1. Genetic Resources Policy and Intellectual Property I. Ownership and control of genetic resources II. Movement of genetic resources III. Intellectual Property Rights IV. African Union Robert J. Lewis-Lettington Legal consultant rjl34@alumni.st-andrews.ac.uk Regional workshop on Learning agrobiodiversity: options for universities in Sub-Saharan Africa ICRAF, Nairobi, Kenya. January 2009.

2. Ownership and control of genetic resources: what is the relevant law? A. Convention on Biological Diversity (www.cbd.int) www.cbd.int - applies to most genetic resources and is default framework - Country of origin is a key concept in access - not directly applicable in national law but still seen as framework for good conduct - usually reflected in national law through access to genetic resources regulations in developing countries

3. Ownership and control of genetic resources: what is the relevant law? B. International Treaty on plant genetic resources for food and agriculture (www.planttreaty.org) www.planttreaty.org - as far as access and benefit sharing is concerned this only applies to material of species listed in Annex I and under the management and control of the state and in the public domain; as well as - also applies to material in international and other collections placed in Treaty framework - to date, mostly reflected in national law through administrative practice (rules, contracts etc) but this may change

4. Ownership and control of genetic resources: what is the relevant law? C. Other initiatives - A more detailed, binding, framework for access and benefit sharing is being developed under the CBD - With the adoption of the Global Plan of Action for the Conservation and Sustainable Use of Animal Genetic Resources, discussions on access and benefit sharing are developing (probably only domestic livestock but maybe also wild relatives?) - The role of microbial genetic resources in agriculture is beginning to be discussed in terms of access

5. Ownership and control of genetic resources: what is your source of material? A. Wild material - what is the location of the collection? - do you have national access to genetic resources regulations? - is the sample native or an alien species? B. Ex situ collection - was it collected pre or post-1992? - who holds the collection and what species are you accessing? C. What country are you accessing material from?

6. II. Movement of genetic resources: Sanitary and phytosanitary standards A ‘SPS’ Agreement ‘SPS’ Agreement Primarily umbrella agreement lending force to technical agreements Primarily umbrella agreement lending force to technical agreements More info: http://www.wto.org/english/tratop_e/sps_e/ sps_e.htm More info: http://www.wto.org/english/tratop_e/sps_e/ sps_e.htm The ‘three sisters’ The ‘three sisters’ Codex Alimentarius Commission (CAC) Codex Alimentarius Commission (CAC) Food stuffs Food stuffs Includes means of production, preparation, storage etc Includes means of production, preparation, storage etc

7. II. Movement of genetic resources: Sanitary and phytosanitary standards B The ‘three sisters’ cont. The ‘three sisters’ cont. International Plant Protection Convention (IPPC) International Plant Protection Convention (IPPC) Regulates plant pests, Secures action to prevent the spread and introduction of pests of plants and plant products; and promote appropriate measures for their control Regulates plant pests, Secures action to prevent the spread and introduction of pests of plants and plant products; and promote appropriate measures for their control More info:https://www.ippc.int/IPP/En/default.jsp More info:https://www.ippc.int/IPP/En/default.jsp Organisation Internationale des Epizooties Organisation Internationale des Epizooties Technical mandate similar to that of IPPC but animals rather than plants Technical mandate similar to that of IPPC but animals rather than plants More info: http://www.oie.int/ More info: http://www.oie.int/ Cartagena Protocol Cartagena Protocol

8. II. Movement of genetic resources: Sanitary and phytosanitary standards C Cartagena Protocol Cartagena Protocol Biosafety: The need to protect human health and environment from the possible adverse effects of the products of modern biotechnology. Biosafety: The need to protect human health and environment from the possible adverse effects of the products of modern biotechnology. Protocol Objective: Adequate protection in the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the environment & human health Protocol Objective: Adequate protection in the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the environment & human health Scope: Transboundary movement, transit, handling and use of LMOs (Article 4) that can affect sustainable use of biological diversity. Pharmaceuticals are excluded. Scope: Transboundary movement, transit, handling and use of LMOs (Article 4) that can affect sustainable use of biological diversity. Pharmaceuticals are excluded. Adopts a Precautionary approach. Adopts a Precautionary approach.

