1. European Health Forum 2003Reinhart Waneck1 Safety and Quality of Human Blood Products and Human Blood Derivatives in an Enlarged European Union The experience of an EU- Member State Prof. Reinhart Waneck, M.D. Secretary of Health Federal Ministry of Health and Women

2. European Health Forum 2003Reinhart Waneck2 Our Common Goal: Access to Safe and Reliable Blood and Blood Product Supply Our Common Goal: Access to Safe and Reliable Blood and Blood Product Supply

3. European Health Forum 2003Reinhart Waneck3 Donor Screening Donor Testing Viral removal/ inactivation Quarantine Product release Prinicples of Collection and Manufacturing Process

4. European Health Forum 2003Reinhart Waneck4 Programme  MoH  Organisation  Law  Enforcement  Blood Act  Development  PIC/S  Pharmaceutical Inspection Co-operation Scheme  EU Blood Directives  main concerns  Blood products safety  general aspects  Self-Sufficiency and Remuneration

5. European Health Forum 2003Reinhart Waneck5 Federal Ministry of Health and Women

6. European Health Forum 2003Reinhart Waneck6 Tasks Import Blood Products Marketing Authorisation Biologicals Batch Release Authority Inspection Biologicals

7. European Health Forum 2003Reinhart Waneck7 „Blood“ Premises in Austria 3 Fractionators 13 Whole Salers 12 Blood Banks 14 Plasmacenters 326 Hospitals 2 BCE AMG BSG AMG KAG

8. European Health Forum 2003Reinhart Waneck8 History Before 1975 Donors died during plasmapheresis  reasons —manual plasmapheresis —mix up of retransfused blood —defect plasmapheresis machines Recipients died from infections

9. European Health Forum 2003Reinhart Waneck9 1975 Austria was co- founder of PIC  Control of Pharmaceutical Companies  Exchange of Information  Introduction of EFTA- Standards

10. European Health Forum 2003Reinhart Waneck10 Original Goals of PIC  Harmonised GMP requirements  Mutual recognition of inspections —Uniform inspection systems —Training of Inspectors —Mutual confidence

11. European Health Forum 2003Reinhart Waneck11 PIC/S Members (26 in 2003) AUSTRIA, AUSTRALIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LIECHTENSTEIN, MALAYSIA, NETHERLANDS, NORWAY, PORTUGAL, ROMANIA, SINGAPORE, SLOVAK REPUBLIC, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM

12. European Health Forum 2003Reinhart Waneck12 1975 Plasmapheresis Act 1978 Plasmapheresis Ordinance  Detailed SOP for plasmapheresis  Donor suitability criteria

13. European Health Forum 2003Reinhart Waneck13 1984  Austrian Medicines Act   Blood is a medicinal product  Plasma Fractionators —inspected & licensed

14. European Health Forum 2003Reinhart Waneck14 1991 Blood banks — inspected & licensed 1992 Hospital Blood Depots — inspected - not licensed — optimal use of blood

15. European Health Forum 2003Reinhart Waneck15 1993 — Guidelines on blood group serology & transfusion medicine 1994 — Specialist for blood group serology & transfusion medicine

16. European Health Forum 2003Reinhart Waneck16 Preparation for joining EU 1995 EU standards implemented

17. European Health Forum 2003Reinhart Waneck17 Medicinal Products Import Act, §7 Blood Products Application Plasma Intermediate Plasma Derivate Import permit Certificate Plasma Master File Certificate Plasma Master File and Batch Release

18. European Health Forum 2003Reinhart Waneck18 Market Authorisation Batch Release Import PMF Inspection Hemovigilance

19. European Health Forum 2003Reinhart Waneck19 Import of blood products 1988 - 2003  Medical Products Import Act  Inspection Agreements & Exchange of information

20. European Health Forum 2003Reinhart Waneck20 New Understanding for the Need of Product Quality  International standards for Donor Screening  Harmonization?  Different epidemiology

21. European Health Forum 2003Reinhart Waneck21 1999 Blood Safety Act HCV NAT: each donation for transfusion HIV & HBV NAT voluntarily

22. European Health Forum 2003Reinhart Waneck22 Article 152(4)(a) of the Amsterdam Treaty The Amsterdam Treaty will enter into force on May 1st 1999, the 15 EU Member States having completed their ratification procedures on 30 March. This will have a fourfold legal impact on current legislative proposals: 1.- The Treaty Articles...

23. European Health Forum 2003Reinhart Waneck23 Directive 2002/98/EC European Parliament & Council setting standards of quality and safety for Collection/ Testing/ Processing/ Storage/ Distribution of human blood and blood components amending Council Directive 89/381/EC

24. European Health Forum 2003Reinhart Waneck24 The main Concern: encouragement of voluntary & unpaid blood donations

25. European Health Forum 2003Reinhart Waneck25 Safety Measures within the Directive 2002/98/EC  Privacy at donor interview  Validated virus inactivation  Load of infectious agents  Look back  Traceability

26. European Health Forum 2003Reinhart Waneck26 No Brokers!!!  Direct sale  Direct shipment  Inspection by buyer  Import & Export control  Data exchange - Rapid Alert !

27. European Health Forum 2003Reinhart Waneck27 Trade Issues One product quality!  Local epidemiology  Traceability  Optimal use  Harmonized licensing criteria  Harmonized inspection criteria

28. European Health Forum 2003Reinhart Waneck28  The desire of a domestic blood source  Improvement of a safe supply  Patients’ and physicians’ right for supply with high quality and safe products  But:  Reduction of innovation, quality and safety?  Negative effect on patients’ access to care?  Increased costs? Self Sufficiency

29. European Health Forum 2003Reinhart Waneck29  Is there evidence of different viral safety between compensated and non- compensated donors?  Is there enough plasma from non- compensated donors available?  Would supply problems and product shortages occur, if there is a requirement only for non-compensated donors? Remuneration

30. European Health Forum 2003Reinhart Waneck30  We have to continue communicating with science, industry and patient organizations;  All Stakeholders – government as well as industry, physicians and patients – must continue, and probably intensify to work together Lessons Learned

31. European Health Forum 2003Reinhart Waneck31 Thank you Thank you for your (donation) attention!