International Alliance for Biological Standardization

Article 1

The International Alliance for Biological Standardization (referred to herein as the “Alliance” or the “IABS”) is a nonprofit-making association governed by Articles 60 – 79 of the Swiss Civil Code and by the present Articles of Association (hereinafter the “Constitution”).
The former names of the association were International Association for Biological Standardization and subsequently the International Association for Biologicals, both also known under the acronym “IABS”. The first Statutes of the IABS were adopted by the General Assembly meeting on 20th September 1959, in Tel Aviv.

In order to further promote the federative intent of its worldwide activities in the field of biologicals, the General Assembly of the IABS decided, at its 28^th meeting in Langen, Germany, to include the term “Alliance” in its name and to revise its Constitution accordingly.

For-profit entities shall not have voting rights at the General Assembly, but representatives of such entities may be elected to the Board of Directors (the “Board”), be elected to an office, and participate in the work of committees with the same rights as representatives of other organizations.

The Seat of the Alliance is located in Switzerland at Rue Mina-Audemars 3, 1204 Genève (Switzerland)

Due to the international nature of its activities, English shall be used as the primary language for written and spoken communication within the Alliance.

Article 2

The  mission of the Alliance  which is related to the scientific and medical advancement of biologicals, include:

• To host conferences and workshops, facilitate communication, and develop consensus on key contemporary issues related to biologicals among those who discover, develop, produce and regulate biological products for human and animal health;
• To foster evidence-based science as the standard for improving and ensuring the quality and the safety of biological products and
• To share scientific advancements and innovative regulatory solutions through our journal Biologicals.

In addition, the Alliance is prepared to offer assistance to national and international organizations active in this field.

Article 3

Members shall be persons and organizations interested in research, characterization, standardization, quality control, production, or clinical assessment and the marketing authorization of biological products. Each member must formally subscribe to the mission of the Alliance, as described in Article 2.

The Alliance shall be composed of the following classes of members :

1. General members: individuals active in the field of biological whose membership application has been approved. General members have voting rights and they pay dues. Attendees to an IABS meeting may be offered a free membership for a two-year period with possible renewal. During their free membership time, general members have no voting rights. Upon expiration of their free membership time, they may become voting General members upon application to the Secretary.
2. Contributing members: individuals involved in IABS activities, such as, but not limited to, Board and Committee members, individuals active in the publication process of Biologicals… subject to confirmation of their membership by the Secretary. They pay no dues during their mandate and have voting rights.
3. Distinguished members: individuals no longer active in IABS operations, who are recognized for their exceptional contributions to the Alliance. They are nominated for life time by the Board upon proposal from at least three Board members. They pay no dues and have voting rights.

(1) who pay dues ; or

(2) are members of the Board or Committees, in which case they pay no dues.

Honorary Life Members: The Honorary category is meant as recognition of persons for their contributions to the field of Biologicals who are not members of IABS in any other category. They pay no dues

Emeritus Members: Individuals who meet the following conditions:

(1) have informed IABS that they are retired,

(2) are no longer active in IABS; and

(3) are recognized by the Board as having contributed to the Alliance. They pay no dues.-

• Complimentary Members: individuals who attend an IABS conference and received complimentary membership for a period of up to one year subject to article 3. They pay no dues. Upon expiration of their complimentary membership, they may join as General Members.
• Fellows : Individuals who are recognized by the Board for their exceptional leadership and contribution to the Alliance. They pay no dues.

Article 4

The membership dues are decided at the General Assembly for a two-year period.

Voluntary contributions exceeding the annual dues shall be considered as donations.

