Enriching knowledge and enhancing care through health data

Articles of association

November 24, 2014

Contents

SECTION I: LEGAL STATUS - NAME - HEAD OFFICE - DURATION - OBJECTIVES - ETHICAL CONDUCT

SECTION II: MEMBERSHIP

SECTION III: ORGANIZATION OF THE INSTITUTE

SECTION IV: OTHER CLAUSES

DESIGNATION OF DIRECTORS

FIRST BOARD OF DIRECTORS

START OF ACTIVITIES

DULY ACKNOWLEDGE AND HENCE ACT

  1. LEGAL STATUS, NAME AND HEAD OFFICE
  2. DURATION
  3. OBJECTIVES AND ACTIVITIES
  4. ETHICAL CONDUCT
  5. CATEGORIES AND CONDITIONS OF MEMBERSHIP
  6. APPLICATION FOR MEMBERSHIP
  7. TERMINATION OF MEMBERSHIP
  8. FINANCIAL CONTRIBUTION
  9. ORGANIZATION STRUCTURE
  10. GENERAL ASSEMBLY
  11. BOARD OF DIRECTORS
  12. CENTERS OF EXCELLENCE, ADVISORY BOARDS, STANDING COMMITTEES AND TOPIC GROUPS
  13. INSTITUTE'S OFFICE
  14. INSTITUTE'S SECRETARY-GENERAL
  15. INSTITUTE'S PRESIDENT AND VICE-PRESIDENTS
  16. INSTITUTE'S TREASURER AND AUDITORS
  17. REPRESENTATION
  18. ACCOUNTS, BUDGET, AND COS
  19. CHANGES TO THESE STATUTES
  20. DISSOLUTION
  21. BYLAWS
  22. LANGUAGE
  23. APPLICABLE LAW

SECTION I: LEGAL STATUS - NAME - HEAD OFFICE - DURATION - OBJECTIVES - ETHICAL CONDUCT

1. LEGAL STATUS, NAME AND HEAD OFFICE

1.1 The Association is governed by the provisions of Title III of the Belgian law of 27th June 1921 on non-profit organizations, international non-profit organizations and foundations, as modified.

1.2 The AISBL is named -THE EUROPEAN INSTITUTE FOR INNOVATION THROUGH HEALTH DATA AISBL- (hereafter -THE INSTITUTE-).

1.3 The registered office of THE INSTITUTE is located at 165 Oude Mechelsestraat, B-1853 Strombeek-Bever (Belgium). By exemption to Article 10.3.2(b) of the present Statutes, the office of THE INSTITUTE can be transferred to any other address in Belgium following a corresponding decision of the Board of Directors (see Article 10) and in compliance with the linguistic legislation. The address change shall be published in the annexes of the Moniteur Belge and submitted to the registered file at the competent commercial court within a month from the date of the decision.


2. DURATION

THE INSTITUTE is incorporated for an indefinite duration. THE INSTITUTE shall be granted legal personality at the date of the Royal Decree recognizing the incorporation, in conformity of Article 50 paragraph 1 of the law of 27 June 1921.


3. OBJECTIVES AND ACTIVITIES

3.1 The overall objective of THE INSTITUTE is to enable, coordinate, and accelerate the efficient development and deployment of interoperable health Information and Communication Technology (ICT) solutions and research strategies, towards achieving best practices and sustainability of integrated person-centred health care, to optimize health and wellness in Europe, and beyond.

3.2 The specific objectives will include but are not limited to:

Championing harmonised health information and standards for capturing, curating, protecting and exchanging health data in a trustworthy and transparent manner using best practices. This is to enable complete and interoperable health records on individuals and populations to deliver benefits to all stakeholders, supporting and guiding the best use of standards and assets for semantic interoperability and privacy protection.

