Tokyo

Sequencing solutions: but regulatory guidelines proposed so far have not been coordinated. Credit: MAINICHI

The Japanese government announced last week that is has created an expert advisory panel in a bid to coordinate the drafting of ethics guidelines for human genome research. The goal is to bring some order to a growing number of regulatory proposals issued by government agencies by establishing a common ethical ground for all such research in Japan.

According to government officials, the panel is expected to draft model guidelines “as soon as possible”, and no later than December. Although these guidelines would not be binding, individual agencies would be expected to use them as a reference point.

The panel has been set up by the four agencies that fund most of Japan's human genome research: the Science and Technology Agency (STA), the Ministry of International Trade and Industry, the Ministry of Health and Welfare (MHW) and the Education Ministry (Monbusho). Most panel members come from the agencies' advisory committees.

The country's Millennium Project — a five-year plan targeting areas of science and technology with high economic potential — has boosted funding for biomedical research, especially genomics. Following this, committees at various government agencies have drafted proposals for regulating the use of human material in research and protecting genetic information.

Advisory committees under the STA and MHW released guidelines for human genome research earlier this year. But so far regulation has been limited in scope and often applies only to research funded by a single agency or to activities within the Millennium Project.

An informal ‘genome constitution’ approved in late June by a subcommittee of the Council for Science and Technology, an advisory body close to the STA, has so far attracted little support from other agencies.

Critics in Tokyo argue that having the genomics guidelines drafted by an informal expert body without any legal status reflects fundamental problems in the Japanese approach to regulating biomedicine and biotechnology.

Flaws in the country's regulatory approach were revealed earlier this year when its parliament rejected a bill drafted by the STA to prohibit human cloning. Critics argued that the content of the proposed law was inadequate and its wording scientifically contentious.

According to Shohei Yonemoto, a policy analyst at the Mitsubishi Kasei Institute of Life Sciences in Machida near Tokyo, the committees drafting research guidelines in Japan typically lack the “capability, autonomy and legitimacy” needed in a field of regulation that is exposed to public scrutiny.

Japanese industry has kept a low profile. As the international standardization of approval procedures for clinical trials enables Japanese pharmaceutical companies to use data from trials in Europe or the United States in applying for drug approval in Japan, companies such as Yamanouchi have decided to carry out clinical trials in areas such as pharmacogenomics abroad.

Various industry organizations, including the Japan Biotechnology Association and the Japanese Pharmaceutical Manufacturers Association, have issued broad statements on the ethics of human genome research. But companies have been cautious to move into areas with an unclear regulatory regime.