About principles, activities and resources Dr. . Thoma mas s Van anag agt (ABS-in int) Aberd rdeen works rkshop 28 28-06 06-20 2018 18
M inerals, fish and genetic resources Mineral resources Fish (in fisheries) MGR • Extractive • Non-extractive • Extractive • Non-depleting • Finite and depleting • Depends on management • No to low environmental impact • High environmental impact • Depends on method • ? • Exclusive licenses • ‘no restrictions’ • Medium to High investment • High investment • Low to medium investment • High technology requirements • High technology requirements • Low to medium technology • Value created exclusively on land • Value created at sea and on land • Value creating in principle at sea • Limited market • Limited market • Global local market
applying principle Common heritage of mankind: M anagement of M GR • Principle related to resources • Linked to the management of resources Benefit sharing • Important components: benefit sharing, future generations, non-appropriation, joint Capacity building and sustainable management M anagement of (M )SR Freedom of the high seas on M GR • Principle related to activities • Not an unrestricted freedom Track & trace
M are Geneticum Freedom + Common Heritage Freedom high seas Common Heritage
M are Geneticum and the principles Common heritage Freedoms • Benefit sharing • In principle no restriction to the MSR activity linked to MGR • Joint management (e.g. biorepositories) • Not unrestricted • Future generations (e.g. • Limitations depending on curation) location (MPA), gear (impact) and volume • Non appropriation (open access + biorepositories)
Supportive vs restrictive Ex situ In silico In situ Organism/ Genetic material Genetic resource organism
M andatory benefit sharing • M eaningful • High impact for developing states and for the scientific community • Low ‘cost’ to the users • Search for a bundling of resources available to BS
(M andatory) benefit sharing • Sharing of metadata • Sharing of GSD • Possibility for extended embargo period for a fee • Sharing of biochemical data volunatary • Engagement in CB and TT • Possible idea: organized through research funding organizations
Types of Data the Mare Geneticum Proposal Could Cover: Categories of Explanation Types of data information • Data only Raw data (e.g. M etadata associated with the samples • genetic sequence Initial taxonomic analysis of the samples • data) Genetic sequence data (DNA) • Transcriptome data (RNA of the genes that are functional at that time) • Automatic gene/ transcriptome function annotations • Protein sequence data (DNA/ RNA data automatically translated to give amino acid sequence) • Data and Genetic sequence Initial taxonomic analysis of the samples (DNA methods?) • analysis data which has been Automatic gene/ transcriptome automatic function annotations • annotated with Protein sequence data (DNA/ RNA data automatically translated to putative gene give amino acid sequence) • functions using an Protein structure data (Embargo) • algorithm M etabolite data (mainly commercial databases) • Data, analysis Critical evaluation of Full taxonomic analysis of the samples • and the data and its M anual gene/ transcriptome function annotations • interpretation analysis conducted Protein structure data (Embargo) • by an expert M etabolite data (mainly commercial databases) 9
Thank you! Contact: thomas.vanagt@abs-int.eu
Organisms Genetic M aterial Genetic Resource
What are (M )GR?
Central dogma of molecular biology Derivatives RNA – translates Transcription Information from DNA Into proteins DNA (GR/ Functional Units of Heredity) Translation Genetic Sequence Data Derivatives Proteins/ Enzymes M etabolites Derivatives In Silico Data
What is Access and Benefit Sharing (ABS)?
