Foundation for Quality and Efficiency in Health Care
Note: The Foundation for Quality and Efficiency in Health Care is the supporting organization of IQWiG. Its purpose is the promotion of science and research.
Charter of the Foundation
§1 Name, Legal Form and Registered Headquarters of the Foundation
In accordance with §91 SGB V, the Federal Joint Committee (Gemeinsamer Bundesausschuss), an institution established under public law, establishes the private law foundation, with legal capacity, bearing the name
Foundation for Quality and Efficiency in Health Care
(Stiftung für Qualität und Wirtschaftlichkeit im Gesundheitswesen)
(hereinafter referred to as the "Foundation") as the governing body of the Institute with the same name pursuant to §139a (1) SGB V.
The Foundation has its registered headquarters in Berlin. The Institute has its head office in the Cologne/Bonn region until 31 December 2008, and thereafter in Berlin. It can establish a branch office in Berlin.
§2 Purpose of the Foundation
The Foundation exclusively and directly pursues charitable purposes as defined in the Section "Purposes with Tax Relief" in the Tax Code.
The aim of the Foundation is the promotion of science and academic research, as well as the promotion of the publicly funded health service. The purpose of the Foundation will be exclusively realised by the establishment and maintenance of the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; hereinafter referred to as the "Institute") provided for in §139a SGB V, whose tasks are specified in § 7.
§3 Use of Funds
The Foundation works in the public interest. It pursues no economic aims of its own. Funds of the Foundation may only be used for purposes that conform to the Charter.
§4 Bodies and Institutions of the Foundation
(1) The bodies of the Foundation are
- the Federal Joint Committee for resolutions to alter the Charter and terminate the Foundation
- the Foundation Council
- the Board of Directors.
(2) The Institute is an institution of the Foundation under scientifically independent responsible management. Advisory committees of the Institute are:
- the Board of Trustees
- the Scientific Advisory Board.
(3) A Financial Committee of the Foundation will be appointed, which advises the bodies of the Foundation and in particular reviews the budget and the annual account prepared by the Institute Director.
§5 Foundation Council
(1) The Foundation Council comprises 6 representatives of the Central Federal Association of Health Insurance Funds (Spitzenverband Bund der Krankenkassen), together with a total of 6 members of the Board of Directors or the management of the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung), the German Federal Association of Sick Fund Dentists (Kassenzahnärztliche Bundesvereinigung), and the German Hospital Federation (Deutsche Krankenhausgesellschaft). The stipulated organizations of the service providers will agree internally on the allocation of the seats on the Foundation Council to which they are entitled. They can also agree on a representative who does not belong to their bodies. The representatives will in each case be appointed by the respective organizations. The appointment must be adjusted in accordance with the current membership of the respective Board of Directors or management. A representative according to Sentence 3 can be removed from office at any time. Appointed representatives stay in office until such time as they are replaced by newly appointed representatives. The representatives themselves can be represented by third parties authorized in writing. These parties must belong either to the health care funds or to the organizations of service providers named in Sentence 1. The Chairperson of the Federal Joint Committee belongs to the Foundation Council as an advisory member without the right to vote. The Foundation Council elects a Chairperson and a Vice-Chairperson for a term of 4 years from among the members entitled to vote. They fulfil these functions on an annually alternating basis. After expiry of the office term, the acting function holders at this point in time remain in office until the election of a new Chairperson and a new Vice-Chairperson.
(2) The Foundation Council resolves on the establishment of the Institute as an institution of the Foundation. The Foundation Council appoints 4 members of the Board of Directors pursuant to § 6 and discharges the Board of Directors. The Foundation Council proposes the Institute Director and his or her deputy. The Foundation Council is in addition also responsible for approving the budget of the Foundation and the Institute, including the approval of expenditure exceeding and expenditure outside the budget, the monitoring of the budget and economic management, and the adoption of the annual accounts. In the course of this, however, the scientific and professional independence of the Institute must be safeguarded. The Foundation Council also decides on the auditor who has the obligation to examine the regularity of the management and to produce an audit report on the results in accordance with § 8 (2) StiftGBIn (Foundation Act, Berlin).The audit instruction must also encompass the maintenance of the Foundation's assets and the use in accordance with the Charter of the earnings and other payments. The Foundation Council approves the report to be produced by the Board of Directors on the fulfilment of the Foundation's purpose, and the audit report assessed by it as the annual report. (3) The Foundation Council passes its resolutions with the majority of the votes present, unless the Charter provides otherwise. The written authorization of a third party pursuant to (1), Sentence 8, as well as a transfer of voting rights in writing, are permissible. In the case of a tie in the voting, the vote of the Chairperson of the Foundation Council is decisive (or, if absent, of the Vice- Chairperson).
Resolutions on budget matters require the consent of at least 7 members.
