Novozymes Guiding principles for accessing genetic resources -and experience with the ABS management tool

1. Novozymes Guiding principles for accessing genetic resources -and experience with the ABS management tool Lene Lange, professor, dr.scient. Science Director, Molecular Biotechnology

2. Novozymes: ”Unlocking the magic of Nature” • Novozymes technology platform builds on biologically contained production of fungal and bacterial proteins in fungi and bacteria • We chose ”Unlocking the magic of Nature” as our main branding when we de-merged from Novo Nordisk in 2000 • Discovery from nature is one of our corner stones!

3. Sustainable use: Microbial isolation does not put pressure on the environment and Enzymes are eco-friendly solutions Replacing chemicals Saving energy Diminishing pollution Better use of raw materials Saving water With enzymes, tanneries use less rinse water in leather production Enzymes replace bromate in bread production Detergents with enzymes wash the clothes at lower temperatures Enzymes in animal feed reduce the amount of phosphorus in the dung Enzymes sqeeze out all of the juice from the fruits

4. food industrial enzymes function: 100 oC Starch/fuel textile baking detergent feed 1 pH 12 dairy Personal care -under very varying process conditions in the different market segments! 5 oC

5. Novozymes Annual Environmental Report-includes a CBD update and -is part of the Tripple Bottom Line reporting

6. How to be in CBD compliance • Before access and transfer of any biological material (soil sample, fruiting body, pure culture): • Priof informed consent must be achieved = PIC • from proper national governmental authority • under a contract of mutually agreed terms = MAT

7. Desirable: CBD should not be a barrier! • CBD should not be a barrier for scientific studies, for international collaboration, or for sustainable exploitation of nature´s biodiversity • CBD compliance should be achievable through win/win collaborations between the country of origin and the user • without exceeding red tape! • How do we get there?

8. Novozymes Guiding Principles (1995): we will do our utmost to ensure that: • no microbial strains or natural material obtained without prior informed consent from the country of origin will be included in screening • all such accessed materials must be covered by contracts and/or material transfer agreements • conditions should be on mutually agreed terms and should include benefit sharing, intellectual property rights and technology transfer where appropriate • contracts should be cleared by the proper authority in the country of origin • the country of origin should do the collections and will be named in relevant publications and patent applications

9. The Basic principle:Establishing win/win collaborations • Include both monetary and non-monetary compensations (viz technology transfer and capacity building) • Include compensations to country of origin for the mere option to screen accessed strains AND benefits if later commercialized • Prioritize scientist to scientist collaboration

10. Accessing the “magic of nature”-only one part of the discovery pool • Biodiversity -directly from nature • Man-made diversity • In silico discovery

11. CBD in perspective: importance of new pools of diversity is increasing • genome sequencing • => more genes from fewer organisms • other types of organisms as gene donors • not only microbes; alsoplants and animals • synthetic genes for heterologue expression • family and domain shuffling give new diversity • not just Protein Engineering • sophisticated bioinformatics searching tools • searching also among unknowns

12. Rodney Roberts - USDA Many Grey areas: are they covered by CBD or not? • isolation from exported/traded products? • normally you have exhausted your rights when selling the product, if not specifically stated • botanical gardens? • seed borne microbes? • universally ubiquitous species? • accessions from before 01.12.93?

13. Five CBD Pitfals • Mismatch of expectations! • Middle-men takes the benefit! • Difficulties to get PIC! • Obstacles for Scientist to Scientist collaboration! ?

14. More CBD Obstacles • lack of implemented national legislation • many countries simply out of the loop! • lack of contract and patenting experience • difficult to be sitting on both sides of the table • lack of knowledge about differences in the various business segments • (e.g. profit margin differences between pharma and industrial) • academia not fully implementing CBD! • we risk that the hits end up in industry and when we ask for PIC it cannot be provided => we can not evaluate the new hit

15. The SECO ABS Management Tool • Recommendations regarding • PIC, • MAT, • Benefit sharing, • Conservation and sustainable use, • Information and transparency • are useful and well described. • In full accordance with the NZ guiding principles • The recommendations regarding TK and on Community and Indigenous peoples participation are more complex

16. Additional points to be considered for the ABS management tool –as good practice! • provider to do the collection • building on scientist to scientist collaboration • duplicate sample to be left in country of origin • disclosure of country of origin and PIC details • importance and value of technology transfer • integration of CBD compliance in the R&D project structure and decision process of companies • benefit sharing, reflecting the contribution made • progressively more screening work done in provider country => fewer strains / higher benefit • guiding principles for use of culture collections • (ABS:OK from organization governing the collection?)

17. Accessing from International Culture collections, -an important CBD issue • A Code of Conduct for accessing culture collection strains is needed

18. Recommendation for code of conduct on CBD/Culture collections • Purchased strains from culture collections should be freely included into both scientific and industrial screening/evaluations but only moved into commercialization when CBD compliance has been ensured • The establishment of an international fund for such CBD compensations should be considered

19. The international discussion: there are three major outstanding CBD issues • Introduction of a Certificate of Origin to track genetic resources • Integration of CBD in the patent system? • done e.g. by making a voluntary or compulsory disclosure of origin a demand for patent application completion • How could indigenous people´s rights be ensured • even if the Biodiversity Convention builds on and specifically states that the biological resources are the government´s souvereign rights

20. Thank you for your attention!