Congenital anomalies are a major cause of childhood morbidity, disability, and fetal and infant mortality. According to the latest data from the World Health Organization (WHO), approximately 300,000 newborns worldwide die before 28 days of age each year due to congenital anomalies^.¹ In France, these conditions are the second leading cause of death before the age of one (21%) and account for just over a quarter of neonatal deaths in France². The prevalence of congenital anomalies in France for the 2013–2015 period is estimated at 3.5% of all births and 2.7% of live births3.

As part of its mandate, Santé publique France is responsible for monitoring congenital anomalies. In France, as in most Western countries, this monitoring system relies in particular on collaboration with registries.

France currently has six congenital anomaly registries covering 19% of births (Appendix 1). All children with one or more malformations in an area covered by a registry are recorded, whether they were born alive, stillborn after a pregnancy of at least 22 weeks of amenorrhea (SA), or whether the pregnancy was terminated due to fetal malformation, regardless of gestational age. The geographic distribution and population covered by these registries are as follows: 2 overseas registries (the Antilles and Réunion), 1 registry with an exclusively urban population (Paris), 1 registry with a predominantly rural population (Auvergne), 1 registry with both rural and coastal populations (Brittany), and 1 registry with rural, urban, and industrial populations (Remera, covering the departments of Rhône, Ain, Isère, and Loire) (Appendices 1 and 2). Some registries have been in operation for over 30 years (Paris since 1981, Auvergne since 1983), while others are more recent (Brittany since 2011).

The objective of this call for projects is to establish a collaboration with a seventh congenital anomalies registry that would complement the collaborations already underway with the six existing registries, in order to strengthen the surveillance of congenital anomalies conducted by Santé publique France. This new registry should, in particular, through its geographic location and the expertise of the applicant team, enable the development of research in the environmental field.

The new registry selected following the initial evaluation by an independent scientific committee will be subject to a new evaluation by the Registry Evaluation Committee (CER) after a period of three years.

The Registry's Responsibilities

The expected missions of this new registry are:

• To ensure the epidemiological surveillance of congenital anomalies in an uncovered territory with specific demographic characteristics and an environmental context that complement existing registries, through the use of an internationally recommended nomenclature, and through the creation, management, and operation of a high-quality database;

• Participating in national and international surveillance, notably by annually submitting data to the national shared database and to the body designated by the EU;

• Participate in health monitoring and surveillance, notably by fully participating in investigations and other work conducted by Santé publique France;

• Promote research on congenital anomalies, particularly regarding risk factors, especially those related to the environment and exposure to teratogens or xenobiotics, in collaboration with the scientific community;

• Contribute to public health activities by supporting local, regional, or national health policies.

Funding Arrangements

Projects aimed at contributing to the ongoing and comprehensive collection of personal data pertaining to one or more health events within a geographically defined population, for the purposes of surveillance, evaluation, and research are supported by an annual grant provided by the national public health agency within the limits of the funds allocated in its budget, as well as a contribution from the organization’s own funds and from various potential funding sources.

Instructions for Preparing the Application Package

To this end, applicants should refer to the consultation guidelines. The application package and the various forms to be completed can be downloaded from the National Public Health Agency’s website.

Important Notes

When applications are evaluated by an independent scientific committee, particular attention will be paid to the following points:

• Understanding of public health issues, particularly in the field of congenital anomalies

• The existence of a written case validation protocol based on rigorous documentation and procedures;

• The ability to establish a comprehensive case collection system based on multiple sources, to manage data access challenges, and to produce high-quality data in coordination with other data sources (such as the SNDS);

• The ability to ensure data security and comply with the GDPR;

• The candidate team’s affiliation with a research institution accredited in epidemiology and public health, particularly regarding the relationship between environmental and pharmaceutical exposures… and the occurrence of congenital anomalies, as well as close collaborations with teams specializing in the diagnosis, assessment, and counseling/management of congenital anomalies;

• The ability to collaborate proactively on investigative and surveillance work conducted by Santé publique France;

• The ability to regularly submit collected individual data to the national registry database and the European EUROCAT network;

• Experience in research on the link between environmental or non-environmental exposure and congenital anomalies.

Frequently Asked Questions

Geographic area and population size covered by the registry

Case collection and validation activities

The Registry's Monitoring and Research Functions

Registry Team

Regulatory approvals

Funding