(4) For a quorum to pass resolutions, the presence of the Chairperson or Vice- Chairperson of the Foundation Council and of at least 4 representatives or authorized third parties each from the Central Federal Association of Health Insurance Funds and the service providers is necessary, pursuant to (1), Sentence 8; in this context the Chairperson or Vice-Chairperson is counted as a representative.
(5) The meetings will be called by the Chairperson of the Foundation Council at least twice a year. A meeting must be called if the Board of Directors of the Foundation or 3 members of the Foundation Council so require.
(6) The Foundation Council can also pass a resolution in writing if all members agree to this procedure in writing. A resolution is passed with a majority of the members.
§6 Board of Directors
(1) The Board of Directors consists of 5 members with voting rights who hold office on an honorary basis. Four members are appointed by the Foundation Council for a term of 4 years, one member is appointed by the Federal Ministry of Health (representative of the Federal Ministry of Health pursuant to §139a (2), Sentence 2, SGB V). After the expiry of the term of office of the members appointed by the Foundation Council, the Board of Directors holding office continues the business until the election of the new Board of Directors. The members of the Board of Directors appointed by the Foundation Council can only be removed from office as members of the Board of Directors before the expiry of their term of office for important cause or with a vote passed by two thirds of its members. The member appointed by the Federal Ministry of Health stays in office until the Ministry appoints a new member. The rights of the Foundation Supervisory Authority remain unaffected. If a member of the Board of Directors appointed by the Foundation Council leaves office before the expiry of his or her term of office, the Foundation Council will elect a replacement member for the remainder of the term of office without undue delay. Until the Board of Directors is supplemented in this way, the number of members in the Board of Directors reduces by the number of persons who have left. The Institute Director belongs to the Board of Directors in a consultative capacity.
(2) The Board of Directors deals with the current business of the Foundation and supervises the Institute Director in respect of proper management. For this purpose, it decides after consultation with the Institute Director on the necessary principles, in particular for the organizational structure of the Institute, regular reporting of the use of funds, the obligation to obtain consent for certain legal transactions exceeding a defined framework (details on this issue are regulated in the Standing Orders of the Institute), on the award of external commissions and their remuneration, as well as the conditions of employment for Institute staff. It must produce a budget at the start of each business year, and annual accounts at the end of each business year, which must in each case be prepared by the Institute Director. Expenditure exceeding or outside the budget requires its consent.
(3) The Board of Directors meetings will be held in rotation in a way agreed amongst the members of the Board of Directors and chaired alternately. The Chairperson of the Federal Joint Committee may participate in the Board of Directors meetings in a consultative capacity. The Chief Operating Officer and Legal Advisor of the Institute have the right to submit applications to the Board of Directors, as well as the right to participate and speak in the meetings. Applications can be submitted both at the meetings and within the framework of a written procedure to pass resolutions. The Board of Directors may also meet exclusively within the circle of its members with voting rights and pass resolutions. The Board of Directors passes its resolutions by majority vote unless the Charter provides otherwise. The member appointed by the Federal Ministry of Health can be represented by a third party authorized in writing, who is attached to the Ministry.
The Board of Directors can also pass a resolution in writing if all members consent to this procedure in writing.
(4) The Board of Directors has an obligation to submit the annual report adopted pursuant to §5 (2), Sentence 8 to the Foundation Supervisory Authority. This must take place within 8 months after the end of the business year. The resolution of the Foundation Council must be attached.
(5) In all its decisions, the Board of Directors must respect the scientific and professional independence of the Institute.
§7 The Institute
(1) The Institute will work on issues of fundamental importance for the quality and efficiency of the services performed within the framework of the statutory health insurance (SHI) system as an independent scientific institution of the Foundation, in particular in the following areas:
- Search for, assessment and presentation of current scientific evidence on diagnostic and therapeutic procedures for specific diseases;
- Preparation of scientific reports and expert opinions on quality and efficiency issues of SHI services, taking age, gender, and personal circumstances into account;
- Appraisal of evidence-based clinical practice guidelines on the epidemiologically most important diseases;
- Issue of recommendations on disease management programmes;
- Assessment of the benefits and costs of drugs;
- Provision of easily understandable information for all citizens on the quality and efficiency of health care services, as well as on the diagnostics and treatment of diseases of high epidemiological relevance.
Its task is to support the Federal Joint Committee in fulfilling its statutory duties in these areas by the submission of recommendations (§139b  SGB V).
(2) The Institute Director, at the proposal of the Foundation Council, will be appointed by the Board of Directors. The latter will also produce the contract of employment. The appointment will be for a limited period of time. Re-appointment is permissible. The Institute Director must have a high scientific reputation and experience in the management of scientific and/or clinical institutions commensurate with the significance of the Institute's tasks.
