Law 31/2006

Law 31 - February 2, 2006

Introduction

The italian Law n.31, “Regulations for Diagnostic Post Mortem Investigation in victims of the Sudden Infant Death Syndrome (SIDS) and Unexpected Fetal Death” is a revolutionary innovation that provides measures to significantly reduce the toll of human lives in the developing world: information and awareness campaigns, training programs, promotion of research-clinical anatomical, genetic and epidemiological projects and psychological support to the families of victims. According to the Law n.31, all Regions should identify the reference centers for diagnostic examination of infants who died suddenly within one year of life and of fetuses died without apparent cause after the 25th week of gestation ".

Following the deactivation of the Institute of Pathology, University of Milan (quoted in the arts. 1 and 3 of the Law), the Italian Ministry of Health in 2008 has recognized the "Lino Rossi" research Center as national reference Center for the implementing the Act.

A similar Law "To amend the Public Health Service Act to enhance public health activities related to preventing stillbirth and sudden unexpected infant death (SUID)" has been proposed in USA, on initiative of the ex-President B. Obama.

Download the letter of the Law 31 - Febraury 2,2006 in Italian - PDF format

Download the letter of the USA Law - PDF format

Law 31 - February 2, 2006

"Regulations for Diagnostic Post Mortem Investigation in victims of the Sudden Infant Death Syndrome (SIDS) and Unexpected Fetal Death" published on Gazzetta Ufficiale no. 34 - February 10, 2006

ART. 1.

1. Infants that die suddenly within one year of life without any apparent cause, and fetuses that die after the twenty-fifth week of gestation without any apparent cause, must be rapidly submitted, with the consent of both parents, to diagnostic post mortem investigation to be performed in authorized centers, according to the criteria specified in article 2, to which their organs must be sent. Information about the pregnancy, fetal development and delivery and, in the case of sudden infant death syndrome (SIDS), about the environmental and familial situation where the death occurred, must be collected during family interviews, accurately recorded and, to complete the post mortem investigation and for scientific research purposes, assessed by the obstetrician-gynecologist, the neonatologist, the pediatrician involved in the case and the pathologist, in accordance with the international protocols.

2. The post mortem investigation to be set up as in comma 1 are performed according to the diagnostic protocol drawn up by the Institute of Pathological Anatomy, First Chair, University of Milan. To be applicable, the above protocol must be approved by the Ministry of Health.

ART. 2.

Within one hundred eighty days of adoption of the decree as in comma 1, the regions are called upon to individuate in their relative territory, the scientific centers, of University or Hospital appurtenance, that will take on the function of reference centers for the post mortem investigation of infants that die suddenly without any apparent cause within one year of life and of fetuses that die after the twenty-fifth week of gestation, without any apparent cause.

ART. 3.

The results of the post mortem investigation performed as in article 1 will be communicated by the authorized centers to the of the Institute of Pathological Anatomy, First Chair, University of Milan, that will, while fully respecting the norms for the treatment of personal data, set up a national data bank and send the collected data to the competent region, to the general practitioner and pediatricians, and to the relatives of the victim.

ART. 4.

1. The national and regional Health Authorities will be responsible, within the context of the ordinary budget allocation, for:

a) promoting campaigns to ensure awareness and prevention, promulgating correct information about the problems associated with SIDS and unexpected fetal death without any apparent cause;

b) setting up appropriate multidisciplinary research programs carrying out studies of cases from the anamnestic, clinical, laboratory, anatomo- pathological, histological standpoints.

2. In the context of actuation of permanent training in medicine, as disciplined in article 16-bis of the law decree n. 502 of 30 December 1992, the national Commission for permanent training, detailed in article 16-ter of the same law decree n. 502 of 1992 and subsequent modifications, will ensure that all obstetricians, gynecologists, pediatricians, neonatologists, anatomo-pathologists, histologists, general practitioners and nursing staff undergo training and receive training credits in the area of SIDS.

3. To guarantee the best assistance to families affected by cases of SIDS or unexpected fetal death without any apparent cause, the regions can set up psychological support programs for the families of victims, and foster contacts with associations for families that have suffered analogous experiences.