ABS of MGR in ABNJ: building blocks for a pragmatic solution dr. Thomas Vanagt mr. Dominic Muyldermans Contact: thomas.vanagt@abs-int.eu
Talk Overview Short Bio ABS under the CBD The ABC of ABS Lessons learnt from ABS under the CBD Access Benefit-sharing Compliance 2
Thomas Vanagt PhD in marine ecology from Ghent University (Belgium) Research experience in Latin America and SE Asia MBA from the Vlerick Business School Founder of ecoast (2010): Marine environmental research Offices in Belgium and Netherlands 10 staff Founder of ABS-int (2015): Access and Benefit Sharing consultancy Clients include European Commission and large pharma 3
ABS under CBD: the basics Provider Country Rights holder Country / Collection / User Benefit Sharing User (person/ legal entity) 4
ABS under CBD: the basics Access (domestic) Nagoya Protocol 5
Country of utilization Country of Access The ABC of ABS Access Domestic-level access measures Prior Informed Consent (PIC) Defining scope of permitted utilization Benefit sharing Domestic-level benefit-sharing measures Mutually Agreed Terms (MAT) Monetary or non-monetary Compliance Measures in the country of utilization, e.g. due diligence system in the EU Checkpoints Clearing House Mechanism 6
ABS under CBD: some lessons from real-life cases Bilateral and sovereign rights of states: Every provider state could have different rules and procedures Access and compliance have different legal regimes, not always aligned (cfr. EU regulation) The process can be very burdensome, expensive and intransparant Potential competition between providers (in both ways!) Not necessarily bringing legal certainty, and not compliance-friendly 7
ABS under CBD: some lessons Using genetic resources is, in practice, way more complicated than going from organism to product ABS has much larger reach than its intended focus Many more sectors impacted than foreseen Mismatch between timing of access negotiation and (monetary) BS 8
Linking the ABS risks with financial risks ABS Risk Financial Risk 9
ABS under CBD: some practical issues Collecting is often non targeted, especially for MGR: many access regimes are not adapted to this Issues with ongoing and new practices in science 10
ABS under CBD: some lessons from working with scientists Extremely difficult to: Motivate scientists Get information Track information Keep information Research institutes and universities do not understand how to lawfully get access and organize compliance Scientists do not know the difference between MAT and MTA From a total lack of awareness over denial to help us 11
ABS of MGR in ABNJ: starting points The multilateral setting offers the opportunity of having consistent rules and principles It also gives the opportunity to faze out the difficulty of the negotiated part under (some) national access laws One regime for all BBNJ could stimulate MSR on MGR in ABNJ Remember that for many sectors, it is easy to hide origin 12
ABS of MGR in ABNJ: starting points One regime for all BBNJ could stimulate MSR on MGR in ABNJ For scientist, it is about facilitated access For industry, it is about legal certainty, stability and predictability. Risk management is more important than free or cheap! Practical, and taking into account the future of science (even the present ) 13
Access Starts with in situ or ex situ (in case of retroactvity) No commercial access in situ: generic facilitated access possible PIC could be replaced by a notification obligation in a centralized database (upon approval of project) No need for justification of intent (see further) Even if material would be obtained through commercial cruises, same situation (see further) 14
Benefit-sharing Keep in mind: non-monetary cost money as well Multilateral situation offers opportunity to faze out negotiated BS terms Non-monetary BS linked to access and non-commercial utilization Monetary BS linked to commercialization 15
Benefit-sharing: non-monetary Should be about capacity building and global access to material/information Should not impede the necessity for advances in science and technology For ex situ storing: publically accessible biorepositories (cfr. Marbank in Norway) For in silico storing: centralized genebank for BBNJ Possibility for embargo period 16
Benefit-sharing: non-monetary PRACTICAL SOLUTION: Make the funding bodies responsible through a binding code of conduct 17 Oldham, P; Hall, S; Barnes, C; Oldham, C; Cutter, AM; Burns, N; Kindness, L (2014) Valuing the Deep: Marine Genetic Resources in Areas Beyond National Jurisdiction. Defra Contract MB0128 Final Report Version One. London: Defra.
Benefit-sharing: binding code of conduct De facto % of funding budget for BS Funding of biorepositories and centralized genebank (through global fund?) Notification requirement fulfilled by funding bodies upon approval of project Capacity building compliance checked by funding bodies 18
Benefit-sharing: monetary Pre-set monetary benefit sharing terms, thus not case by case Percentage capped per sector in agreement with sector Payment into a global fund Milestone payment system to coincide with R&D steps 19
Compliance Due diligence system cfr. EU ABS regulation Two checkpoints: research funding and commercialization/end of utilization Submission of standard form to CHM/centralized databank? Submission at stage 1 by funding body (DD and notification) Submission at stage 2 by company MTA obligation for third-party transfer Compliance checks for non-commercial by funding bodies Compliance checks for commercial through global fund 20
Compliance Trace & Track Research Research Development Market 21 FTO Evaluation DD Declaration
The research leading to these results has received funding from the European Union's Seventh Framework Programme (FP7/2007-2013 under grant agreement n 312184)
ABS: some clarifications Important to distinguish access and utilization : access to a genetic resource can be in situ: collecting or sampling ex situ: in any material form in a collection in silico: non-material collection (DNA information) utilization is never in situ. A lot of the utilization is now in silico 23