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

1. WP2 Legal, Governance& EthicalIssues Stakeholder Meeting in Heidelberg 30 January2012 Co- Chairs Dr. Edvard Beem, ZonMW, NL Dr. Silke Schumacher, EMBL

2. WP2 – Deliverables • DeliverablesbyJanuary 2012: • D 2.1 Evaluation ofsuitable legal structures • D 2.4 Draft ethics policy – in progress • D 2.5 Draft IPR policy – in progress • Deliverableby May 2012: • D 2.3 Report on governanceand legal issues • includingethicalissuesand IPR

3. WP2 Legal, Governance& EthicalIssues Stakeholder Meeting in Heidelberg 30 January 2012 Breakout Session Evaluation ofsuitable legal structuresfor Euro-BioImaging Dr. Vera Herkommer (EMBL)

4. WP2 – Outline Outline • Introduction • WP2 deliverables • Review • Challenges of WP2 • Contents of Evaluation • D 2.1 Evaluation of suitable legal structures • Governance

5. Introduction Introduction

6. 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

7. WP2 – Past Meetings WP2 - Past Meetings • WP2 breakoutsession at Stakeholder Meeting • 22 October 2010 (Vienna) • WP2 meeting on 11 March 2011 (Heidelberg) • WP2 meeting on 20 September 2011 (Frankfurt)

8. Legal challenges Challenges linked to setting up suitable legal structure for Euro-BioImaging • 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

9. Distributed infrastructure Euro-BioImaging: possible governance structure for a distributed infrastructure = medical imaging community = biological imaging community • Hub • Central hub • Legal model to be decided • Nodes • Existing national researchinstitutes • Bilateral servicelevelagreementwith hub • Nodes makescientificandtechnicalcontributions

10. Evaluation of suitable legal structures

11. 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

12. Legal models: examples • ThreeESFRI projects consider one of these legal models: • European Research Infrastructure Consortium (ERIC) considered by LifeWatch • “Mixed models”: International Consortium Agreement linked to • existing legal entity (e.g. ELIXIR uses EMBL) • legal entity to be newly established such as national legal model, e.g. GmbH or `Company limited by guarantee´, (INSTRUCT)

13. Framework conditions • General framework conditions of Euro-BioImaging • Distributed RI • Membership structure: States and Intergovernmental Organisations

14. ERIC – European Research Infrastructure Consortium

15. LifeWatch: a mixed distributed research infrastructure Distributed independent entities, but crucial for infrastructure operations Distributed entities “owned” by the ERIC

16. 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

17. ERIC • Fiverequirementstobemet: • Necessaryfor European research • Addedvaluefor ERA andsignificantimprovement in relevant S&T fields • Provideaccessto European researchers • Contributestothemobilityofknowledgeand/orresearcherswithinthe ERA • Dissemination / optimizationofthe RTD results

18. 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 members • Process 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

19. 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

20. ERIC ESFRI projects that plan to become an ERIC: • Netherlands: • Clarin (applied in May 2011) • EATRIS • Norway • CESSDA • Spain: • Lifewatch • UK: • European Social Survey (ESS) • Unknow host country: • EUROFEL in Germany ? • ELI? • EMSO? • EU-Openscreen? • Austria: • BBMRI • Belgium: • MYRRHA • Finland: • ICOS • France: • Euro-Argo (applied in Aug 2011) • ECRIN (applied in July 2011) • Dariah • Italy • CERIC

21. 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

22. Legal Model for Euro-Bioimaging • International Consortium Agreement linkedto • Existing legal entity • National legal model such as a company

23. 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 • PrecededbyMoU?

24. Legal Model for Euro-Bioimaging • International Consortium Agreement linkedto existing legal entity • Example: • ELIXIR implementedas an „EMBL Special Project“

25. ELIXIR: Data for life

26. ELIXIR’s mission To build a sustainable European infrastructure for biological information, supporting life science research and its translation to: medicine environment bioindustries society

27. ELIXIR ELIXIR: distributed RI • 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 Hub @ EMBL-EBI ELIXIR members establish governance structure in ICA • Nodes • Existing national researchinstitutes in ELIXIR MS • Bilateral servicelevelagreementwith hub • Nodes makescientificandtechnicalcontributions

28. 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

29. Legal Model for Euro-Bioimaging • 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“

30. 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”)

31. 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

32. INSTRUCT INSTRUCT • Central INSTRUCT hub • Located at Uni Oxford • Legal model = Comp. Ltd. by guarantee • Coordinates access, R&D and training • Executive Committee headed by Director National User Groups INSTRUCT members establish governance structure in International Consortium Agreement • Core and Associate Centres • National research institutes in INSTRUCT MS • Core provide 20% access to INSTRUCT users • Associate provide complementary technologies • National Affiliated Centres • National research institutes • Provide additional access to specific technologies • Manage National User Groups

33. 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

34. Legal Model for Euro-Bioimaging • National legal model: company • ArticlesofAssociation (= statutes) include • governancestructure, rights, obligationsand • liabilitiesofpartners/shareholder • Popularexamples: • XFEL, FAIR andInfrafrontier: German GmbH • INSTRUCT: UK Company ltd. byGuarantee

35. Legal Model for Euro-Bioimaging • 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

36. Legal Model for Euro-Bioimaging Governance

37. Governance – general requirements • Governancestructure – generalrequirementsfordistributed 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

38. Basic Governance Structure Basic governance structure Assembles MS Oversees strategic and scientific development Decision making body (Board, Council) Advises decision makers and executive body in scientific matters and selection of nodes/centres SAB Executive Body and Director Advisory Committee • Advises decision makers and/or executive body; Examples: • Stakeholder Forum • Peer-review Committee • Ethical Review Board Node / Centre Node / Centre Operative level: scientific, technical, training activities in national research institutes; Connected with RI via agreements

39. 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

40. 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

41. Governance Structure for Euro-BioImaging Euro-BioImaging: possible governance structure for a distributed infrastructure = medical imaging community = biological imaging community • 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

42. Thank you for your attention! Dr. Vera Herkommer: vera.herkommer@embl.de