1.
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:

2.
In search for an inventory and assessment of barriers
at 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.
2

3.
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

4.
Academic research on barriers
PEARL Barriers
(Technical)
Political
Ethical
Administrative
Regulatory
Legal
‘ Others’
4
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

5.
5
Actual concern and involvement
on data sharing goes far beyond
the scientific community

6.
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
6
We are scientists:
Do we have to
solve?
find a way around?
ignore?
throw over the fence?

7.
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?
7
[……… ] 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 Use
Australia Group Convention
EU – US Safe Harbour treaty
GMO Legislation
EU Data Protection Regulation 2016
Etc.

8.
8
PIP Framework 2011
To ‘tax’ the commercial use of GISRS materials
Problem: public domain sequence repositories ?
Beneficiary: WHO -> GISRS
To consent with the use of genomic resources
under state’s (legal) conditions on benefits
Problem: public domain sequence repositories ?
Beneficiary: Providing country
Flu strains with pandemic potential All pathogens including seasonal Flu
Example: The access and benefit sharing paradigm
Have ethics become economics?
CBD/Nagoya Framework 2014

9.
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.
9
Nagoya 2010

10.
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
10

11.
11
[ ….. ] 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

12.
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
 Universityof Edinburgh (UEDIN) UK
 Universitäts Klinikum Bonn (UK-Bonn) G
 Academic Medical Center (AMC) NL
 Universiteit Antwerpen(UA) B
 Artemis Wildlife HealthBV (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

13.
COMPARE Work package 12
Pearl Barriers
G. B. Haringhuizen – RIVM,
The Netherlands
E. S. Pronker – RIVM,
The Netherlands
J. Schlundt – NanYang Un,
Singapore
13
This 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