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Constitution of the International Association for Biologicals
Version 6 November 2006
I. NAME, LOCATION, OBJECTIVES
Article 1
The International Association for Biologicals (hereafter called "The Association") is a non-profit making Association governed by Articles 60 - 79 of the Swiss Civil Code and the present Constitution. A logo for the Association shall be adopted by the Board.
The Board of Directors shall adopt By-laws implementing the present Constitution Article 2
English shall be used as the primary language for written and spoken communication.
Article 3
The mission of the Association is to promote the scientific and medical advancement of biologicals through partnerships of those involved in research, development, production and regulation of human and veterinary medicinal biological products.
The objectives of the Association are:
-To provide a unique forum where consensus can be reached on topics of importance to medical scientists and other healthcare professionals.
-To create an ongoing interface among leaders in clinical and basic research, biological product development, public health, manufacturing, and regulation.
-To educate healthcare professionals on topics relating to biological product discovery, development, and regulation.
-To promote the Association among those who work on the scientific issues in the biopharmaceutical industry, public health organizations, regulatory bodies, academic medicine and research.
In addition, the Association is prepared to offer assistance to international organizations active in this field. The Association, through its conferences and publications, facilitates the establishment of international reference materials and the formulation of international guidance documents for biological substances used in human and veterinary medicine.
Article 4
In particular, the Association shall be concerned with the following:
A. to serve as a platform for discussion and the development of consensus positions on contemporary issues related to biologicals;
B. to organize scientific conferences, and to publish reports of such meetings;
C. to make known to the membership information of general interest concerning the characterization, standardization, quality control, and where applicable, the production and clinical assessment of biological products;
D. to promote uniform methods for establishing the international quality control of biological products;
E. to promote the knowledge and use of international reference materials established by WHO;
F. to encourage research in connection with the characterization, standardization, quality control, production, and clinical use of biological products.
II. MEMBERSHIP Article 5
Members shall be persons and organizations interested in research, characterization, standardization, quality control, production, or clinical assessment and the marketing authorization of biological products.
The Association shall be composed of the following classes of members:
A. Individual Members, comprising the following subclasses
i. Ordinary Members (individuals who are actively working in the field and who pay dues),
ii. Emeritus Members (individuals who have been members for at least ten (10) years and who have retired),
iii. Honorary Members (individuals who have been elected to membership by the Board in special recognition of their contributions to the field of biologicals),
iv. Student Members (individuals who are pursuing a degree in science or medicine and who pay dues),
v. Developing Country Members (individuals who reside and work in developing countries as defined by the United Nations).
B. Collective Members, comprising the following subclasses
i. Member Societies (national and international scientific societies active in the field)
ii. Associate Societies (scientific societies wishing to only cooperate with the Association without financial obligations)
iii. Supporting Organizations (industrial companies and foundations, individual trusts and foundations, and other bodies of individuals similarly interested in supporting the objectives of the Association)
Associate Societies and Supporting Organizations shall not have governance privileges. Supporting Organizations may however be accorded such other privileges and benefits as the Board may direct.
Article 6
Applications for membership shall be addressed to the Geneva secretariat of the Association which shall refer such applications to the Secretary for decision. Should the Secretary not approve the candidate, the case will be submitted to the Board. A two-thirds (2/3) majority vote of the Board members present or represented by proxy shall be required to overrule the Secretary. The Secretary shall not participate in such votes.
Article 7
Membership shall be terminated by:
A. resignation;
B. failure to pay dues to the Association for two (2) consecutive years;
C. expulsion for such reasons as the Board shall determine to be in the interest of the Association. If a member is expelled by the Board, the member may appeal to the General Assembly. A two-thirds (2/3) majority of members shall be required to overrule the Board. Voting shall take place by secret ballot.
III. ORGANIZATION
Article 8
The Association shall include the following bodies:
A. the General Assembly
B. the Board
C. the Executive Committee
D. other committees that the Board determines are appropriate
IV. THE GENERAL ASSEMBLY
Article 9
The supreme authority of the Association 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 Association and assumes all tasks not assigned by the Statutes to the other organs. The General Assembly reserves the right to revoke the organs of the Association 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.
Unless the present Constitution provides otherwise, each Individual Member of the Association shall be entitled to one vote.
Each Member Society shall be entitled to one vote, and may select one voting representative to attend the General Assemblies.
