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

EU Regulation implementing the Nagoya Protocol in the Union: user obligations 11 January 2016, Bert Visser


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


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


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


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


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, .......


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


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


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


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.


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.”


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


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


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.


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

http://www.cbd.int/doc/lists/nfp-abs-cna.pdf







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.


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

http://www.cbd.int/abs/


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)?


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


ABS National focal point


ABS National focal point

See www.absfocalpoint.nl for●more background information●frequently asked questions●any new developments●asking your own questions

http://www.absfocalpoint.nl/


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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Documents

Centre for Genetic Resources, the Netherlands EU Regulation implementing the Nagoya Protocol in the Union: user obligations 11 January 2016, Bert Visser