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国际强制许可能否使药品分级定价与健康权相协调?

Could international compulsory licensing reconcile tiered pricing of pharmaceuticals with the right to health?

作者信息

Ooms Gorik, Forman Lisa, Williams Owain D, Hill Peter S

机构信息

Department of Public Health, Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium.

Law and Development Research Group, Faculty of Law, University of Antwerp, Antwerp, Belgium.

出版信息

BMC Int Health Hum Rights. 2014 Dec 18;14:37. doi: 10.1186/s12914-014-0037-4.

DOI:10.1186/s12914-014-0037-4
PMID:25518744
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4279690/
Abstract

BACKGROUND

The heads of the Global Fund and the GAVI Alliance have recently promoted the idea of an international tiered pricing framework for medicines, despite objections from civil society groups who fear that this would reduce the leeway for compulsory licenses and generic competition. This paper explores the extent to which an international tiered pricing framework and the present leeway for compulsory licensing can be reconciled, using the perspective of the right to health as defined in international human rights law.

DISCUSSION

We explore the practical feasibility of an international tiered pricing and compulsory licensing framework governed by the World Health Organization. We use two simple benchmarks to compare the relative affordability of medicines for governments - average income and burden of disease - to illustrate how voluntary tiered pricing practice fails to make medicines affordable enough for low and middle income countries (if compared with the financial burden of the same medicines for high income countries), and when and where international compulsory licenses should be issued in order to allow governments to comply with their obligations to realize the right to health. An international tiered pricing and compulsory licensing framework based on average income and burden of disease could ease the tension between governments' human rights obligation to provide medicines and governments' trade obligation to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights.

摘要

背景

全球基金和全球疫苗免疫联盟负责人最近倡导建立药品国际分级定价框架,尽管民间社会团体表示反对,担心这会减少强制许可和仿制药竞争的空间。本文从国际人权法所定义的健康权角度,探讨国际分级定价框架与当前强制许可空间能够协调的程度。

讨论

我们探讨由世界卫生组织管理的国际分级定价和强制许可框架的实际可行性。我们使用两个简单的基准来比较各国政府购买药品的相对可承受性——平均收入和疾病负担——以说明自愿分级定价做法如何无法使药品对低收入和中等收入国家而言足够可承受(如果与高收入国家购买相同药品的财政负担相比),以及何时何地应发放国际强制许可,以便各国政府履行其实现健康权的义务。基于平均收入和疾病负担的国际分级定价和强制许可框架可以缓解各国政府在提供药品的人权义务与遵守《与贸易有关的知识产权协定》的贸易义务之间的紧张关系。

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本文引用的文献

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Mark Dybul, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria.马克·迪布尔,抗击艾滋病、结核病和疟疾全球基金执行主任。
BMJ. 2016 Jun 27;353:i1475. doi: 10.1136/sbmj.i1475.
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Improving access to vaccines through tiered pricing.通过分级定价提高疫苗可及性。
Lancet. 2014 Jun 28;383(9936):2265-7. doi: 10.1016/S0140-6736(13)62424-1. Epub 2014 Mar 11.
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Minimum costs for producing hepatitis C direct-acting antivirals for use in large-scale treatment access programs in developing countries.在发展中国家用于大规模治疗获取项目的丙型肝炎直接抗病毒药物的最低生产成本。
Clin Infect Dis. 2014 Apr;58(7):928-36. doi: 10.1093/cid/ciu012. Epub 2014 Jan 6.
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Funding innovation for treatment for rare diseases: adopting a cost-based yardstick approach.为罕见病治疗创新提供资金:采用基于成本的衡量标准方法。
Orphanet J Rare Dis. 2013 Nov 16;8:180. doi: 10.1186/1750-1172-8-180.
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What is the optimal first line antiretroviral therapy in resource-limited settings?在资源有限的环境中,最佳的一线抗逆转录病毒治疗方案是什么?
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