WP2 Legal, Governance & Ethical Issues Stakeholder Meeting in Heidelberg 30 January 2012 Co- Chairs Dr. Edvard Beem, ZonMW, NL Dr. Silke Schumacher, EMBL
Jan 22, 2016
WP2 Legal, Governance & Ethical IssuesStakeholder Meeting in Heidelberg 30 January 2012
Co- Chairs Dr. Edvard Beem, ZonMW, NL
Dr. Silke Schumacher, EMBL
WP2 – Deliverables
Deliverables by January 2012:
• D 2.1 Evaluation of suitable legal structures• D 2.4 Draft ethics policy – in progress• D 2.5 Draft IPR policy – in progress
Deliverable by May 2012:
• D 2.3 Report on governance and legal issues
including ethical issues and IPR
WP2 Legal, Governance & Ethical IssuesStakeholder Meeting in Heidelberg 30 January 2012
Breakout Session
Evaluation of suitable legal structures for Euro-BioImaging
Dr. Vera Herkommer (EMBL)
WP2 – Outline
• Introduction• WP2 deliverables• Review• Challenges of WP2 • Contents of Evaluation
• D 2.1 Evaluation of suitable legal structures• Governance
Outline
Introduction
Introduction
WP2 – Deliverables
Deliverables by January 2012:
• D 2.1 Evaluation of suitable legal structures• D 2.4 Draft ethics policy• D 2.5 Draft IPR policy
Deliverable by May 2012:
• D 2.3 Report on governance and legal issues
including ethical issues and IPR
WP2 – Past Meetings
• WP2 breakout session at Stakeholder Meeting 22 October 2010 (Vienna)
• WP2 meeting on 11 March 2011 (Heidelberg)
• WP2 meeting on 20 September 2011 (Frankfurt)
WP2 - Past Meetings
Legal challenges
• Legal and governance model designed for distributed infrastructure (“Hub and Nodes” structure)
• Diverse requirements of biological and medical imaging communities
• Funding situation for RI is difficult
• What is the scope of ethics and IPR policy – examine existing policies and use experience from other RI
Challenges linked to setting up suitable legal structure for Euro-BioImaging
Distributed infrastructure
Euro-BioImaging: possible governance structure for a distributed infrastructure
Hub• Central hub • Legal model to be decided
Nodes • Existing national research institutes• Bilateral service level agreement with hub• Nodes make scientific and technical
contributions
= medical imaging community
= biological imaging community
Evaluation of suitable legal structures
Evaluation legal structures
Contents of the „Evaluation of suitable legal structures”• Purpose and Background• Evaluation of legal structures
• Experience from other ESFRI Projects• General framework conditions• ERIC• Mixed models: ICA linked to existing or
new legal entity• Governance
Legal models: examples
Three ESFRI projects consider one of these legal models:
1. European Research Infrastructure Consortium (ERIC) considered by LifeWatch
2. “Mixed models”: International Consortium Agreement linked to
a) existing legal entity (e.g. ELIXIR uses EMBL)
b) legal entity to be newly established such as national legal model, e.g. GmbH or `Company limited by guarantee´, (INSTRUCT)
Framework conditions
General framework conditions of Euro-BioImaging
• Distributed RI• Membership structure: States and
Intergovernmental Organisations
ERIC – European Research Infrastructure Consortium
LifeWatch: a mixed distributed research infrastructure
Distributed entities“owned” by the ERIC
Distributed independententities, but crucialfor infrastructure operations
Legal Model for Euro-Bioimaging
ERIC:• Principal task: establish and operate a Research
Infrastructure, on a non economic basis (limited economic activities are however possible)
• Based on EU law (Article 187 TFEU, ex-171 EC Treaty)
• EU legislation on jurisdiction applies, national law only when not covered by EU law
• Entered into force on 28.08.2009
ERIC
Five requirements to be met:
• Necessary for European research
• Added value for ERA and significant improvement
in relevant S&T fields
• Provide access to European researchers
• Contributes to the mobility of knowledge and/or
researchers within the ERA
• Dissemination / optimization of the RTD results
ERIC
Recognition process at national level• Duration unpredictable• In some cases major stumbling block• Normally no ratification by host country necessary
