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Report To The President Of The Republic On Order No. 2005 - 1087 Of 1 September 2005 On National Public Institutions Health Character And Blood Transfusion Litigation

Original Language Title: Rapport au Président de la République relatif à l'ordonnance n° 2005-1087 du 1er septembre 2005 relative aux établissements publics nationaux à caractère sanitaire et aux contentieux en matière de transfusion sanguine

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Legislative records




JORF n°204 of 2 September 2005 page 14258
text No. 24



Report to the President of the Republic on Order No. 2005-1087 of 1 September 2005 on National Health Institutions and Litigation in Blood Transfusion

NOR: SANX0500159P ELI: https://www.legifrance.gouv.fr/eli/rapport/2005/9/2/SANX0500159P/jo/texte


Mr. President,
This order is made pursuant to Article 73 (1°, 5° and 6°) of Law No. 2004-1343 of 9 December 2004 on simplification of the law.
The 1st of Article 73 empowers the Government to take, by order, any measures to "specify, harmonize and supplement the provisions relating to the various national public health institutions, including by modifying, as appropriate, the extent or distribution of their competences and their means of action and by harmonizing the powers of directors in institutions with health monitoring, regulation or security missions".
In this context, the purpose of this Order is to extend the competence of the French Environmental Health Safety Agency (AFSSE), to modify the competence of the French Health Safety Agency for Health Products (AFSSAPS), as well as those of the French Blood Establishment (EFS) and the French Food Safety Agency (AFSSA).
It also includes certain provisions for harmonization with respect to personnel or persons assisting agencies, as well as certain financial provisions.
The 5th of Article 73 allows for the unification of jurisdictional jurisdiction to hear disputes relating to contamination, whether prior to or after the creation of the SSA. The 6th is related to the transfer to the ESA of the obligations of certain legal entities of public law.
I. - The extension of the competence of AFSSE responds to the need to develop knowledge of hazards and exposures and the assessment of risks in the occupational environment, by introducing the field of health to work in the health safety device. It is one of the health plan measures at work 2005-2009.
AFSSE becomes the French Agency for Environmental and Labour Health Safety (AFSSET); his guardianship is extended to the Minister of Labour.
AFSSET is responsible for assessing the risks associated with products, while the Health Care Watch Institute retains its general competence to monitor the health of the population and will develop monitoring throughout the health of workers.
Senator Saulnier, in his report on the evaluation of the application of the Act of July 1, 1998 on the strengthening of the health watch and the health safety of human products, stressed the need for a competent agency to assess the risks associated with all living environments, including the risks of work and those caused by chemicals.
The Government has decided to maintain the AFSSE as an autonomous public institution and to expand its missions to occupational health while seeking close rapprochement and synergies between AFSSE and AFSSA.
Section 1 of this Order rectifies a codification error.
Section 2 amends the title of title III of Book III of Part I of the Public Health Code and rewrites Chapter VI of this title to take into account the extension of AFSSE's skills to work, which becomes the AFSSET:
- Article L. 1336-1 sets out the agency's duties and specifies how it exercises them. The agency organizes a network with State departments and public institutions as well as with other relevant bodies, which coordinates the risk assessment work. The list of institutions and bodies concerned will be established by decree in the Council of State. The modalities of their coordination will be covered by conventions.
This section also provides for the obligation of any person to communicate to the agency any information in his or her possession relating to risks to human health, including information covered by medical secrecy or commercial and industrial secrecy, in accordance with confidentiality with respect to third parties. Such a provision is already provided for in Article L. 1413-5 for the benefit of the Health Care Watch Institute. These obligations are necessary for the benefit of both agencies because the information is not used for the same missions.
Finally, he recalls that the agency must contribute to the public debate on environmental and labour health security;
- Article L. 1336-2 opens the possibility of seizing the agency to the professional and trade union organizations represented on the board of directors as well as to certain associations having at the national level activities in the areas of the agency's competence. The conditions of the agency will be fixed by decree in the Council of State;
- section L. 1336-3 amends the composition of the board of directors to include representatives of employers' and employees' organizations and determines the purpose of its deliberations.
This article also states that it is the Director General who issues opinions and recommendations (not just decisions) on behalf of the agency, as is the case in the AFSSA;
- Article L. 1336-4 specifies the obligations of members of the boards and boards in matters of professional secrecy, conflicts of interest and anti-cademic rules;
- Article L. 1336-5 lists the main resources of the agency;
- Article L. 1336-6 refers to a decree in the Council of State the terms of application of the chapter.
