GENOMICS MONITOR

Issue No. 4

August 2007

Catherine Rhodes

Bradford Disarmament Research Centre
Department of Peace Studies
University of Bradford

GENOMICS MONITOR - ISSUE 4

Aims of the Monitor

• To provide regularly updated information and analysis on developments in the international regulations relevant to the control of the biotechnology revolution.
• To highlight the connections, in applicability to biotechnology, between regulations in the areas of arms control, health and disease control, environmental protection, trade, drugs control, development, and social and ethical impacts of human genetics.
• To raise awareness of the scope and limitations of the current regulation in this area.

Aims of Issue 4

Issue 4 of the Genomics Monitor provides updated information on the status of the regulations applicable to the control of the biotechnology revolution (summaries of the regulations were provided in Issue 1) and reports on relevant interstate and international organisation meetings and initiatives. In this issue there is also an analysis of the role of industry in the international regulation of biotechnology.

Importance of this Area

Current information sources on the international regulation of biotechnology are very limited. Five years ago a website (www.genomics-gateway.net) was established to bring together, in one central location, information on all the international regulations in this area, with links provided to the official texts. A more thorough study of developments in this area is now provided through the Monitor, to inform all those working in this area of current issues and debates and of the status of the regulations. Its value lies in the range of information it provides on the regulations, its emphasis on the interconnections between the regulations, and highlighting of debates that cut across regulatory areas. It will provide a central authoritative source for anyone interested in this area.

Acknowledgements

The development and production of the Monitor is made possible through a grant from the Carnegie Corporation of New York, as part of the work of the Bradford Disarmament Research Centre, based in the Department of Peace Studies at Bradford University. The Department and Centre have a long history of work in this area, producing over the last ten years series of Briefing Papers, Review Conference Papers, Evaluation Papers, and Science and Technology Reports connected to the project on Strengthening the Biological Weapons Convention. Recognising the links between regulation of biotechnology in the arms control area and wider international regulation of biotechnology, work on exploring these connections began five years ago with the development of the Genomics Gateway Website.

Structure of Issue 4

The Issue is divided into three parts: Part I provides information on regulatory developments; Part II covers the role of industry in the international regulation of biotechnology; and Part III provides information on forthcoming events and recent publications. Figures given on numbers of states parties were accurate on 27th July 2007.

PART I - REGULATORY DEVELOPMENTS

1) HIGHLIGHTS

Changes to the numbers of states parties to the regulations are reported in each section (health and disease control; environmental protection; trade; drugs control; and social and ethical impacts of human genetics). There are also reports, within the relevant sections, on:

- 60th World Health Assembly - 75th General Session of the Office International des Epizooties
- 2007 Meeting of the Codex Alimentarius Commission
- Entry into force of the International Health Regulations
- OECD High-Level Forum on Medicines for Neglected and Emerging Infectious Diseases
- Ten Year Strategy on Tackling Diseases of Poverty
- 12th Meeting of the Convention on Biodiversity's Subsidiary Body on Scientific, Technical and Technological Advice
- 11th Session of the Commission on Genetic Resources for Food and Agriculture
- 4th Session of WIPO's Provisional Committee on Proposals Related to a WIPO Development Agenda
- Meeting of the WIPO's Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

Links to the texts of the regulations and the associated international organisations can be found in Issue 1 of Genomics Monitor (http://www.brad.ac.uk/acad/sbtwc/gateway/monitor/genomicsmonitorissue1.pdf) or through the summary pages on Genomics Gateway (http://www.genomics-gateway.net).

Quick Reference Table of the International Regulations Applicable to the Control of the Biotechnology Revolution

REGULATION	INTERNATIONAL ORGANISATION (WHERE APPLICABLE)	NUMBER OF STATES PARTIES (WHERE APPLICABLE)
Arms Control
1925 Geneva Protocol		132
Biological and Toxin Weapons Convention		155
Chemical Weapons Convention	Organisation for the Prohibition of Chemical Weapons	182
Convention on the Prohibition of Military or Any Other Hostile Use of Environmental Modification Techniques		70
Health and Disease Control
International Health Regulations	World Health Organisation	193
Terrestrial Animal Health Code	Office International des Epizooties	OIE has 169 member states
Aquatic Animal Health Code	Office International des Epizooties	OIE has 169 member states
International Plant Protection Convention	Food and Agriculture Organisation	162
Laboratory Biosafety Manual	World Health Organisation	WHO has 193 member states
Laboratory Biosecurity Guidance	World Health Organisation	WHO has 193 member states
Guidance on Regulations for the Safe Transport of Infectious Substances	World Health Organisation	WHO has 193 member states
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals	Office International des Epizooties	OIE has 169 member states
Manual of Diagnostic Tests for Aquatic Animals	Office International des Epizooties	OIE has 169 member states
Principles for the Risk Analysis of Foods Derived from Modern Biotechnology	Codex Alimentarius Commission	CAC has 174 member states plus the European Community
Guideline on Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms	Codex Alimentarius Commission	CAC has 174 member states plus the European Community
Guideline on Food Safety Assessment of Foods Dervied from Recombinant-DNA Plants	Codex Alimentarius Commission	CAC has 174 member states plus the European Community
Environmental Protection
Convention on Biodiversity	Convention on Biodiversity Secretariat	190
Cartagena Protocol on Biosafety	Convention on Biodiversity Secretariat	141
Trade
Sanitary and Phytosanitary Agreement	World Trade Organisation	151
Technical Barriers to Trade Agreement	World Trade Organisation	151
Trade Related Aspects of Intellectual Property Rights Agreement	World Trade Organisation	151
Patent Cooperation Treaty	World Intellectual Property Organisation	137
Patent Law Treaty	World Intellectual Property Organisation	14
Budapest Treaty on the Deposit of Microorganisms for the Purpose of Patent Procedure	World Intellectual Property Organisation	67
Convention on the Protection of New Varieties of Plants	International Union for the Protection of New Varieties of Plants	64
International Treaty on Plant Genetic Resources	Food and Agriculture Organisation	113
Bonn Guidelines on Access to Genetic Resources	Convention on Biodiversity Secretariat
Drugs Control
Single Convention on Narcotic Drugs	International Narcotics Control Board/ Commission on Narcotic Drugs	183
Convention on Psychotropic Substances	International Narcotics Control Board/ Commission on Narcotic Drugs	183
Convention Against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances	International Narcotics Control Board/ Commission on Narcotic Drugs	183
World Anti-Doping Code	World Anti-Doping Association	573 sporting organisations
International Convention Against Doping in Sport	United Nations Educational, Scientific and Cultural Organisation	58
Social and Ethical Impacts of Human Genetics
Universal Declaration on the Human Genome and Human Rights	United Nations Educational, Scientific and Cultural Organisation
International Declaration on Human Genetic Data	United Nations Educational, Scientific and Cultural Organisation
Universal Declaration on Bioethics and Human Rights	United Nations Educational, Scientific and Cultural Organisation
United Nations Declaration on Human Cloning	United Nations General Assembly

2) HEALTH AND DISEASE CONTROL

60th World Health Assembly

The World Health Assembly (WHA) is the governing body of the World Health Organisation (WHO) and is made up of its member states. In her address to the WHA, the WHO's Director-General, Dr. Margaret Chan, noted the international context for public health is: "a landscape of enormous complexity, but with enormous opportunities. It is one of shared threats, collective responsibility, mutual support, and global solidarity." (WHO, 15/05/07)

WHA resolutions of potential interest include:

Resolution WHA60.28, 23rd May 2007 - Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits

This resolution recognised:

• The sovereign right of states over their biological resources;
• That intellectual property rights do/should not prevent protection of public health;
• The importance of sharing specimens and viruses for pandemic risk assessment, vaccine development, updating of diagnostics and tests and surveillance of anti-viral resistance;
• The need for international mechanisms for benefit-sharing;
• The relevance of the Jakarta Declaration on Sharing Avian Influenza Viruses (March 2007); and
• The importance of the WHO's global pandemic influenza action plan.

