Download - Drafting the Genetic
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
100 80 60 40 20
X 103
Plant garden
500300100
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South American
North American
Central American
Caribbean Tropical Africa
Southern Africa
EuropeUSSR
South Asia
China
Japan
South East Asia
Austra-New Zeland
World distribution of plant species and botanic gardens From: WWF & IUCN
Political Economy of Genetic Resources
CDB vs WTOBonn Guidelines TRIPs
Genetic Resources
Right
IntellectualProperty
Right
Prior Informed Consent
BioprospectingGenetic ResourcesTraditional Knowledge
The South
The North
Patent
Access Invention
Benefit Sharing
ConservationUtilisation
Technology Transfer
Political Economy of Genetic Resources
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.
Status of National legislation
Australia, India, South Africa, Ethiopia, Gambia, Bulgaria, Costa Rica, Peru, Venezuela 9
In force Biodiversity Laws
Access and benefit sharingPhilippines, Portugal, Bolivia, Brazil, Panama 5
Drafting Asia 19 Countries Pacific Islands 14 Countries Africa 11 Countries America 9 Countries 53
TAIWAN, islands of diversified biota
Taiwan % of the world
terrestrial acreage (ha) 3,602,042 .03 % (1)native plant species 5,676 1.9 % (63)native animal species 29,195 2.5 % (82)native microbe species 10,665 8.3 % (277)
native species % endemic
fungi 5749 2 %birds 456 17 %plant 5676 25 %
reptiles 98 31 %insects 19011 63 %
TAIWAN, islands of diversified biota
http://taibnet.sinica.edu.tw/chinese/taibnet_reference_sum.asp
Bio-prospecting in TaiwanRHS Garden, 1998, 123:441-3
http://www.crug-farm.co.uk/news/news_taiwan.htm
Nothapodytes nimmoniana Grahamcamptothecin
irinotecan hydrochloride
CPT-11, Camptosar
Bio-prospecting in Taiwan
By Camptosar, the Japanese company YAKULT earns 150 million Euro per year without benefit sharing with Taiwan.
Bio-prospecting in Taiwan
Yangmingshan National Park
14 Plant Patents
The DraftersWarren H.J. KUO, AgronomyMing-Yan SHIEH, LawJau-Hwa CHEN, LawChung-His LEE, Law Kuei-Jung NI, Law
Four biologists:BotanyMicrobiologyMarine BiologyEntomology
Drafting The Genetic Resource ActTAIWAN
Genetic resource: genetic material of actual or potential value.Genetic material: biological material that containing functional units of heredity
Definition
CBD
The definition is useless, because any genetic material is of potential value sometime somewhere.
OECDBiological material Genetic material
Biological resources
Genetic resource
Definition The OECD’s interpretation of the definition of CBD is somewhat obscure to us, for linguistic reason.
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.
Definition
Biological Resources : alive
Biological Resources : dead
GeneticResources
Biological material
Genetic material
Dead
AliveCapable of reproduction
Definition
Living bulk commodities for commercial consumption, planting/decoration,
other traditional use within the country
Living materials for breeding, compositionscreening et al.
Non-viable specimen for taxonomic studies
Control over bioprospecting
Biological materials should be controlled
at the customs
Definition
x
x
“First class bio-prospecting”
“Second class bio-prospecting”
For the purpose of academic research
Living materials for breeding, composition screening et al.
Collected from natural habitat
Subjected to germbank policy / International Treaty on Plant Genetic Resources for Food and Agriculture
Acquired from germplasm bank
Application and approval of bio-prospecting
The first class bio-prospecting
The second class bio-prospecting
Application of an acquisition
Preliminary examination by competent authority
Asked to revise the proposal by competent authority
Preliminary examination finished
Acquisition rejected
Inform/Consult with landholder, shcolars, et al.
Acquisition approvedPermission certificate issued
All required documents submitted
First class bio-prospecting
Application of an acquisition Preliminary
examination by competent authority
Asked to revise the proposal by competent authority
Preliminary examination finished
Application rejected
Permission certificate issued
All required documents submitted
Second class bio-prospecting
Application accepted
The landholder informed. Representatives of the holder, applicant and competent authority to reach an agreement concerning bioprospecting activities, material transfer, and benefit sharing
The competent authority to examine the agreements
Agreement do not reach, Acquisition rejected
Acqisition approved
Consult with scholars
Post supervision and control
The progress of the bio-prospecting;
Biological materials collected and the conditions of their transportation;
Any information that is associated with the collected materials.
1. Prospecting report
Post supervision and control2. Commercial implication derived from genetic material
the applicants must notify the competent authority and the landholder
the applicants should proceed with the whole procedure of application and approval of the second class
The first class bio-prospecting
The second class bio-prospecting
Post supervision and control3. 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
Post supervision and control4. Disclosure of origin in patent applications
USAfrican Group
Switzerland
Brazil et al.
EU
TaiwanDisclosure requirement by Genetic Resources Act, not by Patent act
Post supervision and control4. Disclosure of origin in patent applications
The permits for exploring genetic resources in Taiwan
Describing the origins of genetic resources they used for the invention
Patent seekers should submit to Patent Office:
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