Law and Ethics of Human Tissue Uses:
A Comparison of the Approach to Regulation in
England (Human Tissue Act 2004) and Japan

Proceedings of the Workshop Meeting for theInternational Understanding of Human Tissue Uses,
Harumi, Tokyo, Japan, November 18-19, 2006

Edited by
T. Matsumura, V. English, Y. Sato and S. Utsugi
with editorial assistance of R. Matsui

Released on Internet by T. Matsumura(2008)

--------------------------------------------------------------------------------------------------------------------------Released by T. Matsumura
Fujisawa, Kanagawa, Japan (2008)
Hard copies of limited number are available at request from the publisher.
All rights of individual papers belong to the authors of the papers, except the right of releasing themthrough Internet, and of supplying the limited number of hard copies as granted from the authors to
the publisher.
---------------------------------------------------------------------------------------------------------------------------

Contents
・ List of Participantsⅴ

・ Snap Photosⅷ

・ Prefacexi・ Introduction Session

1

・
・
・
・
・

Introduction to This Workshop Matsumura, T.
Keynote Address Utsugi, S.
Greeting Wright, E.
The Current Position of this Workshop Matsumura, T.
Attached Materials: Slide presentation

1
2
3
4
5

・ Session 1:-Regulations and moral-ensuring mechanisms in the U.K. and Japan, an overview-

13

・ Lecture English, V.
-Human Tissue Legislation: Problems and Solutions・
Attached Materials: Slide presentation 1・ Discussion
・ Lecture Sato, Y.
-Human Tissues as Materials for Research and Practical Use・ Comment Muto, K.
-Considerations on Japanese issues with special references to liver organtransplantation from live donors・ Discussion

13・ Session 2:-Special session for the research use of human tissues・ Lecture Utsugi, S.
-Some Points of Issue around the Research Use of Human Materials・ Comment English, V.
・ Lecture by English, V.
-Research use of tissue・
Attached Materials: Slide presentation 2・ Comment Maruyama, E-Japanese governmental guidelines concerning the issues・
Attached Materials: Legal Limitations on Genetic Research and theCommercialization of its Results: Japan・
Attached Materials: Slide presentation
・ Presentation Masui, T.
-Comments on the Japanese government guidelines・ Discussion

ⅲ

23
36
40
46

48
56

56
60
61
69
75
77
87
96
98

・ Session 3:
104-Diversity in rules among countries with references to the social and cultural environmentof individual countries, and where to seek for international harmonization・ Lecture Matsumura, T.
-Comparisons between the U.K. and Japan in social and cultural environments
surrounding human tissues with a proposal of internationally acceptable rules・ Lecture English, V.
-Human Tissue Legislation-Culture and context・
Attached Materials: Slide presentation 3
・ Lecture Norton, M.
-Fundamental differences between the U.K. and Japan in approving process・ Lecture Kai, K.
-Diversity in rules among counties with references to the cultural backgroundof individual countries, and where to seek for international harmonization・ Discussion
・ Conclusion Matsumura, T.

104

152
159
165
168

170
177

ⅳ

List of Participants

Guest Participants：
English, Veronica*

British Medical Association
Tavistock Square, London, WC1H 9JP
venglish@bma.org.uk

Norton, Mike

Shinshu University Innovation Management Institute4-17-1 Wakasato, Nagano
norton@im.shinshu-u.ac.jp

Wright, Edward

British Embassy
1 Ichibancho, Chiyoda-ku, Tokyo
Edward.Wright@fco.gov.uk

Domestic Participants：
Adachi, Toshitaka

The Institute of Moralogy
2-1-1 Hikarigaoka, Kashiwa, chibatadachi@moralogy.jp

Asakawa, Shigeki

Riken Research Ethics Section Safety Division
2-1 Hirosawa, Wako, Saitama
asakawas@postman.riken.go.jp

Ida, Ryuichi

Kyoto University School of Government/Graduate School of Law
Yoshida, Sakyo-ku, Kyoto
ida.ryuichi@law.kyoto-u.ac.jp

Kai, Katsunori

Waseda Law School
1-6-1 Nishiwaseda, Shinjuku-ku, Tokyo
kai@waseda.jp

Kamisaka, Ryoichi

Tokai University Law School
2-28-4 Tomigaya, Shibuya-ku, Tokyo

Kato, Shun-ichi

Tokai University School of Medicine
143 Shimokasuya, Isehara, Kanagawa
skato@is.icc.u-tokai.ac.jp

Kihara, Akiko

Tokai University Law School
2-28-4 Tomigaya, Shibuya-ku, Tokyokiha-tok@umin.ac.jp

Kijima, Hiromasa

Nagoya University School of Science
3-27-4-503 Nakano, Nakano-ku, Tokyokijimash@nifty.com

Kobayashi, Eiji

Jichi Medical University
3311-1 Yakusiji, Shimotsuke, Tochigi
eijikoba@jichi.ac.jpⅴ

Kurihara, Chieko

Clinical Evaluation/Controller Committee
1-11-2 Ebisu, Sato-Jitsugyo-Ebisu-Bldg. 4F, Shibuya-ku, Tokyo
chieko.kurihara@nifty.ne.jp

Maruyama, Eiji

Kobe University Faculty of Law
2-1 Rokkodai-cho, Nada-ku, Kobe
emaruyam@kobe-u.ac.jp

Masui, Tohru

National Institute of Biomedical Innovation
7-6-8, Saito-Asagi, Ibaraki-shi, Osakamasui@nibio.go.jp

Mitsuishi, Tadataka

Mitsuishi Legal and Patent Office
1-9-15 Akasaka, Minato-ku, Tokyo
bcl07104@nifty.ne.jp

Muto, KaoriThe Institute of Medical Science The University of Tokyo
4-6-1 Shirokanedai, Minato-ku, Tokyo
krmt@ims.u-tokyo.ac.jp

Nakamura, Yukio

RIKEN BioResource Center
3-1-1 Koyadai, Tsukuba, Ibaraki
yukionak@brc.riken.or.jp

Nishijima, Hideki

Ministry of Economy, Trade and Industry
1-3-1 Kasumigaseki, Chiyoda-ku, Tokyonishijima-hideki@meti.go.jp

Obata, Yuichi

RIKEN BioResource Center
3-1-1 Koyadai, Tsukuba, Ibaraki
yobata@brc.riken.jp

Okumoto, Takeki

Mitsubishi Pharma
2-2-6 Nihonbashi-honcho, Chuo-ku, Tokyo
Okumoto.Takeki@mb.m-pharma.co.jp

Saio, Takeo

Fuji Toranomon Health Promotion Center
1067-2 Nakahara, Kawashimada, Gotenba, Shizuoka
saio@ppp.bekkouame.ne.jp

Sasaki, Hiroko

Roman Industries Co., Ltd.
1-10-4 Fukuura, Kanazawa-ku, Yokohama
ctc@roman-industries.co.jp

Shimosaka, Shigehiro

Roman Industries Co., Ltd.
1-10-4 Fukuura, Kanazawa-ku, Yokohama
ctc@roman-industries.co.jp

Shinozaki, Naoshi

Tokyo Dental College Ichikawa General Hospital
5-11-13 Sugano, Ichikawa, Chibanaoshi@eyebank.or.jp

Shiratsuchi, Tatsuko

Nihon University School of Medicine30-1 Oyaguchi-kamicho, Itabashi-ku Tokyot-shirat@w5.dion.ne.jpⅵ

Soda, Atsushi

Nagasaki Public Health Office2-10 Tateishi-cho, Nagasaki
usagi120@mxa.cncm.ne.jp

Tamura, Chieko

Ochanomizu University Graduate School of Humanities and Sciences
2-1-1 Otsuka Bunkyo-ku Tokyoc_tamura@t3.rim.or.jp

Yamamoto, Soichi

Ministry of Economy, Trade and Industry
1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo

Meeting Organizers :Utsugi, Shin*

Tokai University Law School
2-28-4 Tomigaya, Shibuya-ku Tokyosutsugi-tok@umin.ac.jp

Sato, Yuichiro*

Yokohama City University School of Medicine
3-9 Fukuura, Kanazawa-ku, Yokohama
RXP05223@nifty.ne.jp
Present address:
Kobe Gakuin University Faculty of Law
1-1-3 Minatojima, Chuo-ku, Kobe
ysato@law.kobegakuin.ac.jp

Matsumura, Toshiharu*

Roman Industries Co., Ltd.
1-10-4 Fukuura, Kanazawa-ku, Yokohama
matsumura@roman-industries.co.jp

Editors of the Proceedings :* indicated by asterisk*
Editorial Assistant :Matsui, Rie

Roman Industries Co., Ltd.
1-10-4 Fukuura, Kanazawa-ku, Yokohamaⅶ

Snap Photos

Veronica English

Mike Nortonⅷ

Katsunori Kai

Eiji Maruyama

Tohru MasuiⅸShin Utsugi

Yuichiro Sato

Toshiharu MatsumuraⅹPreface
Developments in technology relating to the use of human organs and tissue for donation andresearch have brought benefits to humankind but have also raised new ethical dilemmas. Humantissue (used collectively to include: organs, tissues, cells, and in some cases cellular components) may
be used for transplantation, transfusion, and diagnostics, as well as the industrial production ofpharmaceuticals and biomaterials. These developments raise issues of consent, information,
appropriate uses and human dignity and views on these matters differ both within and between
countries. What is traditional and unquestionable for one person in one country, could beunbelievable and unacceptable to another person in another country. With increasing emphasis on
international harmonization and co-operation, it is important to study and understand the regulatory
systems in different countries and the principles that underpin them.
Here, the sweeping changes in England from the Human Tissue Act, 1961 to that of 2004 (HTA2004), and the subsequent process of implementing the new legislation, may be understood not justfor its practical value in the U.K., but also in giving a timely opportunity to undertake such a
comparative study.
The Workshop Meeting for the International Understanding of Human Tissue Uses was aimed attaking that opportunity, for Japanese people to study the framework of the British law and thephilosophy underlying it, to compare them with the Japanese regulatory framework and its underlying
philosophy, and to discuss the future for international co-operation.
The workshop was held in November 18-19 2006 in Harumi, Tokyo. It was a closed meeting inwhich thirty two participants joined, as shown in the attached list, three among them are from theU.K.
In the workshop, core introduction and analytical studies on HTA 2004 and its enforcement were
given by Veronica English, while those on the current Japanese regulatory system were given by Shin
Utsugi, Yuichioro Sato and several other Japanese scholars. Then, comparative analyses anddiscussion for mutual understanding was undertaken by Veronica English, Toshiharu Matsumura,
Mike Norton and others.
In order to ensure an accurate and comprehensive record of the meeting, contributors were
subsequently given the opportunity to review the report of the meeting. Because of this, it took sometime to complete the proceedings. Nevertheless, we hope and believe that the proceedings are still ofconsiderable value for people in both countries, and for those in other parts of the world with aninterest in this area, to advance mutual understanding and co-operation on the use of human tissue.
The workshop has been supported by Pfeizer Health Research Foundation, and by the Japanese
Ministry of Health, Labour and Welfare through grants in aid for the research of human gemone andregeneration medicine, both to S. Utsugi and his research group, and by EY Memorial Foundation for
Ethical Researches to T. Matsumura, and the publication of the proceedings by EYMF.
The organizers of the workshop gratefully acknowledge officers of British Embassy of Japan,
Akiko Kihara of Tokai University Law School, and staffs of Roman Industries Cell Technology
Center, for their encouragement and help during the course of this workshop and of preparing theproceedings.

November 2008
The Editorsxi

Introduction Session
Introduction to This Workshop
Toshiharu Matsumura, Director, Cell Technology Center, Roman Industries Co. Ltd.,
1-10-4 Fukuura, Kanazawa-ku, Yokohama
Human tissue age
Human tissue issues are new issues that have come around since mid 20th Century. Here, theterm human tissues will be referred to as removed parts of human body, including organs, tissues intheir narrow sense, cells, and in some occasion, part of cells such as cell nuclei and genetic elements.
We are now in the age when human tissues play, and will continue to play, central roles in social
welfare and well-being.
Their roles are in organ and tissue transplantation, cell infusion, and in the production of
bio-pharmaceutical drugs. In addition, more advancement of social welfare is expected to comethrough the applications of molecular genomic study of individual people, and the development ofregeneration medicine for which human tissues play central roles.
Behind these successful advancements, we may have to note that, a considerable amount of
human tissues have been given by people of good will, and subjected to science and technology
including cell and molecular biology, genetics, immunology, and pharmaceutical and medical
sciences.
New issues
Now, human tissues are so important as the essential component of the society that fears against,
and even some signs of, undesirable conflicts are becoming apparent among people. Buying andselling human tissues, breaching private information, paying little attention to the ownership or
custodianship of the tissues, and handling without or against the consent of relevant people are among
them. The major reason for such conflict to happen appears to come from the fact that what iscommon for one person to handle human tissues is not at all common for another, or for people in acountry while not for people in another country.
In this situation, one may easily reach to the conclusion that it is about time to think ofinternationally appreciable common rules for handling human tissues.
Why this workshop
Because human tissue issues are new issues, one may think it easy to accomplish such rules. The
current situation, however, appears to be far remote from the above idea of easy accomplishment, andsuggests that we need detailed studies beforehand.
To accomplish internationally appreciable rules, it may be a good idea to begin with comparing
rules of two countries with different situation. A very good example of such two countries is, as I
believe and as will be shown in this workshop, that of the U.K. and Japan.
Many Japanese people are interested and eager to study the recent British activities related tohuman tissue issues, i.e., the revision of Human Tissue Act 1961 for that of 2004 and its enforcement.
To extend this line of study in Japan, we need a British expert who could kindly come and join us
in Japan to introduce us British situation, and to discuss the matters of mutual interests.
It was the reason why we sent a letter of invitation to Ms. Veronica English to this workshop. As
many participants of this meeting know, Ms. English has been playing a key role in leading the recent
development of regulatory framework in the U.K.
It is such an honor and pleasure to have her here with us.
Our thanks are not only to Ms. English, but to Dr. Mike Norton, Professor of Shinshu University,and Dr. Edward Wright, British Embassy, with whom we are expecting discussion in depth of current
issues.
Since the intention of holding this workshop had been shared among the participants of theworkshop through preceding workshops and letters of correspondence, the oral presentation of thisintroductory remark was skipped in the workshop, and is presented only in the proceedings.
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan1

Keynote Address
Shin Utsugi, Professor of Tokai Law School, University of Tokai
2-28-4 Tomigaya, Shibuya-ku, Tokyo
Welcome to our workshop and I thank you very much for your joining our workshop on the
Research Use of Human Materials.
It is remarkable, nowadays, to see the increasing usage of the Human Tissue, cells and DNA in
medical practice, biomedical research as well as industrial field. And according to the widening of theusage, the character or nature of the usage changes. The users are not medical staff in front of thepatients, the places are no more medical institutions, and the human cells can be placed in the tube
side by side with those of animals. But it is no doubt human.
So very many problems come up to be resolved scientifically, socially, as well as ethically. We
are, it looks like to me, we ourselves are on trial.
Today and tomorrow morning we have the privilege to hear and to talk with English-san from theUK. English-san is, as you have already known her with the brief and to the point explanatory note on
the Human Tissue Act of the UK sent to you from Matsumura-san via net, the most appropriate expert
on the matter, I suppose, as the responsible member of the British Medical Association. We can hearfrom English-san the precise and also practical side of this new and quite intricate system which isvery difficult for us, foreigners.
We have planned to focus in this workshop, on the research use of the materials, but we have nointention to restrict to it. Quite recently we heard the incredible news on the diseased kidneytransplantation-case in Uwajima, and we have many other matters to be discussed. I hope a lively
debate among the excellent members gathered.
This workshop is held as some extra-activity of Utsugi-han which is supported by the Ministry of
Health, Labor and Welfare. And as the Head of that working-group I appreciate very much
Matsumura-san for his great effort to make up this workshop, he has planned, called for, and made-up
every thing by himself and with the aid of Kihara-san. I would like to thank for his and her great
endeavor. Thank you.

T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan2

Matsumura
May I introduce Dr. Edward Wright? He is from British Embassy. In this chance, I would like tothank British Embassy people very much, including Dr. Wright and the previous head of the scienceand technology division, Dr. Mike Norton. They have been presenting us a number of excellent
seminars inviting distinguished people from the U.K. For this workshop, too, we take the advantage ofputting the name of British Embassy on the announcement of the open seminar to be held on Tuesday.
It is a great honor to have Dr. Wright today. Please.

Greetings
Edward Wright: Life Sciences Attache at the British Embassy
1 Ichibancho, Chiyoda-ku, Tokyo
My name is Edward Wright, life sciences attache at the British Embassy here in Tokyo
My role is to promote the life sciences relationship between Japan and the UK in any way that I canbusiness, academic and policy.
Delighted to be able to give a short greeting here today, and I thank Dr. Matsumura for theinvitation to join this meeting on a very important and complex topic.
From the UK’s perspective the timing is very good, just a couple of months ago the Human
Tissue Act came into force which will directly affect post mortem services, anatomy schools,
transplantations and establishments storing human tissue.
And so I welcome Veronica English from the UK’s British Medical Association who will betalking on this topic, and I look forward to her comments very much.
The use of human tissue is a highly emotive subject. In the UK as elsewhere, there have been
controversies relating to the use of human tissue without proper consent or authorization, and thisexperience has informed the development of the new legislation.
The UK has been developing a number of large scale initiatives which have implications for the
discussion today, and a lot of care has been taken to establish a suitable legal and ethical framework.
Just to give two examples, earlier this year the UK’s Biobank Project was started. This aims to be
the world’s biggest resource for the study of the role of nature and nurture in health and disease, withsamples from 500,000 volunteers.
Following consent, each participant is asked to donate a blood and urine sample, have somestandard measurements (e.g. blood pressure) and complete a confidential lifestyle questionnaire.
Over the next 20 to 30 years UK Biobank will allow approved researchers to use these resources
to study the progression of illnesses such as cancer, heart disease, diabetes, and Alzheimer’s disease.
From this they hope to develop new and better ways of preventing, diagnosing and treating suchproblems.
Another example is in stem cells where the UK has been building up a number of centres of
excellence, along with clarification of the appropriate legal framework for such research. We watched
the lengthy discussions at CSTP in Japan with great interest and perhaps that will be discussed today.
To support stem cell research in the UK, a new stem cell bank has been created. Cell banks are
already in existence for many other types of cell line, but this initiative from the UK’s Medical
Research Council, with the full backing of the UK Government, is the world’s first stem cell bank of
its type. The UK stem cell bank will provide a repository for stem cell lines of all types, and will be
developed to supply cell lines both for basic research and for the development of clinical applications.
It operates in accordance with strict principles of governance laid down by a high level steeringcommittee. A key point is that stem cell lines are deposited from and distributed abroad which brings
me to my final point.
Research is international and the positive results of research should be international. The UK has
its own legal framework for the issues being discussed today but it is also bound by European
legislation and United Nations protocols and conventions. The topic today has ethical, cultural andreligious aspects that differ significantly across the world. And so I hope that today’s discussions will
provoke some interesting debate and provide new insight for both sides.
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan

3

The current position of this workshop
Toshiharu Matsumura, Director, Cell Technology Center, Roman Industries Co. Ltd.,
1-10-4 Fukuura, Kanazawa-ku, Yokohama
Thank you very much. In the program I am to talk a little about preceding and on-going activities.
But, to make it short, I just want to tell you that, in addition to this group, i.e., Utsugi-study group,
there are currently at least three other groups in Japan that are actively talking the same issues.
One is Human and Animal Bridging Research Organization, or HAB, a not-for-profit
organization distributing human tissues for research, maintaining a partnership with an Americanorganization, called NDRI. A study group has been working actively in HAB. Prof. Utsugi is amember of the group. They are talking on what is allowed, or not allowed, in the current legal
framework of Japan for handling human tissues. We are looking for the publication of their study.
Another one is the co-operative group of Human Science Foundation and National Institute of
Biomedical Innovation. They are operating a human tissue bank for research uses, and also promoting
discussion in this subject. Some of their seminars have been published.
A new study group has been organized recently in Science Council of Japan (Nihon Gakujutzu
Kaigi). It is headed by Prof. Ida, and is composed of top members in this field of Japan, and is going
to present a paper, next January.
So, Utsugi-study group is just one of several study groups currently active in this field here in
Japan.
I am not presenting slides. Please look at the first page of my hand out. If we go back to thehistory of this meeting, it may go back to early 1990s's activities of the Japanese Tissue Culture
Association. This association hosts members using human cells and tissues in laboratories including
myself. In early 1990s they had a small committee with the purpose of protecting the acting membersof the JICA from any troubles regarding law and ethics.
The first report was presented in 1995 from the committee. This was an interim report. At thattime we very much realized that we needed the help of law professors. It was Professor Utsugi whovery kindly joined us since then. Then, the committee was expanded to form Japanese Tissue Culture
Association Committee for Ethical Issues. It presented a second and a full report in 1998.
Two years later, Professor Utsugi organized a study group, applied for a governmental research
grant, and obtained it successfully. In the first three years starting from 2001, the research objectivesof his study group was forwarded mostly to human tissues, cells and human subjects.
Then, in the second three years beginning from 2004, main objectives have more been oriented
to the issues of patient information or medical information. Therefore, tissue issues are only a smallpart of the current research objectives of his study group.
For other historical details if you are interested in, please take a look at the handout.

T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan4

Human Tissues as Materials for Research and Practical Use
A Workshop for International Understanding in Related Law and Ethics
with Special References to British and Japanese Systems
Date:

Saturday, 18th & Sunday 19th, November 2006
Place:Harumi Grand Hotel, Tokyo

A note on previous workshops
Toshiharu Matsumura

1

Matsumura 2006.11.

Studies on ethical legal and social issues concerning humantissues in Utsugi-research group have their roots on those ofJapanese Tissue Culture Association

1990s JTCA Cell Bank Committee Subcommittee for Ethics
1995 An interim report published from the subcommittee
1997 JTCA Committee for ethical issues
1998 A full report from the JTCA Committee
2001-3 The 1st Utsugi-han research group(MHWL Program for Genome and Regeneration Medicine)
2004-6 The 2nd Utsugi-han research group(MHWL Program for Genome and Regeneration Medicine)2

5

Matsumura 2006.11.

In the early 1990s, a small working group was set in the JTCA
Cell Bank Committee:･to protect scientists and technologists working with humantissues from ethical, legal and social troubles.
･to help the establishment of social consensus to develop anduse human tissue resources for research and industry.

3

Matsumura 2006.11.

‘Points to consider on the handling of human tissues andcultured cells. 1995.4.’ (JTCA subcommittee for ethicalissues of the JTCA Cell Bank Committee published an internalreport)Umeda, M., Sato, K., Tanaka N., Matsumura, T.

･History of utilizing human tissues and cells in research andindustry･Fundamental principles having been developed during the last 50
years after the world war 2･Analyses in current issues related to the utilization of humantissues and cells･Proposals from the JTCA subcommittee
Return from the entity of science, technology and industry to
the entity of those who donate tissues and cells.
4

6Matsumura 2006.11.

JTCA 1995 Annual Meeting Workshop 1995.5.17.
Report from the JTCA Subcommittee for Ethical Issues of the
JTCA Cell Bank Committee.
Matsumura T.
From Japan Organ Transplant Network: What is expected to JTCA.
Nomoto, K.

･Open discussion based on the interim report･Introduction of valuable experiences obtained during the courseof the establishment of the Japanese organ transplantation law

5

Matsumura 2006.11.

JAACT 1995 Annual Meeting Symposium 1995.11.6-10.
Published in Animal Cell Technology, 8: 107-120(1997)
A study for the development of human biomaterial research resources
in JapanMatsumura, T.
Organization and expansion in organ and tissue procurement networks
in the 1960’s and 1970’s in the U.S.A.
Stevenson, R.E., ATCC
Human Organs and Tissues for transplant, research and education:
Current practice in the U..S.
Eidbo, E.E., Schaeffer, M.J., and Brighem, L.E.,･Realization that Japanese situation is very different from thatof the U.S.
･What can Japan learn from the U.S.?
The processes of the establishment of Uniform Anatomical Gift
Act (1961), organ procurement organizations and tissue banks in
the U.S.
･Importance of law making stressed by US speakers.
6

7

Matsumura 2006.11.

JTCA annual meeting symposium 5.23.1997
The use of human cells for the production of human biologicals
Hayflick, L., UCSF
Organization and activities of human tissue banks in the U.S.
Bode, D.C., IIAM, USA.
A self regulatory framework for research and service on human biomaterials
Matsumura, T., Tanaka, N., Sato,K., Hirai, R., Masui, T.,Umeda, M.

･More study on the history of science and industry based on humantissues and cells, and of logistics of research resources.
･We need the help of law experts!
･Invitation of Professor Utsugi to the JTCA Committee for EthicalIssues.

7

Matsumura 2006.11.

On the handling of human tissues and cells without intention ofutilizing them for donor’s own therapy (A full report from JTCA
Committee for Ethical Issues, available from the JTCA website).
Tiss. Cult. Res. Commun. (JTCA official journal) 17:117-171 (1998)
Matsumura T., Umeda, M., Sato, K., Shibanuma, M., Tanaka, N.,
Hasumura, T., Hata, H., Hirai, R., Masui, T., Utsugi, S.

･A collection of reference materials and information for JTCA
members to establish self-regulatory rules for handling humantissues and cells in institutions where they work
･Attention called of concerning people outside of JTCA for theestablishment of regulatory framework to handle human tissues
in Japan88Matsumura 2006.11.

JTCA annual meeting workshop 2000.9.8.
Treatize on human tissues and cells as research resources
Matsumura T., Umeda, M., Sato, K., Shibanuma, M., Tanaka, N.,
Hasumura, T., Hata, H., Hirai, R., Masui, T., Utsugi, S. (JTCA
Committee for Ethical Issues).
Promotion of Cell Banking at the Ministry of Health Welfare and Labor
Masui, T., Mizusawa, H.
What we have learned from a pilot study of tonsil tissue collection
Enosawa, S., Matsumura, T., Utsugi, S., Suzuki, S., Amemiya, H.,
Kawashiro, N.
Current status of importation of human tissue cells.
Ii, K., Ozawa, Y., Asaga, I., Shimooka, M.
Issues related to the utilization of human tissue resources and banking
Sato, T., Suzuki, S., Shimizu, T., Yasuhara, H., Kurata, T.,
Kobayashi, E., Niikura, Y.
Tissue cell banking at Human Science Research Resource Bank.
Yamamoto, T., Kanzaki, T.
･Organized procurements and supply of human tissues as researchresources started around this time in Japan.
9

Matsumura 2006.11.

HAB Annual Meeting 2002.5.23-24．Tokyo
Informed consent in pharmaceutical research
Yasuhara, H. & Matsumrua, T (organizers)
Informed consent at the site of tissue procurement
Ida, R.
What can be managed with informed consent and what cannot
Shimazu, I.
Acceptance of the concept of informed consent in Japan
Nomoto, K.
Human tissue for research in the U.K.: Ethics and PracticeColeman, R.

･The time of further analyses and comparative study has come.
10

9Matsumura 2006.11.

Establishments of research groups
Hitomono research group managed by Prof. Utsugi
Utsugi research group funded by MHWL in 2001
Shirai research group funded by MHWL in 2001

･Cores of the legal and ethical study groups have been
established for human tissues issues.

11

Matsumura 2006.11.

Utsgi-han Workshop On the basic principles related to human tissues
2004.3.12. Tokyo
US 45CFR46 and its background ethical principles:
Belmont report etc. Adachi T.
French laws related to bioethics.
Nudeshima J.
A proposal of a Japanese law for the protection of humansubjectsfor research.
Mitsuishi, T., Nudeshima J., and Kurihara, C.
Report of the related activity of Utsugi research group and atentative proposal of Japanese rules.
Matsumura,T.
･Comparative studies continued･New future Japanese regulatory frameworks proposed
Mitsuishi, T., Nudeshima J., and Kurihara, C. A proposal of law for theprotection of research subjects. Rinsho Hyoka. 30:369-395(2003)
Matsumura T., Handling human tissues, cells and genes for biotechnology:
principle or practice. Bioscience and Industry 61:38-40 (2003)
Matsumura, T., Ethical and legal requirements in handling human tissues: A
draft proposal with special references to Japanese and western cultural
backgrounds. Tiss. Cult. Res. Commun. (JTCA official journal) )23:91114(2004) (open in the JTCA website)
12
Matsumura 2006.11.

10

Utsugi-han Workshop on the basic principles for handling human tissues:With special references to the influence of cultural and physicalbackgrounds on the decision making process. 2005.3.5.Tokyo
Basic strategy to cope up with the problems and proposal of tentative
rules for single body problems, two body problems and three bodyproblems.
Matsumura, T.
Views from brain science
Kijima, H. & Kuroda, Y.
A view from clinical psychology.
Kemmi, K.

･Matsumura’s interim proposal was discussed in some details.
Matsumura, T., Thoughts on organ donation with special references tobasic rules for handling human materials without intention of utilizingthem for donor’s own therapy. Transplantion (Official Journal of Japan
Association for Transplantation) 40:129-142(2005).

13

Matsumura 2006.11.

Utsugi-han workshop on the rules for those who face at nonautonomous humane existence including developing eggs.
2005.12.17. Tokyo
Legal protection of humane organisms yet to be born: with specialreferences to discussions in Germany.
Kai, K., Waseda University (Invited lecturer)
Ishi M., Meiji Univeristy (Commentator)
洪 賢秀 Center of Life Science and Society (Commentator)
Kijima, H, Nagoya University (Commentator)
Shimazu, I., Chiba University (Commentator)･Contrastive views on the in-vitro human life have been
analyzed in some details with special references to German
laws.
14

11

Matsumura 2006.11.

Today and Tomorrow

We are given a rare opportunity:
to study the new U.K. legislation.
to present the Japanese regulatory system for comments
to have a time of discussion on future domestic andinternational rules.

15

12

Matsumura 2006.11.

Session 1
Human Tissue Legislation: Problems and Solutions
Veronica English, Deputy Head of Medical Ethics, British Medical Association
Tavistock Square, London, WC1H 9JP
Why was new legislation needed?
Human Tissue Act 1961 was out of date and unclear
Before the new Act the use of body parts after death for transplantation, education and researchand the carrying out of post-mortem examinations were covered by the Human Tissue Act 1961. By
the late 1990s it was increasingly clear that the legislation needed to be reviewed.
•
•
•

•

The wording was unclear and subject to confusion - it used terms such as “the person lawfullyin possession of a body” and “such reasonable enquiries as may be practicable” without
definition.
It did not require “consent” to these activities but relied instead on a vague notion of “lack ofobjection” which led to confusion about the precise requirements, particularly how muchinformation needed to be given in order to allow people the option of objecting.
Its terminology was also out of date with modern day society – it referred to “spouse”
meaning husband or wife, with no reference to the increasing number of long-term partners
who live together without marrying or same sex couples who may now go through a formal
civil partnership ceremony.
There were also no penalties within the Act so if someone broke the law, they could not bepunished.

For all these reasons, there was wide agreement and recognition that the Act was no longer
suitable for purpose and needed to be revised. This gained added impetus by the “organ retention
scandal” at Alder Hey Children’s Hospital in Liverpool and elsewhere.
Organ retention scandal
In 1999 it emerged that Alder Hey Hospital had, for many years, been retaining organs and bodyparts (including some children’s “heads and bodies”) following post-mortem examinations without
the knowledge or agreement of the parents or family. The Health Secretary commenting in Parliamenton the subsequent Inquiry reported that one doctor at the hospital – Professor van Velzen“systematically ordered the unethical and illegal stripping of every organ from every child who had
had a post-mortem. He ignored parent's wishes even when they told him explicitly that they did notwant a full post-mortem, let alone the retention of any of their child's organs.”
When this came to light, it emerged that other hospitals, on a much lesser scale, had also beenretaining organs and body parts without consent. A survey in England found that over 54,000 organs,body parts and stillborn children or fetuses had been retained since 1970 and were still held bypathology services. There were similar findings in Wales, Scotland and Northern Ireland. Many ofthese organs had never been used for education or research and were simply left untouched on shelves.
Many practitioners believed they did not need the consent of families to retain organs forresearch following a post-mortem examination. They believed if the relatives did not object thenorgans could be retained but, in practice, many parents or relatives did not object to organ retention
because they were never asked.
In the subsequent inquiry, one of the major criticisms was the lack of clear information provided
to bereaved parents. Even when they were consulted about organ retention, the literature was not
explicit referring to “tissue” or “samples of human material” when the intention was to retain wholeorgans – hearts, brains, kidneys etc.
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan

13

This scandal led to calls for a thorough review of the legislation making consent the fundamental andexplicit principle underpinning the use of any human material following death and introducing
penalties for any breach of the legislation.
Increasing gap between supply and demand for cadaveric organs
Over the last 10 years in the UK there has been considerable concern about the availability ofdonor organs. The gap between the number of organs available and the number on the waiting list fortransplants has continued to grow for more than a decade and shows no sign of reversing. As an
example, during 2005 the number of transplants carried out was 11% lower than in 2004 while thenumber of people waiting for a transplant increased by 9% over the same period. There are a numberof reasons for concern:•

90% of the UK population support organ donation•

22% signed up to the Organ Donor Register to say they wish to donate organs after their death•

40% of relatives refuse•

More than 400 people die each year waiting for a transplant

Since April 2003 UK Transplant (which is responsible for promoting and co-ordinatingtransplantation) has carried out a “potential donor audit” to assess all deaths in intensive care units
and consider why people who are potential donors did not go on to donate. This found that between
April 2003 and March 2006 less than half (45.7%) of potential donors went on to actually donate. It
also found that in a number of cases the relatives overruled the prior consent of the deceased patient.
It has been widely recognised that action needs to be taken to improve the transplantation rateand, as one part of that, clear legislation aimed at facilitating donation was needed.
Uncertainty about the legality of non-heartbeating donation
One of the ways of increasing donation rates that was being promoted was the use of nonheartbeating donors. Most donors are those who die on a ventilator (and are known as heartbeating
donors). Non-heartbeating donors are those who die in a general wards or in whom active treatment
is withdrawn. In these cases death is confirmed and then a small incision is made in the groin, acannula is inserted and the kidneys are perfused in order to keep them in a good condition fortransplantation. The organs are then removed and transplanted. In some cases consent is obtained
before the perfusion is carried out but in others the procedure is undertaken while attempts are madeto contact the relatives.
UK Transplant and the Government were trying to encourage the development of more nonheartbeating donation programmes around the country but a number of coroners (who are responsible
for the investigation of sudden or unexplained deaths) argued that such intervention would be
unlawful if consent for transplantation had not been given by the donor or by the donors’ relatives. A
number of units therefore could not, or were reluctant to, begin non-heartbeating donation. Although
the Government believed the procedure would be lawful, it needed to clarify this before nonheartbeating donation could really begin to be developed.
Disparity between related and unrelated living donors
Another way in which it was hoped to increase the number of transplants was to encourage moreliving donation. Living organ donation was covered by the Human Organ Transplants Act 1989.
This legislation was passed in reaction to a scandal whereby a London hospital was found to be
paying people from Turkey to donate their kidneys. The legislation made it unlawful to pay organ
donors and also set up a body called ULTRA (the Unrelated Live Transplants Regulatory Authority)

14

to approve, in advance, all organ donation involving unrelated living donors. It was illegal to use an
unrelated living organ donor without the approval of ULTRA.
So, if the donor was a relative – a DNA test would be done to confirm the claimed relationshipand then the donation could proceed. Although it was within its power to do so, ULTRA would not
sanction donation by strangers and so all unrelated donations were from partners or long-term friends.
In these cases, an application needed to be submitted to ULTRA to ensure that no payment had been
made and that the donor was giving consent voluntarily and free from pressure or coercion – this wasa lengthy procedure and frequently caused delay to the transplant. The legislation was also based on
the erroneous assumption that there was more likely to be pressure brought to bear on friends than on
families, whereas in reality the pressure to donate to a family member is likely to be just as great.
It was recognised that if living donation was to be encouraged, all cases should be subject toscrutiny to ensure that the consent was valid and not given under pressure but that the procedure
should be streamlined to make it less onerous to have to seek approval.
There was also growing support for seeking other ways of increasing living donation.
For these reasons, it was recognised that changes in the law were needed in order to achieve theaim of increasing the number of living donors.
EU Tissues and Cells Directive
As a member of the European Union, the UK is bound by any Directives agreed by the Union
and all member states are required to incorporate them into their national legislation within a given
timescale. The relevant Directive in the case of tissue was the EU Tissues and Cells Directive. The
Directive sets out standards of quality and safety for the donation, procurement, testing, processing,preservation, storage and distribution of human tissue and cells intended for human application (ie.
treatment not research).
Among the requirements of the Directive are that:•••

The UK appoints a “competent authority” to ensure compliance with the standards set out in
the Directive
All establishments where the activities covered by the Directive are carried out must be
licensed by the competent authority once it has verified that the standards are being met.
All licensed establishments must be inspected at least every two years

So, in order to comply with the Directive, the UK needed to establish a regulatory body toinspect tissue establishments and act as the competent authority for tissues and cells.
The Human Tissue Act 2004
The Human Tissue Act 2004 came into force on 1 September 2006. It replaces:•••

Human Tissue Act 1961
Anatomy Act 1984
Human Organ Transplants Act 1989

and equivalent legislation in Northern Ireland. The Act covers England, Wales and Northern Ireland.
There is separate legislation for Scotland, the Human Tissue (Scotland) Act 2006 which is rather
different.
The Human Tissue Act covers, for deceased people, the removal, storage and use of humantissue and for living people the storage and use of tissue (not removal).
The Act refers to “relevant material” which is material that has come from a human body thatconsist of, or includes, human cells except: hair and nails from living people, live gametes (sperm andeggs) and embryos created outside the body (gametes and embryos are covered under the Human
Fertilisation and Embryology Act).