Each Associate Society and Supporting Organization may send a representative to the General Assemblies, but the representative shall have no vote. Associate Societies and Supporting Organizations shall not count towards computing quorums or majorities.
Only administrative, financial and legal matters may be put to the vote. Scientific and technical matters shall not be voted upon.
Article 10
The General Assembly shall meet every two (2) years on the occasion of a scientific conference sponsored by the Association.
The Secretary shall notify the membership at least three (3) months 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 (1) month, 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 one (1) month before the General Assembly. The General Assembly shall not take any decisions on items not included on the agenda.
Article 11
The General Assembly is validly constituted if a quorum of at least five percent (5%) of the members of the Association is present or represented by proxy.
If a quorum is not present, a second Assembly shall be announced within a period of one (1) month with the same agenda. This Assembly must be held not earlier than one (1) month and not later than two (2) 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 12
The General Assembly shall be presided over by the President, or in his absence, by one (1) of the two (2) Vice Presidents.
Article 13
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 Vice President for Human Biologicals
- the Report of the Vice President for Veterinary Biologicals
- the Reports of Committee Chairmen
- the Report of the Treasurer
- the Report of the Auditors
- the Budget.
The General Assembly shall:
- approve the annual membership dues
- discuss the other items on the agenda
- elect the Board members Article 14
Unless the present Constitution provides otherwise, all decisions at the General Assembly shall be reached by a simple majority vote of the members present and represented by proxy and shall take place by a show of hands. Two (2) members of the Board or five (5) 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 Association, 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.
V. THE BOARD OF DIRECTORS (BOARD)
Article 15
The Association shall be administered by a Board of Directors (Board). Except as provided in article 17 below, the Board shall have fifteen (15) 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 (2) consecutive terms of six (6) years each. Five Board members shall be elected every two (2) years as specified in the By-laws.
The Board should include at least two members from each of the scientific fields as specified in the By-laws.
Any Individual Member of the Association in good standing may be nominated as a candidate for election to the Board by five (5) Association members or two (2) members of the Board. Collective Members may not become members of the Board, Officers, or members of committees, but may each send a non-voting representative to Board meetings.
The election of the members of the Board shall be carried out by postal vote among all members of the Association, except Associate Societies and Supporting Organizations. A postal 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 postal vote shall be announced. The vote must not be earlier than one (1) month and not later than two (2) months after the announcement has been sent to the membership. A paper ballot shall be sent to each member 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 (6)-year term. 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.
The Board is responsible for ensuring that the Association'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 Association's assets, including its income, are adequately employed.
The Board shall review the annual accounts of the Association and submit these every two (2) years to the General Assembly for ratification.
The Board decides upon the admission, termination and expulsion of members in accordance with the present Constitution.
Article 16
The Board shall meet at least twice a year and at such other times as the activities of the Association require.
The Board shall, in principle, be convened by the President with reasonable advance notice. The Board also shall be convened by the Secretary upon the request of either three (3) members of the Board or of thirty (30) members of the Association.
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 the Board shall be valid when at least 10 Board members are present in person or represented by proxy.
The President shall have the deciding vote if the number of votes cast is equal. The Board may consult absent members of the Board, provided all absent members are consulted. Minutes of such correspondence shall be recorded.
Article 17
The Board shall elect the following Officers from among its members, each for a term of two (2) years:
- The President
- The Vice President for Human Biologicals
- The Vice President for Veterinary Biologicals
- 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 (2) 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 President and Vice Presidents may serve in the same office for no more than three (3) consecutive terms of two (2) years each. The other Officers are not limited in the number of terms they can serve.
The Officers may be assisted by advisors, selected for their specific competence. Subject to approval by the President, such advisors may be invited to the meetings of the Board.
Article 18
The Board shall delegate the daily planning and implementation of the Association's various activities to the following bodies, which shall act in accordance with the functions attributed to them by the present Constitution: a) the Executive Committee, and b) other committees that may be established.
Article 19
In order to ensure the ongoing administrative functions of the Association, to disseminate information and to coordinate the Association's activities, the Board shall maintain a permanent secretariat in Geneva, Switzerland.
VI. OFFICERS
Article 20
The President shall preside over the meetings of the General Assembly, the Board and the Executive Committee. He/she shall represent the Association in negotiations with external bodies, but may delegate those responsibilities to other appropriate members of the Association when it is in the interest of the Association to do so. The President directs the activities of the Association 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 two (2) Vice Presidents shall assist the President in the execution of his/her duties, and one of the two (2) Vice Presidents shall preside at meetings of the Association, including the Board and Executive Committee meetings, in the President’s absence.
