Guidelines for the regulation of cell and tissue banks released by the Japan Tissue Culture Association (JTCA) have been interpreted as a first step towards a legal framework governing the research use of human material in biomedical research. Japan presently lacks such a framework, a fact that is seen as a major constraint on the country's biomedical research work.

Under current legislation, tissue can only be removed from corpses for pathological examination in cases in which cause of death is questionable. And although organ donation from brain-dead individuals has now been permitted in Japan, the law demands that bodies be burned after removal of the organ for transplant. Therefore, research use of tissue remains unregulated, meaning that many scientists avoid using cell and tissue bank facilities because their legal status is not clear.

Setting up new tissue repositories, such as brainbanks that are vital to neuroscience research, is "almost unthinkable at present," according to Nobuyuki Nukina, who heads the molecular neuropathology group at Institute for Physical and Chemical Research (RIKEN). Tissue banks that do exist are small-scale operations run by universities and are accessible only in-house. Most of the human tissue used for research is imported either through commercial suppliers, or through the Human & Animal Bridge Discussion Group, a Japanese organization linked to the US National Disease Research Interchange.

Pharmaceutical companies have found it particularly hard to access sufficient quantities of the variety of tissues that they require, and last year they pressed the health research council of the Ministry of Health and Welfare (MHW) to consider regulating access to excess tissue from surgical interventions. Their lobbying paid off in part with a promise by MHW's council to upgrade an existing cell bank facility at the Osaka research center at a cost of around yen 1.6 billion (US$ 13.3 million).

But so far, MHW has been reluctant to consider the subject of regulating material from corpses. The JTCA's guidelines may force this issue because they call for ethics committees be set-up at all levels of the system—donors, tissues banks and research scientists—and provide general indications for drafting regulation.