Negotiation process with future ERIC membersProcess of coordination and planning at government level among future member states
Application process at EU level (minimum 3-9 months)
Send application to EC including:• Request to become ERIC, statutes, tech + scientific
description,• Declaration of host MS recognising ERIC as int‘l body and
organisation based on EC Directives
EC decision to be published in Official Journal
ERIC
ERIC Membership:
• Countries• Intergovernmental organisations
Minimum three EU Member States
State may be represented by one or more public entities or private entities with public-service mission
ERIC
Austria:• BBMRI
Belgium:• MYRRHA
Finland:• ICOS
France:• Euro-Argo (applied in Aug 2011) • ECRIN (applied in July 2011)• Dariah Italy• CERIC
ESFRI projects that plan to become an ERIC:
Netherlands:• Clarin (applied in May 2011)• EATRISNorway • CESSDA
Spain: • Lifewatch
UK:• European Social Survey (ESS)
Unknow host country:• EUROFEL in Germany ?• ELI?• EMSO? • EU-Openscreen?
ERIC
ERIC for Euro-BioImaging?
Advantages:• Designed for European RI• Privileges, e.g. tax exemptions• No national ratification process necessary
Disadvantages:• New legal instrument, implementation challenging
• National labour law applies
Legal Model for Euro-Bioimaging
International Consortium Agreement linked to
• Existing legal entity• National legal model such as a company
Legal Model for Euro-Bioimaging
International Consortium Agreement (ICA)
• To be concluded by states and IO • Contents:
• Mission and strategy • Obligations of the Consortium Partners• Governance structure• Budget • Liability etc.
• Guarantees for identity and visibility• Binding or non-binding• Preceded by MoU?
Legal Model for Euro-Bioimaging
International Consortium Agreement linked to existing legal entity
Example:
ELIXIR implemented as an „EMBL Special Project“
European Life Sciences Infrastructure for Biological Information
www.elixir-europe.org
ELIXIR: Data for life
ELIXIR’s mission
medicine
environment
bioindustries
society
To build a sustainable European infrastructure for biological information, supporting life science research and its translation to:
ELIXIR
ELIXIR: distributed RI
Hub @ EMBL-EBI
Hub• Central hub located at EMBL-EBI• Legal model: EMBL Special Project• Hub hosts Executive Mgm and
Secretariat• By 2016 hub will employ 100 staff• Director appointed by members
Nodes • Existing national research institutes in ELIXIR
MS• Bilateral service level agreement with hub• Nodes make scientific and technical
contributions
ELIXIR members establish governance structure in ICA
ELIXIR – EMBL Special Project
• ELIXIR will have a Hub and Nodes structure• ELIXIR Hub will become an "EMBL Special Project“ =
Int’l Consortium Agreement (ICA) + using legal structure of
EMBL as an Intergovernmental Organisation• EMBL Special Project takes advantage of EMBL’s existing
legal personality and its privileges and immunities• States and EMBL will become Consortium Partners and
conclude ICA • ELIXIR Hub located physically at the EMBL-EBI site in the
UK and provides coordination for European RI• EMBL’s obligation in ICA = operation of ELIXIR Hub• ELIXIR budget separately identifiable from EMBL budget
Possible legal structures for Euro-BioImaging:
ICA using EMBL as existing organisation
Advantages:• Uses existing structures and experience – speeds up
implementation process• Privileges, e.g. tax exemptions• Easy to transfer into ERIC at a later stage
Disadvantages: • Extra effort to give new RI „corporate identity“
Legal Model for Euro-Bioimaging
Legal Model for Euro-Bioimaging
International Consortium Agreement linked to new legal entity
Example:
INSTRUCT establishing Company limited by Guarantee located in Oxford („Instruct Academic Services Limited”)
INSTRUCT
ICA linked to establishment of national legal model: INSTRUCT
• Combination between International Collaboration
Agreement and national legal model, i.e. Company
limited by guarantee, to be established by Oxford