Providing and/or fostering capabilities to enable better quality health data, and the legitimate sharing and uses of health data, including:

  • Semantic interoperability info structures and assets
  • Exchange and research platforms and tools
  • Informatics standards and resources to support standards adoption
  • De-identified health data repositories
  • Research data source catalogues and metadata

 

Facilitating, deriving and using intelligence from health data (scientific and clinical intelligence, research, knowledge discovery, service improvement and business intelligence) through advancing the uses of:

  • EHRs and PHRs
  • Citizen sourced data
  • Mobile health sources
  • Social care records
  • Disease, device and quality registries
  • Reimbursement claims and reporting databases
  • Cohort studies and Bio Banks
  • Clinical trial and case records
  • Other potential sources of health related data

Performing and commissioning quality assessments, and conducting or overseeing quality audits of:

  • Health related ICT systems and applications
  • Health data
  • Personnel using health data
  • Relevant organisational processes

 

Building synergy and consensus: acting as a focal point bringing stakeholders together to share experiences, agree common priorities and approaches, working towards convergence and cross-fertilization between:

  • Patient associations
  • Citizen, family and carer associations
  • Health professional associations
  • Clinical and informatics academia
  • Healthcare providers
  • National decision makers
  • Third party payers, commissioners
  • EHR system and applications vendors
  • Medical Device vendors
  • Pharma, Bio-tech
  • Regulators
  • Standards development organisations (SDO)
  • Multi-national decision makers
  • Social care providers
  • Electronic health (eHealth) competence centers

 

Defining and supporting the adoption of best practices in information governance, including ethics, privacy protection, and codes of conduct, relating to the capture, sharing and trustworthy use of health data

Defining and driving a cohesive strategy and vision for ICT supported (eHealth, pHealth, mHealth), person-centred care, wellness and prevention, especially from data and knowledge perspectives

Creating awareness and promoting THE INSTITUTE and its objectives, promoting the value of high-quality health data, and delivering training and education in topics relating to THE INSTITUTE's objects

Ensuring sustainability of THE INSTITUTE and of initiatives within the health data ecosystem, through business model innovation and value assessment (including health benefits, cost-effectiveness, financial impact, etc.), by developing an assessment framework and tools, and by collating and disseminating the existing and future evidence of value from catalysing the development and implementation of well-coordinated interoperable eHealth strategies and programmes.

3.3 THE INSTITUTE shall carry out acts and take steps and commit to all activities that are deemed appropriate or useful in view of achieving its objectives.

3.4 THE INSTITUTE is a non-profit-making organization.

3.5 Any application to the Belgian authorities for an alteration or expansion of objectives and activities of THE INSTITUTE shall require the formal approval of the General Assembly.


4. ETHICAL CONDUCT

4.1 Each Member of THE INSTITUTE is committed to integrity and to respect the confidentiality of THE INSTITUTE's internal documents.

4.2 Each Member shall maintain and enforce adherence to lawful business practice and shall act in good faith and transparently with respect to other Members.

4.3 THE INSTITUTE and its Members shall operate in full compliance with European Competition Law.


SECTION II: MEMBERSHIP

5. CATEGORIES AND CONDITIONS OF MEMBERSHIP

5.1 General provisions

5.1.1 There are two types of Membership: with and without voting rights.

5.1.2 Members with voting rights are Citizen- and Patients Organisations (as defined in Article 5.2.1), healthcare providers and funders, and health data providers(as defined in Article 5.2.2), companies active in the field of clinical and/or biomedical research (as defined in Article 5.2.3), Health data processors, platform service providers and health ICT vendors (as defined in Article 5.2.4) and Health informatics Standards Development Organisations and scientific centres active in the field of biomedical or clinical research, health informatics or equivalent (as defined in Article 5.2.5)

5.1.3 Members without voting rights are Associate Members (as defined in Article 5.3).

5.1.4 Members shall be entities that can be formally represented by a duly empowered natural person. Membership shall not be possible for natural persons except for honorary and associate members.

