Genetic tests can detect the predisposition to various diseases. The demand for gene diagnostics and corresponding prophylactic measures is increasing steadily. In the German healthcare system, however, legal uncertainties exist as to whether a mere risk of disease is reason enough to bear the costs for prophylactic measures. When medically effective prophylactic measures are available in certain cancer diseases, such as in hereditary breast cancer, the current practice of deciding in individual cases appears to be insufficient.The fact that persons with a high or very increased risk of breast cancer are precluded from a standard care procedure raises questions concerning ethical justification as well as medical plausibility. Moreover, it is remarkable that the statutory healthcare system treats persons at risk differently. In some cases there is a regulated way of reimbursement for preventive measures for persons at risk (factor V Leiden mutation) and in other cases there are only case-by-case decisions. Finally, in light of social regulations for persons at high and very increased risk this article considers the need of optimization regarding the risk communication in the decision-making process and the crucial question of budgetary impact for the German healthcare system.From a medical, ethical and legal perspective, a social regulation for persons at high and very increased risk of disease is inevitable and the consequences should be discussed in advance.
Keywords: BRCA1/2; Budget impact; Decision-making process; Disease; Genetic risk.