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2016 | OriginalPaper | Buchkapitel

4. Stem Cells, Patents and Regulation in China: Inadequacy

verfasst von : Li Jiang

Erschienen in: Regulating Human Embryonic Stem Cell in China

Verlag: Springer Nature Singapore

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Abstract

Despite the bright future of HESC research in conquering incurable diseases, its development faces many legal and ethical challenges. The complexity of HESC research creates most unusual and fraught situations for regulators in China.

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Vorheriges Kapitel The Moral Dilemma of Stem Cell Science and Medicine

Nächstes Kapitel Stem Cells, Patents and Policy in the US: Inefficiency

The Administrative Measure on Clinical stem cell research in China, http://www.moh.gov.cn/qjjys/s3581/201508/28635ef99c5743e294f45e8b29c72309.shtml accessed 8 September 2015.

ibid.

In China, Military hospitals are the mainstream in stem cell therapy. Type stem cell therapy in search engine, hundreds of military hospitals which provide stem cell therapy were listed, including People’s Liberation Amy hospitals, Air Force hospitals and Armed Police Force hospitals. According to a survey made by Dr. Dominique McMahon from university of Toronto, 36 % of all stem cell therapies carried in China are performed by Military hospital. See Qiu R. Z., ‘Behind the Vogue for Stem Cell Therapy: Ethical and Regulatory Issues in Clinical Translation of Stem Cells in China’ (2013) 3 Science and Society 8–25.

The Administrative Measure on Clinical stem cell research in China, http://www.moh.gov.cn/qjjys/s3581/201508/28635ef99c5743e294f45e8b29c72309.shtml accessed September 8 2015.

ibid.

See http://www.takefoto.cn/viewnews-536704.html Accessed September 8 2015.

See http://finance.sina.com.cn/stock/t/20150403/050921879643.shtml Accessed September 8 2015; also see http://www.howbuy.com/news/2015-03-30/3115549.html Accessed September 8 2015.

Stem cell therapy in EU is mainly governed by three Directives: Directive 2001/20/EC, Directive 2003/63/EC and Directive 2004/23/EC. Directive 2001/20/EC, similar to GCP of China, aims to establish a clear, transparent procedure and creating conditions conducive to effective coordination of trials on medical products for human use in the Community.

See Article 2 of Directive 2001/20/EC.

The Guideline for ethical review of biomedical research 2007 in China.

ibid.

Glasner (2005).

EC Regulation No 1394/2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004, [2007] O.J.L324/121.

Pattinson (2005).

Meet the regulations, European Medicines Agency, CAT Secretariat & US Food and Drug Administration, 6 Regenerative Medicine (2011) 90-96, http://wenku.baidu.com/link?url=Pd2ekyiyqTazFZDrHGhRr9b9oax9cgXEDXm2EFIyQrAL1Ak8cLxUEjc4VaI8TANwoQSQO8nI8DkNXID52wAbz-SAj6JSAWj969SoLT8beMO accessed September 8 2015.

ibid.

Supra note 20.

Liao and Zhao (2008).

Qiu et al. (2004).

Doring (2009).

Ninette Amariglio, Abraham Hirshberg, Bernd W Scheithauer, Yoram Cohen, Ron Loewenthal, Luba Trakhtenbrot, Nurit Paz, Maya Koren Michowitz, Dalia Waldman, Leonor Leider Trejo, Amos Toren, Shlomi Constantini and Gldeon Rechavi, ‘Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient’ (2009) PLOS Medicine http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.100002 accessed November 20 2015.

ibid.

Whether stem cell therapy can be used in patients prior to clinical testing? http://www.bioon.com/biology/bioenginering/310200.shtml accessed November 23 2015.

