COllaborative Management Platform for

detection and Analyses of (Re-) emerging

and foodborne outbreaks in Europe

WP 12 – PEARL Barriers

In search for an inventory and assessment of barriers

at different community levels

GMI 9 Annual Meeting

23 – 25 May 2016, FAO Rome

This project has received funding from the European Union’s Horizon 2020

research and innovation programme under grant agreement No 643476.

George Haringhuizen | RIVM

Funded by SPR of:

In search for an inventory and assessment of barriersat different community levels

A snapshot

“ Several barriers for global sharing exist but, in our opinion, the presumed magnitude of the problems appears larger than they are, and solutions can be found.”

“ [ …. ], developing the information and communication infrastructure to meet this coming demand is imperative.“

“ Fundamentally, such data should always be released publicly, but options to keep data private for a shorter period and share them in a closed group are, in our opinion, also needed, not only for research purposes, but also for public health to have time to evaluate potential undesired effects such as public panic or misuse of data. “

Aarestrup e.a., March 2016, Trends in Microbiology.

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What did we learn so far?

• We are standing on the shoulders of – the Wellcome Trust, NIH and US Department of Energy and their partners

– 1996 Bermuda Principles, the 2003 Fort Lauderdale confirmation of these, the 2009 GESTURE recommendations and the 2009 Toronto Statement

– Microbial Commons / Genome Commons

3Courtesy: Amye Kenall, 2014

Focus on barriers in the scientific community

Academic research on barriers

PEARL Barriers(Technical)

Political

Ethical

Administrative

Regulatory

Legal

‘ Others’

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Recent Research(Technical)

Political

Ethical

Motivational : personal, institutional, (supra) governmental

Economic : micro, meso and macro level

Legal

On global sharing:The interaction between barriers to data sharing in public health is complex, and single solutions to single barriers are unlikely to be successful. (Chatham 2015)

• (Sub)regional networks -> one global network• Genetics discussion in non-health domains• Single pathogen -> multi pathogen • Single domain -> integration of domains• Homogeneous community -> heterogeneous community• One set of values -> differences in perspective on values / interests• One Health? -> global, centralized databases

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Actual concern and involvement on data sharing goes far beyond the scientific community

Looking at Barriers ‘ Streetwise’

Accusation of lack of reciprocity

Nagoya: no benefit sharing – no access

Loosing control over PIP-revenues?

Security and dual use regulations

Individual privacy – triangulation

Safe Harbor Frameworks

Economic impact of public data release

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We are scientists: Do we have to

solve?find a way around?ignore?throw over the fence?

Example: Security and the global sharing of WGS/NGS

• Security issues: complex to address– Highly political

– Controlled by forces outside the scientific and health community

– Legally underpinned through international treaties

– Proportionality? | Diagnostics?

– Endangers the public access / fast sharing of crucial public health data?

– Whom to address?

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[……… ] in suspected bio-safety situations the free flow of data may be subject to special regulations, like mutatis mutandis strict export regulation exists on the shipment of specific biological agents listed under the convention of The Australia Group, signed by 41 countries. More detailed research on this aspect needs to be performed.

(WHA 2010: Gesture side event on global sharing)

EU/428/2009 on Dual UseAustralia Group ConventionEU – US Safe Harbour treaty

GMO Legislation EU Data Protection Regulation 2016

Etc.

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PIP Framework 2011

To ‘tax’ the commercial use of GISRS materialsProblem: public domain sequence repositories ?

Beneficiary: WHO -> GISRS

To consent with the use of genomic resourcesunder state’s (legal) conditions on benefitsProblem: public domain sequence repositories ?

Beneficiary: Providing country

Flu strains with pandemic potential All pathogens including seasonal Flu

Example: The access and benefit sharing paradigmHave ethics become economics?

