本文是我们关于在德国医疗保健系统中建立风险调整预防的法律概念的提案的修订版,以规范处于高和中度遗传性癌症风险的人获得降低风险的措施(Meier等人。RisikoadaptiertePrävention\'.Leistungsansprüchebeigenetischen(Brustkres-)Risiken,Springer,威斯巴登,2018)。总结了德国上下文细节,以使源文本能够用于其他特定国家的医疗保健系统。建立这样一个法律概念与所有类似于德国的全民和免费医疗体系有关。使用生物信息学和生物统计学创新(“大数据”)可以越来越精确地确定疾病风险,由于鉴定了癌症风险基因中的致病性种系突变以及非遗传因素及其相互作用。这些新技术为复杂疾病的个体风险状况提供了调整治疗和预防措施的机会,这是以前未知的。不仅能够进行适当的治疗,而且在最好的情况下,预防。遗传风险携带者获得降低风险措施的机会通常不在保证普遍和平等获得医疗保健福利的医疗保健系统中受到监管。在许多国家,包括奥地利,丹麦,英国和美国,获得福利的权利基本上与治疗已经明显的疾病有关。围绕预防措施的利益主张的问题不仅涉及临床选择的评估(遗传诊断,化学预防,降低风险的手术),而是财务成本和——从社会伦理的角度——它们之间的关系。本章的第1节使用遗传性乳腺癌的具体例子来说明为什么从医学,社会法律,健康经济和社会伦理的观点,受监管的福利权利对于癌症高风险和中度风险的人是必要的。第2节讨论了患有遗传性癌症风险的人的医疗需求,并继续开发了健康的患病模型,该模型能够将不同学科的问题整合到一个方案中,并建立了对处于高和中等风险的人进行法律承认的标准(乳腺癌)。在德国的背景下,经典治疗医学的社会法律类别并不能充分代表预防措施作为医疗保健系统内的常规服务。我们提出风险调整预防是基于启发式健康疾病模型的新法律概念。对于有遗传性癌症风险的人,这一类别可以作为社会法律监管的法律框架。原则上,任何医疗保健系统都可以建立风险调整后的预防。还制定了与风险集合和分配有关的标准(Sects。3、4、5)。
This article is a revised version of our proposal for the establishment of the legal concept of risk-adjusted prevention in the German healthcare system to regulate access to risk-reduction measures for persons at high and moderate genetic cancer risk (Meier et al. Risikoadaptierte Prävention\'. Governance Perspective für Leistungsansprüche bei genetischen (Brustkrebs-)Risiken, Springer, Wiesbaden, 2018). The German context specifics are summarized to enable the source text to be used for other country-specific healthcare systems. Establishing such a legal concept is relevant to all universal and free healthcare systems similar to Germany\'s. Disease risks can be determined with increasing precision using bioinformatics and biostatistical innovations (\'big data\'), due to the identification of pathogenic germ line mutations in cancer risk genes as well as non-genetic factors and their interactions. These new technologies open up opportunities to adapt therapeutic and preventive measures to the individual risk profile of complex diseases in a way that was previously unknown, enabling not only adequate treatment but in the best
case, prevention. Access to risk-reduction measures for carriers of genetic risks is generally not regulated in healthcare systems that guarantee universal and equal access to healthcare benefits. In many countries, including Austria, Denmark, the UK and the US, entitlement to benefits is essentially linked to the treatment of already manifest disease. Issues around claiming benefits for prophylactic measures involve not only evaluation of clinical options (genetic diagnostics, chemoprevention, risk-reduction surgery), but the financial cost and-from a social ethics perspective-the relationship between them. Section 1 of this chapter uses the specific example of hereditary breast cancer to show why from a medical, social-legal, health-economic and socio-ethical perspective, regulated entitlement to benefits is necessary for persons at high and moderate risk of cancer. Section 2 discusses the medical needs of persons with genetic cancer risks and goes on to develop the healthy sick model which is able to integrate the problems of the different disciplines into one scheme and to establish criteria for the legal acknowledgement of persons at high and moderate (breast cancer) risks. In the German context, the social-legal categories of classical therapeutic medicine do not adequately represent preventive measures as a regular service within the healthcare system. We propose risk-adjusted prevention as a new legal concept based on the heuristic healthy sick model. This category can serve as a legal framework for social law regulation in the
case of persons with genetic cancer risks. Risk-adjusted prevention can be established in principle in any healthcare system. Criteria are also developed in relation to risk collectives and allocation (Sects. 3, 4, 5).