Genetic Resources Policy and Genetic Resources Policy and Intellectual PropertyIntellectual PropertyI.I.Ownership and control of Ownership and control of genetic resourcesgenetic resourcesII.II.Movement of genetic resourcesMovement of genetic resourcesIII.III.Intellectual Property RightsIntellectual Property RightsIV.IV.African UnionAfrican Union

Robert J. Lewis-LettingtonRobert J. Lewis-LettingtonLegal consultantLegal consultantrjl34@alumni.st-andrews.ac.ukrjl34@alumni.st-andrews.ac.uk

Regional workshop on Learning agrobiodiversity: options Regional workshop on Learning agrobiodiversity: options for universities in Sub-Saharan Africa for universities in Sub-Saharan Africa

ICRAF, Nairobi, Kenya. January 2009.ICRAF, Nairobi, Kenya. January 2009.

Ownership and control of genetic resources: Ownership and control of genetic resources: what is the relevant law?what is the relevant law?

A.A. Convention on Biological Diversity (Convention on Biological Diversity (www.cbd.int)- applies to most genetic resources and is - applies to most genetic resources and is default frameworkdefault framework- Country of origin is a key concept in - Country of origin is a key concept in accessaccess- - not directly applicable in national law not directly applicable in national law but still seen as framework for good conductbut still seen as framework for good conduct- usually reflected in national law through - usually reflected in national law through access to genetic resources regulations in access to genetic resources regulations in developing countriesdeveloping countries

Ownership and control of genetic resources: Ownership and control of genetic resources: what is the relevant law?what is the relevant law?

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

Ownership and control of genetic resources: Ownership and control of genetic resources: what is the relevant law?what is the relevant law?

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

Ownership and control of genetic resources: Ownership and control of genetic resources: what is your source of material?what is your source of material?

A.A. Wild materialWild material- what is the - what is the locationlocation of the collection? of the collection?- do you have - do you have national access to genetic national access to genetic resources regulationsresources regulations??- is the sample - is the sample native or an alien speciesnative or an alien species??

B.B. Ex situ collectionEx situ collection- was it collected - was it collected pre or post-1992pre or post-1992??- - who holds who holds the collection and the collection and what species what species are you accessing?are you accessing?

n What country What country are you accessing material are you accessing material from?from?

II. Movement of genetic resources: Sanitary II. Movement of genetic resources: Sanitary and phytosanitary standards Aand phytosanitary standards A

‘‘SPS’ AgreementSPS’ Agreement Primarily umbrella agreement lending Primarily umbrella agreement lending force to technical agreementsforce to technical agreements

More info: More info: http://www.wto.org/english/tratop_e/spshttp://www.wto.org/english/tratop_e/sps_e/sps_e.htm_e/sps_e.htm

The ‘three sisters’The ‘three sisters’ Codex Alimentarius Commission Codex Alimentarius Commission (CAC)(CAC)

Food stuffsFood stuffs Includes means of production, Includes means of production, preparation, storage etcpreparation, storage etc

II. Movement of genetic resources: Sanitary II. Movement of genetic resources: Sanitary and phytosanitary standards Band phytosanitary standards B

The ‘three sisters’ cont.The ‘three sisters’ cont. International Plant Protection Convention International Plant Protection Convention (IPPC)(IPPC)

Regulates plant pests,Regulates plant pests, Secures action to Secures action to prevent the spread and prevent the spread and introduction of pests introduction of pests of plants and plant products; and promote of plants and plant products; and promote appropriate measures for their control appropriate measures for their control

More More info:info:https://www.ippc.int/IPP/En/default.jsphttps://www.ippc.int/IPP/En/default.jsp

Organisation Internationale des Organisation Internationale des EpizootiesEpizooties

Technical mandate similar to that of IPPC but Technical mandate similar to that of IPPC but animals rather than plantsanimals rather than plants

MMore info: http://www.oie.int/ore info: http://www.oie.int/ Cartagena ProtocolCartagena Protocol

II. Movement of genetic resources: Sanitary II. Movement of genetic resources: Sanitary and phytosanitary standards Cand phytosanitary standards C

Cartagena ProtocolCartagena Protocol BiosafetyBiosafety: The need to protect human health and : The need to protect human health and environment from the possible adverse effects of environment from the possible adverse effects of the products of modern biotechnology.the products of modern biotechnology.

Protocol ObjectiveProtocol Objective: Adequate protection in the safe : Adequate protection in the safe transfer, handling and use of living modified transfer, handling and use of living modified organisms (LMOs) resulting from modern organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the biotechnology that may have adverse effects on the environment & human healthenvironment & human health

ScopeScope: Transboundary movement, transit, handling : Transboundary movement, transit, handling and use of LMOs (Article 4) that can affect and use of LMOs (Article 4) that can affect sustainable use of biological diversity. sustainable use of biological diversity. Pharmaceuticals are excluded.Pharmaceuticals are excluded.

Adopts a Precautionary approach.Adopts a Precautionary approach.

