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asian medicine �0 (�0�5) 3�6–339 brill.com/asme Promoting Chinese Herbal Drugs through Regulatory Globalisation The Case of the Consortium for Globalization of Chinese Medicine Wen-Hua Kuo Institute of Science, Technology, and Society, National Yang-Ming University [email protected] Abstract This study explores the social dynamics in promoting traditional Chinese medicine (TCM) drugs by making them acceptable to biomedical markets. It investigates the Consortium for Globalization of Chinese Medicine (CGCM), an organisation based in Hong Kong in pursuit of advancing TCM, and traces the development of the herbal formula PHY906, a Chinese herbal product intensively discussed at the CGCM that has been tested according to the US Food and Drug Administration’s regulation for approval. Departing from accounts on the organisation’s success that focus either on its scientific approach or its leader Yung-chi Cheng, this paper argues that it was the synergy between the CGCM and the pursuit of approval for PHY906 that contributed to the regulatory globalisation of TCM. In this process, not only organisations like the CGCM are required to streamline efforts for producing globalised TCM; also research- ers are needed who, with cultural commitment, seek for transforming TCM to meet biomedical indications. Keywords Consortium for Globalization of Chinese Medicine (CGCM – traditional Chinese medi- cine (TCM) – regulatory globalisation – reformulation of TCM drugs Regulatory Globalisation of Traditional Chinese Medicine (TCM) and the CGCM In recent years herbal drugs have been used as an alternative form of treatment by those who suffer from illness and discomfort but are not satisfied with the © koninklijke brill nv, leiden, ���6 | doi �0.��63/�5734��8-��Downloaded34�35� from Brill.com09/28/2021 11:31:09AM via free access Promoting Chinese Herbal Drugs Through Regulatory Globalisation 317 biomedical drugs they have received. When the Nobel Prize in Medicine 2015 went to Youyou Tu (屠嗷嗷) for the discovery of the isolated active ingredient of artemisinin (known as qinghaosu 青蒿素) in Artemisia annua that treats malarial symptoms, the therapeutic value of traditional Chinese medicine (TCM) appeared to be both scientifically and culturally valid. Some argued that TCM is as effective as biomedicine and should have made equal contributions to the improvement of health. As a competitor of biomedicine and a living tradition predominately used in East Asian countries, in the past two decades TCM has gained global pop- ularity. As the historian of medicine Charlotte Furth puts it, ‘the medicine we call “Chinese” today emerges as a pluralistic system with global reach involving complex accommodations with local medical cultures and insti- tutions both at home and abroad’.1 Along the same line, anthropologist Mei Zhan further argues that Chinese medicine is ‘otherworldly’; the nuance of the terms ‘Chinese’, ‘traditional’, and ‘medicine’ is re-invented and negotiated as these terms travel to the United States (US), where she observes TCM is used to create a new preventive, mild yet effective healing style for the cosmopolitan middle-class.2 Both Furth and Zhan open up new approaches for understand- ing TCM when it goes global—it transforms from a therapeutic lifestyle shared by the Chinese to products under the global circulation of cure, knowledge, and profits. It was also the attention paid to Youyou Tu and her work that made apparent a subtle gap between the popularity of TCM and the acceptance of TCM drugs as qualified therapeutics. As historian of medicine Marta Hanson assesses Tu’s achievement and the future of TCM, stating that her discovery is nothing but ‘the tip of the iceberg of the extensive and global scientific study of pharmaco- logically active Chinese medicinals’.3 Even so, it does not mean that following the example of qinghaosu, people will trust TCM drugs’ safety and believe in their efficacy. Without an ability to understand both biomedicine and TCM, or in Hanson’s own terms ‘medical bilingualism’, TCM will not be a permanent part of ‘therapeutic interventions in the present’.4 There is even a wider gap between the consumption of TCM herbs and the status they enjoy as legitimate remedies. The increasing demand for non-bio- medical medicine and the global market for plants and plant-derived medici- nal products is 24.4 billion US dollars in 2014 according to a recent evaluation 1 Furth 2011, p. 5. 2 Zhan 2009. 3 Hanson 2015. 