Compulsory Licenses for Pharmaceutical Patents in China in Light of the Trips Agreement
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AbstractThe recurrence of public health emergencies has made the issue of access to drugs a pertinent problem for developing countries. As a public health safeguard, the compulsory license system for patented pharmaceuticals is embodied in the international intellectual property (hereinafter “IP”) norms related to public health. The Agreement on Trade-Related Aspects of Intellectual Property Rights (hereinafter “TRIPS Agreement”) flexibility is a double-edged sword for the pharmaceutical patent system in developing countries. On the one hand, the exception clauses to IP protection under the TRIPS Agreement, especially the compulsory licensing system, give member states the possibility of exempting their treaty obligations in the event of a public health crisis. On the other hand, the different interpretations deriving from the ambiguity of TRIPS ‘‘flexibility’’ defer members from implementing compulsory licensing in response to a public health crisis. China has established a systematic set of rules, including legislation and policies on compulsory licensing and integrated the TRIPS flexibility into Free Trade Agreements (FTAs). However, it still lacks clear procedural provisions regarding the compulsory licensing of pharmaceutical patents in the context of the public health crisis, which affects China’s ability to use TRIPS flexibility of Compulsory licenses effectively.
Furthermore, China’s compulsory license law is never implemented despite the increasing need to ensure drug access and effectively respond to public health emergencies. This article aims to assess China’s compulsory license system in light of the TRIPS Agreement. The article analyses how and why China’s domestic compulsory license system fails to take advantage of TRIPS flexibility in substance and implementation. It suggests points for reform to enhance China’s compulsory license system for pharmaceutical patents, which can effectively be utilized in public health emergencies, as well as heading towards better integration and implementation of the TRIPS flexibility, referring to the interest-balanced guiding principle.
All Author(s) ListQian Yin
Journal nameAsian Journal of Wto and International Health Law and Policy
Year2023
Month3
Volume Number18
Issue Number1
PublisherNational Taiwan University Press
Place of PublicationTaiwan
Pages131 - 180
ISSN1819-5164
LanguagesEnglish-United States

Last updated on 2024-09-04 at 00:39