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

III. TRIPs: other rightsIII. TRIPs: other rights

Protection of undisclosed Protection of undisclosed information (e.g., hybrids)information (e.g., hybrids)

Trademarks (associated with Trademarks (associated with seeds’ generic seeds’ generic denomination)denomination)

Geographical indicationsGeographical indications

III. UPOVIII. UPOV The Union for the Protection of New Plant The Union for the Protection of New Plant Varieties (UPOV)Varieties (UPOV)

A ‘sui generis’ form of intellectual A ‘sui generis’ form of intellectual property right for any kind of plant property right for any kind of plant varietyvariety

Basic principles include: Basic principles include: commercial noveltycommercial novelty distinctnessdistinctness uniformityuniformity stabilitystability

Broad exceptions for research and breedingBroad exceptions for research and breeding Limited, optional, exceptions for small Limited, optional, exceptions for small holder useholder use

This refers to the 1991 text but, in This refers to the 1991 text but, in developing a national law, a country could developing a national law, a country could use earlier textsuse earlier texts

III. Patents vs. PVPIII. Patents vs. PVP

PATENTS PATENTS

PVPsPVPs

Genes, cells, plants, Genes, cells, plants, varietiesvarieties

Plant varieties Plant varieties

Novelty, inventive Novelty, inventive step, industrial step, industrial applicabilityapplicability

Novelty, Novelty, distinctness, distinctness, uniformity, stabilityuniformity, stability

Exclusive rights over Exclusive rights over use, research and use, research and breedingbreeding

Farmers’ privilegeFarmers’ privilege

Breeders’ rightsBreeders’ rights

III. Some IPR concernsIII. Some IPR concerns How do private intellectual property rights link How do private intellectual property rights link with sovereign rights over genetic resources?with sovereign rights over genetic resources?

Third parties can be prevented from producing or Third parties can be prevented from producing or selling goods or services using protected selling goods or services using protected information without the title-holder's information without the title-holder's authorisation, e.g. a common issue in cut flower authorisation, e.g. a common issue in cut flower exports to Europeexports to Europe

Another issue that has generated concern is the Another issue that has generated concern is the impact that the appropriation of genetic impact that the appropriation of genetic materials under IPRs may have on the access to materials under IPRs may have on the access to such materials for further research and such materials for further research and developmentdevelopment

The granting of plant breeders’ rights (PBRs) The granting of plant breeders’ rights (PBRs) does not limit the use of the protected material does not limit the use of the protected material as a source for further research and breeding, as a source for further research and breeding, because of the generally accepted ‘breeders’ because of the generally accepted ‘breeders’ exemption’exemption’

The treatment of traditional knowledge in IPR The treatment of traditional knowledge in IPR regimes has been seen as allowing for the regimes has been seen as allowing for the appropriation of developments based on such appropriation of developments based on such knowledge without recognising rights to the knowledge without recognising rights to the knowledge itselfknowledge itself

IV. African UnionIV. African Union There are two models:There are two models:

The African Model Law for the Protection of The African Model Law for the Protection of the Rights of Local Communities, Farmers the Rights of Local Communities, Farmers and Breeders, and for the Regulation of and Breeders, and for the Regulation of Access to Biological ResourcesAccess to Biological Resources

Draft Model National Legislation on Safety Draft Model National Legislation on Safety in Biotechnologyin Biotechnology

Not binding – advisory documents Not binding – advisory documents adopted by OAU/AU ministerial adopted by OAU/AU ministerial conferences conferences

Very useful for identifying principles Very useful for identifying principles and key concernsand key concerns

Do not replace the need for work at the Do not replace the need for work at the national level – difficult to implement national level – difficult to implement in a ’cut and paste’ approachin a ’cut and paste’ approach

IV. African UnionIV. African Union The African Model Law for the Protection The African Model Law for the Protection of the Rights of Local Communities, of the Rights of Local Communities, Farmers and Breeders, and for the Farmers and Breeders, and for the Regulation of Access to Biological Regulation of Access to Biological ResourcesResources

Where UPOV focuses on rights of Where UPOV focuses on rights of downstream users of biological materials, downstream users of biological materials, i.e. researchers and breeders, Model i.e. researchers and breeders, Model focuses more on rights of material focuses more on rights of material providersproviders

Seeks to establish/maintain rights to Seeks to establish/maintain rights to farmers’ varieties and other informally farmers’ varieties and other informally developed or used materialdeveloped or used material

Balance between role and rights of Balance between role and rights of individuals, communities, government and individuals, communities, government and the private sector can be difficult to the private sector can be difficult to achieve and probably needs further achieve and probably needs further analysis at the national levelanalysis at the national level

Concluding comments: what should a Concluding comments: what should a university teach its students?university teach its students?

How to responsibly and fairly How to responsibly and fairly collect and use materialcollect and use material

How to protect their rights and How to protect their rights and those of their institutions, as those of their institutions, as well as those of otherswell as those of others

Focus on promoting research and Focus on promoting research and pre-empting problemspre-empting problems

Universities will need to engage Universities will need to engage their respective national their respective national authorities in policy developmentauthorities in policy development