New legislation in Japan will require the government and manufacturers of hepatitis C-contaminated blood products to compensate those infected with the virus years ago. The manufacturers of the contaminated products are expected to jointly administer a compensation fund with the government. The law, which was enacted by the Japanese Parliament on December 28, 2007, was followed by a statement from Yasuo Fukuda, Japanese Prime Minister.
“We must frankly admit the state’s responsibility for causing huge harm to the victims and for failing to prevent the harm from spreading,” said Fukuda. “I express my apologies from my heart.”
Momentum had been building in favor of the law as a group of approximately 200 HCV patients had brought multiple successful suits to several district courts during the past five years. The plaintiffs claim that the government’s failure to properly regulate blood products from the 1970s to early 1990s demonstrated clear negligence, resulting in as many as 10,000 HCV infections. Some Japanese media outlets report an even higher number--upwards of two million people infected. According to the Health Ministry, approximately 1,000 individuals are eligible to file a claim. They will receive $109,450-$365,000, depending on how severely they were affected.
“Our five-year battle was finally rewarded,” said Michiko Yamaguchi, leader of the plaintiffs nationwide.
The case for government culpability was made stronger in light of events abroad. In 1977, a plasma-derived fibrinogen concentrate lost U.S. Food and Drug Administration approval after it became clear that the product could transmit HCV. Nonetheless, the Japanese government continued to approve the product long after the U.S. ban. Fibrinogen and other plasma products were commonly used in the 1970s by Japanese obstetricians, gynecologists and surgeons to treat hemophilia or simply stop hemorrhaging during childbirth or surgeries.
Several pharmaceutical companies also share a significant responsibility for failure to use viral-inactivation technologies that had become available by the late 1970s. Although these technologies, which included heat and solvent-detergent treatment, effectively eliminated HCV from plasma-derived products, pharmaceutical companies were reluctant to implement them, citing cost and efficacy concerns. Nihon Pharmaceutical Co. and Mitsubishi Tanabe Pharma (formerly Mitsubishi Pharma Corp.), along with Mitsubishi’s subsidiary, Benesis Corp., are all expected to contribute to Japan’s HCV compensation fund.
Sources: ABC news (online), December 28, 2007; BBC news (online), January 8, 2008; and International Herald Tribune, January 11, 2008