Investigating these various alerts is complex, as it requires both clinical and epidemiological validation. Indeed, it is necessary to ensure, during the initial stages of the investigation, that all diagnosed congenital anomalies in the various identified newborns belong to the same nosological entity, or share the same etiology or a common risk factor.

The lack of a registry in certain areas necessitates the use of tools and methods for collecting data and validating complex cases. Methodological challenges also arise; due to the extensive duration of the exposure period—from the preconception phase through pregnancy—there are broader social concerns regarding maternal and newborn health, as well as ethical challenges in ensuring the protection of families’ privacy and in sensitive situations involving retrospective interviews with families of deceased children.

Moreover, the risk factors for congenital anomalies are poorly understood, with more than 50% remaining of unknown cause. When the mechanism of occurrence has been identified, it often results from the combined effect of multiple factors of a genetic or infectious nature, or factors related to a maternal pathology or exposure to teratogens (such as pesticides) before or during pregnancy. Finally, the low number of cases diagnosed in certain clusters of reported cases limits the statistical power during investigations, which hinders the ability to identify a causal relationship with exposure to risk factors.

It is essential that the agency be able to provide public health responses, with the objectives of improving perinatal health and recommending measures to protect the health of women, newborns, and their families. These responses must be based on independence, scientific rigor, and the use of the latest available knowledge. It is therefore necessary to establish a committee of multidisciplinary experts capable of formulating, in accordance with the Charter of Health Expertise, opinions and recommendations to public authorities and other stakeholders in perinatal health regarding the actions to be implemented.

In addition, to ensure adequate surveillance of congenital anomalies, Santé publique France, in collaboration with the congenital anomalies surveillance registries, will develop a work program in which themes of high public health importance will be defined and prioritized over the coming years.

“Within its field of competence and to carry out its missions, the agency provides expertise that complies with the principles set forth in Article L. 1452-1. Its opinions and recommendations are issued in accordance with the provisions of Article L. 1452-2. Subject to respect for privacy and secrets protected by law, in particular the rules relating to the protection of national defense secrets, its opinions and recommendations are made public.

The Committee's mission will be to provide advice and recommendations on:

• the management of different alerts

• validation of suspected spatio-temporal clusters

• validation of abnormal trends in the prevalence of congenital anomalies

• the work program and deliverables for the surveillance of congenital anomalies

The Committee may also assist the Agency on other matters for which the support of the Expert Committee is deemed necessary. It may thus be required to interact with other committees established within the Agency that could provide complementary expertise in the field of congenital anomaly surveillance, such as the Health-Environment-Work Expert Committee.

Expected deliverables

• Provide a clear definition of what constitutes a suspected spatio-temporal cluster or abnormal trend in the prevalence of one or more groups or subgroups of congenital anomalies for the committee to examine,

• Develop a standardized questionnaire to be used for investigations,

• provide advice and recommendations for each case of suspected clustering,

• provide advice and recommendations on abnormal spatial and temporal trends in the prevalence of congenital anomalies, and

• provide advice and recommendations on the work program for congenital anomaly surveillance.

Specific expected deliverables

• For exposure to a risk factor in a given area:

  • To determine the relevant groups or subgroups of congenital anomalies to be monitored;

  • to establish a methodology for this surveillance (in particular the relevant data sources to be mobilized) and the duration of this surveillance, depending on the timing of exposure to the risk factor

• For suspected spatio-temporal clustering:

  • Determine the minimum number of cases and the spatial-temporal area required to initiate an investigation;

  • determine the relevant group or subgroup of anomalies to be studied;

  • determine the most appropriate statistical methods to analyze spatio-temporal clustering and

  • identify possible risk factors for the relevant group or subgroup of congenital anomalies

• For changes in prevalence:

  • Determine the criteria for a change in prevalence to be considered abnormal;

  • Formulate hypotheses that can explain these changes in prevalence that may require further investigation or study, and

  • Suggest a methodological framework aimed at investigating these changes in prevalence and identifying the potentially associated causes.

• Regarding the work program:

  • Identify priority surveillance and research themes for the next 5 years, based on available epidemiological data and the latest knowledge regarding surveillance and risk factors for congenital anomalies.

This committee will consist of approximately fifteen members, appointed by the Director General of Santé publique France. The members of the committee will serve in their personal capacity (intituiae personae) and cannot be replaced.

The diversity of the required skills within this committee should ensure multidisciplinary and complementary expertise, enabling it to provide a comprehensive and structured response to the various situations presented to it. The targeted profiles are qualified experts at the national and international level, who are French or English speakers, with a sufficient command of French and/or English to follow the discussions and ensure a thorough review of documents related to public health and perinatal and early childhood health.

General Competencies

• Ability to work collaboratively and in a multidisciplinary manner, or within expert groups.

• Very good knowledge of public health approaches.

• Experience in developing operational responses for decision-makers, prevention and health promotion stakeholders, and the public.

• Very good knowledge of issues related to perinatal and early childhood health.

• Very good knowledge of risk factors for congenital anomalies.

