HIV/AIDS Drugs for Sub-Saharan Africa: How Do Brand and Generic Supply Compare?
HIV/AIDS Drugs for Sub-Saharan Africa: How Do Brand and Generic Supply Compare?
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DOI：
10.1371/journal.pone.0000278
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发表时间：
2007-03-14
期刊：
影响因子：
3.7
通讯作者：
Chien, Colleen V.
中科院分区：
文献类型：
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作者：
Chien, Colleen V.
背景。撒哈拉以南非洲地区 20 年来首次采购了大量用于治疗艾滋病毒/艾滋病的抗逆转录病毒药物 (ARV)。这为实证研究品牌和仿制药供应商在提供抗逆转录病毒药物方面的作用提供了一个新的机会。方法/主要发现。根据 2004 年 1 月至 2006 年 3 月向世界卫生组织全球价格报告机制报告的撒哈拉以南非洲 2,162 份艾滋病药物订单数据集，对品牌和仿制药供应进行了观察性研究。仿制药公司供应了 63% 的研究药物，其价格平均约为品牌公司定价的三分之一。 96%的采购是一线药品，主要由仿制药公司提供，而其余4%的二线药品主要来自品牌公司。样本中85%的仿制药是在印度生产的，而印度采购的大部分药品都不符合专利保护的条件。其余 15% 是在南非生产的，大部分是品牌公司向一家仿制药公司提供的自愿许可。在撒哈拉以南非洲国家，数据集中的四种一线药物已获得广泛专利，但没有发现基于专利的对仿制药购买的普遍威慑。结论/意义。仿制药和品牌公司在增加撒哈拉以南非洲地区抗逆转录病毒药物的供应方面发挥了独特的作用。仿制药公司提供了大部分研究药物，价格低于品牌公司的价格，到目前为止，几乎只提供几种固定剂量的组合药物。品牌公司提供了几乎所有的二线药物，与仿制药公司签署了自愿许可，并且在某些国家没有严格执行专利。有必要进一步调查如何实现二线药物的降价以及如何实际采购最便宜的药物。
Background. Significant quantities of antiretroviral drugs (ARVs) to treat HIV/AIDS have been procured for Sub-Saharan Africa for the first time in their 20-year history. This presents a novel opportunity to empirically study the roles of brand and generic suppliers in providing access to ARVs. Methodology/Principal Findings. An observational study of brand and generic supply based on a dataset of 2,162 orders of AIDS drugs for Sub-Saharan Africa reported to the Global Price Reporting Mechanism at the World Health Organization from January 2004-March 2006 was performed. Generic companies supplied 63% of the drugs studied, at prices that were on average about a third of the prices charged by brand companies. 96% of the procurement was of first line drugs, which were provided mostly by generic firms, while the remaining 4%, of second line drugs, was sourced primarily from brand companies. 85% of the generic drugs in the sample were manufactured in India, where the majority of the drugs procured were ineligible for patent protection. The remaining 15% was manufactured in South Africa, mostly under voluntary licenses provided by brand companies to a single generic company. In Sub-Saharan African countries, four first line drugs in the dataset were widely patented, however no general deterrent to generic purchasing based on a patent was detected. Conclusions/Significance. Generic and brand companies have played distinct roles in increasing the availability of ARVs in Sub-Saharan Africa. Generic companies provided most of the drugs studied, at prices below those charged by brand companies, and until now, almost exclusively supplied several fixed-dose combination drugs. Brand companies have supplied almost all second line drugs, signed voluntary licenses with generic companies, and are not strictly enforcing patents in certain countries. Further investigation into how price reductions in second line drugs can be achieved and the cheapest drugs can actually be procured is warranted.