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是否存在将质量有保证且价格可承受的药品带给低收入和中等收入国家的政治意愿?

Does the political will exist to bring quality-assured and affordable drugs to low- and middle-income countries?

作者信息

Beck Eduard J, Mandalia Sundhiya, DongmoNguimfack Boniface, Pinheiro Eloan, 't Hoen Ellen, Boulet Pascale, Stover John, Gupta Aashta, Juneja Sandeep, Habiyambere Vincent, Ghys Peter, Nunez Cesar

机构信息

a Programme Branch , UNAIDS , Geneva , Switzerland.

b NPMS-HHC CIC , London , UK.

出版信息

Glob Health Action. 2019;12(1):1586317. doi: 10.1080/16549716.2019.1586317.

Abstract

BACKGROUND

Increased coverage with antiretroviral therapy for people living with HIV in low- and middle-income countries has increased their life expectancy associated with non-HIV comorbidities and the need for quality-assured and affordable non-communicable diseases drugs . Funders are leaving many middle-income countries that will have to pay and provide quality-assured and affordable HIV and non-HIV drugs, including for non-communicable diseases.

OBJECTIVE

To estimate costs for originator and generic antiretroviral therapy as the number of people living with HIV are projected to increase between 2016 and 2026, and discuss country, regional and global factors associated with increased access to generic drugs.

METHODS

Based on estimates of annual demand and prices, annual cost estimates were produced for generic and originator antiretroviral drug prices in low- and middle-income countries and projected for 2016-2026.

RESULTS

Drug costs varied between US$1.5 billion and US$4.8 billion for generic drugs and US$ 8.2 billion and US$16.5 billion for originator drugs between 2016 and 2026.

DISCUSSION

The global HIV response increased access to affordable generic drugs in low- and middle-income countries. Cheaper active pharmaceutical ingredients and market competition were responsible for reduced drug costs. The development and implementation of regulatory changes at country, regional and global levels, covering intellectual property rights and public health, and flexibilities in patent laws enabled prices to be reduced. These changes have not yet been applied in many low- and middle-income countries for HIV, nor for other infectious and non-communicable diseases, that lack the profile and political attention of HIV. Licensing backed up with Trade-Related Aspects of Intellectual Property Rights safeguards should become the norm to provide quality-assured and affordable drugs within competitive generic markets.

CONCLUSION

Does the political will exist among policymakers and other stakeholders to develop and implement these country, regional and global frameworks for non-HIV drugs as they did for antiretroviral drugs?

摘要

背景

在低收入和中等收入国家,接受抗逆转录病毒治疗的艾滋病毒感染者覆盖面有所扩大,这延长了他们与非艾滋病毒合并症相关的预期寿命,也增加了对质量有保证且价格可承受的非传染性疾病药物的需求。资助者正撤离许多中等收入国家,而这些国家将不得不自行支付并提供质量有保证且价格可承受的艾滋病毒及非艾滋病毒药物,包括用于治疗非传染性疾病的药物。

目的

随着预计2016年至2026年期间艾滋病毒感染者人数增加,估算原研药和仿制药抗逆转录病毒治疗的成本,并讨论与增加仿制药可及性相关的国家、区域和全球因素。

方法

根据年度需求和价格估算,得出低收入和中等收入国家仿制药和原研药抗逆转录病毒药物的年度成本估算,并预测2016 - 2026年的情况。

结果

2016年至2026年期间,仿制药的药物成本在15亿美元至48亿美元之间,原研药的药物成本在82亿美元至165亿美元之间。

讨论

全球应对艾滋病毒行动增加了低收入和中等收入国家获得价格可承受的仿制药的机会。更便宜的活性药物成分和市场竞争导致药物成本降低。国家、区域和全球层面在知识产权和公共卫生方面监管变革的制定与实施,以及专利法的灵活性使得价格得以降低。这些变革尚未在许多低收入和中等收入国家应用于艾滋病毒治疗,也未应用于其他缺乏艾滋病毒那样的关注度和政治重视的传染病及非传染性疾病。以与贸易有关的知识产权保障为后盾的许可应成为在有竞争力的仿制药市场提供质量有保证且价格可承受药物的规范。

结论

政策制定者和其他利益相关者是否有政治意愿像为抗逆转录病毒药物那样,制定并实施这些针对非艾滋病毒药物的国家、区域和全球框架?

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2a1/6484498/e31c50987556/ZGHA_A_1586317_F0001_OC.jpg

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