II. - Change of AFSSAPS skills.
1° The transfer to AFSSAPS of responsibility for the publication of good practices.
The purpose of this provision is to replace, with respect to good practices, the orders of the Minister for Health, the orders of the Minister for Health made on the proposal of the Director General of the AFSSAPS and other public agencies or institutions, as well as the interdepartmental orders made on the proposal of the Director General of the AFSSAPS, with decisions of the AFSSAPS made, if any, on the advice of other public institutions. These decisions are taken on behalf of the State by the Director General of the AFSSAPS pursuant to Article L. 5322-2.
This amendment recommended in Senator Claude Saunier's report entitled "Health Watch and Safety: Assessing the Application of Act No. 98-535 of July 1, 1998" is based on two justifications:
- on the one hand, only the agency has the technical competence in this matter;
- on the other hand, it will ease the procedure for the adoption of texts, especially when it comes to the transfer of community directives, including guidelines on good manufacturing practices (GMP) and good laboratory practices (BPL).
The contents of the certificate establishing that an establishment for the manufacture, import or distribution of raw materials for pharmaceutical use is currently defined by a decree of the Minister for Health, on the proposal of the AFSSAPS. Following the same approach, it is proposed that this order be replaced by a decision of the AFSSAPS.
Accordingly, in section 4, amendments to the Public Health Code are proposed to the following articles:
- in the seventh paragraph of Article L. 1121-3 on the rules of good clinical practice applicable to biomedical research on drugs and recommendations of good clinical practices applicable to other research relating to products referred to in Article L. 5311-1;
- the second and third paragraphs of Article L. 1125-2 on good practices for biomedical research on the therapeutic use of organ, tissue and cells of animal origin in the human being;
- Article L. 1223-3 on good practices applicable to blood transfusion institutions, the armies transfusion centre and blood deposits;
- Article L. 1245-6 on good practices of removal, preparation, preservation and transport and use of tissues, cells, cell therapy preparations and human body products used for therapeutic purposes;
- Article L. 1261-3 on good practices for the preparation, processing, conditioning, preservation, import of transport and distribution of the attached therapeutic products;
- in the first paragraph of Article L. 5121-5 on Good Manufacturing Practices;
- in the second paragraph of Article L. 5121-5 relating to good practices in the manufacture, conservation, assignment and export of gene therapy preparations and xenogenetic cell therapy preparations referred to in 12° and 13° of Article L. 5121-1;
- the first and second paragraph of Article L. 5121-7 on good laboratory practices applicable to drugs;
- Article L. 5131-5 on good manufacturing and laboratory practices for cosmetic products;
- Article L. 5138-2 on good practices in the manufacture and distribution of raw materials for pharmaceutical use;
- Article L. 5138-3 on the certificate establishing that a pharmaceutical establishment respects good practices in the manufacture and distribution of raw materials for pharmaceutical use.
Finally, jurisdiction to make decisions where specific provisions provide for it is added to Article L. 5311-1 which deals with the AFSSAPS missions.
2° The explicit mention of breast milk in the AFSSAPS jurisdiction field (Article 5-I).
The maternal milk collected, qualified, prepared and preserved by the lactariums, as a product of human origin with a health purpose, meets the characteristics of health products entering the AFSSAPS jurisdiction field under section L. 5311-1 of the Public Health Code. However, for the sake of clarity and with regard to the specific rules applicable to this product, it seems preferable to include it explicitly in an 8° of this list.
In addition, in the second paragraph of Article L. 2323-1 is introduced the concept of good practices applicable to the activities of collection, preparation, qualification, treatment, conservation, distribution and delivery on medical prescription of breast milk referred to in Article L. 5311-1 8. However, the definition of the operating conditions and organization of the lactariums remains a ministerial competence.
3° The removal of AFSSAPS's dietary food skills for special medical purposes (Article 5-II).
Dietary foods for special medical purposes (ADDFMS) referred to in the 13th of Article L. 5311-1 of the Public Health Code are a subcategory of ADDFMS whose regulation and control are within the competence of the General Directorate of Competition, Consumption and Suppression of Frauds (DGCCRF).
AFSSA conducts nutritional expertise and risk assessment for all foodstuffs including ADDFMS.