15

Consent is the central principle in the Act – making it a legal requirement for appropriate consent
to be in place before carrying out certain activities.
The Act also set up the Human Tissue Authority to be the competent authority under the EU
Tissues and Cells Directive and to regulate this area.
Carrying out certain activities without a licence from the Authority or without the necessaryconsent is a criminal offence punishable by imprisonment for up to 3 years, or a fine or both.
What activities need consent?
The activities covered by the Act are referred to as “scheduled purposes”. They are divided into
two groups. As a general rule part 1 activities require consent, whether the patient was alive or deadwhen the tissue was removed. The part 1 scheduled activities are:
•
•
•
•
•
•
•

Anatomical examination
Determining the cause of death – post-mortem examination
Establishing, after a person’s death, the efficacy of any drug or other treatment administered
to that person
Obtaining scientific or medical information about a living or deceased person which may be
relevant to any other person (genetic testing)Public display
Research in connection with disorders or the functioning of the human body
Transplantation

There are a few exceptions. Consent is not required:
•
•
•
•
•
•

For a post-mortem examination ordered by a coroner to determine the cause of death
For material stored for the coroner’s or criminal justice purposes“existing holdings” that were already in storage for one of the activities covered by the Act on
1 September 2006
Residual tissue from living individuals used anonymously for research that has been approvedby a research ethics committee
Imported tissue – it may be impossible to guarantee that consent has been given as required in
the Act but it is still good practice to ensure that consent is in place
Tissue from the body of a person who died before1 September 1906 (i.e. over 100 years oldwhen the Act came into force) - in order that museums can continue to accept and display
ancient bodies (Egyptian mummies, for example) even though they do not have consent.

Part 2 activities require consent if the tissue is removed after death but do not require consent if
the patient was alive when the tissue was removed (because these activities are seen as an integral partof diagnosis and treatment).
•
•
•
•
•

Clinical audit
Education or training relating to human health – such as teaching about diagnosis
Performance assessment – including testing equipment
Public health monitoring – such as anonymous testing to determine the prevalence of HIV ina given population
Quality assurance – so double-checking test results for accuracy

There was quite a lot of debate when the legislation was under discussion about whether, fordeceased patients, these basic procedures should be considered an intrinsic part of the post-mortem
examination and therefore permitted using tissue removed after death without explicit consent but theGovernment would not permit this and so consent must always be sought.

16

Who may give consent?
The legislation sets out not only what activities require consent but also who may give consent inorder to comply with the Act.
Living competent adult – the adult
Living competent child – the child or the child’s parent
Deceased adult - the adult before death- a person nominated by the adult to make decisions after death- a relevant family member
Deceased child - the child before death- the child’s parent- a relevant family member
There are a couple of exceptions: for anatomical examination and the use of a deceased body or
body parts for public display can only be authorised by the person him or herself before death;relatives or the parents of children cannot consent to these uses.
Even where the family have a role to play, the individual’s own views always take precedence.
So, it is only if the individual has not given consent before death that a nominated individual or afamily member will be asked for consent.
The Act also sets out which relatives can give consent and the order in which they must be
consulted. So the first person is the deceased patient’s spouse or partner – if there is no spouse ofpartner or that person cannot be contacted, then the deceased person’s parent or child will be
consulted and if there is no parent or child then a brother or sister’s view should be sought and so on.
If there is more than one person at the same level of the hierarchy, for example, if a person had abrother and a sister, the consent of only one of them would be sufficient to proceed. If, however, theperson at the top of the hierarchy refuses consent, that will be determinative and it is not acceptable toask the next person until someone agrees.
If the individual has not given consent and has no relatives, a “friend of longstanding” may giveconsent.
The Human Tissue Authority
The Human Tissue Authority was established on 1 April 2005. It is made up of 17 members, themajority of whom are “lay” ie not doctors or scientists and never having had any professional
involvement with the activities covered. The chairman is also lay. Members and chairman are
appointed by the Secretary of State for Health via the NHS Appointments Commission – so all
vacancies are advertised in the media and anyone can apply. The HTA is supported by an executive
staff (currently 20) divided into teams looking at: regulation, policy, communications and resources.
The Human Tissue Authority was developed on the model of the Human Fertilisation andEmbryology Authority (HFEA) which has regulated infertility treatment and embryo research in the
UK for 15 years.
The main roles of the HTA are:•••Inspecting and issuing licences to establishments carrying out certain activities
Approving applications for living organ donation
Preparation of codes of practice setting out standards and guidelines – currently has 7 codesand one out for consultation. They are:o Consento Donation of organs, tissues and cells for transplantationo Post-mortem examinationo Anatomical examination17

Removal, storage and disposal of human tissue
Donation of allogenic bone marrow and peripheral blood stem cells fortransplantationo Public displayo Import and export of tissues is currently out for consultation
Provide advice to the Secretary of State for Health and the publicoo•Ways of working• Close collaboration with relevant medical and scientific groups• Public consultation – this is a feature of all public bodies
Licensing and the HTA
The deadline for receipt of applications from establishments carrying out activities covered by
the Act was 31 August 2006. By that date the HTA had received a total of 471 applications:
•
•
•
•
•

118 under the EU Tissues and Cells Directive to store tissue for human application
110 for storage for general research use (tissue banks)
194 for pathology
39 for anatomy
10 for public display

Much of the licensing work is undertaken by the staff, rather than by the members of the
Authority. There are two phases of licensing. The first phase is a “desk-based analysis” so this isessentially a review of the information submitted and of a self-assessment completed by applicants ofthe extent to which they believe they have achieved the standards set. (This mechanism has beentested and where visits have been undertaken to validate the self-assessment there has, so far, been agood match).
The second phase is based on site visits – this will involve visiting and inspecting the physicalpremises and interviewing staff. Those activities covered by the EU Tissues and Cells Directive(those storing human tissue for human application) must be inspected at least every two years but
there is no requirement in the Act to physically “inspect” other establishments. For others a risk
analysis will be undertaken to decide whether an inspection should be carried out. Where there areconcerns a site visit will be undertaken and some centres that appear to be excelling will also beinspected in order to see what lessons can be learnt.
Inspections will usually be arranged in advance but unannounced inspections can and will be
undertaken. The procedures are currently still being worked on but the intention is to outsource someof the site visits to other licensing and accrediting bodies, with others carried out by HTA staff.
Decisions about licensing are made by a licensing panel (of HTA staff) which may decide to:•••Issue a licence
Issue a licence with conditions attached
Rarely, refuse to issue a licence.

Licences are usually issued for 3 years but during that time a licence may be revoked or varied.
If an establishment is unsatisfied with the licensing decision, an appeal may be made to an
Appeals Committee made up of not less than five members of the Authority. If, following a decisionby an Appeals Committee, the applicant considers that there is a point of law that has not beensatisfactorily resolved, an appeal may be made to the High Court.
All of this, of course, costs money. The HTA receives some funding from the Government but it
is required to recoup the full costs of its regulatory function from charging licence fees to licensed
establishments. The fees vary depending upon the activities undertaken but for most places arearound £6,000 per year.

18Implications of the Act
Post-mortem examinations
In the UK there are two types of post-mortem examination.
••

A coroner’s PM which is required to determine the cause of death where death was sudden or
unexpected – these do not require consent.
A hospital PM where the consent of the individual prior to death or the family is required

Any retention or use of material once the PM has been completed requires explicit consent. This
includes use for research, education, audit, quality control and includes retaining a block or slide on
the medical record.
Any establishment carrying out a PM examination (both coroner and hospital) must be licensed
by the Human Tissue Authority
In addition to the changes introduced by the Human Tissue Act, new Coroner’s rules wereintroduced in June 2005. These require coroners to notify the relatives about any material that has
been retained as part of the post-mortem examination and to ask them what should happen to thetissue once the coroner’s investigation is complete (i.e. whether it may be used for research, education
etc or if it should be returned for burial or destroyed). This was important because there was concern
when the legislation was being debated that it was unclear who was responsible for seeking consent toretention and subsequent use of material following a coroner’s PM and as a result, the family may not
be approached and an important source of material would be lost.
Anatomical examination
Under the Act, anatomical examination means where people donate their bodies for medical
science to be used for dissection and the teaching of anatomy.
Written, witnessed consent is required from the individual before death; nobody else (including
the family) may give consent for anatomical examination. One concern that is currently being
expressed is that not enough people are signing up for anatomical examination and that the training of
the next generation of doctors may be hampered because of the shortage of bodies available. The
BMA has been trying to encourage the Department of Health to undertake some publicity work to
inform people of the need for the donation of bodies for anatomical examination and telling people
how to sign up to donate.
Anatomical examinations may only take place on premises licensed by the HTA. In the past
places undertaking anatomical examinations were inspected and licensed by HM Inspector of
Anatomy, and this role has now been taken over by the HTA. So inspections are not new for thoseworking in anatomy although there has been some unhappiness about the size of the licence fee as
under the old system no fees were charged.
Research
Deceased individuals – where tissue is removed after death, consent is required for its storage
and use of that tissue for research
Living individuals – where tissue is removed from living patients as part of a diagnostic ortherapeutic procedure (for example residual tissue left over from an operation) consent is required forthe storage and use of the tissue for research unless:• The tissue has been anonymised; and• The research project has research ethics authority approval or approval is pending
Research is not a licensable activity so a licence is not required for the research but a licence may
be required for the storage of tissue for research.

19

Storage
Again, consent and licensing are the two main implications of the Act on those who are storing
human tissue and again there is a difference between material removed from living patients and tissue
removed after death.
For living patients – consent is required for storage for part 1 activities except where it isanonymised tissue stored for a specific research project that has research ethics authority approval orapproval is pending.
For deceased patients – consent is required for all storage of human tissue
A licence is required to store tissue from living individuals only if it is stored:• For future research that does not have ethical approval. This means where tissue is stored ina bank for general research purposes as opposed to for a particular research project.
The reasoning behind this is that there should be a separation between those who are runningtissue banks and those who are “end users” – actually carrying out research or training.
•

For more than 48 hours for the purpose of transplantation – this does not include storage ofblood but it does include other tissue, bone etc to be used for transplantation (this is in order
to comply with the EU Tissues and Cells Directive).

A licence is required for the storage of tissue taken from a deceased individual except if:••

It is stored for a particular research project that has research ethics authority approval
It is sent to unlicensed premises for analysis and will be returned to the licensed premises
once the analysis is complete.

This allows samples taken during a post-mortem examination to be sent to a laboratory thatspecialises in a particularly rare condition for analysis without that laboratory needing to be licensed.
Transplantation after death
Consent must be obtained for transplantation.
In the UK there is an Organ Donor Register where people can record during their lifetime theirwish to donate organs for transplantation after their death. The register currently has nearly 13.8
million names on (22% of the population). Under the Act, registration on the ODR is sufficientevidence of consent for donation to proceed.
If the individual has not registered their wish to donate and they have not nominated someone
else to make decisions for them, the relatives will be asked to give consent on behalf of the deceased.
Under the Act the relatives do not have a legal right of veto.
If the individual had given consent, the relatives do not have the legal right to override thatconsent and donation may proceed despite their objection. Guidance on good practice in the HTA’scode of practice on transplantation recommends that, in the event of disagreement, the family should
be informed that they do not have a legal right of veto and should be encouraged to respect the wishesof their deceased relative. Nevertheless, the Act does not require donation to proceed but only permits
it to do so. Where there is sustained opposition from the family, it may not be appropriate to proceedboth because the health professionals has some duties to consider the wellbeing of the recently
bereaved family and, from a very practical point of view, because bad publicity may damage donation
rates.
This is a subtle but important change. In the past, irrespective of whether the deceased person
was on the ODR, the family were asked for consent to donation and their views held sway. Now, the20

family will be informed that their relative wanted to donate organs and that the intention is to proceedin accordance with those wishes.
The Government believes that this change will, over time, have a significant effect on donation
rates. The BMA very much hopes it will but is sceptical about this. During the passage of thelegislation the BMA lobbied for a change to a system of presumed consent, whereby everyone isconsidered to be a donor unless they have opted out during their lifetime. The type of system wesupported was one where the family would also be asked if they were aware of any unregisteredobjection by the deceased and also where donation would not proceed if to do so would cause severe
distress to the relatives. Despite growing support for such a change, both among professional groups
and the public, this was rejected.
Non-heartbeating donation is lawful
The legislation now makes clear that invasive procedures may be carried out to perfuse theorgans after death, if necessary before consent to donation has been obtained. This has led to a fairly
big increase in the number of non-heartbeating donation programmes that are being established.
Living organ donation
Consent must be obtained
It is an offence to offer or receive payment for transplantation
The provisions in the Human Organ Transplants Act 1989 are reproduced in the new Human
Tissue Act – this makes it a criminal offence to offer or receive money or other benefits for the supplyof organs for donation.
An application needs to be made to the HTA for each case
The Unrelated Live Transplant Regulatory Authority has been abolished and the HTA has takenover its role. The same procedures are now followed whether the donor and recipient are geneticallyrelated or unrelated but emotionally close – such as a partner or long-term friend. So for every case,an application needs to be made to the HTA for approval.
The donor and recipient must be interviewed by an Independent Assessor
The HTA has trained around 120 people around the country who are known as “independent
assessors”. Their role is to interview the donor and the recipient and to ensure that sufficient
information has been given, and understood, that no money is paid for the donation and that theconsent is freely given and the donor is not in any way being coerced into donating. If the Assessor is
happy with the proposal, he or she will recommend to the HTA that the application should beapproved.
Approval must be given by the HTA
On receipt of the recommendation from the Independent Assessor the HTA will decide whether
to approve the donation. In order to minimise delays in considering applications, it is expected that instraightforward cases this decision will be made on the Authority’s behalf by a member of staff, rather
than by the Authority itself.
There are some cases, however, where additional scrutiny is considered necessary such that thedecision must be made by a panel of at least three members of the Authority. These include cases
where the donor is a young child or an adult who lacks capacity to make a decision. In both of thesecases, the donation can only proceed if the donation is considered to be in the “best interests” of thedonor (not the recipient). It is expected that these cases will be very rare and it may be necessary toseek a declaration of a court that it would not be unlawful to remove the organ for this purpose before
the donation can proceed.

21

Paired and pooled donations are permitted
The legislation permits, for the first time, paired and pooled donation whereby a donor andrecipient who are not compatible with each other can pair up with one or more other incompatible
donor and recipient pairs in an organ exchange (so donor A’s kidney goes to recipient B, donor B’s
kidney goes to recipient C and donor C’s kidney goes to recipient A). As this is new, all cases need tobe agreed by a panel of at least three members of the Authority.
Donation to strangers is permitted
Donation to a stranger is also now permitted under the legislation. An altruistic person may offerto donate a kidney to a complete stranger – in the same way that strangers donate eggs or bonemarrow to others without reward. As with paired or pooled donation, each case needs to be agreed inadvance by a panel of at least three members of the HTA.
Public display
Written consent is required from the adult or child in their lifetime; nobody else can give consent
to public display.
A licence is required from the HTA for the public display of bodies of people who have died ormaterial taken from bodies of those that have died.
These requirements do not apply where the material comes from the body of a person who diedmore than 100 years before the Act came into force.
Have we got it right?
It is really too early to tell but there are a few points that are worth highlighting at this stage.
The Act makes no distinction between tissue blocks and slides and whole organs – which somepeople feel is a mistake given the different emotional significance of a whole brain or heart, forexample, compared with a slide of tissue.
The Act is also very complex and is much broader than it, perhaps, needed to be. There has
never been any problem with the use of tissue from living individuals for research purposes – and its
storage does not need to be licensed under the EU Tissues and Cells Directive – yet the Government
decided to include this in its legislation which, again, many people feel is a mistake.
The regulatory aspects of the Act place a high workload and high expenditure on those that are
subject to regulation. Is this a proportionate response?
As with any complex piece of legislation, when it comes to implementation there are often
unforeseen difficulties:
It had been thought that straight forward living donations could be approved at a local level by
the Independent Assessors but the Government’s legal advisors said this was not possible with theway the legislation is drafted and so each case has to be sent to the HTA for approval. We wait to see
whether this will cause delays when the intention was to introduce a new streamlined procedure.
Another issue that is covered in the legislation is the use that can be made of tissue samples
where the individual cannot give consent. It limits the use to activities that are in the best interests ofthe patient and allows some forms of research. This is creating problems where there has been aneedlestick injury to a health professional where the usual practice would be to test a blood sample tosee if the patient is HIV positive in order that an informed decision can be made about whether the
doctor should take post-exposure prophylaxis. Unless the test for HIV is for the benefit of the patient– this will no longer be possible. We are currently in negotiation with the Government about making
Regulations under the Act to permit testing in these limited circumstances.
On the whole though the legislation has been welcomed, it was certainly needed and there is adegree of optimism, particularly about transplantation. We will need to wait and see whether that
optimism continues.

22㩷

Human Tissue Act 2004:
Problems and Solutions
Human Tissue Act 2004:⺖㗴䈫䉸䊥䊠䊷䉲䊢䊮Veronica English
Deputy Head of Medical Ethics
British Medical Association

㪈

Why was new legislation needed?
• Human Tissue Act 1961 wasout of date and unclear• Organ retention scandal• Increasing gap between
supply and demand for
cadaveric organs• Uncertainty about thelegality of non-heartbeating
donation• Disparity between related
and unrelated living donors• EU Tissues and Cells Directive• Human Tissue Act 1961䈲ᤨઍㆃ䉏䈮䈭䉍䇮⿰ᣦ䈏ਇ᣿⏕• ⤳ེ଻▤䈮㑐䈜䉎䉴䉨䊞䊮䉻䊦• ᱫ૕䈱⤳ེ䈱㔛⛎ᩰᏅ᜛ᄢ• ᔃᜉ䈏஗ᱛ䈚䈢ੱ䈎䉌䈱ឭଏ䈮㑐䈜䉎วᴺᕈ䈏ਇㅘ᣿• ⴊ✼㑐ଥ䈮䈅䉎⠪䈎䉌䈱ឭଏ䈫䇮䈠䈉䈪䈭䈇⠪䈎䉌䈱ឭଏ䈱㆑䈇• ⚵❱෸䈶⚦⢩䈮㑐䈜䉎EUᴺ઎
㪉

23

㩷

The Human Tissue Act 2004
• Came into force on 1st
September 2006
• For deceased people covers
the removal, storage and useof human tissue• For living people covers thestorage and use of tissue (notremoval)• Consent is the central principle
underpinning the Act• Established the Human Tissue
Authority (HTA)• 2006ᐕ9᦬1ᣣᣉⴕ• ᱫ૕䈮䈧䈇䈩䈲䊍䊃⚵❱䈱៰಴䇮଻▤෸䈶૶↪䈮㑐䈚䈩✂⟜• ↢ሽ䈚䈩䈇䉎ੱ䈮㑐䈚䈩䈲⚵❱䈱଻▤෸䈶૶↪䉕✂⟜(៰಴䈲㒰䈒)• หᗧ䈏หᴺ䈱ᩮᐙ䉕ᡰ䈋䉎• Human Tissue Authority (HTA)䈱ഃ⸳㪊Part 1 activities – consent needed• Anatomical examination• Determining the cause ofdeath• Establishing, after death,the efficacy of treatment
provided• Obtaining scientific ormedical information that isrelevant to another person• Public display• Research• Transplantation• ⸃೬ᬌᩏ• ᱫ࿃䈱․ቯ• ᱫᓟ䇮᦭ല䈭ᴦ≮䈏䈘䉏䈢䈖䈫䈱⸽᣿• ೎䈱ੱ㑆䈮㑐ㅪ䈜䉎⑼ቇ
⊛䈅䉎䈇䈲කቇ⊛ᖱႎ䈱
ขᓧ
• ౏㐿
• ⎇ⓥ
• ⒖ᬀ
㪋

24

㩷

Exceptions
Consent is not needed:• Coroner’s post-mortem
examination• Storage by the coroner or for
criminal justice purposes• “existing holdings”• Tissue from living individuals
used anonymously for approved
research• Imported tissue• Tissue from the body of aperson who died before
1st September 1906એਅ䈱႐ว䇮หᗧ䈲ਇⷐ䋺• ᬌᱫቭ䈱ᬌᱫ• ᬌᱫቭ䈮䉋䉎଻▤䈅䉎䈇䈲‽⟋ᱜᒰൻ䈱䈢䉄䈱଻▤• 䇸ᣢ䈮଻▤䈘䉏䈩䈇䉎䇹• ⹺䉄䉌䉏䈢⎇ⓥ䈱䈢䉄䇮↢䈐䈩䈇䉎ੱ䈎䉌䈱ඞฬ䈱䊍䊃⚵❱• ャ౉䈘䉏䈢䊍䊃⚵❱• 1906ᐕ9᦬1ᣣએ೨䈮ᱫ੢䈚䈢⠪䈱䊍䊃⚵❱
㪌Part 2 activities –
consent only needed if from deceased• Clinical audit• කቇ⋙ᩏ

• Education or training
relating to human health• ஜᐽ䈮㑐䈜䉎ᢎ⢒䈅䉎䈇䈲ታ⠌• Performance assessment• 䊌䊐䉤䊷䊙䊮䉴䉝䉶䉴䊜䊮䊃• Public health monitoring• ౏ⴐⴡ↢䈱䊝䊆䉺䊥䊮䉫• ຠ⾰଻⸽

• Quality assurance

㪍

25

㩷

Who may give consent?
Living competent adult• the adult↢ሽ䈚䈩䈍䉍䇮ᱜᏱ䈭್ᢿ䈏䈪䈐䉎ᚑੱ• ᚑੱ

Living competent child• the child or the child’s
parent↢ሽ䈚䈩䈍䉍䇮ᱜᏱ䈭್ᢿ䈏䈪䈐䉎ሶଏ• ሶଏ䉁䈢䈲ሶଏ䈱ⷫ㪎

Who may give consent?
Deceased adult• the adult before death• a person nominated by theadult to make decisions
after death• a relevant family member
Deceased child• the child before death• the child’s parent• a relevant family memberᱫ੢䈚䈢ᚑੱ• ᱫ੢䈜䉎೨䈱ᧄੱ• ᧄੱ䈮䇮ᱫᓟ䈱᳿ቯ䉕છ๮
䈘䉏䈢ੱ
• ⷫᣖ
ᱫ੢䈚䈢ሶଏ• ᱫ੢䈜䉎೨䈱ᧄੱ
• ⷫ
• ⷫᣖ
㪏

26

㩷

The Human Tissue Authority• 2005ᐕ4᦬1ᣣ䈮ഃ⸳• Established on 1st April
2005• 17 members, the majorityof whom are “lay”• Modelled on Human
Fertilisation andEmbryology Authority(HFEA)• 䊜䊮䊋䊷17ੱ䇮ㆊඨᢙ䈲䇸ኾ㐷ᄖ䇹಴り• Human Fertilisation andEmbryology Authority(HFEA)䉕䊝䊂䊦䈮䈚䈩䈇䉎㪐

The Human Tissue Authority
The role of the HTA includes:• Inspecting and issuinglicences to establishments• Approving applications forliving organ donation• Preparation of codes ofpractice• Provide advice to theSecretary of State for
Health and the public

HTA䈱ᓎഀ䋺• 䊤䉟䉶䊮䉴䈱ᬌᩏ䈫ᯏ㑐䈻䈱⊒ⴕ• ↢ሽਛ䈱ੱ䈎䉌䈱⤳ེឭଏ↳⺧䈱ᛚ⹺
• ⴕേⷙ▸䈱╷ቯ• ౏ⴐⴡ↢ᄢ⤿䈻䉝䊄䊋䉟䉴
ឭଏ

㪈㪇

27

㩷

Licensing and the HTA• 471 licence applications
received by 31st August
2006• Phase 1 – “desk based
analysis”• Phase 2 – site inspections• Licences usually issued for
3 years• Licence fees – £6,000 per
annum (¥ 1,338,321)• 2006ᐕ8᦬31ᣣ䉁䈪䈱䊤䉟䉶䊮䉴↳⺧ઙᢙ471ઙ
• ╙1Ბ㓏 - 䇸᧍਄ಽᨆ䇹• ╙2Ბ㓏 – ታ⁁⺞ᩏ• 䊤䉟䉶䊮䉴䈲ㅢᏱ3ᐕ㑆᦭ല• 䊤䉟䉶䊮䉴ᢱ –ᐕ㑆6ජ䊘䊮䊄(¥ 1,338,321)
㪈㪈Implications forpost-mortem examinations• Coroner’s post-mortem
examination – noconsent needed• Hospital post-mortem
examination – consent
required• ᬌᱫቭ䈮䉋䉎ᬌᱫ –หᗧ ਇⷐ• ∛㒮䈪䈱ᬌᱫ –
หᗧ ⷐ

㪈㪉

28

㩷
Implicationsforpost-mortem examinations• ᬌᱫਛ䈮ណข䈚䈢⚵❱䈱଻▤䈅䉎䈇䈲૶↪䈲หᗧ䉕ⷐ䈜䉎• Any retention or use ofmaterial removed during
post-mortem examination
requires consent• Post-mortem examinations
must only take place on
premises licensed by the HTA• ᬌᱫ䈲HTA䈱䊤䉟䉶䊮䉴䉕ฃ䈔䈢ᣉ⸳એᄖ䈪ታᣉਇน⢻㪈㪊Implications forpost-mortem examinations
Coroner’s Rules require thatthe family is informed of any
organs or material to beretained and is asked whatshould happen to them oncethe examination is complete.

ᬌᱫቭ䊦䊷䊦䈪䈲䇮⤳ེ䈅䉎䈇䈲⚵❱䈱଻▤䈮䈧䈇䈩䈲ኅᣖ䈮વ䈋䇮ᬌᱫቢੌᓟ䈮䇮䈬䈱䉋䈉䈭ಣℂ䈏
䈘䉏䉎䈼䈐䈎ᗧ⷗䉕᳞䉄䉎ᔅⷐ䈏䈅䉎䈫䈚䈩䈇䉎䇯㪈㪋

29

Implicationsfor㩷
anatomical examination• Written, witnessed
consent is required fromthe individual before death• The family may not giveconsent• Anatomical examinations
may only take place on
premises licensed by the
HTA• ᱫ੢೨䈮ᧄੱ䈎䉌ᦠ㕙䈮䉋䉎⸽ੱઃ䈱หᗧ䈏ᔅⷐ• ኅᣖ䈲หᗧ䉕ਈ䈋䉎䈖䈫䈏䈪䈐䈭䈇น⢻ᕈ䈏䈅䉎• ⸃೬䈲HTA䈱䊤䉟䉶䊮䉴䉕ขᓧ䈚䈢ᣉ⸳䈪䈱䉂น⢻㪈㪌Implications forresearch• Deceased individuals – consent • ᱫ੢䈚䈢୘ੱ – ⎇ⓥ䈱䈢䉄䈱⚵❱೑↪䈮䈲หᗧ䈏ᔅⷐrequired for the use of tissue forresearch• Living individuals – consent• ↢ሽਛ䈱୘ੱ- ⎇ⓥ⋡⊛䈪⚵❱䉕૶required for the use of tissue for↪䈜䉎䈮䈲หᗧ䈏ᔅⷐ䇯research unless:ૉ䈚䇮એਅ䈱႐ว䈮㒢䉌䉏䉎䋺o The material has been䂾 ⚵❱䈏ඞฬൻ䈘䉏䈩䈇䈭䈇anonymised; and䂾 ⎇ⓥ䊒䊨䉳䉢䉪䊃䈏୶ℂᆔຬળ
o The research project has research
ethics committee approval䈱ᛚ⹺䉕⚻䈩䈇䈭䈇• Research is not a licensable• ⎇ⓥ䈲䊤䉟䉶䊮䉴䈱ኻ⽎䈮䈭䉌䈭䈇
activity㪈㪍

30

Implicationsfor㩷
storage of tissue• Living patients – consent
required for storage forpart 1 activities except foranonymised tissue stored
for a specific research
project that has research
ethics committee approval• ↢ሽਛ䈱ᖚ⠪ – 䊌䊷䊃1䈱ⴕὑ䈱ὑ䈱଻▤䈮หᗧ䈏ᔅⷐ䇯ૉ䈚䇮୶ℂᆔຬળ䈱ᛚ⹺䉕⚻䈢․ቯ䈱⎇ⓥ䈱
䈢䉄䈱ඞฬ⚵❱䈱଻▤䈲㒰䈒䇯• Deceased patients –consent always required• ᱫ੢䈚䈢ᖚ⠪ – ᔅ䈝หᗧ䈏ᔅⷐ㪈㪎Implications forstorage of tissue
A licence is required to store
tissue taken from living
individuals only if it is stored:• For future research that
does not have ethicalapproval (tissue bank)• For more than 48 hours
for the purpose oftransplantation (not blood)↢ሽਛ䈱୘ੱ䈱⚵❱䉕៰಴䈚଻▤䈜䉎႐ว䈲䊤䉟䉶䊮䉴䈱ขᓧ䈏ᔅⷐ䇯䈖䉏䈲એਅ䈱଻▤䈱႐ว䈮㒢䉎䋺• ୶ℂ⊛ᛚ⹺䉕⚻䈩䈇䈭䈇዁᧪䈱⎇ⓥ䈱䈢䉄䋨䊍䊃⚵❱䊋䊮䉪䋩
• ⒖ᬀ䈱䈢䉄䈱48ᤨ㑆䉕⿧䈋䉎଻▤䋨ⴊᶧ䈲㒰䈒䋩㪈㪏

31

Implicationsfor㩷
storage of tissue
A licence is required to store
tissue taken from deceased
individuals except if:ᱫ૕䈱⚵❱䈱଻▤䈮䈲䊤䉟䉶䊮䉴䈱ขᓧⷐ䇯ૉ䈚䇮એਅ䈱႐ว䈲㒰䈒䋺• It is stored for a particularresearch project that has
research ethics committee
approval• It is sent to unlicensed
premises for analysis (notresearch)• ୶ℂᆔຬળ䈱ᛚ⹺䉕⚻䈢䇮․ቯ䈱⎇ⓥ䊒䊨䉳䉢䉪䊃䈱䈢䉄䈱଻▤• 䋨⎇ⓥ䈱䈢䉄䈪䈲䈭䈒䋩ಽᨆ䈱䈢䉄䈱䇮䊤䉟䉶䊮䉴䉕ขᓧ䈚䈩䈭䈇ᣉ⸳䈻䈱ㅍઃ㪈㪐Implications forliving organ donation• Consent must be obtained• It is an offence to offer or
receive payment fortransplantation• An application needs to bemade to the HTA for eachcase
• The donor and recipient
must be interviewed by an
Independent Assessor• หᗧ䉕ᓧ䉎ᔅⷐ䈅䉍• ⒖ᬀ䈮ኻ䈜䉎ႎ㈽䈱ឭଏ෶䈲ฃ㗔䈲㆑ᴺ• ฦ䉬䊷䉴Ფ䈮HTA䈻䈱↳⺧䈏ᔅⷐ• 䊄䊅䊷䈫ᖚ⠪䈲⁛┙䈚䈢ᩏቯ⠪䈱㕙ធ䉕ฃ䈔䉎ᔅⷐ
䈏䈅䉎
㪉㪇

32

㩷

Living organ donation
Paired and pooled donations are permittedએਅ䈱䉋䈉䈭
䊄䊅䊷䈫ᖚ⠪䈱⚵䉂ว䉒䈞䇮⤳ེ଻▤䈏⸵䈘䉏䈩䈇䉎

Donor

䊄䊅䊷

Recipient ᖚ⠪

A

A

B

B

C
Donation to strangers is permittedC╙ਃ⠪䈻䈱ឭଏ䈏⸵䈘䉏䈩䈇䉎㪉㪈Implications for
public display• ᧄੱ䈱หᗧ䈏ᔅⷐ – ኅᣖ䈲หᗧ䉕ਈ䈋䉎䈖䈫䈏䈪䈐䈭䈇• り૕䇮り૕䈱৻ㇱ䈅䉎䈇䈲⤳ེ䈱౏㐿䈮䈲䊤䉟䉶䊮䉴䈱ขᓧ䈏ᔅⷐ• หᗧ䈫䊤䉟䉶䊮䉴䈱ขᓧ᧦
㗄䈲100ᐕએ਄⚻䈦䈢⚵❱䋨ඳ‛㙚╬䋩䈮䈲ㆡ↪䈘䉏䈭䈇• Consent must be obtained
from the individual –family cannot consent• A licence is required for
public display of bodies,body parts or organs• Consent and licensing
provisions do not apply totissue over 100 years old(museums)
㪉㪉

33

㩷

Have we got it right?
Too early to tell, but …
• No distinction between
whole organs and tissues
and cells• Very complex and broader
than needed to be• High workload andexpense for those subject
to regulation• Unforeseen difficulties
with interpretationᤨᦼዏᣧ䈪䈲䈅䉎䈏䇮એਅ䈱ὐ䈮⺖㗴䈏䈅䉎䋺• ቢో䈭⤳ེ䇮⚵❱෸䈶⚦⢩䈮㑐䈚䈩඙೎䈚䈩䈇䈭䈇• 㕖Ᏹ䈮ⶄ㔀䈪䇮ᔅⷐએ਄䈮ㆡ↪▸࿐䈏ᐢ䈇• ⷙ೙ኻ⽎䈫䈭䉎䈫੐ോ⊛䇮
㊄㌛⊛⽶ᜂ䈏ᄢ䈐䈇• ੍ᦼ䈪䈐䈭䈇⁁ᴫ䈮䈍䈔䉎
ᴺ⸃㉼䈱㔍䈚䈘
㪉㪊