5.1.5 Members with voting rights must pay a financial contribution as determined in Article 8.

5.2 Members with voting rights

Membership with voting rights is open to:

5.2.1 Citizen- and Patients Organisations

5.2.2 Healthcare providers and funders, and health data providers (e.g. hospitals, health care professional associations, health ministries, associations representing health insurers)

5.2.3 Commercial Companies active in the field of clinical and/or biomedical research (e.g. pharmaceutical or biotech industry, medical device manufacturers)

5.2.4 Health data consumers(e.g. data brokers and integrators, analytics companies, Contract Research Organisations, )

5.2.5 Associations representing vendors of health ICT products and services, health informatics Standards Development Organisations

5.2.6. Scientific centres active in the field of biomedical or clinical research, health informatics or equivalent (e.g. universities, departments of universities, non-profit research or research supporting organisations)

5.3 Associate Members

Associate Membership is open to trade unions, non-governmental organizations, regional clusters and other stakeholders including natural persons not falling in the Member categories defined in 5.2 but with an interest in THE INSTITUTE's activities.

5.4 Honorary Members

Honorary Membership is open to distinguished individuals who have made extraordinary contributions to the advancement of the health data ecosystem either through outstanding personal scientific activity or through exceptional leadership. Honorary Members have the same rights as Associate Members.

5.5 Rights and obligations of Members

5.5.1 Members with voting rights enjoy the following rights:

  1. Attending, also through a representative duly empowered by proxy, the meetings of the General Assembly;
  2. Voting at the General Assembly;
  3. Calling for an extraordinary General Assembly as provided for by Article 10.2.2;
  4. Being excluded from Membership only after having been able to present in person their defence before the General Assembly;
  5. Resigning from THE INSTITUTE after having notified this decision to the Secretary-General (see Article 14) of THE INSTITUTE by registered letter to the registered office of THE INSTITUTE;
  6. Participating in the activities of THE INSTITUTE;
  7. Electing the Board of Directors;
  8. Being elected to the Board of Directors.

 

5.5.2 Members without voting rights enjoy the following rights:

  1. Participating in the General Assembly as observers without voting rights;
  2. Participating in the activities of THE INSTITUTE without voting rights;
  3. Resigning from THE INSTITUTE after having notified this decision to the Secretary-General of THE INSTITUTE by registered letter to the registered office of THE INSTITUTE.

 

5.5.3 Membership includes the following obligations, but is not limited to:

  1. Notifying the Secretary-General of any changes regarding the status of Membership, in particular the Membership criteria as defined in this Article 5;
  2. Operating in accordance with the law of their country of origin.

 


6. APPLICATION FOR MEMBERSHIP

6.1 Applications for Membership shall be addressed in writing to THE INSTITUTE's Secretary-General.

6.2 Every application for Membership implies complete adherence to the Statutes of THE INSTITUTE, to all its rules and bylaws and to all decisions of its governing bodies and an undertaking to actively participate in activities.

6.3 The Secretary-General of THE INSTITUTE shall be entitled to request additional information from an applicant.

6.4 Membership is granted by the General Assembly upon the proposal of the Board of Directors.

6.5 New Members may however be admitted provisionally by a resolution of the Board of Directors according to Article 11.2.3. Such provisional admission shall be subject to formal confirmation at the following meeting of the General Assembly.


7. TERMINATION OF MEMBERSHIP

7.1 Membership can be terminated by resignation, by exclusion of the Member and by the liquidation of the Member and is terminated in case of death of a natural person who is Member.

7.2 Any Member, which ceases to possess the qualification required under Article 5, shall ipso facto cease to be a Member of THE INSTITUTE.

7.3 Resignation from membership must be notified to the Secretary-General by registered letter three months before the end of the financial year; otherwise the full financial contribution for the following financial year shall be due. During the notice period the rights and obligations attached to being a Member and the obligation to the financial contribution (see Article 8) remains unchanged.

7.4 The Board of Directors may terminate the Membership of any Member:

  1. In case of default of payment of the financial contribution;
  2. For contravention of the Statutes, the Bylaws, or a resolution of the General Assembly;
  3. For acting in a manner gravely injurious to the reputation of THE INSTITUTE or the interests of the Members.
The Member whose exclusion has been requested shall be allowed to present its defence in person before the Board of Directors and the General Assembly. The exclusion of a Member may be decided by a simple majority in the General Assembly.