Article 5

Individual Member :

“The Secretary shall have the right to approve or not the individual candidatures. When the candidature is questionable, the Secretary shall contact the President for decision”

Organizational Member:

“The Secretariat of the Alliance sends the applications to the President and the Secretary. Following consultation with the relevant Committee Chair, the President on behalf of the Executive Committee, approves or rejects the candidature and informs the Secretary of the decision by electronic mailing. The decision is registered in the minutes of the subsequent Executive Committee meeting. The Secretariat prepares a letter signed by the President to inform the organizations about the decision” 

Article 6

Membership shall be terminated by :

1. Resignation.
2. For those members who have to pay dues according to this Constitution, failure to pay such dues to the Alliance for two years.
3. For complimentary members, the expiration of their complimentary membership, unless they are admitted in another category of membership upon such expiration.
4. Expulsion for such reasons as the Executive Committee shall determine to be in the interest of the Alliance. If a member is expelled by the Executive Committee, the member may appeal to the General Assembly. A two-thirds (2/3) majority of members shall be required to overrule the Executive Committee. Voting shall take place by secret ballot.

Article 7

The Alliance shall include the following bodies :

1. The General Assembly
2. The Board
3. The Executive Committee
4. Other committees that the Board determines as appropriate and which are listed in Appendix 1 of this Constitution
5. The Alliance may establish affiliates, which are listed in Appendix 2 of this Constitution, and may join other nonprofit organizations with similar interests.

Article 8

The supreme authority of the Alliance is vested in the General Assembly which shall be constituted from the membership. The General Assembly covers and controls all of the other organs of the Alliance and assumes all tasks not assigned by the Constitution to the other organs. The General Assembly reserves the right to revoke the organs of the Alliance and to supervise the activities of the organs. In particular, the General Assembly shall not delegate to the Board or to another organ the responsibility to approve or reject the accounting reports, and to dismiss the auditors.

Except as provided in Article 3A of the present Constitution, each Individual Member of the Alliance shall be entitled to one vote.

Unless the present Constitution provides otherwise, each Member Organization shall be entitled to one vote, and may select one voting representative to attend the General Assemblies.

Article 9

The General Assembly shall convene every two years usually on the occasion of a scientific conference sponsored by the Alliance.

The Secretary shall notify electronically the membership at least one month in advance of the date, hour, and place where the General Assembly will be held. The proposed agenda shall accompany such notification.

Each member may, within a period of one week, ask for an amendment or amendments to the agenda. The final agenda, including any amendments to the proposed agenda, shall be sent to the membership two weeks before the General Assembly. The General Assembly shall not take any decisions on items not included on the agenda.

Article 10

The General Assembly is validly constituted if a quorum of at least five percent (5%) of the members of the Alliance is present or represented by proxy in accordance with article 13 of the present Constitution.

If a quorum is not present, a second Assembly shall be announced within a period of one month with the same agenda. This Assembly must be held not earlier than one month and not later than two months after the announcement has been sent to the membership.

This second Assembly is validly constituted whatever the number of members present or represented by proxy.

Article 11

The General Assembly shall be presided over by the President, or in his absence, by the Vice President.

Article 12

The following items shall be presented to the General Assembly for approval:

– the Minutes of the last General Assembly

– the Report of the President

– the Report of the Secretary

– the Report of the Treasurer

– the Report of the Auditor

– the Budget.

The General Assembly shall :

– elect the Board Members

– approve the annual membership dues

– discuss and decide upon the other items on the agenda

Article 13

Unless the present Constitution provides otherwise and providing there is a quorum, all decisions at the General Assembly shall be reached by an affirmative vote of the majority of the members present and represented by proxy and shall take place by a show of hands. Two members of the Board or five members of the General Assembly may, however, demand a secret ballot.

Voting by proxy shall be permitted. A member voting by proxy shall give her/his representative, who shall be a member of the Alliance, at the General Assembly an authorization to vote on her/his behalf. The Secretary shall be notified in writing of such authorization prior to the General Assembly.

A vote by proxy is equivalent to a vote by a member present at the General Assembly.

Article 14

The Alliance shall be administered by a Board of Directors whose members fulfill their function pro bono. Except as provided in article 16 below, the Board shall have fifteen members, each elected for a period of six (6) years. Unless the present Constitution provides otherwise, a Board Member may serve for no more than two consecutive terms of six years each.