The resolution urged states to:

• Support WHO's Global Influenza Surveillance Network;
• Support and promote public health research relating to "prevention, detection, diagnosis and management of influenza viral infection" (WHO, 23/05/07);
• Include policies on vaccines within national influenza-pandemic preparedness plans; and
• Strengthen the ability of regulatory authorities to rapidly approve candidate vaccines, including through international collaboration.

And the Resolution requested that the Director-General:

• Identify and propose benefit-sharing mechanisms;
• Establish vaccine stockpiles for pandemic influenza;
• Establish mechanisms and guidelines for fair, equitable, timely and affordable distribution of vaccines during a pandemic;
• Establish an interdisciplinary working group on sharing viruses; and
• "commission an expert report on the patent issues related to influenza virus and its genes" (WHO, 23/05/07).

Resolution WHA 60.30, 24 May 2007 - Public Health, Innovation and Intellectual Property

This Resolution noted that:

"access to medicines, vaccines and diagnostic kits is hampered by, inter alia, inadequate health-care systems, lack of resources and prices that are beyond the reach of many in the developing world." (WHO, 24/05/07).

Member states are urged to support the work of WHO's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property and the Director-General is requested to ensure adequate technical and financial support for the Working Group. The Director-General is also requested to provide technical and policy support to countries on flexibilities within the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) and on the implementation of the related Doha Declaration (on TRIPS and Public Health).

An Annex to Document A60/27 - Report by Secretariat - Public Health, Innovation, and Intellectual Property: Progress Made By the Intergovernmental Working Group, listed areas for early implementation towards a global strategy and plan of action (WHO, 05/04/07). The Resolution also asks the Director-General to provide background documents on key elements of this plan of action.

75th General Session of the Office International des Epizooties (OIE)

The 75th General Session of the OIE's International Committee (its governing body) was held from 20th-25th May 2007. Resolutions adopted at the General Session can be found online at http://www.oie.int/downld/SG/2007/A_RESO_2007_webpub.pdf. Those of potential interest include:

Resolution XIV - Universal Declaration of Animal Welfare

The International Committee of the OIE gave its support to the development of this Declaration which would call "on all countries to acknowledge the importance of animal welfare and, at the same time, recognises the OIE as the established international animal welfare standard-setting body."

Resolutions
XV - Modification of the Composition of the OIE Laboratories Commission
XVI - Modification of the Composition of the OIE Scientific Commission
XVII - Modification of the Composition of the OIE Aquatic Animals Commission

Each resolution committed the OIE to increase the membership of each Commission by one member as of elections in 2009.

Resolution XXVI - Animal Production Food Safety

OIE's Working Group on Animal Production Food Safety intends to produce a draft chapter for the Terrestrial Animal Health Code on animal identification and labelling and the International Committee decided that the Working Group should "give special attention" to this in its 2007 Work Programme.

Resolution XXVII - Adoption of the Sixth Edition of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

The International Committee adopted the new edition of the Terrestrial Manual, it has not yet been published online.

Resolution XXX - Amendments to the Aquatic Animal Health Code

Amendments which were recommended by the Aquatic Animal Health Standards Commission (AAHSC) were accepted by the International Committee with some minor adjustments. The recommended amendments are in AAHSC March 2007 Report, Appendices III-XX of Document 75 SG/12/CS4 B.

Resolution XXXI - Adoption of one draft chapter for the Manual of Diagnostic Tests for Aquatic Animals

The International Committee approved this pending work by the AAHSC on comments received from member states.

Resolution XXXII - Amendments to the OIE Terrestrial Animal Health Code

Amendments that were recommended by the Terrestrial Animal Health Standards Commission (TAHSC) in document 75 SG/12/CSI B were adopted by the International Committee with slight modification.

2007 Meeting of the Codex Alimentarius Commission - Work on low-level presence of not yet authorised recombinant-DNA plant material

The 2007 Meeting of the Codex Alimentarius Commission was held from 2nd -7th July. Among its decisions was the approval of a project, proposed by the Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology, to draft an Annex to the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants on Low-level Presence of Recombinant-DNA Plant Material (Plant Guideline). The annex is intended to cover situations in which:

"the recombinant-DNA plant has already been found to be safe and authorized for commercialization for food by one or more countries through an assessment performed according to the Codex Plant Guideline, but the importing country has not determined its food safety" (CAC, May 2007)

It is not intended to apply where the importing country has refused authorisation of the plant based on its own food safety assessment.

The Annex should identify: relevant sections of the Plant Guideline; information sharing mechanisms to support use of the Annex; and the data need by the importing country. It will not define the 'low-level'; this will be a national decision. It is expected that a draft of the Annex will have been circulated to member states for comment, and be ready for consideration by the Ad Hoc Intergovernmental Task Force at its next meeting (scheduled for the 24th-28th September 2007).

Entry into Force of the International Health Regulations

The 2005 IHR entered into force on 15th June 2007. The following is from a WHO press release of the 14th June:

"The Regulations will help to ensure that outbreaks and other public health emergencies of international concern are detected and investigated more rapidly and that collective international action is taken to support affected States to contain the emergency, save lives and prevent its spread."

OECD High-Level Forum on Medicines for Neglected and Emerging Infectious Diseases

Participants at the Forum, held in Noordwijk-Aan-Zee 20th-21st June 2007, included national officials and representatives of industry, the scientific community, and international and non-governmental organisations.

The Forum called on governments, with the assistance of industry, international and non-governmental organisations:

"to further intensify collaborative efforts and promote coherent policies to improve the availability of and access to medicines, vaccines and diagnostics for neglected and emerging infectious diseases." (OECD, no date given)

The forum produced the Noordwijk Medicines Agenda, a "general agreement…about the problems, goals, and work that needs to be done."

It recognised that:

• There is a socio-economic impact of infectious disease beyond its direct health impacts
• It is in the interest of all countries to tackle infectious disease
• Investment in basic science and research and development (R&D) is important
• There is a developmental need for "Access to affordable essential drugs and availability of the benefits of new technologies…" (OECD, 21/06/07)
• There are existing initiatives within the World Health Organisation, other international bodies and public and private groups
• Many developing countries have a 'research infrastructure deficit'

In regard to innovation several further important points were acknowledged, including:

• "an urgent need for greater policy coherence in health, science, development, trade, finance and industry policies" along with an increase in "policy makers' understanding of the interdependencies of these policy areas." (OECD, 21/06/07)
• The WHO's intergovernmental working group on Publich Health, Innovation and Intellectual Property "presents a unique opportunity to reach international agreement on an integrated framework for accelerating innovation and improving access to medicines in the developing world." (OECD, 21/06/07)
• There is a lack of long-term sustainable financing and R&D incentives and a need for institutional capacity-building for R&D in developing countries.

Under three broad areas for research to focus on the document lists several specific aims. The three areas are:

1. exploring collaborations with the WHO's intergovernmental working group to increase R&D investments and the number of researchers,
2. exploring models that promote R&D, and
3. supporting efforts by developing countries to strengthen their health and R&D systems.

Ten Year Strategy on Tackling Diseases of Poverty

WHO's Special Programme for Training in Tropical Diseases (TDR) was established in 1975 to "support the development of new tools to fight tropical diseases of poverty and to strengthen the research capacity of affected developing countries." (WHO, no date given)

This new strategy from the TDR aims to enhance the role of key stakeholders from developing countries in which tropical diseases are endemic in developing TDR's research programme. The headline for the strategy is: "An effective global research effort on infectious diseases of poverty, in which disease endemic countries play a pivotal role." (WHO, no date given)

The strategy has three core strands:

"to: provide a collaborative framework and information service for research partners; empower scientists from disease endemic countries as research leaders; and support research on neglected priority needs." (WHO, no date given)

And these result in three main strategic functions for TDR:

1. "A major new role as facilitator and knowledge manager to support needs assessment, priority setting, progress analysis and advocacy, and to provide a neutral platform for partners to discuss and harmonize their activities."
2. "Empowerment of researchers and public health professionals from disease endemic countries." Including on leadership-building and using research to inform policy.
3. Research on neglected priority needs including: "product discovery and development", "development and evaluation of intervention in real life settings" and "access to interventions." (WHO, no date given)

Other key points from the strategy include a move from the previous focus on ten neglected diseases to cover all infectious diseases of poverty, an increased regional focus, and stronger links with co-sponsoring agencies - particularly the WHO.

