EU Regulation implementing the Nagoya Protocol in the Union: user obligations

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

2. Thispresentation • Convention on BiologicalDiversity • Nagoya Protocol • EU Regulation 511/2014 • EU Implementing Act 2015/1866 • EU Guideline • National law • Consequencesfor NL users

3. Convention on BiologicalDiversity • CBD = international agreement = internationallaw • needsnationalimplementation • Objectives • conservation of biologicaldiversity • sustainableuse of itscomponents • fair and equitablesharing of the benefits • Entry intoforce and membership • 28 December 1993; almostuniversalmembership • New principle and concept • sovereign rights of states; access and benefit-sharing (ABS)

4. FromIPRsto ABS: the Grand Bargain South ← → North PoorRich GeneticallyRichGeneticallyPoor Genetic Resources → Bio-industries Share of benefits ← Products of bio-industries ↓ Incentives and means fornatureconservation Justice in exchange

5. Nagoya Protocol (NP) • Protocol to the CBD • elaboration of the ABS provisions of the CBD • What is new? • ABS concept operationalised • Compliance restswithPartiesto the NP (= member states) • Entry into force • 12 October 2014 • EU and NL have ratified

6. Implementation in the EU • Nagoya Protocol is an agreement betweenstates • binding between “ContractingParties” • Needsfurtherlegislationtobecome binding tocitizens • EU Regulation • EU Regulationappliesdirectlytoall EU citizens

7. 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, .......

8. EU Regulation 511/2014 • Implementing the Nagoya Protocol • Binding and applicablefrom 12 October 2014 in NL • Someprovisionsonlyoperationalfrom 12 October 2015 • Major principles • Due diligence • Show thatyoudidyour best to follow the law • Registeredcollections • Safe providers, no further user obligations • Best practices • Associations of users with “qualityscheme” • Tracking and tracingdemonstrable

9. 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

10. EU Guideline • Tobepublishedsoon • Contents • regulation scope (when does it affect me? what is utilization? howtointerpretthe term R&D?) • manyexampleslisted as cases • explanation of the concept of due diligence • whento make a declaration of use? • selected sector-specific issues • Further sector-specificguidancedocuments (7) under development in 2016

11. National law TweedeKamer 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.

12. National law • Tofill in national level implementation in NL • NVWA monitoring agency (operationalby April 2016) • CGN nationalfocal 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.”

13. What is relevant forwhom? • The EU Regulationmayapplytoall users of genetic resources in all EU Member states • The EU Regulation does notapplyto exchanges forwhich the International Treaty and Standard MTA apply • = most genetic resources obtainedfrom plant genebanks

14. 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

15. 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.

16. What are myobligations? • Ifyouperform R&D on genetic resources obtainedfrom 12 October 2014 onwards: • ifpossiblethrough/withlocal counterpart, seekdocumentedpermissionfrom Competent National Authority (normallydelegated in case of collections) (http://www.cbd.int/doc/lists/nfp-abs-cna.pdf) • proceedtonegotiateconditionswith provider and document in the form of contract (a local counterpart helps!) • document further R&D (tracking and tracing) • show documentation in case of submittingproposalsforgrants and of marketing products (obligationunder EU Regulation) • pass on obligationstofurther users

17. Whatto document? • internationally-recognisedcertificate, 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.

18. What is aninternationally-recognisedcertificate? • Onlydocumentsposted on the CBD website by the providing country • See http://www.cbd.int/abs/ • In case youobtaingenetic resources from a collectionholder, check ifsigningregular MTA is sufficient • Always the case for EU registeredcollections

19. What more can I do? • Document whatyou had alreadyobtainedbefore 12 October 2014 byprintingpassport data on CD-ROM • not a legalobligation but a precautiontoavoidfutureconflicts • Be preparedforquestions on the legal status of acquiredgenetic resources • e.g. publicationpoliciesjournals • Consideryour options in accessinggenetic resources • worth the effort? • from a collection, or fromnature or farmers’ fields? • fromwhich country (track record)?

20. Basic guidance • Rules do notapplyifyouonlyprovide a service (e.g. sequencing) for a third party • Ifyoubuyabroadfrom a local market, Regulationapplies • Ifyoubuyfrom a trader, request access documentation • Stilltobedecided: yourobligationswhenusing a UPOV-protectedvariety • Obligationsalsoapplytoimportsfromother EU countries • USA willnotjoin Nagoya Protocol: rules do notapplytoimportsfrom USA • In doubt, do notproceed

21. ABS National focal point

22. ABS National focal point • See www.absfocalpoint.nlfor • more background information • frequentlyaskedquestions • any new developments • askingyourownquestions

23. Recommendations Document whatyou have in stock Secure legal status of new materials at access Document howyouuse new materialsfor R&D Pass on obligationstofurther users Be aware of sanctions