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Article R1211-20 of the French Public Health Code

When the nature of the element or product of the human body removed or collected and the uses envisaged for it allow this without impairing the effectiveness of these uses, treatments, in particular physical or chemical treatments, to eliminate or inactivate infectious agents that reduce the risks of transmission are carried out.

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Article R1211-21 of the French Public Health Code

The doctor may waive the prohibition mentioned in the first paragraph of article R. 1211-14 when, despite the risk of transmission of a virus by the donor, the therapeutic alternatives to the transplant or to the use of human body products for therapeutic purposes are inappropriate and the prognosis is life-threatening. An order of the Minister for Health specifies the cases in which, despite the risk of transmission of a…

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Article R1211-22 of the French Public Health Code

In situations of vital urgency and in the absence of therapeutic alternatives, the doctor may also waive the prohibition mentioned in the first paragraph of article R. 1211-14. An order by the Minister for Health specifies the cases in which, despite the risk of transmission of a virus by the donor, the graft or the use of products of the human body for therapeutic purposes may take place in the…

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Article R1211-22-1 of the French Public Health Code

When the samples referred to in the first paragraph of article R. 1211-12 are taken for autologous administration and concern elements or products of the human body intended to be prepared or preserved, tests to detect infectious diseases are carried out. The list of these diseases and the conditions under which these tests are carried out are laid down by order of the Minister for Health.

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Article R1211-22-2 of the French Public Health Code

In order to be used for autologous therapeutic purposes, any element or product of the human body removed or collected must be accompanied by a document containing an analysis report signed by the person responsible for the analyses performed, mentioning the individual results of these analyses in accordance with article R. 1211-22-1. This report also mentions the laboratory that performed the analyses. It is produced in the original, by fax…

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Article R1211-25 of the French Public Health Code

The practitioner meeting the criteria mentioned in articles R. 2142-10 and R. 2142-11 carrying out sperm collection or oocyte retrieval with a view to donation is required : 1° Enquire about the gamete donor’s personal and family history and the clinical data he considers necessary to collect. If necessary, he will arrange for any additional examinations that he deems useful, in particular if the donor has been exposed in an…

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Article R1211-26 of the French Public Health Code

The orders mentioned in 2° of article R. 1211-25 specify the conditions under which the practitioner mentioned in article R. 1211-25 is required to repeat the test for all or some of the biological markers of the infections mentioned in the same 2°: 1° In the case of sperm donation, at the time of donation or at the time of the last collection if donations are made on several dates;…

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Article R1211-27 of the French Public Health Code

Gametes may only be made available if they are accompanied by a document drawn up by the practitioner mentioned in article R. 1211-25 specifying : 1° The name and address of the authorised establishment that collected the gametes and, where applicable, the name and address of the authorised establishment that carried out the in vitro fertilisation of the oocytes made available; 2° The results of the medical biology examinations provided…

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Article R1211-28 of the French Public Health Code

The practitioner carrying out medically assisted procreation, whether this involves artificial insemination or in vitro fertilisation with gametes from a donation, is required to have prior access to the document mentioned in article R. 1211-27, to be aware of the results of the examinations mentioned in 2° of article R. 1211-25 and article R. 1211-26 and to ensure that they do not reveal a risk of transmission of an infection.

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Article R1211-28-1 of the French Public Health Code

Research into risk factors for the transmission of a genetic anomaly may only be carried out with the consent of the donor and in compliance with articles R. 1131-4 and R. 1131-5 and the rules of good practice defined by the decree provided for in article L. 1131-2. Gamete donors who refuse to undergo this research cannot be retained.

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