 

7.5 The Member who sees its Membership terminated by resignation, exclusion or liquidation has no right whatsoever to the assets of THE INSTITUTE or to the financial contribution and other contributions already paid. Any Member shall be deemed to have resigned if it has not paid its annual financial contribution in full and, after notice from the Secretary-General, remains in default of its obligations. If such resignation becomes effective during the first nine months of the financial year, THE INSTITUTE shall be entitled to claim payment of the entire annual financial contribution. If the resignation becomes effective during the last quarter of the year, THE INSTITUTE shall be entitled to claim payment of financial contributions due up to the date at which the resignation becomes effective, and a sum equal to the financial contribution due for the following financial year.


8. FINANCIAL CONTRIBUTION

8.1 In order to pursue the Objectives and to carry out the activities of THE INSTITUTE as described in Article 3 the Members will be required to pay an annual financial contribution, which is the Membership fee.

8.2 The amount of the Membership fee as well as the payment terms thereof are decided annually by the General Assembly upon proposal from the Board of Directors. The detailed calculation methods are established in the Bylaws.

8.3 THE INSTITUTE may receive grants, donations and testamentary provisions and any transfer not prohibited by law.

8.4 THE INSTITUTE may charge beneficiaries of certificates or other INSTITUTE'S services (e.g. trainings, tutorials, publications) with cost covering fees.


SECTION III: ORGANIZATION OF THE INSTITUTE

9. ORGANIZATION STRUCTURE

9.1 THE INSTITUTE'S management is ensured by the following bodies:

  1. The General Assembly (see Article 10)
  2. The Board of Directors (see Article 11)

 

9.2 THE INSTITUTE also employs or subcontracts a Secretary-General (see Article 14) who ensures the operational implementation of the decisions taken by the managing bodies and who is in charge of the Institute's day-to-day operations. This Secretary-General may be assisted by an Office (see Article 13).

9.3 THE INSTITUTE may create Centers of Excellence, Advisory Boards, Standing Committees and Working Groups within the -Objectives- of the Institute in various forms. They are established under the authority of the Board of Directors. Further details will be defined in the Bylaws.


10. GENERAL ASSEMBLY

10.1 Composition

The General Assembly is composed of all Members with voting rights. Members without voting rights may participate as observers (see Article 5.3 and 5.4).

10.2 Organization of the General Assembly

10.2.1 The General Assembly of THE INSTITUTE shall be convened by its President (see Article 15) or named substitute (see Article 10.5) and shall meet at least once a year at the place and on the date fixed by him or her after deliberation with the Board of Directors. A convening notice with an agenda, in the form of a letter or electronic mail, shall be sent at least four weeks before the date fixed for the meeting. The venue of the General Assembly shall be indicated in the convening notice and can be anywhere in the European countries. Further details on the organization of the meetings of the General Assembly will be detailed in the Bylaws.

10.2.2 An extraordinary General Assembly shall be convened whenever the Board of Directors judges it necessary or when at least one third of the Members with voting rights inform both the President and the Secretary-General that they would like to organize an extraordinary General Assembly.

10.2.3 Each Member with voting rights is represented at the General Assembly by one delegate with full powers. Each Member with voting rights has one vote. Members with voting rights are entitled to exercise their voting rights by proxy or transfer of voting rights to another Member as defined in the Bylaws.

10.2.4 Voting in the General Assembly is subject to a weighted voting system to reach a balanced representation of all categories of Members with voting rights.

  1. The votes of the 5.2.1 Members (Citizens- and Patients Organisations) present or represented constitute 1/13 of all votes at the General Assembly. The votes of the 5.2.2 Members (Healthcare providers and funders, and health data providers) present or represented constitute 3/13 of all votes at the General Assembly. The votes of the 5.2.3 Members (Commercial Companies active in the field of clinical and/or biomedical research) present or represented constitute 3/13 of all votes at the General Assembly. The votes of the 5.2.4 Members (Health data consumers) present or represented constitute 2/14 of all votes at the General Assembly. The votes of the 5.2.5 Members (Associations representing vendors of health ICT products and services, health informatics Standards Development Organisations) present or represented constitute 2/13 of all votes at the General Assembly, The votes of the 5.2.6 Members (Scientific centres active in the field of biomedical or clinical research, health informatics or equivalent) present or represented constitute 2/13 of all votes at the General Assembly.
  2. The weights within the Member categories can be further defined in the Bylaws. The President (see Article 15) has a casting vote in case of equality of votes.

