From Bio Journal - May 2003

Regulations for genetically modified organisms come into force in Japan

The Cabinet officially endorsed its ratification of the Cartagena Protocol on March 14, 2003. On March 18, the Cabinet also endorsed a bill to restrict use of genetically modified organisms to ensure biodiversity, in order to ratify the Protocol. The bill has been submitted to the current Diet session, and the deliberation began on April 15. The Japanese government plans to ratify the Protocol after the bill comes into force.

The Protocol is established for the purpose of securing the safety of transboundary movements of genetically modified organisms, for example by trade. The bill is the first regulation dealing with GMO movement. The Ministry of Environment played a central role in drafting this multi-ministry bill involving six Ministries - the Ministry of Finance; the Ministry of Education, Culture, Sports, Science and Technology; the Ministry of Economy, Trade and Industry; the Ministry of Agriculture, Forestry and Fisheries; and the Ministry of Health, Labour and Welfare. (See CBIC articles: 6 Ministries work for ratification of Cartagena Biosafety Protocol - Mar 2002 and Preparing domestic laws in order to ratify Cartagena Protocol - Nov 2002.)

The bill will make it compulsory for the GMO industry to include further assessments for impacts on biodiversity on top of the conventional safety assessment. Currently, in the case of GM crops, cultivation must be approved by MAFF, and for food use must be approved by MHLW. After the new bill becomes effective, the GMO industry will have to obtain additional approval from the Ministry of Environment. Furthermore, when there is a new scientific study that indicates any problems, the company will be required to reassess their products. However, the methods for screening and re-examination are not yet finalized.

Whether the new bill will be an effective law in regulating GMOs is totally dependent on who is chosen as the members of the expert committee, on whether information disclosure will be taken into account, and also on whether public participation will be actually be put into practice. The bill, which is submitted to the current Diet session, lacks these points, yet the focal point is how the bill will subsequently be made effective after additional resolutions and the issuing of ministerial ordinances.

Fujishima Town implements a restriction on GM crop cultivation

On April 1, 2003, Fujishima Town of Yamagata Prefecture implemented the first local ordinance to restrict GM crop cultivation in Japan. Fujishima Town introduced its new environmentally thoughtful town law "town-building for harmonious co-existence of nature and humans" in December 2002, which includes a restriction of GM crop cultivation. Prefectural institutions have also terminated their R&D of GM crops and have no plan to undertake such research in the foreseeable future.

MHLW says no need to review GM food and allergy link

Dr Masaharu Kawata (Assistant Professor, School of Science, Nagoya University, Japan) has called for a review of the safety assessment on GM food by the Japanese government after a new study by Gijs A Kleter and Ad ACM Peijnenburg at RIKILT Institute of Food Safety, the Netherlands, was published in the December 2002 issue of BMC Structural Biology, which indicates a link between GM food and potential allergens. However MHLW, in its response to Dr Kawata, expressed its opinion that there is no need for a review of the safety assessment. The reasons MHLW pointed out for this were; 1) the current allergenic evaluation is not simply a comparison of known allergens, and 2) the study conducted at RIKILT is a computer prognosis and not results discovered by actual research. (Nikkei Biotech 2002/03/31)

MHLW to finalize report on infertility treatments

On 10 April 2003, the subcommittee on reproductive assistance medicine (under the MHLW's Health Sciences Council), which is preparing standards for infertility treatments, held its 27th meeting, at which the final report was completed. Although the MHLW Maternal and Child Health Division will modify the wording of the report, the subcommittee, which first convened in July 2001, has now disbanded. There was some disagreement between committee members concerning the disclosure of personal information (identity) of donators of sperm, ova, and embryo, but the "right to know one's roots" was approved in order to give priority to the welfare of the child. Further, as has been widely reported in the press, the donation of fertilized ova from third parties has been approved, but the donation of fertilized ova from siblings has been banned for the reason that it may cause possible confusion in family relationships. MHLW will now consult with relevant ministries and the ruling parties in order to work towards legal enactment of the report this year.

MEXT approves Gifu University plan for use of ES cells

A meeting of the human-embryo research subcommittee in the Life Ethics Committee of the Council for Science and Technology (MEXT) was held on 27 March 2003, at which an application by Gifu University Faculty of Medicine for a program to utilize human ES cells was approved. Under this program, human ES cells will be imported from overseas and used to generate blood plasma cells. This brings the total of programs utilizing human ES cells approved thus far to seven. Another application by Gifu University to generate heart muscle (myocardium) cells was also submitted, but a decision was referred to a later committee meeting due to insufficient discussion by the university ethics committee.

Closeup: Program for bank of genetic information from 300,000 people begins

A meeting of the life ethics and safety subcommittee in the Life Ethics Committee of the Council for Science and Technology (MEXT) was held on 20 March 2003. Professor Yusuke Nakamura of the Tokyo University Medical Research Institute attended as a witness to give an explanation of the "Project to Realize Medical Treatment based on Genetic Information from Individuals," which was due to start from the new fiscal year (April 2003). The center for this project is the Tokyo University Medical Research Institute, which has received the cooperation of seven medical institutions nationwide in acquiring blood plasma samples from 300,000 people. Under this national project, the samples are to be analyzed for their genetic information, which will become a huge genetic bank. The budget for this project is 20,000,000,000 yen (about US$170,000,000) over five years. MEXT has already appropriated 8,300,000,000 yen in the supplementary budget for fiscal 2002, and 2,200,000,000 yen in the regular budget draft for fiscal 2003.

Surveys of genetic information of residents have already been taking place in Japan, in Hisayama Town in Fukuoka Prefecture, in Suita City in Osaka Prefecture, and in Ohhasama Town in Iwate Prefecture, but these have been limited to sample sizes of a few hundred or thousand, not the 300,000 of this program, making it the first of its kind in Japan. A similar project is the world-famous project in Iceland, where a local biotech company is surveying the genetic information of all 275,000 residents. If the Japanese project is completed, it will overshadow even this Icelandic survey.

What is proposed to be done with the banked genetic information from the 300,000 people. In short, a search for genetic resources. The human genome sequencing project was completed in April 2003. Now that this is done, the next stage is that researchers the world are frantically searching for genes within the genome, especially those related to diseases, or SNPs (Single Nucleotide Polymorphisms) which are the basis for differences between individual humans. By identifying these genes, patent rights can be obtained, and then a huge industry can be built up on the development of new medications and order-made treatments to match the individual characteristics of each individual patient.

In contrast to Iceland's survey, the current Japanese project does not directly involve private companies, but it will be the private companies which obtain genetic information from the bank in order to develop new medications and so on. In other words, what could be called our "ultimate privacy," the genetic information of the individual, is being acquired in large numbers, and the data will be used for a genetic "treasure hunt" by big business. That is the reality of the program for a bank of genetic information from 300,000 people, and it began this April without any attempt to inform the general public of this country and without any discussion.

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