In addition, on the 13th of Article L. 5311-1 of the Public Health Code, derived from Act No. 98-535 of 1 July 1998 on the strengthening of the health watch and the control of the health safety of products intended for human use, entered the competence field of the AFSSAPS " dietary foods intended for special medical purposes which, because of their composition, are likely to pose a risk to persons who are not intended for special medical purposes".
According to Article L. 5137-1 of the same code, the products referred to in 13° of Article L. 5311-1 are subject to the control of the AFSSAPS only with respect to their marketing declaration and the vigilance to be exercised on their adverse effects.
However, AFSSAPS cannot exercise effective control over these products as it only controls a minor part of the chain leading from manufacturing to the use of these products.
It is therefore preferable that the same administrative authority, in this case the DGCCRF, be responsible for controlling the entire ADDFMS category.
That is why it is proposed to delete:
- the 13th of Article L. 5311-1 of the Public Health Code, relating to the competence of the AFSSAPS with respect to ADDFMS, which, because of their composition, are likely to pose a risk to persons to whom they are not intended;
- the obligation to report before AFSSAPS, provided for for the above-mentioned products in the first paragraph of Article L. 5137-1 of the Public Health Code;
- as well as the obligation for manufacturers, importers or distributors of these products and for any person who has prescribed or issued to transmit to the AFSSAPS any information on the unexpected or unacceptable effects that may be due to them and of which they are aware, provided for in the last paragraph of section L. 5137-1 of the Public Health Code.
4° The extension of the AFSSAPS' powers with respect to products referred to in Article L. 5311-1 of the Public Health Code (Article 6).
This order shall take the consequences of the decision of the Council of State of 19 November 2003, which cancelled part of the decision of 17 June 2002 prohibiting the manufacture, import, export, wholesale distribution, packaging, placing on the market for free or expensive purposes, detention for the sale or distribution on a free or expensive basis and the use of cosmetic products containing bovine extracts, o
The Act already allows the Director General of AFSSAPS to suspend or prohibit activities related to products or product groups. It therefore provides a basis for decisions prohibiting all or part of the cosmetics activities with certain ingredients. On the other hand, it does not permit the continuation of these activities to be subject to certain conditions that the decision would establish. This explains the cancellation of the 2002 decision.
A new version of section L. 5312-1 of the Public Health Code is proposed to provide in the first paragraph that the decisions of the Director General of AFSSAPS may not only be intended to suspend the activities but also to subject them to specific conditions or restrictions. The third preambular paragraph that provided for this second possibility only for use is no longer necessary since use is part of the activities listed in the first preambular paragraph; the purpose mentioned in the third paragraph, namely health security, is the purpose pursued by all the police measures that the director general of the agency can take and can therefore be deleted without disadvantage.
This measure, which concerns all products within the agency's scope of competence, is a softening which, by offering it new possibilities of intervention, can result in a reduction in the number of ban and suspension measures.
5° The deletion of AFSSAPS' proficiency in the accreditation of processes and devices used for disinfection of premises and vehicles referred to in Article L. 3114-1 of the Public Health Code (Article 7).
Accreditation of these devices and processes raises, on the one hand, legal difficulties (constrained by the regulatory framework for accreditation under the regulation of biocide products and superfluous superposition of two licensing regimes when disinfection involves products already authorized as biocide products) and, on the other hand, technical difficulties (AFSSAPS does not have adequate facilities for testing).
With respect to the processes, it is anticipated that, in the application file for the marketing of biocide products transmitted to the Minister responsible for the environment, the method of use of the product (see article 3, point 3.3, of the Order of May 19, 2004 on the control of the marketing of biocide active substances and the authorization to market biocide products). This does not explicitly concern the device's method of use. However, it is possible to consider, without a health safety problem, that the terms "product method" include the process. Indeed, we use a product with a device and the whole according to a process. It is then possible to remove the accreditation of the processes issued by AFSSAPS.
With regard to the devices, it is proposed that these devices remain within the scope of the AFSSAPS but that the approval be issued by independent bodies (LNE or APAVE) on a list established by the AFSSAPS, pursuant to the 3rd of Article L. 5311-2 of the Public Health Code. This formula has the advantage of retaining the competence of the AFSSAPS to provide expertise and, if necessary, to take health police measures while exempting it from the issuance of a priori approvals.
6° The transfer to the Director General of AFSSAPS of the responsibility for the registration of a labile blood product on the list of products that may be made available to blood transfusion institutions (section 8).
