8.6  Funding

  To date the majority of databases is the responsibility of government and have been assembled with public money. Principally, this has involved the funds of MHW, the Science and Technology Agency, the Ministry of Education, Sport and Science and the Ministry of International Trade and Industry. There is however some private activity, such as that of the JPMA and its 43 member companies. In these cases funding is derived directly from industry.

  8.7  As for provision of new tissue, gene and cell banks, funding for these is not necessarily derived from government. JHSF a government supported organisation is charged with putting together many of these new resources. Nevertheless some funding is derived not from government but from NGOs such as the Sasagawa Foundation and the Red Cross.

8.8  Organisational responsibilities

  The government and research organisations recognise the need to establish and maintain the confidence of current and future donors alike. Achieving this will necessarily involve a high degree of respect for privacy. The Government's Council for Science and Technology has put in place guidance on the "Fundamental Principles for genetic research" and the Ministry of Health and Welfare has in turn produced guidelines governing human genome analysis. Currently the basis for the protection of donors' privacy, it is hoped that these will be augmented by the "Basic Law for Personal Data Protection", currently under discussion within the Prime Minister's office and relevant Ministries. A draft bill will be put to the next Ordinary Diet Session, starting early next year.

  8.9  At the same time, common research guidelines for all parties, including research funded by MITI, STA, MHW, Monbusho, as well as that funded by the private sector, are under construction. The final guidelines are expected by the end of the year. MHW guidelines are currently considered too costly for small private research institutes. It is intended that the common guidelines will remove this burden.

  8.10  Consent, including consent for possible future uses, is likewise being given a high priority. The Ministry of Health and Welfare consider their system for achieving consent to rank with those of most developed nations (although excluding France). The system is designed to solicit consent for all intended future uses.

  8.11  In an effort to build understanding and confidence within the general population, the work of the ministries and their affiliated organisations is brought to the attention of the public via presentations and inclusion on the Internet. The government is sensitive to the need for transparency and public accountability. In this context, MHW has insisted that research institutes establish ethical committees, with a minimum 50 per cent external, non-medical representation.

8.12  Intellectual property

  In the post-sequencing era, researchers are well aware of IP value accrued through the identification of useful genes and those causing disease. Where the Millennium projects give rise to patentable information, MHW, via its Organisation for Pharmaceutical Safety and Research (OPSR), will file the patents. Right to the IP will be shared between OPSR and all those having had an input, including, where appropriate, universities, research institutes and companies.

9.  CONCLUSIONS

  9.1  Human genetic databases in Japan range from those long established by individual clinics, through to the new national initiatives being supported by large investments of public money. Accompanying the emphasis given to the new initiatives is a recognition of the need for increased data originating from the Japanese population. In support of this, initiatives are underway to expand the country's tissue and cell resources. Associated with this expansion is increased emphasis on the key issue of consent and anonymity.

  9.2  Major national databases include many that are longstanding, including GenomeNet, KEGG, the DNA Database of Japan, Kazusa cDNA and RIKEN's new Human Genome database, "Howdy". Over the next few years, the emphasis, under the Millennium projects will be to augment these with comprehensive databases focusing on single nucleotide polymorphisms. Through cross-ministry collaboration, databanks on Healthy SNPs (Institute of Medical Science, University of Tokyo), Disease SNPs (MHW and RIKEN), Drug Responder SNPs (MHW and private company consortium) will be produced. Integration of these into a Comprehensive Database for the private sector is currently the intention. Considerable sums of public and more recently private company money are being targeted towards generating databases that will be of increasing importance to the health of the Japanese population, will enhance the means by which this can be maintained or improved and will ultimately save expenditure or generate revenue.

  9.3  However, it is evident that there is no universally clear idea amongst those involved as to the exact motives for developing the new databases or to the applications to which these will be put. Opinions amongst some commentators differ on the expected scope of data usage. Whether this will simply be used to study information such as that relating to SNPs and expression profiles or whether development of tailor made drugs is the final goal, remains unclear. This is however an early stage in the programme and as with other aspects, ongoing discussions are likely to clarify the possibilities that this work presents and the extent to which these will be exploited.

Christopher Stuart
First Secretary, Science and Technology

2 October 2000