IN THE FRAMEWORK Sample Clauses

IN THE FRAMEWORK. THE SHORTCOMINGS AND FAILINGS OF ARTICLE 31BIS Article 31bis, in theory, was meant to ameliorate the shortcomings and challenges presented by Articles 31(f) and (h), but, unfortunately, has served as little more than an ineffective patch that is already showing cracks in its new framework. Here, I argue that there are three main ways that Article 31bis fails its mandate: first, it fails to consider the administrative burden placed on the importing, and often resource-poor, member; second, the framework arguably applies well to chemical-based formulation drugs, but novel therapeutics, including biologics, cellular-based therapies, and gene- based therapies present particular challenges that were not addressed in the 109. The 2019 global coronavirus pandemic (COVID-19, caused by the SARS-CoV-2 virus) illustrates how rapidly national health emergencies can evolve. Naming the coronavirus disease (COVID-19) and the virus that causes it, WORLD HEALTH ORGANIZATION, xxxxx://xxx.xxx.xxx/emergencies/diseases/novel-coronavirus-2019/technical- guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it (last visited Mar. 21, 2020). In mere months, the situation has rapidly evolved from one of a novel virus causing respiratory symptoms in Wuhan, China, to a fulminant, global pandemic. See Xxxxxxx Xxxxx, et al., Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China, 395 THE LANCET 497 (2020); Xxxxx Xxxxxxxxx & Xxxxxx Xxxxxx, WHO declares the coronavirus outbreak a pandemic, STAT (Mar. 11, 2020), xxxxx://xxx.xxxxxxxx.xxx/2020/03/11/who-declares-the-coronavirus-outbreak-a-pandemic/; Interestingly, there have already been discussions of, and calls for, compulsory licensing in this rapidly developing area. See, e.g., Xx Xxxxxxxxx, Chilean lawmakers support compulsory licensing for coronavirus medicines and vaccines, STAT (Mar. 18, 2020), xxxxx://xxx.xxxxxxxx.xxx/pharmalot/2020/03/18/chile-compulsory-licensing-coronavirus- covid19-vaccines/. 110. WTO Doc. IP/C/57, supra note 104, at ¶ 44. 111. Id. at ¶ 62. 112. Id. at ¶ 251. XXXXXXX 2.3 AT 1030AM .DOCX (DO NOT DELETE) 2/3/21 10:59 AM 22 Gonzaga Journal of International Law Vol. 24: 1 drafting of Article 31bis and its associated components; finally, it fails to consider data exclusivity agreements that are part of other international agreements, and, as a result, it fails to provide any means for how the TRIPS provisions may be reconciled with conflicting provisions in other ...
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