01 December 2016 - Authored by:Eveline Van Keymeulen
As of 1 December 2016, the Biomedicine Agency has replaced the French National Agency for Medicines and Health Products Safety (ANSM) as the competent authority for biomonitoring (concerning breast milk, organs, tissues, cells and cell therapy preparations). From that date onwards, declarations of serious incidents and adverse effects need to be made to the Biomedicine Agency at email@example.com (declarations forms here).
This transfer of competence was introduced by the Law on the Modernisation of the Healthcare System and implemented by Decree No 2016-1622 of 29 November 2016 relating to biomonitoring and monitoring mechanisms in the field of medically assisted procreation. In addition, the decree clarifies the definition of biomonitoring set out in Decree 2003-1206 concerning the organisation of biomonitoring to include:
Systematic monitoring of all incidents and adverse effects.
Reporting without delay serious incidents and unexpected adverse effects to the local biomonitoring representative, and subsequently declaring them without delay to the Biomedicine Agency.
Analysing, assessing and using the information with the aim to limit the likelihood of any new serious incident or unexpected adverse effect, or to reduce its severity.
Carrying out all investigations and studies on serious incidents and unexpected adverse effects.
Decree 2016-1622 also specifies the role of the different actors involved in the biomonitoring system. Furthermore, it harmonises existing monitoring provisions in medically assisted procreation with the biomonitoring provisions.
The Biomedicine Agency will cooperate with professionals with the aim to increase their reporting in order to improve professional practices and healthcare quality.
This post was originally co-authored by Audrey Aboukrat.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2016 Issue (Thomson Reuters).