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Privacy and Biobanking in China: A Case of Policy in Transition

Published online by Cambridge University Press:  01 January 2021

Extract

With a population of over 1.3 billion, China is the most populous country in the world. It is facing an acute aging population problem, with a projected 440 million residents over age 60 and 101 million over age 80 by 2050. Furthermore, rapid industrialization and urbanization in China have resulted in serious air pollution and associated public health problems, including an increase in respiratory diseases and cancers. These and other demographic trends have generated concerns about the cost of health care and its impact on population health. In recent years, the Chinese government has invested heavily in the fields of translational research and biobanking with the hope that research in both fields can yield effective solutions to improve the public’s health and quality of life. The establishment of national biobanks was identified as a major initiative needed for the biomedical industry in the 12th Five-Year National Development Plan of Strategic Emerging Industries promulgated by the State Council in 2012.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2015

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References

Banister, J. Bloom, D. E. Rosenberg, L., “Population Aging and Economic Growth in China,” Program on the Global Demography of Aging Working Paper Series No. 5 (Cambridge, MA: Harvard Center for Population and Development Studies, 2010).Google Scholar
McMichael, A. J., “The Urban Environment and Health in a World of Increasing Globalization: Issues for Developing Countries,” Bulletin of World Health Organization 78, no. 9 (2000): 11171126.Google Scholar
Marko-Varga, G., “Biobanking as the Central Tool for Translational Medicine,” Clinical and Translational Medicine 2 (2013), available at <http://www.clintransmed.com/content/2/1/4> (last visited November 12, 2015).Google Scholar
Fan, J. Zhang, J., “Shanghai Biobank Network (SBN),” Biopreservation and Biobanking 9, no. 2 (2011): 133.Google Scholar
Chu, J. Huang, W. Kuang, S. Q. et al. , “Genetic Relationship of Populations in China,” Proceedings of the National Academy of Science 95, no. 20 (1998): 1176311768.CrossRefGoogle Scholar
Zika, E. Paci, D. Schulte, T. et al. , “Biobanks in Europe: Prospects for Harmonisation and Networking,” commissioned by the European Commission's Joint Research Center Institute for Prospective Technological Studies (Luxembourg: Publications Office of the European Union, 2010).Google Scholar
Jiang, C. Thomas, G. N. Lam, T. H. et al. , “Cohort Profile: The Guangzhou Biobank Cohort Study, a Guangzhou–Hong Kong–Birmingham Collaboration,” International Journal of Epidemiology 35, no. 4 (2006): 844852.CrossRefGoogle Scholar
Chen, Z. Lee, L. Chen, J. et al. , “Cohort profile: The Kadoorie Study of Chronic Disease in China (KSCDC),” International Journal of Epidemiology 34, no. 6 (2005): 12431249.CrossRefGoogle Scholar
Zhou Xuexun, General Manager of Avantech: Biobanking Solutions, informed one of the authors that some departments run their own biobanks (personal communication, February 13, 2012).Google Scholar
Song, Y. Wang, P. Yu, G. Gan, R., “Turning Point: Biobanking in China and the Future of Translational Research,” Biopreservation and Biobanking 13, no. 1 (2015): 23.Google Scholar
Gan, R. Wang, H. Song, Y. et al. , “Chinese Biobanking Initiatives,” Biopreservation and Biobanking 13, no. 1 (2015): 47CrossRefGoogle Scholar
Id., at 4.Google Scholar
Id., at 5.Google Scholar
McDougall, B. S., “Privacy in Modern China,” History Compass 2, no. 1 (2004): 18, at 3.Google Scholar
Yao-Huai, L., “Privacy and Data Privacy Issues in Contemporary China,” Ethics and Information Technology 7, no. 1 (2005): 715, at 8.CrossRefGoogle Scholar
See McDougall, , supra note 16, at 5.Google Scholar
See Yao-Huai, , supra note 17, at 8.Google Scholar
Wang, C., “Genetic Privacy: A Challenge to Genetic Testing in China,” in Kaaan, T. S. Ho, C. W., eds., Genetic Privacy: An Evaluation of the Ethical and Legal Landscape (London: Imperial College Press, 2013): 125142, at 128.Google Scholar
