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Decree No. 2014-1066 Of 19 September 2014 Concerning The Conditions Of Removal Of Organs, Tissues And Human Cells, And Activities Related To Those Levies

Original Language Title: Décret n° 2014-1066 du 19 septembre 2014 relatif aux conditions de prélèvements d'organes, de tissus et de cellules humaines et aux activités liées à ces prélèvements

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Keywords

HEALTH , HEALTH , PUBLIC HEALTH CODE , CSP , HEALTH , HUMAIN CORPS , ORGANIC , PATIENT , ORGANIC DON , ORGANIC FIRST , RISK , RISK , TRANSPLANTATION ,


JORF n°0219 of 21 September 2014 page 15461
text No. 8



Decree No. 2014-1066 of 19 September 2014 on the conditions for the removal of organs, tissues and human cells and the activities related to these samplings

NOR: AFSP1409296D ELI: https://www.legifrance.gouv.fr/eli/decret/2014/9/19/AFSP1409296D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2014/9/19/2014-1066/jo/texte


Publics concerned: persons responsible for the clinical and biological selection of donors, transplant teams, institutions authorized to prepare and maintain cells or tissues, organ donors, tissues or cells.
Purpose: Ethical, forensic and health safety framework for certain activities related to organs, tissues and cells.
Entry into force: the text comes into force on the day after its publication.
Notice: This Order completes the transfer of community directives in national law relating to organs, tissues and cells with respect to the information and clinical and biological selection of donors. It also specifies the medical-technical conditions for authorization of institutions that prepare and maintain tissues or cells. Finally, it updates the regulation in the field of hematopoietic stem cells with regard to the intervention of the bioethics law of 7 July 2011 and the decree on innovative therapy drugs.
References:
Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on the establishment of quality and safety standards for the donation, obtaining, controlling, processing, conservation, storage and distribution of human tissues and cells.
Directive 2006/17/EC of the Commission implementing Directive 2004/23/EC of the European Parliament and Council 2010/45/EU of the European Parliament and the Council on the standards of quality and safety of organs of the human body for transplantation.
Act No. 2011-302 of 22 March 2011 bringing various provisions for adapting legislation to the European Union's right to health, work and electronic communications (art. 8).
Decree No. 2012-1236 of 6 November 2012 on innovative therapy drugs.
The Prime Minister,
On the report of the Minister of Social Affairs, Health and Women ' s Rights,
In light of Directive 2004/23/EC of the Parliament and Council of 31 March 2004 on the establishment of quality and safety standards for the donation, obtaining, controlling, processing, conservation, storage and distribution of human tissues and cells;
In light of Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and the Council on certain technical requirements relating to the donation, obtaining and controlling of tissues and cells of human origin;
Having regard to Directive 2010/45/EU of the European Parliament and the Council on standards of quality and safety of organs of the human body for transplantation;
Vu le Public Health Codeincluding articles L. 1211-9, L. 1242-3 and L. 4151-1;
The State Council (Social Section) heard,
Decrete:

Article 1 Learn more about this article...


The single chapter of Book II title I of the first part of the Public Health Code is thus amended:
1° Under section 2, subsection 1, after the word "therapeutic", the words "for others" are added;
2° Section R. 1211-13 is replaced by the following provisions:


"Art. R. 1211-13.-I.-Before any collection or collection of elements and products of the human body for therapeutic purposes on a living or deceased person, doctors and, in the situation mentioned in IV, midwives ensure the identity of the potential donor and the respect for the sanitary safety rules in force.
"II.- Physicians and, where appropriate, midwives are selecting potential donors. The purpose of this selection is to exclude individuals whose donation could either have a risk to their own health, or have a higher risk to the recipient than the expected benefit.
"To assess these risks, they must:
« 1° Search for the personal and family medical and surgical history of the potential donor;
« 2° Inform yourself of the clinical condition of the patient, by conducting his clinical examination, if any post mortem;
« 3° See any document containing relevant information, including its medical records.
"III.-When sampling or collection is considered on a living donor, the doctor conducts a medical interview with the potential donor and, if necessary, with his legal representative in order to obtain the additional information necessary for his selection. During this interview, he informs the donor of the risk of disease transmission to the receiver and ensures that the donor, and, where appropriate, his legal representative:
« 1° Includes the information given;
« 2° had the opportunity to ask questions and received satisfactory answers;
« 3° Confirmed that all the information they provided is, to their knowledge, accurate.
"IV.-When the sample is taken from the cord blood or the placenta collection, this selection can also be ensured by a midwife.
"V.-When sampling or collection is considered on a deceased donor, the doctor collects, to the extent possible, the additional information required for the clinical selection of the donor to relatives of the deceased donor or persons who may provide it.
"VI.-The information thus collected is included in the donor's medical record which is kept on the sampling site. Information on the donor's medical history and, where appropriate, the risk factors that were discovered during the donor's clinical selection are transmitted, if any in anonymous form, to the transplant teams or establishments referred to in Article L. 1243-2, which subsequently make them available to the transplant teams.
" VII.-A at the end of the clinical selection of donors operated under the conditions referred to in II, III, IV and V, the doctor or midwife, as well as, where applicable, the doctor in charge of the receiver, departs from the gift the living or deceased persons who have contraindication.
"VIII.-In addition to the provisions of this Article, special provisions are applicable in respect of organ removals, in R. 1231-1 and in respect of tissues and cells in R. 1241-19-1 to R. 1241-19-3. » ;