The responsibility for the registration of a lab blood product (PSL) on the list referred to in section L. 1221-8-1° of the Public Health Code is transferred to the Director General of the AFSSAPS. Enrolment on the above list is authorized for EFS to make these labial blood products available to blood transfusion institutions, health institutions or manufacturers of medicines in the case of plasma. AFSSAPS is responsible for the evaluation, monitoring and control of labile blood products. For the sake of simplification and by analogy with the authorization to put on the market the drugs it has charge, it appears consistent to entrust to the AFSSAPS the care to set the list and characteristics of the labile blood products without the intervention of an order of the minister responsible for health. The drafting of the article is further improved in such a way that:
- all LSPs can be prepared even if they are not on the list;
- but only LSPs listed on the list may be distributed or delivered for therapeutic purposes, except for products intended for biomedical research.
Section L. 1222-2 is repealed. Indeed, on the one hand, the requirement to register a LLP on the list before any therapeutic use already falls within the provisions of Article L. 1221-8. On the other hand, the list of information that the SEF should communicate to the PSSSAPS falls within the regulatory level rather than the legislative level. The new article L. 1221-8-2 explicitly gives competence to the AFSSAPS to carry out the assessment of the PSL for inclusion in the list provided for in article L. 1221-8-1 and provides that this assessment is made on the basis of a record of which the AFSSAPS defines the content and which can be provided either by the ESA or by the Centre for Blood Transfusion of Armies (CTSA)
III. - The modification of the skills and organization of the French Blood Institution (EFS) as well as some skills of the AFSSAPS in the field of labile blood products (article 10).
1° Amendments to specify the EFS's missions.
Section L. 1221-10 deals with the specific competencies of the SSA, which can only be specified in this particular case as opposed to that of health facilities. In fact, the ESA has the competence to preserve, distribute and deliver labile blood products (LPS).
In order to enrol in the law that distribution is a monopoly of the EFS, it is also necessary to register that health institutions can only keep LSPs to deliver them. This separation between the activities of the health institutions and the EFS is a result of a health safety requirement: only the EFS has the means and personnel necessary to ensure, 24 hours a day, the quality, safety and traceability of this distribution. Thus, the blood deposits of health facilities are ensured to have LSPs in accordance with the maximum health safety requirements to deliver them to hospitalized patients in their establishment.
Section L. 1222-1 supplements the list of activities organized by the ESA in the national territory by adding the issuance of the LHPs and specifies that this organization is carried out within the framework of the blood transfusion organization plans approved by the Minister for Health.
Section L. 1223-2 is subject to consistency and terminology amendments.
Section L. 1223-3 adds the issuance to the list of activities of blood transfusion institutions of the ESA, CTSA and health institutions that must be governed by good practices defined by the AFSSAPS.
2° Modification of some AFSSAPS competencies in the field of labile blood products.
A new section L. 1221-10-1 takes the second part of the current section L. 1221-10 on the regulation by the AFSSAPS of the use of LSPs.
Article L. 1221-13 defining hemovigilance, whose responsibility the AFSSAPS has, is amended. The AFSSAPS has a general jurisdiction over vigilance under Article L. 5311-1. The field of each of the vigilances that AFSSAPS provides is defined in the section of the product code concerned. Since hemovigilance is more broadly defined at the community level, it is proposed to extend the definition in the Public Health Code accordingly. This extension concerns the field of incidents and adverse events that must be reported to the AFSSAPS.
3° The responsible person within the ESA:
Since January 1, 2000, the EFS is the single national blood transfusion operator, federating structures from the law of January 4, 1993. This organization marks the will of the legislator to establish a single central authority that dictates a line of conduct to its regional emanations and controls their activity. In addition, section 9 of Directive 2002/98/EC provides for each blood transfusion institution, the function of "responsible person" responsible for the implementation and application of the legislative and regulatory provisions relating to the quality and safety of LLPs. To fulfill these missions, the responsible person must meet minimum requirements for qualification and professional experience.
Accordingly, sections L. 1222-2 and L. 1223-4 relating to the designation and functions within the SSA of a "responsible person" state that:
- the responsible person is responsible for ensuring compliance with legislative and regulatory provisions relating to the quality and safety of LLPs in all blood transfusion institutions;
- it is designated by the President of the ESA and has, for the exercise of its function, authority over the directors of blood transfusion institutions;
- without being able to delegate his or her function, the responsible person is assisted in his or her task by the directors of blood transfusion institutions who ensure the implementation of these same provisions under his or her authority.