To the extent possible and taking into account the relative representation of the various scientific fields among the membership of the Alliance, the Board should include at least two members from the following scientific fields: Human Vaccines, Human Biotherapeutics, Cell & Gene Therapy, and Veterinary Biologicals. No Member Organization is entitled to be represented by more than one person on the Board and Individual Members must strictly represent only their own personal views.

Unless the present Constitution provides otherwise, any Individual Member or Representative of a Member Organization in good standing may be nominated as a candidate for election to the Board by five Alliance members or two Members of the Board.

The election of the Members of the Board shall be carried out by postal or electronic vote among all Member Organizations and Individual members of the Alliance. A vote is valid if a quorum of at least five percent (5%) of such members submits a ballot. If less than five percent (5%) of such members submit a ballot, a second vote shall be announced. The vote must not be earlier than one month and not later than two months after the announcement has been sent to the membership. A paper or electronic ballot shall be sent to such members by the Secretary or the President.

In the event of a vacancy occurring on the Board during a Board Member’s term of office, the vacancy may be filled by a nominee of the Board for the remaining portion of the defaulting Board Member’s six-year term. The Secretary may receive nominations proposals for a replacement member from one or more Board Members three weeks in advance of a Board meeting. These nominations proposals shall be sent to Board Members with the regular Board meeting agenda, to be voted upon at the next Board meeting.

Approval of the nominee shall be documented by the Secretary and communicated to the Board and the membership. The time served by the Board member filling the vacancy shall not count towards the maximum consecutive number of terms of office as specified above.

Resignation from the Board must be in writing and received by the Secretary. A Board member may be removed for excess absences from the Board if she/he has two unexcused absences from Board meetings in a year. A Board member may be removed for other reasons by a three fourths vote of the remaining Board Members.

The Board is responsible for ensuring that the Alliance’s goals are respected and that all of its activities are undertaken in a satisfactory manner. The Board also is responsible for ensuring that the present Constitution is properly applied and that the Alliance’s assets, including its income, are adequately employed.

The Board shall review the annual accounts of the Alliance and submit these every two years to the General Assembly for ratification.

Article 15

The Board shall meet face-to-face or by teleconference or videoconference at least twice a year, and at such other times as the activities of the Alliance require.

The Board shall be convened by the President with at least 14 days advance notice, except if urgent matters warrant a shorter notice. The form, time and place of the meeting shall be determined by the President and notified by the Secretary. The Board may also be convened with the same advance notice by the Secretary upon the request of either three members of the Board or of thirty members of the Alliance. In all cases, the initiator(s) of such special meeting shall specify its purpose(s) and such purpose(s) shall be set forth in the notice of the meeting.

A member voting by proxy shall give his/her representative, who shall be a member of the Board, an authorization to vote on his/her behalf. The Secretary shall be notified in writing of such authorization prior to the Board meeting.

A decision by a majority of the Board shall be valid if a quorum of at least ten Board members takes part in person or are represented by proxy. The President shall have the deciding vote if the number of votes cast is equal.

Upon being proposed by the President or by at least three members of the Board and provided that all members of the Board agree to this procedure, a decision may be taken by correspondence, including fax or electronic mail.

Once the agreement of all the Board members has been ascertained, the decision to be taken is communicated to all the members for their vote. With regard to quorum, majority and casting vote, the decision by correspondence is governed by the same rules as a vote made during a meeting.

Article 16

The Board shall elect the following Officers from among its members, each for a term of two years :

            -The President

            -The Vice President     

            -The Secretary

            -The Treasurer

The President is expected to serve as the Immediate Past President at the conclusion of his/her term as President. The Immediate Past President shall serve in this capacity and be an ex officio member of the Board for a term of two years, which may be in addition to his regular six-year term(s) as member of the Board. In that instance, he or she shall be a sixteenth (16th) member of the Board.

The Vice President ordinarily will be elected to the Presidency.

