The Nagoya protocol – implications on

CWR conservation (in situ, ex situ and

non-conserved) Katileena Lohtander-Buckbee

Senior adviser, Finnish Environment Institute,

Species protection

19.9.2016

Riku Lumiaro/Ympäristöhallinnon kuvapankki

The Nagoya protocol – implications

on CWR conservation (in situ, ex

situ and non-conserved)

History of the protocol

Consequences and procedures

Legislation

Implications for conservation

7.1

0.2

016

Nagoya protocol - history Countries of high biodiversity

wanted to have their share of

benefits from GR

Traditional knowledge of

indigenous peoples and local

communities related to genetic resources

(GR)

7.1

0.2

016

Riku Lumiaro/Ympäristöhallinnon

kuvapankki

Convention on biological diversity

(CBD)

Adopted in 1992 (Earth Summit in Rio de

Janeiro), entered into force 1993

Three main objectives:

• conservation of biological diversity

• sustainable use of its components

• fair and equitable sharing of the benefits

arising out of the utilization of genetic

resources (art. 15) – not legally binding • New legally binding instrument was needed

7.1

0.2

016

Nagoya protocol

7th Conference of the Parties (CBD),

2004: Working Group on ABS mandated

to negotiate an international regime on

ABS

10th Conference of the Parties,

2010: Adoption of the Nagoya

Protocol on ABS

Nagoya protocol entered into

force in CBD-COP12 on 12 October 2014

7.1

0.2

016

The Convention on

Biological Diversity,

1993 (CBD)

Nagoya protocol on

genetic resources,

2014 (NP)

Cartagena protocol on

biosafety,

2003 (CP)

Nagoya-Kuala Lumpur

supplementary protocol

on Liability and redress,

(not yet in force)

Nagoya protocol - Consequences

Legally binding treaty

Countries have sovereign rights over their genetic

resources

-> a party to the protocol may decide that it

regulates the access for genetic resources

In such cases access to genetic resources or

traditional knowledge related to GR can only be

obtained in a legal manner if PIC (prior informed

consent) has been acquired and MAT (mutually

agreed terms) have been negotiated

7.1

0.2

016

Nagoya protocol – provider

obligations Providers of genetic resources:

legal certainty, clarity and transparency

fair and non-arbitrary rules and procedures

clear rules and procedures for PIC and MAT

issuance of a permit or equivalent

7.1

0.2

016

Anja Holmsten/Ympäristöhallinnon kuvapankki

Nagoya protocol – special considerations

According to the protocol Parties to the Protocol may

(in their national legislation):

Create conditions to promote and encourage

research which contributes to the conservation and

sustainable use of biological diversity

Pay due regard to cases of present or imminent

emergencies that threaten or damage human, animal

or plant health

Consider the importance of genetic

resources for food and agriculture

and their special role for food security

7.1

0.2

016

Riku Lumiaro/Ympäristöhallinnon kuvapankki

Genetic resource - definition

Art. 2 of the CBD defines genetic resources:

"Genetic resources" means genetic material of

actual or potential value.

Genetic material: "Genetic material" means

any material of plant, animal, microbial or

other origin containing functional units of

heredity.

7.1

0.2

016

Riku Lumiaro/Ympäristöhallinnon kuvapankki

Ngoya protocol - scope Traditional knowledge associated with genetic

resources

In principle any biological material used for research

and development when genes or biochemical

compounds of the material is involved

Examples:

Development of drugs from the use of plant

components, such as compounds found in resin and

latex

Commercialization of a gene sequence from wild

plants to e.g. increase the resistance of crops to

pests

7.1

0.2

016

Nagoya protocol – not in scope

Plant Genetic resources for Food and Agriculture,

Plant treaty (ITPGRFA) Annex 1 species

genetic resources used as bulk commodities ƒ

genetic resources acquired from areas beyond the

limits of national jurisdiction (e.g., high seas, deep

seabed, Antarctic Treaty Area)

ƒhuman genetic resources

7.1

0.2

016

Nagoya protocol – benefit sharing

Defined in MAT; mutually agreed terms

Benefits may be monetary or non-monetary

such as royalties and sharing research results

7.1

0.2

016

Riku Lumiaro/Ympäristöhallinnon kuvapankki

Nagoya protocol – information and

authorities

National focal points (NFPs) and competent

national authorities (CNAs) serve as contact

points for information, grant access or cooperate on

issues of compliance

Access and Benefit-sharing Clearing-House shares

information, such as domestic regulatory ABS

requirements or information on NFPs and CNAs

https://absch.cbd.int/

Information on the permit (PIC or its equivalent) will be

sent to the ABS Clearing-House for the constitution

of the internationally recognized certificate of

compliance

7.1

0.2

016

Nagoya protocol - legislation

Three levels

1. International law (the Protocol)

2. EU Implementation (regulation)

• EU level: ONLY user compliance measures

3. Member states approaches to access

(national laws)

• Member state level: ABS rules & principles

7.1

0.2

016

EU regulation 511/2014

Objective to implement compliance element

of Nagoya protocol

Main principle: Due diligence of users

Controls and checkpoints

Registered collections and Best practices

Entry into force on 12 October 2014

Is applicable as such in the member states

7.1

0.2

016

EU regulation – Due diligence

- Preventing misuse of GR: Due diligence

obligation for users of GR (Art. 4)

