Safety and Quality of Human Blood Products and Human Blood Derivatives in an Enlarged European Union

1. 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 HealthFederal Ministry of Health and Women Reinhart Waneck

2. Our Common Goal: Access to Safe and Reliable Blood and Blood Product Supply Reinhart Waneck

3. Donor Screening Donor Testing Viral removal/ inactivation Quarantine Product release Prinicples of Collection and Manufacturing Process Reinhart Waneck

4. 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 Reinhart Waneck

5. Federal Ministry of Health and Women Reinhart Waneck

6. Tasks Import Blood Products Marketing Authorisation Biologicals Batch Release Authority Inspection Biologicals Reinhart Waneck

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

8. History Before 1975 Donors died during plasmapheresis • reasons • manual plasmapheresis • mix up of retransfused blood • defect plasmapheresis machines Recipients died from infections Reinhart Waneck

9. 1975 Austria was co- founder of PIC • Control of Pharmaceutical Companies • Exchange of Information • Introduction of EFTA- Standards Reinhart Waneck

10. Original Goals of PIC • Harmonised GMP requirements • Mutual recognition of inspections • Uniform inspection systems • Training of Inspectors • Mutual confidence Reinhart Waneck

11. 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 Reinhart Waneck

12. 1975 Plasmapheresis Act 1978 Plasmapheresis Ordinance • Detailed SOP for plasmapheresis • Donor suitability criteria Reinhart Waneck

13. 1984 • Austrian Medicines Act  Blood is a medicinal product • Plasma Fractionators • inspected & licensed Reinhart Waneck

14. 1991 Blood banks • inspected & licensed 1992 Hospital Blood Depots • inspected - not licensed • optimal use of blood Reinhart Waneck

15. 1993 • Guidelines on blood group serology & transfusion medicine 1994 • Specialist for blood group serology & transfusion medicine Reinhart Waneck

16. Preparation for joining EU 1995 EU standards implemented Reinhart Waneck

17. Medicinal Products Import Act, §7 Blood Products Application Plasma Intermediate Plasma Derivate Import permit Import permit Plasma Master File and Batch Release Plasma Master File Certificate Certificate Reinhart Waneck

18. Batch Release Market Authorisation Import PMF Import Inspection Hemovigilance Reinhart Waneck

19. Import of blood products1988 - 2003 • Medical Products Import Act • Inspection Agreements & Exchange of information Reinhart Waneck

20. New Understanding for the Need ofProduct Quality • International standards for Donor Screening • Harmonization? • Different epidemiology Reinhart Waneck

21. 1999 Blood Safety Act HCV NAT: each donation for transfusion HIV & HBV NAT voluntarily Reinhart Waneck

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

23. 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 Directive 2002/98/EC Reinhart Waneck

24. encouragement of voluntary & unpaid blood donations The main Concern: Reinhart Waneck

25. Safety Measureswithin the Directive 2002/98/EC • Privacy at donor interview • Validated virus inactivation • Load of infectious agents • Look back • Traceability Reinhart Waneck

26. No Brokers!!! • Direct sale • Direct shipment • Inspection by buyer • Import & Export control • Data exchange - Rapid Alert ! Reinhart Waneck

27. Trade Issues One product quality! • Local epidemiology • Traceability • Optimal use • Harmonized licensing criteria • Harmonized inspection criteria Reinhart Waneck

28. Self Sufficiency • 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? Reinhart Waneck

29. Remuneration • 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? Reinhart Waneck

30. Lessons Learned • 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 Reinhart Waneck

31. Thank youfor your (donation)attention! Reinhart Waneck