To operationalise the strategy, management and administration will be improved, indicators for monitoring and evaluation of progress will be developed, and resources will be increased with a projected doubling of its current ($50 million) annual budget by 2012.

CHANGES TO THE NUMBER OF STATES PARTIES TO THE HEALTH AND DISEASE CONTROL REGULATIONS:

There are now 162 states parties to the International Plant Protection Convention, and 169 member states of the Office International des Epizooties.

References/Links

CAC, (July 2007), Codex Alimentarius Commission 30th Session - Report - Advanced Version, ALINORM 07/30/REP, ftp://ftp.fao.org/codex/CAC/CAC30/al30REPe_advance_e.pdf. The final version should be available from September 2007.

CAC, (May 2007), List of Proposals for the Elaboration of New Standards and Related Texts (Including Projects Submitted) and for the Discontinuation of Work, ALINORM 07/30/8, ftp://ftp.fao.org/codex/CAC/CAC30/al30_08e.pdf.

OECD, (21/06/07), Noordwijk Medicines Agenda, http://www.oecd.org/dataoecd/62/11/38845838.pdf.

OECD, (no date given), "OECD High Level Forum on Medicines for Neglected and Emerging Diseases: Policy Coherence to Enhance Their Availability", http://www.oecd.org/development/policycoherence/infectiousdiseases.

WHO, (15/05/07), Address by Dr Margaret Chan, Director-General to the Sixtieth World Health Assembly, A60/3, http://www.who.int/gb/ebwha/pdf_files/WHA60/A60_3-en.pdf.

WHO, (05/04/07), Document A60/27 - Report by Secretariat - Public Health, Innovation and Intellectual Property: Progress Made by the Intergovernmental Working Group, http://www.who.int/gb/ebwha/pdf_files/WHA60/A60_27-en.pdf.

WHO, (14/06/07), "International Health Regulations Enter into Force - New Opportunity to Respond to International Public Health Threats", Press Release, http://www.who.int/mediacentre/news/releases/2007/pr31/en/print.html.

WHO, (22/06/07), "New Strategy Adopted on Diseases of Poverty", Press Release, http://www.who.int/mediacentre/news/releases/2007/pr33/en/print.html.

WHO, (23/05/07), Resolution WHA 60.28 - Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits, http://www.who.int/gb/ebwha/pdf_files/WHA60/A60_R28-en.pdf.

WHO, (24/05/07), Resolution WHA 60.30 - Public Health, Innovation and Intellectual Property, http://www.who.int/gb/ebwha/pdf_files/WHA60/A60_R30-en.pdf.

WHO, (no date given), Ten Year Vision and Strategy: Executive Summary, http://www.who.int/tdr/about/strategy/strategy_06_summary.htm.

Full list of documents from the Sixtieth World Health Assembly - http://www.who.int/gb/e/e_wha60.html.

3) ENVIRONMENTAL PROTECTION

Twelfth Meeting of the Convention on Biodiversity's Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA)

The SBSTTA held its Twelfth meeting from 2nd-6th July 2007. It was attended by representatives of 108 countries, the European Community, 16 United Nations bodies, and many other international and non-governmental organisations (CBD Secretariat, 09/07/07). It considered the topic of biofuels for the first time, and this issue had now been put on the agenda of the 9th Conference of the Parties to the Convention on Biodiversity in May 2008.

Eight recommendations were adopted:

• "Application of the ecosystem approach;
• Implementation of the Global Strategy for Plant Conservation;
• Review of the Millennium Ecosystem Assessment;
• Lessons learned from the preparation of the second edition of the Global Biodiversity Outlook;
• Biodiversity and climate change;
• Biodiversity of dry and sub-humid lands;
• Potential impacts of biofuel production on biodiversity;
• Process to elaborate the procedure for the inclusion of emerging issues on the agenda of its meetings." (CBD Secretariat, 09/07/07)

Recommendation XII/7 - Biodiversity and Biofuels Production was adopted by the SBSTTA at its meeting. It asked that states parties be invited to provide information on their experience of the impacts of biofuels on biodiversity, and for the Secretariat to compile additional information from other sources. This information should then be synthesised and submitted to the 9th COP allowing it "To identify options for consideration of this emerging issues in the programmes of work of the Convention." (CBD Secretariat, July 2007)

The Resolution notes beneficial effects that biofuels can have for biodiversity:

"reduction of the consumption of fossil fuels… decrease in land use for agricultural purposes associated with the increase in energy outputs per area… reduced management inputs, an increase in crop diversity, the restoration of degraded lands, a reduction in the application of pesticides and fertilizers, a reduction in water used for irrigation and increased water use efficiency of crops… decreasing land abandonment and decreasing conversion of agricultural land to other uses… increase of the income-base for farmers and forest owners and improvements of employment opportunities in rural areas… reduction of greenhouse-gas emissions…" (CBD Secretariat, July 2007)

And also adverse effects:

"loss, fragmentation and degradation of valuable habitats… their biodiversity components and the loss of ecosystem services… increases in greenhouse gas emissions… competition for land managed for the production of alternative crops.. and competition for the commodity prices potentially leading to food insecurity… increased water consumption, increased application of fertilizers and pesticides, increased water pollution… soil degradation and erosion… uncontrolled cultivation, introduction and spread of genetically modified organisms… uncontrolled introduction and spread of invasive alien species… emissions from burning biomass and potential adverse effects on human health." (CBD Secretariat, July 2007)

From these lists it is obvious that this is a complex issue, but that the way biofuels are produced and used will affect whether they have largely beneficial or largely harmful impacts on biodiversity. The Resolution recognised that there are significant gaps in knowledge about impacts at present and that these need to be addressed.

CHANGES TO THE NUMBER OF STATES PARTIES TO THE ENVIRONMENTAL PROTECTION REGULATIONS:

The Cartagena Protocol now has 141 states parties.

References/Links

CBD Secretariat, (09/07/07), "Communiqué - Subsidiary Body on Scientific, Technical and Technological Advice Concludes its Twelfth Session", Press Release, http://www.cbd.int/doc/press/2007/pr-2007-07-09-sbstta-en.pdf.

CBD Secretariat, (July 2007), Recommendations Adopted by the Twelfth Meeting of the Subsidiary Body on Scientific, Technical and Technological Advice - Advanced Unedited Version, http://www.cbd.int/doc/meetings/sbstta/sbstta-12/official/sbstta-12-xx-en.pdf

4) TRADE

11th Session of the Commission on Genetic Resources for Food and Agriculture (CGRFA)

The CGRFA met from 11th-15th June 2007. Areas of interest from its report include:

• Section III - programme of work on animal genetic resources;
• Section IV - programme of work on plant genetic resources;
• Section V - progress report on the draft code of conduct on biotechnology as it relates to genetic resources for food and agriculture;
• Section VI - sectorial and cross-sectorial matters; and
• Section VII - cooperation with other international organisations

Section III - programme of work on animal genetic resources

Member states welcomed FAO's report on The State of the World's Animal Genetic Resources for Food and Agriculture, and requested that it be printed for the Interlaken International Technical Conference on Animal Genetic Resources to be held in September 2007, and that it generally be made widely available. A text has been put forward for consideration by the Conference as part of the Global Plan of Action for Animal Genetic Resources (Annex 1 of Appendix D to the Report of the 11th Session).

The Global Plan of Action will provide an internationally agreed framework for the conservation and sustainable use of animal genetic resources, which are essential for food security and development. The text produced by CGRFA has a list of 23 strategic priorities within four priority areas:

1. Characterisation, inventory and monitoring of trends and risks;
2. Sustainable use and development;
3. Conservation;
4. Policies, institutions and capacity-building.

A second annex in Appendix D, provided text for an agreement on implementation and financing for the Global Plan of Action. It is recognised that it "will require substantial, long-term strategic investments" in a range of activities, including: national focal points; international networks; assessment; monitoring; progress reports; development and transfer of technologies; coordination among governments, international agencies, and other groups; training and research initiatives; technical assistance; and adequate regulatory support (CGRFA, June 2007).

