Legal foundations of IQWiG
The Institute was established under the Health Care Reform 2004 as an institution of the Foundation for Quality and Efficiency in Health Care.
Since then the legal foundations and responsibilities of IQWiG have been laid down in the German “Social Code Book V (SGB V) - Statutory Health Insurance”, and adapted and expanded in further health care reforms. In addition, the framework of its work is defined more precisely in the code of procedure of the Federal Joint Committee (G-BA) and in IQWiG’s methods.
Legal regulations on IQWiG in SGB V:
- §139a (“Institute for Quality and Efficiency in Health Care”) describes the Institute’s establishment, legal form, committees, responsibilities etc.
- §139b (“Conduct of tasks”) stipulates the commissioning of the Institute, the involvement of external experts in its working processes, and the importance of its recommendations. It also transfers the public proposal procedure for HTA reports (in German: "Themencheck Medizin", means "Topic check medicine") to IQWiG.
- §139c (“Funding”) regulates the modalities of the Institute’s funding.
- §35a (“Assessment of the benefit of drugs containing new active ingredients”) contains the legal requirements for the early benefit assessment of drugs.
- §35b (“Evaluation of the benefits and costs of drugs”) provides the legal basis for the health economic evaluation of drugs.
- §130b (“Agreements between the Central Federal Association of the Health Insurance Funds and pharmaceutical companies on reimbursement prices for drugs") describes the mode of negotiations on reimbursement prices of drugs that may be conducted between health insurance funds and pharmaceutical companies after an early benefit assessment.
- §137e (“Testing of examination and treatment methods”) regulates the testing of examination and treatment methods by the G-BA.
- §137h ("Assessment of new examination and treatment methods containing high-risk medical devices") stipulates the legal basis for the assessment of medical devices.
- §303e (“Data processing and utilization”) contains the regulations on the utilization of health insurance fund data for scientific purposes.
The Federal Joint Committee (G-BA) awarded a general commission to IQWiG in December 2004, which was extended in March 2008. This allows IQWiG to select topics for scientific evaluation independently. The topics do not have to be approved by the G-BA or the Federal Ministry of Health (BMG).
Further laws and regulations
Numerous further laws and regulations that directly influence IQWiG’s work have been added since the establishment of the Institute:
- The Act to Promote Competition in Statutory Health Insurance (GKV-WSG) offers the opportunity for the G-BA to commission IQWiG with health economic evaluations. It also provides for the involvement of interest groups in “all important phases of the assessment procedure”.
- The Act on the Reform of the Market for Medicinal Products (AMNOG) and the Regulation on the Benefit Assessment of Drugs (AM-NutzenV) form the legal basis for the procedure of the early benefit assessment of new drugs. The legal regulation of the BMG supplements §35a SGB V.
- The Structure of Health Care Act of the Statutory Health Insurance (GKV-VStG) provides the legal basis for the G-BA to be able to initiate high-quality clinical studies if medical devices or diagnostic procedures show the potential of a treatment alternative.
- The Third Law for Amendment to Pharmaceutical and Other Regulations (3rd AMGÄndG) in §139d lays the foundation for further testing regulations.
- The Fourteenth Amendment to SGB V (14th SGB V-ÄndG) stops the benefit assessment of drugs from the established market.
- The Act to Strengthen the Provision of Health Care (GKV-VSG) aims to ensure easily accessible high-quality health care for patients. Among other things, it provides the legal basis for the systematic assessment of particularly invasive high-risk class medical devices that are based on a new theoretical-scientific concept.