 

10.2.5 If on the moment of a vote not all categories of Members with voting rights are existing Members or if a category of Members is not present or not represented each category of Members present or represented keep their weighing rights whereby the not existing or not represented categories are not taken into account (f.e. if during a general meeting only members of the Article 5.2.2 and 5.2.3 are present or represented they will have each 50% of the votes).

10.3 Competence

10.3.1 The General Assembly is the ultimate decisional body of THE INSTITUTE. The General Assembly approves the general policy of THE INSTITUTE on the basis of proposals of the Board of Directors and gives recommendations to the Board of Directors for its application.

10.3.2 The General Assembly shall have exclusive competences which cannot be delegated on the following matters:

  1. Admitting and excluding Members;
  2. Amending the Statutes of THE INSTITUTE subject to the specification in Article 3.5 and subject to modifications of the registered office;
  3. Electing and dismissing the members of the Board of Directors;
  4. Appointing and dismissing the Auditor(s), if any, upon proposal of the Board of Directors;
  5. Discharging the President, the members of the Board of Directors and the Auditor(s), if any, from liability for the exercise of their mandate;
  6. Receiving and approving reports on the activities in the past year from the Board of Directors;
  7. Approving the main policy lines to be followed by THE INSTITUTE on the basis of recommendations of the Borad of Directors;
  8. Approving proposals for resolutions and plans of activities proposed by the Board of Directors;
  9. Approving the annual financial reports and the budget proposed by the Board of Directors;
  10. Adopting internal rules for the calculation of the Members' financial contributions and the payment terms thereof, upon proposal of the Board of Directors;
  11. The dissolution and liquidation of THE INSTITUTE;
  12. THE INSTITUTE's membership of any other international body or its withdrawal from any such body.
  13. The decision about eventual remunerations of the board of directors.

 

10.4 Quorum and Adoption of Resolutions

10.4.1 A General Assembly is always competent to pass resolutions.

10.4.2 The General Assembly shall strive to adopt its resolutions by consensus. If a vote proves necessary, the resolution shall be adopted if it receives a:

  1. Simple majority of votes (as specified in Article 10.2.4) of the Members with voting rights present or represented in the case of regular resolutions;
  2. Two-third majority of votes (as specified in Article 10.2.4) of the Members with voting rights present or represented in the case of an amendment of the Statutes (according to Article

 

10.3.2 (b) or dissolution and liquidation resolutions (according to Article 10.3.2 (k)).
Resolutions adopted are binding for all Members of THE INSTITUTE.

10.4.3 The General Assembly resolves only on the points in the agenda.

10.5 Chairperson of the General Assembly

At all meetings of the General Assembly, the President (see Article 15) acts as a chairperson. In his absence the meeting is chaired by the Vice-Presidents or, in case they are unavailable, by the eldest member of the Board of Directors.

10.6 Minutes

10.6.1 The minutes of the General Assembly are established by the Secretary-General and are signed by the Chairperson and one Member with voting rights participating at the meeting and shall be circulated to all Members within one month.

10.6.2 The minutes shall be electronically archived and shall be accessible to all Members through the Website of THE INSTITUTE.

10.7 Consent in lieu of a Meeting

Any resolution of the General Assembly may be adopted without holding a meeting by means of a written consent of Members with voting rights. The form of the written consent in lieu of a meeting is detailed in the Bylaws.

11. BOARD OF DIRECTORS

11.1 Composition and designation

11.1.1 THE INSTITUTE is managed by the Board of Directors whose members are individuals of Members with voting rights and are elected by the General Assembly. The number of Directors shall be higher than two and not higher than fourteen. The composition of the Board of Directors shall be such that all Member categories with voting rights as defined in 5.2 are adequately represented. Each group representing a Member category shall therefore propose between two and five candidates, from which the General Assembly chooses one to four according to the seats the Member category inures to.

The complete Board of Directors consists of:
One Director representing member category 5.2.1:
Three Directors representing member category 5.2.2
Four Directors representing member category 5.2.3
Three Directors representing member category 5.2.4
Two Directors representing member category 5.2.5
One Director representing EuroRec.