The Secretary shall report to the General Assembly regarding the administration of the Association. 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 Association 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.
Two of the Officers, selected by the Board, shall manage the Secretariat in Geneva.
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 as specified in article 17 above. In case of a vacancy in the Immediate Past President position, the vacancy shall not be filled.
VII. THE EXECUTIVE COMMITTEE
Article 21
The Executive Committee is constituted by the President, the Immediate Past President, the Secretary, the two (2) Vice Presidents, and the Treasurer. The Executive Committee shall be presided over by the President or in his absence by one of the two (2) Vice Presidents.
Except for the power to amend the Constitution and By-Laws, the Executive Committee shall have all of the powers and authority of the Board of Directors for the day-to-day operations of the Association in the intervals between meetings of the Board of Directors, subject to such additional limitations that may be imposed by the Board of Directors in the By-Laws.
The Executive Committee shall approve the programme of activities and coordinate the activities of the different committees that may be established by the Board.
The Executive Committee also shall be authorized to make decisions with regard to the engagement of permanent staff for the secretariat in Geneva as well as concerning the day-to-day running of the secretariat, within the limits of the approved budget.
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.
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. VIII. OTHER COMMITTEES
Article 22
The Board may create committees as needed.
Each committee established by the Board shall be under the responsibility of a chairman appointed by the Board. At the start of each calendar year, the chairman shall submit to the Executive Committee for approval an activity report for the past year, an action plan for the new year, and a budget for the new year. Each committee shall have as many members as necessary. The Board reserves the right to dismiss a committee chairman or an entire committee, if, in the view of the Board, the chairman or the committee fails to meet its responsibilities, or for other reasons that are in the interest of the Association.
IX. AUDITORS
Article 23
Two (2) auditors shall be appointed by the Executive Committee and report to the General Assembly. Only the General Assembly may dismiss the auditors.
X. COMMITMENT BY SIGNATURE
Article 24
The signature of two (2) of the following: the President, the Secretary or the Treasurer, shall constitute a valid and binding commitment of the Association towards third parties.
XI. SOURCES OF INCOME
Article 25
The Association’s income shall be derived from:
A. members’ dues and donations
B. grants which it may receive
C. gifts or legacies which it may receive
D. scientific conferences and publications
E. other sources.
The amount of dues for each member category shall be set by the Board within the limits set below.
The maximum annual dues are the following for each category of members:
Ordinary Members: USD 100.00
Student Members: USD 50.00
Developing Country Members: USD 50.00
Member Societies: USD 10,000.00
Supporting Organizations: USD 10,000.00
Emeritus Members, Honorary Members and Associate Societies shall pay no dues. Student members and Developing Country Members benefit from reduced rates of dues to be set by the Board.
Voluntary contributions exceeding the annual dues shall be considered as donations.
XII. CHANGES TO THE CONSTITUTION AND DISSOLUTION OF THE ASSOCIATION
Article 26
Proposals for changes to the Constitution shall be submitted to the General Assembly by the Board. At least five (5) members of the Association 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 (2) months before the General Assembly.
Changes to the Constitution must be approved by a two-thirds (2/3) majority of the members present and voting at the General Assembly.
Article 27
The Association 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 Association 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.
XIII. MISCELLANEOUS
Article 28
The methods by which these Articles are to be implemented are stipulated in the By-laws. The original text shall be drafted by the Board and submitted to the General Assembly for approval. Subsequent revisions to the By-laws may be made by the Board as specified in the By-laws that were originally approved by the General Assembly.
Article 29
The President and the Secretary, both being present at the General Assembly, shall each be required to acknowledge by signature the authenticity of the present Constitution and any amendments to the Constitution as may be adopted by the General Assembly.
Article 30
The first Statutes of the Association were adopted by the General Assembly meeting on 20th September, 1959, in Tel Aviv. This revised Constitution was accepted by the General Assembly meeting on 6th November 2006, in Lyon, France.
Secretary
(signed) Daniel Gaudry (France)
6 November 2006 |
President
(signed) John Petricciani (USA)
6 November 2006 |
Permanent office of the
International Association for Biologicals I A B S
79, Avenue Louis-Casai
CH-1216 Cointrin-Geneva
Switzerland
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