A third annex in Appendix D provides a draft for an Interlaken Declaration on Animal Genetic Resources. This draft recognises:

• The essential roles and contribution to food security of animal genetic resources;
• Common but differentiated responsibilities;
• Countries' sovereign rights over animal genetic resources;
• The need for immediate action for the sustainable use of animal genetic resources;
• The need to promote technical and financial cooperation;
• The need to protect traditional knowledge and recognise the contribution of indigenous and local communities and farmers to animal genetic resources; and
• "that major gaps and weaknesses exist in national and international capacities to inventory, monitor, characterize, sustainably use, develop and conserve animal genetic resources." (CGRFA, June 2007)

Section IV - programme of work on plant genetic resources

This area is further developed than work on animal genetic resources and a Global Plan of Action for Plant Genetic Resources was adopted in 1996 (it can be found at http://www.fao.org/ag/AGP/AGPS/GpaEN/gpatoc.htm).

Member states suggested that "in order to avoid duplication of efforts… a cooperative mechanism… be established" between the CGRFA and the governing body of the International Treaty on Plant Genetic Resources (ITPGR) (CGRFA, June 2007). The importance of improved information sharing was particularly noted including through adding "crop-specific nutrient composition and consumption data" to existing information systems, and development of the World Information and Early Warning System on Plant Genetic Resources for Food and Agriculture (WIEWS) in connection with the development of the Global Information System on Plant Genetic Resources for Food and Agriculture under ITPGR (CGRFA, June 2007).

Section V - progress report on the draft code of conduct on biotechnology as it relates to genetic resources for food and agriculture

No particular progress on developing the code of conduct was noted, although the importance and urgency of this work was emphasised, particularly in regard to capacity-building. The CGRFA noted work that had taken place on developing guidelines for the protection of the integrity of ex situ collections, particularly through a report on CGIAR centres' policies, and its Global Public Goods 2 Project. The CGRFA also stated its appreciation for the information sharing and policy advice activities of the FAO under its Priority Area for Interdisciplinary Actions on Biotechnology in Food and Agriculture (PAIA - Biotechnology), and asked it to report on relevant activities and experience to its twelfth session.

Section VI - sectorial and cross-sectorial matters

This section included discussion of:

Forest genetic resources;

Recognising their importance for food security, poverty alleviation, and environmental sustainability, but that there is a currently lack of information on their status, and need for their conservation and sustainable use to be urgently addressed.

Aquatic genetic resources;

The importance of aquatic genetic resources for food, agriculture and ecosystem stability was recognised, along with their vulnerability. It recommended that a scoping policy analysis be undertaken, information systems be reviewed and strengthened, and technical guidelines be developed for their conservation and sustainable use. The FAO was recognised as the appropriate body for coordinating this work.

Microorganisms and insects;

It was recognised that genetic resources of microorganisms and insects have not received adequate international attention, but are also important for food security and sustainable agriculture. The need for increased knowledge and understanding was noted and two international initiatives in this area were mentioned: the initiative for the conservation and sustainable use of pollinators; and the initiative for the conservation and sustainable use of soil biodiversity. The Commission will consider microorganisms and insects separately in its multi-year work programme, and the topic will be addressed again at its 14th regular session.

The ecosystem approach; and

It was recognised as important that the ecosystem approach be applied to biodiversity for food and agriculture through the work of the FAO, and that countries should be supported in doing so.

International cross-sectorial policy issues and genetic resources.

Access and benefit sharing will be considered as an early task in the CGRFA's multi-year work programme. The Secretariat has been asked to review developments on intellectual property and genetic resources in all relevant forums. And the CGRFA wants targets and indicators on biodiversity in food and agriculture to be produced in order "to promote policy coherence among international forums." (CGRFA, June 2007)

Section VII - cooperation with other international organisations

Other international organisations mentioned here include the governing body of the International Treaty on Plant Genetic Resources for Food and Agriculture, the Convention on Biodiversity Secretariat, and the World Intellectual Property Organisation.

4th Session of WIPO's Provisional Committee on Proposals Related to a WIPO Development Agenda (PCDA)

The PCDA has been working on proposals for integrating development issues into intellectual property policy which will be submitted to the September 2007 meeting of WIPO's General Assembly. The fourth session of the PCDA was held from 11th-15th July 2007 and was attended by 93 member states and 41 observers. Covering the same topics as the third session (technical assistance and capacity-building; norm-setting, flexibilities, public policy and public domain; technology transfer, information and communication technology, and access to knowledge; assessments, evaluation and impact studies; and institutional matters including mandate and governance) it provided an additional 21 proposals for consideration. (WIPO, 18/06/07) The proposals are listed in an annex to the report of the meeting.

Member states decided not to renew the PCDA's mandate but instead to:

"establish a Committee on Development and Intellectual Property composed of member states and open to the participation of all accredited intergovernmental and non-governmental organisations… to be convened in the first half of 2008…" (WIPO, 18/06/07)

This Committee is expected to: "develop a work programme for implementation of the adopted recommendations"; monitor, assess and report on progress with the work programme; discuss intellectual property and development issues; and report annually to WIPO's General Assembly (WIPO, July 2007).

Meeting of the World Intellectual Property Organisation's Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC)

IGC met from 3rd-12th July 2007. The meeting focused on:

• "fundamental policy challenges… for more effective protection against misuse and misappropriation."
• Review of options including: patent disclosure requirements; the interface between the patent system and genetic resources; and intellectual property aspects of access and benefit-sharing contracts.
• An "update of international developments relevant to the genetic resources agenda." (WIPO, 16/07/07)

The Committee's current mandate expires in December 2007. It has recommended that its mandate be renewed so it can continue its work in this area. This will be subject to a decision of WIPO's General Assembly.

CHANGES TO THE NUMBER OF STATES PARTIES TO THE TRADE REGULATIONS:

There are now 64 states parties to the Convention on the Protection of New Varieties of Plants and 113 states parties to the International Treaty on Plant Genetic Resources. Membership of the World Trade Organisation has increased to 151 states.

References/Links

CGRFA, (June 2007), Report of the Commission for Genetic Resources in Food and Agriculture, 11th Regular Session, ftp://ftp.fao.org/ag/cgrfa/cgrfa11/r11repe.pdf.

WIPO, (16/07/07), "IGC Recommends Mandate Renewal to Continue Negotiations on Core Issues", Press Release, PR/2007/501, http://www.wipo.int/pressroom/en/articles/2007/article_0044.html.

WIPO, (July 2007), Provisional Committee on Proposals Related to a WIPO Development Agenda (PCDA) Fourth Session, http://www.wipo.int/ip-development/en/agenda/pcda07_session4.html.

WIPO, (18/06/07), "WIPO Director-General Welcomes Major Breakthrough Following Agreement on Proposals for a WIPO Development Agenda", Press Release, http://www.wipo.int/pressroom/en/articles/2007/article_0039.html

5) DRUGS CONTROL

CHANGES TO THE NUMBER OF STATES PARTIES TO THE DRUGS CONTROL REGULATIONS:

There are now 58 states parties to the International Convention Against Doping in Sport.

PART II - THE ROLE OF INDUSTRY IN THE INTERNATIONAL REGULATION OF BIOTECHNOLOGY

Introduction:

This section of the Genomics Monitor looks at the role of industry in the international regulation of biotechnology. While international agreements in this area are negotiated by states, they can have a significant impact upon industry particularly where they affect trade. It is not surprising, therefore, that industry, both in terms of individual companies and larger industry organisations, takes an interest in international regulatory processes and attempts to influence them. First, this section looks at industry and international regulation in general, outlining the role of corporations and business associations as actors in international relations, and reviewing some theoretical points about the attitudes of industry to international regulation and some of the methods it can use to influence regulatory processes. The section then moves on to look more specifically at industry and biotechnology regulation, giving some examples of industry influence on regulatory processes in this area, and connecting these examples to the theoretical points.

Industry in International Relations

The role of industry in international relations has received increasing attention since the end of the Cold War as the role of non-state actors generally has been recognised as important1. Many multinational corporations (MNCs) and industry associations are now considered to be significant actors in world affairs. This is largely because of their economic power and their ability, at least to some extent, to operate outside national jurisdiction. In terms of economic power, when comparing GDP2 to revenues3 , in a list of states and MNCs, eleven MNCs appear in the top 50 and 46 in the top 100. Most of these are oil, motor, utility and financial companies, but several companies with major biotech interests are also on Fortune's Global 500 list4 , and in 2005 the ten largest5 ranked above the lowest 65 countries on the World Bank's list6.

