The International Regulation of
Biotechnology
Lecture No. 19
1. Outline
•
Introduction to the international regulation of
biotechnology
–
•
Slides 2-4
Arms Control
–
•
Slides 5-8
Health and Disease Control
–
•
Slides 9-13
Environmental Protection
–
•
Slides 14-15
Trade
–
•
Slides 16-17
Drugs Control
–
•
Slide 18
Social and Ethical Impacts
–
•
Slide 19
Summary
–
Slide 20
2. Complexity of decision whether to export a genetically
engineered bacterium
Is it for
contained
use?
Cartagena Protocol
on Biosafety
Y
Y
Could it threaten
biodiversity?
Is there
potential for
misuse?
N
UN3700
Is it for
deliberate
release into
the
environment?
N
Y
Is it for
use as
food or
feed?
Y
Guidance on Regulations
for the Transport of
Infectious Substances
B
Is it a Category A or B
infectious substance?
A
Does it affect humans;
humans and animals:
animals only; or plants?
N
Humans and
animals
Sea
Rail
Air
Modal regulations should be
read alongside Guidance
Y
What is the
end use?
N
Is it a risk to
national security?
Plants
Land
Is it a risk to health?
UN2814
Y
What mode of
transport will be used?
Mixed
Is it or might it
be pathogenic?
International Health
Regulations
Humans
Animals only
Check importing
country’s regulations
Biological
and Toxin
Weapons
Convention
Y
N
N
Laboratory
Biosafety
Manual
Export a G.E.
bacterium ?
Terrestrial Animal
Health Code
N
Y
Trade restrictions
may be applied
N
Trade restrictions
may be applied
UN2900
International Plant
Protection Convention
Check importing country’s regulations
Technical Barriers to
Trade Agreement
Sanitary and
Phytosanitary
Agreement
Check importing
country’s regulations
3. Issue Areas (i)
In which there is a need for coordinated state
action and significant applications/impacts of
biotechnology
• Arms control:
– The 1925 Geneva Protocol;
– The 1975 Biological and Toxin Weapons Convention;
– The 1997 Chemical Weapons Convention
• Health and disease control
• Environmental protection
4. Issue Areas (ii)
•
•
•
•
Trade
Drugs control
Development, and
Social and ethical impacts of human
genetics
5. Arms Control
• Geneva Protocol for the Prohibition of the Use in
War of Asphyxiating, Poisonous, or Other
Gases, and of Bacteriological Methods of
Warfare
• Biological and Toxin Weapons Convention
• Chemical Weapons Convention
• Convention on the Prohibition of Military or Any
Other Hostile Use of Environmental Modification
Techniques
6. BTWC Article X
“The States Parties to this Convention
undertake to facilitate, and have the right to
participate in, the fullest possible exchange of
equipment, materials and scientific and
technological information for the use of
bacteriological (biological) agents and toxins
for peaceful purposes.”
7. CWC Article XI
• “The provisions of this Convention shall be
implemented in a manner which avoids
hampering the economic or technological
development of States Parties, and
international cooperation in the field of
chemical activities for purposes not
prohibited under this Convention…”
8. BTWC – Scope of Article I
• “The Conference declares that the Convention is
comprehensive in its scope and that all naturally
or artificially created or altered microbial and
other biological agents and toxins, as well as
their components, regardless of their origin and
method of production and whether they affect
humans, animals or plants… are unequivocally
covered by Article 1.”
(6th Review Conference of the Biological and Toxin Weapons
Convention, Final Declaration, 2006)
9. Health and Disease Control
• The types of rules apply in this area:
– Disease control;
– Biosafety and biosecurity;
– Food safety
10. Disease Control
• For human health – the International
Health Regulations
• For animal health – the Terrestrial and
Aquatic Animal Health Codes
• For plant health – the International Plant
Protection Convention
11. Biosafety and Biosecurity
• Laboratory Biosafety Manual
• Guidance on Regulations for theTransport
of Infectious Substances
• Laboratory Biosecurity Guidance
• Provisions within the Manual of Diagnostic
Tests and Vaccines for Terrestrial Animals
and Terrestrial Animal Health Code
12. Biosafety and Biosecurity
“‘Laboratory biosafety’ is the term used to describe
the containment principles, technologies and
practices that are implemented to prevent
unintentional exposure to pathogens and toxins,
or their accidental release.
‘Laboratory biosecurity’ refers to institutional and
personal security measures designed to prevent
the loss, theft, misuse, diversion or intentional
release of pathogens and toxins.”