If the total number of Directors, due to resignation, death or dismissal by the General Assembly, falls under the minimum of six members, the remaining members shall call a General Assembly in order to secure the requested appointment(s). The Board of Directors may decide to replace the missing Director temporarily with a delegate from the missing Director's organisation or with a new individual from a Member with voting rights from the same member category who is able to fulfill the missing Director's tasks including representation, until a newly elected Director can take office.

11.1.2 The Board of Directors shall elect from among their number the following candidates

  1. A Chairperson of the Board of Directors and of the General Assembly, who will be called the 'INSTITUTE'S President';
  2. One Vice-President of THE INSTITUTE;
  3. A Treasurer of THE INSTITUTE.

11.1.3 Further persons can be invited to the Board of Directors in an advisory capacity, especially from European level strategic organisations. These persons will however not have any voting rights.

11.1.4 The Board of Directors is elected by the General Assembly for a renewable period of three years. The Directors shall continue to act until re-election or until new Directors take office. When, in the course of his or her mandate, a Director ceases the functions occupied within his or her company or Institute, which were deemed a requirement at the time of election, a member of the Board of Directors shall be deemed to have resigned from his or her function on the Board of Directors. Subject to the conditions specified in the present Article 11, further details on the Board of Directors are specified in the Bylaws.

11.1.5 Except by lawful resignation resulting from the application of the Statutes, the resignation of a Director must be notified by registered letter with acknowledgement of receipt to the President. The resignation is deemed to be effective at the date of the registered receipt. The dismissal of a Director in case of serious offence shall be decided by the General Assembly.

11.2 Competence

11.2.1 The Board of Directors follows the resolutions, instructions and recommendations adopted by the General Assembly.

11.2.2 The Board of Directors implements the policies and the plans of activities adopted by the General Assembly.

11.2.3 The Board of Directors shall have exclusive competence (without possibility of delegation) on the following matters:

  1. Preparing the consolidated annual plan of activities and the long term strategic vision of THE INSTITUTE for approval by the General Assembly, on the basis of input from the Members, preferably consolidated through topic working groups (hereinafter referred to as 'Topic Groups', see Article 12), and discussions with the public side
  2. Setting up and dissolving Centres of Excellence, one or more multi-stakeholder Advisory Boards, Standing Committees and Topic Groups to assist THE INSTITUTE in fulfilment of its objectives (membership of such boards may not be limited to members of THE INSTITUTE) and determining requirements and funding for the establishment of such groups.
  3. Drafting, approving and amending Bylaws;
  4. Employing and dismissing the Secretary-General of THE INSTITUTE (see Article 14);
  5. Appointing an organization to run THE INSTITUTE's Office (see Article 13);
  6. Proposing the agenda of the General Assembly;
  7. Proposing internal rules determining the calculation of the Members' financial contributions to the General Assembly;
  8. Providing recommendations to the General Assembly on applications for Membership or exclusion of Members;
  9. Inviting advisers or honorary members to meetings of the Board of Director, as stipulated in Article 11.1.3;
  10. Having the power of ordinary management, including the right to perform all administrative acts and other necessary arrangements including legal proceedings;
  11. Being in charge of the financial management, preparing of budgets, including subscriptions for approval of the General Assembly, budgets and the control of expenditure;
  12. Proposing amendments to the Statutes of THE INSTITUTE in accordance with Article 17;
  13. Representing THE INSTITUTE at external events, promoting THE INSTITUTE's visibility, public relation work and identity.
  14. Approving standards and granting certifications upon proposals of the Standards Committee and the Certification Committee.
  15. Temporarily replacement of a missing Director in accordance with Article 11.1.1.

11.2.4 The Board of Directors shall meet according to rules defined in the Bylaws. The calling notice shall be notified by surface mail or email.

11.2.5 Except for resolutions requiring a certified document, meetings of the Board of Directors may be held virtually, without the members physically attending the meeting in the same place, by conference call or video conference or by any other relevant communication means, according to practical procedures defined in the Bylaws.

