Genetic Engineering, Intellectual Property Rights & Small Scale Farmers

Contents (James)

1. History – The Rise and Rise of GE 2. What is Genetic Engineering (GE)? 3. Agribusiness 4. Intellectual Property Rights

Contents (Amaya)

1. Arguments For & Against GE 2. The Impact of GE on Small scale Farmers 3. Domestic GE Policies in Developing Countries 4. GE in South Africa – Case Studies

History – The Rise and Rise of GE

http://www.pub.ac.za/resources/teach.html

 In 1973, researchers lifted genetic materials from one organism's DNA and copied them into another's to produce insulin.  In the 1980’s, testing of biotechnology-derived foods began.  In 1994, the FlavrSavr® tomato was introduced.  By 1997, 18 biotechnology derived crops had been approved by the U.S. government  Biotechnology continues to evolve and new varieties are currently being produced using transgenic techniques. http://www.dupont.com/biotech

What is Genetic Engineering (GE)?
Colorado State University

http://www.ornl.gov/sci/techresources/Human_Genome/publicat/primer2001/1.shtml

Genetic Engineering

What is GE (I)

http://www.pub.ac.za/resources/teach.html

What is GE (II)

GE in Agriculture (& Pharming)
Crop Types:
- Herbicide Resistant / Tolerant Crops. - Bio-pesticide Producing Crops. - Disease Resistant Crops. - Environmentally Adaptive and Tolerant Crops. “Plants as “green” factories
Plants are particularly suitable for the synthesis of complex chemical molecules and hence for the production of high-performance specialties. The advantage of plants is their low-cost raw materials – carbon dioxide, water and sunlight – and easy cultivation in tilled soil. Potential applications range from special fatty acids for industrial applications, to biopolymers, to vitamin production in plants.”
http://www.corporate.basf.com/en/produkte/biotech/plantscience/pflanzenalsfabrik/?id=OXN_I6mYlbcp35U

ICGEB (EU Body) GE Crop Statistics
The International Centre for Genetic Engineering and Biotechnology
Global Area of Transgenic Crops by Year million hectares Global Area of Transgenic Crops in 2003 by Country million hectares percentage (%) percentage increase from 2002 (%) 1996 1.7 USA 42.8 63% +10% 1997 11.0 Argentina 13.9 21% +3% 1998 27.8 1999 39.9 2000 44.2 Brazil 3.0 4% 2001 52.6 2002 58.7 South Africa 0.4 1% +33% 2003 67.7 Others * 3.8 6% +533%

Canada 4.4 6% +26%

China 2.8 4% +33%

*Australia, India, Romania, Uruguay, Spain, Mexico, Philippines, Colombia, Bulgaria, Honduras, Germany, Indonesia. Global Area of Transgenic Crops in 2003 by Crop million hectares percentage (%) percentage increase from 2002 (%) Soybean 41.4 61% +13% Maize 15.5 23% +25% Cotton 7.2 11% +20% Canola 3.6 5% +20% Others <0.1 <0.1% -

Global Area of Transgenic Crops in 2003 by Trait million hectares percentage (%) percentage increase from 2002 (%)

Herbicide tolerance 49.7 73% +12%

Insect resistance 12.2 18% +20%

Bt/Herbicide tolerance 5.8 9% +32%

Others <0.1 <0.1 -

GMO's background (*) data from: James, C. 2003. Global Status of Commercialized Crop: 2003. ISAAA: Ithaca, NY.

% Patents (1998)
26

Pharmaci, DuPont, Syngenta, Dow, Aventis & Others

World Agribusiness (Oligopoly)

74

An oligopoly is a market form in which a market is dominated by a small number of sellers (oligopolists). Oligopolistic markets are characterised by interactivity. The decisions of one firm influence, and are influenced by, the decisions of other firms.
http://en.wikipedia.org

% Pesticide Sales (1998)
30

Sygenta, Monsanto, Aventis, DuPont & BASF Others
70

Source: Bowring, 2003

Monsanto
http://www.monsanto.com

Delta and Pine Land, etc
http://www.deltaandpine.com

http://www.syngenta.com

http://www1.dupont.com

http://www.pioneer.com http://www.corporate.basf.com

“Biotechnology is one of the most promising future technologies of the 21st century. BASF is looking for competitive new technologies and is strongly committed to this dynamic area. We want to take full advantage of the great economic potential of biotec hnology.”
http://en.sanofi-aventis.com
http://www.corporate.basf.com/en/produkte/biotech/?id=OXN_I6mYlbcp35U

Intellectual Property Rights
Document no IP/C/W/438 From India, Brazil, and others

http://www.wto.org Intellectual Property Rights (IPR’s) Rights given to people over the creations of their minds.
IP/C/W/434 US

