European Blood Alliance: mission, objectives, current activities

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European Blood Alliance mission, objectives,
current activities
Gilles Folléa, MD, PhD
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Agenda

• 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

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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.

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EBA strategic objectives

• 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

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Membership

• 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

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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

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Working structure

• 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

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Funding

• 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

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Current activities and projects to improve
performance through collaboration

• Working groups / networks

• EBA promoted EU funded projects

• 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)

• SOP
• EUBIS
• EUOBUP
• DOMAINE

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EU Blood Inspection Systems (EUBIS)
http//www.eubis-europe.eu

• 1st 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
• BEs in need to optimise their quality system and
  self-inspection
• process/ EC directives
• BEs to prepare for regulatory inspections by
  CAs
• CAs wishing to use the manual and training guide
  as a reference for implementation of EC
  legislation related to regulatory inspections

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EU Optimal Blood Use Projecthttp//www.optimalblo
oduse.eu

• 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

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Donor Management in Europe (DOMAINE)

• Objectives
• Maintaining a safe and sufficient blood supply
  for the European community through effective
  donor management
• Putting together individual experiences
• Cooperation of BEs 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
• Training programme first in 2011
• Workshop on donor selection in 2012

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To engage in regulatory affairs to promote best
practice lobbying EU Institutions

• 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

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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
  AUCAUS)
• 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)

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Managed convergence

• 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
• BEs 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

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Cooperating in the global blood supply chain
the managed convergence

• Collaborative work
• Blood Establishments
• Hospitals
• Technology supplying Companies
• Regulators

Large scale implementation

• Conception of innovative technologies to improve
  
• Blood safety
• Blood use

Collaborative Validation
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Apheresis connector safety a constructive
partnership (ABO Suppliers CA), a pilot for
MC

• 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 BEs (EBA)
• Experts from suppliers (EUCOMED)
• Representative from 1 CA (AFSSaPS)
• Elaboration of a harmonized solution for
  connectors of apheresis disposables to improve
  donors 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
• 1st step agreement of suppliers on common
  specifications (2012)
• 2nd step ISO standardisation (2014)

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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

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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)