Table 1. Revenue ($US million) of the top ten biotech-related companies and comparison states' GDP ($US million)7

Globalised economic relations have encouraged this situation, providing both opportunities and incentives for companies to operate internationally. Some international structures encourage industry to play certain roles in international relations, and it is worth noting that:

"[MNCs are] embedded in an institutional setting and socio-economic and political context of both a material and non-material nature and thus not entirely autonomous players." 8

 

Industry and International Regulation

The term international regulation is used here to cover public international law in both its hard and soft forms - that is legally-binding treaties and voluntary standards, guidelines, codes and declarations. This regulation is agreed between states to govern their relations, and is open to all states to agree to.

MNCs are not party to these agreements, but they are affected by them and can play influential roles in their development and implementation. This influence is sometimes controversial, but their interest is understandable - international regulations across a variety of sectors significantly impact their trade and investment opportunities, creating costs and benefits. The impacts that regulation has will vary between companies, but there are frequently common interests involved and common responses formulated.

Often, the interests of MNCs and states will coincide, particularly for those states in which many MNCs are based, e.g. the US, Japan, and the UK, and governments will often encourage industry involvement in the development of regulation.

The Influence of Industry on International Regulation

Methods

Industry actors have the potential to influence international regulation through activities at national, regional, and international levels, and have a variety of options available to pursue. Activities may target decision-makers directly, e.g. through lobbying of government departments or negotiating teams, or through more indirect routes, such as influencing public opinion. Interventions may be made while a national negotiating position is being formulated, during interstate negotiation of an agreement, during implementation (influencing national legislation and enforcement mechanisms), and at subsequent intergovernmental meetings that oversee the agreement.

These activities may be undertaken by individual companies acting independently, but companies often find it more efficient and effective, particularly in regard to international regulatory processes, to be represented by an industry association or coalition. In the biotech and pharmaceutical sectors there are many national, regional and international associations, both permanent and ad hoc, that take on this role.

Methods of influence include:

• Providing information and advice to governments and negotiating teams
• Explaining industry standpoints through media
• Agenda-setting
• Shaping the public discourse and framing the issue
• Funding of think tanks, and public education and outreach bodies
• Participating in policy advisory committees, and
• Participating in government consultations.

A paper by Clapp and Fuchs9 examined different types of power used by MNCs and they identified three main types:

1. Instrumental

Based on material resources at the company's disposal, this is used for direct political influence on decision makers, e.g. lobbying.

2. Structural

Based on the economic position of companies in society this form of power can be used for agenda-setting, it can also involve the ability to form networks of private governance.

3. Discursive

Based on public perceptions of the status, legitimacy, authority, and expertise of the company in a particular area and gives the ability to frame policy issues and link them to particular norms and values.

Motivations

Industry motivations for influencing international regulation are mainly economic and concern issues such as competitiveness, profitability, and costs. Industry is not necessarily hostile to international regulation, but is generally wary of rules that may constrain its activities. Perceptions of interests, costs and benefits will vary with different regulations (even within regulatory areas) and so industry does not respond uniformly to all types and areas of regulation.

A 2003 article by Levy and Prakash10 provides an explanation of different responses MNCs may have to international regulation. Their argument is based on there being four main types of international regulatory regime11 :

• Market enabling - domestic

Where the implementing authority is at the national level and provisions "tend to reduce transaction costs and provide collective goods to MNCs".12

• Market enabling - supranational

Where the implementing authority is at the international level and transaction costs are reduced.

• Regulatory - domestic

Where the implementing authority is at the national level and the provisions tend to constrain activities.

• Regulatory - supranational

Where the implementing authority is at the international level and the provisions constrain activities.

Levy and Prakash found that generally MNCs will favour market enabling regimes with domestic authority (where they may be more influential), but that this is not always the case and it is necessary:

"to examine MNCs perceptions of their relative influence versus other actors across governance areas as well as the competitive implications of specific regimes."13

So a market enabling regime may be disliked because it could open the market to competitors; supranational authority may be preferred because it diminishes the options for states in regulating a certain area14 ; and a constraining regime may be preferred because it can reduce the costs of complying with unharmonised regulation.

The Biotech Industry and International Regulation

Biotechnology globally is dominated by the private sector and it is subject to a range of national, regional and international regulations. It is not surprising therefore that the biotech industry should take an interest in this regulation and seek to influence it. For regulatory influence companies in this area frequently organise through industry associations such as the Biotechnology Industry Organisation (BIO), BioIndustry Association (BIA), Pharmaceutical Research and Manufacturers of America (PhRMA), EuropaBio, and BioteCanada. The following are quotes from some of the major biotech and pharmaceutical industry organisations, which provide insight into their roles and methods of influence:

"We are actively engaged in dialogue with the European institutions and contribute to the creation of a coherent legislation for bioindustries. EuropaBio ensures a steady flow of information about biotechnology to the European Parliament, the European Commission and the Council of Ministers." 15

"AusBiotech will achieve its mission by advancing the interest of members through developing and contributing to policy development and implementation, advocacy, networking, advice, education, support services and international outreach." 16

"A constant theme of the BIA's work [is] identifying legislation which has the potential to stifle innovation and to help steer it to help innovate instead."17

"We operate an active public affairs programme, a well-developed conference and seminar programme, trade missions, regular publications for internal and external audiences plus a series of committees whose interests range from regulatory affairs and intellectual property to personnel and finance and taxation." 18

"PhRMA's mission is winning advocacy for public policies that encourage the discovery of life-saving and life enhancing new medicines for patients by pharmaceutical/biotechnology research companies.
To accomplish this mission, PhRMA is dedicated to achieving in Washington D.C., the states and the world: 1. Broad patient access to safe and effective medicines through a free market, without price controls; 2. Strong intellectual property incentives, and; 3. Transparent, efficient regulation and free flow of information to patients." 19

While industry will be interested to some extent in all areas of international biotechnology regulation, it has demonstrated particular interest in the areas of arms control, trade and intellectual property rights, health and food safety, and environmental protection. Some examples of industry activities and influence in these areas are presented below, along with discussion of where these match up with some of the theoretical ideas just outlined.

Industry and the Biological Weapons Convention Verification Protocol

States parties to the Biological Weapons Convention (BWC) began to examine possible verification measures to strengthen the Convention in 1991. By 2001 an Ad Hoc Group established by the states parties had reached the final stages of drafting a verification protocol20 but at this point US support for the protocol was withdrawn and the protocol negotiations ended without agreement. The US pharmaceutical industry is believed to have had some influence in changing the US position on the protocol, although there were other factors at play too.

Commercial interests were specifically referred to in official US statements on its withdrawal from the protocol process, for example:

"the draft Protocol would put national security and confidential business information at risk" 21

"Declarations and investigations… would have revealed trade secrets and sensitive bio-defense information." 22

And this matches closely industry expressions of concern:

"PhRMA concludes that the most probable outcome of a routine inspection at one of its companies would be loss of CBI [confidential business information]…" 23

Industry influence prior to the rejection of the protocol is described in an article by Wright and Wallace24 . It details opposition to intrusive verification measures by the pharmaceutical and biotech industry organised mainly through the industry associations PhRMA and BIO25. Their reasons for opposition included concerns about:

"the loss of CBI [confidential business information], unwarranted damage to the reputation of pharmaceutical companies, and new, onerous and expensive regulations."26

The main routes of industry influence were through lobbying of the US State Department and Department of Commerce, and through participation in panels debating the policy area, such as the Federation of American Scientists Working Group on Biological Weapons27. Industry didn't necessarily oppose the idea of a verification protocol, but they made it very clear to the US and other governments that proprietary information would have to be sufficiently protected, otherwise there would be huge economic costs and industry would be unwilling to cooperate.

