1 ITALIAN NATIONAL BLOOD CENTRE REGULATION OF CORD BLOOD BANKING: GLOBAL IMPLICATIONS Paolo Rebulla
2 European Directives National Laws In the case of blood and blood components & tissues and cells European Directives National laws Quality & safety requirements Concern what to do to adequately and homogeneously manage defined activities Involve essential healthcare services and quality assurance Provisions aimed at guaranteeing essential healthcare services delivery May concern where and by whom the activities must/should be managed Involve technical and political choices
3 Regulation on cells and tissues Advances in stem cell research over the last two decades have coincided with large increases in haemopoietic stem cell transplantation using either bone marrow, peripheral blood or cord blood-derived stem cells. In parallel, the role played by regulatory bodies, both institutional and professional, has increased in order to ensure that specialists undertake the above procedures in a manner so as to minimize the risk to patients and guarantee high quality levels.
4 European Directives concerning tissues and cells 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
5 Historical perspective of European regulation on cells and tissues Directive 2004/23/EC of CoE sets standards that ensure a comparable level of quality and safety for donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells throughout the EU. The directive had to be transposed into the legislation of member states within 2 years of its adoption by the EU.
6 Historical perspective of European regulation on cells and tissues Two Directives of the European Commission - derived from Directive 2004/23/EC - were published in 2006 providing more detailed requirements: Directive 2006/17/EC which provides detailed requirements for donation, procurement and testing and Directive 2006/86/EC including coding, processing, preservation, storage and distribution requirements
7 The European regulation on cells and tissues The European regulation designs an appropriate comprehensive framework and establishes detailed technical requirements for tissue and cell banking, to be applied to CB banking in all member states, according to the specificity of this activity.
8 The European regulation on cells and tissues Each member state has to harmonize/update its national regulation with the Community s provisions so as to guarantee equal quality and safety levels for donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells throughout the EU. This is hopefully to be realized in all member states soonest possible.
9 Cord Blood Banking European directives National provisions International standards Safety and quality requirements
10 International standards Collection Processing Testing Banking Selection Release
11 The Italian regulation of cord blood banking authorisation and accreditation
12 National provisions (who and where) Blood Tissues and cells Law n. 219 New discipline of transfusion medicine activities and national production of blood derivatives of 21 October 2005 Decree n. 191 of 6 November 2007 implementing Directive 2004/23/EC Decree n.16 of December 2010 implementing Directives 2006/17 and 2006/86/EC
13 Law n. 219 New discipline of transfusion medicine activities and national production of blood derivatives of 21 October 2005 (Competenze del Ministero della salute) Art Entro nove mesi dalla data di entrata in vigore della presente legge, il Ministro della salute, con proprio decreto, predispone un progetto per l istituzione di una rete nazionale di banche per la conservazione di cordoni ombelicali ai fini di trapianto, nonché programmi annuali di sviluppo delle relative attività By a decree of the Minister of Health, a project for the institution of a national network of cord blood banks (CBBs) aimed at cord blood preservation for haematopoietic stem cells (HSC) transplantation is implemented; the project provides for annual plans of development of relevant activities
14 Art. 10 By a decree of the Minister of Health, the Italian Cord Blood Network (ITCBN) of cord blood banks (CBBs) has been instituted in 2009.
15 Law n. 219 New discipline of transfusion medicine activities and national production of blood derivatives of 21 October 2005 (Compiti del Centro nazionale sangue) 4. Il Centro nazionale sangue, nelle materie disciplinate dalla presente legge, svolge le funzioni di coordinamento e di controllo tecnico scientifico, di intesa con la Consulta. Art. 12 The National Blood Centre, entrusted with the coordination and technical and scientific control of all issues ruled by this law, coordinates the ITCBN.
16 Law n. 219 New discipline of transfusion medicine activities and national production of blood derivatives of 21 October 2005 Donazione di sangue, emocomponenti e cellule staminali emopoietiche) 1. Sono consentiti la donazione di sangue o di emocomponenti, nonché il prelievo di cellule staminali emopoietiche periferiche, a scopo di infusione per allotrapianto e per autotrapianto, e di cellule staminali emopoietiche da cordone ombelicale, all interno delle strutture trasfusionali autorizzate dalle regioni. Art. 3 Blood and blood components donation, peripheral HSC collection and CB collection, are allowed within the Blood Transfusion Services licensed by regional authorities.
17 Italian Cord Blood Network (ITCBN) 17/19 CBBs operate in Blood Establishments Milano Treviso Verona Torino Pavia Padova Bologna Genova Firenze Pisa Roma Pescara Napoli SG Rotondo Cagliari Sciacca Reggio Calabria
18 Centro Nazionale Sangue Banche di sangue di cordone ombelicale Report 2010 No. of CB units banked and released by Italian CBBs during Non Fam-rel Directed Auto listed at IBMDR Non Fam-rel Directed Auto 1,200 1,100 1, Total No. Banked Units HLA-typed Not yet typed Total No. Rel. Units
19 DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 has been transposed into: Decree n. 191 of 6 November 2007
20 «Tissue institute»: Decree n. 191 of 6 November 2007 (transposing Directive 2004/23/EC) Art. 2 (Definitions) a tissue bank a unit of a public hospital a blood establishment section another body no profit where activities of processing, preservation, storage and distribution of human tissues and cells are undertaken.
