1. 1 Regulating transgenic technology in China: Law, regulation, and public policy Yinliang Liu Dr. of Laws, M.S. (Biology), Associate Professor Vice Director, Institute of IP Law Director, Bio-Law Research Center China University of Political Science and Law 3 December 2007

2. 2 Outline  Administrations of transgenic technologies  Laws and regulations involving agricultural GMOs  Laws and regulations involving medical transgenic technologies  Conclusion

3. 3 I. Administrations of transgenic technologies  Ministry of Science and Technology: policy making, R&D  Ministry of Commerce: GM trade  Ministry of Health: GM food, medicine  Ministry of Agriculture: GM crops  State Forestry Administration: GM trees  State Environmental Protection Administration: biosafety  State Food and Drug Administration: GM food, medicine  State Administration of Quality Supervision, Inspection, and Quarantine: inspection & quarantine of GM products  SIPO/MOA/SFA: IP issues, patent and plant varieties  National Natural Science Foundation: R&D support  CAS, CAAS, CAMS: R&D

4. 4 # Different concepts  Law: promulgated by National People’s Congress or its Standing Committee  Regulation: State Council  (Administrative) rule: ministries  Local regulation: local people’s congress  Local rule: local government  Policy document

5. 5 II. Laws and regulations involving agricultural GMOs

6. 6 Laws and regulations may involve Ag GMOs  Food Hygiene Law (1995)  Forest Law (1998 revised)  Environmental Protection Law (1999)  Marine Environmental Protection Law (2000)  Seed Law (2000)  Patent Law (2000 revised)  Drug Administration Law (2001 revised)  Grassland Law (2002 revised)  Wild Animal Protection Law (2004 revised)  Animal Husbandry Law (2005)  Regulation on Protection of Nature Reserves (1994)  Regulation on Protection of Wild Plants (1997)  Regulation on Protection of New Varieties of Plant (1997)

7. 7 Regulations & rules governs directly Ag GMO  Administrative Measures for Safety of Genetic Engineering (1993, NCST/MOST)  Regulation on Safety Administration of Agricultural GMOs (2001, State Council)  Administrative Measures for Safety Assessment of Agricultural GMOs (2002, MOA)  Administrative Measures for Safety of Imported Agricultural GMOs (2002, MOA)  Administrative Measures for Labelling Agricultural GMOs (2002, MOA)  Administrative Measures for Hygiene of GM Food (2002, MOH)  Administrative Measures for Inspection and Quarantine of GM Products (2004, State Administration of Quality Supervision, Inspection and Quarantine)

8. 8 Definition and scope of Ag GMOs  Those transgenic animals, plants, microbes, whose genomes have been modified by genetic engineering  Their products  The processed products derived directly from them, such as, herbicide, animal medicine, fertilizer, food, feed, or their additives

9. 9 Activities involving Ag GMOs  Manufacture, process, transport, stock, sale. The responsbile parties shall maintain necessary conditions, e.g.,  Manufacturer of GMOs shall: (1) get safety license from MOA; (2) establish files to record information, including the transferred gene and its resource, transgenic method, manufacturing place, flow of the reproductive materials of GMOs; (3) report information to administration regularly; (4) furnish necessary safety control measures during transportation

10. 10 Licenses of Ag GMOs (2002-2005) Plants Animals Microbes Total Experiment 1 4 0 5 Pilot test 305 5 146 456 En. release 147 0 64 211 Production test 143 0 38 181 Safety license 379 0 45 424 - Research and Biosafety Regulation of Agricultural GMOs in China (July 2006)

11. 11 Import of Ag GMOs  Comply essentially with the Biosafety Protocol  GMO could be used: for research, test, production, processing, products  Safety license from MOA  Simplified procedure: first approval, then simplified

12. 12 License of imported Ag GMOs as processing materials  From 2004 - 2006, 36 licenses  Four kinds of GMO: cotton, soybean, corn, rapeseed  Bayer CropScience: 15 licenses, 3 GMOs  Monsanto: 14 licenses, 4 GMOs  Syngenta: 4 licenses, 1 GMO  Du Pont/Dow Agrosciences Cbiilia: 3 licenses, 1 GMO

13. 13 Labeling Ag GMOs  Compulsory label: listed GMOs by MOA, 17 kinds of products belong to 5 varieties of GMOs (soybean, corn, rapeseed, cotton, tomato)  Voluntary label: for GMOs not listed by MOA  Labeling could be one of the followings: (1) “transgenic (organism or product)”; (2) “transgenic (organism) processed product”; (3) “this product is processed from transgenic (organism), but it now does not have any transgenic components”

14. 14  Labels shall be in standard Chinese, marked apparently, fixed to products or their package or by plate  Labels shall be approved before use by administration of agriculture at local level; labels of the imported GMOs shall be approved by MOA  Negative label, i.e., “GM free product”, has not been encouraged or prohibited

