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Section 139a of Book V of the Social Code - The Institute for Quality and Efficiency in Health Care

(1) The Federal Joint Committee in accordance with section 91 shall establish an academic Institute for Quality and Efficiency in Health Care, which shall be impartial, shall have legal capacity; the Committee shall be its financing entity. A foundation under private law may be established to this end.

(2) The management of the Institute shall be appointed in agreement with the Federal Ministry of Health. If a foundation under private law is established, agreement shall be reached within the board of the foundation, to which the Federal Ministry of Health shall second a representative.

(3) The Institute shall act on issues of fundamental importance for the quality and economic viability of the benefits provided within statutory health insurance, in particular in the following areas:

1. research, illustration and evaluation of the current state of medical knowledge on diagnostic and therapeutic procedures with selected diseases,

2. drawing up academic documents, reports and statements on issues related to the quality and economic viability of the benefits provided within statutory health insurance, taking account of age-, gender- and situation-specific particularities,

3. evaluations of evidence-based guidelines for the most important diseases in epidemiological terms,

4. submission of recommendations on disease management programmes,

5. evaluation of the benefit and costs of medicinal products,

6. provision of general information that is understandable for all citizens on quality and efficiency in healthcare, as well as on diagnostics and treatment of diseases with considerable epidemiological significance.

(4) The Institute shall ensure that the evaluation of the medical benefit is effected in accordance with the internationally-recognisable standards of evidence-based medicine and that the economic evaluation is carried out in accordance with the internationally-recognised standards which are relevant for this, in particular health economics. It shall report publicly at regular intervals on the working processes and results, including the foundation for decision-making.

(5) The Institute shall afford to experts of medical, pharmaceutical and health economic science and practice, the medicinal product manufacturers, as well as the organisations relevant for representing the interests of patients and the self-help of chronically ill persons and persons with disabilities, and the Federal Government’s Commissioner for Patients’ Affairs, the opportunity to make a statement at all important stages of the evaluation procedure. The statements shall be taken into consideration in the decision.

(6) In order to ensure the impartiality of the Institute, the staff shall disclose prior to their recruitment all connections with lobbies, contract institutes, in particular of the pharmaceutical industry and the medical device industry, including the nature and amount of any payments.

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