34

Slide presentation 1

Editors comments for Japanese readers regarding terminology
日本語訳に対する編者のコメント

ｐ23、スライド No.2

そうでない者→血縁関係のない生者
EU 法令→EU 指令

ｐ24、スライド No.4

公開→（博物館などにおける）公衆展示

ｐ25、スライド No.5

犯罪正当化→刑事司法(criminal justice)のこと

ｐ26、スライド No.7

成人→その成人
正常な判断ができる→判断能力のある

ｐ26、スライド No.8

死後の決定を任命された→死後の決定をするために任命された

ｐ27、スライド No.10

行動規範→実施要領
公衆衛生大臣へアドバイス提供→保健大臣および公衆へアドバイス
提供

ｐ30、スライド No.15

家族は同意を与えることができない可能性がある→「法的に同意を与えることができない」の意

ｐ30、スライド No.16

但し、以下の場合に限られる：○ 組織が匿名化されていない○ 研究プロジェクトが倫理委員会の承認を経ていない→
但し、以下の場合を除く：○ 組織が匿名化されており、かつ○ 研究プロジェクトが倫理委員会の承認を経ている場合

ｐ33、スライド No.21

以下のようなドナーと患者の組み合わせ、臓器保管が許されている→「ペアード・ドネーションとプールド・ドネーションは許容されている」の意。禁止も強制もされていないことを意味する
第三者への提供が許されている→「血縁者でも知り合いでもない、
まったく他人への提供は許容されている」の意。禁止も強制もされていないことを意味する

ｐ33、スライド No.22

公開→（博物館などにおける）公衆展示

35

Discussion
Mitsuishi: Consent forms
Thank you very much for a very interesting and very beneficial presentation. I would like to
ask the difference between organs and tissues. Question as to whether there is a difference between
consent for use of organs, tissue and cells (organs consist of tissue, tissue consists of cells) or whether
consent for organs covers consent for tissue and cells.
EnglishConsent would need to be specific. So, if it were for transplantation, for example, an individual
would sign up for organ donation and there would be a discussion with the family about tissue
donation, but the implication would be that if you agree to organ donation you are likely to support
tissue donation as well. There is talk about extending the nature of consent so that it explicitly says
“organs and tissue” and I think that we will go much further along that road of being more explicit.
If you are giving consent for research use of tissue, then that would include tissue and cells but would
not extend to organs. In terms of donation of organs for research after the death or post-mortem, theform will be quite explicit about what the individual or family are agreeing to. I think after AlderHey consent was very explicit and families were given so much information. It was felt that it wascounter-productive and it was more than relatives wanted. So it’s a matter of getting the rightbalance and I think we’re moving back now so that we might talk about cells, we might talk about
tissue and we might talk about organs but we wouldn’t go into any more detail than that. At one
stage when talking to relatives about transplantation immediately after Alder Hey they were talking
about organs and blood vessels and listing absolutely everything that would be taken. So it’s a matterof getting the balance right about how much the relatives want to have. It’s actually about having“enough” information – which is enough for most people – but always being willing to give more
information if the relatives or the individual wants it. So that’s the way that it’s going.
Mitsuishi
Do you mean that consent form put details always like organs, tissues, cells?
EnglishI haven’t actually seen the standard consent forms yet so I’m not sure how much detail there will
be but what is clear is that what they are consenting to will be made explicit. It has to be madeexplicit now after Alder Hey when they were talking about tissue but what they actually meant wasorgans so it is going to be much more explicit.
Mitsuishi
So, the grounds of individual right to consent to organs or tissues or cells…are different?
EnglishI think that somebody may well be happy to donate tissue but not organs, for example. So I
think yes, there might be. I’m not sure about cells and tissue, I think probably less so, certainly inthe public’s mind. The public has a very clear view about what is an organ and what is tissue so I
think that they definitely might make that distinction.
Kurihara: Researches on tissue from living donors
Thank you very much for your very clear explanation about very very complicated situation. I
have many questions but time is not enough so I would like to ask you about little thing concerning
research use of the tissue from living donor. What I would like to confirm is relationship between
license by regulatory authority and authorization by ethics committee. Is it right to say that if
regulatory authority’s license is acquired, there is no need to acquire an authorization by an ethics
committee?
EnglishResearch ethics committee approval always has to be provided for research and research itself
does not require a licence so the Authority would not licence research projects. They might licence36

storage if you have a tissue bank, so that’s the only side of regulation that’s relevant. In terms ofconsent, you have to give consent for the use of identifiable tissue but that still has to have research
ethics committee approval. If the tissue is to be used anonymously, so if it’s taken for diagnosis andthere is left-over tissue and it’s anonymised, then that can be used without consent provided there isresearch ethics committee approval. So research ethics committee approval is required for all
research.
Kurihara
I understand there is some provision to define the function of the research ethics committee…
EnglishThat’s right and I’ll talk a little bit about that this evening when I talk about research. There has
been a lot of work on improving research ethics committees over recent years. This legislation has
put a lot more weight on research ethics committees and that has required a review of their working
because they have not always worked well in the past. There have been real problems with ethics
committees and they haven’t had the support and they haven’t had the respect that they needed and so
there are a number of changes and I’ll go into the detail of some of that later on.
Maruyama
I would like to ask the meaning of anatomical examination. From your talk, I understand thatthe main focus is placed on the dissection of human bodies for the purpose of medical education, but I
am wondering if this concept of anatomical examination includes the human body dissection for the
purpose of pathological purposes.
EnglishI think that would probably be covered under a hospital post mortem examination. Anatomical
examination means training in medical schools, training medical students in dissection for example.
If the examination is for pathology, then that would be covered by a post mortem examination. The
coroner’s post mortem examination is specifically to determine the cause of death whereas a hospital
post mortem is much broader – it’s looking at other aspects too.
Maruyama
If you dissect a human body for the purpose of determining whether the diagnosis was proper ortreatment was proper or what the main cause of death was, is that dissection will be included in…
EnglishIn post mortem examination.
Obata
You mentioned about the Human Tissue Authority. Are they full-time jobs?
EnglishNo, they’re part-time jobs. They are paid but it will be a certain number of days per month so it
may be two or three days per month or something like that. They will attend meetings and they will be
paid – normally a daily rate. So they don’t get paid a set amount for being a member of the
Authority but they are required to give a certain number of days to attend meetings and they are paid adaily rate for every meeting they attend.
Obata
Are they able to handle such a huge amount of job?
EnglishWell, most of the work on the applications will be done by the staff and there are full-time staff
who are employed to do that. They will be the ones that will look at the applications as they come in,they will decide whether a site inspection is needed, they will go on the site inspection if one is37needed and they make up the licensing panels. So the Authority itself – the members of the
Authority itself – don’t do that but they do hear appeals against licensing decisions. So if somebody
is unhappy with the decision made by a licensing group made up of staff, then they will appeal tomembers of the Authority, and as I mentioned with living transplantation, there are certain types ofliving transplantation where there has to be a panel of three members of the Authority. There aresome things that the Authority members have to do. They will also meet on a regular basis –probably once a month I imagine – that’s how they’re meeting at the moment and they will look atwhat is happening, they will identify any problems, they will keep an overview and they will look atpolicy issues so decide the policy of the Authority, for example whether they’re going to produce any
more information for patients, whether any more codes of practice or any more guidance are needed,
so it’s more those sorts of thing Authority members will do rather than dealing with the day-to-day
research or licensing applications.
Obata
Are there 20 people hired for this?
EnglishYes, that’s right and what they may do is to out-source some of the inspections. There are otherbodies in the UK who do inspections and they may get some of those bodies to do some of theinspections for them. That still has yet to be decided – they’re still deciding how to do that and also
how many inspections they will do, because of course it’s only, as I said, the establishments that are
storing tissue for human application that must have site visits. So there’s quite a lot of issues thatthey are still deciding how to implement.
Norton: Postmortems
There's one thing that I find puzzling but maybe I misunderstood it -where the postmortem with
the Coroner establishing the cause of death, this often leads to a possible criminal matter. I got the
impression that there was a possibility if specific permission was not granted, after the postmortem iscompleted, they couldn't keep the slides or organs or other bits and pieces without specific permission.
You thus have the possibility that having done the tests and reached your conclusions, you then haveto dispose of the slides and human material. Then if some new piece of evidence comes along, you
may want to be re-examine the slides and are unable to do so.
EnglishWell, it’s very interesting because we had exactly the same discussion. It’s not quite as you said
because the material can be stored as long the coroner requires it. So once the coroner has decided
that he or she no longer needs it, then it has to be disposed of unless you have consent for further
retention. Now, they can say, well, we need to keep this because there may be more evidence
coming up. If there’s a criminal case then obviously it has to be retained in order for that. What it
doesn’t cover – and we did raise this issue with the government – is if the coroner is happy, says itshould all be disposed of, but then exactly as you said, more evidence comes to light – we raised that
but they said well, it’s up to the coroner to decide when it goes and as soon as the coroner says they nolonger require it, then it has to be disposed of.
NortonSo there is a possibility?
EnglishI don’t know whether what will happen is the coroners will therefore keep the slides because they
will say that they need to keep them for longer periods. I suppose that is possible. Of course, oneof the difficulties is that under Alder Hey a lot of the organs were removed from coroners’ post
mortems. It wasn’t just hospital post mortems. A lot of them were from coroners where they had
been retained so that’s why they really didn’t want to give any more power to retain them without
consent.

38

NortonSo the period of retention is very relevant. Only a couple of weeks ago someone was arrested fora murder carried out 35 years ago on the basis of DNA evidence, so that material had been kept for avery long period. Now I can't imagine the coroner saying to be on the safe side, we will keep thissample in perpetuity.

39

Human Tissues as Materials for Research and Practical Use: A Workshop forInternational Understanding in Related Law and Ethics with Special References to
British and Japanese Systems
Session I: Regulations and moral-ensuring mechanisms in the U.K. and Japan, an
overview
Yuichiro Sato, Associate Professor of Yokohama City University
3-9 Fukuura, Kanazawa-ku, Yokohama
1. Statutory background of human tissues/cells in Japan
We have Civil law system, but legislature process is very slow. So general statutes such as civil
law and penal law are very old, and there are a few specific statutes concerning human tissues/cells.
Japanese civil law (imported from Germany) has a dichotonomy of subject-object of the property
right. It is said that living person is subject of right, but that when he/she deceases, or where a part isremoved, it becomes the object (Supreme Court of Japan, 1921). Of course it is very “classical” wayof thinking, and it should be argued whether it still applies in the contemporary context where bodyparts may make lots of money.
Japanese case-law is that dead body and/or its part belongs to one of the family member who is
expected to do memorial ceremony of the family, like tombstone and altar are succeeded.
(1) The law concerning human cadaver general is provided in those two statutes below:①The act of anatomy and hold of cadaverThis was enacted in 1948, soon after we surrendered to the Allies (USA, UK, China and so on) in
World War II. There are two reasons of this enactment. In those days many were died in road fromhunger, so General MacArthur directed to Japanese Government that they should search the cause ofdeath (corresponds to coroner / medical examiner post mortem). And many medical schools were
instituted during WWII, and the need for cadaver for medical education increased. According to these
two reasons, Japanese government provided two temporary regulations respectively, and soon
legislature enacted one statute combining these two.
This act provides the anatomy for search of the cause of death, dissection for criminal procedure,
dissection for administrative purposes (without suspicion of criminality, just the cause of death isunknown. But this is done in only 5 cities in Japan, Tokyo, Yokohama, Nagoya, Osaka and Kobe, andeven in these cities there are many problems), dissection in hospitals, and dissection for medical
education. Relatives’ consent is generally needed, but in case of medical examiners’ case, in criminal
investigation and some specific cases, there is no need to get consent from surviving relatives.
Besides, this act provides the requirements for keeping cadaver/parts. There are 3 provisions.
One is in university hospitals and some special hospitals. The chief of hospital may keep cadaver/parts
with consent of surviving relatives. Second is after dissection. Doctors who do dissection may keep
parts (not the whole cadaver) without consent, but they must return to relatives if relatives claim. And
third other hospitals may keep cadaver/parts with consent of relatives and permission of the governor.
Section 17 Medical schools and some specific hospitals may preserve whole body or body parts as a
specimen when it is needed for medical teaching or research, with surviving relatives’ authorization.
Section 18 Those who are entitled to do autopsy by section 2 of this act may preserve body parts as a
specimen when it is needed for medical teaching or research, except the surviving relatives claim it be
returned.
Section 19 Besides the above two sections, those who preserves whole body or body parts should get
authorization of surviving relatives and permission from the governor of the prefecture.
Object of preservation
Succeeded byauthorization of relatives
Sec 17
whole body and body partsneededSec 18
only body parts
autopsy
not mentioned*
Sec 19whole body and body partsneeded* But authorization of surviving relatives’ for autopsy is needed generally.
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan40

②The act concerning donation the body after his/her death
The statute above permits the keeping if there is consent of relatives, but in practice they don’t
tend to give permission in spite of the wish of the deceased. So a patient group supported to enact new
statute that enables to dissect for medical education with (only) the deceased’s consent. This statutepermits this, if there is no refusal from surviving relatives.
(2) The law concerning organ transplant①Former act
Professor Imaizumi at Iwate Medical School (a private school) first did corneal transplant in
1949, and later he did by using cornea from eye-bank (he himself established) in 1957. But it was notclear whether removal of cornea from cadaver fitted within “destroy of cadaver” in the criminal code
(article 190). So legislature enacted the act on corneal transplant in 1958. This permitted the removalof cornea from dead body if there was written authorization of surviving relatives.
And in 1969, this was succeeded by the act on corneal and renal transplant. The requirement ofremoval was the same in corneal transplant act.
②Current act
In 1968, soon after Dr. Bernard did heart transplant in South Africa, professor Wada at Sapporo
Medical School (a municipal school) did heart transplant. But this was criticized that the selection ofrecipient was not proper and that there was room for life saving of the donor. After this, no hearttransplants were done in Japan. 80’s and 90’s, we had a lot of debates on organ transplant, especiallyon brain death and the “right to self-determination” of the deceased. Two drafts were proposed toparliament, both are based on “self-determination” of the deceased, but, one provided brain death tobe general (regardless of transplant), the other did not permit brain death to be the death criteria but
only permitted removal of organ to be legal. The former was approved by the majority, and became alaw in 1997.
This act permits the removal of organ (heart, lung, liver, kidney and some organ (pancreas andsmall intestine, according to the regulation) and eye ball if there is written authorization of thedeceased himself/herself and there is no refusal of surviving relatives. And once removed, the organ
may not be used for other than transplant. That means if the organ is not transplantable, it should becremated and we may not use it for research, even if the deceased gave consent to such a use.
③Living donor
Organ Transplant Act described above regulates cadaver transplant only (but ban of give/get
remuneration is also applied to transplantable material from living donor). Recently many problems
came to light. It was reported that living kidney donor(creditor) got 30 thousands yen and small carfrom recipient(debtor), and both of them were arrested and prosecuted. Donor was found guilty insummary proceeding and fined 1 million yen (10/27). And it also came to light that the urologicalsurgeon who did transplantation in this case did around 30 disease kidney transplants.

(2) The law on special circumstances is provided as below:①The act on abortion and professional guidance on research use of fetus
Japanese criminal code bars abortion (article 213, two year imprisonment or less, and if doctors
and midwives commit, three month to five years (article 214)), but special statute (protection of
mother) makes abortion legal on the ground of physical and economical reason of the mother.
There are no statutory provisions on the dispose of the fetus (but it is contagious waste in themeaning of act on disposal of waste (Yokohama District Court Judgment, 5/12/2005)). The
requirements to research use of fetus are provided in professional guidance of Japan Society of
Obstetrics and Gynecology (January of 1987).
The requirements are:
1: The handling of fetus and stillborn child should be according to the act of anatomy and hold of
cadaver (described above in (1)①).

41

2: The research use is permitted only where there are no alternatives and where the result
expected is to be of great importance.
3: The person who uses fetus and stillborn child should be a medical doctor, and others who help
him/her should understand the special characteristics and its importance to society.
4: The person who is to use fetus and stillborn child should inform the purpose to mother andfather (parents) and get their permission prior to the use. The privacy of fetus, stillborn child andparents should be respected.
* Research involving living fetus and child may be done if it is expected to improve the life
expectancy and with the consent of mother and father (parents).
②The legal situations on hES cells and cloning
A. Statute and regulations on human cloning
Legislature enacted an act banning reproductive cloning. It delegates the requirements ontherapeutic cloning to regulations. But it also provided that draft regulations should be consulted by
Sogo Kagaku Gijutu Kaigi (Council for Science and Technology Policy) before its publishing (Art.
4(3)). In the discussion of special committee under CSTP, therapeutic cloning was criticized becauseof the "dignity of embryo". So the regulations permitted only Animal-human chimeric embryo(Art.2 (1) 20).
B. Research on human ES cells
We don't have staturoty ban nor regulation on hES cells, but ethical guidelines.
* The Japanese for "regulations" on therapeutic cloning and "guidelines" for hES cells are sameword, "Shishin"（指針）. The distinction is my personal opinion, based on whether it is legally binding
or not.
C. Recent discussions
CSTP published a report on human embryo on 23/07/2004, in which they proposed to permit
therapeutic cloning for the research where there is no way of therapy for that disease. Ministry of
Education established an committee, and this committee published an interim report on 20/06/2006,
and it was under public consultation from 12/07 to 31/08. This proposed to permit therapeutic cloning
under strict requirements, but some researcher (inc. Professor Nakatsuji of Kyoto University, who is
the only researcher developing hES cells in Japan) oppose that is too strict to be practicable.
(2) Governmental guidelines① Fundamental Principles of Research on the Human Genome (2000)
http://www.mext.go.jp/a_menu/shinkou/shisaku/principles.htm
This is the adaptation of UNESCO’s Universal Declaration on the Human Genome and Human
Rights (1997). It calls itself as “constitutional document” (but doesn’t have any legal authority), andrequires sets of guidelines on genome research and its clinical use should be established following thisPrinciples. And under this, sets of guidelines have been provided by the government as below.
② Ethical Guidelines for Human Genome and Genetic Research (2001)
It succeeded guidelines for government-funded genetic research, extending its focus to
private-funded research. Its statutory authority is not clear (and whether it is legally binding). It
provides responsibility of head of research institution and researcher, establishment of research ethics
committee, and information to be provided to research participants.
③ Ethical Guidelines for Epidemiological Research (2002)④ Ethical Guidelines for Clinical Research (2003)
Interestingly, these process started from narrower research field (genome research) to broader
field (clinical research, in which research on identifiable data and materials are included). And there isso called “inverse order”, that is, more ministries in the narrower field, and fewer ministries in the
broader field. GLs② were published from three ministries (M of Education, M of Health and M of42

trade), GLs③ from two (M of Education and M of Health) and GLs④ from only one (M of Health).
These guidelines above generally provide IC of research subject (and proxy consent where the subject
doesn’t have competency) and approval of RECs.
2. Cases around human tissues/cells(1) Jichi-Idai case: handling of blocks/slides
Fact of this case:
05/16/1988 A woman (plaintiff’s mother) was admitted to the defendant hospital.
Diagnosed as renal crisis (from systematic sclerosis).
06/20 She died from respiratory failure caused by bleeding in lungs.
After her death plaintiff and his father were asked by the attendant physicians (not by
pathologists) to give permission to hospital post mortem and organ retention. They consented todissection and retention of only internal organs and brain, and the plaintiff specifically opposed toremoval of one finger (it was disputed whether plaintiff opposed removal of any bone at that time. But
it seems that they did not discuss about bone or bone marrow.) Plaintiff also insists as a requisite that alist of retained organs and pathological report to be handed afterwards.
Pathologists released a summary (in Japanese?) and later full pathological report in English toplaintiff including the description of “hypercellular bone marrow”, which means that pathologists
retained and examined bone. The plaintiff told pathologists and the head of hospital that he had meant
to authorize only internal organs and brain, so he wanted whole bones returned. A pathologist
explained to him that, in a medical sense, bone marrow was included in internal organs, but plaintiff
was not convinced by this. Plaintiff insisted that all retained organs and tissues should be returned.
09/28/2000 According to this, defendant pathologists returned formaldehyde-fixed organs to theplaintiff. But they still kept some paraffin blocks and slides.
Case 1: replevin on property right(Tokyo district court, 11/24/2000)
Plaintiff filed this suit claiming that all materials (blocks and slides) should be returned on the
ground that he had property right to them. Defendants argued that bone marrow was so importanttissue to human body function that removal and retention of sternum(breastbone) and vertebra (onepart of spine) was done worldwide without surviving relatives’ consent (they said this practice“common sense of the world”). They also insisted that microscope specimens should be excluded
from “body parts” in Anatomy Act because they could not be substituted by photographs and they had
little nature of remembrance of the deceased by surviving relatives, and that such a claim was abuseof rights because the retention and use of body parts were of great importance to public health andmedical education.
< Judgment for the plaintiff >The Act has only administrative effect, so for hospitals to retain organs lawfully there shouldhave been certain contract (gift or bailment) between the surviving relatives and hospital. But for thiscontract there must be a relationship of mutual trust between these parties. But in this case, thisrelationship was destructed by the defendant conduct, that is, plaintiff’s opposition to removal of bone
was not properly observed. So plaintiff may withdraw his permission. And defendants’ pleading on
the “microscopic specimens exception” are without merit because, with the application of work andskill, they are still parts of the corpus.
Case 2: compensation on mental distress (Tokyo district court, 8/30/2002)
Plaintiff filed another suit on negligence for around 20 million yen. His claims are:1) that defendant failed to get plaintiff’s permission for removing and keeping bone marrow; heargued that he, as a successor of the deceased, had a right to limit the area of autopsy; defendants
argued (1) that the person who might give permission had been the deceased spouse (plaintiff’s father)so he did not have a standing, and (2) that plaintiff did not oppose the removal of bone explicitly.
2) that defendant failed to give plaintiff the list of preserved organs, which had been was therequisite of autopsy;
3) that defendant failed to return organs on plaintiff’ claim; and434) that defendant negligently broke one of the slides.
< Judgment for the defendants. >*This case was addressed in “medical malpractice section” of the Tokyo district court!
1) Plaintiff has a legal standing to limit the area of dissection according to Anatomy Act, which
provides “surviving relatives’ consent should be obtained to hospital post mortem.” But he did not
oppose explicitly the removal of bone at the autopsy.
Of course, it would be a good practice for doctors to tell surviving relatives the details ofdissection, including what organs be removed, and they treat bone and bone marrow as internal organs.
But at that time doctors apprehended bone marrow as internal organ which makes blood cells andreasonable people could imagine “Pathological dissection” includes removal of internal organs for
detecting the cause of death. And it is reasonable not to get explicit authorization from surviving
relatives to dissection where the area is covered with clothes. And at that time “INFORMEDCONSENT”* to surviving relatives were not perceived. So defendants’ removal of bone marrow withthe authorization on internal organs is not negligent.
*In Japan, “INFORMED CONSENT” is (mistakenly) understood as doctors’ disclosing
information to patients.
3) Section 17 of the Anatomy Act does not have provision of claims from surviving relatives,
whereas provided in section 18. So in this case retention is authorized by the section 17, so defendant
hospital do not need to return retained material. Civil contract should be a gift. Guidelines from
Ministry of Health provide that regardless of the provision of Anatomy Act, retained materials should
be returned on the claim from surviving relative without delay. It would be a good practice andreasonable, but breach of this does not give rise to legal responsibility on negligence.
Appealed by the plaintiff, and Appellate court held the judgment of the district court (Tokyoappellate court, 1/30/2003), and the Supreme court rejected appeal.
(2) Kansai idai case: insert of catheter for preservation of kidney before death
This case was subject to former Corneal and Renal Transplants Act, which authorized removal of
cornea and kidney by the surviving relatives' written consent.
A woman, with a husband and parents, was suffered by SAH. She was in "clinically brain dead"condition, and an attending physician asked relatives to kidney donation, and they consented andsigned a document. But they didn’t consent to vessel donation. Before circulation system ceased,
physicians inserted a catheter to the patient's vein as preparation for cold perfusion. She died at theage of 40, and after her cardiac death, physicians did cold perfusion and removed both kidney andvessel.
The mother of the deceased, who was a registered nurse (the decease had been a RN also), filed
this suit.
Issues disputed among the parties were:(1) the validity of the consent; the plaintiff argued that they had not allowed to have enough time todeal with donation so the consent was not valid.
(2) the appropriateness of treatment.
(3) whether the insertion of catheter was unlawful or not; plaintiff argued that this had been done withneither the deceased's nor the surviving relatives' consents. The deceased had been alive at the time ofinsertion, so physical intervention to the body without the purpose of treatment should be illegal
activity. Relatives may not authorize such an intervention (it is personal right) but it becomes more
culpable without disclosure to them.
(4) whether the removal of vessel had been done under the physician's direction, and if so, whether it
was unlawful.
The court approved plaintiff's claim on the above (3), and ordered the defendants to pay 200
thousands yen to the plaintiff.

44

The reason was that:(1) The husband had been consented to the donation, because partly on the ground that the deceased
had had a wish to donate kidney for transplantation. The physicians had asked him to ensure that otherrelatives had not had opposition to this, and sometime after he had not disclosed that it had been.
Physicians had made a phone call to the deceased’s father (plaintiff's former husband) and he had
consented also.
(3) Physical intervention without the intention of treatment was generally illegal. To make such aintervention lawful, the person's explicit consent was essential. In this case, the insertion of catheter
was not for treatment to her. We could not find any reason that husband’s consent made the insertion
lawful, and even if we could, he had not made informed consent.
This had caused the deceased's mental distress, and this should amount 900 thousands yen. The
plaintiff succeeded a sixth of this, so she should be awarded to 150 thousands yen. Also she should be
paid 50 thousands yen for her load of her attorney fee.

45

Consideration on Japanese issues with special references to liver organ transplantationfrom live donors
Kaori Muto, Associate Professor: The Institute of Medical Science The University ofTokyo
4-6-1 Shirokanedai, Minato-ku, Tokyo
Hello everybody, my name is Kaori Muto, and my background is sociology. I’m doing a lot ofwork in the field of science, society and medicine. I’m doing some research about living liver
donation in Japan. So I’m going to talk about living liver donation at first, second, research ethics
committee like I belonged, and third one is public consultation and public discussion how to follow
public.
As Dr. Sato introduced Japanese situation, family members are the first candidates for organ
donors. Living donor contributed 98 percent of whole liver transplantation in Japan and 80 percentof whole kidney transplantation until they started. I think numbers of Japanese organ recipients who
underwent transplantation outside Japan have not been counted until this year. On the other hand,
Japanese health insurance policy covers several forms of organ transplantations. Actually most oforgan transplantations are covered by health insurance The recipients have to pay very small amountof money compared to other countries. Since the first living organ was transplanted in 1989, themedia has created the beautiful human stories. Transplant physicians also have neglected to argue
legislation to collect living donors with that kind of act, so why liver transplantation in Japan fromliving donors we have not any social security policy to recover their health as nearly perfect as before
transplant. I have heard that in United Kingdom they have discussion about social security, living
donors have to take an official leave.
A female liver donor to her husband was killed by transplantation, and another female who
donated her liver to her husband was paralyzed this year. I and other colleagues have conducted two
kind of studies of diving donors. We conducted questionnaire survey to Japanese living liver donors
between 1989 to 2003. We sent 2411 questionnaires and collected 1480 answers. The thing I
remember is 10 percent of all donors didn’t receive these questionnaires because hospitals didn’tknow where they lived. This means nationally they are not traced. I think most of people say thatthey recover on their health and they are satisfied with their experiences of transplantations. But it’sfrom only 17 percent of respondent. Some of them suffers very severe guilty, regret, distrust in
family adverse evens including unexpected divorce and attempted suicide. They didn’t have good
relationship with hospitals, they didn’t go to ask their doctors, they didn’t get counseling.
Regarding to motivation for donation, most of female donor reminded themselves just strongly
believed “I am only one person who can help my child or my husband.” Or some people say thatthey want to earn or re-earn the high esteem from family members. Is this voluntary or not? But
actually the consent forms, physician says we confirmed their voluntary view in organ donation.
Even though they have old family histories or many kind of motivations.
The second study was conducted last year, we asked Japanese liver transplant hospitals to sendbrochures and consent forms about liver transplant which are given to living donor candidates. And
these brochures and consent forms are prepared and provided by each hospitals, not standardized bynational level. The purpose of the study is to count how many and what kind of items are describedfor donor candidates in these brochures, and to suggest improvement for the better understanding.
We collected these written materials from 41 hospitals and analysed these contents and find out 126
items that are categorized into 66 groups. That means these items are explained to donor candidates.
93% of brochures comment of this complications are after operation. But the most surprising thing
to me is no common items are there. Other 7% of brochures don’t mention it. And 76% of
brochure mentioned the period of hospitalization. And the most programmatic thing is the right ofwithdrawal of donation is covered only 59 % of brochures. And also scar, pain or body change thatis very familiar to the donors are not described yet. It’s really low level. That the consent form ofJapanese living donation. So I’m really wonder what is the voluntary will or what is consent for.
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan

46

Re-conducted other studies doing for this, to the research ethics committees, physicians, donors
and recipients, what kind experiences they have. Some people said members of research committeecame to the bedside and asked their voluntary will. And some other doctor who are not involved in
the transplantation asked them again “Are you really voluntary or not?” The style is barrier, it’s notstandardized, also.
The second question regarding this is what is the research ethics committee and what is thecorrelate research committees and ethics committees in Japan. Most of Japanese ethics committees
are combined research and clinical trial. In my experience, I have worked for research ethics
committees or ethics committees in universities or hospitals for some years, but I havn’t experienced
any training before doing this. Are there any people who are working for research ethics committeeor ethics committee in Japan have experienced any training before doing this? Regarding to this talk,I’d like to ask Veronica what is training for HTA members? Or how is their training to independent
assessors?
And regarding the third question is public consultation, and most of research ethics committees
and ethics committees in Japan welcome lay people, very minority members. But lay people also
don’t experience any training for research ethics, science or medicine. I heard that central office of
research ethics committee in England provoke some discussion of this, they provide education to, if
you comment of experience because of quality of ethics committee or research reviewing ethics
committee and also quality of health care are equal. I’m very happy if you comment that thing.
Finally, I mention to Dr. Sato’s presentation. You mentioned aborted fetuses may be collected
as resources of cosmetic company. But I think most of them are not fetuses, but placenta.
Cosmetic companies used to collect human placenta to produce cosmetics. I visited some placenta
collecting industry, there are so big placenta collecting industry in Japan, and they say they do not use
human placenta now, they use pig’s one to produce cosmetics. I think it is really difficult to use
fetuses to cosmetics.
That’s it. Thank you very much.

47

Discussion
EnglishThank you. That was absolutely fascinating – very interesting. To answer your specificquestions about training and you raised three different groups: independent assessors, Human Tissue
Authority members and ethics committees – I’ll take them each in turn.
The independent assessors have training provided by the Human Tissue Authority and they haveto go through that training and they have to be accredited by the Authority to say they have been
through that training before they are allowed to see any donors and recipients.
I think they have
now got 120 trained assessors and they have all attended training sessions. I don’t know the exact
details of what that involves but I understand that it is fairly detailed and involves a lot of emphasis oncommunication skills and talking to people. One of the skills they need is to be able to try to assess
people’s motives. Sometimes if people are acting under pressure the independent assessors need to
be able to judge and assess that and try to encourage them to express those views. Independent
assessors also need to understand the clinical information because they have to ensure that the patient
has understood what the procedures involve, what the risks are. That is important. As you said thefact that only 93% of brochures for living liver donors say that there are complications is really quite
surprising.
In fact, in the UK, there is very little living liver donation. It’s very new – we really only haveliving kidney donation on any scale at the moment. In fact until very recently there was no living
liver donation on the National Health Service. There were maybe one or two units that were doing asmall number privately so I was astonished by the number carried out here. So the independent
assessors have a very vigorous training before they can be appointed.
The Human Tissue Authority members will be given training. I don’t know exactly what
training they have but they will certainly be given training on the terms of the legislation and what
they will be required to do. Because members come from different backgrounds - some are clinical,
some scientific and some lay – I imagine the training they receive will depend on their existing levelof knowledge. It is important to ensure that everyone has sufficient basic information in order thatthey can make the judgments they are required to make.
Moving on to ethics committees, I will talk this evening about some of the things that havebeen happening with ethics committees but this has been a very big problem because until recently
there was very little if any training for ethics committee members. As I said earlier to the questioner,
because we have now put so much weight on research ethics committee approval, they have greater
status and it is therefore even more important than ever that those decisions are carefully thought
through and that the people are trained. So there is now a lot of work going on to ensure that there istraining. As you said the Central Office for Research Ethics Committees (COREC) has beenworking on this for a number of years but it is something that is going to increase. Now there arealso a lot of other changes coming in to make them much more professional because until now ethics
committees have really been volunteers doing the best they can in their spare time with very little
support, little or no training frequently, and very little administrative help. The proposal now is toactually pay ethics committee members for their time so that there are people who see it as a job andmaking it much more professional, so there are changes afoot on those grounds.
Matsumura: Validity of consent
Informed consent is a key word. My understanding, however, is that making decision by one's
own self is really a fragile thing.
Particularly in this country, we do not have a long inheritance of making decision by one's own
self. As Muto sensei says, making decision as a living donor needs to be quick, but can be emotional.
In Human Tissue Act, what is regarded as important condition for an informed consent to bevalidly and effectively made?
EnglishInterestingly, the Human Tissue Act does not use the term “informed consent” at all. It uses theterm “appropriate consent”. When there were debates in Parliament, they deliberately did not use
the term “informed consent” because it is a difficult concept. “Appropriate consent” in terms of thelegislation, only relates to who gives the consent so it is “appropriate consent” if it is given by the48

person themselves or, if they haven’t given consent, then the person they’ve nominated or a certain
family member. So the only reference to consent in the legislation is about who gives the consent
but obviously we have a general understanding of what “informed consent” means. In fact weusually use the term “valid consent” rather than “informed consent” – one part of being “valid” is thatyou have information but there are other aspects to make the consent “valid”.
If you use “informed consent” it sounds as if information is the only factor whereas actually you
need to be competent to give the consent, it needs to be voluntary and there needs to be no pressure on
you so we use that broader term “valid consent”. There are, as I mentioned, a number of codes ofpractice from the Human Tissue Authority and one whole code of practice is specifically on consent
and in that, it talks about what information should be provided in order that people can give consent.
In the UK generally there is a view that the individual should control how much information they
have. If we’re talking about medical treatment, most people want quite a lot of information about theircondition or the proposed treatment. Some people want to have less but the general view in the UK isthat you have to have a certain amount of basic information in order that your consent can beconsidered valid but how much detail you want is a matter for the individual to decide
I think in terms of living donation, which is obviously the context in which you raised it, it is avery difficult issue and I think that’s why we have regulation and why we have independent assessors.
An important part of their role as somebody separate from the transplant team - so somebody who iscompletely separate and independent – is to talk to the individual and try to determine how muchinformation they have understood. So they might, for example, say “tell me what you understandabout what this will involve” so they can try to gauge that the individual has not only been given theinformation but has actually understood it, and also as I said to try to ensure that they’re not acting
under pressure.
Muto
I have a question really uncomfortable to ask you.
uncomfortable to have those discussion.

