Memorandum by the Science and Technology
Section of the British Embassy, Tokyo (continued)
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
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.
9.1 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.
First Secretary, Science and Technology
2 October 2000