Investigating these various indicators is complex because it requires a phase of clinical and epidemiological validation. Indeed, during the early stages of the investigation, it is necessary to ensure that the congenital anomalies diagnosed in different newborns do indeed belong to the same nosological entity, or share the same etiology or a common risk factor. The lack of a registry in certain areas of the country necessitates the use of tools and methods for data collection and validation of complex cases.

Added to these challenges are methodological issues related to defining the exposure period, which may extend from the periconceptional period through pregnancy, as well as societal concerns (significant public anxiety regarding the health of mothers and newborns) and ethical considerations (protection of individuals’ privacy, retrospective investigations involving families of deceased children who must be interviewed during investigations of these reports).

Furthermore, the risk factors for congenital anomalies remain poorly understood; in more than half of cases, no known cause has been identified. When the mechanism of occurrence has been identified, it often results from the combined effect of multiple factors—genetic, infectious, or related to a maternal condition or exposure to teratogens (such as pesticides)—occurring before or during pregnancy. Finally, the small number of diagnosed cases in certain clusters of reported cases limits the statistical power of investigations, which in turn limits the ability to identify relationships between exposure to risk factors and the occurrence of anomalies.

It is essential that the agency be able to provide public health responses, with a view to 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. To this end, it is necessary to establish a multidisciplinary expert committee capable of formulating, in accordance with the Charter of Health Expertise^³, opinions and recommendations to public authorities and other stakeholders in perinatal health regarding the actions to be implemented.

Furthermore, to ensure adequate surveillance of congenital anomalies, Santé publique France, in collaboration with the congenital anomaly surveillance registries, will develop a work program that will define priority surveillance activities for the coming years.

“Within its scope of competence and to carry out its missions, the agency applies expertise in accordance with the principles set forth in Article L. 1452-1. Its opinions and recommendations are issued in compliance 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 Expert Committee will be tasked with issuing opinions and recommendations regarding:

• The handling of various signals.

• The validation of suspected spatio-temporal clusters.

• The validation of abnormal trends in the prevalence of congenital anomalies.

• The work program for the surveillance of congenital anomalies and its results.

The committee may also assist the agency on cases where the support of the Expert Committee is deemed necessary. It may thus be called upon to interact with other committees established within the agency that could provide complementary expertise in the context of congenital anomaly surveillance, such as the Health-Environment-Work Expert Committee.

Expected Deliverables

• Definition of eligibility criteria for the committee to review a suspected spatio-temporal cluster or an abnormal trend in the prevalence of one or more groups or subgroups of congenital anomalies.

• Validation of a standardized questionnaire to be used for investigations.

• Production of opinions and recommendations for each suspected cluster.

• Production of opinions and recommendations on the spatiotemporal trends in the prevalence of congenital anomalies.

• Issuance of opinions and recommendations regarding the work plan for the surveillance of congenital anomalies.

Expected specific objectives

• For exposures to an event:

  • Be able to identify the relevant groups or subgroups of congenital anomalies to monitor in the event of exposure to a risk factor in a given area

  • Establish a methodology for this surveillance (including the relevant data sources to be utilized) and the duration of this surveillance, based on the timing of exposure to the risk factor

• For the perception of a cluster of cases:

  • Determine the minimum number of cases and the spatial-temporal scope that could warrant an investigation

  • Determine the relevant nosological entity to be studied

  • Determine the most appropriate statistical methods for conducting a statistical analysis of the suspected spatio-temporal cluster

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

• For changes in prevalence:

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

  • Formulate hypotheses regarding these changes in prevalence (points to verify, explanatory factors, hypotheses raised that require further investigation or studies)

  • Propose a methodology for studies aimed at investigating these changes in prevalence and identifying potentially associated causes.

• Regarding the work program:

  • Determine, based on available epidemiological data and the most recent knowledge regarding surveillance and risk factors for congenital anomalies, the priority surveillance and research activities for the next 5 years.

This committee will consist of approximately fifteen members, appointed by the Director General of Santé publique France. Committee members will serve in their personal capacity and therefore may not be represented by a substitute.

