Japan

The Japanese Government stance towards stem cell research is firmly in line with that of the UK, as was evident in their support during UN therapeutic cloning negotiations. Two major factors underpin this. Firstly, Japan is keen to maintain its international scientific competitiveness in life sciences, while a nagging insecurity remains that for its economic and scientific stature the country did not make a strong enough contribution to the human genome project. Secondly, the Government has a keen eye to the potential healthcare benefits that such research may bring for Japan's rapidly aging population.

In line with this positive stance, huge investments have been made in national facilities and fundamental research. However, human ES cell research and clinical work has remained to a large extent held back by slow development of the regulatory framework. For the UK this represents an opportunity, as we are seen as a natural partner, and the British Embassy in Tokyo has been working hard to promote this positive image and develop UK-Japan engagement.

Stem cell research in Japan continues to receive very significant amounts of public funding. The vast majority of Government investment has gone into developing the infrastructure at two centres: a £20 m flagship research centre (the RIKEN Centre for Developmental Biology or CDB), and the Frontier Institute of Biomedical Research at Kyoto University. Both of these facilities are described below. Overall, the emphasis in Japan has been towards fundamental research into developmental biology and the development of techniques using animal models, and the quality of this fundamental research ranks with the best in the world. However, slow development of the regulatory framework has played a part in limiting the breadth of research using human ES cells. Nevertheless, three human ES cell lines have been derived at Kyoto University using frozen embryos, and twelve research projects using human ES cells have been approved, covering differentiation into, and subsequent application of, endothelial cells, nerve cells, hematopoietic cells, cardiac cells and hepatocytes.

In addition, the Ministry of Education, Culture, Sports, Science and Technology (MEXT) disburses a further £5 m annually to various groups specifically in the field of stem cell research in a competitive award process, and in 2004 60% of this in fact went to RIKEN CDB and Kyoto University. The general field of tissue engineering receives a further £5 m in competitive grants, but this is more widely dispersed across different research centres.

Although Japan is slowly placing more emphasis on competitive grant awards for Government funded research, a significant proportion of funding still goes direct as a block grant to each public University, and it is up to that University to decide how to direct those research funds. National figures are not collated for such funds. For this reason, and also due to the lack of reporting on the research expenditure of private Universities, it is not possible to calculate a precise total figure for research expenditure in a given field.

The flagship research centre for stem cell research in Japan is the RIKEN CDB. RIKEN is a publicly funded network of research institutes, coming formally under the wing of the Ministry of Education (MEXT). Established in 2000 in Kobe, the CDB accommodates 30 research groups with a total of nearly 400 researchers, plus 160 technicians. This is by far the largest recipient of public funds for developmental biology. The initial cost of creating the centre was around £20 m, and it had an annual budget in 2004 of £26 m for research and running costs. Designed by Professor Nishikawa, the CDB Group Director, the centre has a very modern organizational structure, with an emphasis on attracting international researchers. Research covers a very broad range of topics arranged around three main themes: Mechanisms of development, Mechanisms of regeneration, Scientific bases of regenerative medicine. Experimental and technological foundations developed to support the emergence of regenerative medicine as a clinical field. Research at the CDB mainly focuses on a fundamental understanding of developmental biology using animal models (in particular, roundworm, flatworm, fly, zebrafish, mouse and chicken). In addition, three projects using human ES cells have been approved.

On 23 July 2004, Japan's Council for Science and Technology Policy (CSTP), the Government's top science and technology policy body, approved the final report of its Bioethics Expert Panel on human embryo and stem cell research in Japan. After much agonising, the report recommended a change in Japanese policy to allow the creation of human embryos using therapeutic cloning techniques for stem cell research. This step brings the Japanese policy on cloning and stem cell research even closer to the UK.

The law concerning Human Cloning Techniques and Other Similar Techniques was enforced on 6 June 2001. This law has two roles:

• it specifically bans reproductive cloning;
• it required MEXT to produce national guidelines for the creation of "Specified Embryos" for research purposes. As of August 2005, revision of these guidelines to reflect the CSTP recommendations is still under discussion.

There is excellent potential for collaboration between the UK and Japan in this area. As mentioned above, the emphasis in Japan has been towards the investigation of animal models and on development of fundamental techniques. Human ES cell research appears to have been held back by the slow development of the appropriate regulatory framework. Both policy makers and researchers in Japan have taken a keen interest in the ground-breaking developments in South Korea, and it seems that this is viewed less as a threat and more as an opportunity for collaboration. Promotion of UK developments, particularly in human ES cell work, may provide similar opportunities. BBSRC established the JPA scheme to promote the growth of partnership links between UK and Japanese life science laboratories in 2000. Through the scheme, awards of up to £50k, over a three-year period, are made to BBSRC-supported laboratories in the UK to partner with one or more Japanese equivalents. Awards are used to fund scoping studies, workshops in emerging areas of science, and travel for researchers in either direction. Professor Austin Smith, has received two successive JPAs to partner the RIKEN CDB and the Institute for Stem Cell Research, University of Edinburgh, aimed at understanding and manipulating stem cells and cell differentiation. Professor Smith is also on the international advisory board of the CDB, attending regular board meetings in Japan. This partnership has led to a commercial collaboration through the company Stem Cell Sciences (SCS), which now has centres in the UK, Australia, and Japan in Kobe.

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