The pharmaceutical and biotech industries are particularly strong in the US and there is an understanding by the state of their economic importance. Newell and Glover point out how strong the relationship is between the biotech industry and government:

"The relationship is intensified in the case of biotechnology because the interests of industries coincide strongly with government's own definitions of their national interest, envisaged as generating growth through hi-tech development in the biotech sector… The biotech industry has been able to present itself as a key component of the knowledge economy, invoked as a major driver of growth by both European and North American governments." 28

The industry emphasised its economic value during communications on the Protocol, for example:

"the pharmaceutical industry is one of the few remaining U.S. industries with a positive trade balance that has been maintained for over ten years. We are relying on the U.S. Government to help us maintain this position as the BWC is negotiated."29

Wright and Wallace noted (p.54), accurately as it turned out, that:

"The U.S. biotech industry's desire for protection of industrial secrets appears to be on a collision course with the requirement of a compliance or verification regime for high levels of transparency."

The US Government was willing to listen to the views of industry, not only because of its economic importance, but also because of its knowledge and expertise on the potential impacts of various types of verification regime, and industry saw this as a key role:

"the role of PhRMA and its member companies in the development of an effective protocol is to explain the possibilities and limitations of the technologies in a manner that can best answer the questions of the international negotiators."30

"The pharmaceutical industry and other enterprises around the world that would incur potential costs… need to be given an opportunity to explain the limitations of any proposed measure and encouraged to suggest alternative means of achieving the specified compliance objective."31

The verification protocol does not fit closely to either the market-enabling or regulatory type of regime in its impacts on industry, however, it was clearly perceived as threatening to industry interests because of the potential loss of proprietary information to competitors.

Industry and Trade Rules

Regulation of trade is of obvious and direct relevance to industry and industry has been influential in the development of the rules of the international trade system through the General Agreement on Tariffs and Trade and the World Trade Organisation. Methods of influence include: provision of information and expert advice to government departments and negotiating teams; lobbying at the national and international level; and participation in key policy advisory committees. For example, industry is well represented on the advisory committees of the Office of the US Trade Representative32, and is believed to have a similar level of influence on EU policy33 .

Pharmaceutical and biotech industries have shown particular interest in the area of intellectual property protection. They are considered to have been influential in the achievement of higher international standards for intellectual property protection, and in getting intellectual property onto the global trade agenda in the first place. Industry leaders from US, European and Japanese corporations and lobby groups helped to create a draft that formed the basis of the TRIPS Agreement, and have assisted countries in devising national implementing legislation for the agreement34. These are clear examples of use of expertise to influence the development of regulation.

In regard to the motivations for pharmaceutical and biotechnology companies to influence international regulation on intellectual property protection, it can serve as a market-enabling regime for established companies because it enhances their market opportunities by ensuring intellectual property can be protected in all WTO member states, and it can also act as a barrier to entry to rivals (as established companies are better resourced to take advantage of IPRs), protecting the market position of the dominant corporations. Levy and Prakash35 refer to this as a hybrid regime with features of both market enabling and regulatory types:

"The enforcement of IPRs can represent a form of protectionism for MNCs that constrains competition, though the establishment of property rights also has a market enabling dimension by encouraging investment in new technologies and trade in resultant products."

And they argue that this has happened specifically for the pharmaceutical MNCs with the adoption of TRIPS, which removed the ability of states to bypass pharmaceutical patents (although some limitations on this have subsequently been negotiated), "thereby expanding markets for MNCs at the expense of local pharmaceutical firms"36.

Industry and Food Labelling at the Codex Alimentarius Commission

Industry interest in the activities of the Codex Alimentarius Commission - an international food safety standard setting body - increased after its inclusion in the WTO's Sanitary and Phytosanitary (SPS) Agreement as a legitimate source of international standards compliance with which is considered to be in line with the Agreement37. Thus, their use cannot be challenged as an unjustified barrier to trade.

A study by Smythe38 examined the influence of industry in negotiations over labelling of genetically modified foods in the Codex Alimentarius Commission. She found that industry was well represented at Commission Meetings - where, for example, in 2000 and 2002 70% of observer organisations present were industry based - and also in its Committee on Food Labelling, where in 2006 80% of observer organisations at its meeting represented industry. She also observed that some national delegations included industry representatives at times. A news report about the 1999 meeting picked up on this issue:

"The Canadian delegation includes six government representatives and 13 non-governmental delegates. Industry representatives fill nine of those 13 non-governmental spots. The companies include Nestle Canada, Procter & Gamble, Bestfoods Canada, Monsanto Canada, and trade organizations representing food companies.
The U.S. delegation includes 14 non-government advisers, 10 of whom represent multinational food companies or their trade organizations and consultants who help get the products to market. The companies include Nestle USA, Bestfoods, Procter & Gamble and Mead Johnson and Co."39

The biotech industry has been particularly interested in work in the Codex Committee on Food Labelling on the issue of labelling of genetically modified foods. The Committee began to address this issue in the early 1990s, and work is still ongoing as states are yet to reach a satisfactory compromise40. Debate has generally been split between those favouring comprehensive and mandatory labelling and those wanting minimal labelling requirements applicable only to foods that are substantially different from their conventional counterparts41. The biotech industry has supported the latter position, and as noted above has been represented on the delegations of key states taking that stance.

As well as these more direct attempts to influence national governments and international negotiators, industry has been attempting to frame public discourse on the issue. Industry statements on the subject include:

"Adoption of a mandatory 'biotech labelling' standard not only likely would drive manufacturers and consumers to less safe alternatives, but it would also increase consumer costs."42

"such labels communicate to consumers nothing relevant to health, safety, or nutrition, and indeed serve only to confuse and mislead consumers."43

"The scientific consensus, recognized by Codex, is that foods produced through biotechnology that are compositionally and nutritionally equivalent to conventional counterparts raise no safety or nutritional concerns."44

Motivations for industry interest in this area are due to the potential costs that could be incurred by mandatory compliance with labelling rules, and concern that it sends the message to consumers that such foods are unsafe. Mandatory labelling rules would fit with the regulatory type of regime in Levy and Prakash's analysis by constraining activities, and because the rules would be enforceable under the WTO system, authority would be supranational.

Industry and the Cartagena Biosafety Protocol

The Cartagena Biosafety Protocol is of interest to industry because it has the potential to affect trade in genetically modified organisms (GMOs). The Protocol aims to protect biodiversity from potential damage from deliberate releases of GMOs into the environment, and its main mechanism is a system of advanced informed agreement for imports of GMOs, combined with risk assessments. It drew great interest from industry during its negotiation and industry remains interested in its operational development through decisions of meetings of states parties particularly regarding possible provisions on liability.

Many corporations and industry associations coordinated their position for the negotiations under the umbrella organisation the Global Industry Coalition (GIC). The GIC has attended and made statements at meetings of the states parties and provided information to negotiators. The involvement of industry in these negotiations has been criticised by consumer and environmental groups45, particularly since the majority of the corporations represented are based in the major GM exporting countries which are not party to the Protocol - the US, Canada and Argentina46. Nonetheless, these are the companies that will be most affected by the operation of the Protocol, and so again their interest in influencing regulation is understandable.

GIC press releases during negotiation of the Protocol demonstrate attempts to frame the issue, for example:

"Biotechnology is an important tool for the global economy. It offers solutions to problems such as diseases, food security and environmental degradation. This technology provides benefits for all countries through job creation, economic growth, sustainable agriculture, and international competitiveness."47

The Cartagena Protocol, with its potential to constrain trade in GMOs and create additional costs for companies and where import decisions are made at a national level, can be viewed as a regulatory-domestic regime under Levy and Prakash's model. The same is true of liability provisions that have been proposed by meetings of states parties to the Protocol. The biotech industry is resisting these provisions stating that such a system is unnecessary and would harm developing countries through inhibition of research, development and technology transfer48. However, the Protocol also has market-enabling potential through harmonisation of standards and because "the existence of an accord on this trade serves to 'legitimise' the trade in GMOs, which industry sees as important for gaining public trust in GMOs."49

A study by Clapp makes an interesting comparison between industry response to the creation of the Stockholm Convention on Persistent Organic Pollutants and the Cartagena Protocol, where the same industries took divergent positions - favouring restrictive regulation in the Stockholm Convention and resisting it in the Protocol. The study reached the conclusion that:

"the positions taken make perfect sense in light of economic considerations faced by the industry… Rules embodied in both treaties legitimise and create market opportunities for their higher profile products." 50

With the positions being explained by their being better opportunities for intellectual property protection for GMOs, along with better revenue growth and profitability, than for the agricultural chemicals covered by the Stockholm Convention, which many of the major companies had already moved away from producing.