15. 15 GM food  GM food includes food or its additives, made of/from GMO or its processed products or the materials derived from them  Must be safe, have nutrient value not less than its non- GMO equivalence  Principle of assessment of GM food: substantially equivalent; case-by-case  All GM food must be labeled: in either “transgenic (organism) food”, or, “made of the transgenic (organism) food”, or, additionally, “persons allergic to (certain) food should be alerted”

16. 16 III. Laws and regulations involving medical transgenic technologies

17. 17 Medical applications of transgenic technologies  GMOs as medicine or vaccine  Recombinant proteins  Gene therapy  Stem cell culture for healthy cell, tissue and organ  Therapy clone  Xenotransplantation  Other medical processes  etc

18. 18 GMOs or GM products as medice or involved in medical processes  Shall register at SFDA and have a license for clinical use  Must comply with the Drug Administration Law and its regulation  Safety and efficacy must be guaranteed --- Administrative Measures for Safety of Genetic Engineering (1993, NCST/MOST)

19. 19 Medical laws  Law on Mother and Infant Healthcare (1994 ）  Law on Blood Donation (1997)  Law on Medical Practioners (1998)  Drug Administration Law (2001 revised)  Law on Prevention and treatment of Occupational Diseases (2001 revised)  Law on Population and Family Planning (2001 revised)  Law on Prevention and Treatment of Infectious Diseases (2004 revised)

20. 20 Medical regulations  Regulation on Administration of Family Planning Technical Services (2001)  Regulation on Treatment of Medical Malpractices (2002)  Regulation on Public Health Emergencies (2003)  Regulation on Prevention and Treatment of HIV/AIDS (2006)  Regulation on Transplantation of Human Organs (2007)

21. 21 Related rules by MOH  Measures on Administration of Assistant Human Reproduction Technique (2001)  Measures on Administration of Human Sperm Banks (2001)  Measures on Administration of Prenatal Diagnosis Technology (2002)  Provisional Measures on Administration of Organ Transplantation Technique in Clinical Application (2006)  Interim Measures on Ethical Review of Biomedical Researches Involving Human Subjects (2007)

22. 22 Technical standards by MOH & SFDA  Key Elements of Quality Control of Clinical Tests Regarding Human Somatic Cell Therapy and Gene Therapy (MOH, 1993)  Administrative Standard for Clinical Tests of Medicine, State Food and Drug Administration (SFDA, 1999)  Principles of Guideline on Application of Clinical Tests of Human Gene Therapy, Annex No.9 to the Measures for Review of New Biological Products (SFDA, 1999)

23. 23  Technical Norms for Assisted Reproductive Technologies (2003)  Basic Criteria and Technical Norms for Human Sperm Banks (2003)  Administrative Norms for Technology of Transplantation of Unrelated Hematopoietic Stem Cells (2006)  Administrative Norms for Technology of Collection of Unrelated Hematopoietic Stem Cells (2006)

24. 24 What the Measures and/or Standards say # e.g., Technical Standard of Assisted Reproductive Technology by MOH demands technicians conducting ART shall:  Obey strictly the population and family planning laws and regulations  Obey strictly the principles of informed consent and informed choice  Respect patients’ right of privacy

25. 25 The following activities prohibited  Sex selection without medical evidences  Nuclear transplantation for treatment of infertility  Mixing human gametes with non-human ones  Transplantation into human of non-human gametes or embryos; and, vice versa  Genetic maneuvers of human gametes, fertilized eggs, or embryos for purpose of reproduction

26. 26 Additionally, prohibited  Combination of gametes with close kinship  Without patients’ informed and voluntary consent, transfering gametes, fertilized eggs or embryos to others or for scientific research  Research on chimera of human & non-human embryos  Human clone  During a same therapeutic period, using gametes and fertilized eggs not from the same man & woman

27. 27 What have and lack  It seems almost every aspect regarding biotechnological manipulations in medicine has been in the rules (administrative measures) or technical standards, which is being ready to protect the right of human subjects and the public welfare  However, it is noticed more contents exist in the technical standards or administrative measures that generally lack legal powers, and fewer contents in the relevant laws and regulations which may prescribe civil or criminal liabilities and damages

28. 28 IV. Conclusion  It is showed China has been following the world actively to ensure both safety (food, medicine, environment/ecology) and benefit of transgenic technologies  Till present, a framework has been established in China for regulating transgenic technologies in both agriculture and medicine  The framework may reflect an approach mixed with elements adopted in EU and USA, respectively  However, it may still lack a harmonized system of laws and regulations for all kinds of GMOs and transgenic activities  Further biotechnology legislation is needed