ABSTRACT The COVID-19 pandemic has brought into stark relief the gaps in global preparedness to address widespread outbreaks of deadly viral infections. This article proposes legal mechanisms for addressing critical issues facing the international community in terms of providing equitable access to vaccines, treatments, diagnostics, and medical equipment. On the supply side, the authors propose the establishment of mandatory patent pools (‘Licensing Facilities’) on a global or regional, or even national basis, depending upon the degree of cooperation that may be achieved. The authors also discuss the importance of creating shared production facilities. On the demand side, the authors propose the establishment of Regional Pharmaceutical Supply Centers (RPSCs) for the collective procurement of products, and the need to coordinate the issuance of necessary compulsory licenses for production and/or importation, depending on relevant circumstances. The authors envisage that centralized coordination by RPSCs should assist in overcoming difficulties individual countries may encounter in addressing administrative and technical issues in procuring supplies, as well as creating improved bargaining leverage with potential suppliers. The authors finally address the problem created by the decision of various high-income countries to ‘opt out’ as eligible importing countries under the World Trade Organization TRIPS Agreement Article 31bis amendment that addresses the predominant export of pharmaceutical products under compulsory licenses.

中文翻译：

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促进获得专利药品的跨境供应：以 COVID-19 大流行为例

摘要 COVID-19 大流行使全球在应对致命病毒感染广泛爆发的准备方面的差距明显缩小。本文提出了解决国际社会在公平获得疫苗、治疗、诊断和医疗设备方面面临的关键问题的法律机制。在供应方面，作者建议根据可能实现的合作程度，在全球或区域甚至国家基础上建立强制性专利池（“许可设施”）。作者还讨论了创建共享生产设施的重要性。在需求方面，作者提出建立区域药品供应中心（RPSCs）进行产品的集体采购，需要根据相关情况协调颁发必要的生产和/或进口强制许可。作者认为，RPSC 的集中协调应有助于克服个别国家在解决采购供应的行政和技术问题时可能遇到的困难，并提高与潜在供应商的谈判筹码。作者最终解决了根据世界贸易组织与贸易有关的知识产权协议第 31 条之二修正案，各个高收入国家决定“选择退出”作为合格进口国所造成的问题，该修正案涉及强制许可下的医药产品的主要出口。作者认为，RPSC 的集中协调应有助于克服个别国家在解决采购供应的行政和技术问题时可能遇到的困难，并提高与潜在供应商的谈判筹码。作者最终解决了根据世界贸易组织与贸易有关的知识产权协议第 31 条之二修正案，各个高收入国家决定“选择退出”作为合格进口国所造成的问题，该修正案涉及强制许可下的医药产品的主要出口。作者认为，RPSC 的集中协调应有助于克服个别国家在解决采购供应的行政和技术问题时可能遇到的困难，并提高与潜在供应商的谈判筹码。作者最终解决了根据世界贸易组织与贸易有关的知识产权协议第 31 条之二修正案，各个高收入国家决定“选择退出”作为合格进口国所造成的问题，该修正案涉及强制许可下的医药产品的主要出口。