The World Health Assembly Resolution on availability, safety and quality of blood products (WHA 63.12) Adopted May 2010

Transcription

1 The World Health Assembly Resolution on availability, safety and quality of blood products (WHA 63.12) Adopted May 2010 Dr Ana Padilla Blood Products & related Biologicals Essential Medicines and Pharmaceutical Policies Department Health Services and Systems Cluster World Health Organization

2 WHO Achilles project: The World Health Assembly 193 Expected Member Outcomes States The World Health Assembly (WHA) the Supreme decision-making body for WHO Main function is to determine the policies of the Organization The WHA expresses itself in Resolutions WHA 63.12: Availability, safety and quality of blood products Recalls previous resolutions: need to strengthen blood establishments Measures to improve/upgrade quality and safety of plasma Need for implementation of blood products regulations 2 HSS/EMP/QSM: ICDRA2010

3 WHA63.12: "Blood Products" definition "Any therapeutic substances derived from human blood, including whole blood, labile blood components and plasma-derived medicinal products" 3 HSS/EMP/QSM: ICDRA2010

4 WHA 63.12: WHO Model List of Essential Medicines Human plasma derived medicinal products Plasma for Fractionation Blood Coagulation Factors: FVIII, PCC Human Normal Immunoglobulin (IV and IM) Anti-D immunoglobulin Anti-tetanus immunoglobulin 4 HSS/EMP/QSM: ICDRA2010 Blood-derived medicinal products for the treatment of haemophilia and immune diseases are included in the WHO Model List of Essential Medicines:

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6 WHA 63.12: Availability, quality and safety of blood products 1. URGES Member States: 1. (2) to take all the necessary steps to update their national regulations on donor assessment and deferral, the collection, testing, processing, storage, transportation and use of blood products, and operation of regulatory authorities in order to ensure that regulatory control in the area of quality and safety of blood products across the entire transfusion chain meets internationally recognized standards; 6 HSS/EMP/QSM: ICDRA2010

7 WHA 63.12: Availability, quality and safety of blood products 2. REQUESTS the Director-General: 2. (1) to guide Member States to meet internationally recognized standards in updating their legislation, national standards and regulations for effective control of the quality and safety of blood products and associated medical devices, including in vitro diagnostics; 7 HSS/EMP/QSM: ICDRA2010

8 WHA 63.12: Availability, quality and safety of blood products 2. REQUESTS the Director-General: 2. (3) to augment the support offered to Member States for developing and strengthening their national regulatory authorities and control laboratories so as to increase their competence in the control of blood products and associated medical devices, including in vitro diagnostic devices, and to foster the creation of regional collaborative and regulatory networks where necessary and appropriate; 8 HSS/EMP/QSM: ICDRA2010

9 The Achilles project WHO guidance to NRAs What do we have? WHO Guidelines for production, control and regulation of plasma for fractionation WHO Guidelines for Good Manufacturing Practices for Blood Establishments WHO Guidelines on Viral Inactivation and Removal procedures Assessment criteria for national blood regulatory systems Biological reference materials (Standards and Reference Panels) for: quality control of blood products and of quality control of blood safety related in vitro biological diagnostic devices 9 HSS/EMP/QSM: ICDRA2010

10 The WHA Resolution WHO Achilles and WHO project: Achilles Project Expected Outcomes Expected outcomes Optimal use and benefit from donated blood and plasma Use of local plasma to improve supply of blood products Increased availability of blood/plasma derived essential medicines Independent regulatory systems for blood products established 10 HSS/EMP/QSM: ICDRA2010

11 Relevant Web site Web addresses site addresses HSS/EMP/QSM: ICDRA2010

12 ACKNOWLEDGEMENTS WHO Expert Committee on Biological Standardization: Blood Products and in vitro diagnostic Track WHO Blood Regulators Network WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices and WHO Collaborating Centres for Biological Standards and Standardization International scientific and professional societies 12 HSS/EMP/QSM: ICDRA2010

13 Blood as Source of Life-Saving Medicines Blood for transfusion Whole blood collected into containers, anticoagulant to prevent clotting, cold chain Blood components, obtained from whole blood by separation (centrifuge or apheresis): Red blood cells: Oxygen transport Platelets: Hemostasis (preventing bleeding) Plasma: clotting factors, immunoglobulins etc. Cryoprecipitate 13 HSS/EMP/QSM: ICDRA2010 Blood Plasma derived Medicines Plasma for "fractionation, further purification of plasma proteins, e.g. Blood Coagulation Factors, e.g. Factor VIII for treatment of hemophilia A Specific Immunoglobulins, e.g. anti-hepatitis B, anti-rabies, anti-tetanus, anti-d IM and IV normal IgG Albumin, involved in the regulation of body fluids, used for resuscitation Blood-derived medicinal products for the treatment of haemophilia and immune diseases are included in the WHO Model List of Essential Medicines