1. European Blood Alliance: mission, objectives, current activities 1 Gilles Folléa, MD, PhD

2. Brief presentation of EBA – Mission and scope, strategic objectives – Membership, structure – Current activities and projects Main achievements in 2011 Main projects for 2012 Discussion: potential benefits for / from Lithuania 2 Agenda

3. EBA missions and scope Blood and tissue supply – To contribute to the availability, quality, safety and cost-effectiveness of the blood and tissue supply for the citizens of Europe by developing and maintaining an efficient and strong collaboration amongst European blood and tissue services. Voluntary and non-remunerated donation – To increase public and professional awareness of voluntary and non-remunerated donation of blood and blood components as an indispensable therapeutic means to help patients. Performance – To assist European blood establishments to continuously improve their performance, based on scientific and ethical principles for the benefit of patients. 3

4. Performance –To improve performance through collaboration Regulatory affairs –To engage in regulatory affairs to promote best practice Networking –To facilitate information collection and knowledge exchange 4 EBA strategic objectives

5. EBA – an association of not for profit Blood Establishments Creation – Created in 1998 with 9 members: Be, UK, Fi, Fr, Irl, Lux, NL, Port, Scotl Current members – 21 EU members : Au, Be, Dk, Est, Fi, Fr, Ge, Hu, Irl, It, Lat, Lit, Lux, Mal, NL, Port, Rom, Slov, Sp, Swe, UK – 2 EEA members: Nor, Switz – 1 observer: ABC – 1 candidate member: Cr – 4 « dormant members »: Cyp, Gr, Icl, Cz Global partnership – ABO: with CBS, ABC, ARC, ARCBS and NHSBT – Alliance of Alliances: with ABC and Asia Pacific Blood Network 5 Membership

6. 13 12 8 24 27 21 14 26 1 11 3 24 9 10 2 17 25 6 24 15 7 16 19 18 5 1. Austria 2. Belgium - 2 operators 3. (Czech Republic 4.(Cyprus) 5. Denmark 6. Estonia 7. Finland 8. France 9. Germany - 2 operators 10. (Greece) 11. Hungary 12. (Iceland) 13. Ireland 14. Italy 15. Latvia 16. Lithuania 17. Luxembourg 18. Malta 19. The Netherlands 20. Norway 21. Portugal 22. Romania 23. Slovenia 24. Spain 25. Sweden 26. Switzerland 27. United Kingdom - 4 operators Population: 450 M Blood donations: 18 M 6 6

7. Executive Board: 6 board members (elected, meet 4 x per year) – President: Jeroen de Wit (Sanquin, the Netherlands) – Vice President: Philippe Vandekerckhove (Belgium, Red Cross Flanders) – Treasurer: Andy Kelly (Ireland, IBTS) – Secretary: Alex Aquilina (Malta BS) – Jørgen Georgsen (Denmark BS) – Erhard Seifried (Germany, German Red Cross BS) Board: all members (appointed, meets 2 x per year) – 2 seats and 1 vote per country Permanent staff: – 1 Executive Secretary (Willemijn Kramer, Amsterdam), – 1 Executive Director (Gilles Folléa, Brussels) Decision making: based on consensus Working language: English 7 Working structure

8. Mainly from members’ fees (calculated according to specific rules) Other sources (under discussion) Expenses (2011): 390 k€ Basic principle: to give the members value for money 8 Funding

9. Working groups / networks Emerging Infectious Disease Monitor Benchmarking Joint procurement (EPG – GPO) Collaborative validations Collaborative supplier audits Tissues and Cells Education and training VNRD vs paid donations (2012) EBA promoted EU funded projects SOP EUBIS EUOBUP DOMAINE 9 Current activities and projects to improve performance through collaboration

10. 1 st project that has brought regulators and manufacturers together to develop criteria and standards jointly. Two manuals – EUBIS Common criteria for the inspection of Blood Establishments – EUBIS Audit/inspection training guide Manuals and training sessions aimed to assist: – BE’s in need to optimise their quality system and self-inspection process/ EC directives – BE’s to prepare for regulatory inspections by CA’s – CA’s wishing to use the manual and training guide as a reference for implementation of EC legislation related to regulatory inspections 10 EU Blood Inspection Systems (EUBIS) http://www.eubis-europe.eu http://www.eubis-europe.eu

11. Manual aimed at promoting improvement in the quality of the clinical transfusion process, defined as “Transfusion of the right unit of blood to the right patient at the right time, and in the right condition and according to appropriate guidelines”. The manual contains information to: – Deliver QA of the clinical transfusion process – Promote best practice in blood transfusion – Comply with relevant EU directives 11 EU Optimal Blood Use Project http://www.optimalblooduse.eu http://www.optimalblooduse.eu

