ABS governance: the biodiversity, agriculture, health and other schemes

Charles LawsonAustralian Centre for Intellectual Property in Agriculture

Outline

§ Regulatory spaces§ The regulatory schemes

» UN Convention on Biological Diversity (CBD)» FAO International Treaty on Plant Genetic Resources for

Food and Agriculture (Plant Treaty)» WHO Pandemic Influenza Preparedness Framework (PIP

Framework)

§ Contract models§ Interpretation

» Correct and preferable decisions

§ Decision making tools§ Regulatory crucible§ Conclusions 2

The “genetic resources” international regulations§ Antarctica

» Antarctica Treaty (1959) » Protocol on Environmental Protection to the Antarctic Treaty (1991) » Convention on the Conservation of Antarctic Marine Living Resources (1980) » Convention for the Conservation of Antarctic Seals (1972) » Convention on the Regulation of Antarctic Mineral Resource Activities (1988)

§ Outer space» Declaration of Legal Principles Governing the Activities of States in the Exploration and Use of Outer Space (1963)» Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space, Including the

Moon and Other Celestial Bodies (Outer Space Treaty) (1966) » Agreement Governing the Activities of States on the Moon and Other Celestial Bodies (Moon Agreement) (1979) » Principles Relating to Remote Sensing of the Earth from Outer Space (1986) » Declaration on International Cooperation in the Exploration and Use of Outer Space for the Benefit and in the

Interest of All States, Taking into Particular Account the Needs of Developing Countries (1996) § Seas and oceans

» Law of the Sea Convention (1982) » Agreement Relating to the Implementation of Part XI of the United Nations Convention on the Law of the Sea of 10

December 1982 (1994)§ Biodiversity

» Convention on Biological Diversity (1992) » Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their

Utilisation (Bonn Guidelines) (2002) » Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their

Utilization (Nagoya Protocol) (2010) » International Treaty on Plant Genetic Resources for Food and Agriculture (2004)» WHO PIP Framework (2011) 3

The “genetic resources” regulation timeline

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Antarctica Treaty(1959)

Outer Space Treaty(1966)

Law of the Sea Convention (1982)

Convention on Biological Diversity (1992)

Bonn Guidelines(2002)

Outer Space Resources Treaty (1996)

Plant Treaty (2004)

Nagoya Protocol (2010)

PIP Framework (2011)

The resources sovereignty “schism”

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Heritage of human kind

Nation State sovereignty

Free and available to first takers

Controlled by nation state regulation

Around 1991/1992

Jurisdictions

Territorial sea

EEZ

Antarctica

Area south of 60º South

Continentalshelf

Land

High seas

Outer space

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Jurisdiction – Convention on Biological Diversity

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Antarctica

Area south of 60º SouthHigh seas

Outer space

Land

Territorial sea

EEZ

Continentalshelf

Outer spaceOuter Space Treaty

Genetic resources withinnational jurisdiction …

Contributed plant genetic resources SMTA

CGIAR CentresSMTA (CGIAR)

Everything else …Nagoya ProtocolBonn Guidelines(Voluntary contract)

Agricultural genetic resources- animal- forestry- fisheries- microorganisms(Under negotiation …)

Pandemicinfluenza virusesPIP Framework(SMTA 1 & 2)

Oceans areas beyond national jurisdiction Law of the Sea Convention

AntarcticaAntarctica Treaty

All other genetic resources …Convention on Biological Diversity

Plant genetic resources in Multilateral System for research, breeding and trainingInternational Treaty on Plant Genetic Resources for Food and Agriculture

Genetic (biological or living) resources

Schemes for accessing and benefit-sharing genetic resources

Schemes for accessing and benefit-sharing genetic resources

Outer spaceOuter Space Treaty

Genetic resources withinnational jurisdiction …Convention on Biological Diversity

Contributed plant genetic resources

SMTA Bonn Guidelines(Voluntary contract)

Nagoya Protocol

Pandemicinfluenza virusesPIP Framework

Oceans areas beyond national jurisdiction Law of the Sea Convention

AntarcticaAntarctica Treaty

All other genetic resources …Convention on Biological Diversity

Plant genetic resources in Multilateral System for research, breeding and trainingInternational Treaty on Plant Genetic Resources for Food and Agriculture

