The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic
The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic
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TRIPS 知识产权豁免提案：在专利法和政治中创造适当的激励措施以结束 COVID-19 大流行
DOI：
10.2139/ssrn.3851737
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
S. Thambisetty
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文献类型：
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作者：
S. Thambisetty
世界贸易组织（WTO）《与贸易有关的知识产权协议》（TRIPS）中纳入的全球知识产权法结构与当前缺乏抗击疫情所需的COVID-19疫苗、医疗设备、药物和诊断（以下简称“卫生技术”）有关。尽管公平获得疫苗符合全球公众的道德、政治和经济利益，需要全球团结一致，但COVID-19“疫苗民族主义”现象凸显了当前法律的和财政激励措施在公平生产和分配疫苗方面的错位。这场危机进一步表明，高收入国家未能兑现它们在1994年《与贸易有关的知识产权协议》谈判时所作的承诺，即通过同意《与贸易有关的知识产权协议》的条款，中低收入国家将受益于技术转让和生产能力建设。因此，当前的危机不仅暴露了如何应对全球紧急情况的不足之处，而且也暴露了国际“专利交易”本身的缺陷。
本文阐述了围绕印度和南非于2020年10月首次提出的“TRIPS豁免”建议的法律的问题，截至2021年5月，该建议得到了60多个国家的支持，并获得了世界卫生组织（WHO）的支持声明。我们分析了与该提案相关的不同知识产权-主要集中在专利权和商业秘密-这与当前的COVID-19疫苗背景最相关。我们解释了为什么现有的TRIPS关于强制许可的灵活性在程序和法律的实质方面都无法充分应对当前的流行情况。
COVID-19造成的当前健康危机的程度是不可否认的，因为目前的全球应对措施是站不住脚的。鉴于制药业一直没有充分参与拟议的全球机制，以分享知识产权、数据和专门知识来应对这一大流行病，我们认为需要强制性机制。在此背景下，TRIPS豁免是一项必不可少的法律的工具，可以大幅增加COVID-19疫苗的生产能力，从而增加供应，为实现全球公平获取开辟道路。
我们对此提出两个论点：第一，TRIPS豁免是以直接、一致和有效的方式清除知识产权（IP）壁垒的必要和相称的法律的措施，使更多公司能够自由生产COVID-19疫苗和其他卫生技术，而不必担心侵犯另一方的知识产权和随之而来的诉讼威胁;其次，TRIPS豁免是一个重要的政治、道德和经济杠杆，有助于鼓励旨在实现全球公平获得疫苗的解决方案，这符合全球公众的更广泛利益。
The structure of global intellectual property law as incorporated in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is implicated in the current lack of COVID-19 vaccines, medical equipment, medicines and diagnostics (hereafter, ‘health-technologies’), which are needed to combat the pandemic. Although equitable access to vaccines is in the moral, political and economic interests of the global public and requires global solidarity, the phenomenon of COVID-19 ‘vaccine nationalism’ has brought into sharp relief the misalignment of current legal and financial incentives to produce and distribute vaccines equitably. The crisis further demonstrates the failure of high-income countries (HICs) to realise the promise they made at the time of the TRIPS negotiations in 1994, that by agreeing to the terms of TRIPS, lower and middle-income countries (LMICs) would benefit from technology transfer and the building of productive capacity. As such, the current crisis is revealing not only of inadequacies of how to deal with global emergencies, but also of deficiencies within the international ‘patent bargain’ itself.
This paper elucidates the legal issues surrounding the ‘TRIPS waiver’ proposal initially put forward by India and South Africa in October 2020, which, as of May 2021, is supported by more than 60 states, and which has received statements of support from the World Health Organisation (WHO). We analyse the different intellectual property rights relevant to the proposal – focusing primarily on patent rights and trade secrets – which are most relevant to the present COVID-19 vaccine context. We explain why the existing TRIPS flexibilities around compulsory licensing are incapable of addressing the present pandemic context adequately, both in terms of procedure and legal substance.
The extent of the current health crisis posed by COVID-19 is as undeniable as the current global response is untenable. Given the ongoing absence of sufficient engagement by the pharmaceutical industry with proposed global mechanisms to share intellectual property rights, data and know-how to address the pandemic, we argue that mandatory mechanisms are needed. The TRIPS waiver is an essential legal instrument in this context for enabling a radical increase in manufacturing capacity, and hence supply, of COVID-19 vaccines, creating a pathway to achieve global equitable access.
We make two arguments to this effect: first, the TRIPS waiver is a necessary and proportionate legal measure for clearing intellectual property (IP) barriers in a direct, consistent and efficient fashion, enabling the freedom to operate for more companies to produce COVID-19 vaccines and other health technologies without the fear of infringing another party’s IP rights and the attendant threat of litigation; and second, the TRIPS waiver acts as an important political, moral and economic lever towards encouraging solutions aimed at global equitable access to vaccines, which is in the wider interest of the global public.