Abstract
In Japan not only pharmaceutical companies but also authorities have finally acknowledged their responsibility for class-action suits concerning biologicals including non-heated concentrates contaminated with Human Immunodeficiency Virus (HIV), dried dura mater inducing Creutzfeldt–Jakob disease (CJD) and fibrinogen contaminated with hepatitis C virus (HCV).
Japan's yearly consumption of albumin in 1985 was 3.84 million l (800 kg/million person year). That is almost one quarter to one third of the world consumption and this was heavily criticized by other countries.
Anti-HCV antibody was introduced for screening of blood as soon as it became available commercially in the late 1989s. The incidence of Post Transfusion Hepatitis (PTH) fell dramatically from about 10% to about 3% and to less than 1% after the second generation anti-HCV antibody was introduced for screening.
After the out-of-court settlement of the suit concerning concentrates-induced HIV, two victims participated as members of a committee for the amendment of the Pharmaceutical Affairs Law, especially those paragraphs dealing with biologicals, which passed and was made known in 2002. According to the new Law, pharmaceutical companies have to discard, recall and stop selling a product when they know that it could induce harmful health problems.
In the new Law bio-derived products are clearly defined and a pharmaceutical company is obliged to keep records of bio-derived products for at least 30 years after shipping them. Medical institutions are obliged to keep records of bio-derived products for at least 20 years after they used them.
Blood is now strictly screened by 20 mini-pool Nucleic acid amplification technique (20MP NAT).
However, there are still several problems regarding biologicals including:
1. A steady increase of newly approved biologicals.
2. Too easy approval of not only biopharmaceuticals but also devices.
3. A lack of strict regulation of clinical trials done by academia.
4. Questions of dosing of biologicals in the future.
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