The President and Vice President may serve in the same office for no more than three consecutive terms of two years each. The other Officers are not limited in the number of terms they can serve.

Article 17

The Board shall delegate the daily planning and implementation of the Alliance’s various activities to the Executive Committee.

Article 18

In order to ensure the ongoing administrative functions of the Alliance, to disseminate information and to coordinate the Alliance’s activities, the Board shall maintain a Secretariat. The Executive Director or one other officer, selected by the Board, shall manage the Secretariat with the support of the Executive Committee, which shall be authorized to make decisions with regard to the engagement of permanent staff for the secretariat as well as concerning the day-to-day supervision and running of the secretariat, within the limits of the approved budget.

Article 19

The Board may approve reasonable compensation to some of the officers and members of the Alliance for their function and activity, in addition to reasonable expenses, as specified in internal guidance documents.

The President shall preside over the meetings of the General Assembly, the Board and the Executive Committee. He/she shall represent the Alliance in negotiations with external bodies, but may delegate those responsibilities to other appropriate members of the Alliance when it is in the interest of the Alliance to do so. The President directs the activities of the Alliance and takes all appropriate steps to implement, the decisions of the General Assembly and of the Board. In doing so, he shall be assisted by the Executive Committee. If the President resigns during his/her term of office, he/she shall be considered also to have resigned from the Immediate Past President position.

The Immediate Past President shall assist the President, Executive Committee and Board as required.

The Vice President shall assist the President in the execution of his/her duties and shall preside at meetings of the Alliance, including the Board and Executive Committee meetings, in the President’s absence. The specific tasks of the Vice President shall be assigned by the President and communicated to the Executive Committee.

The Secretary shall report to the President and to the General Assembly regarding the administration of the Alliance. He/she also shall be responsible for recording the Minutes of meetings of the General Assembly, the Board and the Executive Committee.

The Treasurer shall be responsible for the financial administration of the Alliance including the implementation of the financial decisions of the Executive Committee, the preparation of the budget, and the statement of audited accounts for presentation at the General Assembly. The Treasurer shall assist in the preparation of the budget, help develop fundraising plans, and make financial information available to Board members and the public. The Treasurer shall present a report at each Board meeting.

If a vacancy arises among the Officers during such Officer’s term of office, the Board shall elect one of its members to serve in that Officer’s position until the end of the defaulting Officer’s term of office. Time served to fill a vacancy does not count towards the maximum number of consecutive terms. In case of a vacancy in the Immediate Past President position, the vacancy shall not be filled.

Article 20

The Executive Committee is constituted by the President, the Vice President, the Secretary, the Treasurer and the Chairs of the Committees. The Immediate Past President, the President of each Affiliate and the Executive Director are ex officio members¹ of the Executive Committee.

The Executive Committee shall be presided over by the President or in his absence by the Vice President.

The Executive Committee shall have all of the powers and authority for the day-to-day operations of the Alliance subject to any limitations that may stems from decisions of the Board. This includes the authority to make decisions with regard to the engagement of permanent staff as well as concerning the day-to-day supervision and running of the operational staff, within the limits of the approved budget.

The Executive Committee shall approve the programme of activities and coordinate the activities of the different Committees that are established by the Board and listed in Appendix 1 hereto.

The Executive Committee may meet by teleconference or in person and make decisions at its meetings or by email. All decisions shall be documented by the Secretary in the minutes. All decisions made by the Executive Committee must be unanimous and made by an affirmative vote of all of its members. The Executive Committee shall meet whenever requested by the President with reasonable advance notice.

A summary of the Executive Committee’s activities will be contained in the general report made to the General Assembly by the Secretary.

– An ex officio member is a member of a body (a board, committee, council, etc.) who is part of it by virtue of holding another office. In this case, by virtue of being the Chair of a Scientific Committee or the Communications Committee, those individuals are considered as members of the Executive Committee  and are expected to participate when an agenda item relevant to their Committee is discussed.

