The new Japanese blood law: its impact on blood safety and usage

Abstract: The New Blood Law and the amendments of the Pharmaceutical Affairs Law were enforced in 2003 for the purpose of securing a stable supply of blood based on domestic voluntary donations and promoting the appropriate use. The safety of blood has been increased dramatically by various safety measures. Adverse reactions/infections reports and nationwide look back studies showed the remaining risk of screening test-negtive, ID-NAT-positive blood transfusion: HBV 1: 130 x 10(3), HCV 1: 22 million, HIV 1 : 11 million. Eight items of safety measures were announced by JRC in 2003 and are being achieved. Implementation of further safety measures requires public understanding and support. Supply of blood has been decreasing owing to the guidelines for appropriate use of blood, the mandated informed consent for transfusion and the enforcement of the Laws. However, additional safety measures and the rapid progress into highly aging society necessitate an expansion of the donor pool, especially among young generations. Public understanding and close collaboration among stakeholders are necessary to achieve what the new laws ask.