But I wonder if the living donors find it

EnglishDo the living donors find it uncomfortable to have those discussions? I’m not sure that they do,
actually. I’m not sure exactly how they would phrase it but they’re not going to say to the individual“have you understood the information that you’ve been given?”. I think you’d want to do more thanthat, to actually try to gauge what somebody has understood to ensure that they have actually taken on
board the information. The extent to which you would do that may depend on the reaction you get
so if you get a good reaction and it’s quite clear that they have understood the basics then you may not
dig deeper. If you suspect that they may not have been told about risks, then I think you would want
to go much deeper to find out what they have been told and what they understand.
Muto
I do think that a few Japanese hospitals try to do that - whether or not the candidates really
understand the information of the brochures. For example, after that they say that they feel very
uncomfortable because they are really tested on their scientific knowledge [inaudible], but that’s not
the important thing, that they understand the full details like scientists or physiciansEnglishNo, it’s just whether they understand things like the risks that are involved. This is a processthat they know they have to go through and determining how much information they’ve understoodwill be only one part of that interview. They know when they go forward for donation that they will
be asked to see an independent assessor and that they will be asked to talk about the procedure they’regoing to go through, what the risks are and what their motivation is, and that there will be a discussion
about those issues. The independent assessors are trained and, as I said, communication skills are avery important part of their training - to make the person feel comfortable so that you can gauge that
information without them feeling that they’re being interrogated or made to feel that they need toknow exactly all of the scientific details, which is not what they’re being asked to understand.

49

Saio: Parent role
I have two questions. In the United States informed consent is based on the self-determination
theory. Is it the same in the United Kingdom?
If so, on what basis can parents consent to theirchildren being donors – parents rights/duties?
EnglishInformed consent is based on self-determination, as you say. If people are not competent andtherefore are not able to express their views, then somebody does that on their behalf. If a child iscompetent to make a decision, then they can consent for themselves so it isn’t that it’s a certain age.
Below that, where they’re not actually competent then the parents would be asked to consent on theirbehalf but they can only consent to procedures that are in the child’s best interests, so they would needto make an argument that it is in the child’s best interests to be a donor, in the same way that if a childneeded treatment, the parent could authorize treatment because it is in the child’s best interests. Now,
I think it is going to be quite difficult to do that. There have been no cases in the UK where either anincompetent child or a mature child or an adult lacking capacity have donated whole organs. They
have donated bone marrow and in those cases it is a balance of the benefits and the risks so if it is alife-saving procedure for a sibling – for a brother or sister – then it would be argued that, with bonemarrow, the risks that the donor would go through are outweighed by the benefit to that child of thesibling staying alive, and of being able to save that person’s life. But they are quite controversial
cases and because there is always going to be a question about best interests, where it is a young childor where it is an adult who lacks capacity – in other words, where they’re not able to give consent –then it would need to go to court and a court would need to make a judgment as to whether it was inthat person’s best interests to be a donor. The court would need to agree to the removal of the bonemarrow, tissue or organ, because the Human Tissue Act doesn’t cover the removal– that’s covered by
the common law of consent. So, where there’s a procedure where it is not clear whether it is in thechild’s best interests, then a court would make that decision.
Saio(Paraphrased) Child transplant donor has no benefit. How can parents consent to child taking partin clinical trial where there is no direct benefit to the child and therefore it is not in the child’s bestinterests?
EnglishThat’s why there is a difference in the way we use the language between “benefit” and “bestinterests”. So “benefit” would be a direct and usually clinical benefit to the child. “Best interests”
is a very much broader term which looks at the clinical benefit and also at other factors and so it has
been argued that it would be in the best interests of this child for the child’s brother or sister to be
saved by this treatment and because the risks to the child in terms of bone marrow donation are
considered to be reasonable and not excessive, then the courts have agreed to some cases of bonemarrow donation from children. I think it’s much more difficult with whole organ donation and I
really would be very surprised if a case of a child being a living kidney donor, for example, or living
liver donor, were to be approved by the courts. They certainly haven’t been yet, because the risks
are so much higher so when you’re balancing the benefits and harm, then the harm is much greater.
Saio: Ethical committee
Can an ethics committee make these decisions, or only a court?
EnglishThe court will be the ultimate decider about where the child’s best interests lie, so the court will
make the decision. In the UK most ethics committees are research ethics committees. There are a
few clinical ethics committees but not very many. If the hospital where the family was being treated
had a clinical ethics committee, they may be consulted for an opinion but it would be simply that – itwouldn’t have any authority, it would simply be an opinion which they take into account along withother opinions but they would still need to go to court.

50

Ida: Basic element of information
Thank you very much for your very interesting and stimulating presentation. I would like to
ask two questions.
One is concerning the consent. You said that the basic knowledge was rather sufficient to havethe consent from the patient or from the donor. Then what is the basic knowledge in each case?
You said also that it is for each individual to decide which kind of information he or she would
like to have. I think that, in Japanese hospitals, universities or research institutes, we make a kind ofmodel of explanation or information to be given to the patient or the donor of the sample, in which thebasic elements of knowledge is written. Is there any kind of such model or basic elements to begiven to patients in the UK?
EnglishI think in both cases really it depends very much on what the procedure is and what the level ofrisks are. When I said that everybody has to have a basic level of information, what I meant was if
somebody goes into hospital or somebody went to see a doctor, they couldn’t simply say “I don’t wantto know anything about what’s wrong with me, I don’t want to know anything about what you’regoing to do, just do whatever you think.” They would not be allowed to do that because they would
need to have some basic information either about what the diagnosis was or about what the treatment
was going to involve. So, having said that, the amount of information that they want is going to varyand so if it is a very risky procedure – a new procedure, for example, or something with a very highrisk – then they would need to have more information in order to be able to go through thattreatment.
The basic view is that people should be encouraged to have information and so what we say isthat they should be prepared to receive information over a period of time. So if somebody initiallygets the diagnosis of a terminal illness, for example, you’re not going to immediately give every
single detail without preparing the patient to receive that information. It’s a delicate balance. It isquite difficult for doctors to make that balance. You need to be quite sensitive and really read thesignals coming from the patient about how much information they need at that time but the view will
always be to try to encourage them gradually to have more information and to understand more
about what’s happening. So it’s really providing information but at a pace and in a supportive
environment that’s right for that individual.
You talked about if there was set information that people have to have and I think that yes, insome cases there is and I think that living donation is a very good example. Partly because that’sdone not for the health benefit of the individual, it’s something that is being done for other reasons,and so obviously there is a certain amount of information that they need to have in order to make that
judgment. In some cases there are standard patient information leaflets and I think that there willprobably be more and more of those developed for different conditions. We also have a number of
support groups for particular conditions that will also have information but in terms of the doctor
seeking consent from the patient, it is sufficient that they have understood enough information to beable to make a decision. And then some patients will want a lot more information. Some patients
will want to know absolutely everything and will come into the doctor’s surgery with lots of paper
downloaded from the Internet about absolutely every aspect and, within reason, it is the doctor’s
responsibility to respond to those questions and to provide as much information as they need to have.
Obviously, they couldn’t take up a whole day of the doctor’s time because it has to be reasonable, but
if they want more information then that should be available to them.
Ida
In Japan it is often said that doctors are so busy that they cannot have enough time to explain thewhole knowledge – even the basic information to the patient or donor. How do you solve thisproblem of time?
EnglishIt is a very real problem but in order for the consent to be valid, in order for the doctor to havelegal authority to carry out that procedure, they have to have provided that information. So they may
give some of the information in writing to the patient, they may ask colleagues to spend time with the51

patient talking it through, but the doctor who is carrying out the procedure needs to ensure that they
have sufficient information. If a patient were to go to court and say that they had not had sufficient
information and the doctor hadn’t given it, the doctor would be in very grave difficulty and essentiallythat treatment would have been an assault because the consent would not have been valid.
Ida: Enforcement of Human Tissue Act
Another question concerning the Human Tissue Act. You said that the former Act is not a kindof criminal law but the current one established some form of punishment. How heavy is thatpunishment for the offence in the Human Tissue Act?
EnglishDepending on the offence that is committed, it is imprisonment for up to 3 years or a fine or
both.
NortonI think there's a basic principle here about how to regulate. It used to be in the UK that there
was a reluctance to regulate on complicated ethical issues and a great deal of emphasis was placed on
professional codes of practice and professional guidance, and the experts agreed voluntarily to comply
with whatever their professional association recommended. And I think that's also the position in
Japan as well because in general, Japanese law is less detailed and less comprehensive than in the UK
and therefore there is more scope for individual professional judgment to be the key factor that
decides on a particular issue. I know there has been a tendency with the European law to move awayfrom that historical approach but was there a time when either the BMA or the Royal College of
Pathologist or other professional group actually tried to create a voluntary code of practice in order toavoid what seems to be under the HTA an incredibly bureaucratic mallet to crack what some people
might regard as a very small nut. And the same question could go to the Japanese speaker in terms of
the pamphlets content – that sort of thing doesn't need a law, it could be left to the Japan Society forTransplantation to just come out with a recommendation on contents for the pamphlet- that would bemuch simpler than passing a law.
EnglishYes, in the past there has been a reluctance to regulate. I think that changed quite a lot back in1990 when we passed the Human Fertilization and Embryology Act, and so in the UK we set up asimilar comprehensive and quite bureaucratic system for regulating IVF treatment and embryo
research. From then we have had much more regulation. Certainly there was guidance, there were
voluntary codes of practice, and more of them were introduced after the organ retention scandal but I
think to be honest the situation was such in the UK after those events came to light, that everybody
realized that regulation was inevitable and that were going to be criminal sanctions and that there wasgoing to be a regulatory body.
What is interesting is that Scotland has taken a different approach because the Human Tissue
Authority does not extend to Scotland. It has not set up a regulatory body. It has delegated to the
Human Tissue Authority the regulation of living donation and regulating the storage of tissue forhuman use which is a requirement under the EU tissue directive but in Scotland they took a different
approach and that wasn’t very controversial, interestingly, and I’m not really sure why that was. I
think there were better established existing facilities in Scotland for monitoring practice in that they
already had established standards for things like post mortem examinations, which were inspected by
one of the already-existing bodies. They chose a different path but in England everybody realizedthat it was inevitable and there really was not very much opposition, if any, to the principle of setting
up a regulatory body in this area and all the political parties supported it.
Muto
I am now producing the model broacher of transplantation. I suggest they should make bythemselves but they say “If you produce, we use it”. That’s not solution I think. And second thing I
want to make is what is the meaning of welfare of the child. HFEAct says they have to take into of thewelfare of the child if a couple want to have a reproductive technology but law didn’t mention of the52detail or definition of the welfare of the child. So counselors and physicians and some couples join a
discussion. I think that is very practical and good communication style. I think in case of living liver
donation, we don’t have to very details guidelines. If we have trained research ethics committees we
can rely the professional decision.
EnglishCan I just make one other point which is interesting. In the UK a lot of these things happened
after there had been a big scandal.
The Human Tissue Authority and Human Tissue Act came about
after the organ retention scandal, the Human Organ Transplant Act came about after there was ascandal about people being brought in from Turkey and paid. So, in those instances there wereparticular cases and then the Government felt the need to take some action. I know you had your own
transplantation scandal here recently about payment of donors – I’m interested to know from any ofyou whether you feel that there will be a similar reaction and feel that the government needs to be
seen to be doing something in order to prevent this from happening again.
Muto
Japanese transplantation authority is discussing now how to prevent organ trade. Maybe hospitals
have to check donor candidate is relative of the recipient. But this is really bureaucratic and unrealistic
to do at the hospital. How do you think of ethics committee members can do such a job?
Matsumura
According to Dr. Muto, the level of Japanese ethical committees is very low. But I appreciatethem highly.
So called ethical committees in Japan are different from the ethical committees in the U.K. The
British one is represented by a local ethical committee, being independent from an organization where
researches are going. On the other hand, many Japanese ethical committees are, in fact, close to theAmerican Institutional Review Board. Therefore, they are not really independent from theorganization. They are just consulting to the organization where researches are going.
It is the head of organization who chooses the members of the committee, and is responsible forteaching and educating the committee members.
In comparison with the U.K.'s ethical committees, the Japanese counterparts are in very earlystages. In that meaning and at this current Japanese status, I appreciate Japanese ethical committees
very highly.I would like to encouraging them, rather than regarding them at a low level, if they wereso at this stage.
Sato
There are many difficulties in this area, but Japan should have a statute as a first step. We needregulatory body with statutory authority.
Matsumura: Japanese laws and guidelines
My feeling is close to Dr. Norton’s. Japanese law system is very simple. Most, not all, are up to
those who at work.
Ida
I do not share Matsumura-san’s opinion on the status of Japanese law. Yes, it is true that Japanese
law is often very general, and the detailed regulations are often done by the ministries. However, theseministry guidelines are based on the law, so it is legally binding. It should be mentioned that on thetop, we have laws, very general and sometimes very abstract. It is very difficult to use on the spot. But
the law often gives the power to the ministries to make regulations and guidelines, which are legallybinding, in order to let the people apply in the hospital or in the research institute. For example wehave a law banning human reproductive cloning. The human reproductive cloning law is a little bitcomplicated but very general. It bans only transferring a cloned embryo into the uterus. And the law
gives the power to make guidelines on other embryos, I mean artificial embryos. So, we are currently
working for making legally binding guidelines for cloning research, I mean therapeutic cloning
research.

53

Matsumura
Yes, I understand it is the only guideline that is bound to law. All other guidelines have no
mentioning about law. Right?
Ida
No. I mean if there is a law, often there are guidelines. However when there is no law, there aresometimes guidelines of ministries, which are not legally binding. But such guidelines are in mostcases respected, or observed by the researchers or the hospitals. I don’t know why, but many doctors
and researchers obey the guidelines. Probably because it is their own benefit or own interest. If they
don’t follow the law or the guidelines, it would be publicly announced that they violated guidelines,
even if it is not legally binding. So, the public opinions may be heavy to the researchers.
Mitsuishi: Uwajima caseIda-san, I have a question. What you said is quite against to one example: Uwajima case. You
said that doctors obeyed and respected guidelines. I want to ask if the doctors concerning the Uwajima
case observed the guidelines of “Ishokugakkai”?
Kurihara
The real situation is completely different. Dr. Mannami’s case is the typical case that Japanese
doctor doesn’t adhere self-governing rule. He should adhere to the professional code by thetransplantation society, but he breached. Not only this guideline, but also he should adhere to the
ethical guidelines for clinical research that was issued by the government, the Ministry of Health,
Labor and Welfare. Almost all the journalist doesn’t mention about this guidelines issued by the
Ministry. This means that Japanese society doesn’t understand international definition of research.
Ida
Which guideline?
Kurihara
Ethical guideline of clinical research.
Ida
Is Uwajima case a research? I don’t think so.
Kurihara
Yes, this case is of course a research. Because he offered presentations in some researchers’society (which means this is the activities to generate “generallizable knowledge”).
You don’t seem to understand definition of “research” and “practice” which is explained in the
Belmont Report.
Ida
Sometimes organ transplantation is done under a research project. However, if Dr. Mannnami
and the patients think it is in a category of treatment or care, how can we decide Uwajima case is a
research? It is very difficult.
Kurihara
In Japan there is no consensus what is research and what is research. This is the problem.
Ida
It is true there are few laws or legally binding regulations in Japan. They are very few. We should
recognize this fact. However, if there is no law, there sometimes, I say “sometimes”, governmental
guidelines which are not legally binding. If there is no law, no ministerial legal regulation. There arealso guidelines made by professional associations. Of course these professional association guidelines
are not legally binding. And the guidelines of a professional association is only applicable to themembers of the association. So there is a big field which lacks national regulation. I should say that54

the professional associations’ guidelines are not always respected by all the members, neither by
non-members of the association. The problem is that there is no rule here made by the ministry or
made by the government. In a few cases where there is no law, no regulations, there are only
professional associations’ guidelines. I think there are many violations, even if it is not legal violation.
Matsumura
May I say one point. I understand that the current Japanese government guideline except the one
mentioned above, are not bound to any laws. Therefore, if the government regards them to be a part oflegal frame work, then, they are not based on democratic constitution, because it is made not by those
who have been voted by people.
Kurihara
There are two problems. One is process and the other is legal enforcement.
Man
Why the administration or the ministries have such a power to make a guideline?
Matsumura
As for the Japanese government to issue guidelines, my impression is that 'governmental
guidelines' have been accepted, or aimed by the government to be accepted by people, like 'codes ofregulation', and therefore misguiding many Japanese people.
I understand that, if law permits them to issue codes of regulation, then, they have the right to doso. On the other hand, if there are no law to permit them to do so, I wonder if they have that right.
Ida
Generally speaking, the government, the administration is given the power to administrate thematters which is set up by the Constitution. So the government has the power to regulate, not always
in a legally binding manner, to control all the things which are done in Japan. So, it is true that the
government or the ministries, for example the Ministry of Education makes different guidelines. But
they are not legally binding. Because, as you said, the democratic control is normally based on the law.
So if there is no law, the ministry does not have power to make legally binding guidance.They makeonly the guidelines which are not legally binding. It is a kind of administrative control. And theycannot enforce the guidelines to the addressee.
Matsumura
But you expect people to obey this.
Ida
The government expects that.

55Session 2
Some Points of Issue around the Research Use of Human Materials
Shin Utsugi, Professor of Tokai Law School, University of Tokai
2-28-4 Tomigaya, Shibuya-ku, Tokyo
Ⅰ. Legal status of Human Materials (HM hereinafter) in general in Japan(Summary of the 1st session)1)Principles
ａ． As to the HM from the dead body, there is a general provision in the Penal Code of Japan(§190 ) which prohibits the destruction, abandonment and unlawful possession of the cadaver and otherthings in the coffin, and this may be construed to prohibit the “activities” on the cadaver. The
term “activities” in the new UK HTA 2004 includes removing, storing, using and displaying the H M.
At least the removing the solid organs for transplantation is, it is usually interpreted, included within
the provision. Of course it is possible to assert that the research use of the body could not be includedin the term of “destruction” nor “abandonment” and accordingly is not prohibited by this provision orit has some other good justifying reasons such as the adequate consent of the victims and the sociallyacceptable character.
Anyway, the research use of the HM could be permitted under some strict conditions.
2)We have some specific statutory exceptions to this fundamental rules.
ａ．First of these exceptions is the removal of organs for transplantation purpose provided in
the Organ Transplantation Act 1997.
In this Act “Organs” are specifically enumerated, with the aid of Regulation, so the other organs
such as “brain” are not excepted by this Act from the banning of the penal code.
These not-enumerated organs may not theoretically, as aforesaid, be totally banned to be
removed, but the Code of Practice of the MHLW prohibit it.
And section 9 of that Act provides that the organs which could not be transplanted should be
disposed of according to the Regulation of MHLW, which in turn prescribes to incinerate.( that is, it
forbids to use the untransplanted organs for other purposes）, （because I suppose of the respect for thedeceased.） And ｔhis set of provisions seems to be a large obstacle for the research use of the humantissue in Japan. I would like to be taught what are the situation in the UK. And Matsumura-san may
talk on this point later.
ｂ．Second statutory exception group is the provisions in the Dissection and Storing of Cadaver
Act 1948. which has been explained extensively by Sato-san that I would like to skip.
★ It should be noted that there is no provision on the “tissue” in this Act, which will bementioned later.
★ And on the living person there is no specific provision. On which have been so muchdiscussed★ As the result, it can be said, there is at present no meaningful provision on the research use of
HM in Japan.
3) There are, however, several clues for the solutions
ａ． A guideline of MHLW on the Organ Transplantation Act 1997 suggests that the HM from the
cadaver could be treated in conventional way, on which the Act had no provisions. Though thisguideline refers only to the transplantation, similar explanation may be possible on the good andproper research. And an attempt is now under way to make use of the intentional removal of the tissue
from the dead. I’ll mention it later.
ｂ． A working group under the MHLW has published a report (1998 Kurokawa Report)suggesting and encouraging the use of the left-over tissue from the surgical operations for thebiomedical research, especially for the pharmaceutical industry. And it recommended also to
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan56

establish some reliable banks under the responsibility of the Government, which was implemented bya agent, which will also be mentioned later.
ｃ． A few guidelines on biomedical research involving human subjects, have envisaged the useof the HM as explained by Prof. Maruyama and others.
According to the recommendation, and because of the pressing need, several trials have begun toestablish public banks.
Ⅱ. Several sorts of banks for biomedical research in Japan
Modern usage of HM has quite different phase from that of the previous time, namely, the HM
are used by scientists who has no relationship with patients and in the institutions far away from the
bed of the patients. This change of the situation requires at least two urgent measures to be taken. The
1st is to establish the ethical rules for the scientists how to use the HM properly and the 2nd is to makeout a system to distribute the materials in proper way, namely the banking system which is quite
necessary not only for the science and scientists but also for the donors themselves, because it
significantly affects the proper development of the medical science as well as the practice.
As to the first points many speakers in this workshop have talked much with reference to theguidelines. So, I would like to report on the 2nd point which is urgent task for the Japanese
Biomedicine.
We can classify the banking system into several groups.
１．Traditional private and closed model
A． Private Storing Ⅰ
This type is characterized as an intra-Medical school storing (which may be envisaged by the 17th
Article of the Cadaver Dissection and Storing Act 1948.) Pathology Department or Legal Medicine
Department or sometimes Surgery Department have had these for their own research and education
purposes.
while it has still reason d’etre, the conditions for the proper storing have not settled. For
instance;
ａ．Do they have obligation to return the HM when requested by the surviving relatives?
ｂ．Block and Slides can be treated as a part of medical records?
ｃ．Retention or Storing include to exhaust out the materials ?
B. Private Storing Ⅱ
This type is found in the inter-universities or medical institutions banking.
Several members of each circles gather, store and use the HM cooperatively.
Some have established the system so much before that the informed consent from the donors havesome ambiguity, and they are a little bewildered how to treat them.
And recently some trials are observed to found this sort of banks (Oosaka. MS, Yokohama City Univ.
MS), which may provide a great advantage to the researchers within that groups.
Static or closed character of these types may have some defects; less effective, often it lacks the
openness to the society, and financially unstable..
２．Recently founded public and open model
A. Resource Bank of the Human Science Foundation (HSFRB)( HSF is a nonprofit foundation backed by the Ministry and funded by 128 companies. It was
founded cooperatively by the government and industries about 10 years before (1986), for thepromotion of the biomedical high technology.)
The Kurokawa Report mentioned above has recommended to set up some public banks of thetissue from the surplus of the surgical operations. The proposal was implemented in 2000 by the
Human Science Foundation. It accepts now the fresh tissue as well as the frozen ones from any
cooperative Medical Schools and Hospitals, and distributes them to any institutions which have57

proper ethical reviewing system. But its capability is quite restricted (at present only 104 items areproposed as distributable).
The institution also operates a bank of cells deposited from the Several Governmental Institutions.
B. Riken Bioresource Center (RBC)(Riken is an Independent Administrative Institution with a near 100 years history)
It stores cell-lines which have already been published by itself or deposited by several existing
private banks and distributes them to any inland as well as abroad institutions under a Mutual Transfer
Agreement(MTA).
C. Registry system of the Japan Tissue Transplantation Association(2006)
The Association is now creating, or has just begun (?) a nation-wide banking system of tissues
removed from the dead body after the organ-removal for transplantation.
The occasion of which is notified by the Japan Organ Transplantation Network when the donor
appears. The central Association informs the local appropriate member institution of the occasion andthe latter removes on the spot and retains the tissue as the independent bank. And it registers its
storing materials to the Association, and the whole storing list is available through the internet systemfor everyone, who can request the tissues to the independent bank. The main purpose of the system isfor transplantation but also available for research use to improve transplantation. Central ethics
committee reviews the properness of the application and permit the local member to distribute.
D. Human & Animal Bridging ( HAB)
( HAB is a NPO Corporation with more than 10 years history, which imports the unused organs
from the NDRI of the USA at the request of the member institutions for research use.)
It is preparing a bank of tissue from the dead body after the organ and tissue removal fortransplantation, for research use only.
E. Banking systems of special Materials
ａ．Bone-marrow Transplantation Foundation :DNA Banking system of the couple of the donor and the patient.
ｂ．Umbilical Cord Blood Bank：
The Bank affords the umbilical Cord Blood mainly for the grafting but also for the related
research via the system of the Rikenbank.
ｃ．Genome projects, EScell will be reported by MASUI.-san.
３．Commercial Companies for Importing and Trading of the HM
At present almost all businesses are trading only imported materials.
Ⅲ. POINTS to be discussed
Finally I would like to present some points to be taught and discussed.
１．The past has not been cleared
There have been in our country somewhat shady or questionable era when the consent principle
was not established, and the HM of that ages has not been properly consented. Turmoil of Alder Hey,
which must have been hard and painful work for the medical profession of the UK, but it may be said
to have encouraged and advanced the reconsideration in the UK. We have at present no cue for thefundamental reconsideration un(?)fortunately.
２．Shortage of the HM for research
As the banking systems have not developed in our country, the industry must depend on theimported materials, and which is quite inadequate not only scientifically but also ethically. Our
Organ Transplantation Act should be transformed into the Human Tissue Act style.
In the UK is it possible and practiced to use for research the organs which were removed fortransplantation but in the end could not be used for that.?

58

３．Dichotomy of consent or anonymisation .
In the Guidelines of our country which are worked out to regulate mainly the use-stage of HM,
basically the policy of dichotomy is adopted. The dichotomy seems to me to be the easiest way to get
the material for the short-sighted researches, but the long-term insight and scientific requisite may
require the identifiable materials.? What policy is taken in the banking system in the UK?
And in Japan there is no distinct difference in the Guidelines, between the materials from thedead and from the living body, except, of course, the difference of the subject of the consent.
According to the report of English-san the storage of materials from the dead must be consented
in the UK, and for that from the living individuals the consent is required unless the storing isanonymised or for a particular research approved by a research ethics committee. Does this mean thatthe materials from the dead is usually removed intentionally for the research with the consent asagainst to that from the living person where the main purpose of the removal is for the treatment of
the individual? Is it not required to obtain consent to use the tissue of the operated part of the patient
for an approved research?
４．In case of the identifiable materials, the HM can be returned to the donor. And actually the
Retained Organs Commission of the UK had to manage to return the uncosented tissue, I suppose.
Then should it be returned when the donor withdraws the will of donation afterwards?
５．The role and limit of the “general consent” of the donors.
In case of banking the consent of the donor has necessarily to be a general or generic consent,
because the future research has not been come into sight and the information could not be sufficientenough clear to be called “informed consent”. The contents of the general consent is, however, quite
clear, I think, that the donated tissue should be used properly for the biomedical development and forthe welfare of the future patients and future generation. Is the general or generic consent enough forthe storing for the subsequent using? The general consent is, I suppose, permitted only under someconditions.
６．Mechanism to oversight the whole system.
In order to permit the general consent there should be a licensing or registry system through out
our country, I suppose. At present, the majority opinion in our country is that the prior review by theInstitutional Review Board is enough for the guarantee of the properness..
What would be the function of the THA as a licensing organization for the ethical purposes? Itfunctions as the Competent Authority under the EU Directive and must guarantee the security andidentity of the transplanted organs.
Is it intended for THA to function other than the security aforesaid ?.
７．And lastly please allow me to make quite a specific question.
What is, and should be the difference between HM and paraffin blocks and/or preparedspecimens？
According to my memory, the Retained Organs Commission chaired by Prof. Blasier recommended to
distinguish the blocks and slides from the other tissue. Will the blocks and slides be treated as a partof the medical record?

59

What is BMA’s role?
Veronica English, Deputy Head of Medical Ethics, British Medical Association
Tavistock Square, London, WC1H 9JP
OK. Thank you. Before I start what I want to say, perhaps I could make just a couple ofcomments. The first is to apologise that this morning when I introduced myself I didn’t actually
explain to you what the role of the British Medical Association is and it might be helpful if I just very
briefly explain what the BMA is and what its role in all of this is.
The British Medical Association is the professional association for doctors, so we’re amembership organisation and doctors choose to become a member and they pay a membership fee.
Having said that, we do have very high membership levels: about 90% of doctors in the UK are
members of the British Medical Association. The Association’s work is divided into two parts. One
part is a trade union side which negotiates with the government about doctors’ pay and about theirterms of service, and the other side, which I belong to, is the professional side of the Association.
Our role is to give guidance to doctors, to try to influence public policy, and get changes in legislation,
to reflect our members’ interests – so obviously that’s where I’m coming from in this work. I should
say that the British Medical Association is not the regulatory body for doctors – we don’t give doctors
their license to practice. That’s done by the General Medical Council, which is something completely
separate. Our guidance is considered to be good practice and we try and encourage our members tofollow our guidance, but it isn’t binding on them. So they’re not going to end up in difficulties with
us if they don’t follow it. I do apologise that I didn’t explain that at the very beginning.
I’d also just like to pick up on one point because I think that most of the questions that wereasked by the last speaker are going to be covered in what I want to say and I’ll try to pick up on themas I go through. The one point I just want to clarify is about blocks and slides because that won’t
come into what I want to say. You’re absolutely right that there was a distinction in that the Retained
Organs Commission and a lot of people believed that there should be a distinction made between
blocks and slides and whole organs, and we certainly discussed that with the government but they
were adamant that they would treat all human material in the same way. Whether it’s a slide, whether
it’s a whole organ, it would be treated in exactly the same way. So to answer the specific question,
blocks and slides may be kept on the medical record after a patient has died but only if you haveconsent for that. Again, that’s an area where Scotland is different because Scotland has made thatdifferentiation, which I think is probably more sensible but we have the legislation and so we now
have to advise our members on how to implement that – it’s too late to go back and change that.

T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan

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Research use of tissue
Veronica English, Deputy Head of Medical Ethics, British Medical Association
Tavistock Square, London, WC1H 9JP
In this session I am going to focus on the rules and guidelines relating specifically to the researchuse of various types of human tissue. Some of this is covered by the Human Tissue Act, some by the
Human Fertilisation and Embryology Act and some by good practice guidance.
I shall begin by looking at some aspects of the Human Tissue Act that relate to the research useof human tissue. In fact, this turned out to be one of the most controversial aspects of the legislationand the BMA, together with a number of other organisations lobbied the Government and managed tonegotiate changes.
Tissue from living individuals
It should be remembered that the backdrop to the legislation was the problems encountered atAlder Hey Hospital in Liverpool and as a result, there was an almost obsessive focus on the need for“consent” for anything to do with human tissue. The Government repeatedly referred in debates toconsent being the “golden thread running through the legislation”. The problem arose from theGovernment’s decision to include the research use of human tissue from living individuals in thelegislation. Where samples are taken specifically for research, or where the samples are identifiable
and may have future implications for the individuals, there is widespread agreement that consent isneeded. But the legislation, as originally drafted included the need for consent for the use ofanonymous left-over tissue for research. So, every time someone had a blood or urine sample taken,
or when they had a cervical smear test, or where there was tissue left over from a biopsy ortherapeutic removal of tissue, it could only be used for research – even anonymously – if consent had
been obtained.
In the past “left over” tissue – from operations, biopsies, cervical smears, blood tests etc – hadbeen used for research, on an anonymous basis without the need for individual consent. This was on
the basis that it was “waste” material that would otherwise be disposed of. Once anonymised, thetissue had no further implications for the individual patient and potentially great benefit for the publichealth. The BMA has always stressed that patients should be informed in a general way of such use
and given the option for their sample not to be used but had not argued for explicit consent. When
our Medical Ethics Committee considered the use of tissue in the draft legislation, it agreed that, postAlder Hey, there was a need for more information to be given to patients about uses of tissue andwherever possible consent should be sought. So, we were willing to consider the need for consent foruse of anonymous material for research. Research bodies, however, disagreed and strongly opposed
any additional restrictions on the availability of tissue for research.
Over the following months, we entered into discussions about the practical implications of the
proposals. One of the pathologists who was very active in the debate estimated that throughout theUK, laboratories handle around 150 million samples each year. If consent needed to be sought foreach of these samples – to allow the possibility that they might be used for research in the future –then even allowing just 1 minute for each patient, this would require an additional 1,300 full time staff.
Given that money was not being made available for additional staff for this purpose, fewer patientswould be able to be seen. We knew from surveys of public opinion that the vast majority of people
saw left-over tissue, blood or urine samples, as waste products and had no objections to their use on
an anonymous basis for research. If the samples would only be disposed of, and patients did not
object, arguably there was a strong moral argument for allowing them to be used for importantresearch that would benefit the public’s health.
Another major practical problem was that the clinician who seeks consent for the surgicalprocedure or for the sample to be taken will usually not be involved in research and so will have no
incentive to seek consent. The researchers who need the samples have an interest in the research but
have no contact with the patient. We looked at various ways to try to overcome these practicalproblems but eventually came to the same conclusion as the research bodies – that left-over tissue
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan61

from diagnostic or therapeutic procedures should be able to be used on an anonymous basis without
consent. After many discussions, the Government accepted this position.
So the legislation now says that tissue taken from living individuals may be used anonymously,
without consent, provided the project has research ethics committee approval. The ethics committee
still has the option to decide that a particular piece or area of research requires explicit consent, even
if the tissue is to be used anonymously – for example if it is into contraception or some other area of
research that some people might object to.
There has been quite a lot of discussion about what “anonymous” means. It is clear that the
sample does not need to be irreversibly anonymised and there can be a link to the medical record of
the patient – provided that the person carrying out the research does not know the patient’s identity.
It was also clarified that it is the time that the tissue was removed that determines whether tissue
is covered by the rules for living or deceased patients. So, if the patient has an operation and thensubsequently dies – the rules that apply are those relating to living patients, even though the patient
may be dead at the time the tissue is used.
There are still some issues that need to be looked at as the legislation is implemented:
We have argued that patients need to be know about this possible use of their tissue and haveasked the Human Tissue Authority to provide a leaflet in hospitals and general practice surgeries
explaining what might happen to the tissue and how patients can object if they wish to do so. As amatter of good practice, if an individual objects to the use of a sample, even anonymously, reasonable
steps should be taken to prevent its use for that purpose, but it would not be a criminal offence to useit.
We have also asked that guidance is given to research ethics committees about the type of
research where consent should always be sought, even it if the tissue is to be used anonymously.
It was made clear in debates in Parliament that consent for the research use of tissue can begeneric and ongoing. In other words, it does not need to be given for each individual research projectbut may be given generally for future research. If there may be implications for the patient as a resultof the use of the tissue in a particular research project, however, explicit consent for the project would
be expected.
Tissue from deceased individuals
The situation regarding the research use of tissue from deceased individuals was lesscontroversial during the passage of the legislation. Given the emotional significance of the retentionof material for research after death – and particularly after Alder Hey – nobody objected to the needfor consent for the use of this material.
An individual may consent during his or her lifetime to the use of tissue removed after death forresearch but there is currently no established mechanism for recording this and it seems unlikely that
this is something many people would think to do. In the absence of consent from the individual, any
person nominated by an adult to give consent after death may authorise the retention and use of tissue
for research or, if nobody has been nominated, a relevant family member may give consent, as
discussed earlier.
In terms of use of tissue removed after death for research there are three likely scenarios:•

Use for a particular research project – with consent and with ethics committee approval•

Use for future, undefined research – with consent. Information should be clear that the
precise nature of the research has yet to be decided and that research ethics committee
approval will be sought for every project before it is used. Relatives should also be given theopportunity to opt out of certain types of research.

•

Donated for transplantation but unsuitable and so used for research – when consent fortransplantation is sought, this scenario must be discussed with the person giving consent andexplicit consent sought. Where the individual was on the Organ Donor Register but had not
expressed any views about research, this possibility should be discussed with the relatives.

