Centre for Genetic Resources, the Netherlands
EU Regulation implementing the Nagoya Protocol in the Union: user obligations 11 January 2016, Bert Visser
Centre for Genetic Resources, the Netherlands
This presentation
Convention on Biological Diversity Nagoya Protocol EU Regulation 511/2014 EU Implementing Act 2015/1866 EU Guideline National law Consequences for NL users
Centre for Genetic Resources, the Netherlands
Convention on Biological Diversity
CBD = international agreement = international law● needs national implementation
Objectives● conservation of biological diversity● sustainable use of its components● fair and equitable sharing of the benefits
Entry into force and membership● 28 December 1993; almost universal membership
New principle and concept● sovereign rights of states; access and benefit-sharing (ABS)
From IPRs to ABS: the Grand Bargain
South ← → North Poor Rich
Genetically Rich Genetically Poor
Genetic Resources → Bio-industriesShare of benefits ← Products of bio-industries
↓Incentives and means for nature conservation
Justice in exchange
Centre for Genetic Resources, the Netherlands
Nagoya Protocol (NP)
Protocol to the CBD● elaboration of the ABS provisions of
the CBD What is new?
● ABS concept operationalised● Compliance rests with Parties to the NP (= member states)
Entry into force ● 12 October 2014● EU and NL have ratified
Centre for Genetic Resources, the Netherlands
Implementation in the EU
Nagoya Protocol is an agreement between states● binding between “Contracting Parties”
Needs further legislation to become binding to citizens● EU Regulation
EU Regulation applies directly to all EU citizens
Centre for Genetic Resources, the Netherlands
Implementation in the EU
REGULATION (EU) No 511/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 April 2014
on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, .......
Centre for Genetic Resources, the Netherlands
EU Regulation 511/2014
Implementing the Nagoya Protocol Binding and applicable from 12 October 2014 in NL
● Some provisions only operational from 12 October 2015 Major principles
● Due diligence● Show that you did your best to follow the law
● Registered collections● Safe providers, no further user obligations
● Best practices● Associations of users with “quality scheme”
● Tracking and tracing demonstrable
Centre for Genetic Resources, the Netherlands
EU Implementing Act 2015/1866
Providing detailed rules on the implementation of Articles 5, 7 and 8 of Regulation 511/2014
● register of collections● due diligence declarations in the case of research grants and
product marketing● application of best practices
Centre for Genetic Resources, the Netherlands
EU Guideline
To be published soon Contents
● regulation scope (when does it affect me? what is utilization? how to interpret the term R&D?)
● many examples listed as cases ● explanation of the concept of due diligence● when to make a declaration of use?● selected sector-specific issues
Further sector-specific guidance documents (7) under development in 2016
Centre for Genetic Resources, the Netherlands
National law
Tweede Kamer der Staten-Generaal Vergaderjaar 2014–2015 34 142 Regels ter implementatie van het Nagoya Protocol (Wet implementatie Nagoya Protocol) Nr. 2 VOORSTEL VAN WET Wij Willem-Alexander, bij de gratie Gods, Koning der Nederlanden, Prins van Oranje-Nassau, enz. enz. enz.
Centre for Genetic Resources, the Netherlands
National law To fill in national level implementation in NL
● NVWA monitoring agency (operational by April 2016)
● CGN national focal point ● sanctions and penalties
● “... om een misdrijf kan een gevangenisstraf van ten hoogste zes jaar, een taakstraf of een geldboete van de vijfde categorie worden opgelegd. Dit is € 81.000,– voor personen en € 810.000,– voor rechtspersonen. Als het gaat om een overtreding, kan hechtenis van ten hoogste één jaar, een taakstraf of een geldboete van de vierde categorie worden opgelegd. Het gaat dan om € 20.250,– voor personen en € 81.000,– voor rechtspersonen.”
Centre for Genetic Resources, the Netherlands
What is relevant for whom?
The EU Regulation may apply to all users of genetic resources in all EU Member states
The EU Regulation does not apply to exchanges for which the International Treaty and Standard MTA apply
● = most genetic resources obtained from plant genebanks
Centre for Genetic Resources, the Netherlands
Important terms
‘Genetic resources’ means genetic material of actual or potential value of plant, animal, microbial or other origin containing functional units of heredity
‘Utilisation of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology
Centre for Genetic Resources, the Netherlands
Important terms
‘Prior Informed Consent’ (PIC) means approval, by the authorities of the country where access is sought, of access to and utilization of genetic resources
‘Mutually Agreed Terms’ (MAT) are reached between two private parties under civil law contract. MTA may be used.
Centre for Genetic Resources, the Netherlands
What are my obligations?
If you perform R&D on genetic resources obtained from 12 October 2014 onwards:
● if possible through/with local counterpart, seek documented permission from Competent National Authority (normally delegated in case of collections) (http://www.cbd.int/doc/lists/nfp-abs-cna.pdf)
● proceed to negotiate conditions with provider and document in the form of contract (a local counterpart helps!)
● document further R&D (tracking and tracing)● show documentation in case of submitting proposals for grants
and of marketing products (obligation under EU Regulation)● pass on obligations to further users
Centre for Genetic Resources, the Netherlands
What to document?
internationally-recognised certificate, or document(s) showing
● date and place of access of resources or traditional knowledge;
● description of the genetic resources or of traditional knowledge;
● source from which the genetic resources or traditional knowledge associated with genetic resources were obtained, as well as subsequent users (development chain);
● rights and obligations relating to access and benefit-sharing including for subsequent applications and commercialisation;
● access permits, where applicable (Competent National Authority);
● mutually agreed terms, including benefit-sharing arrangements, where applicable.
Centre for Genetic Resources, the Netherlands
What is an internationally-recognised certificate?
Only documents posted on the CBD website by the providing country
● See http://www.cbd.int/abs/ In case you obtain genetic resources from
a collection holder, check if signing regular MTA is sufficient
● Always the case for EU registered collections
Centre for Genetic Resources, the Netherlands
What more can I do?
Document what you had already obtained before 12 October 2014 by printing passport data on CD-ROM
● not a legal obligation but a precaution to avoid future conflicts Be prepared for questions on the legal status of acquired
genetic resources● e.g. publication policies journals
Consider your options in accessing genetic resources● worth the effort?● from a collection, or from nature or farmers’ fields?● from which country (track record)?
Centre for Genetic Resources, the Netherlands
Basic guidance
Rules do not apply if you only provide a service (e.g. sequencing) for a third party
If you buy abroad from a local market, Regulation applies If you buy from a trader, request access documentation Still to be decided: your obligations when using a UPOV-
protected variety Obligations also apply to imports from other EU countries USA will not join Nagoya Protocol: rules do not apply to
imports from USA In doubt, do not proceed
Centre for Genetic Resources, the Netherlands
ABS National focal point
Centre for Genetic Resources, the Netherlands
ABS National focal point
See www.absfocalpoint.nl for●more background information●frequently asked questions●any new developments●asking your own questions
Centre for Genetic Resources, the Netherlands
Recommendations
• Document what you have in stock
• Secure legal status of new materials at access
• Document how you use new materials for R&D
• Pass on obligations to further users
• Be aware of sanctions
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