Blood and Plasma Regulations – Towards a revision of the EU Blood Directive:
What is needed in a new Directive / Should Plasma be included in the Blood directive ?


PLUS Consensus Conference 2016 Intercontinental Hotel, Estoril Portugal
14-15 January 2016

Key strategic areas/topics

• Increasing plasma collection in the European Union to ensure the availability of PDMPs

– Maximize use of recovered plasma – Increased use of plasmapheresis

• Need to focus on availability of treatments for patients


Key strategic areas/topics

  • New scope? Quality, safety and supply
  • Need for better clarification between blood collection/labile blood products and plasma collection/PDMPs
  • Need for clear and precise definitions:
    • –  Blood
    • –  Bloodcomponents
    • –  Plasma
    • –  Plasmafortransfusion
    • –  Plasma for further manufacturing
    • –  Voluntary, voluntary unpaid, self-sufficiency, sufficiency, compensation, remuneration

Key strategic areas/topics

  • Perspectives of patients, healthcare professionals, donors should be pro-actively considered in drafting the directive
  • Involvement of all key stakeholders in drafting the directive
  • Implications of directive for movement of plasma internationally (for internal consideration)

Key strategic areas/topics

  • Patient and donor health & safety
  • Need to update technical directives


Key principles summary-11 Key principles summary-7 Key principles summary-9


EU Blood Directive and Plasma

IFBDO view-point


  • The EU Directives covers patient and donor safety related to components and products from human blood– Including plasma whether it is recovered or source
  • When the source material is human blood, thereis always a donor behind
    – No donors means no plasma
  • We remain dependant on donors to secure blood components and products to treat and improve the life of patients, and there must be an obligation not to harm the donors


• The Donors main interest is to help the patients

– In a society with general awareness and information of the need for donors, together with a good recruitment program, donors will inlist

• IFBDO has member countries in all parts of the world, and work to recruit donors

• For IFBDO it is also important to safeguard the donors


• Donors are interested in staying healthy but relies on the blood centre staff to protect them from harm

– Needle injury
– Fainting
– Low protein levels
– Low Immunoglobulin levels
– Waste of the donated product – exploitation


  • IFBDO/FIODS supports that the EU Directive continue to cover all blood components and products
  • An update could take advantage of recent research and increase the part on donor health and safety
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