Diminished amounts of viable plasma, tighter viral screening and a 20-year ban on blood product imports reduced clotting factor supply to such a degree in China that the health of thousands of hemophilia patients was in danger. The Beijing News reported on September 14, 2007, that since July some patient deaths have been attributed to an inability to procure necessary, plasma-derived factor VIII (FVIII) product. In response, the Chinese government and several consumer support networks of hemophilia patients took steps to relieve the shortage.
Chinese government efforts to improve blood safety, particularly to prevent the spread of HIV and hepatitis C (HCV) infections, have had unintended effects. In 1986, the government banned imported plasma-derived factor products in response to fear of HIV contamination. The supply issue was exacerbated further in 2004 when health officials closed smaller blood collection centers, decreased the volume of plasma allocated for factor and instituted mandatory, pre-fractionation screening of plasma for HIV and HCV.
China has only three pharmaceutical companies now making the product. Although it has the facilities for fractionation, it cannot supply the necessary plasma. Many of the country’s hemophilia patients, their doctors and even large hospitals are now scrambling to find product. However, prior to the shortage nearly 75% of hemophilia patients in the country were unable to receive treatments because of their prohibitively high cost.
The Health Ministry has promised to earmark more plasma for the manufacture of clotting factor. In addition, the Asia Pacific division of Bayer HealthCare has agreed to sell recombinant factor VIII (rFVIII)--exempt from the ban as a nonplasma-derived product--to China at a discounted rate.
The Chinese government was quick to remind the public that the 1986 ban is still in place. “This does not mean that we are easing the two-decade ban on imported blood and plasma-derived products of all kinds,” said Yan Jiangying, spokeswoman for the State Food and Drug Administration.
Bayer HealthCare has donated additional rFVIII to six Chinese hospitals. The donated product, enough to treat approximately 650 patients, was shipped from the U.S. to China in late September.
China’s hemophilia community has also taken action in response to the emergency. Through mutual support networks and the Internet, people with hemophilia are connecting with those in critical need of factor and are “lending” product to them. In addition, a dozen hemophilia support groups-turned-advocates submitted a joint letter to President Hu Jintao and Premier Wen Jiabao to request immediate action. It read: “We appeal to the government to take urgent action to import large amounts of factor VIII from abroad and save the lives of Chinese hemophilia sufferers.”
Sources: The Washington Post (online), September 14, 2007 and China Daily (online), September 20, 2007