Regulating transgenic technology in China: Law, regulation, and public policy

1
Regulating transgenic technology in ChinaLaw,
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
Outline

• Administrations of transgenic technologies
• Laws and regulations involving agricultural GMOs
• Laws and regulations involving medical transgenic
  technologies
• Conclusion

3
I. Administrations of transgenic technologies

• Ministry of Science and Technology policy
  making, RD
• 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 RD support
• CAS, CAAS, CAMS RD

4
Different concepts

• Law promulgated by National Peoples Congress or
  its Standing Committee
• Regulation State Council
• (Administrative) rule ministries
• Local regulation local peoples congress
• Local rule local government
• Policy document

5

• II. Laws and regulations involving agricultural
  GMOs

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
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
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
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
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
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
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
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

• 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
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

• III. Laws and regulations involving medical
  transgenic technologies

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
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
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
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
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
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

• 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
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
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
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
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
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