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

2. 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

3. 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)

4. From IPRs to ABS: the Grand Bargain South ← → North Poor Rich Genetically Rich Genetically Poor Genetic Resources → Bio-industries Share of benefits ← Products of bio-industries ↓ Incentives and means for nature conservation Justice in exchange

5. 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

6. 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

7. 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,.......

8. 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

9. 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

10. 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

11. 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.

12. 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.”

13. 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

14. 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

15. 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.

16. 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)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

17. 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.

18. 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/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

19. 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)?

20. 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

21. Centre for Genetic Resources, the Netherlands ABS National focal point

22. Centre for Genetic Resources, the Netherlands ABS National focal point  See www.absfocalpoint.nl forwww.absfocalpoint.nl ● more background information ● frequently asked questions ● any new developments ● asking your own questions

23. 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