4 Ibid. asian medicine 10 (2015) 316–339 Downloaded from Brill.com09/28/2021 11:31:09AM via free access 318 Kuo report.5 Nonetheless, most herbal drugs (plants and phytopharmaceuticals) in reality are not recognised as drugs when being circulated in major markets. Historically, the major regulatory authorities such as the US Food and Drug Administration (FDA) did not consider separately botanical drug products (let alone TCM drugs); rather, the current regulations for drug approval evolved in the 1960s as a response to worldwide drug disasters (notably thalidomide- induced phocomelia). The national regulations started to be harmonised in the 1990s, focusing on the safety, quality, and efficacy of synthetic drugs for the markets of the US, Europe, and Japan.6 Except for some Asian countries, where a dual system of biomedicine and their traditional medicine is in place, other states do not grant TCM the status equal to biomedicine, neither do they regu- late TCM drugs with different standards used for biomedical drugs. Focusing on the regulatory aspect of pharmaceuticals, this paper traces the challenges for the promoters of TCM drugs when attempting to sell these drugs by negotiating the regulations set for their biomedical counterparts. The process, which I call ‘regulatory globalisation’, concerns the rules and regula- tions that facilitate and control the spread of drugs and, in the case of TCM drugs, that may secure its status as legitimate or disqualify them when they travel globally.7 It is not simply a task of science. As medical anthropologist Margaret Lock points out, the epistemic and social nature of medicine, no matter whether it is orthodox or alternative, is ‘an assemblage of knowledge and practices inextricably associated with political expediencies, social inter- est and embedded values’.8 According to this viewpoint, the difference between TCM and biomedi- cine is not to show that the former is as scientific as the latter. Rather, as a ‘latecomer’ in global pharmaceuticals, TCM is expected, if not forced, to pass the regulations that have evolved with the biomedical industry for over 50 years. What is equally significant is the changing identity of these drugs while passing through these regulations. Inspired by Laurent Pordié and Jean-Paul 5 BCC Research 2015. 6 For more discussion on the harmonisation of regulations for drug approval and its impact on East Asia, see Kuo 2009. 7 This paper is based on a multi-year research project on the globalisation of traditional Asian medicines sponsored by Taiwan's Ministry of Science and Technology (project no: NSC 101-2410-H-010-002-MY3). I would like to express my sincere gratitude for funding this research. My gratitude also goes to the organisers of several international conferences and panels in 2013 and 2015 where I presented versions of this paper. I also thank the reviewers and editors of this special double issue for their comments. The author shall take full respon- sibility for the arguments made in this paper. 8 Lock 2010, p. 59. asian medicineDownloaded from 10 Brill.com09/28/2021(2015) 316–339 11:31:09AM via free access Promoting Chinese Herbal Drugs Through Regulatory Globalisation 319 Gaudillière’s notion of the reinvention of ayurvedic medicine as being a poly- herbal ‘reformulation’,9 this paper argues that TCM drugs must be reformu- lated to give them accessibility to the markets of biomedical drugs by targeting the same therapeutic indications. To use the metaphor of tourism, what TCM needs in order to travel globally as drugs is not only a passport named ‘sci- ence’, but they must also apply for ‘visas’ for the countries to which they intend to travel, and they must meet the requirements of regulatory authorities, the ‘custom’s agencies’ of these countries. From the perspective of regulatory globalisation, I became aware of the Consortium for Globalization of Chinese Medicine (CGCM), an international organisation that aims to overcome global and national regulatory barriers for TCM drugs. The CGCM was founded in 2003 by a group of Chinese scholars led by Yung-chi Cheng (鄭永齊),10 a mainland-China born, Taiwan educated, renowned pharmacologist and drug developer who teaches at Yale University. It is certainly not the first organisation that aims to justify TCM drugs’ thera- peutic value. Nonetheless, unlike other groups of this sort, which expand slowly and function with restrictions within East Asia, in just ten years the CGCM has grown into a colossal consortium consisting of more than 130 member institu- tions, many of which are located outside of East Asia, notably in Europe, the US, and Australia. At first glance, the CGCM seems to be an organisation resembling the Chinese Academy of Traditional Chinese Medicine (中医研究院, later renamed the China Academy of Chinese Medical Sciences 中国中医科学院) that backed up Youyou Tu’s investigation. However, if we look at this organisation carefully, one person and one drug stand out consistently whose roles can be perceived as being key to understanding the CGCM. The prominent figure is the char- ismatic founder of the CGCM, Yung-chi Cheng, a self-learned TCM expert. In the era of global pharmaceuticals, his previous achievement in biomedicine and personal connections have helped the CGCM to quickly establish its repu- tation in creating paths needed for TCM drugs to pass these regulations. The drug referred to is PHY906, a Chinese polyherbal drug developed by Yung-chi Cheng’s team at Yale University.

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