Genetic (biological or living) resources

SMTA 1 & 2

CBD’s access regime – nutshell§ CBD (29 December 1993)

» Access must be from countries of origin or countries that have acquired the genetic resources according to the CBD

» Mutually agreed terms» Prior informed consent» Recognising, at least, minimum standard intellectual property (IPPs)

§ In Australia this is TRIPS plus the AUSFTA (plus TPP?)§ Bonn Guidelines

» Model voluntary contract§ Commonwealth’s Environment Protection and Biodiversity Conservation Act 1999 (Cth)§ Queensland’s Biodiscovery Act 2004 (Qld)§ Northern Territory’s Biological Resources Act 2006 (NT)

§ Nagoya Protocol (12 October 2014)» Appropriate legislative, administrative or policy measures » Procedural standards for establishing prior informed consent» “Access and Benefit-sharing Clearing-House”» “Internationally recognized certificate of compliance”» Protects “Traditional Knowledge” associated with genetic resources

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Plant Treaty’s access regime – nutshell

§ Effective from 29 June 2004§ Facilitated access to the Multilateral System§ Multilateral System comprises materials contributed

that are under state control and in the public domain» Annex 1» Non-Annex 1

§ Only for purposes of “research, breeding and training”» Expressly excludes “chemical, pharmaceutical

and/or other non-food-feed industrial uses”» Otherwise CBD (and Nagoya Protocol)

§ Standard Materials Transfer Agreement (SMTA)

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Plant Treaty’s access regime – nutshell …

§ Standard Materials Transfer Agreement (SMTA)» Provide with non-confidential information» Respect existing intellectual property claims» Make no intellectual property claims on materials

“in the form received”» Transfer benefit sharing obligations on to

subsequent recipients» Benefit sharing if restrict further research and

breeding uses on commercialisation§ Make payments on sales

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PIP Framework access regime – nutshell

§ Effective from 15 June 2007§ Only covers human pandemic influenza viruses

» Does not cover seasonal influenza and other non-influenza pathogens

§ Obligation to provide human pandemic influenza viruses to WHO Collaborating Centers or WHO H5 Reference Laboratories

§ Samples, sequence data and analyses then shared through Global Influenza Surveillance and Response System (WHO GISRS)

§ Two Standard Materials Transfer Agreements» SMTA 1 – Transfers within WHO GISRS» SMTA 2 – Transfers outside WHO GISRS

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PIP Framework access regime – nutshell …§ SMTA 1 – Transfers within WHO GISRS

» Supports and strengthens laboratory and surveillance capacity» Engage scientists from developing countries» Acknowledge sources in publications» Suggests intellectual property should not be obtained and must

respect existing intellectual property in any technology used» Retain conditions on subsequent transfers within WHO GISRS or

impose SMTA 2 outside WHO GISRS§ SMTA 2 – Transfers outside WHO GISRS

» To private sector manufacturers of vaccines or anti-virals » Require subsequent recipients to negotiate new SMTA 2» Acknowledge sources in publications» Can claim intellectual property» Commit to benefit-sharing “options” + subscription fee

§ eg. Donate 5-20% vaccine production, reserve 5-20% vaccine production at affordable prices, grant developing country manufacturers licenses, and so on 14

CBD, Plant Treaty and PIP Framework summary

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CBD (and Nagoya Protocol)

Plant Treaty PIP Framework

Materials Genetic resources within jurisdiction

Materials in the Multilateral System

Human pandemic influenza viruses

ABS agreement Voluntary contract with prior informed consent and mutually agreed terms

SMTA SMTA 1 and SMTA 2

ABS benefits Whatever parties agree

Fixed price as proportion of commercialized product

Two from a list of options covering products and licenses AND participation contribution

The CBD contract model

§ The contract is the favoured instrument » Allows private actors to set the terms and conditions of their

transaction that is best suited to their particular circumstances § Exchange of access to biodiversity for a “price” agreed

between the parties§ The “price” comprising:

» Money» Transfer of technology» Training and capacity building» Access to research results and new information» Intellectual property» … and so on

§ High transaction costs in negotiating unique contracts§ Plant Treaty and PIP Framework use SMTA to lower

transaction costs16

Contract and benefit-sharing model

Content of benefits?