• Experience in conducting critical reviews of the literature.

Specific skills related to perinatal health and the occurrence of congenital anomalies in:

• Epidemiology (descriptive, analytical, evaluative)

• Biostatistics (particularly the use of methods for spatio-temporal aggregate analysis and statistical methods applicable to the epidemiological surveillance of rare health events)

• Public health with expertise in data sources that can be used for the surveillance of congenital anomalies (surveillance registries, medical-administrative databases)

• Public health professionals responsible for the registration and coding of congenital anomalies

• Genetics and syndromology

• Obstetrics (including prenatal diagnosis)

• Pediatrics/Pediatric Surgery

• Toxicology

• Environmental and nutritional epidemiology (expertise on risks related to exposures during the preconception period and pregnancy)

• Infectious epidemiology (expertise in risks related to exposures) during the preconception period and pregnancy

• Pharmacology and pharmacoepidemiology

• Humanities and Social Sciences

• Veterinary Sciences

A chairperson will be appointed by the members of the committee and will be responsible for its management, in collaboration with experts in the field at Santé publique France.

The composition of this committee will be published on the Santé publique France website.

Term of office

Committee members will be appointed for a term of 4 years.

Required availability

One meeting will be held at the Saint Maurice site to launch the scientific experts committee, and a minimum of four meetings will be held per year via videoconference. Email communication will take place between meetings as needed.

Workload

To enable the experts to produce their opinions and recommendations, data on epidemiological surveillance and literature reviews will be provided by Santé publique France professionals. Reviewing these documents may require additional time from the experts outside of meetings. Members will sign a “Confidentiality and Commitment to Participate in Meetings Clause” and agree to participate regularly in meetings and to take part in any required drafting or proofreading work. The Director General of Santé publique France will provide the resources necessary for the committee to function.

The committee may hold hearings with any person whose knowledge and experience are deemed necessary for its mission, subject to the submission of a public declaration of interest to DPI and its review.

Scientific and administrative support for the committee

This will be provided by the congenital anomalies surveillance team of the Noncommunicable Diseases and Trauma Directorate of Santé publique France.

Allowances and travel expenses

Travel and subsistence expenses are reimbursed under the conditions provided by the State. Compensation for loss of income in the case of self-employment and compensation for time spent attending meetings and for work done will be based on the scale established by the Board of Directors of Santé publique France.

The selection of applications for the expert committee on congenital anomalies will be based on the information provided in the letter of motivation, the candidates’ alignment with the required competencies, an analysis of potential conflicts of interest, and the necessary multidisciplinary and diverse composition of the group to address all of the cases presented. Only complete applications will be considered.

Members of the Scientific Council, the Ethics and Professional Conduct Committee, and the Orientation and Dialogue Committee of Santé publique France are ineligible to apply, as are members of other committees of the Agency. The exclusion criteria apply to candidates who have not been professionally active for more than three years, as such situations prevent them from updating their skills and knowledge in their field.

Declarations of interest will be reviewed by the Santé publique France Internal Ethics Committee. Please note: in accordance with the best practices for preventing conflicts of interest in effect at Santé publique France, receiving personal compensation from industry entities within the scope of the Committee’s missions and participating in scientific or strategic advisory activities for those same entities constitutes a proven conflict of interest that is incompatible with appointment to the Committee.

Members will be appointed by decision of the Director General of Santé publique France. Candidates will be informed of the outcome of the review of their application via email from the administrative support staff of this committee, and the DPI records of the members of the Expert Committee on Congenital Anomalies are published on the DPI SANTE portal.

Your personal data is processed under the responsibility of Santé publique France. This processing is based on the implementation of pre-contractual measures related to the application submitted by the data subject to the Scientific Expert Committee on Congenital Anomalies.

• For unsuccessful candidates: the CV and application file will be deleted within three months of the end of the selection process;

• For successful applicants to the committee:

  • CVs and application files will be retained for up to one year after the end of your term of office as part of your participation in the committee;

  • certain financial details (bank account information, proof of identity, etc.) that may be requested at a later date, as they are necessary for the payment of your travel expenses and allowances, must, in accordance with the law, be retained for 5 years after the final payment.

The data will be processed by authorized representatives of Santé publique France and by its subcontractors, who will have access to this information only to the extent necessary for the performance of their duties.

You may exercise your rights to object, access, rectify, delete, and restrict the processing of personal data by contacting Santé publique France, Data Protection Officer, 12 rue du Val d'Osne, 94415 Saint Maurice Cedex or dpo@santepubliquefrance.fr (please mention the name of your committee).

You may exercise your right of access, rectification, and restriction regarding other data by also contacting Santé publique France, Data Protection Officer, 12 rue du Val d'Osne, 94415 Saint Maurice Cedex or dpo@santepubliquefrance.fr (please mention the name of your committee).

If you feel that your data rights have not been respected, you can file a complaint with the National Commission for Data Processing and Liberties. For more information on these processing activities: dpo@santepubliquefrance.fr