Title Date The relationship between the TRIPS Agreement and the 10 December 2004 Convention on Biological Diversity (CBD) and the protection of traditional knowledge — elements of the obligation to disclose evidence of prior informed consent under the relevant national regime Article 27.3(b), relationship between the TRIPS 26 November 2004 agreement and the CBD, and the protection of traditional knowledge and folklore Further observations by Switzerland on its proposals regarding the declaration of the source of genetic resources and traditional knowledge in patent applications Elements of the Obligation to Disclose the Source and Country of Origin of Biological Resources and/or Traditional Knowledge used in an Invention 25 November 2004

IP/C/W/433

Switzerland

IP/C/W/429, with Rev.1, Add.1, Add.2, and Add.3 IP/C/W/423

Brazil, India and others

21 September 2004 to 10 February 2005

Trade Related Intellectual Property Rights (TRIP’s) ‘Patentable inventions’ must be new, involve an inventive step (or be nonobvious) and be capable of industrial application (or be useful). Article 27 also lists inventions which governments do not have to make eligible for patent protection.

Switzerland

IP/C/W/420 and Add. 1 IP/C/W/404 IP/C/W/403 IP/C/W/400/

India, Brazil, and others African group India, Brazil, and others Switzerland

Additional Comments By Switzerland on its Proposal 26 June 2003 Submitted to WIPO Regarding the Declaration of Source of Genetic Resources and Traditional Knowledge in Patent Applications The Relationship between the TRIPS Agreement and the 2 March 2004 CBD: Checklist of Issues Taking Forward the Review of Article 27.3(b) of the TRIPS 26 June 2003 Agreement The Relationship between the TRIPS Agreement and the 24 June 2003 CBD and the Protection of Traditional knowledge Article 27.3(b), the Relationship between the TRIPS 18 June 2003 Agreement and the CBD, and the Protection of Traditional Knowledge Access to Genetic Resources Regime of the US National 28 January 2003 Parks Review of Article 27.3(b) of the TRIPS Agreement, and 17 October 2002 the Relationship between the TRIPS Agreement and the CBD and the Protection of Traditional Knowledge and Folklore — “A Concept Paper” The Relationship between the TRIPS Agreement and the 24 June 2002 CBD and the Protection of Traditional Knowledge Technology Transfer Practices of the US National Cancer 25 March 2002 Institute’s Departmental Therapeutics Programme

IP/C/W/393 IP/C/W/383

US EC

IP/C/W/356 and Add. 1

India, Brazil, and others

IP/C/W/341

US

Intellectual Property Rights
TRIP’s Agreement (Article 27.3(b)) Currently Under Review: Allows governments to exclude some kinds of inventions from patenting, i.e. plants, animals and “essentially” biological processes (but micro-organisms, and non-biological and microbiological processes have to be eligible for patents). However, plant varieties have to be eligible for protection either through patent protection or a system created specifically for the purpose (“sui generis”), or a combination of the two. For example, some countries have enacted a plant varieties protection law based on a model of the International Union for the Protection of New Varieties of Plants (UPOV).

http://www.wto.org

The Cartagena Protocol on Biosafety (2000) is an international agreement on biosafety, as a supplement to the Convention on Biological Diversity. Products from new technologies must be based on the precautionary principle and allow developing nations to balance public health against economic benefits. It will for example let countries ban imports of a genetically modified product if they feel there is not enough scientific evidence that the product is safe and requires exporters to label shipments containing genetically altered commodities such as corn or cotton. The Doha Declaration (2001) WTO Should look at: • The relationship between the TRIPS Agreement and the UN Convention on Biological Diversity. • The protection of traditional knowledge and folklore. • Must take development issues fully into account.

Intellectual Property Rights

The International Union for the Protection of New Varieties of Plants (UPOV) is an intergovernmental organization with headquarters in Geneva (Switzerland). UPOV was established by the International Convention for the Protection of New Varieties of Plants. The Convention was adopted in Paris in 1961 and it was revised in 1972, 1978 and 1991. The objective of the Convention is the protection of new varieties of plants by an intellectual property right.
http://www.upov.int/

International Organisations
http://www.biodiv.org/convention

(1992 – Rio - 150 Countries)The Convention establishes three main goals: -The conservation of biological diversity. -The sustainable use of its components. -The fair and equitable sharing of the benefits from the use of genetic resources.

