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Agreement Between The Minister Of Health, Regions And Provinceautonome Of Trento And Bolzano On The Document Entitled: "the Guidelines Inner Collection, Manipulation And Clinical Use Of Hematopoietic Cellulestaminali (Cse)."

Original Language Title: Accordo tra il Ministro della salute, le regioni e le provinceautonome di Trento e Bolzano sul documento recante: «Linee-guida intema di raccolta, manipolazione e impiego clinico delle cellulestaminali emopoietiche (CSE)».

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THE PERMANENT CONFERENCE FOR RELATIONS BETWEEN THE STATE, THE REGIONS AND AUTONOMOUS PROVINCES OF TRENTO AND BOLZANO view the law May 4, 1990, n. 107, stating: "Discipline for the activities' transfusion relating to human blood and its components and to the production of plasma," which art. 1, paragraph 3, allows the procurement of stem cells, bone marrow and peripheral devices, in compliance with the rules set for the hemapheresis, in order to infuse for the allograft in different subject or transplant in the same subject; Given the Law of 1 April 1999, n. 91, entitled: "Standards for the discipline of transplantation of organs and tissues"; Given the Ministerial Decree of 25 January 2001 concerning "Characteristics and methods' for the donation of blood and blood components", which in art. 5, paragraph 1, stipulates that the hematopoietic stem cells, as primitive cells can self-renew, differentiate and mature along all blood lines, are used by the bone marrow transplant centers, after proper conditioning of the recipient for a transplant able to allow the recovery of the normal function 'with bone marrow reconstitution of all blood lines; Given the Ministerial Decree of 26 January 2001, on 'Protocols for ascertaining suitability' of the blood donor and blood components ", which in art. 10, paragraph 3, requires the informed consent of the donor for each type of donation, including the donation of peripheral blood stem cells as well as' of cord cells and art. 13, paragraph 2, provides that, pickup peripheral blood stem cells, in particular situations of need ', and for specific clinical requirements can be adopted for suitability' various criteria, in the opinion of the medical expert in transfusion medicine, in strict protection and health protection of the donor; Having regard to Law 6 March 2001, n. 52, as "Recognition of the Italian register of bone marrow donors," which regulates the search for potentially compatible blood and bone marrow donation and establishing art. 9, paragraph 2, of the National Commission for allogeneic transplants from unrelated; Having regard to Law 28 March 2001 n. 145 "Ratification and implementation of the Council of Europe Convention for the Protection of Human Rights and dignity 'of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine, made to Oviedo 4 April 1997, as well as' the additional Protocol of 12 January 1998, n. 168, on the ban on donation of human beings "; The Order of the President of the Council of Ministers of 29 November 2001 defining the essential levels of health care, confirmed by art. 54 of Law 27 December 2002 n. 289, which, at the fundamental level of point 3 - Hospital care, letter I - identifies 'activities' of collection, storage and distribution of tissues "; Having regard to legislative decree 19 September 1994 n. 626, as amended and supplemented, implements EU directives on improving the safety and health of workers at work; Given the guidance document in question, sent by the Ministry of Health note dated 4 April 2003; Given that the technical review 12 May us and 'started the examination of the measure and that, at its meeting on May 26, 2003, to examine and' was postponed for further study required the Ministry of Health, regarding the consistency of content of that agreement with the legal and financial framework in force; that the Ministry of Health, in a note dated June 17, expressed the opinion that the same is not innovative and ampliativo compared to the levels of essential health care, as defined by the decree of the President of the Council of Ministers of 29 November 2001, confirmed art. 54 of Law 27 December 2002 n. 289; Given that the technical review June 17 us which was also attended by a representative of the Ministry of Economy and Finance, participated were the contents of that note and you and 'agreed the text of the agreement in question; Considering that, during today's session of the Conference of the Presidents of the regions have expressed support for the agreement notice; Considering that, during today's session of this Conference, the representative of the Ministry of Economy and Finance has asked to clarify that the establishment of the Committee referred to in point E) of the text of this agreement does not result in additional charges from the state budget than those already 'provided for by law and that such clarification' was shared by the representative of the Ministry of Health and the chairmen of the Regions; Acquired the consent of the government, regions and autonomous provinces of Trento and Bolzano; Enshrines the following agreement between the Minister of Health, the regions and the autonomous provinces of Trento and Bolzano within the following terms: in view of the Ordinance of the Minister of Health of 30 December 2002, which expresses the need to exert more 'close activity' control and vigilance concerning the use of stem cells from umbilical cord, which is expressly forbidden to the preservation of umbilical cord blood in private structures and reaffirms the requirement of ministerial import and export of hematopoietic stem cells from the umbilical cord both for autologous use allogeneic; It noted that the theme of hematopoietic stem cells and 'was also addressed, among others, in the circular of the Ministry of Health' n. 10 of 22 February 1986 concerning the Centers marrow transplant; in the opinion of the High Council of Health 'of 16 March 1994, the national program for the transplantation of organs and tissues; It found that the set of rules governing quoted in the introduction substantially the donation of stem cells and patient access to the register of bone marrow donors and not extend, in particular, the