Key Benefits:
The Prime Minister,
On the report of the Minister of Health and Solidarity,
Having regard to the public health code, including titles III and IV of Book II of Part I;
The State Council (Social Section) heard,
Decrete:
Section 1 of Chapter II of Title III of Book II of Part I of the Public Health Code (regulatory provisions) is amended as follows:
I. - The title of this section is as follows: "Finding the death before sampling and the conditions for carrying out the samples".
II. - This section is supplemented by articles R. 1232-4-1, R. 1232-4-2 and R. 1232-4-3 as follows:
"Art. R. 1232-4-1. - Organ removals on a deceased person can only be carried out if the latter is assisted by mechanical ventilation and retains a hemodynamic function.
"However, removals from organs on a list set by order of the Minister for Health, taken on the proposal of the biomedicine agency, may be carried out on a deceased person with a persistent cardiac and respiratory arrest.
"Art. R. 1232-4-2. - Samplings referred to in the second paragraph of Article R. 1232-4-1 are carried out in compliance with protocols issued by the biomedicine agency. These protocols include situations in which such sampling can be carried out and the conditions for their implementation.
"Art. R. 1232-4-3. - The medical measures taken prior to the sampling are terminated to ensure the preservation of the organs of a person whose death has been duly recognized if it appears, in the light of the testimony of the relatives of that person collected under section L. 1232-1, that she had shown from her lifetime an opposition to the donation of organs. »
Chapter III of Book II title III of Part I of the Public Health Code (regulatory provisions) is amended as follows:
I. - The title of this chapter is as follows: "Removals authorized to take or participate in this activity".
II. - In each of the articles of this chapter, the words: "French Establishment of Registrys" are replaced by the words: "organization of biomedicine".
III. - Section 1 is amended as follows:
1° In the first sentence of R. 1233-2, the words "on a deceased person" are deleted;
2° The second paragraph of Article R. 1233-3 is repealed;
3° In the second paragraph of Article R. 1233-4, the words: "as provided in the third paragraph of Article L. 1245-1" are replaced by the words: "as provided in the second paragraph of Article L. 1245-1";
4° Section R. 1233-5 is amended as follows:
The first paragraph is completed as follows: "The application for the renewal of the authorization is addressed to the Director of the regional hospitalization agency under cover of the prefect of the implantation department seven months before the expiry date of the authorization. »
In the first sentence of the second paragraph of R. 1233-5, the words: "application for authorization" are supplemented by the words: "or renewal of authorization".
IV. - Section 2 is amended as follows:
1° At 1° of R. 1233-7, the words: "of a person assisted by mechanical ventilation and maintaining a hemodynamic function" are deleted.
2° The second sentence of article R. 1233-10 is thus written: "These institutions also transmit to the Director General of the biomedicine agency the information necessary for the implementation of a monitoring of the health status of living donors. »
3° This section is supplemented by an article R. 1233-11 as follows:
"Art. R. 1233-11. - Regardless of the authorization provided for in section R. 1233-2, health facilities that wish to perform the removals of organs referred to in the second paragraph of article R. 1232-4-1, define by means of a convention with the biomedicine agency the means they undertake to put in the service of this activity. This convention also defines the content and periodicity of the information they must transmit to this agency to enable it to evaluate this activity. »
V. - Section 3, section R. 1233-11 becomes section R. 1233-12.
VI. - It is added to this chapter a section 4 entitled "Sampling networks", which includes an article R. 1233-13 as follows:
"Art. R. 1233-13. - The health facilities referred to in the third paragraph of Article L. 1233-1 which are not allowed to collect organs define, by agreement with the establishments authorized to perform these samplings, the modalities of their participation in a sampling network. These conventions are transmitted to the Director General of the biomedicine agency. »
The single section of Chapter I of Title IV of Book II of Part I of the Public Health Code (regulatory provisions) is supplemented by an article R. 1241-2-1 as follows:
"Art. R. 1241-2-1. - The removal of tissues and cells from a deceased person can only be carried out if it is assisted by mechanical ventilation and retains a hemodynamic function.
"However, tissue and cell samples on a list set by order of the Minister for Health, taken on the proposal of the Director General of the Biomedicine Agency, may be taken on a deceased person with a persistent cardiac and respiratory arrest. »
Chapter II of Book II title IV of Part I of the Public Health Code (regulatory provisions) is amended as follows:
I. - The title of this chapter is as follows: "Accounts authorized to collect or participate in this activity".
II. - In each of the articles of this chapter, the words "French institution of transplants" are replaced by the words "organization of biomedicine".
III. - Section 1 of this chapter is amended as follows:
In R. 1242-2, the words "in R. 1233-2 to R. 1233-6" are replaced by the words "in R. 1233-2 and R. 1233-4 to R. 1233-6".
Section R. 1242-3 is amended as follows:
At 3° and 6°, the words "Article L. 1243-1" are replaced by the words "Article L. 1243-2".
At 4° a, the words "at 5° of Article R. 1233-7" are replaced by the words "at 5° a of Article R. 1233-7".
At 4° b, the words "at 5° of Article R. 1233-7" are replaced by the words "at 5° c of Article R. 1233-7".
The last sentence of section R. 1242-5 is repealed.
An article R. 1242-6 is added as follows:
"Art. R. 1242-6. - The health facilities referred to in the third paragraph of Article L. 1233-1 that are not allowed to collect tissues, define by agreement with the establishments authorized to practice these removals the modalities of their participation in a sampling network. These conventions are transmitted to the Director General of the Biomedicine Agency. »
IV. - In section 2 of the same chapter, section R. 1242-6 becomes section R. 1242-7.
The Minister of Health and Solidarity is responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
Done in Paris, 2 August 2005.
Dominique de Villepin
By the Prime Minister:
Minister of Health and Solidarity,
Xavier Bertrand