(3) In addition, the Board of Directors appoints a deputy for the Institute Director; (2) applies accordingly.
(4) The consent of all members of the Board of Directors is required for resolutions pursuant to (2) and (3).
(5) The Institute Director is responsible for the Institute's fulfilment of its tasks within the framework of the statutory tasks pursuant to §139a and §139b SGB V, the priorities set by the Federal Joint Committee, the budget approved by the Foundation Council and the principles decided by the Board of Directors for the organizational structure and the use of funds pursuant to §6 (2). The Institute will establish a tendering office, in particular for the award of research commissions according to §139b (3) SGB V. The detailed procedure is regulated in a tendering directive of the Institute, which is to be decreed by the Board of Directors. The procedural regulations decided by the Federal Joint Committee on the basis of §91 (4) SGB V must be observed with as far as the involvement of the Institute is concerned. The methodological requirements regarding the scientific, cross-sector evaluation of measures to be regulated in the procedural regulations and the demands on the professional independence of external experts must be defined in close consultation with the Institute Director.
(6) The Institute Director is responsible to the Board of Directors for the proper fulfilment of his/her tasks. He/She must prove his/her professional independence to the Board of Directors in suitable form.
(7) The Institute Director must produce a report each year about the working processes and results of the Institute, including the bases for the decision-making process, and must forward it to the Board of Directors for publication.
(8) Recommendations to the Federal Joint Committee and other decisions and publications stipulated by statute must be submitted to the Board of Directors for its information.
(9) The Institute Director employs the scientific staff and other staff of the Institute in accordance with the budget and the principles passed by the Board of Directors. (3) remains unaffected by this. The position of the Chief Operating Officer is to be filled in agreement with the Board of Directors. The Chief Operating Officer assumes the function of a Budget Officer pursuant to §33 SVHV/§9 BHO. The Institute Director is the superior of the scientific and other staff. The Institute Director must comply with the stipulations in §139a (6) SGB V.
§8 Board of Trustees
(1) The Board of Trustees comprises 30 members. They are appointed by organizations which the Board of Directors specifies at the suggestion of the Foundation Council in consultation with the Institute Director. Ten members must be appointed from each of the following:
- the bodies of self-administration of the governing organizations of the Federal Joint Committee;
- relevant organizations of organizations of service providers not represented in the Federal Joint Committee and of the social partners;
- other organizations relevant to the health system, 6 of which are representatives of organizations representing the interests of patients and Government Commissioner for Patients' Affairs.
(2) The organizations required by the Board of Directors to appoint a representative will notify the name of the representative to the Foundation. He or she will be appointed by the Board of Directors. The nominating organization can remove its representative from office at any time and propose another person, who can be appointed by the Board of Directors.
(3) The members of the Board of Trustees receive from the Institute Director the recommendations of fundamental importance issued by the Institute to the Federal Joint Committee, and have the opportunity to submit comments in writing. They can submit comments together, in groups or individually.
(4) Prior to issuing recommendations of the Institute on matters which directly affect the interests of patients, in particular on the provision of understandable general information on the quality and efficiency in health care, the patients' representatives on the Board of Trustees and the Federal Government Commissioner for Patients' Affairs must be given the opportunity to submit comments within the framework of a hearing. This does not apply to procedures for the benefit assessment of drugs according to §35a SGB V.
(5) At the invitation of the Board of Directors, the Board of Trustees meets once a year. Written authorization by a third party from the same circle of organizations as the member pursuant to (1), Sentence 3, Nos. 1 to 3 is permissible, as well as the written transfer of the voting right to another member of the respective organizations pursuant to (1), Sentence 3, Nos. 1 to 3,. The Board of Trustees elects a Chairperson and a Vice-Chairperson for a term of 4 years, who exchange offices at the start of the third year. In order to ensure a quorum for the election of the Chairperson/Vice-Chairperson of the Board of Trustees, the presence is required of at least 6 members or representatives from each circle of organizations specified in (1), Sentence 3, Nos. 1 to 3. The Chairperson/Vice-Chairperson is elected if he/she receives more than half the votes cast.
The election of the Chairperson/Vice-Chairperson takes place in principle on a show of hands, but can be conducted by secret ballot upon application of at least 11 members of the Board of Trustees present or representatives of members of the Board of Trustees.
(6) The Board of Directors can issue invitations to additional meetings in consultation with the Chairperson of the Board of Trustees.
(7) If the Board of Trustees forms its opinion pursuant to (3) in meetings, the relevant resolution is passed with the majority of votes present. (5), Sentence 2 applies accordingly. In the event of a tie in the voting, the Chairperson's vote is decisive. In order to have a quorum, the presence of the Chairperson or Vice-Chairperson and of at least 6 present or represented members from each circle of organizations, pursuant to (1) Nos. 1 to 3, is required. In this context the Chairperson or Vice-Chairperson counts as a member.