62

All of the evidence from the Alder Hey Inquiry was that relatives were happy for tissue to be
used for research, following post-mortem examination, provided they were informed and were asked
for consent.
Many people were upset that organs had been retained but had never been used for research, andguidance from the Human Tissue Authority advises that those giving consent should be informed that
not all of the tissue retained will definitely be used and some may be held for a long period of time –possibly many years – before it is use. This might be the case, for example, if there is a need tocollect sufficient samples of a rare disorder in order to conduct appropriate research.
There is no time limit for storage of organs or tissue in the Human Tissue Act. Nevertheless, the
HTA also advises that stored samples should be subject to regular review to ensure that their retention
is still necessary and that they remain useful. Any that do not meet these criteria should be disposedof.
Fetal tissue
The use of fetal tissue for research, following termination of pregnancy, miscarriage or stillbirth,is also covered by the Human Tissue Act. This is because it is considered to be tissue from themother and so the rules that apply are those for tissue taken from living individuals.
This means that under the Act, fetal tissue can be used for research without the consent of thewoman, provided it is used anonymously and the project has been approved by a research ethics
committee. Nevertheless, the HTA’s code of practice states that, because of the sensitivity attached tothe subject, it is good practice that consent should always be obtained for the examination of fetal
tissue (at all gestational ages). The BMA has also argued that guidance should be issued to research
ethics committee to the effect that the use of fetal tissue should always require explicit consent fromthe woman.
In addition to the legislation, there is guidance on the use of fetal tissue for research that is in theprocess of being updated. The current guidance – known as the Polkinghorne guidance – wasproduced in 1989. The main requirements of that guidance are that:
•

•
•
•

There must be a clear separation between decisions relating to termination of pregnancy andthose relating to the use of fetal material. Where the fetal material comes from a terminatedpregnancy, consent to the termination of pregnancy must be given before consent is sought tothe use of fetal material
Written consent from the woman should be sought for the use of fetal tissue, but based on
general information to avoid the possibility of termination of pregnancy for ulterior motives(such as donation for a particular type of research)
No inducements, financial or otherwise, should be proposed to the woman who is donating
the material or to other people who may influence her decision
There should be no modification to the termination procedure to facilitate research.

When the Government sought views on the use of tissue in 2002, it looked specifically at the
donation of fetal tissue for research. They indicated at that time that the requirement, under
Polkinghorne, that consent should be general and not for a specific type of research, was increasingly
out of step with the public’s expectation that they should be given proper information before giving
consent and so this is likely to change. The Government also queried the decision not to allow thetermination procedure to be changed in any way to facilitate research and asked if it might beacceptable to use a slightly different procedure (for example, to use ultrasound) if the procedure poses
the same risk to the woman, and the modification is acceptable to the woman and is approved by aresearch ethics committee. It seems likely that this part of the guidance will also change.
Genetic research
Under the Human Tissue Act, research that includes DNA analysis is subject to the same generalrules as non-genetic research and so:63•anonymous tissue from living individuals may be used without consent for a research projectthat includes DNA analysis of samples provided the project has research ethics committee
approval.

•

Where consent is given for the use of tissue for research on an identifiable basis, this may be
used for research involving DNA analysis without the need for specific consent to genetic
analysis – although it is still considered to be good practice to seek explicit consent where
there are implications for the health of the donor and/or the donor’s family•

Research may be undertaken using tissue samples taken from adults who lack the capacity togive consent where:oooThe research has ethics committee approval
Research of comparable effectiveness cannot be carried out using samples frompeople who are competent to give consent; andResearch of comparable effectiveness cannot be carried out using anonymous
samples.

There is also guidance from various bodies about the specific requirements that apply to genetic
research. The main points of this guidance are:••••there should be a clear distinction between diagnostic or predictive genetic testing andresearchwhere identifiable samples are to be used specific consent should be obtained for genetic
testing for research purposes
information should be provided about what, if any, information will be fed back to theparticipant
if information is to be fed back to the participant, information should be provided about the
implications of this for the participant and his or her family

UK Biobank
A major project that has recently been started is UK Biobank. The plan is to develop a major
resource of medical data and samples from 500,000 individuals aged between 40 and 69 years old.
Blood and urine samples will be collected and participants will be asked for current health andlife-style information. They will also be asked to consent to Biobank staff having access to theirfull medical record for the next 30 years and to agree to be contacted again over that period. The
plan is for UK Biobank to have access to patients’ full medical record (with their consent) but
only anonymised information will be made available to researchers. Data will be heldanonymously (as an added safeguard) but, with a key, information can be linked to patient
identifiers. The aim is to build the world’s largest information resource on the genetic andenvironmental factors that cause or prevent human disease.
A three month integrated pilot took place in Manchester earlier this year during which 3,800
people attended for assessment. Recruitment throughout the UK is due to begin by the end of thisyear. Recruiting participants is expected to take 3-4 years in 35 centres throughout the UK. Oncethe participants have been recruited, a committee will consider requests by researchers for accessto anonymised data for research. No feedback will be given to participants from any of theresearch undertaken.

64Embryo research
The use of embryos for research is covered by the Human Fertilisation and Embryology Act
1990.
Although there is now fairly widespread support in the UK for the research use of embryos, thiswas not always the case. The legislation in 1990 followed nearly 10 years of fierce debate about
the moral status of human embryos and whether they should be used for research. In 1984 a
Government appointed Committee of Inquiry, Chaired by Mary Warnock, had concluded that
research should be permitted on human embryos up to 14 days after fertilisation. When thelegislation was originally published it had alternative clauses either permitting or prohibiting
embryo research. After a major campaign by medical and scientific groups the Parliamentary vote
was overwhelmingly in support of allowing embryo research with strict safeguards.
The 1990 Act set up the Human Fertilisation and Embryology Authority (HFEA) – which the
Human Tissue Authority was modelled on – to regulate both IVF and donor insemination
treatment and embryo research. Each individual research project involving human embryos mustbe licensed by the HFEA. Before giving approval the HFEA must be satisfied that the use ofhuman embryos is “necessary and desirable” for one of the following purposes:(a) promoting advances in the treatment of infertility(b) increasing knowledge about the causes of congenital disease(c) increasing knowledge about the causes of miscarriage(d) developing more effective techniques of contraception(e) developing methods for detecting gene or chromosome abnormalities in embryos before
implantation (pre-implantation genetic diagnosis)
In 2001 a further three purposes were added, so that research involving human embryos may also
be undertaken:(f) to increase knowledge about the development of embryos(g) to increase knowledge about serious disease(h) to enable any such knowledge to be applied in developing treatment for serious disease
These amendments were needed so that research to produce embryonic stem cells could be
lawfully undertaken.
The HFE Act permits the use of embryos for research that are “spare” that is, they are left overfrom IVF treatment and are donated to research, and also the creation of embryos specifically for
research purposes. The second source is important in terms of the developments of new techniquesand ensuring their safety before they are used in clinical practice. For example, when intracytoplasmic sperm injection (ICSI) was first proposed, it was necessary to inject sperm into humaneggs that would then be subject to extensive research and destroyed, to ensure that the procedure itself
had not caused damage to the embryos, before any embryos created using the technique were used intreatment. Some people believe there is a moral distinction between these sources of embryos but thisis not a widely held view and is not reflected in the legislation.
The Human Fertilisation and Embryology Act is currently the subject of review and we are
expecting new legislation towards the end of next year. The Government has indicated, however, thatit does not expect the position on embryo research to change.
One of the changes that is proposed by the Government, in the new legislation, is to merge the
Human Fertilisation and Embryology Authority and the Human Tissue Authority to form theRegulatory Authority for Tissues and Embryos (RATE). There is currently some opposition to this as
it is not at all clear that a single body could possibly cover the very wide and diverse area of practicein the sensitive areas covered by these two bodies. The BMA is currently asking the Government toreconsider its commitment to this merger to consider whether other ways of joint working can beconsidered.

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Stem cell research
Stem cell research is a big issue at the moment, not only in the UK but of course around theworld. At the current time the HFEA licenses a total of 33 embryo research projects and, of these, 15
relate to the development of embryonic stem cells.
The HFE Act was amended in 2001 to extend the purposes for which embryo research may beundertaken specifically to permit embryonic stem cell research. Because of the mechanism in place
for regulating embryo research, which has the trust and support of the public, it is widely believed that
the UK was able to move forward far more quickly with stem cell research than many other countries.
There is considerable support for stem cell research in the UK and a general belief that work should
continue using all sources of stem cells (including embryos) in parallel.
In order to allay any fears that the cell nuclear replacement technique being developed could be
used for reproductive cloning – that is the deliberate creation of genetically identical individuals - theGovernment passed the Human Reproductive Cloning Act 2001 to make reproductive cloning acriminal offence.
Another development in this area has been the establishment of the UK Stem Cell Bank to holdand distribute stem cell lines to researchers. The idea of such a bank was first suggested by a Houseof Lords Committee set up to review the area. The rationale behind it is to make the best possible useof the stem cell lines developed, to ensure that good quality samples are available for research andpossible future therapeutic applications and to minimise the number of embryos that need to be used
for research. It is a condition of all HFEA licences that a sample of any embryonic stem cell lines
created must be deposited in the UK Stem Cell Bank for use by other researchers. Researchersdeveloping stem cells from other sources are also invited to deposit a sample in the bank.
Egg donation for research
Until now the majority of embryos used in research have been left over from IVF treatment but
these are few in number and not the greatest quality. There are therefore moves for young, healthy
women to donate eggs specifically for research.
An issue that therefore is currently being debated in the UK is whether women who are nothaving treatment should be able to donate eggs for research and, if so, what safeguards should be inplace. Some people have argued that the risks are too great whereas others, such as the BMA, haveargued that if women are informed of the risks it is for them to decide whether or not to donate.
Another issue that is being considered is whether women should be offered any incentives for
donating eggs. In relation to donation for treatment, the HFEA is opposed to any actual payment for
donation but does allow a practice called “egg sharing”, whereby women who need IVF but who can’t
afford to pay for it, are offered free or reduced price IVF treatment in return for donating eggs. The
HFEA has recently also allowed a clinic to offer egg sharing in return for donation of eggs forresearch.
One of the problems with this is that women are being given treatment that would cost at least£3,500 and it is questionable whether it is really any different than payment itself. In the past the
BMA has opposed the use of egg sharing for treatment, believing that to make such an offer is to givea large inducement to someone who is in a vulnerable position to act contrary to their better
judgement. We are currently considering whether the same objections would apply to donation forresearch (since no child would be born as a result of the donation).
This practice also raises the question of whether donation of eggs for research is closer toparticipation in research, such as clinical trials, for which some payment is allowed, or if it is closer todonation of eggs for treatment, for which payment is not allowed.
Some people within the stem cell community are now beginning to question whether we should
not begin to pay healthy women for donating eggs for research and this is an issue that is likely to bedebated in the UK over coming years.

66

Import and export of tissue for research
Sometimes, of course, tissue for research is imported from other countries. The import andexport of eggs, sperm and embryos is regulated by the HFEA. With this exception, there were no
restrictions on the import of bodies, body parts and tissues into the UK until the Human Tissue Act
came into force.
The import and export of human material does not require a licence or approval but the Human
Tissue Authority is required to produce a code of practice covering it. This is currently out for
consultation but I shall just touch on the main points in the draft code.
The code says that the underlying principle is that all human bodies and tissues should be treatedwith appropriate respect and dignity. Those wishing to import human material must be able todemonstrate that the purpose for which it is imported cannot be adequately met by comparable
material available within the country. This might be, for example, because of the availability or
quality of the tissue, the risk of infection, or cost-effectiveness.
Although the consent requirements in the Act do not apply to imported material it is still goodpractice to ensure that appropriate mechanisms for gaining consent are in place in the country fromwhich tissue is to be imported and it is a requirement of the code that evidence of the donor’s consent
is available.
Ethical approval must be sought from the country of origin before any material is imported.
Where there is no ethical approval procedure in the country of origin, the risks of accepting thematerial must be carefully considered and, if considerable material is to be imported, thought should
be given to establishing such a committee for this purpose
A coding and recording system should be in place to record the reasons for the use of imported
material and to provide a robust audit trail (when and where it was imported, uses to which it was put,
how it was disposed of etc). Relevant information should be recorded on a register which should bemade available to the HTA for inspection upon request. Records should be kept for at least 5 years
after the tissue has been disposed of.
Packaging during transport should comply with international standards for the transport ofhazardous clinical material.
A clear policy for disposal of material, in a sensitive manner, should be in place. If the donor
made any requests about how the material should be disposed of (including return to the homecountry) these must be followed.
Research ethics committees
Research ethics committees are given a much higher profile and very important responsibilities
with the introduction of the Human Tissue Act. This has been a potential problem, because research
ethics committees have not, in the past, had the full confidence of the medical and scientificprofessions or of the public. They have, historically, been of variable quality, relying extensively on
unpaid volunteers, with very little training for committee members, each committee having individual
methods of working and no central co-ordination but steps have been taken over recent years toaddress these problems.
In 2000 the Central Office for Research Ethics Committee (COREC) was established to improve
the system of operation of the committees and to provide advice on necessary changes. Also, in
response to a European Union Clinical Trials Directive, research ethics committees were placed on a
statutory footing in 2003 and the UK Ethics Committee Authority was established to oversee research
ethics approval both within and beyond the National Health Service.
A review of the work of research ethics committees, published in June 2005, noted continued
frustrations by researchers about the approval process but recognised that considerable progress had
been made. Already there was greater co-operation and co-ordination, standard forms and operatingprocedures and training had been put in place. Proposals have now been made to continue thisdevelopment, to ensure that the ethical review of research is conducted on a much more professional
basis. Steps are currently being taken to implement the recommendations, which include:

67

•
•
•
•
•
•

Triage system of consideration by National Research Ethics Adviser to approve those
applications that do not raise ethical issues (surveys etc) and to address poor science
Application form will be further reviewed and standardised
There will be fewer committees with higher workload
Less reliance on volunteers with members paid for their contribution
More emphasis on training
Introduction of a system of “quality assurance” to reduce inconsistency

This will be expensive but the Government has put a lot of weight on ethics committee approval
as a safeguard for research participants and it recognises that change is needed.

68Research use of tissue䊍䊃⚵❱䈱⎇ⓥ䈮䉋䉎૶↪

Veronica English
Deputy Head of Medical Ethics
British Medical Association㪈Tissue from living individuals• Human Tissue Act 2004

• Human Tissue Act 2004
• Identifiable tissue needs
consent• Debate about consent
for use of anonymised
tissue• Anonymous tissue may
be used without consent
with ethics committee
approval• ․ቯ䈪䈐䉎⚵❱䈲หᗧ䈏ᔅⷐ• ඞฬ䈱⚵❱䈱೑↪䈻䈱หᗧ䈮㑐䉒䉎⼏⺰• ඞฬ䈱⚵❱䈲୶ℂᆔຬળ䈱วᗧ䉕⚻䉏䈳หᗧ䈭䈚䈮૶↪
䈪䈐䉎䈖䈫䈏䈅䉎

㪉

69

Tissue from deceased individuals• Always requires consent• Use for a particularresearch project• Use for future, undefined
research• Donated fortransplantation but
unsuitable• No time limits on storage
but should be subject toreview• ᔅ䈝หᗧ䈏ᔅⷐ• ․ቯ䈱⎇ⓥ䊒䊨䉳䉢䉪䊃䈱䈢䉄䈱૶↪
• ዁᧪䈱ਇ․ቯ䈱⎇ⓥ䈱䈢䉄䈱೑↪
• ⒖ᬀ↪䈮ឭଏ䈘䉏䈢䈏೑↪䈪䈐䈭䈇• ଻▤ᦼ㑆䈮೙㒢䈲䈭䈇䈏䇮ᡷቯ䈱ኻ⽎䈫䈜䈼䈐
㪊Fetal tissue• Fetal tissue is treated as
tissue from the woman• Can be used anonymously
without consent but
consent is good practice• Polkinghorne Guidance(1989) currently underrevision:• ⢝ఽ䈱⚵❱䈲Უⷫ䈱⚵❱䈫䈚䈩ᛒ䉒䉏䉎• หᗧ䈭䈚䈮ඞฬ䈪૶↪䈏น⢻䈣䈏䇮หᗧ䉕ᓧ䉎䈖䈫䈏ᦸ䉁䈚䈇• Polkinghorne Guidance (1989)䈲⃻࿷䇮ᡷቯਛ䋺ၿ⢝䈫⎇ⓥ䈱䈢䉄䈱หᗧ䈫䈱᣿⏕䈭඙೎
䂾 ㊄㌛⊛ႎ㈽䉕⹺䉄䈭䈇䂾 ᦠ㕙਄䈱หᗧ䈲ᔅⷐ䈣䈏․ቯ
䈱⎇ⓥ䈪䈲䈭䈒৻⥸⊛䈭⎇ⓥ䈱䈢䉄䂾 ၿ⢝ᚻ⛯䈐䈮㑐䈚䈩䈲ᄌᦝ䈭䈚䂾

o Clear separation between
termination and consent for
researcho No financial incentiveso Written consent but general not
specific type of researcho No modification to the termination
procedure㪋

70Genetic research• Research that includes
DNA analysis subject tothe same general rules• Other guidance on genetic
research:• DNAಽᨆ䉕฽䉃⎇ⓥ䈲ห䈛৻⥸ⷙቯ䈮ᓥ䈉• ㆮવቇ⊛⎇ⓥ䈮㑐䈜䉎䈠䈱ઁ䈱ᜰ㊎䋺䂾 ㆮવሶ⸻ᢿ⊛෸䈶⊒∝೨ᬌᩏ䈫⎇ⓥ䈫䈱᣿⏕䈭඙೎

o clear distinction between diagnostic
or predictive genetic testing andresearcho where tissue is identifiable specificconsent neededo feedback to participant?
o implications for self and family• UK Biobank⚵❱䈱ᧄੱ․ቯ䈏น⢻䈭႐ว䈲หᗧⷐ䂾 ෳട⠪䈻䈱䊐䉞䊷䊄䊋䉾䉪䈲䈅䉎䈼䈐䈎䋿䂾 ᧄੱ䈫ኅᣖ䈮䈫䈦䈩䈱ᗧ๧䂾• UK Biobank

㪌Embryo research• ฃ♖ᓟ14ᣣ䉁䈪䈲น⢻• Permitted up to 14 days after
fertilisation• Covered by Human Fertilisationand Embryology (HFE) Act 1990
• Every project must be licensed
by the Human Fertilisation andEmbryology Authority (HFEA)• HFE Act under review but noplans to change embryo
research• HFEA and HTA to merge toform Regulatory Authority for
Tissues and Embryos (RATE)• Human Fertilisation andEmbryology (HFE) Act 1990䈮䈩
✂⟜• ో䈩䈱䊒䊨䉳䉢䉪䊃䈲Human
Fertilisation and Embryology
Authority (HFEA)䈱⹺นⷐ• HFE Act䈲ᡷቯਛ䈣䈏䇮⢝ఽ䈱
⎇ⓥ䈮䈲ᄌᦝ䈱੍ቯ䈭䈚• HFEA䈫HTA䈲Regulatory
Authority for Tissues andEmbryos (RATE)䈮⛔ว
㪍

71

Stem cell research• HFEA⹺น䉕ฃ䈔䈢33ઙ䈱⎇ⓥ䊒䊨䉳䉢䉪䊃䈱䈉䈤䇮15ઙ䈏ᐙ⚦⢩⎇ⓥ• 䉟䉩䊥䉴䈱࿖᳃䈲⢝ఽ䈱ᐙ• UK public supportive of⚦⢩⎇ⓥ䉕ᡰᜬ
embryonic stem cell research• Of 33 research projects
licensed by HFEA, 15 are forstem cell research• Human Reproductive
Cloning Act 2001

• Human Reproductive
Cloning Act 2001

• UK Stem Cell Bank
established• UK Stem Cell Bank䈱ഃ⸳㪎

Egg donation for research• Should women who are nothaving treatment be able todonate eggs for research?
• Is “egg sharing”
acceptable?
• Is egg donation for researchcloser to donation of othermaterial for research or to
donation of eggs fortreatment?
• Should egg donors be paid?

• ᴦ≮䉕ฃ䈔䈩䈇䈭䈇ᅚᕈ䈲⎇ⓥ↪䈮ฃ♖ෆ䉕ឭଏน⢻䈎䋿• 䇸ฃ♖ෆ౒᦭䇹䈲ኈ⹺䈪䈐䉎䈎䋿• ⎇ⓥ䈱䈢䉄䈱ฃ♖ෆឭଏ䈲䈠䈱ઁ䈱⚵❱ឭଏ䈮㘃ૃ䈎䇮䈅䉎䈇䈲ᴦ≮䈱䈢䉄䈱ฃ♖ෆឭଏ䈮㘃ૃ䈎䋿• ฃ♖ෆឭଏ⠪䈲ႎ㈽䉕ฃ䈔
䉎䈼䈐䈎䋿
㪏

72

Import and export of tissueャ౉䈘䉏䈢⚵❱䈱೑↪䈮䈲ᱜᒰ䈭ℂ↱䈏ᔅⷐ䊄䊅䊷䈎䉌䈱᦭ല䈭หᗧ䈱⸽᣿಴り࿖䈱୶ℂ⊛䈭ᛚ⹺ಣಽᓟ䇮ᦨૐ5ᐕ㑆䈲ᖱႎ䉕଻ᜬ᦭ኂ䈭⥃ᐥ᧚ᢱ䈱ャㅍ䈮㑐䈜䉎ၮḰ䉕ㆩ቞ಣಽ䈮㑐䈜䉎᣿⏕䈭ᣇ㊎• Use of imported material must •be justified• Evidence of valid consent from •the donor• Ethical approval from the•country of origin•• Register of information
retained for at least 5 years
after disposal•• Compliance with standards forthe transport of hazardous•
clinical material• Clear policy for disposal㪐Research ethics committees• Very variable quality• Since 2000 steps taken to
improve quality• Major changes planned:• ຠ⾰䈮ᄢ䈐䈭Ꮕ• 2000ᐕએ㒠䇮ຠ⾰ᡷༀ䈏࿑䉌䉏䈩䈇䉎• ੍ቯ䈘䉏䉎ᄢ᏷䈭ᄌᦝὐ䋺䂾

o Triage system with National
Research Ethics Adviserso Committee members paid
for their contributiono More emphasis on trainingo Quality assurance to reduceinconsistency

National Research Ethics
Advisers䈫䈱䊃䊥䉝䊷䉳૕೙䂾ᆔຬળ䊜䊮䊋䊷䈮ႎ㈽䂾⎇ୃ䉕䉋䉍ᒝ⺞⍦⋫ὐ䉕ૐᷫ䈜䉎ὑ䈱ຠ⾰
଻⸽

䂾

㪈㪇

73

Slide presentation 2

Editors comments for Japanese readers regarding terminology
日本語訳に対する編者のコメント

ｐ69、スライド No.2

匿名の組織は倫理委員会の合意を経れば同意なしに使用できることがある→「法的に使用ができる」の意

ｐ70、スライド No.3

改定の対象とすべき→各機関における審査の対象とすべき

ｐ72、スライド No.7

胎児の幹細胞研究→胚性幹細胞（ES 細胞）研究

ｐ72、スライド No.8

「受精卵共有」→「受精卵の分配」

74

Japanese governmental guidelines concerning the issues
Eiji Maruyama, Professor of Kobe University Faculty of Law
2-1 Rokkodai-cho, Nada-ku, Kobe
I read my papers and other details of the guidelines, which is the topic I speak for this session
described in the handout. I shall speak very summary bit. In this presentation, I would like to show
an overview of governmental ethical guidelines for biomedical research and personalized medicine
and BioBank Japan project, which has so far collected about 200,000 patients who have *** data. I
also would like to submit some observations based upon my personal experience with guidelines,
drafting, and BioBank Japan Project.
As summarized by Professor Sato, there are several guidelines concerning biomedical research.
First, we have guideline for Genetic Analysis Research, the original version of which was drafted in2000 and current one is drafted, enacted in 2001 and amended in 2004, as I explain later.
Next, Human Embryonic Stem Cells Guideline was promulgated in September 2001, and around thesame time, the Guideline for Handling of Specified Embryos such as chimeric embryos or hybrid
embryos and cloned embryos and so on. Epidemiological Research Guidelines were enacted in 2002
and now in the process of amendment. Clinical Research Guidelines were promulgated in 2003 andrecently our government has enacted guidelines for clinical study using Human Stem Cell Guidelines.
These guidelines do not extend to apply to each human embryonic stem cells, nor stem cells derived
from fetuses. These guidelines only applied to the research using the somatic adult stem cells.
Before that, guideline for clinical study of gene therapy was promulgated. It was originally enacted
in 1994. So, there are many guidelines enacted here in Japan.
These are common features of the guidelines and, in a sense, common around the world:
informed consent requirement, personal information protection, and review and approval by research
ethics committee that is composed of members of multiple disciplines and both sexes.
As I said before, these guidelines were amended in order to make them conformant with the
Personal Information Protection Legislation, which was enacted in May 2003 and implemented in
April 2005, last year. These legislations largely follow the model of OECD Guidelines of 1980 on
the protection of privacy and transborder flows of personal data and have the features as a progress.
This personal information law legislation explicitly exempts researchers of academic institutions
from specific obligations regarding personal information processing for the purpose of academic
research, however, most obligations thus exempted in law have been incorporated in the guidelines
revised in December 2004. So, actually these obligations contained in the personal information
legislation imposed researchers.
Now I move to the BioBank, or move to near the BioBank. As BioBank’s researchers who use
their specimens are supposed to make genomic and genetic analysis research, the Genome Guidelines
seems to govern their operation and researches. Genomic and genetic information, which is uniqueto each individual, it is said, will not change for life and may indicate their future onset ofsusceptibility to particular diseases. So, it is said these characteristics of genomic and genetic
information justify individual’s control of it and special protection against the violation of its
confidentiality.
Specifically, the Genomic and Genetic Analysis Guidelines, 10 subsection III provides thatwritten informed consent must be obtained and the participant may withdraw at any time who *** hisor her informed consent without suffering any disadvantages.
Regarding the personal information security measures, these guidelines provide that effective
measures to secure the protection of personal information must be provided. And guidelines make ita rule to anonymize specimens and data before they are used in research so that the same system must
be used as in the United Kingdom or England.
Guideline 14 subsection II provides that where the specimens are deposited to a humancell/gene/tissue bank, it must be ensured that they would be anonymized in an unlinkable manner
when distributed to researchers.
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan75

Personal medicine project and BioBank started in spring 2003, a five-year governmentallyfunded 180 million project led by Professor Yusuke Nakamura of the Institute of Medical Science of
the University of Tokyo where the Professor Muto belonged now, was launch. The project named
Personalized Medicine Project was first conceived as a research and development project to revitalize
the Japanese economy and in a sense, with a successor to the former Millennium Genome Project,which started in 2000.
These are the aims of Personalized Medicine Project, discovery of gene susceptible to disease
was also related to efficacy or adverse reactions of drugs; secondly, evidence-based development ofdrugs for diagnostic method; thirdly, providing the important medical information that can be applied
to establishment of personalized medicine; and fourthly, a genetic and environmental epidemiology.
Here is how to realize personalized medicine. First, collection of DNA, sera and clinicalinformation from 300 patients. Actually, these numbers are now found to be difficult to achieve andabout 300,000 cases will be collected. One patient may have several cases, several diseases, so if
you do not have collected 3,000 patients, you may have collected 300,000 cases. Secondly,
construction of BioBank Japan at the preservation condition and systematic genomics and proteomics
analysis, and identification of genes of medical important.
In this project, some ELSI working group was established in August 2003 and it was notindependent from that project. Next year, this ELSI working group was replaced by the ELSI
committee and now ELSI committee stand parallel with the steering committees and can perform its
duty more efficiently and independently.
Present ELSI committee of the Personalized Medicine Project consists of one medical scientist,one patent specialist, one genetic counselor, two representatives of patient groups, one bio-ethicist,one practicing lawyer and two law teachers. It meets once a month.
Our ELSI committee’s activities include meeting, collaborating with hospitals to make onsite
checking of the informed concept procedures and personal information protection system. Secondly,
inspection of the records of the research ethics committee of the participating institutions regarding
the ethical review of this project. Thirdly, checking the project system for distributing specimens to
outside researchers and finally, in this way it attempts to ensure the project conformity to the revised
genome guidelines.
Lastly, here are some of my personal experiences. Yes, I recently doubt the subject’s ability tounderstand the genomic research and BioBank system. It is so complicated and in a sense, very
remote from the everyday life of the ordinary people, the participant might not really understand what
they give consent to. Secondly, I doubt the researcher’s ability to protect every details of their study
plans, because to obtain the informed consent, researchers must be able to project every detail of theresearch plan, but actually, researchers may not be able to project every detail. And if that were true,
the perfect consent may not be truly obtainable. Thirdly, I found it very difficult to strike an idealbalance between ensuring the voluntariness of subject and efficient implementation of the research.
Fourthly, in Japan, researchers generally do not return the result of their research to individual patientsand I doubt the reason of that policy recently. Lastly, rather technically, the control samples should
be collected and its collection explained to the participant might be difficult.
These are my presentations and actually I returned from Australia last night and I revisited
Australian Law Reform Commission and four major hospitals involved in the genetic research.
Personally, what impressed me most is how important place the public engagement or public
involvement occupies in their system and in your country’s system.
In Japan also we have a public comment procedure in the process of guidelines drafting, but it
seems to me it is a rather formal procedure and public comment does not affect the final guidelines somuch at least like there, your country.
Just minutes ago, your public consultations matters a lot, but in our country, it does not. If you
please either appreciate it, if you could answer my question, I have been asking the same question,
what motivation, what background is there that place that make you place so much emphasis, so much
focused on the public engagement, and when did it happen? About from when did it started to berecognized, I would appreciate it.

76

Attached Material 1: Maruyama, E.

Legal Limitations on Genetic Research and the Commercialization of its Results:
Japan
Eiji Maruyama, Pofessor of Kobe University School of Law, Japan
I. Legal and Administrative Framework Surrounding Medical Research
1. Several Sets of Guidelines for Biomedical Research
Since the fall of 1999, Japanese government ministries have promulgated many sets of ethicalguidelines for biomedical research.
Recent increase of governmental ethical guidelines began with the drafting of the “Guidelines
on Ethical Issues Surrounding Genome Analysis Research” by the Ministry of Health andWelfare (MHW) in April 2000.

In October 1999, MHW announced a large 5 year humangenome analysis research project (Millennium Genome Project) as a part of governmentallyfunded Millennium Project which was to start in April 2000.

MHW, recognizing the ethicaland social problems involved in the genome research, prepared this set of guidelines that was toapply only to genomic research conducted under the Millennium Genome Project.

This set of

guidelines is often called as “Millennium Guidelines.”
As the Millennium Guidelines were not applicable to genome researches outside of theMillennium project, the ministries concerned with genomic and genetic research embarked on
the task of drafting of a common set of genome research guidelines in the summer of 2000.
This effort produced Ethics Guidelines for Human Genome/Gene Analysis Research in March
2001 (hereinafter cited as “Genome Guidelines”)1.
Besides Genome Guidelines, governmental ethical guidelines promulgated so far include
Guidelines for Derivation and Utilization of Human Embryonic Stem Cells (September 2001);
Guidelines for Handling of Specified Embryos (December 2001); Ethical Guidelines for
Epidemiological Research (June 2002); Ethical Guidelines for Clinical Research (July 2003);
Guidelines for Clinical Study of Gene Therapy (March 2002. The original gene therapy
guidelines were enacted in June 1994).
The common features of these guidelines are the requirements of voluntarily given informed
consent, protection of personal information, review and approval by research ethics committees
that is composed of members of multiple disciplines and of both sexes.
2. Revision of Guidelines in 2004
1

An English translation of the original guidelines before amendment in December 2004 can befound at (visited on April 5, 2006) http://www2.unescobkk.org/eubios/eghgr.htm. See generally
Gerald Porter, The Regulation of Human Genetic Databases in Japan, (2004) 1:3 SCRIPT-ed,
available on line at (visited on April 5, 2006)
http://www.law.ed.ac.uk/AHRB/script-ed/issue3/japan.asp.

77

Attached Material 1: Maruyama, E.

Many of the guidelines were revised at the end of 2004 to make them compatible with therequirements of the Personal Information Protection legislation2 that had been enacted in May
2003 and would take full effect in April 2005.

Although the legislation explicitly exempts

researchers of academic institutions from specific obligations regarding personal information
processing for the purpose of academic research, most obligations thus exempted have been
incorporated in the guidelines revised in December 2004.
II. Genome/Gene Analysis Research and Genome Guidelines
1. Requirement of informed consent
The Genome Guidelines provide the requirement of voluntary informed consent andparticipant’s right to revoke his/her consents anytime (but before unlinkable anonymization of
specimens and data) without any disadvantages.
Guideline 10(3) provides that before receiving a specimen and clinical data from a donor, theprincipal investigator must obtain a written consent based on his/her free will (informed
consent), after providing him/her with an adequate explanation of such matters as thesignificance, objectives, methods and expected results of the research, disadvantages that he/shemight suffer, and the method of preservation and use of a human specimen and clinical data.
Guideline 10(9) provides that the donor or his/her proxy may withdraw at any time in writing
his/her informed consent without suffering any disadvantage.
2. Protection of Personal Information through Security Measures and Anonymization
Guideline 6(3) provides that the head of research institution must take the organizationally,
personally, physically and technologically effective measures to secure the protection of
personal information processed by it, including the measures for the prevention of its leakage,loss and destruction.
The Guidelines make it a rule to anonymize specimens and data before they are used inresearch.

Guidelines 14(2) further provide that where the specimens are deposited to a humancell/gene/tissue bank, the principle investigator depositing them must ensure that they will beanonymized in an unlinkable manner when distributed to researchers and abide by theconditions stipulated by the donor or his/her proxy.
3. Gratuitousness of Participation and Intellectual Property Rights Derived from Research
A note to Guideline 10(11) sets out a list of main topics that should be included in the written
information given to the potential participant. According to the note, following topics should2

Its tentative English translation by Government can be found at (visited on April 9, 2006)
http://www5.cao.go.jp/seikatsu/kojin/foreign/act.pdf.

78

Attached Material 1: Maruyama, E.

be contained in the explanation.
That the outcomes of the research may possibly produce intellectual property rights such as
patent rights in the future, and the party to whom such intellectual property rights will
belong.
That provision of samples, etc. is gratuitous.
With respect to the first piece of information, the parties who will be given the rights in a vast
majority of cases will be researchers and their employers (i.e. universities or research
institutions).

In the Millennium Guidelines which preceded the Genome Guidelines provided

that the potential participants should be told that the intellectual property rights will not belong
to them.
III. Human Cloning Technology Regulation Act, 20003
1. History of the Human Cloning Technology Regulation Act
In September 1997, the Bioethics Committee was established at the Council for Science andTechnology, which was an advisory body to the Prime Minister in the development of policy ofscience and technology, after the news spread that a sheep named Dolly that had been createdby the technique of somatic cell nuclear transfer (SCNT) was born.

In December 1999, theBioethics Committee opined in the report "On the Creation of Human Individuals by theTechnology of Cloning" that cloning of human beings should be criminally prohibited.

The

report reasoned that the application of cloning technology to create human individuals will leadto human breeding and making human beings simply as tools or means for something; the childborn by the cloning technology, although having a separate personhood from the nuclear donor,
must always be conscious of his/her relation with the donor; cloning technology that makes
asexual reproduction possible would be a great deviation from our fundamental conception
about creation of human life; social mishap including the demoralization of familial order mightdevelop; the possibility of harm cannot be denied in the creation of human individuals by thecloning technology.