9. III. Intellectual Property Rights WTO Trade Related Aspects of Intellectual Property Rights - 27.3(b) Members may exclude plants and animals from patentability Members may exclude plants and animals from patentability Members must protect microorganisms Members must protect microorganisms Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof

10. III. TRIPs: other rights Protection of undisclosed information (e.g., hybrids) Protection of undisclosed information (e.g., hybrids) Trademarks (associated with seeds’ generic denomination) Trademarks (associated with seeds’ generic denomination) Geographical indications Geographical indications

11. III. UPOV III. UPOV The Union for the Protection of New Plant Varieties (UPOV) The Union for the Protection of New Plant Varieties (UPOV) A ‘sui generis’ form of intellectual property right for any kind of plant variety A ‘sui generis’ form of intellectual property right for any kind of plant variety Basic principles include: Basic principles include: commercial novelty commercial novelty distinctness distinctness uniformity uniformity stability stability Broad exceptions for research and breeding Broad exceptions for research and breeding Limited, optional, exceptions for small holder use Limited, optional, exceptions for small holder use This refers to the 1991 text but, in developing a national law, a country could use earlier texts This refers to the 1991 text but, in developing a national law, a country could use earlier texts

12. III. Patents vs. PVP PATENTS PATENTS PVPs PVPs Genes, cells, plants, varieties Plant varieties Novelty, inventive step, industrial applicability Novelty, distinctness, uniformity, stability Exclusive rights over use, research and breeding Farmers’ privilege Breeders’ rights

13. III. Some IPR concerns III. Some IPR concerns How do private intellectual property rights link with sovereign rights over genetic resources? How do private intellectual property rights link with sovereign rights over genetic resources? Third parties can be prevented from producing or selling goods or services using protected information without the title-holder's authorisation, e.g. a common issue in cut flower exports to Europe Third parties can be prevented from producing or selling goods or services using protected information without the title-holder's authorisation, e.g. a common issue in cut flower exports to Europe Another issue that has generated concern is the impact that the appropriation of genetic materials under IPRs may have on the access to such materials for further research and development Another issue that has generated concern is the impact that the appropriation of genetic materials under IPRs may have on the access to such materials for further research and development The granting of plant breeders’ rights (PBRs) does not limit the use of the protected material as a source for further research and breeding, because of the generally accepted ‘breeders’ exemption’ The granting of plant breeders’ rights (PBRs) does not limit the use of the protected material as a source for further research and breeding, because of the generally accepted ‘breeders’ exemption’ The treatment of traditional knowledge in IPR regimes has been seen as allowing for the appropriation of developments based on such knowledge without recognising rights to the knowledge itself The treatment of traditional knowledge in IPR regimes has been seen as allowing for the appropriation of developments based on such knowledge without recognising rights to the knowledge itself

14. IV. African Union There are two models: There are two models: The African Model Law for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources The African Model Law for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources Draft Model National Legislation on Safety in Biotechnology Draft Model National Legislation on Safety in Biotechnology Not binding – advisory documents adopted by OAU/AU ministerial conferences Not binding – advisory documents adopted by OAU/AU ministerial conferences Very useful for identifying principles and key concerns Very useful for identifying principles and key concerns Do not replace the need for work at the national level – difficult to implement in a ’cut and paste’ approach Do not replace the need for work at the national level – difficult to implement in a ’cut and paste’ approach

15. IV. African Union The African Model Law for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources The African Model Law for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources Where UPOV focuses on rights of downstream users of biological materials, i.e. researchers and breeders, Model focuses more on rights of material providers Where UPOV focuses on rights of downstream users of biological materials, i.e. researchers and breeders, Model focuses more on rights of material providers Seeks to establish/maintain rights to farmers’ varieties and other informally developed or used material Seeks to establish/maintain rights to farmers’ varieties and other informally developed or used material Balance between role and rights of individuals, communities, government and the private sector can be difficult to achieve and probably needs further analysis at the national level Balance between role and rights of individuals, communities, government and the private sector can be difficult to achieve and probably needs further analysis at the national level

16. Concluding comments: what should a university teach its students? How to responsibly and fairly collect and use material How to responsibly and fairly collect and use material How to protect their rights and those of their institutions, as well as those of others How to protect their rights and those of their institutions, as well as those of others Focus on promoting research and pre- empting problems Focus on promoting research and pre- empting problems Universities will need to engage their respective national authorities in policy development Universities will need to engage their respective national authorities in policy development