Id., at 142.Google Scholar
Chen, H. Gottweis, H. Starkbaum, J., “Public Perceptions of Biobanks in China: A Focus Group Study,” Biopreservation and Biobanking 11, no. 5 (2013): 267271.Google Scholar
Zhu, S. et al. , “Investigation and Analysis of Genetic Privacy Protection and Genetic Discrimination Prohibition,” Medicine and Philosophy (in Chinese) 34, no. 1A (2013): 3436.Google Scholar
Zhu, G., “The Right to Privacy: An Emerging Right in Chinese Law,” Statute Law Review 18, no. 3 (1997): 208214, at 211.CrossRefGoogle Scholar
Id., at 212.Google Scholar
(Interim Measures for the Administration of Human Genetic Resources), (Ministry of Science and Technology, and Ministry of Health, PRC), available at <http://www.most.gov.cn/bszn/new/rlyc/wjxz/200512/t20051226_55327.htm> (last visited November 12, 2015) [Interim Measures].+(last+visited+November+12,+2015)+[Interim+Measures].>Google Scholar
Id., at Art. 3.Google Scholar
Id., at Art. 4.Google Scholar
Id., at Art. 14.Google Scholar
Id., at Art. 17Google Scholar
These are some of the issues listed in the Explanation document that accompanied the release of the Draft Ordinance on the Administration of Human Genetic Resources. See (Explanation of the Draft Ordinance on the Administration of Human Genetic Resources), (Legislative Affairs Office of the State Council), available at <http://www.gov.cn/gzdt/2012–10/31/content_2254379.htm> (last visited November 13, 2015) [Explanation].+(last+visited+November+13,+2015)+[Explanation].>Google Scholar
(Decision of the State Council on Establishing Administrative License for the Administrative Examination and Approval Items Really Necessary to be Retained (Order of the State Council No. 412), Effective July 1, 2004, available at <http://www.gov.cn/zwgk/2005–06/20/content_7908.htm> (last visited November 13, 2015).+(last+visited+November+13,+2015).>Google Scholar
Explanation, supra note 37Google Scholar
(Draft Ordinance on the Administration of Human Genetics Resources)), (Ministry of Science and Technology, PRC), available at <http://www.gov.cn/gzdt/att/att/site1/20121031/001e37419a4211fab9e902.doc> (last visited November 13, 2015) [Draft Ordinance].+(last+visited+November+13,+2015)+[Draft+Ordinance].>Google Scholar
Id., at Art. 50. While the Draft Ordinance has not yet been approved as of writing (October 21, 2015), the Interim Measures has already been replaced by Administrative Licensing Service Guide on the Review and Approval of the Collection, Preservation, Trade, and Export of Human Genetic Resources.Google Scholar
Id., at Art. 2.Google Scholar
Explanation, supra note 39.Google Scholar
In the Draft Ordinance, resource providers () refer to all research participants/subjects who provide genetic resources and their derivative data.Google Scholar
Id., at Art. 14.Google Scholar
Id., at Art. 16.Google Scholar
Id., at Art. 19.Google Scholar
Id., at Art. 38(3).Google Scholar
Id., at Art. 31(4).Google Scholar
Id., at Art. 31(2).Google Scholar
Id., at Art 31(5).Google Scholar
(Administrative Licensing Service Guide for the Review and Approval of the Collection, Preservation, Trade, and Export of Human Genetic Resources), which was published by the (Ministry of Science and Technology, PRC) on July 2, 2015, available at <http://www.most.gov.cn/tztg/201507/t20150703_120547.htm> [Service Guide] (last visited November 13, 2015). Implementation of the Service Guide began on October 1, 2015. See <http://www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2015/201509/t20150930_121850.htm> (last visited November 13, 2015).+[Service+Guide]+(last+visited+November+13,+2015).+Implementation+of+the+Service+Guide+began+on+October+1,+2015.+See++(last+visited+November+13,+2015).>Google Scholar
(Notice Concerning the Publication of the Administrative Licensing Service Guide for the Review and Approval of the Collection, Preservation, Trade, and Export of Human Genetic Resources), (Ministry of Science and Technology, PRC), available at <http://www.most.gov.cn/tztg/201507/t20150703_120547htm> (last visited November 13, 2015).+(last+visited+November+13,+2015).>Google Scholar
Id., at Art. 1.Google Scholar
Id., at Art. 7(2)2.1.Google Scholar
