Section 7: Person responsible

The responsible person referred to in Article L. 2142-3-1 must meet one of the requirements set out in Article R. 2142-11 and have at least two years' practical experience in reproductive medicine and biology.

It is responsible for :

1° Ensuring that gametes, germ tissue and embryos used for the purposes of medically assisted procreation or for restoring hormonal function are collected, retrieved, prepared, preserved, made available and transported, in accordance with the legislative and regulatory provisions in force, including in the event of intervention by an external third party as referred to in article R. 2142-3 ;

2° Implementing appropriate control measures to ensure the quality and safety of gametes, germ tissue and embryos;

3° Drawing up the annual activity report provided for in Article L. 2142-2 and ensuring the quality of the individual data transmitted to the Agence de la biomédecine;

4° Ensuring that the Agence de la biomédecine is notified of all the incidents and adverse reactions mentioned in Article R. 2142-40 and receives a report analysing the cause and consequences;

5° Ensuring compliance with the medical criteria relating to the assessment of the risks presented by gamete donors and by persons having recourse to medically assisted procreation, as well as the acceptance of gamete donors;

6° Implementing and updating the quality assurance system provided for in Article R. 2142-21;

7° Ensuring that staff involved in biological activities for medically assisted procreation have the necessary qualifications and receive appropriate training;

8° Transmitting to the Agence de la biomédecine, while respecting confidentiality, and in accordance with the provisions of 4° of Article L. 1418-1, the information required to assess the possible consequences of medically assisted procreation on the health of the persons who have recourse to it or on that of the children born from it;

9° Ensuring the transmission to the Agence de la biomédecine, while respecting confidentiality, of the information required to verify compliance with the provisions relating to gamete donations set out in Article L. 1244-4;

10° Ensuring the transmission to the Agence de la biomédecine, while respecting confidentiality, of information relating to the third-party donor which may be communicated to persons born of the donation when they come of age if they so request.

The director of the establishment, organisation or laboratory or the administrator of the authorised health cooperation group sends the Director General of the Agence de la biomédecine and the Director General of the Agence régionale de santé a copy of the instrument appointing the responsible person. Where the responsible person is replaced, he/she will immediately inform the Director General of the Agency of the name and date of commencement of duties of the newly appointed person.