Bringing a country into compliance with standards and regulations

1
Bringing a country into compliance with standards
and regulations

• Denmark

Jørgen Georgsen, M.D. County of Funen Transfusion
Service Odense University Hospital Denmark
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Basic numbers

• Public tax-paid health care system (gt98 )
• Run by 15 counties and a capital area(from
  January 2007 5 regions)
• Population 5.4 mill.
• gt230,000 regular donors
• Approx. 370,000 collections per year (stable
  since 1991)

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RBC transfused 1994-2003
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Basic numbers, cont.

• Transfusion medicine medical specialty since
  1966(blood group serology ? clinical immunology)
  
• 33 medical specialist positions
• 23 training positions
• Danish Society for Clinical Immunology (since
  1970)
• Standing Committee on Transfusion Medicine

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Organization of Transfusion Medicine

• 1980ies
• gt70 hospital blood banks(collecting, processing,
  most also testing)
• 2005
• 16 county blood establishmentsall hospital based
• 2007
• 5 regional blood/stem cells/tissue
  establishments? Still hospital based!

6
Historical perspective

• 1965
• Board of Blood Transfusion of the Ministry of
  Interior (Professor Erik Freiesleben)Blood
  Transfusion GuidelinesVol. 1 Blood Grouping
  CrossmatchingVol. 2 Blood Collection
  Transfusion
• 1975
• Law of pharmaceutical products comprises plasma
  and other blood components

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Historical perspective, cont.

• 1979
• Licensing of blood banks by authorities
• Responsible person
• Inspections by authorities every 2 to 3 years
• 1986
• Council of EuropeQuality Control in Blood
  Transfusion Services
• 1992
• Guide to the preparation, use and quality
  assurance of blood components, 1st ed. (2005 11th
  ed.)
• 1993
• Danish Medicines AgencyGuidelines for GMP for
  blood bank production and distribution of blood
  and blood components

8
Historical perspective, cont.

• 1994
• Danish Society for Clinical ImmunologyStandards
  for Transfusion Medicine(gt300 pages, 9th version
  2004)
• 1997
• First Danish blood law protecting
  self-sufficiency and national production of
  plasma derivatives at SSIstating donors have to
  be unpaidstating only public hospitals may
  collect blood
• 1998
• Council of Europes Guide incorporated in the
  Danish Pharmacopoeia, thereby becoming law

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Implementation of EU directives

• Revision of the blood law
• 1 page frame lawDanish translation of directives
  2002/98/EC and 2004/33/EC as attachments
• 3 government ordersone from the ministry
  regarding license procedures and registers, two
  from the Danish Medicines Agency regarding
  responsible person and requirements for blood and
  blood components and hemovigilance respectively

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Implementation in practice
11
Implementation in practice, cont.
12
Implementation in practice, cont.
13
Implementation in practice, cont.
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Implementation in practice, cont.

• Directive on technical requirements for blood and
  blood components
• More or less identical to CoEs Guide But
• More information to be provided to donors
• Eligibility criteria change all the time
• Specification of blood components change

15
Implementation in practice, cont.

• Directive on quality system
• Minor modifications from GMP quality system

16
Implementation in practice, cont.

• Directive on traceability and hemovigilance
• No changes regarding traceability
• Hemovigilance changes from voluntary system run
  by peers to official system

17
Conclusions re EU directives

• Do I think that the EU directives will result in
  safer blood transfusion in Denmark?
• No
• Will the changes be cost-neutral?
• No
• Who will pay?
• Tax payers ( patients)
• What could have be achieved instead?
• Electronic identification of patients!