type of systems that deal with the collection, handling and use clinical use of hematopoietic stem cells, the character oncoematologico medical procedure referred to Ministerial decree of 29 January 1992 on the list of high specialty 'and determination of the requirements necessary to health facilities for the exercise of attivita' of high specialty "; noted that the Ministry of Health ', at its meeting on 5 July 2001, in addition to positively express themselves on the stimulation of the production of hematopoietic stem cells with growth factor granulocyte in unrelated donor at the second donation, also it pointed out the opportunities 'to prepare a draft provision concerning the structural, technological and organizational requirements for the exercise of activities' relating to health facilities that undertakes the procurement of stem cells from autologous or allogeneic donor and for transplantation centers that use them in the recipient; therefore it deemed necessary to ensure the quality 'of the donation keeping procedures, processing and transplantation of hematopoietic stem cells by establishing quality standards for preservation and transplantation centers and the collection of data related to these activities' throughout the national territory; It found that in the specific field of stem cell transplantation are active in specific international society 'and named organizations: EBMT (European Group for Blood and Marrow Transplantation), which deals with trapiantologiche procedures and standards for transplant centers, connected to 'ISCT (International Society for Cell Therapy), all'IBMTR (International Bone Marrow transplant Registry) and JACIE (Joint accreditation Committee of ISHAGE and EBMT for the accreditation of transplant centers and indications for transplantation itself); BMDW (Bone Marrow Donor Worldwide), which collects all the donors do not blood relations of the world in one electronic file linked with all national registries and WMDA (World Marrow Donor Association), which deals with standards and procedures, rights and duties of donor in the world; NETCORD (international network for the collection and storage of blood cord), which determines the procedures and the necessary criteria for accreditation of cord blood banks; ISBT (International Society of Blood Transfusion) that deals with standard procedures of transfusion medicine; It noted that the company 'and these international organizations in the preceding subparagraph are connected or associated with corresponding clinical and scientific groups and national organizations called: Gitmo (Group Italian BMT), associated with EBMT; IBMDR / ADMO (Italian Bone Marrow Donor Registry Association and bone marrow donors, associated respectively with BMDWW and WMDA; GRACE (Group collection and amplification of hematopoietic cells), associated with NETCORD; ERCBB (Emilia-Romagna Cord Blad Banf associated with BMDKW); SIE (Societa 'Italian hematology); AIEOP (Italian Association of pediatric oncology and hematology); SIMTI (Societa 'Italian of transfusion medicine and immunoematologia), associated with ISBT; SIDE (Societa 'Italian of hemapheresis); having regard to the guidelines produced by sopraricordate society ', organizations and clinical-scientific groups for the collection, manipulation and clinical use of hematopoietic stem cells; seen the final document produced by the study commission on the use of stem cells for therapeutic purposes, established by decree of the Minister of Health August 6, 2001; It found that transplantation of organs and tissues the aforementioned Law of 1 April 1999, n. 91, it provides, among other things, the establishment of the National Centre for transplants and entrusts to it the collection of data relating to activities 'transplant and the task of setting parameters relating to the quality' of the functioning of trapiantologiche structures, without excluding live donations, including the transplantation of hematopoietic stem cells should certainly be considered; The Minister of Health, the regions and the autonomous provinces of Trento and Bolzano agree as follows: A) activities' collection, manipulation and clinical use of hematopoietic stem cells must be in accordance with guidelines set out in Annex document, which constitutes an integral part of this act, where operating standards in accordance with international standards are described; B) regions and the autonomous provinces of Trento and Bolzano initiate procedures for accreditation of transplant centers and cord blood banks based on the indications of the above lineeguida and in compliance with the general rules on accreditation of health facilities; C) the verification of compliance with the application of these guidelines and 'carried out by the regions and autonomous provinces of Trento and Bolzano, in collaboration with the National Centre for transplants, also using the company', organizations and clinical-scientific groups identified in the introduction, at least every three years; D) activities 'collection, manipulation and clinical use of hematopoietic stem cells and the activities' of immunogenetics dedicated to stem cell transplant can take place only in the centers accredited by the regions and autonomous provinces of Trento and Bolzano; E) by specific decision of the Minister of Health, and 'established without further burden on the state, a committee made up of three representatives of the regions and autonomous provinces of Trento and Bolzano, by three experts appointed by the Minister of Health of which one of' higher Institute of Health ', the director of the national transplant Center, a representative from each of the organizations Gitmo, IBMDR, GRACE, SIMTI, SIDE, SIE, AIEOP and an expert indicated by the Board of Health', responsible for assessing the state implementation of this agreement, and more 'in general the performance of the activities' of transplantation of hematopoietic stem cells, and to report back with periodic reports to the Minister and to the regions and autonomous provinces; agree on the accompanying document under A) he entitled: "Guidelines for the collection, manipulation and clinical use of hematopoietic stem cells (HSCs)." Rome, 10 July 2003 President: La Loggia The secretary: Carpino