12. Objectives – Maintaining a safe and sufficient blood supply for the European community through effective donor management – Putting together individual experiences – Cooperation of BE’s to facilitate solutions – Translating knowledge and experience into ‘Good Donor Management’ Successive steps – Survey (2008) – Manual: presented at ISBT meeting 2010, accessible at http://www.domaine-europe.eu http://www.domaine-europe.eu – Training programme: first in 2011 – Workshop on donor selection in 2012 12 Donor Management in Europe (DOMAINE)

13. Bringing expertise to EU Directorate General of Health and Consumers (DG SANCO, EU regulator for health products): eg EC survey on VNRD, monitoring/surveying WNV outbreaks Presenting the information in a practical way to European Institutions, e.g. EUBIS, EUOBUP, DOMAINE manuals Influencing the preparation of the future EU Blood and Tissues Directives/regulations, eg EC guidance for next WNV outbreaks, VNRD vs paid donors (blood, T & C): EC, EU Parliamentarians Supporting the growing influence of the European Committee on Blood Transfusion of Council of Europe (CoE, 37 countries) on EC for future Blood regulations, eg chapter on Quality Assurance of the CoE Blood Guide, now only recommendations, will become binding in 2013 13 To engage in regulatory affairs to promote best practice: lobbying EU Institutions

14. Main Achievements 2011: networking more effective and visible (including ABC & ABO) EID Monitor: monitoring EIDs, sharing preventive measures, bringing expertise to members and regulators (monthly teleconferences: EBA + AU+CA+US) Member consultations: conclusive and discussed with Board (eg blood supply management, organisation in case of major disasters, donors’ RBC grouping/typing) On line tools: Basecamp (web based community tool), “Webinars” (web + tel conferences) Managed Convergence: Lisbon meeting on Apheresis Connector Safety with BEs (ABO), suppliers (Eucomed, Advamed), regulators (EC, FDA, AFSSaPS) 14

15. Initiated by ABO/ Advamed / Eucomed/ Edma : 2005 Objective: to streamline the movement of devices and diagnostics from product conception to regular sales across regulatory boundaries Beneficiaries of the Project –Patients: safer products being licensed quicker –BE’s: making safe healthcare provision more cost effective and thus potentially more readily available –Manufacturers: reducing cost of bringing a product to market –Regulators: helping to cut out redundant process and speed up safe healthcare provision 15 Managed convergence

16. Large scale implementation Collaborative Validation Collaborative work -Blood Establishments -Hospitals -Technology supplying Companies -Regulators Conception of innovative technologies to improve : -Blood safety -Blood use 16 Cooperating in the global blood supply chain: the “managed convergence”

17. Death of an apheresis donor (France, SEP 2009): human error (confusing AC and saline) but avoidable if specific connectors available. Misconnections: identified as a broader global problem since years Creation of a WG (chaired by EBA) gathering –Experts from BE’s (EBA) –Experts from suppliers (EUCOMED) –Representative from 1 CA (AFSSaPS) Elaboration of a harmonized solution for connectors of apheresis disposables to improve donor’s safety: implemented in France (2011) After the Lisbon meeting, a more sustainable solution (specific connector for AC) is currently built up by involved suppliers (Eucomed, Advamed) with ABO Members and: –1 st step: agreement of suppliers on common specifications (2012) –2 nd step: ISO standardisation (2014) 17 Apheresis connector safety: a constructive partnership (ABO – Suppliers – CA), a pilot for MC

18. Main Achievements 2011: improving member efficiency and lobbying New EBA rules to reinforce collaboration on agreed priorities (eg one Executive liaison for each WG) Benchmarking WG: –Workshop on processing –Flying Squad (experts in Lean) visits to Malta and Estonia Expertise brought to EC (DG SANCO) –Report on VNRD: corrections requested by EBA partly accepted (definition of VNRD) –Expertise brought by EID Monitor accepted: WNV survey 2010, WNV information sharing 2011 18

19. Main projects for 2012 (including ABC and ABO) Benchmarking Workshop on Donor selection (Feb) Joint purchasing: Eurobloodpack JP (2012-13), GPO EID Monitor: contribution to EC WNV 2012 preparedness and follow up ABO document on the value of Cell Therapy activities for Blood Establishments (Apr) Managed convergence (ABO): progressing on standardisation of aph. connectors, new subjects (eg dialogue between blood & MD vigilances), giving a home to MC Developing good practices of blood supply management (with CoE WG, ISBT WP, ABO Think Tank) Reformulating and updating evidence to promote VNRD (with CoE, ARCBS, EC, WHO, IPFA, FIODS) 19