Chapter I: Antenatal diagnostics: prenatal diagnosis and pre-implantation diagnosis

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Article R2441-1

French Public Health CodeIn force

Updated 4 Nov 2023

I.-Chapter I of Title III of Book I of this Part is applicable in New Caledonia and French Polynesia, in the version resulting from Decrees No. 2006-1661 of 22 December 2006, No. 2014-32 of 14 January 2014 and No. 2017-808 of 5 May 2017, with the exception of Articles R. 2131-2-1 to R. 2131-11 and R. 2131-13 to R. 2131-22 and R. 2131-27 to R. 2131-34, and subject to the adaptations provided for in II.

II.-A.- In Article R. 2131-1, IV and VI are not applicable.In article R. 2131-1, IV and VI do not apply.

B.-In article R. 2131-2:

1° In I, the words: "mentioned in the second paragraph of article R. 2122-1 or, failing that, during another medical consultation" are replaced by the words: "or during a medical consultation";

2° In II, the words: ", where applicable a member of a multidisciplinary prenatal diagnosis centre" are deleted;

C.-Article R. 2131-12 is replaced by the following provisions:

"Art. R. 2131-12.-The multidisciplinary team referred to in 2° of Article L. 2445-4 includes:

"1° A doctor qualified in gynaecology-obstetrics or holding an equivalent diploma;

2° A practitioner with training and experience in foetal ultrasound;

3° A doctor qualified in paediatrics or holding an equivalent diploma and qualified in neonatology or holding an equivalent diploma;

"4° A doctor qualified in medical genetics or holding an equivalent diploma;

5° A doctor qualified in psychiatry or holding an equivalent diploma or a psychologist;

6° A doctor qualified in foetopathology or holding an equivalent diploma or equivalent experience;

7° A biologist who carries out prenatal diagnostic tests;

8° A genetic counsellor.

"The multidisciplinary team thus formed may call on the assistance of other persons with relevant skills or experience. "

D.-Article R. 2131-23 is replaced by the following provisions:

"Art. R. 2131-23.-The indication to have recourse to pre-implantation diagnosis is the subject of a certificate drawn up and signed after consultation between the medically assisted procreation doctors and those of the multidisciplinary team mentioned in 2° of article L. 2445-4. It is given to the couple and includes the names of the aforementioned medical practitioners. A copy of this certificate is kept in conditions that guarantee confidentiality.

"The couple is informed that only pathology linked to the parental genetic anomaly that is likely to be transmitted may be sought in the embryo during the examinations leading to this diagnosis.

"If the indication for pre-implantation diagnosis is not accepted, the reasons for this are explained in writing to the requesting couple during a medical interview by one of the doctors mentioned in the first paragraph. "

E.-Article R. 2131-24 is replaced by the following provisions:

"Art. R. 2131-24.-When the indication of a diagnosis on the embryo is accepted, the couple is cared for by the multidisciplinary team that drew up the certificate indicating the diagnosis.

"Before the implementation of medically assisted procreation allowing in vitro fertilisation, and without prejudice to the conditions set out in article L. 2141-10, medically assisted procreation practitioners shall specify to the couple the medical and technical constraints that will enable this diagnosis to be made.

"The practitioner who carries out the cytogenetic examination, including molecular cytogenetic examination, or the molecular genetic examination on the embryonic cell or cells shall inform the couple of the various phases of the genetic diagnosis and the degree of reliability of the examinations.

F.-In article R. 2131-25, the words: "multidisciplinary clinical-biological medical" are replaced by the words: "medically assisted procreation".

G.-In article R. 2131-26, the words: "multidisciplinary clinical-biological medical" are deleted.

H.- In article R. 2131-26, the words: "multidisciplinary clinical-biological medical" are deleted.In article R. 2131-26-1, the words: "the team of the multidisciplinary prenatal diagnosis centre" are replaced by the words: "the multidisciplinary team mentioned in 2° of article L. 2445-4".

I.-In article R. 2131-26-2:

1° In the first paragraph, the words: "the multidisciplinary centre for prenatal diagnosis" are replaced by the words: "the multidisciplinary team mentioned in 2° of article L. 2445-4";

2° In the sixth paragraph, the words: "of the multidisciplinary centre for prenatal diagnosis mentioned in article R. 2131-26-1" are replaced by the words: "of the multidisciplinary team mentioned in 2° of article L. 2445-4";

3° In the seventh paragraph, the words: "multidisciplinary clinico-biological medical" are replaced by the words: "medically assisted procreation".

J.-In article R. 2131-26-3, the reference to article L. 1242-1 is replaced by the reference to article L. 1542-9.

K.- In article R. 2131-36, the words: "must be a doctor or pharmacist qualified in medical biology" are deleted and the words: "by article L. 6213-2 or L. 6213-2-1" are replaced by the words: "provided for by locally applicable provisions having the same purpose".

L.-VI of Article R. 2131-37 is replaced by the following provisions:

"VI.-The holder of the authorisation referred to in Article L. 2131-4 is required to declare to the competent authority in New Caledonia or French Polynesia and to the Agence de la biomédecine the names of the approved practitioners prior to implementation of the authorisation, as well as the name of any new approved practitioner prior to taking up his post. It is also required to inform the competent authority in New Caledonia or French Polynesia and the Agence de la biomédecine of the cessation of activity of these practitioners. "

M.-The last paragraph of Article R. 2131-38 is replaced by the following provisions:

"In the event of non-renewal, the Director General of the Agency shall inform the practitioner, the competent authority in New Caledonia or French Polynesia and the organisation where the practitioner was practising of this decision. "

N.-The last paragraph of article R. 2131-39 is replaced by the following provisions:

"The Director General of the Agency shall inform the practitioner, the competent authority in New Caledonia or French Polynesia and the organisation where the practitioner practises of this decision. "

Mariela Petrova

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Mariela Petrova

Mariela Petrova

Avocate au Barreau de Paris

Toque #C2396

15+ Years In Corporate Practice

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