Conservators of genetic resources

Owners (or future owners) of technology and IP protected creations and inventionsCommercialisation

of a product

BENEFITSMonetary- cashNon-monetary- know how- technology transfer- training- capacity building

Content of benefits?

Private benefits?Trade, investment, IP and access to technologiesPublic benefits?Ecosystem services, and economic, social and cultural development

The ABS governance issues … what regulation applies to “this” sample?

§ What does “governance” mean?» Identifying the relevant legal schemes and laws» Interpreting the applicable laws» Assessing the risks of different interpretations in the

context of the decision» Making the “correct” and “preferable” decision

§ A “correct” decision is one that is lawful and so within the bounds of what the law allows

§ A “preferable” decision is one that is qualitatively better than others for whatever reasons

» Implementing decision consistently

… so what regulation applies to “this” sample?18

Interpreting and implementing “The Matrix”

§ Problems of interpretation » Basic legal tools

§ Plain meanings of words§ Vienna Convention on the Law of Treaties§ Surrounding materials§ Interpretive lenses

§ Über-realist§ Economic§ Human rights

» Norms of practice over time§ Agreed meanings§ Agreed practices

§ Reasonable people can disagree …19

Interpreting and implementing “The Matrix”

Does the Nagoya Protocol impose traditional knowledge obligations?

Article 7 Access to TK associated with Genetic Resources“In accordance with domestic law, each Party shall takemeasures, as appropriate, with the aim of ensuring thattraditional knowledge associated with genetic resourcesthat is held by indigenous and local communities isaccessed with the prior and informed consent or approval andinvolvement of these indigenous and local communities, andthat mutually agreed terms have been established” (emphasisadded)

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Interpreting and implementing “The Matrix”§ CBD Article 15(1)

“Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation”

§ Linking ABS and TK in the CBD» CBD Article 15 ABS» CBD Article 8(j) TK (in context of in situ conservation)“Each Contracting Party shall, as far as possible and as appropriate … (j) Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity …”» CBD Article 10(c)“Each Contracting Party shall, as far as possible and as appropriate … (c) Protect and encourage customary use of biological resources in accordance with traditional cultural practices that are compatible with conservation or sustainable use requirements” 21

Interpreting and implementing “The Matrix” – economic lens?

§ Nagoya Protocol Preamble“Reaffirming the sovereign rights of States over their natural resources and according to the provisions of the Convention”

§ Efficient»Minimizing compliance and other costs imposed on the community

§ Effective»Addressing an identified problem

èWhat’s the problem that needs a solution?èWhat’s the most efficient solution?

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Interpreting and implementing “The Matrix” – human rights lens?

§ Nagoya Protocol Preamble“Noting the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP)”

§ Other human rights instruments»Universal Declaration of Human Rights»International Covenant on Civil and Political Rights»International Labour Organisation Convention No 169»Special Rapporteur on the Rights of Indigenous Peoples

èWhat are the relevant human rights obligations?èHow can the Nagoya Protocol advance those obligations?

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Other sources of assistanceWhere to look for guidance»Treaty governing bodies

§ Decisions of interpretive bodies§ Official documents (especially meeting and information

documents)»International institutional policies and guidelines

§ CGIAR Intellectual Assets Principles§ CGIAR Intellectual Assets Guidelines

»National government policies and guidelines§ National Focal Points (NFPs) and Competent National

Authorities (CNAs)

èCorrect – one that is lawful and so within the bounds of what the law allowsèPreferable – one that is qualitatively better than others for whatever reasons 24

Which ABS scheme applies?

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Which ABS scheme applies?Collected in outer space

yesno

yes

yes

yes

yes

no

no

no

no

START See Outer Space Treaty

Collected below 60o

south

See Antarctic Treaty

Collected in the Area of water column beyond EEZ

See Law of the Sea Convention

Is it pandemic influenza?

See International Health Regulations

Is it PGRFA? Is material in the Multilateral System?

yes

no

yes See Plant Treaty

Is it other GR?yes See CBD/Nagoya Protocol

When were samples collected?

