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

Export a G.E. bacterium ?

Is it or might it be pathogenic?

Is it a Category A or B infectious substance?

Does it affect humans; humans and animals: animals only; or plants?

What is the end use?

Could it threaten biodiversity?

Is there potential for misuse?

Is it a risk to health?

Trade restrictions may be applied

Is it a risk to national security?

What mode of transport will be used?

Is it for use as food or feed?

Is it for deliberate release into the environment?

International Health Regulations

Terrestrial Animal Health Code

International Plant Protection Convention

Biological and Toxin Weapons Convention

Cartagena Protocol on Biosafety

Guidance on Regulations for the Transport of Infectious Substances

Laboratory Biosafety Manual

AirSea Rail Land

Sanitary and Phytosanitary Agreement

Technical Barriers to Trade Agreement

Check importing country’s regulations

Mixed

Y

N

N

N

N

N

Y

Y Y

Y

Check importing country’s regulations

N

N

N

Y

Y

Y Humans

Animals only

Plants

Humans and animals UN2814

UN2900

UN3700

B

A

Check importing country’s regulations

Trade restrictions may be applied

Modal regulations should be read alongside Guidance

Is it for contained use?

2. Complexity of decision whether to export a genetically engineered bacterium

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:

Questions1. “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/chemical-weapons-convention/articles/article-xi-economic-andtechnological-development/

(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: Dual-Use 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#trade

(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#drugs

(Slide 19)

University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009]. Available from http://www.brad.ac.uk/acad/sbtwc/gateway/summaries.html#social