3° It is inserted in section 2, after subsection 1, a sub-section 1 bis as follows:


"Subsection 1 bis
“ Organs, tissues and cells taken for autologous therapeutic purposes


"Art. A. 1211-22-1.-Where the sampling referred to in the first paragraph of section R. 1211-12 is carried out for autologous administration and is carried out on elements or products of the human body intended to be prepared or preserved, analyses intended to detect infectious diseases are performed. The list of these diseases and the conditions for carrying out these analyses are determined by order of the Minister for Health.


"Art. R. 1211-22-2.-To be used for autologous therapeutic purposes, any component or product of the human body collected or collected must be accompanied by a document containing a report of analyses signed by the person responsible for the analyses performed mentioning the individual results of these analyses in accordance with R. 1211-22-1. This report also mentions the laboratory having performed these analyses. It is produced in the form of original, fax or in any other form with guarantees of authenticity. It takes, if any, the form of a certificate established by the head of the tissue or cell conservation body.
“In addition, this document shows:
« 1° The information on the label affixed to the outer packaging and the primary packaging of the item or product of the collected human body;
« 2° Information to ensure traceability of human body elements and products from sampling to transplantation. The content of this additional information is determined by order of the Minister for Health. The user doctor is required to read this document. »

Article 2 Learn more about this article...


I.-Chapter I of Title III of Book II of Part I of the Public Health Code is amended as follows:
1° R. 1231-1 becomes R. 1231-1-1;
2° At the end of the second paragraph of article R. 1231-1-1, is added a sentence as follows:
"The donor is also informed of the need to collect and store biological samples for biovigilance and their possible use for scientific purposes in accordance with the provisions of Article L. 1211-2."
II.-Before chapter I, a preliminary chapter is inserted as follows:


“Preliminary Chapter
"Clinical selection of organ donors


"Art. A. 1231-1.-Before any transplant, and as part of the general obligations referred to in R. 1211-13, the medical sampling team collects information to select donors and to characterize organs that may be transplanted.
"The information collected must at least include minimum data set by order of the Minister responsible for health taken after notice of the Director General of the National Drug Safety Agency and Health Products and the Director General of the Biomedicine Agency. This order also determines the additional data collected at the request of the medical team based on their availability and the specificity of each situation.
"By derogation from the provisions of the first paragraph, where in a particular situation, particularly in vital emergency situations, a risk and benefit analysis indicates that the benefits expected for the receiver outweigh the risks arising from incomplete data, the Registry of that body may be considered, even if all the minimum data specified in the order mentioned in the second paragraph of this article are not available. »

Article 3 Learn more about this article...


Section 2 of Chapter I of Title IV of Book II of Part I of the Public Health Code is amended as follows:
1° Sub-section 1 is as follows:


"Subsection 1
"Common provisions for major donor sampling


"Art. R. 1241-3.-I.-In compliance with the requirements mentioned in section L. 1211-2, any major person who lends himself or herself to a collection of tissues or cells shall, prior to his or her consent to the donation or non-opposition to the use of these tissues or cells when they have been taken for the purpose of a surgical procedure practised in his or her interest,
"This information is delivered by a person from the sampling team, trained and able to transmit it in a clear and appropriate manner.
"This information concerns:
« 1° The nature and purpose of the gift for therapeutic purposes, including its potential benefits to the recipient;
« 2° The potential risks incurred by the donor and, where appropriate, the foreseeable consequences of a physical and psychological nature of the gift and its possible impact on the personal, family and professional life of the donor and the possible need for follow-up after the sampling;
« 3° The need to conduct medical biology analyses, including screening for certain communicable infectious diseases and the possibility of being kept informed of the results;
« 4° The need to conduct an assessment of the donor's health during a medical interview and clinical examination;
« 5° The need to collect and maintain biological samples intended for biovigilance as well as their possible use for scientific purposes, or for the realization or control of in vitro diagnostic medical devices or for the quality control of medical biology examinations or in the context of technical expertise and controls carried out by the National Agency for the Safety of Medicine and Health Products;
« 6° The protection of personal data concerning the donor and, in the case of unrelated gifts, on the anonymous nature of the donation to the recipients.
"II.-Subject to the specific provisions applicable to hematopoietic cell donors collected in the bone marrow or peripheral blood referred to in R. 1241-4, and specific provisions relating to major donors receiving legal protection measures that must express their consent under the conditions referred to in Article L. 1241-3 and Article L. 1241-4, the consent or non-written consent of the team shall give The original of the document expressing this consent or non-objection is retained in the donor's medical file and a copy is transmitted to the establishment authorized under section L. 1243-2. » ;


2° After article R. 1241-3, a new sub-section 1 bis is inserted which reads as follows: "Hematopoietic cells collected in the bone marrow or peripheral blood on a major donor" and which includes article R. 1241-4 as follows:


"Art. R. 1241-4.-When a person wishes to be taken from hematopoietic cells collected in the bone marrow or peripheral blood, he expresses his consent to the President of the High Court or his delegate under the conditions set out in R. 1231-2 and R. 1231-3.
"In the event of a vital emergency, consent shall be obtained by the Attorney General of the Republic under the conditions defined in article R. 1231-4. » ;


3° Sub-section 2 is amended as follows:
(a) Its title is replaced by the following title: "Removal of hematopoietic cells collected in the bone marrow or in the peripheral blood on a major donor subject to curatal or safeguard justice";
(b) Article R. 1241-5 is as follows:


"Art. R. 1241-5.-When the hematopoietic cell donor from the bone marrow or peripheral blood is subject to a curatal measure, the information provided to the protected adult referred to in R. 1241-3 is also issued to the curator";


4° Sub-section 3 is amended as follows:
(a) Its title is replaced by the following title: "Hematopoietic cells collected in the bone marrow or peripheral blood on a major donor subject to a guardianship measure";
(b) Article R. 1241-12 is as follows:


"Art. R. 1241-12.-When the hematopoietic cell donor collected in the bone marrow or peripheral blood is the subject of a guardianship measure, the information provided to the protected adult referred to in R. 1241-3 is also issued to the guardian";


5° Sub-section 4 is amended as follows:
(a) Its title is replaced by the following title: "Hematopoietic cells collected in the bone marrow or peripheral blood on a minor donor";
(b) Article R. 1241-16 is as follows:


"Art. A. 1241-16.-Where a lematopoietic cell sampled from the bone marrow or peripheral blood is considered on the person of a minor under the conditions defined in section L. 1241-3, the information provided for in section R. 1241-3 is issued to each of the holders of the parental authority or to the legal representative of the minor by the practitioner who has made an alternative Appropriate information is provided to the minor if the age and maturity permit. »

Article 4 Learn more about this article...


Chapter I of Book II title IV of Part I of the Public Health Code is thus amended:
It is inserted after section 2, a section 2 bis as follows:


“Section 2 bis
« Clinical selection of tissue and cell donors


"Subsection 1
"Common provisions for clinical selection of live donors and deceased donors


"Art. R. 1241-19-1.-Before sampling, and as part of the general obligations referred to in R. 1211-13, tissue or cell donors must meet selection criteria.
"The general criteria and situations that base contraindications to the donation of tissues and cells are set by order of the Minister for Health, taken after notice by the Director General of the National Agency for the Safety of Medicine and Health Products and the Director General of the Agency for Biomedicine.
"Unless a documented analysis of the risks associated with the use of the donor's tissues and cells, approved by the responsible person referred to in R. 1243-12, justifies it, the living or deceased persons who have contraindication are excluded from the gift.


"Subsection 2
"Specific provisions for clinical selection of live donors


"Art. R. 1241-19-2.-The medical maintenance referred to in the III of section R. 1211-13 is carried out using a questionnaire that is intended to detect the history or clinical criteria against the sample.
"This questionnaire is based on general criteria and situations that base counterindications to the donation of tissues and cells in the order referred to in R. 1241-19-1. All requested information relating to the health status of the potential donor as well as his medical and surgical personal history is provided by the physician or midwife referred to in section IV R. 1211-13.
"A model type of questionnaire, prepared by the Biomedicine Agency after the advice of the National Drug Safety Agency and Health Products, is sent by the Biomedicine Agency to the sampling teams.