Therefore, the report concludes, there exists a serious problem of

invading the human dignity in the creation of human individuals by the cloning technology, andconsidering the extensiveness of the anticipated harm, it must be legally prohibited by thecriminal penalty.

With respect to the creation of individuals from the chimerical or hybrid

embryo of human and animal, the report said because it would give birth to a creature that will
endanger the identity of human species and might cause still more serious harm than cloning
technology, it should be banned by criminal penalty.
Based on the report, Human Cloning Technology Regulation bill was drafted and introduced3

Its provisional English translation by MEXT can be found at (visited on April 9, 2006)
http://www.mext.go.jp/a_menu/shinkou/seimei/2001/hai3/4_houritu.pdf.

79

Attached Material 1: Maruyama, E.

into Parliament in April 2000.

It would prohibit cloning of humans under the maximum

penalty of 5 years’ of imprisonment and/or a fine of 5 million yen (about US$42,000).
However, the bill was strangled by the dissolution of the lower house of Parliament in June.
October 2000, the bill was reintroduced into Parliament.

In

In this bill, the maximum penalty

was doubled to 10 years’ of imprisonment and/or a fine of 10 million yen.

In November 2000,

the bill was passed in both houses of Parliament and in June 2001 the main portion of the Act
came into effect.

Under the authority of the Act, the Guidelines for Handling of Specified

4

Embryos (hereinafter cited as “Specified Embryos Guidelines”) were enacted in December
2001.
2. Summary of the Human Cloning Technology Act and Specified Embryos Guidelines
Section 4 of the Act lists the following 9 categories of "specified embryos".
(1) Human somatic clone embryo
An embryo produced by transferring the nucleus of a human somatic cell into a humanenucleated egg.
(2) Human embryonic clone embryo
An embryo produced by transferring the nucleus of a human embryonic cell into a humanenucleated egg.
(3) Human split embryo
An embryo produced by a split of a human embryo.
(4) Human-animal hybrid embryo
An embryo produced by having a human gamete and an animal gamete fertilize with eachother.
(5) Human-animal fused embryo
An embryo produced by transferring the nucleus of a human cell into an animal enucleated
egg.
(6) Animal-human fused embryo
An embryo produced by transferring the nucleus of an animal cell into a human enucleatedegg.
(7) Human-human chimerical embryo
An embryo produced by unification as a result of aggregation of a human embryo and otherhuman embryo or cells.
(8) Human-animal chimerical embryo
An embryo produced by unification as a result of aggregation of a human embryo and an
4

Its English translation can be found at (visited on April 9, 2006)
http://www.mext.go.jp/a_menu/shinkou/seimei/2001/hai3/31_shishin_e.pdf.

80Attached Material 1: Maruyama, E.

animal embryo or cells.
(9) Animal-human chimerical embryo
An embryo produced by unification as a result of aggregation of an animal embryo andhuman cells.
Section 3 of the Act provides that no person shall transfer a human somatic clone embryo, ahuman-animal hybrid embryo, a human-animal fused embryo or a human-animal chimericalembryo into a human or animal uterus.

In addition, Specified Embryos Guidelines prohibittransferring the remaining 5 categories of specified embryos into a human or animal uterus forthe time being.

In short, at present, creation of an individual from a specified embryo iseffectively prohibited.
Guideline 1 of Specified Embryos Guidelines provides that production of a specified embryo
shall be allowed only when the following requirements are satisfied: (1) scientific knowledge,
which cannot be acquired from research using only animal embryos or cells or other research
conducted without a specified embryo, can be acquired with the production and utilization ofsuch a specified embryo; and (2) a person who is going to produce a specified embryo has
sufficient technical ability to study with such a specified embryo.
Guideline 2(1) of Specified Embryos Guidelines provides that among nine categories of
specified embryos, only an animal-human chimerical embryo shall be allowed to be produced
for the time being. The purpose of its production shall be limited to the research concerning
creation of organs derived from human cells that can be transplanted into a human body.
Guideline 2(2) provides that for the production of an animal-human chimerical embryo, neither
human embryo obtained from the fertilization of human ovum by human sperm nor humanunfertilized ovum must be used.
Section 6 of the Act provides that one who is going to produce or obtain *** a specified
embryo, he/she must file the relevant information including (a) the name and address and in thecase of artificial person name of the representative, (b) category of embryo intended to be
produced or obtained ***, (c) purpose (and, in the case of production, method), (d) date theembryo will be produced or obtained ***, (e) the way the embryos produced or obtained will behandled, (f) other information required by the order of the Ministry of Education, Culture,
Sports, Science and Technology (MEXT).

Guideline 10 provides that before he/she files theabove information with MEXT, he/she shall invite and respect the opinion of its ethics review
committee of his/her institution.
Until now, no attempts have been made to produce or obtain specified embryo under the Act
and Guidelines.
3. Creation and Use of Human Somatic Clone Embryo

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Attached Material 1: Maruyama, E.

It is provided in the appendix section 2 of the Act that the Government shall, within three
years after the date when this Act takes effect, take necessary measures based on the results ofthe study by the Council for Science and Technology Policy regarding the appropriate treatmentof the human embryo.

Following the mandate, the Expert Research Committee on Bioethics

established under the Council for Science and Technology Policy studied the problem for about
three years and published an opinion report named "Basic Thinking on the Treatment of Human
Embryo" in July 2004.

Concerning the human somatic clone embryo, it opined that, while thecreation and use of the human somatic clone embryo for the purpose of research cannot be
permitted in principle, it may be exceptionally allowed where its aim is to comply with people's
request for welfare based on their fundamental right to pursue happiness, and it is bothscientifically reasonable and socially sound.

Thus, the creation and use of human clone

embryo is permissible for the purpose of research of regenerative medicine for patients ofotherwise untreatable diseases.

In order to authorize exceptionally its creation and use,

Specified Embryos Guidelines shall be revised and supplemented by other governmental
guidelines to be enacted when necessary.

The preliminary work has been under way by thetask force for the study of research use of human clone embryo established under the Bioethics
and Safety Section of MEXT's Council for Science and Technology since December 2004.
IV. Guidelines for Derivation and Utilization of Human Embryonic Stem Cells5
1. History of the ES Cells Guidelines
One month after the report of successful derivation of human embryonic stem cells at the
University of Wisconsin was published in the Science magazine, the Subcommittee of Human
Embryo Research was established at the Bioethics Committee of the Council for Science andTechnology in December 1998.

In March 2000, the Subcommittee published “Report on the

Human Embryo Research Focused on the Human Embryonic Stem Cells.”

In September 2001,

after the Cloning Technology Regulation Bill passed in Parliament in December 2000, theGuidelines for Derivation and Use of Human Embryonic Stem Cells (hereinafter cited as “ESCells Guidelines”) was promulgated by MEXT.
2. Summary of the ES Cells Guidelines(1) Basic Research Only
Guideline 2 of the ES Cells Guidelines provides that, for the time being, derivation and use of
ES cells shall be limited to the purpose of basic research and that the following activities shallnot be carried out until another set of guidelines have been enacted:
Clinical research applying human ES cells or cells originated from them to the human body
5

Its English translation can be found at (visited on April 9, 2006)
http://www.mext.go.jp/a_menu/shinkou/seimei/2001/es/020101.pdf.

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Attached Material 1: Maruyama, E.

Other utilization of them in medicine and in its related fields.
(2) Respect for Human Embryo and ES Cells
Guideline 3 provides that, considering that a human embryo is nascent human life and thathuman ES cells have the potential for developing into any type of human cell, human embryos
and ES cells shall be handled carefully and conscientiously in order not to offend humandignity.
(3) Gratuitous Donation of a Human Embryo
Guideline 4 provides that the donation of human embryos for the purpose of derivation ofhuman ES cells shall be gratuitous, except that the reimbursement of necessary expenses ispermitted.
(4) Requirements for the Embryos Used for ES Cell Derivation
Guideline 6 provides that the human embryo to be used for derivation of human ES cells shallsatisfy the following requirements:
1) It is the human fertilized embryo which was initially been created for the purpose ofinfertility treatment, but is now not intended to be used for that purpose, and, the donors’
intention to leave it to be destroyed has been confirmed;
2) The donors appropriately consented to it being used for the purpose of derivation of human
ES cells;
3) It has been stored frozen;
4) Not more than 14 days have passed since its fertilization, excluding the days during which
it has been stored frozen.
(5) Procedure to be Followed before ES Cell Derivation
Under the Guidelines 14 - 16, the following procedure must be followed for the derivation ofhuman ES cells:1) Director of the derivation team shall prepare a derivation protocol and ask the approval forit from the head of the institution where the derivation will be attempted (hereinafter
DI=derivation institution);
2) The head of the DI shall seek the opinion of its ethics review committee, and based upon it,
shall decide whether to certify its conformity with the Guidelines;
3) The head of the DI shall obtain the assent to the protocol from the head of the medical
facility where embryos are donated (hereinafter DMF=donation medical facility). The
DMF’s head, in considering the protocol, shall invite the opinion of its ethics review
committee [this requirement of clearance from the ethics review committee of the DMF
seems rarely found in other countries];
4) The head of the DI, in deciding whether to approve the protocol, shall ask the confirmationof its conformity with the Guidelines from the Minister of MEXT;

83

Attached Material 1: Maruyama, E.

5) The Minister shall seek the opinion of the Bioethics and Bio-safety Committee of theCommission on Science and Technology, and based upon it, shall decide whether toconfirm its conformity with the Guidelines.
(6) Requirements for the Donation of Embryos for ES Cell Derivation
Under the Guidelines 22 - 23, the following requirements must be satisfied for the donationof embryos for the derivation of human ES cells:1) Only married couples (excluding those who have not had their marriage registered) can
donate embryos for the derivation of human ES cells;2) The informed consent to the donation shall be expressed in writing;3) Donated embryos shall not be used for the derivation for at least one month after the
informed consent is given.

In the meantime, the donors shall be able to withdraw the

donation;
4) The explanation shall be given not by physicians attending to the donors but by the persons
who belong to the institution where the derivation will be made.
(7) Information to be given to Donors for Informed Consent
Under Guideline 23, the written information to be given to donors shall include but not belimited to the followings:
1) The purposes and methods for deriving human ES cells;2) That the donated embryos will be destroyed in the derivation process;3) The anticipated method to utilize human ES cells and expected outcomes;
4) That the conformity of the derivation protocol with the Guidelines has been certified byboth the institution where the derivation is made and the medical facility where embryos
are donated, and has also been confirmed by the Government;
5) That all personal information of the donors will be removed from the embryos before thederivation;6) That the donors will be never offered compensation;7) That human ES cells may be analyzed genetically;
8) That the information regarding the ES cells including research results cannot be conveyed
to the embryos donor, because of the impossibility of identification of the donor from thecells;
9) That the processes and outcomes of the ES cell research may be published in academic
meetings and on other occasions;10) That ES cells will continue to be cultured for a long time and distributed to the user
institutions gratuitously;
11) That intellectual property rights such as patents or copyrights might be granted or
economic benefits obtained from the ES cell research, but these rights or benefits will not

84

Attached Material 1: Maruyama, E.

belong to the donor;
12) That whether to consent or refuse to donate their embryos will result neither in theiradvantage nor disadvantage;13) That donated embryos are stored for at least one month after the consent has been given
and that the consent can be withdrawn in the meanwhile.
(8) Deriving Human ES Cells in JapanThe first and so far the only application for the MEXT’s clearance of the ES cell derivation
protocol [=confirmation of its conformity with the Guidelines] was submitted at the end of
December 2001 by the researchers led by Professor Nakatsuji of Kyoto University.
clearance was granted in March 2002.
by them.

The

By November 2003, three ES cell lines were developed

These lines continued to be propagated well and began to be distributed in March

2004.
(9) Requirements for the use of human ES cells
Guideline 26 provides that the use of human ES cells shall be permitted only when thefollowing requirements are satisfied:
1) Its purpose is basic research contributing to(a) Clarification of the mechanisms of human development, differentiation andregeneration, or(b) Development of a new method of diagnosing, preventing or treating diseases ordevelopment of new medicines and drugs;
2) The use of human ES cells in the research is both scientifically necessary and appropriate.
It further provides that the human ES cells shall be those which were derived in conformity
with the Guidelines.

At the same time, Guideline 26(3) permit the use of the human ES cells

generated overseas, when the Minister certifies that such cells have been appropriately derived
in accordance with the standards of the Guidelines.

According to MEXT, included in thestandards are (a) the lines are derived from the so called surplus embryos, (2) adequate informed
consent was obtained for the donation of the embryos, and (3) the donation was gratuitous.
Under Guidelines 32 - 33, the following procedure must be followed for the use of human ES
cells:
1) Director of the team intending to use human ES cells shall prepare a use protocol and ask
the approval from the head of the institution (hereinafter UI=use institution).
2) The head of the UI shall seek the opinion of its ethics review committee, and based upon it,
shall decide whether to certify its conformity with the Guidelines.
3) The head of the UI, in deciding whether to approve the protocol, shall ask the confirmationof its conformity with the Guidelines from the Minister of MEXT.
4) The Minister shall seek the opinion of the Bioethics and Bio-safety Committee of the85Attached Material 1: Maruyama, E.

Commission on Science and Technology, and based upon it, shall decide whether toconfirm its conformity with the Guidelines.
(10) Use of Human ES Cells in Japan
So far, more than thirty protocols were granted the MEXT's clearance.

As the number ofapplication for MEXT's clearance is continuing to increase and experience has been
accumulated concerning the current set of Guidelines, MEXT is now in the process of revisingit.
V. Patenting the Results of Biomedical Research6
In Japan, like in Europe, methods for medical treatment, however novel and original, cannot
be regarded as industrially applicable inventions. Hence their patentability has been denied.
On the other hand, products used for medical treatment have been treated as patentable.

Onthis reasoning, inventions of pharmaceutical substances and medical devices, as well as specificmedicinal uses of them, even though that specific uses are to be made of already known
products, can be granted patents.

However, the discovery that a combination of the known

medicinal ingredients has a synergistic or otherwise remarkable effect or that that a change ofadministering mode of known medicines including the dose and dosing interval results in morefavorable or less adverse effects comes very close to the invention of the method of prescriptionof medicines by physicians that will not be qualified to be patented.

To make clear this point,

the Japan Patent Office in April 2005 revised its Examination Guidelines.

Guideline VII-3

now provides that medicinal inventions intended to specify the mode of medical treatment suchas the frequency of administration and dosage and combination of medicinal ingredients are tobe patented as product inventions.
One of the aims of Genome/gene analysis research is to realize the personalized medicine
through the discovery of the genes and SNPs related to efficacy or adverse reactions of
medicines.

Under the revised Examination Guidelines, it has now become possible to obtainpatents for medicinal use invention that determine the dose and dosing interval dependant on thepatients' gene and SNP information.

6

I. Shimbo, A. Cobden & K Sumikura, The Patentability of Medicinal Inventions Related to
Personalized Medicine in Japan. 2005. Nature Biotechnology 23(11):1367.

86

The Legal and BioethicalImplications of Research andBiobanking inJapanEiji Maruyama
Kobe University School of Law
Japan
1

Introduction
In this presentation, I would like to show an
overviewofgovernmental
ethicalguidelines for biomedical research andPersonalized Medicine and Biobank
Japan Project which has collected so far
about 200,000 patients’ blood and healthdata. I also would like to submit someobservations based upon my personal
experiences.
2

87

Guidelines for Biomedical Research◆ Ethics Guidelines for Human Genome/ Gene
Analysis Research (“Genome Guidelines”, MEXT,MHLW, METI, March 2001).
◆Guidelines for Derivation and Utilization of Human
Embryonic Stem Cells (MEXT, September 2001)◆Guidelines for Handling of Specified Embryos(MEXT, December 2001)
3

Guidelines for Biomedical Research◆ Ethical Guidelines for Epidemiological Research(MHLW, June 2002)◆Ethical Guidelines for Clinical Research (MHLW,
July 2003)◆Guidelines for Clinical Study Using Human StemCells (MHLW, June 2006)◆Guidelines for Clinical Study of Gene Therapy(MEXT & MHLW, March 2002. The original genetherapy guidelines were enacted in June 1994)
488

Features of Ethical Guidelines
 The requirements of voluntarily given informed
consent
 Protection of personal information
 Review and approval by research ethics
committees that is composed of members ofmultiple disciplines and both sexes.

5

Personal Information Protection
legislation in May 2003
Largely follows the model of OECD Guidelines on theProtection of Privacy and Transborder Flows of
Personal Data.
 Specification of purposes for which data are collected.
 Limitation of Use of data to the purposes.
 Nondisclosure to third parties without the consent of
the subject or the authority of law.
 Protection by reasonable security safeguards.
 Subject’s right to disclosure and correction.
6

89Personal Information Laws
and Ethical Guidelines Personal Information Protection legislation (taking
full effect in April 2005) explicitly exempts
researchers of academic institutions from specificobligations regarding personal information
processing for the purpose of academic research.
 However, most obligations thus exempted havebeen incorporated in the guidelines revised in
December 2004.
7

Biobank and Genome Guidelines As biobanks and researchers who use their
specimens are supposed to make genome/gene
analysis research, the Genome Guidelines govern
their operation and researches.
 Genomic/genetic information, which is unique toeach individual, will not change for life, and may
indicate the future onset of or susceptibility toparticular diseases.
These characteristics ofgenomic/genetic information justify an individual’scontrol of it and special protection against theviolation of its confidentiality.
890Requirement of Informed Consent
Guideline 10(3) provides that before receiving a specimen
and clinical data from a donor, the principal investigatormust obtain a written consent based on his/her free will
(informed consent), after providing him/her with anadequate explanation of such matters as the significance,
objectives, methods and expected results of the research,disadvantages that he/she might suffer, and the method ofpreservation and use of a human specimen and clinicaldata.
Guideline 10(9) provides that the donor or his/her proxy may
withdraw at any time in writing his/her informed consent
without suffering any disadvantage.
9

Personal Information Security Measures
and Anonymization
Guideline 6(3) provides that the head of research
institution must take the organizationally, personally,physically and technologically effective measures tosecure the protection of personal information.
Guidelines make it a rule to anonymize specimens anddata before they are used in research.
Guidelines 14(2) provide that where the specimens aredeposited to a human cell/gene/tissue bank, it must be
ensured that they will be anonymized in an unlinkablemanner when distributed to researchers.
1091Personalized Medicine Project andBiobank Japan
Spring of 2003: A five year governmentally funded$180 million project led by Professor Yusuke
Nakamura of the Institute of Medical Science of the
University of Tokyo was launched.
The project, named “Personalized Medicine Project,”
was first conceived as a research and development
project to revitalize the Japanese economy, and, ina sense, is a successor to the Millennium Genome
Project.
11

The Aims of “Personalized Medicine “ Project
1. Discovery of genes susceptible to diseases, or thoserelated to efficacy or adverse reactions of drugs
2. Evidence-based development of drugs or diagnostic
methods
3. Providing the important medical information that can beapplied for establishment of “Personalized Medicine”
4. Genetic and environmental epidemiology

How to realize “Personalized Medicine “ ?
1. Collection of DNAs, sera, and clinical information from
300,000 patients
2. Construction of Biobank Japan (DNAs at 4oC and sera at 150oC)
3. Systematic genomics (mainly SNP analysis) and proteomics
analysis12
4. Identification of genes of medical
importance92

ELSI Committee of
the Personalized Medicine Project
Summer of 2003: ELSI Working Group was establishedunder the Project’s Steering Committed (Working
Group’s first meeting was held in August 2003).
It was not independent of the Steering Committee andlacked its own secretary office, it could not work
efficiently.
Sept. 2004: ELSI committee replaced ELSI-WG.
ELSI committee stands parallel with the Steering
Committee and can perform its duty more efficiently.
13

The ELSI Committee◆The committee now consists of 9 members.
a medical scientist
a patent specialista genetic counselor
two representatives of patient groups
a bioethicist
a practicing lawyer
two law teachers(4 are female and 5 are male.)◆It meets once a month.

14

93

The ELSI Committee
The committee’s activities includes(1) visiting collaborating hospitals to make on-sitechecking of the informed consent procedures andpersonal information protection system;(2) inspection of the records of the research ethics
committees of the participating institutions regarding
the ethical review of this project;(3) checking the project’s system for distributing
specimens to outside researchers;(4) ensuring the project’s conformity to the revised
Genome Guidelines.
15

Personal Experiences
The subjects’ ability to understand the genomic
research and biobank.
Researchers’ ability to project the every detail of theirstudy plan.
The difficulty of striking an ideal balance between
ensuring the voluntariness of subjects and efficient
implementation of the research.
The rule of no returning of personally useful information
to participants.
The ways control samples should be collected and its
collection explained.
16

94

Thank you.
Acknowledgement
The following people kindly helped me in making thispresentation:
Professor Yusuke Nakamura (Tokyo University)
Dr. Yozo Ohnishi (Tokyo University)
And many others involved in Personalized Medicine
and Biobank Japan Project and J-MICC Study Project.

1795

Comments on the Japanese government guidelines
Tohru Masui, Senior Associate of National Institute of Biomedical Innovation
7-6-8, Saito-Asagi, Ibaraki-shi, Osaka
I would like introduce 4 sentences in relating to the issues discussed here. First 3 are fromdocuments indicated.
“Term medical purposes explicitly include medical research.”“We are all potential donors.”
These two sentences are closely related to the issue discussed here. Since I am working forcellbank, my concern is that how we can use human materials and information in a socially acceptableway. In this meeting we are informed that there are so many ways to achieve the information.
Medical research should be considered in the context of clinical practice, as Dr. Maruyama mentioned
on genome research and R&D activities. Medical research is not an isolated issue, it is closely
related with everyday practice of medicine. The first two sentences clearly show the conceptual
relation of medical practice and medical practice. Hearing the talks of Ms. English, I feel that wehave very different idea of medical research and consequently regulation is very different.
In Japan philosophy of medical research is represented by following two sentences.
1. Science is a tamed knowledge supporting by reasoning and assumption.
2. Science is a risky adventure motivated by intuition and instinct.
The fist one is currently very popular in Japan. The second one reflects reality of science.
Japanese guidelines are very much favour the first definition. Of course, medical research targets
human subjects and this situation demands caution. However, English San mentioned repeatedly
about the concept supported by the second sentence. I read regulatory documents of UK or USA in
medical research. They said that the regulatory frame is indispensable because of the second natureof science. The regulatory frame supports not only the human subjects, but also researchers andsociety as a large. Science naturally creates risks for research subjects. However, the second natureof science is indispensable of existence of the first definition.
I think that the difference came from the perception of risks on Japan. Japanese regulatory
people might seem to believe that nothing risky should happen if the medical research or science isdone right. It means that something should contain only good consequences if it is done right.
However, reality shows it seems wrong. Every thing has good and bad consequences and we could
reduce the bad consequences with caution. The worse is that trying to promote good part makes theincrease in risks invisibly.
This idea is typically demonstrated in our Clinical Research Guidelines. It had been madebased on Helsinki Declaration. In Helsinki Declaration, chapter 7, “i[I]n current medical practiceand in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks andburdens”. This sentence had been in the draft version of the guidelines, but it was deleted in the final
version.
Problem is complicated but philosophy seems simple.
Now we return to the basics, policy and ethics. In Japanese, these two sentences do not goalong well. However, if we define policy, in what society we would like to live, in what society wewould like to create, or what society we would like to hand to the next generation. What we can do
now for the future reflects ethics.
We have to cautious on thinking this, because there are differences in tense and in person. Itmeans that I should do something now for them for the future.
It could be phrased as the following; what mine is my own, what mine is ours, what mine isyours, and what mine is theirs. The medical research could bridge the first and the last phases.
If we think of the present situation of tissue and cell banking, we could realize it. Donors
donate his/her parts to banks and banks provide them to researcher. The research will reword bankwith their research outcome and appreciation. Then what could be exchanged between the banks
and donors. Monetary, reputation, or something should be returned to the donors.
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan96

We researchers used to show our appreciation by naming outcomes, i.e. cell lines, with the donor
names, like HeLa. This is the contrary to the philosophy of annonymization. In the case, we have toshow their names as contributors for the science.
In the last part I would like to comment one thing. We experienced heat in publicizing a series of
the guidelines on medical research. During the course, however, researchers have become reactive,
not responsible. English San mentioned about reluctance of researchers having strict regulatory
frame. Reluctance, I think, is better than becoming reactive. As I mentioned, research activity andethics are based on voluntariness of stakeholders. This could not be realized by putting outside
regulatory frame. We have to be responsible, not reactive, and this should be essential in being
ethical in medical research.

97

Discussion
Matsumura: Industrial use, import and export
May I ask one question, Ms. English? You did not note much about industrial use.
Now, wasted materials, or something which is left after surgery can be a great resource forindustry. For example, there are a number of woman with big breast. Too big. So that they may
want to cut a bit of the skin. This is beautiful normal skin.
We can cultivate this, and get keratinocytes or fibroblasts, which can be reconstituted to artificial
sheets of skin.
Do you think this can also be used in industry in the same way as for research? I mean if you
have ethical committee's approval.
EnglishIt doesn’t matter whether the research is being conducted within the National Health Service orwhether it is being conducted in the private sector or in industry, as the rules are the same for all. Any
use of “relevant material” which is material that includes human cells is treated in the same way.
One of the things that is included in the code of practice from the Human Tissue Authority is that
individuals should be informed if there may be an industrial application or there may be financial
benefit from the research. It should be made clear that they would not have any call on any profitsthat may be made and that’s the basis on which – if the tissue is identifiable and so they are asked forconsent - consent is given. I assume that if the Human Tissue Authority provides information about
research use of anonymous tissue, that would also be included – that the donor would have no claim
over any money which may accrue from the research.
Matsumura
You mentioned about import. But not about export. Is there any condition for exporting tissues?
In Human Tissue Act, do you require any condition for exporting human tissues?
EnglishThat’s a very interesting point because the code of practice is called “Import and Export ofTissue” but it’s virtually all about import. It says very little about export. I assume what theywould require that the conditions that must be satisfied in this country for the tissue to be used, arealso satisfied if research material is to be exported. I think the same would apply in terms of things
like keeping records of where the material has gone, and about safe transport: all of those issues I
think would also apply to export as well as to …
MatsumuraIf this is the case. I think that at least several Japanese industrial companies will very muchappreciate your system, since these companies currently have big difficulties in obtaining humantissue materials. This difficulty may partly be due to that Japanese guidelines mention only about
research uses. But this may not be a major reason, since what is needed for Japanese companies tohandle human tissue materials is law, rather than guidelines without legal bases in any way.
EnglishI don’t know how much material is actually exported, to be honest, because as I said there havenever been any checks, there has never been any regulation or any sort of mechanism for looking atthat before and in fact there’s still not going to be. You don’t need to have a license to export but
they are required to keep records, so I don’t know how much material is exported, to be perfectly
honest.
Norton: Negotiating parties for designing regulations
I would like to make a general comment that designing these types of regulations is through aprocess of negotiation and from Veronica English’s presentation, it is clear that in the case of the
Human Tissue Act there was quite extensive negotiation between professional associations,researchers and whatever other negotiating parties were involved. One of the factors which madenegotiations more rather than less difficult was that it was against a backdrop of the outrageous

98

problem illustrated by the Alder Hay case. And I think you rightly drew a comparison with the Human
Fertilization and Embryology Act which was actually anticipatory legislation-it wasn't brought in in
response to a crisis, it was actually anticipated by scientists, medical scientists, ethicists andpoliticians and of course religious groups, who played a somewhat more constructive role than they
do in the USA. And it was possible to deliver if not a consensus and least a visible compromise which
has allowed the various parties to allow the law to continue for about 15 years without serious
challenge. So I think there's a lesson there that says that in negotiating a future set of regulations, if
you can negotiate in the absence of crisis then you are likely to get more long-lasting and reasonable
and workable set of regulations then if you wait for a crisis to emerge. That's one of the generalrules of regulation!
The other key question is who is negotiating with who. I think again there is a contrast in mymind with the Human Fertilization Act. Because I worked in Parliament before, I was evaluating the
HFEA proposals at the time, I know the degree of care which went into balancing the various
strongly-held positions and which ended up with a workable compromise. But the people involved
could all be recognized as having a legitimate interest. But I can't quite work out from thepresentation which interests were involved in the Human Tissue Act. I can quite see thepathologist’s interest and the research interest, but when you mentioned negotiating with thegovernment, it sounds like they were very strongly driven by some other forces. So I'm asking what
were the things which really drove the people you were negotiating with - was it just the intuition ofpoliticians about what the public really want or will accept? Or were their some more highly
motivated other forces, whether ethically or religiously driven, or even human-rights driven. I'm justwondering what were the other forces that were driving you towards such a potentially very broad
ranging and restrictive-even unreasonably restrictive- law. Where were those forces coming from?
EnglishIf you’re talking mainly about the research use, then the push to have consent for absolutely
everything came from the organ retention scandal. The parents who were affected by this were very
angry and they wanted something to happen. They argued very strongly that something must change
and that consent must always be sought. Everybody agreed with that in relation to material fromdeceased people. What the government then did was to take that and apply the same principle totissue from living individuals generally, and actually extended that as well to anonymous tissue. I
think to be honest they were very nervous of offending these people even more. I’ll mention more
tomorrow but when the organs were returned, if it wasn’t bad enough what had happened, the waythat the return of organs was handled was very chaotic and that resulted in some families having twoor three additional funerals as more and more tissue was found. They were told “This is the tissue
we have” or “These are the organs we have”, and those would be buried. Then two months later
they would be called again and told “Oh, we’ve just found some more” and so they’d have anotherfuneral and then would be told there was some more. So that just made a very bad situation muchworse and really it was so bad – there was so much concern amongst the government and that tippedover unnecessarily into living tissue. I think that’s what was behind the call to restrict it very much.
NortonSo that was the political response?
EnglishYes.

That’s my opinion.

NortonWere there any complications over human rights ?
EnglishNo, not really. There was some discussion about human rights legislation. The Human Rights
Act has now been brought into UK law and so we all need to consider the Human Rights Act and theimplications of that whenever any public body is making decisions but there wasn’t a feeling that useof anonymous tissue breached human rights.

99With the retention of organs after death there wasn’t initially a problem because people did notknow what was happening. This whole thing came to light because there was an inquiry in Bristol
about heart surgery on babies – they had very low success rates and other. Quite by chance one of thewitnesses who was called mentioned that organs were retained, and then they said “Well, you should
see what’s happening at Alder Hey, because they have a massive collection” and that’s how all thiscame to light.
Mitsuishi
Professor Warnock’s committee setting 14-day limit for research on embryos and fetuses can beaborted. Is there any consistency between pre-embryo and embryo, i.e. pre-embryos can be used but
embryos cannot be used in research.
EnglishThat’s a very good question. It’s something that is often discussed, that we don’t allow embryos
past 14 days to be used for research, but people can have a termination of pregnancy. I think what
we need to consider is that there are, of course, two different motivations here.
If I can just start
off by picking up the first point you made, which is there was no scandal, which is absolutely true, butwhat you need to understand is that there was an awful lot of opposition to embryo research at thattime and there was real fear amongst scientists that that research would be prohibited.
Mitsuishi
Religious argument?
EnglishCertain religious groups were putting that argument forward but there was also a lot of
opposition in Parliament and a lot of opposition in the public. In 1985, I think it was, there was a
Private Member’s Bill (coming from a member of Parliament rather than from the Government) by
Enoch Powell and that was proposing to outlaw all embryo research and it got a lot of support. It did
get a majority, but it didn’t get enough time to get through Parliament. So that’s what started thisdebate I talked about, about educating the public, educating Parliamentarians, about what embryos
actually are and what the research is for. There was quite a long period of time where it was felt thatembryo research would be prohibited and it was all about it’s potential life – you are creating a
potential life and then you’re using human life for research – so there was a lot of opposition at thattime and that gradually changed as people got more information. That’s why there was a need tohave the Warnock Committee. It wasn’t just, of course, the research side but also the treatment side,
because IVF was still quite new. Louise Brown was only born in 1978, and the Warnock Committee
reported in 1984 and was set up, I think, in 1982, so there had been a few babies born by IVF but nothuge numbers and so there was also concern that this was completely new – developing human life
outside the human body. What would scientists do with this information? How were they going touse it? It was partly about the research, but the treatment side was also raising concern at that time,so that’s what led to the Warnock Committee being set up. In amongst all that opposition andconcern, and taking evidence from a very wide range of people, they decided that 14 days was an
appropriate limit to set because that’s the stage, or around then, that the primitive streak develops
where you know whether the cells are going on to form part of the placenta or going on to form partof the embryo proper. So there’s a reason why 14 days was chosen.
The difference, of course, with a termination of pregnancy is that, as you said, some people dosee that as a contradiction – that we don’t allow research on embryos but we do allow people toterminate pregnancy. In the UK we don’t have abortion on request or abortion on demand. Certain
criteria have to be met in order that a woman can have a termination. So before a woman can have atermination of pregnancy, she has to have two doctors who agree that she meets one of the criteria –those are going to be risks to her mental or physical well-being - it’s about the mother. The reason
you are doing the termination is because there are grounds under legislation to do that, so I think it isslightly different although I understand that people think there is a contradiction there.

100NortonBut the actual law only came in in 1990.
EnglishThat’s right.
NortonAnd between the Warnock Report and the actual legislation there was the traditional British wayof doing things, which is to have a voluntary scheme so there was actually the equivalent of the HFEA
before that, wasn’t there?
EnglishI used to run that, actually – the Voluntary Licensing Authority.
NortonSet up on a voluntary basis so it wasn’t just suddenly nothing happening and then the law. It
was anticipating the problem first of all voluntarily and of course in the research area “voluntary” israther a misnomer as if you are doing research you can’t really just ignore it, you have to comply
which brings it on to the statute book in a sense.
EnglishBut the other point to make about that is that it goes to show what I was saying earlier about
doctors and scientists who work in this area really wanted to have legislation – they agreed to belicensed voluntarily. Interestingly, we were discussing over dinner that there was one case where adoctor refused to abide by the guidelines of the Voluntary Licensing Authority and so he had his
Voluntary License withdrawn and the effect of that was that he had such bad publicity – because thepublic and the media supported the need for regulation in this area so much – he had such bad
publicity that he was losing business. He was a private doctor and patients weren’t going there.
They were then starting to “vote with their feet” as we say – go to a centre that was licensed – so hevery quickly decided that he would abide by the guidelines and he got his license back, so although it
was voluntary, there was a lot of pressure on people to comply even though it was a voluntary system.
Mitsuishi
Do you mean that there is no inconsistency between these two systems? Like one system is just
14 days after fertilization so that after 15 days you cannot use it for research, you cannot destroy it,
and yet the fetus can be destroyed.
NortonThe abortion is a therapeutic procedure on the mother for the mother’s health and welfare.
Brief discussion about selective abortion on grounds of genetics, handicapped fetus.
EnglishShe has a right if it is in compliance with the legislation but she has to show justification and she
has to show that she has reasons which are set out in the legislation to have a termination. She
doesn’t just have a right to go and say “I don’t want this pregnancy. Terminate my pregnancy.”
She could not do that in the UK. She has to show that she’s complying with the legislation, that she
is meeting one of the criteria for having an abortion.
Maruyama
This is a question that I have been asking myself for a while. Why does public engagement or
involvement stand so prominently in the formation of the public policy in your country, I mean,
compared to Japanese situation?

101

EnglishIn the UK there is a strong emphasis on individual autonomy and self-determination. The
individual has a right to make decisions about their own treatment. Questions of medical ethics andpublic policy are also not seen as just issues for doctors but they are about the society we live in andas such people in society feel they have a right to be consulted and help to shape public policy. Overthe last ten years we have seen a great expansion in the information made available to the public–through the media and the internet – and increasingly members of the public are encouraged tosubmit their views via public consultations.

