, effective, and affordable medicines. Yet despite its track record and recognized importance to health, funding for the programme remains uncertain.
在监管和法律监督薄弱、大多数人无力负担药品费用、官方供应往往无法惠及患者的国家，药品质量问题比比皆是。质量对于确保有效治疗、维持患者及医护人员对治疗的信心以及防止耐药性的产生至关重要。2001年，世卫组织设立了药品预认证计划，以满足为联合国采购挑选优质药品的需求。世卫组织成员国请求其协助评估低成本仿制药的质量，这类药品越来越容易获得，尤其是在艾滋病毒/艾滋病治疗方面。从公共卫生角度来看，世卫组织药品预认证计划的最大成就是提高了当今发展中国家数百万人使用的救命药品的质量。预认证使人们相信世界上每个人都能获得安全、有效且可负担的药品。然而，尽管该计划成绩斐然且对健康的重要性得到认可，但其资金仍不确定。
