The Cross-Strait Medical and Healthcare Cooperation Agreement 

Yulan Kuo, Yi-Ming Hsu 

On June 29, 2010 Taiwan and China, both members of the World Trade Organization, signed the Economic Cooperation Framework Agreement (ECFA). The ECFA is analogous to a free trade agreement but has been used for the special relationship between Taiwan and China. On the same day, both countries signed the Cross-Strait Agreement on IP Rights Protection. Based on the trend of cross-strait cooperation since ECFA and the Cross-Strait Agreement on IP Rights Protection, the Cross-Strait Medical and Healthcare Cooperation Agreement was subsequently signed on Dec. 21, 2010. In this Agreement, Taiwan and China agreed on the cooperation of the following: 

 (1) Prevention and treatment of infectious diseases, 

 (2) Safety management and R&D of pharmaceuticals, 

 (3) Traditional Chinese medicine research and exchange and safety management of  

Chinese crude drugs, 

 (4) Emergency aid and treatment, and 

 (5) Other fields as agreed between the two parties. 

Although the SARS break-out in 2003 facilitated the cross-strait communication of infectious disease prevention and control and the melamine-contaminated diary event in 2008 further urged the health care cooperation between China and Taiwan, the cross-strait Medical and Health Care Cooperation Agreement provides authorized guidelines of further medical and healthcare cooperation between the two parties. 

In the chapter on safety management and R&D of pharmaceuticals, the two parties agreed to conduct exchange and cooperation on their systems and regulations, specifications, inspection technology and other related matters of the non-clinical testing, clinical testing, premarketing review, production management and post-marketing management of the pharmaceuticals across the strait. The pharmaceuticals referred herein include drugs, medical appliance, health food and cosmetics. 

As to the clinical trial cooperation, the two parties agreed to conduct exchanges and cooperate on their systems and regulations relating to clinical trial, the management of implementation authority and team, the protection of subjects�� rights and interests, and the approval mechanism of clinical trial plan and trial results, etc. The cooperation in R&D of clinical trial and pharmaceuticals across the strait shall be actively strengthened in accordance with Good Clinical Practice (GCP) with a view of reducing repetitive trials through the preferential methods of pilot and special projects. Methods shall then be probed to accept the implementation results of the two parties on the foregoing basis. 

According to the data from SFDA, in 2015, the pharmaceutical market in China is expected to grow and become one of the world��s top 5, and may become one of the top 2 markets in the world in 2019. However, the remarkable lags of the marketing process of pharmaceuticals in China are consistently viewed as a major gap of improving healthcare quality. In the past 20 years, Taiwan, on the other hand, has successfully developed high-tech industries, mainly focusing on electronic, information technology and semiconductor products. According to these positive experiences, the establishment of the R&D of medical devices and bio-tech industry in Taiwan is believed to have high potentials as well. Furthermore, the ethnicity similarities, geographic proximity and common culture between the cross-strait countries enable Taiwan to be considered as the natural gateway for collaboration with China. Via the cooperation as arranged in the Cross-Strait Medical and Healthcare Cooperation Agreement, Taiwan��s pharmaceutical human resources and medical facilities, such as the medical centers and healthcare professionals experienced in clinical trials, especially in early-phase clinical trials, hopefully could help solve the current obstacles that are causing the lags of the marketing process of pharmaceuticals in China. The huge populations in China as the potential pools for later-phase studies could also facilitate the marketing process for both parties vice versa. These will further incentivize foreign businesses looking to enter the Chinese market to set up their R&D, production and operation in both countries. 

To achieve these above goals, further harmonization of the regulation of IND, clinical trials, and premarket evaluations of new drugs (or medical devices) in order to achieve the mutual recognition of clinical trials results, the new drugs (or medical devices) research and development will be the major tasks of the working groups organized by both parties. It is now generally expected that the signing of this Cross-Strait Agreement of Medical and Healthcare Cooperation is an important milestone not only for both parties but also for the global healthcare system in regards to the protection of human health value and rights.