CBD/Nagoya Framework 2014

Benefit sharing paradigm

• 2010: The Nagoya Protocol -> EU Regulation /511/2014 – Each State may demand an agreement on the sharing of benefits arising out of the use of genetic

resources with (potential) value, (which includes animal, plant and microbial)

– The use of genetic resources means: to conduct research and development on the genetic and/or biochemical composition

– The burden of demanding consent and proof lies with the receiving party / researcher / entrepreneur

– Exempt are existing arrangements with the same goals and impact (e.g. PIP Framework)

– Exempt in EU for max 3 months : research regarding potential outbreak situations of international concern

• 1993: The Convention on Biological Diversity (CBD) recognizes that States have sovereign rights over natural resources and the authority to determine access to their genetic resources.

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Nagoya 2010

Preliminary conclusions

• The awareness of inevitability of ‘centralized’ databases grows– Equity, benefit sharing and fear for exclusion / patronizing are to be taken seriously

– One stop solutions: research/experts have to formulate consensus on practical ToR

• Motivational and economic barriers are additionally to be researched– On levels of micro/researcher, meso/institutional, macro/state/supra-national

– To identify opportunities/incentives -> sustainable platform

– To find common ground for non-commercial (commercial?) & public health research

• Political, economic and legal obstacles seem the most challenging– Uncertainties are barriers that have to be addressed and taken seriously

– Differentiate between involved groups/stakeholders (motivation)

– The ‘magnitude’ of barriers may be perceived or real -> explained and put in a realistic perspective -> separate position papers

– Essential barriers need further research: whom to address on which motivation and by what means

– A need for health-driven global data-sharing resolutions and frameworks

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[ ….. ] However, multiple global consumer surveys have shown that more than 80% of individuals are ready to share their medical data provided that they are anonymized and their privacy maximally assured

Eric Topol (NATURE REVIEWS | GENETICS VOLUME 16 | MAY 2015 | 253

Courtesy: NIH 2015

Meanwhile: Civil initiatives

COMPARE Consortium

Technical University of Denmark (DTU) DK Erasmus Medical Center (EMC) NL Statens Serum Institut (SSI) DK Friedrich-Loeffler-Institute (FLI) G Agence nationale de sécurité sanitaire de

l’alimentation, de l’environnement et du travail (ANSES) F

Robert Koch-Institut (RKI) G European Molecular Biology Laboratory (EMBL)G Instituto Superiore di Sanita (ISS) IT RijksInstituut voor Volksgezondheid en Milieu

(RIVM) NL Animal Health and Veterinary Laboratories

Agency (AHVLA) UK University of Edinburgh (UEDIN) UK Universitäts Klinikum Bonn (UK-Bonn) G Academic Medical Center (AMC) NL Universiteit Antwerpen (UA) B

Artemis Wildlife Health BV (Artemis) NL University of Cambridge (UCAM) UK Tierärztliche Hochschule Hannover (TIHO) G Universidad Castilla de la Mancha (UCLM) ES Fondation Mérieux (FMER) F Aristotle University Thessaloniki (AUTH) GR L'Institut Français de Récherche pour

l'Exploitation de la Mer (IFREMER) F Erasmus Universiteit Rotterdam (EUR) NL Australian National University (ANU) AU Magyar Tudomanyos Akademia Wigner Fizikai

kutatokozpont (WIGNER) HU Civic Consulting Alleweldt & Kara Gbr (CIVIC) G Responsible Technology (RT) F University of Bologna (UNIBO) IT Leibniz-Institut DSMZ GmbH (DSMZ) G Wellcome Trust Sanger Institute (WTSI) UK

Visit: wwww.compare-europe.eu

COMPARE Work package 12

Pearl Barriers

G. B. Haringhuizen – RIVM,The Netherlands

E. S. Pronker – RIVM, The Netherlands

J. Schlundt – NanYang Un, Singapore

13This project has received funding from the European Union’s Horizon 2020

research and innovation programme under grant agreement No 643476.

Funded by SPR of:

Email: george.haringhuizen@rivm.nl