(8) Members of the Board of Directors, the Foundation Council and the Institute Director can participate in the meetings.
§9 Scientific Advisory Board
(1) The members of the Scientific Advisory Board are appointed by the Board of Directors in agreement with the Institute Director. If no agreement can be reached, the Board of Directors can appoint the member with the majority of its members. The Scientific Advisory Board comprises at least 6 and not more than 12 scientists. The members of the Scientific Advisory Board are appointed for a term of 4 years. They can usually only be reappointed once.
(2) The Scientific Advisory Board decides on a Chairperson and Vice-Chairperson from amongst its members with the majority of the votes of its members.
(3) The Institute Director invites the Scientific Advisory Board to meetings which are chaired by the Chairperson of the Scientific Advisory Board.
(4) The Scientific Advisory Board is intended to advise the Institute Director on fundamental issues he/she submits.
§10 Finance Committee
(1) The Finance Committee comprises 3 representatives of the Central Federal Association of Health Insurance Funds, and one representative each from the National Association of Statutory Health Insurance Physicians, the German Federal Association of Sick Fund Dentists, and the German Hospital Federation. The representatives are appointed by the Foundation’s Board of Directors upon the recommendation of the Foundation Council. The Institute Director and the Chief Operating Officer participate in the meetings in a consultative capacity.
(2) The Finance Committee advises the Foundation Council, the Foundation’s Board of Directors, and the Institute Director in financial affairs. The Committee reviews the budget and the annual account prepared by the Institute Director.
§11 Minutes of the Bodies' Resolutions
A written record of the resolutions passed by the bodies of the Foundation in meetings must in each case be produced and signed by the Chairperson of the respective meeting. In case of voting by written procedure, the results must be verified and signed by a member of the responsible body.
§12 Representation of the Foundation
(1) The Foundation is represented in and out of court in each case by 2 members of the Board of Directors elected by the Foundation Council. The Institute Director and his/her deputy, as special representatives pursuant to § 30 BGB (German Civil Code) within the framework of the principles resolved by the Board of Directors pursuant to § 6 (2), are entitled to act independently for the Institute and in this respect represent the Foundation in and out of court.
(2) The representative authorisation is evidenced by a certificate of representation issued by the Supervisory Authority.
§13 Raising Funds
(1) The Federal Joint Committee makes available the funds required on the basis of the resolutions of the Foundation Council on the budget pursuant to §5 (2), Sentence 4. The financing takes place in accordance with §139c SGB V. The allocation of unused funds to the assets of the Foundation requires the consent of all members of the Board of Directors. It can only be given within the framework of §58 AO (Tax Code).
(2) The assets of the Foundation are EUR 50 000.00. They are indefeasible and must be invested in analogous application of the provisions on the investment of monies with trustee investment status; yields from the assets and any payments by third parties which are not specified as assets must only be used for the fulfilment of the purpose specified in the Charter. The acceptance of payments by third parties – with the exception of payments pursuant to (1) – requires the consent of the Board of Directors. “Outside funding contracts” require the consent of all members of the Board of Directors. If this is not obtained, the decision is taken by the Foundation Council.
(3) No person or organization may benefit from the assumption of administrative tasks foreign to the purposes of the Foundation or from disproportionately high remuneration.
§14 Business Year
The business year is the calendar year.
§15 State Supervision
According to § 8 StiftGBIn (Foundation Act, Berlin), the members of the Board of Directors have an obligation to notify without undue delay and prove to the Supervisory Authority the respective composition of the bodies of the Foundation and the Institute Director and his/her deputy, including the distribution of the offices within the bodies (election records, deeds of appointment, declarations of acceptance and resignation, or other evidentiary documents) and to notify the address of the Foundation and the residential addresses of the members of the Board of Directors, and of the Institute Director and his or her deputy. Proof of the composition of the Federal Joint Committee is provided by a declaration of the Chairperson of the Federal Joint Committee with a legitimating effect in relation to third parties.
§16 Alterations to the Charter and Liquidation
(1) This Charter can be altered by the Federal Joint Committee with a majority of two thirds of its members.
(2) The Foundation can only be terminated in case of a significant change in the circumstances by a resolution of the Federal Joint Committee pursuant to §91 (2) SGB V with a majority of two thirds of its members.
(3)Resolutions pursuant to (1) and (2) require the consent of the Foundation Supervisory Authority.
§17 Accession of Assets
In case of dissolution or termination of the Foundation, or in case of cessation of the purposes subject to tax relief, the assets accrue to the Federal Joint Committee, which must use them exclusively and directly for purposes subject to tax relief as defined in §2.
Berlin, 14 April 2011
Chairperson of the Federal Joint Committee
Dr. jur. Rainer Hess