The expertise brought together on this committee must provide multidisciplinary and complementary knowledge, in order to offer a comprehensive and structured response to the various situations presented to it. The target profiles are qualified individuals at the national and international level, French- or English-speaking, with sufficient proficiency in French and/or English to follow discussions and read documents in the fields of public health, perinatal health, and early childhood health.

General Skills

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

• Very good knowledge of public health approaches.

• Experience in developing practical solutions for policymakers, health prevention and promotion stakeholders, and the general public.

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

• Strong knowledge of risk factors for congenital anomalies.

• Experience in conducting critical literature reviews.

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

• Epidemiology (descriptive, analytical, evaluative).

• Biostatistics (particularly regarding the use of methods for analyzing spatiotemporal aggregates and statistical methods applicable to the epidemiological surveillance of rare health events).

• Public health with expertise in data sources usable for the surveillance of congenital anomalies (surveillance registries, medical-administrative databases).

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

• Genetics and syndromology.

• Obstetrics (particularly in prenatal diagnosis).

• Pediatrics/Pediatric surgery.

• Toxicology.

• Environmental and nutritional epidemiology (assessment of risks related to exposures during the periconceptional period and pregnancy).

• Infectious disease epidemiology (risk assessment related to exposure) during the periconceptional period and pregnancy.

• Pharmacology and pharmacoepidemiology.

• Humanities and social sciences.

• Veterinary sciences.

A chairperson will be appointed from among the committee members and will be responsible for leading the committee, in collaboration with experts from 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 four-year term.

Required availability

One meeting per year will be held at the Saint Maurice site, and at least four annual meetings, primarily via videoconference. Electronic communication will take place between meetings as needed.

Workload

To enable experts to produce their opinions and recommendations, materials related to epidemiological surveillance data and literature review data will be provided to them by professionals at Santé publique France. Reviewing these documents may require experts to spend time working outside of meetings. Members will sign a “Confidentiality and Commitment to Attend Meetings Agreement” and commit to regularly attending meetings and participating in any necessary drafting or proofreading work in between meetings. The Director General of Santé publique France will provide the resources necessary for the committee’s operation.

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

Scientific and Administrative Secretariat of the Committee

It will be provided by the congenital anomalies surveillance team of the Directorate of Noncommunicable Diseases and Injuries at Santé publique France.

Compensation and Travel Expenses

Travel and accommodation expenses are reimbursed under the conditions applicable to civilian government employees. Compensation for loss of income in the case of self-employed individuals, as well as compensation for time spent participating in meetings and for work performed, will be provided in accordance with the schedule established by the Board of Directors of Santé publique France.

Applications for the Expert Committee on Congenital Anomalies will be selected based on the information provided in the cover letter, the candidates’ alignment with the required skills, an analysis of conflicts of interest, and the need for a multidisciplinary and diverse group to address the full scope of the issue at hand. Only complete applications will be considered.

Members of the Scientific Council, the Ethics and Professional Conduct Committee, and the Steering and Dialogue Committee of Santé publique France are not eligible to apply, nor are members of other committees of the agency. Exclusion criteria apply to candidates who have not been professionally active for more than three years, as such situations do not allow for the updating of their skills and knowledge in their field.

Declarations of interest will be reviewed by Santé publique France’s Internal Ethics Committee. Please note: Given 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 constitute a 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 committee’s secretariat, 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. The processing is based on the implementation of pre-contractual measures related to the applicant’s application to the Scientific Expert Committee on Congenital Anomalies.

• For unsuccessful candidates: CVs and application materials will be deleted within three months following the conclusion of the selection process;

• For successful candidates on the committee:

  • CVs and application materials will be retained for up to one year after the end of your term on the committee;

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

The data will be processed by the relevant staff at Santé publique France, and its subcontractors 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, erase, 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 rights 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 believe that your data rights are not being respected, you may file a complaint with the Commission Nationale de l’Informatique et des Libertés (CNIL). For more information on this data processing: dpo@santepubliquefrance.fr