Chen Haidan, ‘stem cell governance in China: from bench to bedside?’ (2009) 28 New Genetic and Society 267–282.

ibid. (some interviews state that since stem cells are there and might bring patients some hope, is it ethical not to treat patients with stem cells when they suffer from incurable diseases and are dying; also some interviews view that controversies raised by experts focus on the fact that there is no strict evidence theoretically, but in my personal view, this is a scientific chauvinism. In reality, they have helped to treat many incurable diseases, but in theory, we can’t disprove it or prove it, there is something science can never solve…we think at least it is good for society and solves people’s real pain.)

ibid.

Chen (2009).

ibid.

The patent law of China, 2008 http://www.gov.cn/flfg/2008-12/28/content_1189755.htm accessed October 10 2015.

ibid.

Achim Roseman, ‘Life without value? Voices of embryo donors for HESC research in China’ (2009) 52 IIAS Newsletter 17 (concluding that equally flawed appears the assumption that due to the high number of abortions carried out in the context of the one-child policy, the value of early forms of human life are generally of low regard among Chinese people.).

Qiu Renzong, ‘The historical, social and philosophical background of Chinese policies regarding HESC research’ presentation at BIONET workshop on bio-ethical governance of stem cell research, October 9-11 2007.

Nie Jing Bao, Behind the Silence: Chinese Voices on Abortion (1st ed., Rowman & Littlefield Publishers 2005) 105.

Liu (2013).

See the Article 9 of the Chinese Civil Law (providing that a citizen shall have the capacity for civil rights from birth to death and shall enjoy civil rights and assume civil obligations in accordance with the law.).

Margaret E Sleeboom Faulkner, ‘National risk signatures and HESC research in Mainland China’ (2010) 12 Health, Risk & Society 1–46 (describing that when in 2001 President Bush announced a moratorium on the federal funding of stem cell research, China as some other countries in Asia (India, Singapore, South Korea, Japan), denied any engagement with the ethics that had informed the decision. In fact, they were ready to jump into the bioethical vacuum it had created. This vacuum was alleged to be a result of western moral scruples about using fertilized human cells, alleged absent in the East.).

Part II Chapter 1 of Guideline for patent examination by the State Intellectual Property Office of China.

Liu (2013).

ibid.

Doring Ole, ‘Chinese researchers promote biomedical regulations: what are the motives of the Biopolitical Daw in China and where are they heading?’ (2004) 14 Kennedy Inst. Ethics Journal 39–42 (commenting that the positivistic principle “if an action is not illegal, by definition, it is legal” does not apply in China. Taking advantage of the fact that policymaking lags behind scientific and economic development, in terms of the entire legal and social infrastructure, amounts to biomedical adventurism.)

Wei Dong, ‘Study on patentability of HESC related inventions’ (2011) East China University of Political Science and law, master thesis.

See Graeme Laurie, supra note 2 at 64.

Lianming Liao and Robert Chunhua Zhao, ‘An overview of stem cell based clinical trials in China’ (2008) 17 Stem Cells & Dev. 613–615. (reporting that at the Fourth Military Medical University of China further used peripher all blood monocytes that had been induced to differentiate into functional hepatocytes in vitro to treat patients with hepatitis B virus (HBV)-related decompensated liver cirrhosis.); see also supra note 861 (reporting that Beike Biotech was set up in Shenzhen, the first special economic zone of China on 18 July 2005. It collaborates with hospitals and treats patients in the hospitals and then shares the resulting profit. Until 2008 Beike cooperated with 13 hospitals; six centers were added in 2008, and five new centers will be initiated in 2009.)

Zhu Huan, ‘Patentability of embryonic stem cells related inventions’ (2008) East China University of Political Science and law, Master’s thesis.

Titel: Stem Cells, Patents and Regulation in China: Inadequacy
verfasst von: Li Jiang
Verlag: Springer Nature Singapore
Buch: Regulating Human Embryonic Stem Cell in China
Print ISBN: 978-981-10-2100-8

Electronic ISBN: 978-981-10-2101-5

Copyright-Jahr: 2016
DOI: https://doi.org/10.1007/978-981-10-2101-5_4

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