Working Out ABS

Int. Chamber of Commerce

24-25 November 2014

EU Regulation implementing the Nagoya Protocol in the Union

Oct. 2010

Pillars of the Nagoya Protocol

- the ABC of ABS -

"Access"

Not implemented at EU level

Each State/Party to decide if they establish access rules, incl. EU Member

States, to be looked up on the ABS Clearing-House

"Compliance"

Due diligence obligation for all users

Key of the EU regulation

"Benefit sharing"

Subject to contractual agreement

June 2014

State of play

• The Nagoya Protocol entered into force on 12 October 2014;

• The EU ABS Regulation (No. 511/2014) is applicable as of then;

• Articles 4, 7 and 9 will only apply one year later;

Overview of the EU ABS regulation

user's due diligence obligation

monitoring =

checkpoints

compliance checks

GR from a registered collection

applying a recognised

best practice

penalties

Receiving funding

at the final stage of

development

Definitions

• EU ABS Regulation contains a number of definitions:

• Genetic material- any material of plant, animal, microbial or

other origin containing functional units of heredity;

• Genetic resources – genetic material of actual or potential value

• Access – acquisition of GR and TKaGR in a Party to NP

• User – natural or legal person that utilises GR or TKaGR

• Utilisation of GR – to conduct research and development on the genetic and/or biochemical composition of GR, including through the application of biotechnology

• TKaGR – traditional knowledge held by an indigenous or local community that is relevant for the utilisation of GR and that is a such described in MAT applying to the utilisation of GR

Definitions – cont.

• Further, EU ABS Regulation defines:

• Mutually agreed terms

• Internationally recognized certificate of compliance

• Collection – a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entity;

• Association of users – organisation established in acc. With the requirements of the MS in which it is located, that represents the interests of users and that is involved in developing and overseeing the best practices

• Definitions of Nagoya Protocol and CBD Convention applicable

Scope of EU ABS Regulation

Does the activity fall under the scope of the ABS regulation?

•On substance, incl. specialised instruments?

•Temporally?

•Geographically?

IF YES

Scope - substance

• The EU ABS Regulation concerns 'utilisation' of genetic resources (not commodity trade)

• It applies to genetic resources (and associated traditional knowledge) obtained from parties to the Nagoya Protocol with ABS legislation in force

• It does not cover genetic resources that are governed by specialised international instruments (e.g. MLS of the ITPGRFA)

Scope – temporal

• EU ABS Regulation applies to genetic resources accessed after entry into force of the Nagoya Protocol for the Union (thus after 12 Oct. 2014)

Scope – geographical

• EU ABS Regulation is applicable to genetic resources within national jurisdictions;

• Genetic resources obtained from areas beyond national jurisdiction (ABNJ), in particular high seas (see UNCLOS), or covered by Antarctic Treaty – outside of the scope

Overview of the EU ABS regulation

user's due diligence obligation

monitoring =

checkpoints

compliance checks

GR from a registered collection

applying a recognised

best practice

penalties

Receiving funding

at the final stage of

development

Key provisions of the EU ABS regulation

user's due diligence obligation

The core of the EU ABS regulation due diligence

Obligation to provide information on:

• When? Where? What?

• From whom and to whom?

• Access permit (PIC)?

• Mutually agreed terms? - incl. benefit-sharing

• Presence or absence of rights and obligations?

Key provisions of the EU ABS regulation

user's due diligence obligation

monitoring =

checkpoints

Receiving funding

at the final stage of

development

Checkpoints

• Two checkpoints foreseen by the EU ABS Regulation:

• At the stage of funding;

• Final stage of product development

• Due diligence declaration to be sent to the competent authorities of a Member State concerned

• Modalities for these checkpoints will be defined by an implementing act

Key provisions of the EU ABS regulation

user's due diligence obligation

monitoring =

checkpoints

compliance checks

penalties

Receiving funding

at the final stage of

development

Compliance checks and penalties

• Compliance checks carried out by competent authorities:

• in accordance with reviewed plan (risk-based approach)

• on the basis of substantiated complaints;

• In case of shortcomings – remedial action or measures.

• Checks need to be effective, proportionate, dissuasive and detect cases of non-compliance.

• Measures for penalties (effective, proportionate and dissuasive) to be put in place by MS

Key provisions of the EU ABS regulation

user's due diligence obligation

monitoring =

checkpoints

compliance checks

GR from a registered collection

applying a recognised

best practice

penalties

Receiving funding

at the final stage of

development

Compliance promotion mechanisms

• Tools aimed at facilitating compliance:

• Registered collections

• Recognized best practices

• Modalities for application of these tools will be provided for in the implementing act

Registered Collections

• Criteria to register collection or part of it defined (Art. 5(3) EU Regulation):

• Standardized procedures for exchanging samples of genetic resources

• Supply of GR only with appropriate documentation

• Recognition granted by Member States

• Register established and maintained by the Commission

Best practices

• Recognition granted by the Commission

• Who can apply?

• Association of users and

• Other interested parties

• Criteria defined in the EU ABS Regulation

• Specific combination of procedures, tools and mechanisms, when effectively implemented by a user enabling the user to comply with the obligations under Article 4 and 7 of the EU Regulation

Implementing act

• Work on implementing act on-going;

• It will define modalities for: • Art. 5 – collections

• Art. 8 – best practices

• Art. 7 - checkpoints

• Expected entry into force – 3Q 2015

Ideas for the implementing act - registered collection

• The implementing act will define:

• Information, which are required to be in the register;

• Interaction between competent authorities and the Commission when including the collection into the register;

• Frequency and nature of checks;

• Remedial actions.

• GR obtained from registered collection – user is considered to have exercised due diligence – reflected in due diligence declarations

Ideas for the implementing act - best practice

• Application for recognition

• Addressed to the Commission

• Justification for interest that qualifies the association of users or other interested party to develop and oversee combination of procedures, tools or mechanisms

- which ensure that, when effectively implemented by a user, enable the user to comply with the obligations under Article 4 and 7 of Regulation )

• Procedural steps:

• Granting the recognition and withdrawal

• Information on subsequent changes

• Procedure for situations where deficiency in best practice is established

Ideas for the implementing act – compliance checks (1)

• Due diligence declaration at the stage of research funding

• MS and Commission to request the due diligence declaration from all recipients of funding

• If mixed private/ public sources declaration required only once

• If mixed MS and the Commission funding – declaration submitted to the MS

• If exclusively private sources – declaration submitted to competent authority of MS where located

• If funding granted outside EU – also included

Ideas for the implementing act – compliance checks (2)

• Due diligence declaration at the stage of final development of a product

• (a) When market approval sought

• (b) When notification required

• (c) When placing product on a market (developed via utilisation of GR)

• When result of utilisation sold or transferred outside of EU

• When result of utilisation sold or transferred for the purpose of a), b) or c).

• Where the utilisation has taken place outside of EU, declaration to be made to MS where the product enters the Union

Implementing act

• Time frame

• Stakeholder meeting – 9 December 2014

• 1st committee meeting – 1st Q 2015

• Adoption – October 2015

Next steps

• EU level: • Work on implementing act

• Preparation of (sectoral) guidance documents

• MS level:

• Designation of competent authorities

• Lay down rules on penalties

• Organize monitoring of compliance checks

Thank you for your attention!

• For more information see:

http://ec.europa.eu/environment/nature/biodiversity/international/abs/index_en.htm

(incl. link to the EU ABS regulation)

as well as

www.cbd.int/abs

• Contact: Alicja Kozlowska, DG ENV.E.2