Japan is pushing ahead with a new five-year, $180 million project to build a bio-repository of blood and tissue samples from 300,000 citizens suffering from cancers, diabetes, rheumatoid arthritis and other common diseases. Led by high-throughput genotyping pioneer Yusuke Nakamura at the University of Tokyo's Institute for Medical Science (IMS), the Biobank Japan project will also investigate the pharmacogenetics of common diseases.

Samples and patient data for the project will be collected by a network of collaborating organizations and by several large private medical schools, including Nihon University, Juntendo University and the Tokushukai group. Genotyping will be undertaken by the SNP Research Center at the Institute for Physical and Chemical Research in Yokohama.

Critics say the project was launched without sufficient debate on its scientific value. The fact that none of the large public universities—with the exception of the IMS—is participating in the project has also raised eyebrows, but Nakamura argues that public university hospitals are ill-equipped to collect large numbers of samples. Private hospitals are also moving much more aggressively toward the standardization of therapeutic approaches, he says.

Although research on disease-related single-nucleotide polymorphisms has been well supported through the government's 'Millennium Project' (Nat. Med. 5, 1095; 1999), access to human specimens remains a major issue for Japanese researchers. As part of the new venture, a facility to store the collected specimens will be built at the IMS. For security reasons, however, medical and genetic data will be stored elsewhere, and will only be available to researchers in statistical form.

In retrospect, says Nakamura, the issue of sample collection should have been addressed early on in the Millennium Project. But a lack of coordination among ministries at the time would have made an endeavor like Biobank Japan impossible, he says.

Once the project is complete, scientists in academia and public-sector research institutes will have access to the samples. But the Japanese education ministry, which is financing the project, has yet to decide whether private companies will be granted access. In its present form, say industry insiders, the project does not sufficiently address industry's interests.

According to Shohei Yonemoto, a science policy analyst and director of the Center for Life Science and Society, a private think-tank near Tokyo, many of the legal and ethical issues surrounding the project have yet to be resolved. For example, Japan lacks legislation to protect patients in clinical studies, and there are no clear rules on the use of human materials for research. A new bill to protect personal information, the first of its kind in Japan, also explicitly exempts data used in scientific research.

Officials at Japan's Ministry of International Trade and Industry have now set up an expert group to help the ministry draft legislation for data protection in scientific research, but it is unclear when the new rules will be available.