The Ministry of Health and the National Population and Family Planning Commission merged in 2013 to create the NHFPC.Google Scholar
(Population Health Information Management Measures (Trial Implementation)), (The National Health and Family Planning Commission, PRC), available at <http://www.nhfpc.gov.cn/guihuaxxs/s10741/201405/783ec8adebc6422bbebdf79db3868d0b.shtml> [PHI Measures] (last visited November 13, 2015).+[PHI+Measures]+(last+visited+November+13,+2015).>Google Scholar
(Interpretation on Population Health Information Management Measures (Trial Implementation)), (The National Health and Family Planning Commission, PRC), English translation available at <http://www.chinadaily.com.cn/m/chinahealth/2014–06/15/content_17588400.htm> (last visited November 13, 2015) [Interpretation].+(last+visited+November+13,+2015)+[Interpretation].>Google Scholar
Carlson, E. Livingston, S., “New Chinese Requirements on Management of Health Information,” Bloomberg BNA: World Data Protection Report 14, no. 7 (2014): 13, at 2.Google Scholar
Id., at Art. 1.Google Scholar
Zhao, X. Wang, P. Tao, X. et al. , “Genetic Services and Testing in China,” Journal of Community Genetics 4, no. 3 (2013): 379390, at 382.Google Scholar
See PHI Measures, supra note 57, at Art. 8.Google Scholar
See Interpretation, , supra note 58.Google Scholar
See PHI Measures, supra note 57, at Art. 9.Google Scholar
See Interpretation, , supra note 58.Google Scholar
See PHI Measures, supra note 57, at Art. 15.Google Scholar
Id., at Art. 14.Google Scholar
Id., at Art. 16.Google Scholar
Id., at Art. 18.Google Scholar
Id., at Art. 21.Google Scholar
Id., at Art. 6.Google Scholar
Id., at Art. 16.Google Scholar
Id., at Art. 18.Google Scholar
Id., at Art. 10.Google Scholar
(Interim Measures on the Ethical Review of Biomedical Research Involving Human Subjects), (Ministry of Health, PRC), available at <http://www.moh.gov.cn/mohbgt/pw10702/200804/18816.shtml> (last visited May 11, 2015).+(last+visited+May+11,+2015).>Google Scholar
(Public Opinion Solicited for the Measures on the Ethical Review of Biomedical Research Involving Human Subjects), (The National Health and Family Committee, PRC), available at <http://www.gov.cn/xinwen/2014–04/30/content_2669345.htm> (last visited November 13, 2015).+(last+visited+November+13,+2015).>Google Scholar
Holden, C., “Harvard and China Probe Disease Genes,” Science 273, no. 5273 (1996): 315.Google Scholar
Sung, W.-C., “Within Borders: Risks and the Development of Biobanking in China,” in Sleeboom-Faulkner, M., ed., Human Genetic Biobanks in Asia: Politics of Trust and Scientific Advancement (Oxford: Routledge, 2008): At 179.Google Scholar
Anonymous, , “Politics, Ethics and Collaborations,” Nature 410, no. 11 (March 1, 2001): 11.Google Scholar
Wang, Y., Human Population Genetic Research In Developing Countries: The Issue of Group Protection (Oxford: Routledge, 2014): At 163.Google Scholar
See Sung, , supra note 79, at 169.Google Scholar
See Draft Ordinance, supra note 40, at Art. 16.Google Scholar
Id., at Art. 38(3).Google Scholar
Normile, D., “China's Sequencing Powerhouse Comes of Age,” Science 335, no. 6068 (2012): 516519.CrossRefGoogle Scholar
See Wang, , supra note 20, at 2.Google Scholar
Cheng, L. Chuan, S. Xian, W. et al. , “Chinese Biobanks: Present and Future,” Genetics Research 95, no. 6 (2013): 157164, at 159.Google Scholar
Zhu, S., “Ethical Management Guidelines for the Shanghai Disease-Based Biobank Network,” Biopreservation and Biobanking 13, no. 1 (2015): 812 [Shanghai Guidelines].CrossRefGoogle Scholar
Id., at Art. 21.Google Scholar
Id., at Art. 22.Google Scholar
Id., at Art. 23.Google Scholar
Id., at Arts. 26 and 28.Google Scholar
Id., at Art. 27.Google Scholar
Id., at Art. 29.Google Scholar
Id., at Art. 35.Google Scholar
Id., at Art. 37.Google Scholar
Id., at Arts. 11 and 33.Google Scholar
During a study conducted with participants in a population-based biobank project in rural China, for instance, Chen observed that many participants did not understand the concept of informed consent and had barely even read the consent form. See Chen, H., “Governing International Biobank Collaboration: A Case Study of China Kadoorie Biobank,” Science, Technology and Society 18, no. 3 (2013): 321338, at 329.CrossRefGoogle Scholar