Article 21

The Board may create Committees as needed. The current Committees and their functions are listed in Appendix 1 hereto, which the Board is entitled to update whenever relevant.

At the start of each calendar year, the Chair shall submit to the Executive Committee for approval an activity report for the past year as well as an action plan and a budget for the New Year. Each Committee shall have as many members as necessary. The Board has the right to dismiss a Committee Chair or an entire Committee, if, in the view of the Board, the Chair or the Committee fails to meet its responsibilities, or for other reasons that are in the interest of the Alliance.

Article 22

The Executive Director is nominated by the Executive Committee.

The Executive Director shall contribute to the implementation of the Mission of the Alliance; supervising the Secretariat, ensuring that financial resources are mobilized to cover the operating costs of the Alliance, and assisting the Board, Executive Committee, and Committee Chairs in their tasks.

Article 23

One auditor shall be appointed by the Executive Committee and report to the General Assembly. Only the General Assembly may dismiss the auditors.

Article 24

The signature of two of the following: the President, the Vice President, the Secretary or the Treasurer, shall constitute a valid and binding commitment of the Alliance towards third parties.

Article 25

The Alliance’s income shall be derived from :

1. Members’ dues and donations
2. Grants which it may receive
3. Gifts or legacies which it may receive
4. Scientific conferences and publications
5. Other sources

Article 26

Proposals for changes to the Constitution shall be submitted to the General Assembly by the Board. At least three members of the Alliance shall be required to petition the Board to submit such proposals to the General Assembly. The text of such proposed changes shall be sent to the Secretary at least two months before the General Assembly.

Changes to the Constitution must be approved by a two-thirds majority of the quorum of members voting at the General Assembly. 

Article 27

The Alliance may propose its dissolution by notice in the Agenda of the General Assembly. Such decision shall be taken by the General Assembly voting by secret ballot. The result of the vote shall be communicated to all members of the Alliance in writing.

After all liabilities have been met, the balance of monies remaining shall be credited to one or more scientific organizations concerned with medical biology. The choice of such a body or bodies shall be made by the General Assembly, to which the Board shall submit its proposals in this connection.

This Constitution was approved on 9 February 2021 by the General Assembly at its 34th meeting held by teleconference

Carmen Jungbäck
Secretary

COMMITTEES

Section 1 : Organization and reporting :

Unless provided otherwise in the Constitution of the IABS :

• The Committees’ Chairs shall be appointed by the Executive Committee. Nominees’ candidature shall be discussed by the Executive Committee before nominees be contacted.
• The Committee Chairs are reaffirmed at each election cycle at the same time than the elections of the Officers.
• The Chair of each Committee shall decide on the number of members of such Committee and appoint the members with the approval of the Executive Committee.

Section 2 : The Scientific Conference Committees

The scientific activities of the Alliance shall be the responsibility of the Scientific Conference Committees, representing special interests within the fields of Human Biologicals and Veterinary Biologicals.

The responsibilities of the Chairs of the Scientific Committees are described in a ToR document approved by the Executive Committee on March 10th 2016.

Any Individual Member or representative of a Member Organization of the Alliance in good standing may be appointed as Chair of a Scientific Conference Committee.

Section 3 : The Communications Committee :

The Communication Committee of the Alliance will be responsible for :

• Establishing a Publications Committee that shall be responsible for all publication activity.
• Coordinating the mailing of information to be published on the website
• Keeping contacts with selected organizations active.

Any Individual Member or representative of a member organization of the Alliance in good standing may be appointed as Chair of the Communication Committee.

AFFILIATES

The Affiliates are IABS-EU (IABS–Europe) and IABS-NA (IABS-North America)

The Affiliates are independent entities that have :

• A legal structure with their own Constitution that is consistent with the IABS Constitution and with the policies and procedures of the Alliance.
• Financial autonomy that respects the relevant laws of their Region.
• The objective of the Affiliates is to support the mission and projects of the IABS in organizing conferences on specific needs and expectations in their region.