Drafting the Genetic

1. Drafting the Genetic Resource Act of Taiwan Jau-Hwa CHEN Warren H.J. KUO Professor, Department of Financial and Economic Laws, Fu-Jen Catholic University Professor, Department of Agronomy, National Taiwan University

2. North American USSR Europe China Central American South Asia Japan _ Caribbean Tropical Africa _ X 103 South East Asia 100 80 60 40 20 _ Southern Africa 500 300 100 Austra-New Zeland South American Plant garden World distribution of plant species and botanic gardens From: WWF & IUCN

3. Political Economy of Genetic Resources Genetic Resources Right Intellectual Property Right CDB vs WTO Bonn Guidelines TRIPs

4. Prior Informed Consent Benefit Sharing Technology Transfer Bioprospecting Conservation Utilisation Patent Access Invention Political Economy of Genetic Resources The North The South Genetic Resources Traditional Knowledge

5. The way of the reconciliation between two rights is by no means unclear. It has been a common ethic doctrine that you should get a “Prior informed consent” before doing something to somebody else, such as to build a biobank or to collect plants in other countries. Also it has been widely accepted that, if your profits are derived from others’ stuffs, then benefit sharing is justifiable. The question is: how to implement PIC and ABS. Before an international consensus is reached, the only way south countries can do is national registration.

6. Status of National legislation In force • Biodiversity Laws • Access and benefit sharing Australia, India, South Africa, Ethiopia, Gambia, Bulgaria, Costa Rica, Peru, Venezuela 9 Philippines, Portugal, Bolivia, Brazil, Panama 5 Drafting • Asia 19 Countries • Pacific Islands 14 Countries • Africa 11 Countries • America 9 Countries 53

7. TAIWAN, islands of diversified biota

8. TAIWAN, islands of diversified biota http://taibnet.sinica.edu.tw/chinese/taibnet_reference_sum.asp

9. Bio-prospecting in Taiwan RHS Garden, 1998, 123:441-3 http://www.crug-farm.co.uk/news/news_taiwan.htm

10. Bio-prospecting in Taiwan camptothecin Nothapodytes nimmoniana Graham irinotecan hydrochloride CPT-11, Camptosar By Camptosar, the Japanese company YAKULT earns 150 million Euro per year without benefit sharing with Taiwan.

11. Bio-prospecting in Taiwan 14 Plant Patents Yangmingshan National Park

12. TAIWAN Drafting The Genetic Resource Act The Drafters Warren H.J. KUO, Agronomy Ming-Yan SHIEH, Law Jau-Hwa CHEN, Law Chung-His LEE, Law Kuei-Jung NI, Law Four biologists: Botany Microbiology Marine Biology Entomology

13. Definition CBD Genetic resource: genetic material of actual or potential value. Genetic material: biological material that containing functional units of heredity The definition is useless, because any genetic material is of potential value sometime somewhere.

14. Genetic resource Biological resources Definition The OECD’s interpretation of the definition of CBD is somewhat obscure to us, for linguistic reason. OECD Biological material Genetic material

15. Definition We agree that, genetic material is embedded in biological material, which may be alive or dead. However, all the biological materials within a confined territory we call it biological resources. Likewise, all the genetic materials within a confined territory we call it genetic resources. It is obvious that to control genetic materials is to control biological materials in most cases.

16. Dead Alive Biological material Genetic material Definition Capable of reproduction Biological Resources : alive Genetic Resources Biological Resources : dead

17. Definition • Living bulk commodities for commercial • consumption, planting/decoration, • other traditional use within the country x Control over bioprospecting Biological materials should be controlled at the customs • Living materials for breeding, composition • screening et al. • Non-viable specimen for taxonomic studies x

18. Collected from natural habitat “First class bio-prospecting” For the purpose of academic research “Second class bio-prospecting” Living materials for breeding, composition screening et al. Acquired from germplasm bank Subjected to germbank policy / International Treaty on Plant Genetic Resources for Food and Agriculture

19. Application and approval of bio-prospecting The first class bio-prospecting The second class bio-prospecting

20. Preliminary examination by competent authority Asked to revise the proposal by competent authority Application of an acquisition All required documents submitted Inform/Consult with landholder, shcolars, et al. Preliminary examination finished Permission certificate issued Acquisition approved Acquisition rejected First class bio-prospecting

21. Asked to revise the proposal by competent authority Application of an acquisition Preliminary examination by competent authority All required documents submitted Preliminary examination finished Consult with scholars The competent authority to examine the agreements Application accepted Application rejected Acqisition approved The landholder informed. Representatives of the holder, applicant and competent authority to reach an agreement concerning bioprospecting activities, material transfer, and benefit sharing Agreement do not reach, Acquisition rejected Permission certificate issued Second class bio-prospecting

22. Post supervision and control 1. Prospecting report • The progress of the bio-prospecting; • Biological materials collected and the conditions of their transportation; • Any information that is associated with the collected materials.

23. Post supervision and control 2. Commercial implication derived from genetic material • The first class bio-prospecting the applicants should proceed with the whole procedure of application and approval of the second class • The second class bio-prospecting the applicants must notify the competent authority and the landholder

24. Post supervision and control 3. Export of genetic materials acquired by certified activities • deposit a copy of each live sample to due germplasm bank • Material Transfer Agreement Dead specimens are free to export, without application to the competent authority • Material Transfer Agreement

25. Post supervision and control 4. Disclosure of origin in patent applications Switzerland EU US African Group Taiwan Disclosure requirement by Genetic Resources Act, not by Patent act Brazil et al.

26. Post supervision and control 4. Disclosure of origin in patent applications Patent seekers should submit to Patent Office: • The permits for exploring genetic resources in Taiwan • Describing the origins of genetic resources they used for the invention

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