11.3 Resolutions of the Board of Directors and Bylaws

11.3.1 The Board of Directors shall strive to reach its decisions by consensus. If a vote proves necessary, resolutions and decisions of the Board of Directors are adopted by the simple majority of the votes of the Directors present or represented. In the event of a tie, the President has a casting vote. The Board of Directors can only act if at least 2/3 of the directors are present or represented.

11.3.2 Resolutions of the Board of Directors shall be distributed to all members of the Board of Directors within two weeks. They shall be electronically archived and be accessible to all Members of THE INSTITUTE via the website of THE INSTITUTE.

11.3.3 Bylaws can be drafted and they shall be adopted by a two-thirds majority of members of the Board of Directors present or represented (see Article 21). Changes to the Bylaws will be announced to all Members together with a list of differences with respect to the previously valid version

.

11.3.4 Any resolution of the Board of Directors may be adopted without holding a meeting by means of a written consent of the Directors in accordance with the quorum set forth in Article 11.3.1. The form of the written consent in lieu of a meeting is detailed in the Bylaws.


12. CENTERS OF EXCELLENCE, ADVISORY BOARDS, STANDING COMMITTEES AND TOPIC GROUPS

12.1 Centers of Excellence, Advisory boards, Standing Committees and Topic Groups can be established to address specific matters of common interest within the 'Objectives' of THE INSTITUTE under the authority of the Board of Directors.

12.2 The Board of Directors shall consider and approve mission statements and terms of reference issued for each group.

12.3 The operational details of the functioning of these groups are further detailed in the Bylaws.


13. INSTITUTE'S OFFICE

THE INSTITUTE's Office operates under the authority of the Secretary-General (see Article 14) and executes the daily management of THE INSTITUTE as described in the Bylaws.


14. INSTITUTE'S SECRETARY-GENERAL

14.1 The Secretary-General of THE INSTITUTE discharges his/her duties in accordance with the Statutes and the Bylaws.

14.2 Together with the President, the Secretary-General is representing THE INSTITUTE to stakeholders and third parties outside THE INSTITUTE.

14.3 The Secretary-General is responsible for the day-to-day management of THE INSTITUTE. He/she shall, inter alia, prepare, coordinate and follow-up the meetings of the Board of Directors and the General Assembly in coordination with the President of THE INSTITUTE. The Secretary-General operates in accordance with the general guidelines he receives from the President of THE INSTITUTE and under the supervision and authority of the Board of Directors. These general guidelines are defined in the Bylaws.

14.4 The Secretary-General is proposed by the President and appointed and dismissed by the Board of Directors.

14.5 The duties of the Secretary-General and the outline of the organization of THE INSTITUTE's Office are specified in the Bylaws.


15. INSTITUTE'S PRESIDENT AND VICE-PRESIDENTS

15.1 The Board of Directors elects among their number a President and a Vice-President for a renewable period of three years. The President is expected to be a highly respected member of the European clinical research community with an affiliation to an Academic Sponsor Member (as defined in 5.2) or a Data Provider Member (as defined in 5.2). No such condition is applicable to the Vice-Presidents or the Treasurer. The President and Vice-Presidents shall continue to act until the new President and/or Vice-Presidents take office.

15.2 The President and the Vice-Presidents are respectively the President and Vice-Presidents of the General Assembly and the President and Vice-Presidents of the Board of Directors.

15.3 The President is in charge of representing THE INSTITUTE vis-à-vis political institutions and other stakeholders at high level and on important occasions and important matters. He will also provide new ideas and impetus for THE INSTITUTE's work.


16. INSTITUTE'S TREASURER AND AUDITORS

16.1 The Treasurer is elected pursuant to Article 11.1.2 above and is responsible for:

  1. Controlling the annual budget of THE INSTITUTE;
  2. Controlling the financial reports and maintaining THE INSTITUTE's accounts;
  3. Proposing the financial contribution, if necessary.

16.2 The Auditors are either appointed/dismissed pursuant to Article 10.3.2 among Members with voting rights or, if necessary, appointed from the Belgium Institute of Auditors, l'Institut des Réviseurs d'Entreprises.