Due diligence = obligation to seek, keep &

transfer information associated with GR

- Due diligence declaration

7.1

0.2

016

Terhi Ryttäri/Ympäristöhallinnon kuvapankki

EU regulation - User obligations

Research and development on genetic resources

obtained from 12 October 2014 onwards:

Seek permission (PIC) from Competent National

Authorities (ABS clearing-house) of the providing

country

Negotiate an agreement with the conditions (MAT)

Send documents to authorities when receiving

research funding / before commercialising product

(due diligence declaration)

Pass on obligations to further users

Keep the documents (20 years)

7.1

0.2

016

User obligations

Other regulations (on e.g. protected

species) must still be complied with

EU Commission is preparing sectoral

guides for users of GR (2016;

http://ec.europa.eu/transparency/regexpert/)

EU guidance on scope is ready

7.1

0.2

016

EU regulation - Scope

Genetic resources after 12.10.2014 (Protocol

entered into force)

Parties to the Nagoya protocol (however, non-

parties may have GR-legislation)

Parties having national access legislation in

force

Parties demanding PIC and MAT

Traditional knowledge associated with GR

Check information from the ABS-CH:

https://absch.cbd.int/countries

7.1

0.2

016

Not in scope

Handling and storing of biological material and

describing its phenotype.

The use of digital data obtained from gene

sequencing, which is frequently stored in publicly

available databases, is considered to be out of scope

of the ABS Regulation. However, the use or

publication of such data might be covered by

conditions set in the mutually agreed terms, which

should be respected – not clearly out of scope!

A person who only transfers material will not be a

user in the meaning of the Regulation. Information to

subsequent users must be given to enable them to

comply with their due diligence obligations

7.1

0.2

016

EU NP scope guidance 7.1

0.2

016

Within scope (cumulative

conditions*) Outside of scope

Geographic

scope

(provenance

of GR**)

Access in

…

Areas within a country's

jurisdiction

Areas beyond national

jurisdiction or covered by

Antarctic Treaty System

Provider

country is

…

Party to the Nagoya Protocol Not a Party to the Protocol

Provider

country

has …

Applicable access legislation No applicable access legislation

Temporal

scope

Access … On or after 12 October 2014 Before 12 October 2014

Material

scope

Genetic

resources

Not covered by a specialised

international ABS instrument

Covered by a specialised

international ABS instrument

Non-human Human

Obtained as commodities but

subsequently subject to R&D

Used as commodities

Utilisation R&D on genetic and/or

biochemical composition

No such R&D

Personal

scope

Natural or legal persons

utilising GR

Persons only transferring GR or

commercialising products based

on it

Geographic

scope

(utilisation)

R&D … Within the EU Exclusively outside of the EU

Nagoya protocol - parties

At the moment there are 78 parties to the

Protocol and 7 ratified but not yet party

EU Commission is a party to the Protocol

E.g. Croatia, Czech Republic, Finland,

Germany, Spain, Hungary, Denmark (EU),

parties as well as Switzerland and Norway

(non-EU), Sweden ratified

Canada, Russia not signed; US not CBD-

party

7.1

0.2

016

Nagoya protocol – parties

- Eg. France, Italy, Greece and Spain will regulate

access

- However, in Spain access is free for taxonomic

research. Commercial and non-commercial research

have different access procedures

- Other EU member states: mostly no access

regulation

Access regulation especially in countries of high

biodiversity (e.g. India, Bolivia, Brazil, South-Africa)

Many countries have special treatment of access for

non-commercial research

7.1

0.2

016

Implications on CWR conservation

Finland, Sweden and Denmark do not regulate

access of GR – no NP implications on conservation

Norway: “The King in Council may make regulations under

the Act introducing a general requirement to hold a permit for

collection and utilisation of genetic material. This provision only

applies to genetic material collected from the natural

environment. Removal from public collections and collection for

use and further breeding and cultivation in agriculture and

forestry are excepted from the requirement to hold a permit.”

- possible implications on conservation

Iceland: non-party - possible implications on

conservation later on

7.1

0.2

016

Implications on CWR conservation

Material from Denmark, Finland and Sweden

is free for any use – no implications for in situ

or ex situ conservation

Norway and Iceland?

Countries that regulate access – no

implications for in situ conservation as such.

There may be implications for ex situ

conservation, especially when R&D is used.

However:

7.1

0.2

016

Implications on CWR conservation

ITPGRFA Annex 1 species are OUT of the NP

scope - when used for plant breeding and

when the country of origin is a party to

ITPGRFA

Storing specimens OUT of the scope

Countries may have differential treatment for

non-commercial research (art. 8 NP): “Parties may

create conditions to promote and encourage research which

contributes to the conservation and sustainable use of biological

diversity” and “Consider the importance of genetic resources for

food and agriculture and their special role for food security”

7.1

0.2

016

Implications on CWR conservation

Nagoya protocol may have implications on

collections, especially when material from

countries regulating access is transferred to

users

When sending material to users, any

documentation on existing PIC or MAT should

be attached

A paragraph reminding users of their

obligation to seek PIC from the country of

origin of the GR may be included to the

SMTAs

7.1

0.2

016

7.1

0.2

016

Thank you!