Recommended Legislative Framework for a National Blood Policy and Blood System

Blood transfusion contributes to saving millions of lives every year, improves Life expectancy and the quality of life of patients suffering from life-threatening conditions, and supports complex medical and surgical procedures.

To meet the needs of all patients every country should put in place policies, a legislative framework, systems and structures to ensure the safety, quality, accessibility and timely availability of blood and blood products. However, there are numerous situations, particularly in the less developed world, where these prerequisites have barely been implemented.

A literature search (PubMed, ResearchGate, Google Scholar) was done on matching combinations of legislation, regulation, and legislation framework, with blood and blood transfusion, which resulted in almost exclusively references with respect to national and international legislation in advanced countries.

Ministries of Health (MoH) should provide effective leadership and governance

in developing a healthcare-integrated national blood system.

To ensure an adequate supply of blood and blood products and safe clinical transfusion practice essential functions of a national blood system should include policy formulation, a legislative framework spelling out the principles and boundaries; standard setting; strategic and operational planning; provision of resources and national coordination and management.

The structure of the national blood system will depend on the organization and level of development of the healthcare system. However, all critical activities within a national blood system should be coordinated nationally to promote: uniform standards; economies-of-scale; consistency in the quality and safety of blood and blood products and best transfusion practices. Key are: Formulation and oversight of the implementation of the national blood policy and strategic plan; defining the roles, responsibilities and accountability of institutions and; setting national standards for blood and blood products, services; processes and systems; defining requirements for the registration, licensing and operation.