Elements of an ABS regime for ABNJ • ACCESS • Definitions • Scoping (temporal and material) • When? • Who? Transfer? Intend? • Access and/ or Utilization? • BENEFIT SHARING • What kind of benefits (non-monetary vs. monetary) • By whom? Transfer? • With whom and what for? • When? • COM PLIANCE • Workable • Enforcable
Biodiscovery pipeline Taxonomy Sampling in ABNJ Universities Large companies Public funding Private funding Universities and SM E’s M ixed funding
Translating to the context of BBNJ Pre P-I P-II P-III Clinic 10 3 7 15 250+ None from ABNJ – mainly reef derived 7 successful compounds came from 28,000 known marine compounds M ainly anti-cancer with a few analgesics and antivirals
What are potential solutions? Requirements: • Inclusivity of developing states • Facilitated access for the scientific community • Legal certainty, predictability and stability for industry • Enforceability for the regulator
What are potential solutions? Access: • Online notification system instead of permitting system • Conditional access • Embargo period • Threshold for environmental impact assessment • One regime for all MGR, both Area and High Seas
What are potential solutions? Benefit Sharing: • Mandatory deposit of material in biorepositories • Mandatory sharing of meta data and raw data (including DSI) • Possibility of extending embargo period in return for a fee • If monetary benefits are requested: at the point of commercialization, and not negotiated • Where possible organization of benefit sharing at international or state level, not at user level
What are potential solutions? Compliance: • User friendly to avoid involuntary non-compliance • Preferably compatible with Nagoya Protocol compliance • Linked clearing house mechanism
M GR Derived Pharmaceutical Products on the M arket Purified fish oil All from EEZ apart from 1 (high seas) – All prior to CBD coming into force None rely on harvesting natural source except fish oils 22
What is the environmental impact? • Number of cruises is and will remain very low (cost) • Gravity coring leaves a 10cm hole that closes within 1h • During an entire cruise, 0,5m² of seabed will be cored • Removing 0,5m² of ABNJ = 0,19cm² of Yellowstone NP • MGR are not mined , you only need them once • Environmental impact of bioprospecting is negligible • EIA requirement for bioprospecting seems redundant • Allow bioprospecting in MPA’s? 23
Synthetic Biology – From Genes to Products DNA (S ynthetic genes M GR From sequence) DNA Product Grow cells Cell with engineered DNA 24
Geographical scope: seabed versus water column Scientific point of view: • ‘Valuable’ MGR in seabed, water column and subsoil • Location can be life-stage specific: e.g. pelagic larvae • Often unknown and unable to tell, except through collection method Arguments to not distinguish between seabed and • ‘Sedentary species’ definition from UNCLOS is insufficient water column • Scientists will rarely target the one or the other Compliance point of view: • The easier, the more likely users will voluntary comply • The more difficult, the more likely users will be involuntary non-compliant‘
M aterial scope: commodity versus genetic resource Commodity or biological resource Based on original resource harvest Cod Fish Oils genetic resource Based on processed information sample or harvest Cod DNA Estimated Cost = US$ 1 Bn/ gramme
M aterial scope: derivatives molecules application/ product Genes as such do not hold value ‘activity’ It was what they encode (=derivatives) that can have value Proteins/ Enzymes M etabolites
M aterial scope: DSI 150 PTZ %PTZ-induced activity VHC PS-243 - 100µg/ml 100 PS-243 - 50µg/ml PS-243 - 25µg/ml ** 50 *** *** * ** *** *** *** *** *** *** *** *** 0 0-5 5-10 10-15 15-20 20-25 25-30 time (min) Bioassay Sampling in ABNJ M GR Product Chemistry Production process
M aterial scope: DSI 150 PTZ %PTZ-induced activity VHC PS-243 - 100µg/ml 100 PS-243 - 50µg/ml PS-243 - 25µg/ml ** 50 *** *** * ** *** *** *** *** *** *** *** *** 0 0-5 5-10 10-15 15-20 20-25 25-30 time (min) Chemical synthesis Bioassay Not targeted for M GR, let alone BBNJ Based on open access and huge numbers Bioinformatics Totally untraceable Product Production process
Intellectual Property: patentability of ‘life’ Requirements for a patent: 1. Novel 2. Inventive step or ‘non-obvious’ 3. Properly described (‘skilled in the art’) Life as such cannot be patented 4. Industrial application or useful Patenting does not work prohibitive for R&D on life Limited in time to allow for investment in R&D • File for patents under national law • International agreements related to trade (WTO) and IP (WIPO) • Limited lifespan
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