(Laboratory Biosafety Manual, p.47)
13. Food Safety
• The Codex Principles for the Risk Analysis of
Foods Derived from Modern Biotechnology
• The Codex Guideline for the Conduct of Food
Safety Assessment of Foods Produced Using
Recombinant-DNA Microorganisms
• The Codex Guideline for the Conduct of Food
Safety Assessment of Foods Derived from
Recombinant-DNA Plants
• Codex Guideline for the Conduct of Food Safety
Assessment of Foods Derived from
Recombinant-DNA Animals
14. Environmental Protection
• Convention on Biodiversity
• Cartagena Protocol on Biosafety (to the
Convention on Biodiversity)
“the conservation of biological diversity, the
sustainable use of its components and the fair
and equitable sharing of the benefits arising out
of the utilization of genetic resources”
(Convention on Biodiversity, Article 1 – Objectives)
15. National Implementation of the
Cartagena protocol
• The Protocol needs National
Implementations
– For example, Japan legislated a new Law
Concerning the Conservation and Sustainable
Use of Biological Diversity through
Regulations on the Use of Living Modified
Organisms*, which entered into force in 2004.
16. Trade
(a) Free trade
• Agreement on Technical Barriers to Trade
• Agreement on the Application of Sanitary and
Phytosanitary Measures
(b) Access to genetic resources
• Bonn Guidelines on Access to Genetic
Resources
• International Treaty on Plant Genetic
Resources
17. Intellectual Property Protection
• Agreement on Trade Related Aspects of
Intellectual Property Rights
• Patent Cooperation Treaty
• Patent Law Treaty
• Budapest Treaty on the Deposit of
Microorganisms for the Purpose of Patent
Procedure
• Convention for the Protection of New
Varieties of Plants
18. Drugs Control
(a) Illicit drugs trade
•
•
•
Convention on Narcotic Drugs
Convention on Psychotropic Substances
Convention Against Illicit Traffic in Narcotic
Drugs and Psychotropic Substances
(b) Anti-Doping
•
•
World Anti-Doping Code
International Convention Against Doping in
Sport
19. Social and Ethical Impacts
• Universal Declaration on the Human
Genome and Human Rights
• International Declaration on Human
Genetic Data
• Universal Declaration on Bioethics and
Human Rights
• United Nations Convention on Human
Cloning
20. Summary
• 37 regulations;
• 14 international organisations:
Questions
1. “The international regulations regarding biotechnology developed
largely isolation from each other, at different times for different
purposes”. Discuss.
2. Briefly outline the range of international regulations governing
biotechnology. Discuss one group of regulations, for example
trade or health and disease control, in detail showing how
effective, or not, they are at the present time.
3. Drug control is an essential component of the growth of
international sport in the view of many people. What is your view
and why do you hold that view?
4. Discuss the Cartagena Protocol on Biosafety and its relationship to
the Convention of Biodiversity. How effective do you think the
Protocol will be in coming decades?
References
(Slide 3-5)
University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009].
Available from http://www.brad.ac.uk/acad/sbtwc/gateway/summaries.html
(Slide 6)
The Biological and Toxin Weapons Convention Website. Convention on the
Prohibition of the Development, Production and Stockpiling of
Bacteriological (Biological) and Toxin Weapons and on Their Destruction
[online]. Undated [cited 15 September 2008]. Available from:
http://www.opbw.org/convention/conv.html
(Slide 7)
Convention on the Prohibition of the Development, Production, Stockpiling and
Use of Chemical Weapons and on their Destruction (Chemical Weapons
Convention). Reproduced in the Organization for the Prohibition of the
Chemical Weapons Convention, Available at http://www.opcw.org/chemicalweapons-convention/articles/article-xi-economic-andtechnologicaldevelopment/
(Slide 8)
United Nations (2006) Sixth Review Conference of the Parties to the Convention on
the Prohibition of the Development, Production and Stockpiling of Bacteriological
(Biological) and Toxin Weapons and on their Destruction. Final Declaration,
BWC/CONF.VI/6 [Online]. 8 December [Cited 15 September 2008]. Available
from: http://www.opbw.org/rev_cons/6rc/docs/6/BWC_CONF.VI_6_EN.pdf
(Slide 9)
University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009].
Available from http://www.brad.ac.uk/acad/sbtwc/gateway/summaries.html#health
(Slide 12)
WHO (2004) Laboratory Biosafety Manual. Geneva: World Health Organization. [3rd
Edition]. Available from
http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf
(Slide 14)
University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009].
Available from http://www.brad.ac.uk/acad/sbtwc/gateway/summaries.html#env
(Slide 15)
Minehata, M., and Shinomiya, N. (2009) Biosecurity Education:
Enhancing Ethics, Securing Life and Promoting Science: DualUse Education in Life-Science Degree Courses at Universities
in Japan. Saitama and Bradford: National Defense Medical
College and University of Bradford. Available from
http://www.dual-usebioethics.net/
(Slide 16)
University of Bradford (2009) Genomics Gateway [Last updated 26
March 2009]. Available from
http://www.brad.ac.uk/acad/sbtwc/gateway/summaries.html#tra
de
(Slide 18)
University of Bradford (2009) Genomics Gateway [Last updated 26
March 2009]. Available from
http://www.brad.ac.uk/acad/sbtwc/gateway/summaries.html#dr
ugs
(Slide 19)
University of Bradford (2009) Genomics Gateway [Last
updated 26 March 2009]. Available from
http://www.brad.ac.uk/acad/sbtwc/gateway/summaries.ht
ml#social