The impact of new prenatal genetic tests on the protection of right to health in the Italian National Health Service

The project deals with the ethical, legal and economic implications of predictive medicine for the right to health, addressing the more specific and current topic of the inclusion of next generation prenatal genetic tests in the essential levels of healthcare services (LEA) ensured by the National Health Service (SSN). Scientific and technological progress in medicine always represents a critical factor for the health policies of a country. The intensity and complexity of its impact, however, vary greatly depending on the configuration of the protection of the right to health in each legal system [1-4]. In Italy, the protection of health guaranteed by Constitution has been fully implemented with the establishment of a universal, comprehensive, equitable and tax-financed healthcare system [5-6]. Later, the introduction of the institute of LEA has provided the system with a key tool for determining the substantial content of the social right to health, confirming the model of comprehensive universalism, but without ignoring the problem of the financial sustainability [7-8]. The update of LEA, while obviously not being the only way for innovative treatments to enter clinical practice, represents a decisive moment for measuring the capability of the system to deal with scientific development and for studying its impact on the NHS. Our research will explore this capability and this impact, with particular reference to new prenatal genetic tests, in order to reconstruct the main problematic knots that their inclusion in the LEA presents under the following profiles, which will be reassembled in an “analytic framework” likely to be applied to other national legal systems as well: principles and techniques for regulating conditions of appropriateness for the provision of services; equity of access and organizational preparedness of regional healthcare services; informed consent and incidental findings’ management; reproductive autonomy, protection of the unborn child.