Medical Patent Protection Impacts on Access to Medicine in China

Abstract: Along with the interrelation between medical patent right, the generics impacts and the right to access to medicines, which as one of intersection issues between Intellectual Property Rights (IPRs) and Human Rights (HR), has drawn more and more attention under the international society, the Doha Declaration on TRIPS and Public Health has reaffirmed the flexibilities of the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS) member states in circumventing patent rights for better access to essential medicines in 2001. Considering the TRIPS flexibilities importance on promoting access to medicines in the most developing and the least developed countries, the thesis basically checks how medical patent rights impact on the access to medicines in China and how China has utilized the TRIPS flexibilities in recent years. The thesis starts with defining the access to medicines and through interpreting its interrelationships with right to health and other relevant human rights, confirming the right to access to medicines is a human right. Then considering its conflict with the recently popular development of patent right, it clarifies the over-protection of medical patent right actually is limiting the access to medicines and mentions there are other non-IP actors which also hinders the access to medicines. Following focus on the balance of IPR and HR protection, the both internal and extraterritorial of states’ obligations would also be acknowledged in the chapter 2. In the chapter 3, the overview of Chinese medical patent legislation can be found. It begins with the introduction and comments of the important provisions within the two most important laws, Patent Law (2008) and Measures on Compulsory License for Patent Exploitation (2012), by following checks how the TRIPS flexibilities, such as compulsory licensing, parallel importation, Bolar exemption etc, have been implemented and practiced by the government. After the legislation review and the enforcement examination, the thesis concludes that the fact of lacking enforcement on making use flexibilities and analyzes the reasons behind of the phenomenon. This chapter also reviews the TRIP-plus provisions that adopted by the domestic legislation, by comparing their implantation and impacts in the US, Japan and other developing countries, it is noted that the TRIPS-plus’ potential dangers to limit the generic entry into market and its necessity of revising the current laws to avoid its reverse impact on access to medicines. The chapter 4 introduces and analyzes other factors, such as the government’s limited financial allocation, inappropriate administrative policies, pharmaceutical companies’ reluctance and the business chains corruption that impeding the access to medicine in China. Those factors are complex while are as severe obstacles on promoting the right to health. As access to medicines is human right, governments have the responsibility to guarantee people can access to medicines especially must prevent the violations from the third parties. In such case, China should take its obligation to fully utilize the flexibilities in order to restrict the overwhelming medical patent protection, by which way to increase the accessibility to medicines. Taking account of the problems within the patent legal framework and other areas, the advices on how to improve the access to medicines in China are presented in the end.