IV. - The modification of AFSSA's skills (Article 11).
1° Good practices for veterinary medicines are currently defined by the Agriculture and Health Ministers' Order, on the proposal of AFSSA. These ministerial orders are replaced by decisions of the Director General of AFSSA:
- Article L. 5141-4 on Good Laboratory Practices and Good Clinical Practices for Veterinary Drugs;
- Article L. 5142-3 on Good Manufacturing, Import and Distribution Practices for Veterinary Drugs.
2° The simplification of the pre-Notice procedure issued by AFSSA in the development of new standards for veterinary drugs.
When developing these new standards, the opinion of the AFSSA may be collected both on the basis of Article L. 261-2 of the Rural Code, which provides that the agency is consulted "on the draft legislative or regulatory provisions relating to the control of animal diseases" and in accordance with the Public Health Code which provides, in its articles L. 5141-16, L. 5142-8, L. 5143-10, L.
Under these conditions, the agency may be required to be seized twice on the same draft text, which generates both unnecessary tasks and a slowdown of the procedure. One of the recommendations in the report on the monitoring and health safety referred to above, in fact, calls for a reduction in the number of referrals from AFSSA, including the removal of the automaticity of the referral on national regulatory texts.
Therefore, it is proposed to amend section L. 261-2 of the Rural Code to indicate that the provisions of this section do not apply to the legislative and regulatory provisions of the Public Health Code relating to the veterinary drug.
V. Harmonization and simplification of certain provisions.
Article 12 extends to agents of the Institute of Prevention and Education for Health and to persons who assist the Institute within the boards and commissions the provisions applicable in other agencies in relation to declaration of interest and anti-cademic provisions.
It harmonizes between the various agencies, the provisions relating to professional secrecy obligations for members of the boards and boards and the persons who occasionally cooperate with them.
Article 13 removes the need for a decree for the agencies currently concerned to determine the conditions under which they can allocate subsidies; the board of directors is responsible for setting these conditions.
VI. - Litigation of blood transfusion.
1° Transfer to the ESA of the rights and obligations of certain legal entities of public law:
Section 14 of the Order, pursuant to the 6th of Article 73 of the Law of 9 December 2004, states that the rights and obligations arising from the development or supply of blood products are transferred to the ESA by public legal persons approved under the law of 21 July 1952 but do not fall within the scope of the B of Article 18-5 of the Law of 9 July 1952.
The transfer covers both the obligations arising from the development or supply of blood products by these persons and the rights attached to them, in particular, the insurance contracts entered into under transfusion activities so that the ESA can call the insurers concerned as collateral.
The transfer to the SSA of the post-transfusion litigations of these individuals is limited to the proceedings that are in progress on the date of establishment creation or subsequently born and that have not resulted in an irrevocable decision on the date of publication of this order. Disputes of public legal persons who were born before or after the date of establishment's creation, already judged on the merits in an irrevocable manner, whether or not they were executed on the date of publication of the order.
2° Unification of jurisdictional jurisdiction over transfusion litigations that have been born previously or after the creation of the SSA:
The statement of the reasons for the 5th of Article 73 of the Enabling Law states that this section "is intended to allow the simplification of the remedy procedure for compensation of persons who are victims of hepatitis C contamination or HIV who have occurred prior to the creation in 2000 of the SSA, by uniting the litigation regime. Administrative jurisdictions, now competent when contamination is after the creation of the SSA, will be in the future regardless of the time the contamination occurred, being recalled that the SEF is substituted, under conditions established by convention, for former blood transfusion institutions in their rights and obligations".
Section 15 of the Order provides that claims for compensation for damages arising from the provision of labial blood products or blood-based medicines developed by public legal persons referred to in section 14 or by organizations whose rights and obligations have already been transferred to the SSA are within the jurisdiction of administrative courts, regardless of the date on which the claim is made. Applications that are the subject of a proceeding brought before a court prior to the date of entry into force of the order are excluded, provided that the order was competent on the date of application.
VII. - Transitional provisions.
Section 16 sets out the time when the current terms of reference of the members of the Board of Directors and the Scientific Council of the PSSA expire.
Article 17 specifies the conditions for the entry into force of the obligation to declare interest for persons already in office in public institutions or commissions placed with them concerned by the harmonization measures provided for in Article 12.
This is the subject of this order that we have the honour to submit to your approval.
Please accept, Mr. President, the assurance of our deep respect.


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