GEGI WORKING PAPER 049 04/2021

ABSTRACT

China has introduced pharmaceutical-related TRIPS-plus rules into its domestic law through its accession to the World Trade Organization and Phase One Agreement with the United States, thus further enhancing China’s protection of pharmaceutical intellectual property (IP) rights. As a developing country, the critical factors for China’s introducing these high standards of pharmaceutical IP protection include: the promotion of innovation in the pharmaceutical industry, the development of generic pharmaceuticals, the accelerated introduction of innovative medicines into the domestic market, and external drivers from negotiating international economic and trade agreements. In practice, the TRIPS-plus rules have been a “double-edged sword” for China’s access to medicines, which has both positive and negative effects. Therefore, to reduce the potential negative impact of the TRIPS-plus rules on access to medicines, China has responded by taking full advantage of the “flexibilities” reserved by the rules of international trade agreements, adding and improving legal provisions to prevent patent abuse, encouraging more patentees to voluntarily implement the patent opening licenses, improving the regulations of its compulsory licensing system for pharmaceuticals, and promoting domestic pharmaceutical pricing and procurement reform. Additionally, China’s practical practices illustrate that the potential conflicts between the TRIPS-plus rules and access to medicines need to be resolved through coordination between the international IP regime and the global health governance arena and it suggests that the design of IP rules for pharmaceuticals at the international level should be changed from avoiding “free-riding” to “returning” all consumers who share the innovation costs.

Key words: TRIPS-plus rules; Pharmaceuticals; Phase One Agreement; China

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