Strengthening Blood Systems and Regulations

The provision of an adequate supply of safe blood and blood products, and their safe and rational use is the responsibility of government and should be an integral part of each country's national health care policy and infrastructure. The ministry of health should establish a sustainable national blood system which is recognized through a national blood policy and supported by appropriate legal instruments. 

The structure of the national blood system will depend on the organization and level of development of the health-care system. Whichever organizational structure is in place in a country,  all critical activities within a national blood system should be coordinated at national level to promote uniform standards, economies of scale, consistency in the quality and safety of blood and blood products and best transfusion practices. Whereas it is possible, critical activities such as blood screening and processing should be consolidated in strategic locations.

The Ministries of Health should ensure that adequate, sustainable financing for the national blood system is integrated within the financial structure of the health system through mechanisms such as a specific budget, cost-recovery and health insurance or a combination of these. Ministries of Health should build resilience into their national blood systems which have the capabilities and capacities to respond to the surge of blood demand during emergencies or other emerging threats to the safety and availability of blood and blood products

Effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes. Inefficient regulatory systems can be a barrier to access to safe, effective and quality medical products. The Global Benchmarking Tool (GBT) represents the primary means by which the World Health Organization objectively evaluates regulatory systems, as mandated by WHA Resolution 67.20 on Regulatory System Strengthening for medical products. To evaluate national regulatory systems of blood products including whole blood, blood components and plasma derived products, the GBT Plus Blood has been developed.