1. WP2 Legal, Governance & Ethical Issues Stakeholder Meeting in Heidelberg 30 January 2012 Co- Chairs Dr. Edvard Beem, ZonMW, NL Dr. Silke Schumacher, EMBL

2. 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

3. WP2 Legal, Governance & Ethical Issues Stakeholder Meeting in Heidelberg 30 January 2012 Breakout Session Evaluation of suitable legal structures for Euro- BioImaging Dr. Vera Herkommer (EMBL)

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

5. 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 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

8. 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

9. 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

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 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)

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 entities “owned” by the ERIC Distributed independent entities, but crucial for infrastructure operations

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 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

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 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) EATRIS Norway CESSDA Spain: Lifewatch UK: European Social Survey (ESS) Unknow host country: EUROFEL in Germany ? ELI? EMSO? EU-Openscreen?

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 linked to 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 Preceded by MoU?

24. Legal Model for Euro-Bioimaging International Consortium Agreement linked to existing legal entity Example: ELIXIR implemented as an „EMBL Special Project“

25. European Life Sciences Infrastructure for Biological Information www.elixir-europe.org ELIXIR: Data for life

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

27. 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

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. 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

30. 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 Central 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

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 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

35. 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

36. Governance Legal Model for Euro-Bioimaging

37. 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

38. Basic Governance Structure Basic governance structure Decision making body (Board, Council) Executive Body and Director SAB 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

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 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

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