European Health Forum 2003Reinhart Waneck1 Safety and Quality of Human Blood Products and Human...

European Health Forum 2003 Reinhart Waneck 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


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


Donor Screening

Donor Testing

Viral removal/ inactivation

Quarantine

Product release

Prinicples of Collection and Manufacturing Process


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


Federal Ministry of Health and Women

Prof.Reinhart W aneck, M .D .Secretary of S tate

for H ealth

Group BLegal AffairsDr. P ietsch

Dept 4B iologica ls/ Inspections

Dr Kurz

Group AMedical Affairs

Prof.Schlögel, M .D .

Section IIIHealth Affairs

Hubert Hrabcik, M .D .Chief Medical O fficer

Federal M inisterMrs. M aria R auch-Kalla t


Tasks

Import Blood Products

Marketing Authorisation Biologicals

Batch Release Authority

Inspection Biologicals


„Blood“ Premises in Austria

3 Fractionators13 Whole Salers

12 Blood Banks14 Plasmacenters

326 Hospitals 2 BCEAMG

AMG

BSG

BSG

AMG

KAG


History

Before 1975 Donors died during plasmapheresis reasons

—manual plasmapheresis—mix up of retransfused blood—defect plasmapheresis machines

Recipients died from infections


1975

Austria was co- founder of PIC

Control of Pharmaceutical Companies

Exchange of Information Introduction of EFTA- Standards


Original Goals of PIC

Harmonised GMP requirements Mutual recognition of

inspections—Uniform inspection systems—Training of Inspectors—Mutual confidence


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


1975Plasmapheresis Act

1978Plasmapheresis Ordinance Detailed SOP for

plasmapheresis Donor suitability criteria


1984

Austrian Medicines Act

Blood is a medicinal product Plasma Fractionators

—inspected & licensed


1991

Blood banks

— inspected & licensed

1992

Hospital Blood Depots— inspected - not licensed— optimal use of blood


1993 — Guidelines on blood group serology & transfusion medicine

1994 — Specialist for blood groupserology & transfusion medicine


Preparation for joining EUPreparation for joining EU

1995 EU standards implemented


Medicinal Products Import Act, §7 Blood Products

Application

PlasmaIntermediate

Plasma Derivate

Import permitImport permit

Certificate

Plasma Master File

Certificate

Plasma Master Fileand Batch Release


MarketAuthorisation

Batch Release

Import

ImportPMF

InspectionHemovigilance


Import of blood products

1988 - 2003

Medical Products Import Act Inspection Agreements &

Exchange of information


New Understanding for the Need of Product Quality

International standards for Donor Screening

Harmonization? Different epidemiology


1999

Blood Safety ActBlood Safety ActHCV NAT: each donation for transfusion

HIV & HBV NAT voluntarily


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 ...


Directive 2002/98/EC

European Parliament & Council setting standards of quality and safety for

Collection/ Testing/ Processing/Storage/ Distribution

of human blood and blood componentsamending Council Directive 89/381/EC


The main Concern:

encouragement of

voluntary & unpaid blood donations


Safety Measures within the Directive 2002/98/EC

Privacy at donor interview Validated virus inactivation Load of infectious agents Look back Traceability


No Brokers!!!

Direct sale Direct shipment Inspection by buyer Import & Export control Data exchange - Rapid Alert !


Trade Issues

One product quality!

Local epidemiology Traceability Optimal use Harmonized licensing criteria Harmonized inspection criteria


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


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


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


Thank Thank youyou

for your

(donation)

attention!

European Health Forum 2003Reinhart Waneck1 Safety and Quality of Human Blood Products and Human...

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