NortonI would like to add that is not just the medical field, it has become a general philosophy toconsult - Its something called democracy! It is now seen as a central part of democracy not justsufficient to have an election every three or four years, it is now expected that there should be
involvement by the public in almost any major regulatory area- not just medical but transport,
environment. And the reason is that there have been a number of big issues, not just science-related
where the public reaction is a critical factor in stopping something. One example is where we tried
to dispose of radioactive waste there was a huge public opposition to that, and the public reaction
turned out to be the key factor which actually stopped a major part of government policy. The reactionof the public to genetically modified foods (rather like Japan) -is another area where there is a feelingthat because the public was not involved at critical stages of the regulatory process, they didn't havetrust in the process and therefore they refused to accept the results of the process when it came out.
So there are now some very ambitious and very expensive efforts to involve the public in newtechnologies. For instance there is a big initiative on nanotechnology where there is the effort todevelop the technology and the debate on its management and use in parallel, so the public arefamiliar with how it's going and won’t just wake up one morning and be surprised by a new
nano-product as they were in the case of GM. So it's quite broad-based; of course medical ethics is a
key area, but this consultative approach covers everything from transport and even the structure ofgovernment is being consulted on now. It is become a procedure of democracy now.
Utsugi
Because the problem of democracy, there must be some technical phase of this…
Masui
Welcome Trust held a meeting on engaging science in April 2006. (SCIENCE FOR ALL: IS
PUBLIC ENGAGEMENT ENGAGING THE PUBLIC? CONFERENCE REPORT, 3–4 APRIL 2006,
MANCHESTER CONFERENCE CENTRE. http://www.wellcome.ac.uk/doc_WTX032160.html )In the meeting they raised two key questions. How can we measure the success? What is the
purpose of public engagement? Still, UK spends so much time on public engagement, UK isstruggling on the issue still. We have to initiate the activity, though we need to mind the questions.
NortonJust one final point on that, it is a very ephemeral or woolly concept in that having had all thisengagement we have to say why did we do it and what were the outcomes. Of course some people
are doing it in order that their view of the desirable outcome should be the one that emerges. So
there's quite a big debate in the social science community about whether public engagement is meant
to be just trying to ensure that the public accept the outcome that is the ‘rational outcome’ or whether
it really is a negotiation between those with power and those who voted -the general public. There isan argument in the social sciences about which one of these it really is, and that's probably what the
Welcome Trust was talking about. I give a lecture on this at Tokyo Tech as part of a public
communications course.
Kurihara
I would like to ask you the real reason why UK biobank project takes so long time until starting
the project, which mean you takes so long time for the activities of getting consumers’ understanding,102

public acceptance, and system development. This situation is completely different from Japanese
biobank project. Japanese biobank project started without such intensive consultation with public andwithout well-designed system development. So would like to ask you real reason why UK biobank
project takes such long time before starting.
EnglishSome of the reason for the delay was getting the money and funding sorted out. A lot of time
was spent discussing recruitment and consent and there was also an issue about how they would
obtain the ongoing health data they needed.
Masui
When I first visited MRC on the issue of Biobank, they were very cautious. I was told that;“unless they are fairly well prepared to give reasons for public and opponents in the issue, they keep
the project in low profile. Otherwise, the project could ruin.” This attitude is constructed by theirexperience in public scandals during the 1990’s on BSE and GMO. The experience made themcautious on the preparation of Biobank. At the opening of the website of Biobank, they showed
everything. Now they are at the last phase of moving into the practice and they are adjusting theprotocols inside, in this way, they can manage the processes easy and quick.
To obtain name and address of the potential participants, Biobank applied PIAG for
authorization.
EnglishPatient Information Advisory Group (PIAG) which means that under certain circumstances you
can make a case for the information to be provided without consent and so they have to make anapplication to PIAG in order to get approval to seek the information without actually getting consent
from patients for them to be given it and that takes time.
Matsumura
OK. Masui-san mentioned about economy, I mean, economic pressure.
If we think of a couple of other small countries where they are mentioning openly that the
purpose of resident research is for them to survive. They devote themselves to that kind of researches
to attract capitals, industries and hospitals form all of the world, and to establish a center of hightechnokogy.
Certainly this is a kind of problem. How is the economic pressure in your country. This is not
mentioned at all in Human Tissue Act.
EnglishGenerally, there is a lot of support in the public for research and so I don’t think it’s necessary to
use those kind of arguments in order to encourage people to participate in research. When we dostudies we find a very high number of people are willing to donate material to research and that
actually turns into fact that people do donate, that people are happy, particularly if it’s anonymised so
I’m not sure that they need to actually use those arguments because there is a lot of support already,generally, for research. I think that’s partly because the media play an important role in promoting
the benefits of research and that helps because people can see where research is going.
Interestingly, there was a case recently where a phase 1 clinical trial went very badly wrong – I
don’t know if you have information about that here – and people went into multi-organ failure and it
was very serious. It was thought that this would lead to a lot of people saying “I’m not participatingin research”. In fact, it led to a massive number of people applying to go into research. The reason
for that is they hadn’t realized just how much money could be made from participating – it wasreported that volunteers had received about £2,000 for participating in that research and people
suddenly became interested and they ended up getting a lot more volunteers. So perhaps it’s not all
altruism – when we’re talking about clinical trials and there’s money involved, there is an economic
angle.

103

Session 3
Comparisons between the U.K. and Japan in social and cultural environments
surrounding human tissues with a proposal of internationally acceptable rules
Toshiharu Matsumura, Cell Technology Center,
1-10-4 Fuku-ura, Yokohama 236-0004, Japan(matsumura@roman-industries.co.jp)

Roman Industries Co. Ltd.,TABLE OF CONTENTS
Introduction
Part A. Fact studies
Statistics
Cultural backgrounds
Ethical backgrounds

A-Ⅰ
A-Ⅱ
A-Ⅲ

Part B. Considerations on fundamental issues
B-Ⅰ
B-Ⅱ

Extraction of several concepts from traditional Japanese customs
Attempted answers to some Japan- specific questions

Part C. Proposal of basic ethical rules for handling human tissues and theirapplication to Japanese cases
C- Ⅰ Approaches to drawing basic rules
C- Ⅱ Proposed basic rules for single body problems
C- Ⅲ Proposed basic rules for two body problems
C- Ⅳ Proposed basic rules for three body problems
Section A: Problems associated with dead bodies
Section B: Problems associated with non- or incompletely autonomous
human existence
C- Ⅴ Proposed solutions for some Japan-specific problems
C- Ⅵ Proposed international rules

Summary and conclusion
Acknowledgments
References

T. Matsumura et al. ( eds ) . Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England ( Human Tissue Act 2004 ) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan104

Introduction
1. The purpose of this paper
The ultimate goal of this paper is to propose a set of Japanese domestic rules and a setof international rules both of which may be understandable and appreciable by peopleinternationally. Here, United Kingdom is regarded as a representing international partner ofJapan.
To attain the ultimate goal, similarities and differences between the two countries infacts in statistics, in background culture, and in basic ethical concepts related with humantissues, are reviewed and analyzed, in the first place.
Then in the second, attempts are made to propose a strategy to draw basic rules forhandling human tissues.
With the strategy as proposed, a set of basic rules with the author's intention so that it
may fit with Japanese society, and may be understandable and appreciable by people
overseas, particularly British people, is proposed.
Finally a set of international rules is proposed as an extension of the proposed Japaneserules.

2.

The objects of this study

The objects of this study are parts of human body removed from a whole body, or thosegrown in vitro. They include organs, tissues, cells, fertilized eggs and developing eggs.
Sometimes genetic materials may also be included. Collectively, they will be reffered to as
tissues. The objects of this category are often referred to as 'hito-mono' in Japan, after
Koichi Bai. Here, 'hito' means human, and 'mono' what exists or stands by itself. 'Mono' isclose to the English word 'thing', but refers to an object that was thought in old days inJapan to contain soul within it. It is close to 'being' used as 'human being'. In this paper,
either 'human tissues', or 'human things' are meant to indicate what are called as 'hito-mono'in Japanese.

3.

Are human tissue issues worthy of considering international rules for them?
Author's position in this paper is YES.
･ Human tissues are already playing indispensable roles in modern society(Columns 1,2).
･ Human tissue utilization is still expanding (Columns 3,4).
･ International flow of human tissues is increasing (Statistic data yet available).
･ There are international imbalances between the availability of, and the demand for,human tissues.
･ Moral and ethical views are diverse among countries while they are becoming playing
important roles (Column 5).
･ In some special circumstances, not only fertilized embryos, but also somatic cells andtissues, the latter of which are frequently transported internationally, are to beconsidered at an equal ethical level with an integral human being, due to the fact thatan integral human body can now possibly be developed from them, using modern
cellular and embryological technology.
・ International rules have been playing important roles for the protection of vulnerable
subjects (Column 6).

105Column 1. Ways to utilize human tissues are expanding.
Transplantation using:Organs: Heart, Lung, Liver, Kidney--Tissues: Skin, Soft bone, Cornea,
Nerve--Cells: Bone marrow, Peripheral
blood, Pancreatic islet --Production of biopharmaceutical drugs using:
Cultured human cells
Genomic- and c-DNA for recombinant
production
Testing for safety, efficacy, metabolism using:
Liver tissues, Cultured cells, Skin,
Intestine
Regenerative medicine using:Embryonic stem cells,
Tissue stem cells,
Tissue precursor cells
Biomedical and pharmaceutical researches using: Everything

Column 2. Human tissues are playing important roles in the society.

OrgansOperation

TransplantationsanTr ctionef

Gene

Transfection

Ge
n
ec
lo n
ing

B
O
D
Y

Gene cloning

H
U
DiifferenIn vitro
Operation Tissues Culture Cultured
tiated Regenerative
differentiation
M
medicine
cells
tissuesA
N
Tissue-Cell-Gene Banking
RecomPharmabinant production ceutical
cells
drugs

Pharmac

recom
binat

ic
o-genomion

medicines

Vector106

gene therapy

H
U
M
A
N
B
O
D
Y

Column 3. Number of research papers dealing with human tissues is
expanding continuously since mid-seventies.

2005

2000

1995

1990

1985

1980

1975

1970

1960

90000
80000
70000
60000
50000
40000
30000
20000
10000
0

1965

Number of papers retreaved from PubMed using
human & research & (organ or tissue or cell or gene or
genome)Column 4. The proportion of research papers dealing with human tissues
among those dealing with human jumped up during mid-seventies, and stayed
constantly over 40% in recent years.

Proportion of the number of papers as retrieved from
PubMed using (human & research & (organ or tissue or cellor gene or genome)) over those using (Human & Research)
50.00%
40.00%
30.00%
20.00%
10.00%

107

2005

2000

1995

1990

1985

1980

1975

1970

1965

1960

0.00%

Column 5. Of research fields dealing with human tissues, the field of law andethics grew constantly during the last twenty-five years.
Proportion of the number of papers on human tissue
research in some specified fields of science and medicine
over the number of papers on human tissue research in
General medicine
general as retreaved from PubMed
60.00%
Biochemitry Molecularbiology

50.00%
40.00%

Microbiology

30.00%
Immunology

20.00%
10.00%
2005

2000

1995

1990

1985

1980

1975

1970

1965

1960

0.00%

Pharmacology
Pharmaceuticalsciences
Law Ethics

Profiles before 1975 are deleted due to small number of papers.

4.

If international rules once established, how are they effective?
They may be effective:･ in stimulating international cooperation.
･ in avoiding international conflicts related with human tissue issues.
･ in solving problems that cannot be solved by individual countries.
･ in drawing a future image and a direction toward the advancement and enrichment of
human life.

108Column 6. Examples of past and present interests in establishing international rules

Earth environments:
Preservation of
Kyoto Protocol 2001, United Nations Framework Convention on Climate
Change (UNFCCC)
Infant and child:Protection of
UN Convention on the Rights of the ChildIntellectual property right: Protection of
A number of international treaties as administered by World Intellectual
Property Organization (WIPO)
Nuclear power:
No proliferation ofTreaty on the Non-proliferation of Nuclear Weapons
Pharmaceutical drugs:
Registration of
The International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH)
Recombinant organisms:
Control of
Cartagena Protocol on Bio-safety to the Convention on Biological Diversity
Privacy:
Protection of
The EU Data Protection Directive 95/46/EC
Wild life:
Protection and Preservation ofConvention on International Trade in Endangered Species of Wild Fauna
and Flora (CITES, Washington Convention)

5. What matters while drawing international rules: Author's position
Do scientific knowledge, technology and economic condition influence ethics?
Author's position in this paper is YES. This issue will not much discussed in thispaper, but needs a thorough treatise separately.

Can we share moral and ethical bases common among people in different parts of theworld and with different cultural backgrounds?
Author's position in this paper is YES, with a reservation that they may changewith time as science and technology develop, and as human environments andeconomy change.

Are traditional life habit important here?
Author's position in this paper is YES. The results of brain science tell thatdecision-making mechanism in the brain develops throughout lifetime and that thebrain refers to his/her accumulated memories before a decision.
When a decision is to be made on a rare matter, the brain tends to consult withearly memories, since there are no pertinent cases in recent memories (Column 7).
Such an early memory is usually based on the local tradition that are notaccompanied with any explanation for their scientific reasons.
The death of a family member is a rare event, and therefore decision making at
such occasion is frequently influenced by tradition.

109

Column 7. Consulting with old memories. A recent Japanese case
After repeated failures of launching artificial satellites in recent
years in Japan, rocket engineers there decided to go andworship at Shinto-shrines (three shrines in fact!!) for good luck before
launching another artificial satellite.
Fortunately it worked out!

110Part A. Fact studies
A-Ⅰ

Statistics

1. Similarities
Economic status
The two countries are in a remarkably equal economic status (Column 8).
Therefore, economical influences on the current subject may be negligible here, atleast at the level of countries.
Column 8. In terms of GDP per capita, the two countries look like almost
identical twin.

GDP per capita (2005 IMF data)
UK
Japan

$30,436$30,615

Governance structure
The two countries are remarkably similar in their governance structure, at least
superficially (Column 9). Therefore, influence of governance structures on thecurrent subject may not be large here.

Column 9. Governance structure of the UK and Japan･ Royal (Imperial) family as the symbol of the country･ Democratic election system･ Two houses of parliament working as law making mechanisms･ Prime minister and a cabinet as the steering mechanism･ Ministries as the enforcing body of laws
･ Courts as judging mechanism

The basic capability of people's intelligence
With no good measures given, a plain assumption is made here so that people inthese two countries are intellectual sufficiently enough to understand and appreciateforeign ways of thinking as long as they are comprehensively described.

111

2. Differences
The incidence of organ transplantation from living donors verses that from cadavers
Generally, the incidence of organ transplantation, particularly that from cadavers,
is low, while that from living donors is high in Japan in comparison with that in
the U.K. It is remarkable to note that liver organ transplantation depends very muchin the U.K. on heart-beating donors, while in contrast on living donors in Japan(Columns 10,11).
Column 10. Profiles of donor status in the U.K.

Number per year of deceased(HB: heart beating, NHB: nonheart beating) and living donors in the U.K.: 1997-2006
900
800
700
600
500
400
300
200
100
0

HB
NHB
Living1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
year

Heart Beating Non-Heart
LivingDonor
Beating Donor Donor
Kidney
609
156
690
Liver
586
50
12
Heart
158
-

2006.4.1-2007.3.31
No. of donors in U.K.

The amount of human tissue supply to research entity
The amount of human tissue supply to the entity of research and development inJapan is mostly from other countries, as the number of organizations providing
Japanese tissues for research resources is only one, i.e., Human Science Research
Resource Bank, while those importing human organs and tissues from abroad are
numerous. No organs procured for transplantation purpose but not used for that
purpose with some or other reasons are allowed to be used for other purposes thantransplantation within the present Japanese regulatory framework (See below).

112

Column 11. Profiles of donor status in Japan showing that the incidence of livertransplantation from living donors is remarkably high in comparison with that in the U.K.

Number per year of deceased(HB: heart beating, NHB: nonheart beating) and living donors in Japan: 1997-2006
1000
900
800

Kidney HB
Kidney NHB
Kidney Living
Liver HB
Liver Living
Heart Domestic
Heart Overseas

700
600
500
400
300
200
100

19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06

0

year

Heart Beating Non-Heart
LivingDonor
Beating Donor Donor
Kidney
15
182
939
Liver
3
505
Heart
10
Domestic
7
Overseas

113

2006
Number of donors in Japan

The amount of industrial contribution from human tissue researchContribution of human tissue research is low in Japan in comparison with that ofhuman genome research as estimated from the entry number of patent (U.S. - Japan
comparison)(Columns 12,13).

Column 12. Profile of US patent entry numbers per year showing
human tissue-related ones at the top

USpatent entrynumber
12000
10000
8000
6000
4000
2000
0
2005

2000

1995

1990

1985

1980

human &gene
human &genome
human &tissue
human &embryo
human &stemcell

Column 13. Profiles of Japanese patent entry numbers per year showing
gene-related ones at the top
Japanese patent entry number
1600
1400
1200
1000
800
600
400
200
0
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005

human & gene
human & genome
human & tissue
human & embryo
human & stem cell

Discrepancy between wish and action for the donation of human tissues
In Japan, around ten percent people of total population have donor cards fororgan-transplantation in recent years. The small number of heart-beatingorgan-donation, as shown in Column 11, therefore, cannot be directly attributed to
the number of donor-card holder.

114

On the other hand, an inquiry study shown in Column 14 shows that the most of
all donor card holders are not reluctant to present their organs to research entity, as
long as they themselves are concerned. Therefore, it can also not be attributed to thenumber of donor-card holders who have wishes to donate human tissues for research
uses.
Here, it is to be noted that a government ordinance under the Japanese organtransplant law tells that those organs that have been procured for the purpose oftransplantation, and later found unsuitable for transplantation, are not to be used forany other purposes including research.
This may imply that crucial negative decision is often made against the will ofdead donors by others than the donor.
Column 14. A recent inquiry study shows that it is not the donor card holders
who make key decision.
Subjects:

Donor card holders

Number of inquiry sent:

3000

Number answered:

1218 (40.6%)

Question:

Can your organs once removed for transplantation
but unused for that purpose be used for research?

Answer: Yes
No
No answer

95%
3%
3%
An inquiry study by HAB research organization(2005)The governance framework to regulate human tissue handlingIn the UK, Human Tissue Act 2004 and Human Fertilization and Embryology Act
1990 cover essentially all issues regarding human tissues including organs, tissues,
cells and embryos to be taken outside of body, and to be used for researches, clinicalpurposes and others.
In Japan, there are a few pieces of laws covering several specific areas regarding
human tissues, such as organ transplantation and pathology. On the other hand, alarge set of ethical guidelines and recommendations, which are not directly bound to
any Japanese laws, have been issues from governmental administrative offices andcommittees to some fields of research and practice (Column 15). A broad area of
human tissue usage, including industrial use and tissue banking has been left without
any regulatory framework (To be described by Sato, Maruyama and Muto in details
in other sessions).

115

Column 15. Representative Japanese laws, ethical guidelines from thegovernmental administrative offices (GEGs) and recommendations fromgovernmental committees (GCRs).
Laws
Postmortem Examination Act
Organ Transplantation Act(This act does not cover tissue transplantation, nor research use of tissues)
Clone Technology Act
Protection of Private Information Act
Governmental ethical guidelines (GEGs) related to human tissues
GEG for clinical research
GEG for epidemiology research
GEG for gene therapy
GEG for human embryonic stem (ES) cell research
GEG for researches on human genome
Reports from governmental committees (GCRs) related to human tissues
GCR on the use of surgical materials for research
GCR on the operation of an institutional review board (IRB)
In this table the English name of a Japanese law, a GEG, or a GCR isgiven by word to word translation, and is not authorized.
These GEGs and GCRs have been appreciated and obeyed generally wellalmost like laws, although none of the GEGs and GCRs are underlined withany enforcing mechanisms except to those organizations that belong to thegovernment.
These GEGs and GCRs have been conformed essentially to the American
ethical framework as established first in the Belmont Report (1979, Seebelow). Particularly, attentions are stressed on the respect for autonomy
principle and setting an institutional review board (IRB) in an individualorganization.

Some key words mean differently between the two countries.
・ Brain death
Brain death is generally accepted as a category of death, not only medically but
also socially in the UK. While in Japan it is not accepted as such, but as a legal
word which can be used only when it is related with organ donation fortransplantation.
・DeathAlthough the term death as a medical term is unique all over the world, this term maysound differently among different part of the world when we look at it from a social view.
Since a careful consideration is needed here, difference in the meaning of death between a
traditional Japanese society and in a western society will be discussed in a later section insome details.
・Ethical committee
An ethical committee usually means in the U.K. a local ethical committee which is116

independent from an acting organization in which human tissues are handled. Whilein Japan, it usually means either an institutional review board that works as aconsulting agency to an acting organization, or a committee of an academic society
with special interests in ethics to which the members of the society are bound, if it
is influential to the society in general.
In both countries, there are exceptional cases in which an ethical committee
belongs to the government.

A-Ⅱ

Cultural backgrounds

With his limited educational background, the author intends only to remind
readers that there are some aspects of cultural backgrounds of the two countries
relevant to the present point of interests.

1. The UK and British people
The cultural background is composed of Celtic, Anglo-Saxon, Mediterranean andChristian inheritances with modern science-based philosophy. It is complex andmature.
Celtic backbone:
Fairies, creatures and ghosts are still alive in the fantasy of British people.
British people can understand polytheistic view of thinking if not taking that view.
Anglo-Saxon backbone:
Inheritance of peer review practiceMediterranean inheritance:
Strong sense of, and affinity to, property right
Christian inheritance:
People tend to regard the status, or the dignity, of human as being distinct from,and incomparable to, that of any other living organisms.
Multiple authorities:
The governance structure is composed of multiple authorities including those of thedemocratic government, the Royal family, Anglican Church, Catholic Church, andmany professional guilds including General Medical Council.
JS Mill's country:
Appreciation of autonomy and utilitarianism
Country of Newton and Darwin:With firm philosophical bases of modern science, the U.K. is among the mostadvanced countries in embryology, cell and molecular biology, and related application
fields.

2. Japan and Japanese people
Japan is one of rare developed countries in that monotheism has never dominated in
its history. It maintains polytheistic and pantheistic traits deep in its cultural backgroundwith influences of Buddhism and Confucianism, co-existing with the modern
science-based culture of Western origin.

117

Country with rich polytheistic and pantheistic inheritance:
Numerous shinto shrines where gods and goddesses, as described in such an old
myth as Kojiki (7th century), are still warmly worshipped, and traditional life habits,
including execution of festivals to celebrate them, are still a firm part of people'slife.
Western concept of death is not, nor even Buddhists' concept of death, easily or
absolutely accepted by many Japanese (See below).
People accept, enjoy, or are bound to, very many kinds of foreign traditional
festivals and taboos easily. Christmas, Halloween, St Valentine's Day all popular.
There are scarcely any 4, 13, 42 numbers on sheets or rooms in many Japanese
hotels, nor in Japanese air planes. A funeral will never be held on a 'tomobiki'(pulling friends) day. Lucky numbers are seven and eight. etc,etc.
People are very careful about gift relationship, where people say 'Sorry' in placeof 'Thanks' at the time of receiving a gift (For details, see below).
Country accepting therapeutic abortion easily:
Therapeutic abortion due to economic reason is accepted by Japanese law, withthe remembrance of 'mabiki' custom (killing a proportion of babies at birth foreconomic and some other reasons) which was common up to late 19th Century.

People with strong ability of adaptation:
Japan changed from a feudalistic country to a modern one with a strong central
government in a short period of time in late 19th Century, and then from afanatically nationalistic country to a friendly democratic one quickly after the world
war Ⅱ .
It is speculated in the later section that such a strong capability of adaptation may
be related to the structural characteristics of Japanese people's mind (See below).

People feeling strong ties between human beings and animals at the level of soul:
Virtually all research institutions using experimental animals have shrines toworship animal souls.
Japanese language maintains numerous animistic words within it core(Column 16).

'Respect for harmony' rather than 'Respect for autonomy' appreciated
The first constitution of Japan was established in 604 AD by Prince Shotoku, adevoted Buddhist, the first article of that is 'Respect for harmony'. The respect for
harmony principle firmly underlays the decision making mechanism of Japanesepeople as exemplified by the 'ne-mawashi' custom (Columns 17, 18).
People with Buddhist and Confucian inheritances but little with Christian inheritance:
A stable order had been maintained for more than 260 years until late 19th
Century, where two contrastive policies, the Confucian policy, 'Tokuchi-Shugi',
meaning 'moral-based governance policy' ( Columns 19,20 ) , and the Chin' dynasty's
policy, 'Hochi-Shugi', meaning 'law-based governance policy' (Column 21), wererespectively applied to different classes of people, i.e., those governing and those
governed (Column 22).
The framework of governance structure according to Confucian policy, as
described in Column 20, is simple, and decision making power is so much given to
bureaucrats, that low-making capability there is very week.
With little Christian inheritance, a human being has never been regarded as a
distinct existence from an animal, and human tie has been stressed on family- andcommunity- bases more than on philanthropic bases.
The political bases for Japanese people to maintain social integrity, before

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democratic mind came in late 19th Century, is considered as composed of the three
ways of thinking, i.e., animistic (philanthropic), Confucian moral-based, and Chin's
law abiding (Columns 23-25).

Country currently absorbing Western modern philosophy and technology strongly
Since late 19th Century, medical education has moved from experience-based
Chinese medicine to experiment-based Western modern medicine.
Scholars have been appreciated highly as the importers of Western cultures toJapan (Dewa-no-kami, meaning Mr. In there), where the easy to absorb (science andtechnology) has come early, and the difficult (Western social inheritance) later, or
has not come.

Country that enjoys life almost the longest in the world:
The longevity of the Japanese has been attributed largely to the traditional foodand life habit, if it is partly due to the development of modern Western medicine,leading to relatively low expenditure to medicine and to low appreciation of medical
science.

Column 16. Examples of pantheistic usage of Japanese words

Japanese
Englishas spoken as written
as spoken and written
mono
物
substance
thing
者
creatureke-mono獣(haired thing)animalwaru-mono
悪者(evil thing)villainkana-mono
金物(metallic thing)metalware
koto
事what happened
event
言what spoken
word, statement
koto-ba言葉leaf of kotoword
iwai-goto
祝事celebrated koto
happy event
Japanese speak in phonographic words, while write using ideographic Chinesecharacters, and think in combination using both.
The word 'mono' means any of materialistic existence that is supposed toharbour soul within it including an aminal, a human being and even a metallic
ware.
The word 'koto' means what has happened, and at the same time, what has
been told.

119Column 17. A typical traditional procedure of decision making following therespect for harmony principle
1.

2.

3.
4.
5.

The key person who wants to do something talks with each of concerning
people for their opinions, drafts a proposal of a plan, and further talks until
every one is satisfied with, or at least admits, it.
The key person finds a man/woman of authority among the concerning
people who may take the role of chairperson of a coming decision-making
meeting. If it is a political matter, then such a person as a university professorof top authority usually takes that role.
The key person helps the man of authority to call a decision-making meetingby the name of the man/woman of authority.
When the meeting is held, the man/woman of authority plays the role ofchairperson of the meeting, and asks opinions to the draft proposal.
As expected, they all accept the proposal. And the chairperson announces ago sign.

In results, the key person does not appear on any official platforms. The undergroundaction taken by the key person is called 'ne-mawashi' (cutting surrounding roots androtating the body of a tree in order for the tree to be transplanted later).

Column 18. An example of traditional Japanese rule against autonomy principle
Protection rule against impulse decision.
When you (a 'bushi') want to go shopping in the town, you must go withsomeone else, and must consult each other before shopping (in order to avoid
impulse buying)(A directive for 'bushi' class people of a local feudalistic county in Edo era
Japan)

Column 19. Traditional Japanese moral-based policy (Confucian policy or
Tokuchi-shugi) introduced from Han Dynasty, China (2nd to 1st Century BC),
for maintaining the social integrity･ Law must be simple and symbolic at its best.
･ Those with faithfulness, husbandry, and warm-hearted mind (ruling classpeople) are to govern people at large.
･ They should be selected by exams on the bases of equal opportunity.
･ At the best achievement of governance, the name of an emperor might evenbe forgotten by the people at large.

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Column 20. Ruling system in current Japan superticially looks likethat of the UK, but the former is a weak democratic system backed-upby the past Confucian inheritance.

Democratic system

Confucian system

Vote ← People ← Decision
Emperor (Symbolic)with fundamental law↑
with simple fundamental law(constitution)↑(constitution)↓↑↓
Representatives/Parliament ↑ ↑ →Exam. ← Literature
Law making
↑ ↑
↓
↑
↓
↑ ↑ Ruling class people↑
Ministers/Cabinet↑ ↑(the elite)
↑
↓
↑ ↑
↓
↑
Code making
↑ ↑
↓
↑
↓
↑ ↑ Case by case decision by the elite
Bureaucrats
↑ ↑
↓
↓
↑ ↑
↓
Practice↑ ↑Practice↓↑ ↑↓People→←PeopleColumn 21. Traditional Japanese law-abiding policy (Houchi-shugi) inheritedfrom the Ch'in Dynasty, China (3rd Century BC), for maintaining the social
integrity･ Governing principles should be itemized and publicized in details in the formof laws or instructions as being set under imperial authority.
･ Penalties due to violation against the laws should also be itemized and publicizedin the laws, and applied equally to every person without regards to social ranks.
･ An emperor should maintain his/her dictatorship always at his/her full capability.

121Column 22. The bi-standard politics that has been developed during Edo era(1603-1867 AD)

Moral-based politics applied to the ruling class people ('bushi' or 'samurai')･ If one has said once YES, and if he changes it later, the change is worthy of his
life.
･ For a 'bushi', being killed in the battlefield is justified as honourable. On theother hand, a penalty due to his crime is the most dishonourable. In the latter
case, he will be given the chance to protect his honour by terminating his life
by his own decision. A chance of such action before such a penalty is given
to him ('hara-kiri').
Law-based politics pressed on the ruled class people･ They should be ruled under a set of itemized laws, orders, or instructions,that are set under the ruling regimen.
･ There is no necessity to explain any reasons for such laws or orders to the ruledclass people.
The pre-democratic base of Japanese governance was on the balance of the
Confucian moral-based policy and the low-abiding policy, together withpantheistic tradition.

Column 23. Traditional pantheistic policy as a prehistoric Japanese inheritancefor maintaining the social integrity･ Spoken words are alive, and have their own souls 'koto-dama'.
･ If you brake what you have said, then the words that you have spoken will
revenge you.
･ If any misfortune happens on you, your family, or on any of your related people,
that must be due to the soul that is angry with the past unfaithful deeds ofyourself, or of someone akin to you (the concept of 'tatari').
･ In order to avoid 'tatari', and not to bring any new angry souls, you have to befaithful. And for the angry souls already brought, you have to honour and comfort
them in order for them not to bring any more 'tatari'.

122Column 24. An estimated figure of an average 19th Century Japanese person's
mind being balanced with the three ways of thinking with that his/her social
integrity was maintained.
Animistic way:･ Words once spoken are alive. If you follow or break your words, then you
shall receive their returns, if it is reward or revenge. Therefore, be faithful to what
you have spoken.
Confucian way:･ Ruling class people should be men of virtue with frugality and faithfulness.
'No two words with a bushi (ruling class person)'Low-abiding way:･ Itemized and publicized rules should be obeyed.
' The sanction against killing a deer in Wakakusa-yama sanctuary is the burial of
the killer alive in a barrel.'Column 25. A typical missing talk between the past and the modern'I, the responsible person, say that the nuclear power plant is safe.''How can you ensure it?''If any accidents, what can you do?''How rude are you to ask such questions!''Do you mean that I am not trustful?'
Past rule:

If an accident happens, then the responsible person must take his
responsibility at the expense of his own life. There is no need tomention this, since the rule is obvious.
Modern rule: If an accident happens, then a penalty within its limitation
described in law will be applied to the responsible person. If
there is no law to be applied to the specific case, then he/she shallnot be regarded as guilty in any way.

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A-Ⅲ

Ethical backgrounds

1. Traditional morals and ethical ways of thinking
Naturally, people are diverse in their ethical ways of thinking in any locality of theworld, and therefore a stereotypic drawing to characterize a local part of the world canoften be misleading. However, it is also natural that there are some tendencies which
differentiate a local part of the world from another. For the purpose of making the pointof discussion clear only, the author dares to try drawing some stereotypic ways ofthinking in below to differentiate Japan and the U.K.

The way of thinking towards single moral world:
In this way of thinking, there will be the single most advanced moral standard in
an ideally civilized stage of human society. Eventually, we (human beings) willattain the goal where all people share and enjoy such the most advanced level ofmorals. We are in the progress of civilization where an inferior society with ancientmorals are to be succeeded by a superior society with advanced morals.

The way of thinking accepting world with a variety of morals:
Here, a society may have several different standards of morals at the same time.
Naturally, people here tend to accept single person with multiple mental selves eachwith different character and philosophy.
The co-existence of multiple selves have already been recognized and appreciated in
the early history of Japan as seen in Kojiki, a collection of myths and history tales of
early Japan finalized in 712 AD, in Shinto-ism, and in Tales of Genji, written in early
11th Century that has been claimed to be the oldest novel in the world (Ref. to Column
26). Social acceptance of co-existence of different standards of morals as well as single
person with multiple selves is also noted in a number of Japanese proverbs as show in Column
27.
Since Japanese people have been influenced by Western ways of thinking now for
more than hundred years, their ways of thinking are also influenced greatly by Western
ways. Therefore, it is not meant here that the acceptance of several different standardsof morals represents Japanese people's current way of thinking. It is also not meant thatevery British have orientation towards the ideal society with the ultimately advanced moral.
Nevertheless, it may be said that Japanese people tend to be the former while British the latter.

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Column 26. Development and appreciation of humanity with multiple selves in Japan

Shinto-ism and Kojiki
In Shinto-ism, a human body is believed to host at least two souls, i.e., 'nigi-mitama',
meaning a peaceful, mild and tamed soul, and 'ara-mitama', an unhappy andaggressive one.
In literature, as early as of 8th Century in Kojiki, Records of Ancient Matters, thefirst collection of myths and historical tales of early Japan finalized in 712 AD, there
appear a number of pairs of, or sets of three, gods or goddesses. In such a pair, thetwo are usually with contrastive characters. In a set of three, two are contrastive andthe remaining one neutral between the two. Such a pair or a set of three havefrequently been interpreted as representing the existence of humanity in single personwith multiple selves.

The Tales of Genj i
Written in early 11th Century by Murasaki Shikibu, a talented court lady in Heianperiod of Japan, the Tales of Genji has been honoured as the first novel in the world.
The novel appears to tell the life of a fictitious noble man, Hikaru Genji, who saw
many women of different characters in his life. A psychological study made recently
by H.Kawai, a leading Japanese psycho-analyst, shows that what the author intended
was not to describe Hikaru, but to describe a women, the author, with multiple
characters each for one of multiple selves of the author, and the progresses of theseselves in her own life.

