French Public Health Code
In forceI.- Foetal medicine refers to medical practices, in particular clinical, biological and imaging practices, aimed at the diagnosis and prognostic evaluation and, where appropriate, the treatment, including surgery, of a particularly serious condition or one likely to have an impact on the future of the foetus or unborn child.
II-Any pregnant woman receives, during a medical consultation, fair, clear and appropriate information about the possibility of having recourse, at her request, to medical biology and imaging tests to assess the risk that the embryo or foetus has a condition likely to affect the course or monitoring of her pregnancy.
III - The prescriber, doctor or midwife, communicates the results of these tests to the pregnant woman and, if she so wishes, to the other member of the couple, when the woman is living as a couple, and gives them all the information they need to understand.
In the event of a proven risk, the pregnant woman and, if she so wishes, the other member of the couple, if the woman is living as a couple, are taken in charge by a doctor and referred, if the pregnant woman or the doctor so requests, to a multidisciplinary prenatal diagnosis centre. Unless they object, they will receive information on the characteristics of the suspected condition, the means of detecting it and the possibilities for prevention, care or appropriate treatment for the foetus and then the child. They are offered a list of associations specialised and accredited in supporting patients with the suspected condition and their families.
IV -In the event of a proven risk, new diagnostic biology and imaging tests may be proposed by a doctor, who may be a member of a multidisciplinary prenatal diagnosis centre, during a consultation tailored to the condition being investigated.
V.-Prior to certain examinations mentioned in II and the examinations mentioned in IV of this article, the consent provided for in the fourth paragraph ofarticle L. 1111-4 is obtained in writing from the pregnant woman by the doctor or midwife who prescribes or, where appropriate, carries out the examinations. The list of these examinations is determined by order of the Minister for Health, particularly with regard to their risks for the pregnant woman, the embryo or the foetus and the possibility of detecting a particularly serious condition in the embryo or foetus.
VI -Prior to obtaining the consent referred to in V and carrying out the examinations referred to in II and IV, the pregnant woman will receive information, unless she objects, duly noted by the doctor or midwife in the medical record, in particular about the objectives, procedures, risks, limits and non-mandatory nature of these examinations.
In the case of obstetric and foetal ultrasound scans, the woman is informed in particular that the absence of any anomaly detected does not mean that the foetus is free of any disease, and that a suspected anomaly may not be confirmed at a later date.
The pregnant woman is also informed that certain diagnostic medical biology examinations mentioned in IV may reveal foetal genetic characteristics with no definite link to the initial indication for the examination and that, in this case, additional investigations, in particular examinations of the genetic characteristics of each parent, may be carried out under the conditions of the system provided for inarticle L. 1131-1.
The doctor referred to in IV of this article will communicate the results of these examinations to the pregnant woman and, if she so wishes, to the other member of the couple, where the woman is living as a couple, unless they object, and will give them all the information they need to understand them. If the results so justify, he will send them to a doctor qualified in genetics, who may be a member of a multidisciplinary team.
VIa -When a foetus resulting from gamete donation or embryo reception is diagnosed with a genetic anomaly that may be responsible for a serious condition justifying preventive measures, including genetic counselling, or care, the prescribing doctor will inform the head of the medically assisted procreation centre so that the latter can inform the third party donor under the conditions provided for in II of article L. 1131-1.
VII - Medical biology examinations intended to establish a prenatal diagnosis are carried out in medical biology laboratories using practitioners able to prove their competence, authorised in accordance with the procedures laid down in Title II of Book I of Part Six and accredited in accordance with the procedures laid down in Chapter I of Title II of Book II of the same Part. Where the laboratory is part of a health establishment, the authorisation shall be issued to that establishment.
If a medical biology laboratory has been involved in transmitting the sample, the result of the examination is communicated to the prescriber by the authorised medical biology laboratory by way of derogation fromArticle L. 6211-11 and II ofArticle L. 6211-19. The other laboratory is informed of this communication by the authorised laboratory.
VIII - The creation of multidisciplinary prenatal diagnosis centres, mentioned in III, in public and private health organisations and establishments of collective interest is authorised by the Agence de la biomédecine ;
IX -The procedures for informing the other member of the couple as provided for in III and the last paragraph of VI are set by decree in the Conseil d'Etat.