Conclusion

International companies with biotech interests understandably take an interest in the development of international regulation of biotechnology, and try to influence it to their advantage. There are various options available for influence, and activities can be targeted at a national, regional or international level. Companies frequently choose to coordinate their positions through industry associations, which pool their resources and provide a stronger voice, particularly for activities at the international level.

The biotech and pharmaceutical industries do not object to international regulation per se, but tend to resist rules that have the potential to negatively impact their profitability and competitiveness. The fragmentation of international biotechnology regulations and their different regime purposes and authority structures mean that MNCs will respond differently to the different rules and regimes, supporting some and opposing others. However, if potential economic impacts on businesses are considered, along with regime structure, as suggested by Levy and Prakash, this can provide some insight into how MNCs may respond to developments in the regulation of biotechnology.

Footnotes

1. The study of international relations traditionally focused on states as the only significant actors in the international system, however, while their dominance is still accepted, a number of other actors with the ability to influence international processes are now recognised as important. These include international organisations, non-governmental organisations, multinational corporations, expert groups, and other transnational political, religious and cultural groups.
2. 2005 figures from World Bank, 23rd April 2007.
3. 2005 figures from Fortune, 5th July 2005.
4. Fortune, 5th July 2005.
5. Pfizer, Johnson & Johnson, BASF, Dow Chemical, GlaxoSmithKline, Bayer, Novartis, DuPont, Roche Group, and Merck.
6. World Bank, 23rd April 2007.
7. World Bank, 23rd April 2007; Fortune, 5th July 2005.
8. Clapp & Fuchs, 2007.
9. Clapp & Fuchs, 2007.
10. Levy & Prakash, August 2003.
11. International regimes have been defined as “persistent and connected sets of rules and practices that prescribe behavioural roles, constrain activity, and shape expectations.”, Haas, quoted in Levy and Prakash, August 2003, p.133.
12. Levy & Prakash, August 2003, p.134.
13. Levy & Prakash, August 2003, p.134.
14. Lake, quoted in Levy and Prakash (August 2003, pp.134-135) gives the WTO as an example of a regime in which “governments are constrained from exercising sovereign powers but no higher authorities are created – in each case further widening the private sphere.”
15. EuropaBio, no date given.
16. AusBiotech, 2nd July 2007.
17. BioIndustry Association, no date given 2.
18. BioIndustry Association, no date given 1.
19. PhRMA, no date given.
20. This can be seen for example in a report of the Ad Hoc Group, 18th May 2001.
21. Mahley, July 25, 2001.
22. Bolton, 26th August 2002.
23. Woollett, January 1998.
24. Wright and Wallace, 2000.
25. Wright and Wallace, 2000, p.53.
26. Woollett, January 1998.
27. See for example, FAS Working Group on Biological Weapons, February 1998.
28. Newell and Glover, July 2003, p.12.
29. Quoted from a 12th June 1996 letter from the President of PhRMA to the Secretary of Commerce, p.53 in Wright and Wallace, 2000.
30. Woollett, January 1998.
31. Woollett, January 1998.
32. 93% of members of the Trade Representative’s 26 expert committees represent corporations or business associations (ActionAid, 2006, pp.15-16).
33. ActionAid, 2006, pp.16-20.
34. ActionAid, 2006, p.26.
35. August 2003, p.136.
36. Levy and Prakash, August 2003, p.136.
37. SPS Agreement – Article 3 – Harmonization
    “2. Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, anima or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.”
    SPS Agreement – Annex 1 – Definitions
    “3. International standards, guidelines and recommendations
    (a) for food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission.”
    (WTO, 1995).
38. Smythe, 2007.
39. Eggerton, 28th April 1999.
40. For a brief description of work done so far, see for example, International Centre for Trade and Sustainable Development, 19th May 2004.
41. Smythe, 2007.
42. American Soybean Association, 9th March 2001.
43. BIO, no date given 1.
44. BIO, no date given 2.
45. See for example, Mayet, July 2006.
46. Argentina and Canada were both early signatories to the Protocol but have not yet ratified it; the US hasn’t ratified the Convention on Biodiversity (the Protocol’s parent treaty) and so cannot sign or ratify the Protocol.
47. GIC, 20th September 1999.
48. CropLife International, 1 March 2005.
49. Clapp, Winter 2003, p.8.
50. Clapp, Winter 2003, p.19.

References

ActionAid, (2006), Under the Influence: Exposing Undue Corporate Influence Over Policy-Makers at the World Trade Organisation, http://www.actionaid.org.uk/doc_lib/174_6_under_the_influence_final.pdf.

Ad Hoc Group of the States Parties to the BWC, (18th May 2001), BWC/Ad Hoc Group/56-1, Procedural Report of the Ad Hoc Group of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, 23rd Session, http://www.brad.ac.uk/acad/sbtwc/ahg56/doc56-1.pdf.

American Soybean Association, (9th March 2001), "A Codex standard mandating 'GMO labelling' of food products containing genetically modified ingredients would decrease global food safety", Press Release, http://www.asajapan.org/english/others/bio/01.html.

AusBiotech, (last edited 2nd July 2007), Mission, http://www.ausbiotech.org/content.asp?pageid=3.

BIO, (no date given 1) "Labelling guidelines for foods containing ingredients derived from biotechnology", http://bio.org/foodag/positions/labeling.asp.

BIO, (no date given 2), Backgrounder - Codex Alimentarius, http://bio.org/foodag/background/codex.asp.

BioIndustry Association, (no date given, 1), About Us, http://www.bioindustry.org/cgi-bin/contents_view.pl?LEVEL1=1.

BioIndustry Association, (no date given, 2), Public Affairs, http://www.bioindustry.org/cgi-bin/contents_view.pl?SITE_ID=34&ID=68.

Bolton, John R., Under Secretary for Arms Control and International Security, (26th August 2002), "The US Position on the Biological Weapons Convention: Combating the BW Threat", Tokyo, http://www.state.gov/t/us/rm/13090.htm.

Clapp, Jennifer, (Winter 2003), "Transnational Corporate Interests and Global Environmental Governance: Negotiating Rules for Agricultural Biotechnology and Chemicals", pp. 1-23 in Environmental Politics, Vol. 12(4).

Clapp, Jennifer and Fuchs, Doris, (2007), "Agro-Food Corporations, Global Governance and Sustainability: A Framework for Analysis", paper presented at ISA 2007 Conference, Chicago, available through http://archive.allacademic.com/one/isa/isa07/index.php?cmd=isa07

CropLife International, (1 March 2005), "Cartagena Protocol on Biosafety: Liability and Redress - The Need for Analysis of Existing Law and National Capacity-Building", Press Release, http://www.asa.org.ar/pdf/ingles/Protocolo.Posici%C3%B3nGICResponsibilidadyCompensaci%C3%B3n.pdf.

Eggerton Laura, (28th April 1999), for the Toronto Star, "Giant Food Companies Control Standards: Critics", http://home.intekom.com/tm_info/rw90506.htm#01.

EuropaBio, (no date given), About Europabio, http://www.europabio.org/eu_index.htm.

FAS Working Group on Biological Weapons with industry co-authors, (February 1998), "Perspectives on BWC Compliance Regime Issues Affecting Industry" FAS Working Papers, http://www.fas.org/bwc/papers/perspectives.html.

Fortune, (5th July 2005), "Fortune's Global 500", Fortune, http://money.cnn.com/magazines/fortune/global500/2005/index.html

GIC, (20th September 1999), "Global Industry Coalition Reaffirms its Support of a Successful Biosafety Protocol", News Release through PR Newswire, http://www.prnewswire.co.uk/cgi/news/release?id=14244.

