A Japanese foundation is set to open a major tissue bank by the end of this year, in a move that pharmaceutical companies hope will bolster drug discovery and clinical research in the country.

Deposit account: researchers worry that Japan won't find enough donors for its tissue bank.

Researchers agree that Japan needs such a bank to provide ready access to useful tissue samples, and to bring it in line with what is available in the United States and Europe. But some worry that filling the bank will not be easy.

The bank will be run by the Japan Health Sciences Foundation, a government-affiliated organization based in Tokyo. Under the plan, tissues including liver, lung and kidney removed during surgery would be stored at a facility in Osaka built by the foundation last year. This would then supply tissue material to both pharmaceutical companies and academic researchers on a non-profit basis.

"The bank will greatly increase research productivity and help companies compete with those overseas," says Kazutaka Ichikawa, senior managing director of the Japan Pharmaceutical Manufacturers Association. Many drug companies already contribute money to the foundation, which has provided them with cell lines and DNA samples for several years.

An official at the health ministry, which oversees the foundation's activities, says the bank will initially depend on tissue collected from eight hospitals in the Tokyo area.

Researchers will use the tissues to experiment with candidate drugs that have proved effective on animals, but are not yet approved for use in human clinical trials, foundation officials say. "This is standard in the United States and Europe, but it is still immature in Japan," says Tetsuo Sato, chairman of the non-profit Human and Animal Bridge Discussion Group.

But the tissue bank will only work if doctors can persuade their patients to provide the necessary, explicit consent. A 1996 law forbids the use of organs in research if they were taken from people who only gave consent for them to be used in transplantation.

As a result of the law, human tissue samples are in short supply in Japan, and researchers have to import samples from the United States or rely on overseas partners to do the work.

Ichikawa and others hope that the presence of an official bank and strict enforcement of informed consent guidelines will help to win the confidence of patients and doctors.

But Masanori Fukushima, an epidemiologist at Kyoto University, says that Japan's existing legal framework will make it difficult for the new bank to receive enough donations. "Guidelines on informed consent were only in place since last year and they have no binding power," he says, arguing that clearer laws are needed to punish doctors or researchers who violate patients' rights to privacy and informed consent.