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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: [email protected]
Tel: +49-228/8491-1311
Fax: +49-228/8491-1319
Web: http://abs.bfn.de