Half a century of newborn screening in Spain: Evolution of ethical, legal and social issues (ELSIs). Part II, legal system

Neonatal screening is a health action specifically regulated in our legislation. The legal system establishes that health screening is a public health action, focused on the prevention of health of the community in general and, at the same time, a health service, that is, a right of individuals, whose interest is the focus of the regulation. In its design and implementation are involved the State and Regional Health Authorities. The effectiveness, efficiency and quality. are the criteria for assessing its suitability, and the adoption of measures to ensure the rights of participants. transparency and voluntariness, are essential for approval. These general requirements are reinforced when the screening is aimed at the paediatric population and when it comes to genetic screening, in which case a review by an ethics committee is foreseen as a prerequisite for authorization.