Tokyo

Research on human embryonic stem cells has come a step closer to being legalized in Japan, as the country's science policy-makers prepare a proposal to the government endorsing such research.

A subcommittee of the Council for Science and Technology (CST), Japan's principal science policy-making body, is expected to submit its proposal to the CST by the end of the month. The proposal should receive approval by the end of March, then be submitted to the government.

The Science and Technology Agency, which manages the CST, will issue guidelines on cloning research and human genetic engineering at the same time.

The use of embryo cells for research is expected to be allowed subject to several conditions. First, that only cells from fertilized eggs less than 14 days old are used. Second, that no money is paid to donors for cells. Third, that research is limited to cells that were not used in fertility treatment.

Under a two-tiered approval system, an internal review board of the institution where the research is be carried out must endorse the research group's plan before sending it to the government for approval.

A major ethical split between obstetricians and prospective stem-cell researchers on the committee was resolved when it was decided that information about embryo donors would not accompany donated cells. Debates continue on the commercialization and patenting of research results.

The issue has stirred up little public interest, especially compared with last year's intense debates over organ transplants from brain-dead donors. But some researchers have voiced concern over the prospect of starting research before adequate regulatory laws or organizations are in place. One member of the stem-cell subcommittee argues that the CST is too weak. He wants to see an information protection law set up, with an authoritative body to oversee genetic and embryo research.

In the absence of these, he says, “research ethics in human embryology and genetics might be handed down to individual researchers or institutes, in which case unethical research protocols might be approved. As a consequence, public trust could be lost.” This would undermine future research initiatives.

A Ministry of Health and Welfare working group will issue its own guidelines on the use of human genetic information by March (see Nature 402, 8; 1999), and the Ministry of Education, Sports and Culture (Monbusho) plans to set up an ethics review committee on human genome research within its managerial board in April.

Lack of a clear central policy, coupled with separate ministerial attempts to assert their own policy-making authority, has long characterized Japanese government activities. Resultant uncertainty in the private sector could severely hamper Japan's plans to lure venture businesses into biotechnology and create 1,000 start-up companies by 2010 (see Nature 397, 554; 1999).

“Unlike in the United States, Japanese businesses are not eager to take the initiative when legal and regulatory matters remain unsettled,” one source warns.