Subsection 2: National monitoring system for medically assisted procreation

The Director General of the Agence de la biomédecine is responsible for implementing the monitoring system relating to medically assisted procreation.

Within this framework, the Agency:

1° Leads and coordinates the actions of the various parties involved;

2° Ensures compliance with the procedures organised by this section;

3° Evaluates the information reported to it, including the results of investigations carried out by the local correspondent and the corrective measures put in place;

4° After evaluating this information, implements the provisions set out in Article R. 2142-44;

5° May ask the local correspondents to carry out any investigations and studies;

6° Carries out epidemiological surveys and studies or has them carried out under its supervision;

7° Drafts, in conjunction with learned societies, criteria to help professionals identify the expected adverse effects related to the activities mentioned in 2° of I of Article R. 2142-39. These criteria are established, for each therapeutic indication, on the basis of data from the scientific literature deemed relevant and are made available to healthcare professionals and local correspondents. They are set by decision of the Director General of the Agence de la biomédecine. In the absence of such criteria for a therapeutic indication, any adverse reaction must be reported to the Agence de la biomédecine;

8° Establishes, in conjunction with the professionals concerned, thresholds above which the frequency of occurrence of incidents and expected adverse reactions requires immediate reporting and declaration. These thresholds are set by decision of the Director General of the Agence de la biomédecine;

9° Establishes a model for the declaration mentioned in Article R. 2142-41;

10° Establishes the model for the annual report mentioned in 8° of Article R. 2142-47;

11° Establishes and updates the list of local correspondents for the vigilance system relating to medically assisted procreation;

12° Draw up an annual report on the vigilance system relating to medically assisted procreation based on the annual reports of the local correspondents for the vigilance system relating to medically assisted procreation. This report is sent to the Minister for Health and to the European Commission by 30 June of the year following the year under review at the latest.