Tokyo

Japan's Ministry of Health and Welfare last week released a set of guidelines covering the transplantation and medical use of human cells and tissues. The guidelines specify safety-assessment procedures and informed-consent rules for donated cells and tissues that are not regulated by Japan's organ transplant law.

In contrast to the transplant law, which requires written consent by the donor, the new guidelines specify that cells or tissues can be taken from dead donors if informed consent has been obtained from family members.

Scientists have welcomed the guidelines as confirming that surplus tissue — as well as tissue that has proved unsuitable for medical use — may be used for research as long as informed consent has been obtained. This was not allowed under the organ transplant law, which specifies that all surplus tissue must be burned.

But Toshiharu Matsumura, a general manager at the Meiji Cell Technology Center, argues that, in the long term, a clear separation of medical and research use may be inevitable. He says it would be more appropriate to regulate the provision of human materials by law rather than through guidelines.

“Without a legal basis, it may turn out rather difficult to build up an efficient support system for human tissues, which are increasingly crucial in many fields of biomedical research,” he says. Some observers argue that public sensitivity towards collecting tissues from dead bodies, along with media criticism, could lead to a backlash, resulting in strict rules — as was the case with organ transplants.