21 Decree n. 191 of 6 November 2007 (transposing Directive 2004/23/EC) Art. 6. Authorisation and accreditation of tissue establishments Tissue institutes must be authorized and accredited by the designated competent authorities that in Italy are the Regional Competent Authorities supported by the National Competent Authorities National Blood Centre (NBC) National Transplant Centre (NTC)
22 The Italian regulation of Cord Blood Banking AUTHORISATION REQUIREMENTS General requirements Organization Human resources Quality management ISO 9000 certification Technology requirements Information technology Specific requirements for the processing laboratory (premises and equipment) Management of cord blood collection centers Management of outsourced cryogenic services (where applicable)
23 The Italian regulation of Cord Blood Banking TECHNICAL & SCIENTIFIC STANDARDS (ITCBN COOPERATIVE WORKING GROUPS) Technical and scientific standards have been approved as mandatory for all Italian Cord Blood Banks
24 The Italian regulation of Cord Blood Banking ACCREDITATION PROCESS AND PROCEDURES MANAGED AT THE REGIONAL LEVEL, COMPLYING WITH SPECIFIC NATIONAL GUIDELINES AND ASSISTED BY THE NATIONAL COMPETENT AUTHORITIES Approved by State/Regions agreement
25 National Accreditation Guidelines for CBBs have been defined: according to the indications from the competent authorities (NBC, NTC) with the CBBs agreement focusing on quality requirements for CB banking actvities in compliance with most international standards shall be updated by the national competent authorities according to the evolution of science in the specific field
26 National HSC Search Centre IBMDR Sportello Unico per la ricerca di cellule staminali emopoietiche Government-Regions agreement on HSC search in Italy and abroad of 5 October 2006 Al Registro nazionale dei donatori di midollo osseo istituito dalla legge 6 marzo 2001, n. 52, presso l ente ospedaliero Ospedale Galliera di Genova, su richiesta delle strutture sanitarie che effettuano il trapianto di cellule staminali emopoietiche, è attribuita la funzione di ricerca di cellule staminali emopoietiche da cordone ombelicale presso le banche italiane ed estere, oltre all attività di ricerca dei donatori di midollo osseo presso i registri nazionali ed esteri prevista dalla citata legge n. 52/2001. The IBMDR (Italian Bone Marrow Donors Registry) is entrusted with the search for CB units in Italian and foreign CBBs, besides its activity of HSC donors search in national and foreign registries, following requests from healthcare organizations performing HSC transplantation.
27 The Italian Network of Cord Blood Banks - ITCBN Institutional framework Regional Blood Centres National Technical Blood Conference Blood Transfusion Centres National Blood Centre ITCBN National Co-ordination of ITCBN Ministry of Health National Institute of Health Hematology services hosting CBBs National Transplant Centre Cooperation with national Co-ordination of ITCBN Regional Transplant Centres Sportello Unico IBMDR HSC Transplantation Services
28 Italian Network of Cord Blood Banks System Governance National Transplant Centre Cooperation with national Coordination CBBsN National Blood Centre National Coordination of CBBs Network CBBs Conference Scientific Board HSC Transplantation Services Technical & Operative Co-ordinating Centre Sportello Unico IBMDR Cord Blood Banks
29 Italian Cord Blood Network designations, certifications, accreditations as of May 2011 Designations Certifications Accreditations 19 Cord Blood Banks YES Regional designation 18 1 ISO 9001 Certified 16 2 EFI/ASHI Accredited 15 3 NO NetCord-FACT accredited NetCord-FACT application
30 International standards and European regulation on cord blood banking The NetCord-FACT accreditation has become the gold standard of good quality in CB banking and a sort of priority flag in international HSC registries. Yet it must be considered that European member states have to sustain considerable commitment and guarantee significant resources in order to comply with the new EU requirements and lead their CB banks to national licensing/accreditation. Should any European CB bank seeking for best qualification and consequent optimization of its global market share run for the NetCord-FACT accreditation, beyond accomplishing the mandatory national licensing/accreditation process?
31 Comments - 1 Voluntary accreditation is considered an important opportunity for improving quality and standardization in CB banking. The overall quality of CB banks throughout the world is not well known. The new European provisions on tissues and cells may lead member states to implement institutional CB banking accreditation programs which include most internationally accepted standards and envisage that accreditation be guaranteed by national competent authorities as independent third parties.
32 Comments - 2 The new EU regulatory framework should hopefully lead to cooperation between European national competent authorities and voluntary accreditation agencies, with the aim to assess institutional requirements suitability on one side and voluntary standards [i.e. NetCord-FACT s] sustainability on the other side. Experimental cooperative programs could be hypothesized aimed at minimizing interpretative options and application variability inevitably affecting even the most vigorous and sound standards.
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