Advisory Group for Blood Regulation, Availability and Safety
WHO has established an Advisory Group for Blood Regulation, Availability and Safety in 2020, in order to supports technical advisory functions of the WHO blood products programme and scale up the implementation of WHO policies and strategies to strengthen blood systems, and advance universal access to safe, effective and quality-assured blood products in the world.

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Original background and mission

Blood products, including whole blood and other blood components for transfusion, and plasma-derived medicinal products (PDMPs) play a critical role in health care and are fundamental for achieving universal health coverage. Safe, effective, and quality-assured blood products contribute to improving and saving millions of lives every year.  To ensure access to safe, effective, and quality-assured blood products, a functioning national blood system is required.

Since 1975, the World Health Assembly has highlighted the global need for blood safety and availability through the adoption of several resolutions that have given greater priority to the issue within global and national health agendas. However, progress in blood regulation and availability has been slow in many parts of the world. A major imbalance exists between higher-income and lower-income countries in access to safe, effective, and quality-assured blood products.  For that reason, the WHO Action Framework to advance universal access to safe, effective, and quality-assured blood products 2020–2023 was developed. The framework gathers recommendations on the WHO programs on the quality of blood products and blood transfusion safety and WHO partners’ global efforts to address present barriers to the safety and availability of blood products.  It aims to provide a unified global strategic direction to ensure access to safe blood products worldwide.

To this effect, it is proposed that the Advisory Group for Blood Regulation, Availability, and Safety support technical advisory functions of the WHO blood products program and scale up the implementation of WHO policies and strategies to strengthen blood systems and advance universal access to safe, effective and quality-assured blood products in the world. 

Since its formation in June 2020, the group has been engaged in the following activities:

  • Review of WHO documents repository related to blood 
  • Compliance check of AABB-Fundamental Standard for blood collection and transfusion with WHO-Guideline on Good Manufacturing Practice for Blood Establishment
  • Development of a strategy for dissemination and promotion of WHO documents including Global Benchmarking Tool (GBT) + Blood
  • Harmonization of definitions/terminology in the area of blood
  • Database to provide information on availability of blood supply during emergencies 
  • The collection and use of Convalescent Plasma and hyperimmune immunoglobulins inresponse to the SARS-CoV2 virus
  • Updating the WHO Guidance on Good Manufacturing Practice for Blood Establishment
  • Support in identification of essential collaborative partners in the area of blood
  • Development of a Policy Consideration on CRoss-Border Transfer of Domestic Plasma to Obtain Plasma-Derived Medicinal Products

Terms of Reference

In its capacity as an advisory body to WHO, the Advisory Group shall have the following functions:

  1. To advise on the development of WHO norms, standards, technical guidelines and high-level strategic recommendations on ensuring safety, quality and availability of blood products.  

  2. To advise on scaling up the implementation of existing WHO policies, strategies, including innovative strategies and tailored approaches; as well as strengthening the national systems for blood supply and regulation to achieve the goal of universal access to safe, effective and quality assured blood products.

  3. To provide scientific assessment of current and emerging threats to the safety and availability of blood and blood products; advise on the recommended measures and actions to be taken by the Member States in preparedness for and in response to the emerging public health threats.