Access To Medicines Under TRIPS Framework

Chapter 1 starts from the analysis of how important it would be to discuss the issue of"access to medicines"within the framework of TRIPS. The rules of intellectual property protection on medicines enshrined by TRIPS are made applicable to all the WTO members. Therefore, on one hand, TRIPS deteriorates the access to medicines, specialized in curing the epidemics discussed in this paper, among the developing members. On the other hand, however, TRIPS provides seven provisions in three ties to solve that problem after the gradual recognition of the idea that"the right of public health prevails over the right of intellectual property"and the introduction of the principle of flexibility. Nevertheless, the author points out that the promotion for the access to medicines is a comprehensive project, after a case-by-case analysis the feasibility of provisions provided within the TRIPS framework. The medicines are special products whose accessibility largely relies on the administration from the government and the development in pharmaceutical industry. Therefore, operational effect in reality of TRIPS'provisions is determined by the following: how and to what extent the WTO member incorporates them into its national legal system, and whether the member could properly taking the influence from the administration and pharmaceutical industry into account.Chapter 2 draws a general picture of access to medicines in China. When the epidemic is becoming a problem in China, the situation of access to medicines by the patient is getting worse accordingly. It is mentioned by the author that efforts have been made to incorporate the above mentioned TRIPS mechanism and flexibilities into Chinese legislation, including the introduction of Bolar exception, parallel importation and compulsory licensing towards patented drugs and the duly control over the undisclosed testing data with the aim of promoting the localization on developing and manufacturing of medicines. Nevertheless, China has established a regime with high level of protection for drug inventions beyond the requirements of TRIPS. Meanwhile, Chapter 2 describes policies and administrative structures in favor of the enhancement of access to medicines. Analysis is also made on the capacities of Chinese pharmaceutical industry in R&D and manufacturing and their impact on access to medicines respectively.The similar domestic and international circumstances between China and Brazil on access to medicines are the basis for comparison research in Chapter 3. The comparison demonstrates that though China has edges on market volume and innovative capacity, Brazil has more experiences for China to learn in both legislation and administration which contributes to its success of strengthening the access to HIV/AIDS medicines. The comparative study indicates that the level of current legislation favorable to the access to medicines shall be elevated whilst the relevant content of legislation shall be updated to optimize the use of flexibilities provided by TRIPS. The whole legal system shall be built to better serve the aim of facilitating access to medicines in China as well. Meanwhile, Brazil's experiences further suggest a model with clear-cut division of power to be established within Chinese administration hierarchy. In regard to the international level, Chinese government should be more involved in the stipulating and practising TRIPS rules by fortifying its negotiation capacity through practices.It is pointed out in Chapter 4 that China and the European Community ("EC") have divergent standing point respectively in the needs of safeguard of access to medicines and protection of medicines-related intellectual property rights. Nevertheless, it is among the interests of China to pay special attention to the interests of the pharmaceutical technology exporter and intellectual property rights holder. As such, the comparative study between China and the EC will help to improve the comprehensive project of promoting the access to medicines. The author recommends that China is to take reasonable measures to avoid the trade diversion on medicines under the tiered-pricing provided by the Regulation of the EC when under the privilege of importing medicines with lower price. Furthermore, the paper also show that the legislation of the EC in implementing the TRIPS mechanism on compulsory licensing not only helps to perfect the corresponding regime in China but also enlightening that the safety of medicines shall be guaranteed by the Chinese customs and medicines administration authorities.Chapter 5 makes the conclusion that the comparative study with developing country reminds China how to establish a sound patient-oriented environment for the current stage whilst the comparison with the representative from developed group enlightens China to how to further improve and secure the access system for a long-term. China is taking an active role in implementing the rights and obligations within the TRIPS framework. Accordingly, it is of importance for China to establish a reality-based and need-driven access system optimizing the law in both intellectual property and administration area. Furthernmore, endeavors shall be made to improve the use of TRIPS theories and localization of drug manuafacture and development. Based on those measures, it could be expected that China may achieve to promote its sustainable access to medicines.