Implementation of the Nagoya Protocol in...

Eine Zukunftsaufgabe in guten Händen

Implementation of the Nagoya Protocol

in Germany

Advancing Implementation of the Nagoya Protocol, Brussels 23rd November 2017

Division I 1.4 "Competent National Authority for the Nagoya Protocol"

Legal Framework

A(ccess)

• Generally free (no PIC)

• Solely subject to general restrictions of public & private law where applicable

B(enefit Sharing)

• Not required (no MAT)

C(ompliance)

• Based on EU legislation

• Regulation (EU) No 511/2014:

Entry into force on 12.10.2014

• Impl. Regulation (EU) 2015/1866:

Entry into force on 9.11.2015

• German Implementing Act

adopted on 25.11.2015

• Entry into force on 1.7.2016

• Party to Nagoya Protocol since

21.7.2016

• Statutory Regulation (under

discussion)

Competent National Authority

German government’s scientific authority

with responsibility for national &

international nature conservation

Tasks:

• Scientific advice to underpin policy & administrative decisions

• Funding programmes

• Information & education

• Enforcement

CITES

Nature conservation in North Sea & Baltic Sea Exclusive

Economic Zone (EEZ)

Antarctic Treaty

German Genetic Engineering Act

Nagoya Protocol

Institutional Structure

NFP: Federal Ministry for the Environment, Nature Conservation, Building

and Nuclear Safety (BMUB)

CNA: Federal Agency for Nature Conservation (BfN)

Cooperation

on human

pathogens

Cooperation on

GR for food &

agriculture

Information on patent

applications

Declarations & applications,

checks & sanctions, information &

advice

User

Division I 1.4 "Competent National Authority for the Nagoya Protocol"

Responsibilities of BfN

• Receiving due diligence declarations

• Processing applications for inclusion in EU

register of collections

• Regularly verifying criteria for such registration

• Commenting on applications for recognition of

best practice

• Checking user compliance

• Enforcing compliance & sanctioning

infringements

• Cooperating with Competent National

Authorities in provider states

• Informing & advising German users &

collections

Informing & Advising

• Flyer

• National Clearing-House

• Presentations & workshops

! ?

!

• ABS Helpdesk

• Booklet • Poster • Christmas card

Informing & Advising

• Encouraging & supporting development of best practices, etc.

• FAQs • Recommendations for action

• BMUB-BfN ABS

Roundtable

Informing & Advising

• Collecting ABS

success stories

• Internat. ABS Dialogue /

Access profiles

• EU CNA Meeting

• Training materials for

collections

Interaction with ABS CH

CPC through DECLARE

Interim Report submitted

Checkpoint(s)

• BfN as only

‘institutional’

checkpoint

• Collects & receives relevant information from

different sources / ‘functional’ checkpoints

• Stage of research funding (Art. 7.1)

• Final stage of product development

(Art. 7.2) – 4 weeks in advance

• Disclosure of origin in patent

applications – 2 times per year

• International collaboration CNAs of

provider states

• User assessments & controls

User checks

-> Anonymous questionnaire to assess / provide indications of ABS awareness of different sectors

-> Additional basis for sector specific assessment

User survey

User identification

-> Data base of potential users as starting point

-> Identification process included estimation of user probability

-> Checks of ”leaders” to learn, practice & determine benchmarks (-)

-> First control cycle based on random selection

-> Following control cycles based on sector & user specific assessments

Step-wise Approach to User Checks

User Identification

Knowing our users:

• 1st assessment of German users & sectors in 2005

• Users of Genetic Resources in Germany (BfN-Skripten 126, 2005)

• ~ 500 users identified

• 2nd assessment in 2016/2017

• ~ 2600 potential users identified

• But how many are real users???

21,2%

35,8%

43,0%

Updating of user information from 2005

Deleted

Updated

Unchanged

User Survey

Sectors

Replies

received

Institutions

contacted

Biotechnology 66 1.051

Public research 50 327

Others 45

Pfant breeding 39 434

Pharma 35 196

Cosmetics 27 410

Food & feed 18 100

Animal breeding 4 53

Do not know 6

Biocontrol 2 59

292 2.630

11,10% 100%

Start in a written manner

On-the-spot checks: inspection of docs (if necessary or randomly)

Taking samples (if necessary)

Enforcing compliance

Ultima ratio: regulatory fines

Basis:

• Periodically reviewed plans using a risk-based approach

• Substantiated concerns

Step-wise approach:

• Reasonable balance between “proportionate” & “effective”

Request for information on

• Measures taken to reduce risk of

non-compliance

• Documentation of due diligence

• Due diligence declarations

Measures:

• Orders to remedy

breaches

• Prohibition of utilization

• Seizure of genetic

resources

• Confiscation of genetic

resources

• No criminal sanctions

but regulatory offences

• Regulatory fine up to

50.000 €

• Regulatory fine may

exceed financial

benefit that perpetrator

has obtained (i.e.

50.000 € may be

exceeded, in principle

ad infinitum)

User Checks

Risk-based Approach

Objective:

More frequent control of high risk users than low risk users

(i.e. not entirely random)

Thank You Very Much!

Federal Agency for Nature Conservation

(Bundesamt für Naturschutz - BfN)

Division I 1.4

Konstantinstr. 110, D-53179 Bonn

Email: Nagoya-CNA@bfn.de

Tel: +49-228/8491-1311

Fax: +49-228/8491-1319

Web: http://abs.bfn.de