The Japanese parliament is currently discussing new data-protection legislation, the first to be introduced in Japan, which will provide scientists with a broad exemption from the proposed rules. This exemption has not been widely discussed, and few citizens are even aware of the issue. Although the biomedical research community and pharmaceutical industry initially indicated tacit consent, concerns are now being voiced.

We believe the bill does not constitute an adequate regulatory framework for privacy protection in biomedical research. Several ministries, agencies and scientific societies have, in the past, drafted guidelines that have increased awareness of ethical issues, such as informed-consent procedures and review by research ethics committees. Yet the scope of the existing guidelines is restricted and there is considerable confusion about how the rules would be applied. We fear that data protection based solely on voluntary guidelines is insufficient to win public trust.

Progress in large-scale human genome research has dramatically increased the amount and content of personal data used in many areas of biomedical research. Large online databases linking personal information with genomic and clinical data are now feasible. For example, BioBank UK (see Nature 417, 8; 2002) is seen by many observers as an important step forward for clinical-genomics research in Britain. But its success will depend on the participation of UK citizens. Such support is unlikely without a well-conceived scientific strategy and, equally important, a convincing legal and regulatory framework for privacy protection.

Assembling large-scale cohorts for genome research remains very difficult in Japan; we believe a more widespread sharing of resources is now inevitable. Yet without a coherent, transparent approach to data security and data protection, the Japanese public is unlikely to support efforts to build large databases containing medical information and lifestyle details linked with genetic samples, because of distrust and the perception that Japan's medical and scientific community is unable to govern itself.

An inadequate data-protection regime could harm progress in clinical genetics and other biomedical sciences in Japan for many years. The result could well be that Japanese scientists and enterprises go elsewhere — already, Japanese companies are choosing Singapore and even Mongolia for new clinical-genomics research facilities. The Japan Association of Bioindustries Executives, a group representing the chief executives of Japan's major biotechnology companies, has just released a statement ( urging the government to strengthen genetic privacy protection.

We believe that large databases containing both genetic and medical information are inevitable for the future of biomedical research. But without adequate data protection or public trust, such databases are unlikely to be set up in Japan. For biomedical research to progress in Japan we, as members of its scientific and medical community, believe it is time for Japanese scientists to engage in a constructive public debate on this issue.