SECTION IV: OTHER CLAUSES

17. REPRESENTATION

17.1 All acts binding THE INSTITUTE as approved by the Board of Directors, other than those of day-to- day business as described in the Bylaws are valid only if signed by one member of the Board of Directors and the Secretary-General.

17.2 Any commitment, contract, investment, bank transfer or payment or any other obligation of THE INSTITUTE that was not foreseen in the annual budget of THE INSTITUTE will require the joint signature of the President or the Vice President and the Treasurer.

17.3 All legal proceedings, whether as plaintiff or as defendant, are conducted, in the name of THE INSTITUTE, by the Board of Directors represented by its President, or by its Vice-Presidents, by the Secretary-General or by any other person appointed for this purpose by the Board of Directors.

17.4 Details regarding the authorities with financial limits delegated to the Board of Directors, the Secretary-General, the President and Vice-Presidents are constituted in the Bylaws.


18. ACCOUNTS, BUDGET, AND COST

18.1 The financial year of THE INSTITUTE starts on 1st January and ends on 31st December of each year.

18.2 During the start-up phase of THE INSTITUTE the financial year will start at the registering date of THE INSTITUTE and will end on 31st December 2015. Financial contributions are due pro rata temporis until 31st December 2015.

18.3 The Board of Directors shall submit for approval by the Annual General Assembly accounts for the past financial year and a budget for the next year.

18.4 As long as nothing else is specified in the Bylaws, every Member, any of its representatives, any Director, the President and the Vice-President as well as the Treasurer shall bear all their own costs in connection with the performance of their activities for the benefit of THE INSTITUTE while any costs and expenses sustained by the Secretary- General and THE INSTITUTE Office in the performance of their duties will be borne by THE INSTITUTE.


19. CHANGES TO THESE STATUTES

19.1 Subject to the provisions of Article 10.4.2, on a proposal from the Board of Directors, the General Assembly may vary the Statutes of THE INSTITUTE.

19.2 The Board must bring any proposals for the variation of the Statutes to the attention of the Members of THE INSTITUTE at least four weeks prior to the date of the General Assembly that will resolve thereon.

19.3 Only modifications of the Statutes in accordance with article 50, §3 of the Law of 27th of June 1921 are subject to the approval of the Belgian Ministry of Justice . Such modifications will be published in the Annexes of the Moniteur Belge.


20. DISSOLUTION

20.1 In case of dissolution of THE INSTITUTE, the General Assembly establishes the method, designates the liquidators and determines their powers and fees.

20.2 The liquidators shall distribute the net assets of THE INSTITUTE, if any, to a European non-profit organization with similar or closely related objectives to that of THE INSTITUTE.

20.3 No Member of THE INSTITUTE shall be held liable for any remaining debts and liabilities of THE INSTITUTE after the dissolution procedure. The President and the Directors of THE INSTITUTE are not liable if they have acted within their powers. Should the President and/or the Directors have exceeded their powers or neglected their obligations they may be held personally liable.


21. BYLAWS

21.1 The Board of Directors shall adopt the Bylaws, which implement and specify the provisions of these Statutes and also regulate the daily activities of THE INSTITUTE.

20.2 In case of discrepancies between the Bylaws and these Statutes, the latter shall prevail.


22. LANGUAGE

22.1 The official working language of THE INSTITUTE is Dutch, in compliance with the Belgian Linguistic legislation. An English and French translation of all documents has always to be made.

22.2 The French version of these Statutes is the official version.


23. APPLICABLE LAW

All questions not covered by these Statutes or by any regulations made for their application shall be settled in accordance with Belgian law.


FIRST BOARD OF DIRECTORS

The abovementioned Directors met and nominated the following positions:

  • As President of the Board of directors,
  • As Vice Presidents of the Board of directors, and
  • As Treasurer of the Board of directors,

 


START OF ACTIVITIES

THE INSTITUTE will begin its activities at the date of signature of the present documents.
The first financial year of THE INSTITUTE will begin on the day of registration of the current statutes at the office of the commercial court and will close the 31st December 2015.


DULY ACKNOWLEDGE AND HENCE ACT

Completed and dated below at -, Belgium.
And after a reading through these documents with time for discussion, the present representatives signed with us, the Notary.