University• ICA = defines RI and sets out its members rights
and obligations• Company = operational body to undertake legal
activities
INSTRUCT
INSTRUCTCentral INSTRUCT hub • Located at Uni Oxford• Legal model = Comp. Ltd. by guarantee• Coordinates access, R&D and training • Executive Committee headed by Director
Core and Associate Centres • National research institutes in INSTRUCT MS• Core provide 20% access to INSTRUCT
users• Associate provide complementary
technologies
INSTRUCT members establish governance structure in International Consortium Agreement
National Affiliated Centres• National research institutes• Provide additional access to specific
technologies• Manage National User Groups
National User Groups
Legal Model for Euro-Bioimaging
National legal model: company
• Model of „limited liability company“ exists in nearly
all European countries, e.g. German GmbH, UK
Private Company ltd. by guarantee, French Societé
Privé• Most popular business structure for profit and
non- profit companies• Liability limited to company‘s assets• Partners = public or private, national institutes,
governments or int‘l organisations
Legal Model for Euro-Bioimaging
National legal model: company
• Articles of Association (= statutes) include
governance structure, rights, obligations and
liabilities of partners/shareholder• Popular examples: • XFEL, FAIR and Infrafrontier: German GmbH• INSTRUCT: UK Company ltd. by Guarantee
Advantages and disadvantages of ICA linked to national
legal model
Advantages:• High level of experience – similar models in all countries• Quick to set up• Flexible membership (might not be compatible with ERIC!)• Later transfer to ERIC normally easily possible because similar
requirements• No national ratification process necessary (may be necessary for ICA)
Disadvantages • Depends on national law unless otherwise negotiated with host country (e.g.
procurement, labour law)• No privileges - unless negotiated with the host country• Rather applied for single-sited RI
Legal Model for Euro-Bioimaging
Governance
Legal Model for Euro-Bioimaging
Governance – general requirements
Governance structure – general requirements for distributed RIs:
• Strong management structures for coordination and integration
• Manageable and easy understandable governance structure
• Clear distribution of tasks and responsibilities – avoid
competition between governance bodies• Clear hierarchy and reporting lines• Acceptable to member states and funding organisations
Basic Governance Structure
Basic governance structure
Decision making body (Board, Council)
Executive Body and Director
SAB
Node / Centre Node / Centre
Advisory Committee
Assembles MS
Oversees strategic and scientific development
Advises decision makers and executive body in scientific matters and selection of nodes/centres
Advises decision makers and/or executive body; Examples:• Stakeholder Forum• Peer-review Committee• Ethical Review Board
Operative level: scientific, technical, training activities in national research institutes;
Connected with RI via agreements
Governance Structure
Governance structure for Euro-BioImaging – what is needed?
• Ensure balanced power between two scientific communities
• Consider distributed organisation
• Organise user access, service and training
• Consider roles and expectations of stakeholders and funders of Euro-BioImaging
Governance Structure
Governance structure for Euro-BioImaging – the funding aspect• Legal and governance structure important to
get MS political and financial support
• Allow for sustainable funding and regular quality assurance
• Consider competition with 50 ESFRI projects – among them 13 BMS projects – all need
funding in times of economic crisis
Governance Structure for Euro-BioImaging
Euro-BioImaging: possible governance structure for a distributed infrastructure
Hub• Central hub • Legal model to be decided
Nodes • Existing national research institutes• Bilateral service level agreement with hub• Nodes provide scientific and technical support
= medical imaging community
= biological imaging community