FAO-BioDeC: a database meant to gather, store, organize and disseminate, updated baseline information on the state-of-the-art of crop biotechnology products and techniques, which are in use, or in the pipeline in developing countries.

http://www.fao.org/biotech/inventory_admin/dep/default.asp

The USDA, APHIS, EPA & FDA
http://www.fda.gov/ http://www.epa.gov

Six Step Process:
1. USDA Notification Process (Greenhouse Trial) 2. USDA Petition for non-regulated status (10 Month Review) (PP) 3. EPA - Experimental Use Permit (especially for biopesticides) (PP) 4. EPA Review - Food Tolerance Determination (PP) 5. EPA Product Registration - 18 Month data review (PP) 6. FDA Review – Pre Market review of Biotech derived crop (3 years)

United States Department of Agriculture Animal and Plant Health Inspection Service

Plant Protection and Quarantine
http://www.aphis.usda.gov/

Arguments
Con’s Pro’s
☺ The solution for hunger ☺ Safe for the environment ☺ Less chemicals ☺ Use marginal land ☺ Maintain biodiversity ☺ Germplasm banks ☺ Incentives to innovation (patents) ☺ Free market regulates supply/demand  Ethics  Patents of life forms  Over natural barriers  Agri-business oligopoly  Hunger is not addressed through increased productivity  Health impact  Allergens  Decrease nutritional diet  Environmental risks  Focused on large-scale farmers

Environmental Risks
• Loss of biodiversity (monoculture) • Increased herbicides use: water & soil pollution • Genetic contamination – Horizontal gene transfer (unrelated species) – Gene escape (cross-pollination) • Of landraces • Disease resistance in crops (Bt) • Super-weeds (herbicides) • Pest resistance (pesticides)

Impact on Small - Scale Farmers (I)
• Unequal power (Agri-Business Oligopoly) – Decision-making – Price-fixing arrangements – Where is the consumers right to decide what food and technology they want? • Bio-piracy / Bio-Prospecting: – Steal indigenous knowledge and genetic material – Displace many farmers in developing countries from international markets (coconut oil, flavour cocoa…)

Impact On Small-scale Farmers (II)

• Sterile crops: 1.4 billion people dependent on farmer-saved seeds • Landraces are not uniform: cannot be registered through UPOV • Research Focus: Agricultural research is directed at High-external-inputs farmers.

Domestic Policies In Developing Countries

Possible Strategies
• Defining the criteria of patentability by defining the term ‘novel’ – Mere discoveries of existing variations in nature are neither ‘novel’ or an ‘invention’ – unpatentable • • Community resources, held in public domain – unpatentable Protecting public benefit (food security, rights…)

GMO Application Process in South Africa

http://www.pub.ac.za/resources/teach.html

2005 18/03/2005 - Biowatch applies for leave to appeal High Court cost award to Monsanto 09/03/2005 - SACU countries don’t include controversial IPR clauses in EFTA agreement 23/02/2005 - Landmark court judgement on access to information about GMO’s. 17/02/2005 - EIA’s should be done on all GMO’s before they are released 20/01/2005 - Monsanto Guilty of Bribery 2004 22/12/2004 - Appeal Board reveals State negligence on genetic modification 19/11/2004 - NGOs demand scrapping of corporate-friendly GMO Act 04/11/2004 - Patently unfair: IPR’s undermine health and food security for the south 23/08/2004 - Appeal Board hearing postponed, Syngenta agrees to stop distributing GM seed. 20/08/2004 - SA judge orders Swiss company to stop distributing GM maize seed. 28/07/2004 - Civil Society Organisations Object to the Importation of GM Wheat. 27/07/2004 - SA Biosafety regulators in bed with industry on GM potatoes? 18/05/2004 - Keep genetically engineered wheat out of South Africa 2003 16/04/2003 - Parliamentary Conference promises to improve the GMO Act. 15/04/2003 - Parliamentary Committee GMO's seeks greater transparency from government. 2002 04/11/2002 - Biowatch calls for rejection of applications brought by Syngenta for Bt 11 maize. 25/09/2002 - Biowatch files papers against Minister of Agriculture. - Controversial GMO Act comes under scrutiny. - Future of GM corn in question given recent decision by General Mills to go organic. - GMO White Maize (Decision on Staple Food).
http://www.biowatch.org.za/

Biowatch (South Africa)

GE in South Africa
• An estimated 300.000 ha is used to grow GE crops, including - white and yellow maize, soybean and cotton. • GE crops In SA, 2004: – 80% of the Cotton – 35% of the Maize (For Human Consumption) – 30% of the Soybean

GE Crops in South Africa - 2004

Source: BioWatch South Africa, 2004

Bt Cotton in Makhathini

• High dependency on support by S.A. Department of Agriculture, Monsanto, Vunisa Cotton and Land Bank. • Credit => Debt trap • Planting GE cotton without the correct information and support services

Conclusion sion

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