"Subsection 3
"Specific provisions for clinical selection of deceased donors


"Art. R. 1241-19-3.-All information collected during the clinical selection of donors pursuant to Article R. 1211-13 II, III and V is recorded in a document whose purpose is to detect the history or clinical criteria against indicating the sampling. This document is prepared by the Biomedicine Agency after the advice of the National Agency for the Safety of Medicine and Health Products on the basis of general criteria and situations that base counterindications to the donation of tissues and cells in the order referred to in R. 1241-19-1. This document may be in electronic form. »

Article 5 Learn more about this article...


Chapter II of Book II title IV of Part I of the Public Health Code is amended to read:
1° At the 6th of article R. 1242-3, after the words: "of article L. 1243-2", the words are added: "L. 4211-9-1, L. 5124-1 or L. 5124-9-1. » ;
2° At the 4th of Article R. 1242-9, after the words: "of Article L. 1243-2", the words are added: "L. 4211-9-1, L. 5124-1 or L. 5124-9-1."

Article 6 Learn more about this article...


Section 1 of Chapter III of Title IV of Book II of Part I of the Public Health Code is amended as follows:
1° After the last paragraph of article R. 1243-12, it is added a paragraph as follows:
"In the event of duly justified incapacity, the activity manager shall be replaced by an acting officer of the activities designated by the responsible person who may be responsible for the activities of another site of the same institution or agency. The acting officer of the activities shall be entrusted, for the replacement period, the same powers and powers as those conferred on the person responsible for the activities of the site and shall exercise them effectively during the replacement period. » ;
2° Section R. 1243-15 is replaced by the following provisions:


"Art. R. 1243-15. - I. Applicant institutions or organizations have medical, paramadical and technical personnel who carry out their duties under the authority of the person responsible or the person responsible for the activities referred to in R. 1243-12. At least:
« 1° A preparation manager. This function can only be performed by persons who, on the one hand, meet the conditions of practice of medicine or pharmacy, or have a doctorate in the field of life and health sciences or an engineering degree and who, on the other hand, justify conditions of professional experience, the terms of which are specified in an order of the Minister responsible for health. Individuals who hold the degree to exercise the profession of medical laboratory technician within the meaning of sections L. 4352-2 and L. 4352-3 may also exercise this function subject to the conditions provided for in the above-mentioned order and to receive a favourable opinion from the responsible person referred to in section R. 1243-12;
« 2° A quality control officer. This function can only be performed by persons who, on the one hand, meet the conditions of practice of medicine or pharmacy, or have a doctorate in the field of life and health sciences or a national master's degree in the field of life and health sciences and who, on the other hand, justify conditions of professional experience, the terms of which are specified in a decree of the Minister for Health. Persons with an engineer's degree may also exercise this function subject to the conditions provided for in the above-mentioned order and to receive a favourable opinion from the responsible person referred to in R. 1243-12.
“II. - The paramedical and technical staff shall be in sufficient number to ensure during the opening hours of the establishment or requesting agency the activities referred to in section L. 1243-2. However, to respond to emergencies and when the nature of tissues, derivatives or cell therapy preparations warrants it, their distribution is possible outside the opening hours.
"III. - As part of their duties, the personnel referred to in I respect the good practices defined under section L. 1245-6. » ;


3° In R. 1243-26, after the words: "in R. 1211-19", the words are added: "and in R. 1211-22-2";
4° In article R. 1243-30, after the word: "Pharmaceuticals" are added the words: "and to establishments or bodies authorized under articles L. 4211-9-1, L. 5124-1 or L. 5124-9-1 to manufacture innovative therapy medications prepared on time."

Article 7 Learn more about this article...


Subsection 5 of Chapter V, section 2 of Book II, Title IV, Part I of the Public Health Code is repealed.

Article 8 Learn more about this article...


Persons exercising the functions referred to in 1° and 2° of I of Article R. 1243-15 at the date of publication of the order provided for in the same article without being able to justify the conditions of diploma, training or experience fixed by that order shall have a period fixed by that order and not more than three years from the date of publication to fulfil the conditions so defined.

Article 9 Learn more about this article...


The Minister of Social Affairs, Health and Women's Rights is responsible for the execution of this decree, which will be published in the Official Journal of the French Republic.


Done on September 19, 2014.


Manuel Valls

By the Prime Minister:


Minister of Social Affairs, Health and Women ' s Rights,

Marisol Touraine


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