Welti Felix
Christian-Albrechts-Universität zu Kiel/Hochschule Neubrandenburg.
Z Arztl Fortbild Qualitatssich. 2007;101(7):447-54. doi: 10.1016/j.zgesun.2007.08.003.
The present contribution examines whether German Social Security Law requires or allows the German health care system to follow the principles of evidence-based health care. The discussion will be based on the relevant example of statutory health insurance (Book of Social Code V-SGB V). According to Sect. 2 SGB V health care provision has to follow medical standards, acknowledging medical progress. It has to be effective and efficient. Special therapies are not outlawed, but also have to follow these principles. Efficiency is defined (Sect. 12 SGB V) by the benefits being sufficient and necessary. The responsibility for achieving these goals and supplying the benefits for all people according to need lies with the health care insurance funds along with the physicians' associations (Kassenirztliche Vereinigung) and the hospitals (Sect. 70 SGB V). These organisations cooperate in the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA, Sect. 92 SGB V), where they have to hear organisations of patients and of the disabled also. The G-BA is allowed by law to exclude therapies not meeting the SGB V criteria. The Institute for Quality and Efficiency in Health Care (IQWiG) advises the G-BA and is also responsible for generating evidence. A major political and constitutional controversy has been triggered on the legitimation of the Federal Joint Committee. In its statute the G-BA recurs on evidence-based health care. It examines therapies according to the degree of available evidence and the usability of the evidence in the respective supply setting. The Federal Social Court (Bundessozialgericht, BSG) decided that the decisions of the G-BA could not be challenged for being medically incorrect. In 2005, the Federal Constitutional Court (Bundesverfassungsgericht-BVerfG) decided that a stricter control over the G-BA by the social courts was needed and that in the case of serious disease a lower evidence level might be sufficient. BSG and G-BA will continue to accept the results and methods of Evidence-based Medicine.
本论文探讨德国社会保障法是否要求或允许德国医疗体系遵循循证医疗的原则。讨论将以法定医疗保险(《社会法典》第五卷 - SGB V)的相关例子为基础。根据《社会法典》第五卷第2条,医疗保健服务必须遵循医学标准,承认医学进步。它必须有效且高效。特殊疗法并非被禁止,但也必须遵循这些原则。效率(《社会法典》第五卷第12条)的定义是效益充足且必要。实现这些目标并根据需求为所有人提供福利的责任在于医疗保险基金、医师协会(Kassenirztliche Vereinigung)和医院(《社会法典》第五卷第70条)。这些组织在联邦联合委员会(Gemeinsamer Bundesausschuss, G - BA,《社会法典》第五卷第92条)中合作,在该委员会中他们还必须听取患者和残疾人组织的意见。法律允许联邦联合委员会排除不符合《社会法典》第五卷标准的疗法。医疗质量和效率研究所(IQWiG)为联邦联合委员会提供建议,并且也负责生成证据。关于联邦联合委员会的合法性引发了一场重大的政治和宪法争议。在其章程中,联邦联合委员会采用循证医疗。它根据现有证据的程度以及证据在各自供应环境中的可用性来审查疗法。联邦社会法院(Bundessozialgericht, BSG)裁定,联邦联合委员会的决定不能因其医学上不正确而受到质疑。2005年,联邦宪法法院(Bundesverfassungsgericht - BVerfG)裁定,社会法院需要对联邦联合委员会进行更严格的监督,并且在严重疾病的情况下,较低的证据水平可能就足够了。联邦社会法院和联邦联合委员会将继续接受循证医学的结果和方法。