On 29th June 2010 Taiwan and China, both members of the World Trade Organisation, 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 parties signed the Cross-Strait Agreement on IP Rights Protection. Then on 21st December 2010, based on the trend of cross-strait cooperation started by the ECFA and the Cross-Strait Agreement on IP Rights Protection, the two countries signed the Cross-Strait Medical and Healthcare Cooperation Agreement. In this agreement, Taiwan and China agreed to cooperate in regard to the following:
- Prevention and treatment of infectious diseases.
- Safety management of and research and development (R&D) for pharmaceuticals.
- Traditional Chinese medicine research and exchange and safety management of Chinese crude drugs.
- Emergency aid and treatment.
- Other fields as agreed between the two parties.
Although the SARS outbreak in 2003 facilitated the cross-strait communication of infectious disease prevention and control, and the melamine-contaminated dairy event in 2008 further urged healthcare cooperation between China and Taiwan, the Cross-Strait Medical and Healthcare Cooperation Agreement provides official guidelines for further medical and healthcare cooperation between the two parties for the first time.
In the chapter on safety management of and R&D for pharmaceuticals, the two countries have agreed to conduct exchanges and cooperate in regard to their systems and regulations, specifications, inspection technology and other related matters (eg, non-clinical testing, clinical testing, pre-marketing review, production management and post-marketing management) for pharmaceuticals across the strait. The pharmaceuticals referred to therein include drugs, medical appliances, health food and cosmetics.
In regard to clinical trial cooperation, the two parties have agreed to conduct exchanges and cooperate on their systems and regulations relating to clinical trials, the management of implementation authorities and teams, the protection of subjects’ rights and interests, and approval mechanisms for clinical trial plans and trial results. Cooperation in R&D for clinical trials and pharmaceuticals across the strait shall be actively strengthened in accordance with good clinical practice, with a view towards reducing repetitive trials through the preferential methods of pilot and special projects. Methods shall then be tested to accept the implementation results of the two parties on this basis.
According to data from the Chinese State Food and Drug Administration, the Chinese pharmaceutical market is expected to break into the top five in the world by 2015, and may be one of the top two by 2019. However, the huge delays in the pharmaceutical marketing process in China are seen as a major gap in its bid to improve the quality of healthcare. In contrast, over the past 20 years Taiwan has successfully developed its high-tech industries, mainly focusing on electronic, IT and semiconductor products. Thanks to these positive experiences, R&D for medical devices and the bio-tech industry in Taiwan is believed to have great potential. Furthermore, the ethnic similarities, geographic proximity and common culture shared by the cross-strait parties enable Taiwan to be considered as the natural gateway for collaboration with China. Through the cooperation set out in the Cross-Strait Medical and Healthcare Cooperation Agreement, it is hoped that Taiwan’s pharmaceutical human resources and medical facilities (eg, medical centres and healthcare professionals experienced in clinical trials, particularly early-phase clinical trials) could help to overcome the obstacles that are causing delays to the Chinese pharamceutical marketing process. The huge Chinese population, as a potential pool for later-phase studies, could also facilitate the marketing process for both parties. These advantages will further incentivise foreign businesses looking to enter the Chinese and Taiwanese markets to set up their R&D, production and operation centres.
To achieve these goals, the working groups organised by both parties face major tasks, including the further harmonisation of the regulation of investigational new drug trials, clinical trials and pre-market evaluations of new drugs or medical devices in order to achieve the mutual recognition of clinical trial results, and R&D for new drugs or medical devices. The Cross-Strait Agreement of Medical and Healthcare Cooperation is an important milestone not only for both countries, but also for the global healthcare system in regard to the protection of human health values and rights.