WP2 Legal, Governance & Ethical Issues Stakeholder Meeting in Heidelberg 30 January 2012

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


International Consortium Agreement linked to

• Existing legal entity• National legal model such as a company


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?


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“



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


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


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


Governance


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

Thank you for your attention!

Dr. Vera Herkommer: [email protected]

mailto:[email protected]

Documents

WP2 Legal, Governance & Ethical Issues Stakeholder Meeting in Heidelberg 30 January 2012