Before 29 June 2004

After 29 June 2004

yes

CG Center

Non-CG Center

no

Collection “plant genetic resources for food and agriculture”⇒ Free access and “common heritage”ABSAnnex 1 in “Multilateral System” (Art 15.1(a))

⇒SMTA for “utilization and conservation for research, breeding and training”⇒Otherwise none other than moral obligations

Annex 1

Non-Annex 1 Collection “plant genetic resources for food and agriculture”⇒ Free access and “common heritage”ABSNon-Annex 1 in “Multilateral System” (Art 15.1(b))

⇒SMTA for “utilization and conservation for research, breeding and training”⇒Otherwise none other than moral obligations

Annex 1

Non-Annex 1

Collection “plant genetic resources for food and agriculture”⇒ Free access and “common heritage”ABSAnnex 1 in “Multilateral System” (Arts 15.1(a) and 15.5)

⇒SMTA for “utilization and conservation for research, breeding and training”⇒Otherwise apply CBD

Collection “plant genetic resources for food and agriculture”⇒ Free access and “common heritage”ABSNon-Annex 1 in “Multilateral System” (Art 15.1(b))

⇒SMTA for “utilization and conservation for research, breeding and training”⇒Otherwise none other than moral obligations

no

no

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Collection “plant genetic resources for food and agriculture” ⇒ Follow CBD (unless already in “Multilateral System”)ABSAnnex 1 in “Multilateral System” (Art 15.1(a))

⇒SMTA for “utilization and conservation for research, breeding and training”⇒Otherwise apply CBD

Annex 1

Non-Annex 1 Collection “plant genetic resources for food and agriculture” ⇒ Follow CBD (unless already in “Multilateral System”)ABSNon-Annex 1 in “Multilateral System” (Art 15.1(b))

⇒SMTA for “utilization and conservation for research, breeding and training”⇒Otherwise apply CBD

Annex 1

Non-Annex 1

Collection “plant genetic resources for food and agriculture” ⇒ Follow CBD (unless already in “Multilateral System”)ABSAnnex 1 in “Multilateral System” (Arts 15.1(a) and 15.5)

⇒SMTA for “utilization and conservation for research, breeding and training”⇒Otherwise apply CBD

Collection “plant genetic resources for food and agriculture” ⇒ Follow CBD (unless already in “Multilateral System”)ABS Non-Annex 1 in “Multilateral System” (Arts 15.1(b) and 15.5)

⇒SMTA for “utilization and conservation for research, breeding and training”⇒Otherwise apply CBD

no

no

Non-CG Center

CG Center

no

When were samples collected?

Before 29 December 1993Between 29 December 1993 and 12 October 2014 Collection

“genetic resources”⇒ Free access and “common heritage”ABS ⇒ None other than moral obligations

nonoAfter 12 October 2014

Collection “genetic resources”⇒ Follow national legislation of countries of origin or countries acquiring according to CBD (presumably already having satisfied national legislation of country of origin) (Art 15):

•Mutually agreed terms•Prior informed consent•Recognising any limitations imposed by national laws (e g IP claims)ABS ⇒ Mutually agreed (see Bonn Guidelines)

Collection “genetic resources”⇒ Follow national legislation of countries of origin or countries acquiring according to CBD (presumably already having satisfied national legislation of country of origin) (Art 15):•Mutually agreed terms

•Prior informed consent•Recognising any limitations imposed by national laws (e g IP claims)⇒Apply Nagoya Protocol requirements (e g TK)ABS⇒ Mutually agreed and following national legislation (especially for indigenous and local communities and associated TK)

The regulatory crucible

And the CBD forum (together with many other forums dealing with ABS) are now grappling with how to embrace:§ Development§ Sovereignty§ Traditional and customary law§ Human rights

… how these will be resolved is uncertain?

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The main point … establishing legal provenance

§ CBD (and Nagoya Protocol)» Look to national ABS laws and negotiate contract

according to those national requirements § Problem that most countries don’t have those laws§ Check clearing houses for certificates of origin§ Even where they do (like Australia) they only apply in

limited places (eg Commonwealth lands)

§ Plant Treaty» SMTA

§ PIP Framework» SMTA1 or SMTA 2

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Conclusions

§ Regulatory spaces§ The regulatory schemes§ Contract models§ Interpretation § Correct and preferable decisions§ Decision making tools§ The regulatory crucible

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