International Centre for Trade and Sustainable Development, (19th May 2004), "Codex discussion on biotech labelling survives challenge" in Bridges Trade BioRes, Vol. 6(9), http://www.ictsd.org/biores/06-05-19/story3.htm

Levy, David and Prakash, Aseem, (August 2003), "Bargains Old and New: Multinational Corporations in Global Governance", pp. 131-150 in Business and Politics, Vol. 5(2).

Mahley, Donald, Ambassador, US Special Negotiator for Chemical and Biological Arms Control Issues, (25th July 2001), "Statement by the United States to the Ad Hoc Group of Biological Weapons Convention States Parties", Geneva, http://www.state.gov/t/ac/rls/rm/2001/5497.htm.

Mayet, Mariam, (July 2006), for the African Centre for Biosafety, Article 18(2)(a): The Trojan Horse of the Biosafety Protocol, http://biosafetyafrica.net/portal/index.php?option=com_content&taks=view&id=42&Itemid=34.

Newell, Mike and Glover, Dominic, (July 2003), Business and Biotechnology: Regulation and the Politics of Influence, IDS Working Paper 192, Institute of Development Studies, Brighton

PhRMA (Pharmaceutical Research and Manufacturers of America), (no date given), Mission Statement, http://www.phrma.org/about_phrma/mission_statement/mission_statement/.

Smythe, Elizabeth, (2007), "In whose interests? Transparency and Accountability in the Global Governance of Food: Agri-business, the Codex Alimentarius and the World Trade Organisation", presented at the ISA 2007 Conference, Chicago, available through http://archive.allacademic.com/one/isa/isa07/index.php?cmd=isa07.

Woollett, Gillian, R., (January 1998) "Industry's Role, Concerns, and Interests in the Negotiation of a BWC Compliance Protocol", chapter in Biological Weapons Proliferation: Reasons for Concern, Courses of Action, Report 24 of the Biological and Chemical Weapons Research Program, Henry L. Stimson Center, http://www.stimson.org/cbw/pdf/report24_woollett.PDF.

World Bank, (23rd April 2007), "Total GDP 2005", from World Bank Development Indicators Database, http://siteresources.worldbank.org/DATASTATISTICS/Resources/GDP.pdf.

World Trade Organisation, (1995), Sanitary and Phytosanitary Agreement, http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm.

Wright, Susan and Wallace, David, (2000), "Varieties of Secrets and Secret Varieties: The Case of Biotechnology", pp.45-54 in Politics and the Life Sciences, Vol. 19(1).

PART III - EVENTS AND RECENT PUBLICATIONS

Arms Control

Annual Biological Weapons Convention 2007 Meeting to discuss and promote understanding of:
(i) ways and means to enhance national implementation, including enforcement of national legislation, strengthening of national institutions and coordination among national law enforcement institutions.
(ii) Regional and sub-regional cooperation on implementation of the Convention.
Meeting of Experts - 20th-24th August 2007, Geneva
Meeting of States Parties - 10th-14th December 2007, Geneva
See: http://www.unog.ch/80256EE600585943/(httpPages)/F7C77C704B89856AC12572BC003225AC?OpenDocument.

OPCW Academic Forum, 18th-19th September 2007, http://www.opcw.org/docs/snotes/2007/s-649-2007.pdf.

OPCW, Industry and Protection Forum, 1st-2nd November 2007, The Hague.

OPCW, (27th June 2007), Draft Report of the OPCW on the Implementation of the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and On Their Destruction in 2006, EC-49/4, C-12/CRP.1, http://www.opcw.org/docs/csp/csp12/en/ec4904.c12crp01(e).pdf.

OPCW, (June 2007), Chemical Disarmament Quarterly, Vol. 5(2), http://www.opcw.org/docs/publications/cdq_jun2007.pdf.

Health and Disease Control

Conference - Novel Vaccines: Bridging Research, Development and Production, 22nd-24th August 2007, Cambridge, Mass., http://www.healthtech.com/2007/vac.

Meeting of the OIE's Terrestrial Animal Health Standards Commission, 17th-28th September 2007, http://www.oie.int/TAHSC/eng/en_tahsc.htm.

Meeting of the Codex Ad Hoc Intergovernmental Task Force on Food Derived from Biotechnology (7th session), Chiba, Japan, 24th-28th September 2007.

OIE, International Symposium on Animal Genomics and Animal Health, 23rd-25th October 2007, Paris, http://www.oie.int/downld/ANNOUNCEMENT_MEETING/Paris%20Symposium.pdf.

Meeting of the Ad Hoc Codex Intergovernmental Task Force on Antimicrobial Resistance, Seoul, 23rd-26th October 2007.

8th OIE/ World Association of Veterinary Laboratory Diagnosticians Seminar - Applications of Biotechnology to the Diagnosis and Pathology of Animal Diseases, Melbourne, Australia, 13th November 2007, http://www.wavld2007.com.

IPPC, (23rd May 2007), Independent Evaluation of the Workings of the International Plant Protection Convention and its Institutional Arrangements, https://www.ippc.int/servlet/BinaryDownloaderServlet/184229_IPPC_Evaluation_Repo.doc?filename=1180006371650_1_IPPC_Final_Evaluation_Report.doc&refID=184229.

IPPC, (28th June 2007, updated 12th July 2007), Response of the Commission on Phytosanitary Measures to the Recommendations of the IPPC External Evaluation Report, https://www.ippc.int/servlet/BinaryDownloaderServlet/185798_response_to_evaluati.doc?filename=1184252885373_CPM_response_to_the_IPPC_evalu1822367661.doc&refID=185798.

WHO, World Health Report 2007, with the theme of promoting international health security, due August 2007.

Environmental Protection

CBD, Ad Hoc Technical Expert Group on Technology Transfer and Scientific and Technological Cooperation, Geneva, 10th-12th September 2007.

Workshop - Biosafety of GM Crops and the Evolution of Regulatory Frameworks: Issues and Challenges, International Centre for Genetic Engineering and Biotechnology and the National Biosecurity Association of Brazil, Belo Horizonte, Brazil, 24th-28th September 2007, http://www.anbio.org.

CBD, 5th Meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing, Montreal, 8th-12th October 2007, http://www.cbd.int/doc/meeting.aspx?mtg=ABSWG-05.

Practical Course - Evaluation of Risk Assessment Dossiers for the Deliberate Release of GM Crops, International Centre for Genetic Engineering and Biotechnology, Biosafety Outstation, 8th -12th October 2007.

CBD, 5th Meeting of the Ad Hoc Open-Ended Working Group on Article 8(j) and Related Provisions [traditional knowledge, innovations and practices], Montreal, 15th-19th October 2007, http://www.cbd.int/doc/meeting.aspz?mtg=WG8J-05.

5th Trondheim Conference on Biological Diversity, "Ecosystems and People - Biodiversity for Development", United Nations Environment Programme and the Norwegian Government, Trondheim, Norway, 29th October-2nd November 2007, http://www.dirnat.no/content.ap?thisId=500025295&language=0.

Trade

FAO, International Technical Conference on Animal Genetic Resources, 3rd-7th September 2007, Interlaken, Switzerland.

UPOV, UPOV Distance Learning Course, DL-205: Introduction to the UPOV System of Plant Variety Protection Under the UPOV Convention,10th September-14th October 2007, http://www.upov.int/en/about/training.html.

WTO, WTO Public Forum 2007, "How Can the WTO Help Harness Globalization?", 4th-5th October 2007.

Sixth Latin American and Caribbean Meeting on Agricultural Biotechnology, REDBIO/FAO, Viña del Mary Valparoiso, Chile, 22nd-26th October 2007, http://www.redbio2007chile.cl.

2nd Session of the International Treaty on Plant Genetic Resources Governing Body, 26th October-2nd November 2007, Rome.

WIPO, June 2007 Issue of WIPO Magazine, including an article "IP Rights and Economic Development: A Historical Perspective", by Professor Zorina Khan, http://www.wipo.int/wipo_magazine/en.

WTO Annual Report 2007, available through http://www.wto.org/english/res_e/reser_e/annual_report_e.htm

Drugs Control

WADA, Third World Conference on Doping in Sport, 15th-17th November 2007, http://www.wadamadrid2007.com.

UNODC, World Drug Report 2007, http://www.unodc.org/pdf/research/wdr07/WDR_2007.pdf.