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

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).

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): 1117–1126.

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).

(The 12th Five-Year National Development Plan of Strategic Emerging Industries), The State Council of the People's Republic of China, available at <http://www.gov.cn/zwgk/2012–07/20/content_2187770.htm> (last visited November 12, 2015).

Fan J. Zhang J. , “Shanghai Biobank Network (SBN),” Biopreservation and Biobanking 9, no. 2 (2011): 133.

Chu J. Huang W. Kuang S. Q. , “Genetic Relationship of Populations in China,” Proceedings of the National Academy of Science 95, no. 20 (1998): 11763–11768.

Zika E. Paci D. Schulte T. , “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).

Jiang C. Thomas G. N. Lam T. H. , “Cohort Profile: The Guangzhou Biobank Cohort Study, a Guangzhou–Hong Kong–Birmingham Collaboration,” International Journal of Epidemiology 35, no. 4 (2006): 844–852.

Chen Z. Lee L. Chen J. , “Cohort profile: The Kadoorie Study of Chronic Disease in China (KSCDC),” International Journal of Epidemiology 34, no. 6 (2005): 1243–1249.

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).

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): 2–3.

Gan R. Wang H. Song Y. , “Chinese Biobanking Initiatives,” Biopreservation and Biobanking 13, no. 1 (2015): 4–7

Id., at 4.

Id., at 5.

McDougall B. S. , “Privacy in Modern China,” History Compass 2, no. 1 (2004): 1–8, at 3.

Yao-Huai L. , “Privacy and Data Privacy Issues in Contemporary China,” Ethics and Information Technology 7, no. 1 (2005): 7–15, at 8.

See McDougall , supra note 16, at 5.

See Yao-Huai , supra note 17, at 8.

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): 125–142, at 128.

Id., at 142.

Chen H. Gottweis H. Starkbaum J. , “Public Perceptions of Biobanks in China: A Focus Group Study,” Biopreservation and Biobanking 11, no. 5 (2013): 267–271.

Zhu S. , “Investigation and Analysis of Genetic Privacy Protection and Genetic Discrimination Prohibition,” Medicine and Philosophy (in Chinese) 34, no. 1A (2013): 34–36.

Zhu G. , “The Right to Privacy: An Emerging Right in Chinese Law,” Statute Law Review 18, no. 3 (1997): 208–214, at 211.

Id., at 212.

(Law of the People's Republic of China on Medical Practitioners), available at <http://www.chinalawedu.com/news/23223/23228/22963.htm> (last visited November 12, 2015).

(Tort Law of the People's Republic of China), available at <http://www.wipo.int/wipolex/zh/text.jsp?file_id=182630> (last visited November 11, 2015).

(Interpretation of the Supreme People's Court on Problems Regarding the Ascertainment of Compensation Liability for Emotional Damages in Civil Torts), (The Supreme People's Court), available at <http://en.pkulaw.cn/display.aspx?cgid=34937&lib=law> (last visited November 12, 2015).

(The National Security Law of the People's Republic of China), (Order of the President of the People's Republic of China), available at <http://en.pkulaw.cn/display.aspx?cgid=250527&lib=law> (last visited November 13, 2015).

(Network Security Law of the People's Republic of China (Draft)) (National People's Congress), available at <http://www.npc.gov.cn/npc/xinwen/lfgz/flca/2015–07/06/content_1940614.htm> (last visited November 13, 2015).

(Criminal Law of the People's Republic of China Amendments) (the Standing Committee of National People's Congress), available at <http://www.npc.gov.cn/npc/xinwen/2015–08/31/content_1945587.htm> (last visited November 12, 2015).

(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].

Id., at Art. 3.

Id., at Art. 4.

Id., at Art. 14.

Id., at Art. 17

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].

(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).

Explanation, supra note 37

(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].

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.

Id., at Art. 2.

Explanation, supra note 39.

In the Draft Ordinance, resource providers () refer to all research participants/subjects who provide genetic resources and their derivative data.

Id., at Art. 14.

Id., at Art. 16.

Id., at Art. 19.

Id., at Art. 38(3).

Id., at Art. 31(4).

Id., at Art. 31(2).

Id., at Art 31(5).

(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).

(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).

Id., at Art. 1.

Id., at Art. 7(2)2.1.

The Ministry of Health and the National Population and Family Planning Commission merged in 2013 to create the NHFPC.

(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).

(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].

Carlson E. Livingston S. , “New Chinese Requirements on Management of Health Information,” Bloomberg BNA: World Data Protection Report 14, no. 7 (2014): 1–3, at 2.

Id., at Art. 1.

Zhao X. Wang P. Tao X. , “Genetic Services and Testing in China,” Journal of Community Genetics 4, no. 3 (2013): 379–390, at 382.

See PHI Measures, supra note 57, at Art. 8.

See Interpretation , supra note 58.

See PHI Measures, supra note 57, at Art. 9.

See Interpretation , supra note 58.

See PHI Measures, supra note 57, at Art. 15.

Id., at Art. 14.

Id., at Art. 16.

Id., at Art. 18.

Id., at Art. 21.

Id., at Art. 6.

Id., at Art. 16.

Id., at Art. 18.

Id., at Art. 10.

(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).

(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).

Holden C. , “Harvard and China Probe Disease Genes,” Science 273, no. 5273 (1996): 315.

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.

Anonymous, “Politics, Ethics and Collaborations,” Nature 410, no. 11 (March 1, 2001): 11.

Wang Y. , Human Population Genetic Research In Developing Countries: The Issue of Group Protection (Oxford: Routledge, 2014): At 163.

See Sung , supra note 79, at 169.

See Draft Ordinance, supra note 40, at Art. 16.

Id., at Art. 38(3).

Normile D. , “China's Sequencing Powerhouse Comes of Age,” Science 335, no. 6068 (2012): 516–519.

See Wang , supra note 20, at 2.

Cheng L. Chuan S. Xian W. , “Chinese Biobanks: Present and Future,” Genetics Research 95, no. 6 (2013): 157–164, at 159.

Zhu S. , “Ethical Management Guidelines for the Shanghai Disease-Based Biobank Network,” Biopreservation and Biobanking 13, no. 1 (2015): 8–12 [Shanghai Guidelines].

Id., at Art. 21.

Id., at Art. 22.

Id., at Art. 23.

Id., at Arts. 26 and 28.

Id., at Art. 27.

Id., at Art. 29.

Id., at Art. 35.

Id., at Art. 37.

Id., at Arts. 11 and 33.

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): 321–338, at 329.