Column 27. Co-existence of different standards of morals and the acceptance ofmultiple selves each with different standards of morals in traditional Japan as seenin Japanese proverbs.
･ 'Once having joined in a local community, one should obey its local habit whatever
it is.'･ 'If with his stomach empty, a 'bushi' ( a ruling class person, a samurai) should look
content, like playing with a toothpick.' , while on the other hand, 'Merchant's life ismoney.'･ A 'Uchi-Benkei' character, behaving as a tyrant at home while as a sheep at work,
generously accepted.
･ 'A noble man, like a leopard, may change his attitude in a sudden.'･ 'One needs not be ashamed of what he/she (as a traveller) has done during his/her
journey (in a foreign place).' ( as long as he/she follows the morals of the foreign
place)

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2. The concepts of mind and soul
Again, as to what kind of concepts people have in different part of the world, it isdifficult to draw a stereotypic view. However, since British people and most of all
people in the Western world have the inheritances of Christian culture andMediterranian culture, both of which Japanese people have very little until recently, it
may not be far from misleading to say that British people have some tendency to accept
concepts of mind, soul and death cultivated in these cultures more than Japanese, while
Japanese people tend to accept other lines of concepts grown in their own culture as
described in below.

Christian way as one of typical stereotypic ways;･ God gives human body in the shape of God, and therefore it belongs to God.
･ At death, the soul departs from the body and goes straight to heaven.
･ Heaven is the eternal residence of the departed soul.
･ In the heaven, the souls of familial ancestors may stay beside, but never be unified
with, God.
･ The departed soul will never come back again. Thus, death is an instantaneous
event.
･ Organ transplantation is acceptable as long as God accepts it as a humanistic action.
･ The idea of equal status between human beings and animals at the level of theirsouls can never be accepted.
･ The status of animals is so that they have been created by God to serve humanbeings.

Classic rationalistic way as another typical stereotypic way;･ Human being is composed of two essential components, i.e., body and mind.
･ The mind resides in the brain.
･ Human beings are distinct from animals since the former have mind with reason
while the latter do not.
･ A body does not belong to God, if it does not belong to mind.
･ Death is, above all, the loss of mind from the body.
･ Brain death is acceptable, since there is no mind in the brain-dead body.

Japanese Shinto-ism and many Japanese sects of Buddhism influenced by nature
worship;･ The body is separable from the soul.
･ The soul is eternal, after being separated from the dead body.
･ The soul once separated from the body usually becomes an existence that protects
and cerebrates its descendants, i.e. ancestral god.
･ The departed soul, particularly of a familial ancestor, may come back around its
descendants, regularly at certain annual memorial days, or when invited, to help andencourage it descendants.
･ Departed souls from those who died without attaining their aims, such as those of
killed soldiers, are to be worshipped carefully and respectfully. Otherwise, they will
harm, or curse ('tataru') the survivors (i.e. 'tatari').
･ A departed soul can be revived when a body is given to it.
･ Such revitalization may happen to the same body after a temporary death of the body,or to another body including that at birth, or even to a non-human animal.

126

･ Death happens through a critical stage with a certain time-span, during which the soul
may be floating around the body, may come back to the body again, or to leave thebody permanently.
･ Animals and human beings are in equal status as long as souls and minds areconcerned.

Zen-Buddhism in Japan;･ Body is inseparable from mind.
･ After death, nothing remains.
Many sects of Japanese Buddhism, except for Zen-Buddhism, have heavily been
influenced by nature worship as long as the idea of life after death is concerned. But
still, there are differences between Shinto-ism and the Japanese Buddhism. In many
Japanese sects of Buddhism, the departed soul is believed to go either to Gokuraku(heaven) or Jigoku (hell), while in Shinto-ism, there are no ideas of heaven and hell,
and the departed soul may float around for some time after it has left from the deadbody, and then goes to its eternal destination located out of human territory, i.e., sea,
mountain or other places.

Science-based way common in most of all part of the world;・ There is no evidence for that body and mind are separable.
・ Mind resides in the brain, and thus there is a good reason for that body with its
brain function completely lost can be regarded as dead.
・ There is no evidence for that mind remains as a departed soul after death ofbrain.

3. Birth as formalized in traditional JapanThe traditional ceremony in cerebration of a birth in Japan may be represented by that
performed at a Shinto shrine. Here, parents with an infant to be celebrated attend,
present some offer to the god enshrined there, and receive blessing from the god. The
offer may be foods, sake, music, dance, or money, the last of which is the mostcommon. God's blessing is performed by oracles at the shrine. Such a cerebration
ceremony is often performed for an infant at one, three, five, and seven years ofinfant's age.
In the past, children before 7 years old had often been regarded as they belonged to God,suggesting that parents' responsibility for the life of an infant up to that age was not verymuch. Such a belief might console the parents when a significant proportion of infants died
due to infectious diseases and to other reasons in those days.
It was also the common understanding in those days until mid 19th century that a certain
proportion of new born babies was killed at birth (mabiki), mostly with economic reasons of
the parents. The traditional consoling explanation for the killing action was that mabiki was notunethical, since it was the action to return the soul of a baby to gods, and the soul will soon
catch another body to come back to this world.
Due to the banning of mabiki tradition, the traditional concept of birth has almost
disappeared in modern Japan. Even so, the legal permission in Japan of abortion due toeconomic reasons may be reminiscent of the historical background.

4. Death as formalized in traditional Japan
Although changing, the traditional death ceremonies are relatively well preserved in modern

127

Japan than those for birth celebration.
As shown in Column 28, the death of a person is usually followed by a series of ceremonies
usually for the period of 49 days. Tsuya, the first ceremony, has its origin to an old custom oftrying to revive a dying person, and watching if the dying person certainly is dead or not. A
recent Tsuya ceremony is only an overnight one, but it was sometimes performed for several
days or weeks of time in old days.
Not only the bereaved family and relatives, but also many those who know the dying person
come to Tsuya ceremony. To those who come to Tsuya ceremony, foods and sake are served.
Tsuya ceremony is followed by Kokubetsu ceremony i.e. the second and the main ceremony
during which the dead body is cremated. After these two ceremonies, the 7th day pray and the49th day ceremony follow. Through the sequence of these ceremonies the bereaved areconsoled and sympathized by many people attending to them.
An average expenditure for a funeral exceeds 3.4 million yen (ca.￡ 15,000)(Statistics obtained within the Tokyo metropolitan area of Japan in recent years).

Column 28. The procedure of typical funeral ceremony in Japan

1. Doctor announces 'Gorinju-desu' meaning 'Now he/her is facing to his/herterminal stage.'
2. Overnight watching (Tsuya), if the departed soul might come back to the body
3. Kokubetsu (parting) ceremony and cremation
4. 7 ｔｈ day ceremony for the good destination of the departed soul
5. 49 ｔｈ day ceremony
Destination of the departed soul determined, and the ashes of the dead placed in
the grave. The chief mourner sends letters to the attendants of the funeralreporting that the destination of his/her soul determined.
6. Then after, parties of bereaved family members are periodically hold withintention of the reunion of the bereaved and the departed soul.

128

Part B. Considerations on fundamental issues
B-Ⅰ

Extraction of several concepts from traditional Japanese customs

1. 'Socially given death' concept
At present in the U.K. and in Japan, a man or a woman may die mostly due to afatal disease or an unexpected fatal accident. However, it may have to be mentioned
that, in old days and even at present, there were, and are, several cases not includedin the above.
'Uba-Sute', told in Japanese old tales, was the custom in that old men or women
were abandoned at unpopulated sites remote from residential area. In a similar old
custom, known in Korea as 'Goryeojang, 高麗葬 ', men and women at the age ofseventy were abandoned.
In the history, there were a number of other customs in which living men andwomen were abandoned to death, and thus it was not the custom unique to Japan and
Korea. For example, in a nomadic society, those who could not walk any more might
be left abandoned to death during travelling. In a highly populated Indian society, anaged might be left abandoned alone in the market place.
Among recent cases in which the society expects death to a person is the case of'Kamikaze' suicide air fighter troop during the second world war. Here a fighter is
destined to attack a warship, but also destined not to come back if he could not findany target.
The point to be stressed here is that these customs of abandoning life have been
performed as a rule of the society, and have not been regarded as killing. Here, boththe abandoning and the abandoned have known, accepted, and obeyed the custom as
the social rule.
In this paper, this category of abandoning life to death will be referred to as'socially given death'. It should be noted that the socially given death is different
from the dignity death, since the choice of death here is made as a social rule, andtherefore it is the society that takes the responsibility for the action, while
responsibility for a dignity death is to the individual person who chooses death.

2. 'Mentally recognized birth' and 'mentally recognized death' concepts
The Japanese traditional custom related birth and death as described in the previous section,suggests that the full recognition of a new life does not always come at the time of physicalpartition, but takes a period of time, and that the full recognition of death also does notalways come at the time of physical termination of life as well. It also suggests that thetermination of an old person's life is sometimes accepted mentally even while the old person isstill physically alive.
Although highly speculative, it is postulated here that, in addition to the recognition of thebirth and death as physical events, the recognition of birth and death as mental events play
important roles in traditional Japanese society. Hereafter the terms 'mentally recognized life'and 'mentally recognized death' will be introduced to refer to these two ways of recognition
respectively. Mental recognition of death may be regarded as 'removal of live image of aperson in the brain' in other words.
A direct conclusion of the above considerations will be that, the term 'death' canmean differently in different parts of the world, Japan and the U.K. for example. If'death' is the idea that is not immediately accepted when a doctor announces his/her
death, but when the live image of the man/woman in the brain is removed, then the129word 'death', as accepted in the traditional Japan, may be used only after a certain
process consoling the bereaved has completed (Columns 29, 30).

Column 29. Physical life and death verses mentally recognized life and death assuspected from Japanese past habit

130Column 30. Objective death (A) and mentally recognized death as assumed tohappen in the brain (B)Objective death (A) and death mentally
recognized in brain (B)ChangeB in mind

ObjectiveAchange4. 'Killing in mind' concept
It may easily be speculated here that the removal of living image of a subject fromthe brain works as a strong mechanism to protect one's brain from the damage that
may otherwise happen due to the actual loss of a life around him or her. Here it isfurther speculated that such removal of living image may happen even before theactual loss of a life.
When we extend the subject from a human to an animal, such an speculation may
easily be accepted: For example:'How delicious does that waddling duckling look!''Cattle have been created so that they may present meat to human beings.'
To such removal of living image of life in the brain, without regard to the actual life
state of the subject, the term 'killing in mind' will be referred hereafter (Column 31).
Column 31. The recognition of death and 'killing in mind': A hypothesis

Current Western concept ofdeath recognition

B happens instantaneously with A

Japanese traditional concept ofdeath recognition

B happens with time after A(Removal of living image from the brain)

Past tradition of killing live bodies

B happens even before A(Killing in mind preceding A)

131

B-Ⅱ

Attempted answers to some Japan- specific questions

Why are many Japanese people reluctant to accept the respect for autonomy
principle?
The Western origin of the respect for autonomy principle can be traced back to
Aristotle, who questioned where is the ultimate goal of human life. His answer wasthat it was where one's potential capability is fully extended, and where one's own
will is fully appreciated.
In the traditional Japanese way of thinking, the ultimate goal of human life iswhere one's own existence is in full harmony with surrounding environment,
including people and nature, i.e., respect for harmony principle.
The respect for autonomy principle and the respect for harmony principle areapparently contradictory, which gives a good reason why Japanese people are
reluctant to accept the former principle (Column 32).
However, these two principles can be harmonized, to the author's understanding,in certain situations as will be described in later sections.
Column 32. Opinions for, or against, the 'respect for autonomy' principle
For:
The mind is independent from the body. The decision making can hardly be
influenced by physical factors, as long as one is a fully grown normal adult personwith reason.
Against:The mind is after all what resides in the body, and naturally, it is influenced by
the physical and other environmental factors including pharmaceutical drugs.
Therefore, there must be a limitation in the responsibility of a person for his/her
own autonomous decision.
Argument:
If, however, things are decided unanimously, as made in the traditional Japaneseway, it may means that some and other persons' autonomy may often be neglectedor suppressed.
Counter argument:
Ideally, unanimous decision is expected to be made after individual opinions are
expressed, preliminary adjustments made, and plans modified, so that benefits andrisks are expected to be shared evenly among all concerning people. A
preliminary adjustment (ne-mawashi) is therefore the prerequisite for a unanimousdecision. Merit of a unanimous decision with ne-mawashi is in that, when any
damage or merit happened due to the decision, then such damage or merit will beshared evenly among all concerning people.

132

Why are guidelines from governmental administrative offices so much appreciated inJapan while they are not underlined by laws ?
The tendency of Japanese governmental bureaucracy to give instructions in the form ofguidelines, easily infringing democratic constitution-based morals, may be explained by thememories of Confucian and pantheistic ways of governance where bureaucrats were highly
appreciated as governing class people. At the same time, it is speculative that the tendencyof people to easily accept such guidelines almost like laws comes from the habit of doing
so for a long time in the past.
Advantages accompanied with the current guideline-based Japanese system is inthat it is quick and can be efficient, since lengthy discussion in the parliaments canbe skipped. The current system relies on the self securing capability of concerning
people that has been still strong in Japan due to Confucian and pantheistic
inheritance.
Disadvantages are in that the traditional self-securing capability of Japanesepeople is falling rapidly, since modern democratic policy denies such unlimited
responsibility as paid at the cost of concerning people's life without any legal lining.
The modern policy claims a limited responsibility that must be clearly described inlaws. While on the other hand, laws have not been well developed yet, or theJapanese parliaments do yet feel its responsibility fully as law-making mechanism
under democratic system, due again to the inheritance of Confucianism.
Putting all together, the current guideline-based Japanese system is considered toplay its role to a certain level of practical meaningfulness, if not ideal, to maintainsocial integrity concerning human tissue handling.

Japanese people are reluctant to accept the brain death. Why?
The majority of Japanese people correctly understand the medical definition ofbrain death. However, since it is different from what they have been treating deathin their traditional way, they usually choose to follow the traditional way.
Traditionally, death is recognized as a process taking place over a period of time,
as seen in a typical Japanese funeral ceremony.

Why is a therapeutic abortion relatively easily accepted in Japan?
A popular belief up to 19th Century in Japan was that a birth is an event for asoul to creep into a body, and that death is simply the departure of the soul from thebody. It was believed as a consoling explanation when a considerable proportion ofbabies died in their early life in those days, that such a departed soul would soon get
another body to creep in, and to be given another chance of birth.
Likewise, killing just after birth was thought to be a deed to get the soul back to
god's hands again, and was regarded not as the work of evil.
Even during infancy, those seven years old or less were regarded as being within
God's hands, meaning that their loss is not to the responsibility of their parents, andnot to be regretted too much.

133

Part C. Proposal of basic ethical rules for handling human tissues and theirapplication to Japanese cases
C-Ⅰ
1.

Approaches to drawing basic rules

Significance of basic rules
As science and technology develop, we face new situations day by day. Basic rules
are aimed to provide a set of essential and minimum requirements for us to handle
human tissues at any new situation (Column 33).
It is requested for those rules to be internationally appreciable, and to provide
general bases for law making people to formulate a law in any country with different
ethical backgrounds.

Column 33. Significance of setting basic rules:

Human
TransPlantation Clone
Act
Act

Act
Act
Act

TissueResearch
Act
Basic rules(general human thing law)
2. Breaking down problems into three levels

Hereafter, ethical and legal problems associated with human tissues will beclassified into the following three groups (Column 34).
Single-body problems
Problems associated with any single autonomous person, who takes part in adonation, research, practical use, or in any other actions related with human tissues.

Two-body problems
Problems associated with any two autonomous persons, who are involved intransferring human tissues between the two.

Three-body problems
Problems associated with any two autonomous persons between whom humantissues are transferred, and in addition, with the existence that is associated with any
biological signs of humanity. The last includes human tissues, fertilized eggs,
developing embryos, and dead bodies.

134Column 34. Single body problems, two body problems and three bodyproblems.
Relationship between the three categories of problems

Single-body problems

Single-body problems
Two-body problems

Three-body problems

3. Advantages of layering basic rules into the three levels
As problems are classified into the three levels, rules will be classified into three,each for each class of problems here. Thus, rules for single-body problems are not only
applicable to single body problems, but also to two-body problems and three-bodyproblems, and rules for two-body problems to three-body problems as well (Column 35).

Column 35. Layering structure of the three rules

Human
Thing
Handler’s
Act

Human
Thing
Transfer
Act

Human
Stem
Cell
Act

Human
Embryo
Act

Human
**
Act

Rules for three-body issues
Rules for two-body issues
Rules for single body-issues

135

C- Ⅱ

Proposed basic rules for single body problems

1. Points of emphasis in general
Diversity among people
Question here is what are the basic rules for any individual person to do with 'humanthings'.
It should be taken into account that different points of emphasis shall be set todifferent persons with different cultural backgrounds.
･ God and me･ Nature and me･ My family and me･ The society and me･ My belief and me

Points of emphasis particularly in the present Japan
Rapid changes are in progress in the relationship between the society and an
individual person in Japan. The most profound changes may be itemized as follows:･ Confucian inheritance of selected- or leading class people's integrity being rapidly
lost, due mainly to the loss of trust in them due to the 2nd world war, and while post
war generations have not been educated of Confucianism.
･ Prehistoric inheritance of animistic integrity being gradually lost due to scientificeducation.
･ Democratic and constitutional law-making- and law-abiding minds, which is expected
to take part in place of the Confucian inheritance and the prehistoric inheritance, isgrowing, but slow.
In results, Japanese situation in integrity-ensuring capability is in a serious gap.

2. A proposed solution for single body problems particularly for Japanese
In principle:
While constitutional and democratic capability is growing but still immature in
Japan, the remaining capability of Confucian inheritance should be appreciated asmuch as possible to maintain the social integrity at this transitional stage of moral
changes.

In practice:･ Respective organizations are to establish self-regulatory rules, and make them open
to the public.
･ A minimal set of laws are to be formulated to give such a self-regulatingorganization a certain responsibility, so that if it fails to follow its own publicizedrules, then a legal sanction may be applied on it in some and other ways. One of the
choices to define such a legal sanction may be that penalties to be pursued are also
described by their own self-regulatory rules by themselves, as long as they do not
infringe Japanese national constitution.
･ Social mechanisms to collect, compare, monitor, and publicize the self-regulatory
rules of organizations, and the achievement of those self regulation by theorganizations, are to be developed.

136

In effect:
Critical discussion and analyses may be needed further as to if the above sets ofrules are internationally acceptable or not. At least, they are simple, and therefore
they may lessen the burden to law making people, a prerequisite that is particularly
important at the present situation in Japan.

C- Ⅲ

Proposed basic rules for two body problems

Two body problems are problems concerning two autonomous persons between whomhuman things are transferred.
In this respect, Helsinki Declaration and Belmont report may be among the mostinfluential in many countries as well as in Japan. Since most of all Japanese GEGs and
GCRs follow the three principles that are presented by Belmont report, they will betaken as composing the framework of basic rules for two body problems here.

1. The three Belmont principles as keys to solve two body problems
1) Respect for persons or autonomy principle
2) Beneficence3) Justice
These three principles of the U.S. origin are well known in Japan. However, adirect and practical application of these principles appears little effective in Japan, as
evidenced by the poor donation of human tissues for example. This is mostpresumably due to the differences in cultural background among countries.
Apparently, for practical application, we may need some detailed considerations if
without changing the three principles themselves.
In the following sections, the author attempts to modify the points of emphasis foreach of the three principles to be practised, aiming such practices may be effective inJapan.

2. Belmont principle 1. 'Respect for autonomy' principle
Original points of emphasis in the principle:･ Individual persons should be treated as autonomous agents.
･ Persons with diminished autonomy are entitled to protection.

Original points of emphasis in its practice:･ Informed consent
Points to consider specifically on Japanese cases here:
Many Japanese people understand and appreciate this principle. Apparently
however, they hardly act according to the original points of emphasis.
It should be considered here that a self-decision without obtaining previous
admission of surrounding people often results in serious difficulties or problems inJapan.
Here, the Japanese inheritance of 'Respect for harmony' principle should beappreciated in the way that these two principles may not compete to each other but
go together.

137

3. Japanese application of 'Respect for autonomy' principle: A proposal
Japanese points of emphasis in the principle
Although 'respect for autonomy principle' is appreciated, it is widely recognizedin Japan that behaving as an autonomous agent does not directly mean self-decision.
Japanese points of emphasis is in that a self-decision is to be made in harmony
with concerning people around the decision maker.

Japanese points of emphasis in its practice
The person, who is expected to act as an autonomous agent, should be allowed toask, by his/her own autonomous decision, some other person (s) (responsibility
sharer (s)) to join in a decision or an agreement, so that any risks, possibly
accompanied by the decision or an agreement, may be shared with these
responsibility sharers.

Expected effectWith this extension of autonomy principle, the action for a person to ask for
responsibility sharer (s) is regarded as an autonomous decision, and therefore, theautonomy principle is respected. At the same time, any risk that could happen withthe decision or agreement, for example, made under the influence of weak physicalstates and/or drugs, can be shared with responsibility sharer (s) .
In addition, the capability of getting consolation, or compensation, against any
possible unexpected mental damages, if ever such could happen, can be increased.

4. Belmont principle 2. Beneficence
Original points of emphasis in the principle:
Do not harm.
Maximize possible benefits and minimize possible harms.

Original points of emphasis in its practice:
Assessment of risks and benefits (by an IRB/Ethical Committee)

Points to consider specifically in Japanese cases
Naturally, what risks and benefits imply is different depending on the differencein the social condition, particularly with regards to health status and economic
status. In this respect, there may be a couple of special points to consider in Japan:
In Japan, one-way benefit is frequently regarded as risk. Benefit should be in
both ways. Thus, 'Sorry' ('Sumimasen' in Japanese, meaning 'Sorry for that I cannot
present any proper return to your gift') is frequently used as meaning 'Thanks',
when one is given a gift. Therefore, stressing pure service, while refusing any
return or reward, on the donation of organs and tissues, may not be accepted bymany Japanese as meant.
Thus, the mental/psychological damages to a Japanese bereaved family member
could happen differently from those to a Western member, due to culturaldifferences as described in the above.
In an ideally hypothetical society where the population's health condition has
already been maximally adjusted, any further intervention, including that ofresource distribution, will only gives risks, without giving any further benefits in
the improvement of health status in social scale. Japan, as well as the U.K., is thekind of country where people's health condition is maintained very high, if not intheir ultimate states, as their extremely high longevity shows. Therefore, as long as
health status in national scale is concerned, a careful choice is needed to judge the138risk/benefit ratio. An example will be the case of live organ donation, particularly
from a healthy mother to her diseased child, which happens frequently in Japan,
and where the former has to take unneglectable risks on her health.
The benefit, however, cannot be counted only in the scale of health, but of
science, technology and economy. It is not strange, therefore, that in some place inthe world, the use of human tissues is intended not directly for the improvement ofhealth status of the people there, but for the advancement of economic status,
through the development of pharmaceutical industry, for example. Here theimprovement of health status may be intended indirectly by way of economic
improvement. Such benefit, however, cannot be ruled out.
What is important here is that the kind of risk and the benefit associated withtissue donation should be well understood by concerning people, including
IRB/ethical committee members.

5. Japanese application of beneficence principle: A proposal
Japanese points of emphasis in the principle:
The principle to maximize possible benefits and to minimize possible harms will
be well accepted. However, it may be stressed that the kinds of risks and benefits
are different among countries. It should be recognized that the mental and/or
psychological damages of the bereaved that could happen being associated with the
donation of tissues from their deceased family member could be serious andtherefore considered heavily in Japan.

Japanese points of emphasis in its practice:Ways to reduce mental and psychological damages, which could happen in the
bereaved family members after donation of organ/tissues from a deceased, should
extensively be studied, and effective ways to prevent them to be devised.
Advances in brain science, particularly of cognitive function, and education in earlyages, are expected to play important roles here.
In the social scale, the direct benefit of using human tissues for the improvementof health, through transplantation and other clinical ways, may not be stressed too
much in Japan, since the Japanese standard the health status is already quite high.
Benefit may be explained more through the development of science, technology andadvanced medicine which will contribute to the people's life through theadvancement of knowledge and economical cycle.
Insurance systems are to be developed to compensate any physical andpsychological damages that could happen to live donors as well as bereaved family
members. A possible way may be for the receiver of human tissues to pay suchinsurance fee for the sake of the donor and the bereaved family.

6. Belmont Principle 3. JusticeOriginal points of emphasis in the principle:
Fairness in distribution

Original points of emphasis in its practice:Excluding discrimination, particularly in the selection of subjects

Points to consider specifically in Japanese cases
Here, the original emphasis in principle, i.e., 'fairness in distribution' may notadequately hit the point in Japan. Japan keeps national health insurance system that139

covers almost equally to all Japanese people. Race issues are not very much
important here.
On the other hand, due to the gradual loss of Confucian inheritance, thegovernmental regimen, formerly having worked well, is becoming less functional.
Too many restrictions set by their directives without any legal bases hamper the
progress of science, technology and business, while essential law structure has still
not clearly been presented by the parliament.

7. Proposed Japanese application of Justice principle
Japanese points of emphasis in the principle:
Freedom and equal opportunity under law.

Japanese points of emphasis in its practice:
From guideline-based practice without being underlaid by laws to law-based
practice.
Establishing a very basic law for human things first of all.

Column 36 Summary of the proposed Japanese applications of Belmont
principles
Principle

Original
application

Proposed Japaneseapplication

Respect forautonomy

Self-decision

Self-decision to choose
co-deciders who could
share the responsibility(risk) of the decision

Beneficence

Risk/benefit
ratio

Ways of compensation to bedevised against risk, or for benefit

Justice

Fairness in
distribution

Equal opportunityand freedom under law

8. Addendum to Belmont principles
Peer review practice and its Japanese application
Although in the Belmont report, the peer review practice is not itemized as theforth principle, but only mentioned in the text, so that this practice may play anessential role to make the three principles effectively. The custom of peer review,on the other hand, is not Japanese origin. Originally, Japanese people tended to relyon the decision of thought-to-be-trustful persons or groups (doctors, bureaucrats,
government committees, etc.).
Therefore, there is a strong criticism in Japan against the peer review practice, as
currently proceeded by IRB/ethical committees, with the reason that they cannot
cope up with current problems sufficiently enough.

140

At the present moment in Japan, the peer review practice may yet be effective asthat in Western countries. To the author's understanding, however, it is already
impossible to come back to the old deteriorating system, if we could take advantage
of its remaining capability. The custom of peer review practice is becoming
accepted, capable, and will soon or later surpass the old Japanese reviewing system.

Proposed Japanese application
Peer review practice is growing and already valid at the present in Japan, andshould not be diminished if it is still not fully functioning as aimed. Efforts tofortify the practice of this promising principle are by all means to be encouraged.

C-Ⅳ

Proposed basic rules for three body problems

Section A: Problems associated with dead bodies
1. Points to consider specifically in Japanese cases
Because of the traditional Japanese habit of accepting death as a process, rather
than as a body status defined in medical terms, Japanese people often encounter
with serious difficulties, when they are asked to regard a medically defined 'brain
dead' body as a direct object for organ procurement.
Although the critical stage as currently defined using the word 'brain death' must
be clearly defined using medical terms, it should be carefully taken into accountthat the word 'death' is not always a medical term in Japan.
Japanese people may appreciate the written will of the dying person, but general
understanding is that 'Things after death should be up to those who survived.'. The
state of life or death of the donor in the bereaved mind is the most crucial for the
bereaved to leave the body up to the will of the dying person.

2. A proposed Japanese solution to Section A problems
1)

2)

3)
4)

When a body at its critical life stage is under consideration for procurement oftissues, the status of human body is to be described using medically defined
objective words, rather than such subjective words as 'dead' or 'alive'. Let us define
the state of total loss of brain stem function as 'State X' here.
A Japanese organ transplantation law should be modified so that the bereaved
may ask a procurement organization to treat, not the 'brain dead' body, but their'State X' body, as the subject of tissue procurement.
The procurement organization so asked may be permitted by the law to treat the'State X' body as the subject of tissue procurement.
The wish of written will shall be respected. But at the same time, details of the
purpose of the procurement and the ways to handle the tissues are further to beagreed among the concerning peoples in a written form.

Additional comments
Although mental acceptance of death, particularly of a closely related family
member may be hard, and may take time, what makes the acceptance easy andprompt is education in an early stage of one's life and exercise of decision making.

141

It is important to share the pain of the decision makers with people surrounding
them. One of traditional Japanese ways to do it would be to build a shrine for thosedonors to be worshipped by the representative of people's good will at national
level, typically by imperial family members. Perhaps, a modern suitable way may
have to be sought for.

Section B: Problems associated with non- or incompletely autonomous humanexistence
The objectives here include such an existence that bears the potential capability to
become an autonomous human being. They may also include such other existence thatcannot become an autonomous human being by itself, but may possess a part of thecapability. They include fertilized eggs, developing embryos and foetuses. But also,
new born babies, infants and mentally retarded adult human beings may also be
included in this category when we consider them in historical views.
Since it is now known that some types of cells, such as cultured embryonic stem cells,
can become a part of body by introducing them into a developing egg to make achimeric developing egg, and also that a hybrid cell obtained from the combination of asomatic cell nucleus and an enucleated egg cell can be grown to a whole body, thedifference between germ-line cells and somatic cells are becoming less distinct inethical terms.

1. Different ethical positions for non- or incompletely autonomous human existence
There are at least three positions as to what they mean to the human society.

Position 1. Respect for human dignity
Human dignity comes first. There are no exceptions. Nobody has the right tomanipulate human fertilized eggs and embryos with any aims other than helping
their normal growth and development.

Position 2. Risk-benefit balance
Human dignity should be respected. Nevertheless, under the circumstances where
careful arrangements are taken so that the risk of violation against dignity may beminimized, and where the benefit obtainable from manipulating such humanexistances as fertilized eggs and embryos may be maximized, such a manipulation
is not regarded as unethical.
A crucial decision to permit, or not to permit, the manipulation of fertilized eggs
and embryos may depend on if they have any trace capability of mental function ornot.
Therefore, as in the case where brain death has been included in the generaldefinition of death (in Western countries, if not in Japan), developing eggs before acertain stage of gestation may be regarded as nothing more than a mass of cells, if
they are to be respectfully treated as those of human origin.

Position 3. Limited acceptance of killing action
Manipulating fertilized eggs and developing embryos without intending to help
their normal growth is without doubt an offence against human life, and thus isregarded as a killing action, if it has any trait of brain function or not.
However, a killing action on human being, including those of fertilized eggs and142

developing embryos, are not always regarded as absolutely unethical. Within acertain limited condition that is well accepted by the community at large, by a law
for example, manipulating fertilized eggs and developing embryos without intending
to help their normal development is to be accepted.

2. Points to consider
Although little has been mentioned in the past history on fertilized eggs ordeveloping embryos, there are a great amount of mentioning on how human beings
have been treating non-autonomous human beings, i.e., new born babies, infants,
mentally retarded people, and even slaves, which will give us valuable suggestions.

Past Japanese ways of thinking and practice･ Human and animal are in an equal status as living thing.
･ There is no reason to make human beings distinct from animals in their dignity.
･ At certain circumstances, one may have to kill an animal. The same is true to ahuman being.
･ What is more important is the lineage of life rather than a life of a single person.
･ Children under age seven may be regarded to belong to gods, meaning that parents
are not much regarded as responsible to their lives if they are lost due to diseases orother reasons.
･ A certain proportion of new born babies were killed.

Past Western ways of thinking and practice･ In the mediterranean civilization, children were often sacrificed to gods.
･ There was a custom to kill all babies born on a certain day in a year.
･ Slaves as non-autonomous existence were often forced to fight to death forenjoyment of citizen.

Modern Western ways of thinking and treatment･ If his/her mental capability and autonomous capability are ever inferior to these of ananimal, his/her dignity as human being must never be underscored by, nor compared
with, those of an animal.
･ They should not be treated as subjects, or tools, of an autonomous person.

An animal way
A mother animal often chooses some of her litter to feed and others not. Naturally,
those not fed will die. If, however, those not fed by their mother animal are
artificially fed, then they would grow normally.
It tells that an animal has a certain standard to choose some to feed and others not
to, and therefore to death. The mechanism of this choice is certainly a subject ofscientific study, and not of ethics. Therefore, also for human being, the standard of
judgment to kill or not to kill can be regarded profoundly related with the physicalbody function and therefore, in some special circumstances it may not be the subjectof ethics but of science.

Why (the author thinks that) Position 3 may be an agreeable position in Japan?
・ In Japan, there has been no strong confidence among people for that human being isparticularly different from animals in terms of mind, soul, and dignity, suggestingthat they cannot find any good reasons to set a distinction between human and animalin the right of killing.
・ On the other hand, for a long time in the past, people had accepted the pain ofkilling a proportion of new born babies, mostly for economical reasons. Even at the143presence, Japanese law permits a therapeutic abortion for economical reasons.
・ Therefore, it is understandable that, as Japanese people accept killing fish andanimals, they have accepted killing human beings in some particular states as aninevitable action.
・ The most important point here is to realize the pain of killing any living things, toshare the pain among all people, to minimize such action as much as possible, and toestablish rules with which a killing is acceptable, in certain limited circumstances,
under a strong public acceptance, that means, by law.

3. Points to consider for drawing a rule commonly applicable to Western countries
and Japan
1)

In any local area of civilization, and in any historical time in the past, we, humanbeings, have established one or other detailed moral standards for judgment withwhich a non- or incompletely autonomous human existence may be killed.
2) It is easily understood that such standards have been influenced by the economical,
health, war, nutritional and populational states of the society.
3) The moral standard for judgment as to if a human existence may become thesubjects of sacrifice, or the subject of life, has been changing with time, and different
in locality, even at the present modern society.
4) It is hard to draw any concrete conclusion that a moral standard as being
established in a modern society will never change in future.
5) The reasoning for the standard, as set by a local community, may have its own
bases, if not clearly mentioned, and therefore, no uniform international standard must
be set, without understanding the reasons, and neglecting such local diversity in thestandards.
6) The action in mind, not in hand, to kill a living human being may not be regarded
as an unethical action in certain circumstances.
7) The action of mind to regard a dead as if he/she is still alive may also beappreciated as a respectful action.

4. A proposed Japanese solution to section B problems
Position 3 is proposed here as the Japanese position, with a condition thatpeople at large in those countries which take Position 1, and Position 2 could
understand, and agree with, that Japanese people take this position.
It is obvious that the right of killing in this case must be specifically defined bylaw on the bases of democratic constitution, as any other rights of killing humanbeings, such as that applied at death penalty, and that at sending soldiers to abattle field.
It is important that the law must describe what sort of authority takes the
responsibility of the execution. Also it is important that the law describes the way
to share and to console the pain among those directly related with the killing andall people surrounding them.

144

C-Ⅴ

Proposed solutions for some Japan-specific problems

1. An application of the 'killing in mind' concept to solve organ donation problems
To many Japanese, it is hard to admit taking organs and tissues from the body of
their intimate family member's body at the time when a doctor announces his/her death(at Transition A in Column 30) or entering State X as described in C- Ⅳ , Section A.
This is because, as the author speculates in an early section, such an announcementmeans only one event during the course of his/her death process in the traditional
concept of death in Japan. Thus, procurement of an organ at that moment may well
give rise to a great amount of mental pain or trauma to the bereaved.
However, if circumstances are such that they are ready in their mind to abandon the
dying person's life (by 'killing in mind') already at the time of Transition A or ofState X, then they may easily agree to submit the body to procure organs fortransplantation. In that case, their mental and psychological damages may be reduced.
What matters, therefore, does not appear to be the rightness or wrongness ofcalling a body with no brain stem function as dead, but the admission, support andtaking responsibility by the society at large, for the bereaved family members to take akilling in mind action on one of their close family members with his/her brain stemfunctioning no more.

2.

Reconciliation of 'Respect for harmony' principle with 'Respect
principle

for autonomy'

As describe earlier (Section B Ⅱ and Column 32), many Japanese people are
reluctant to follow the respect for autonomy principle due to the reason that they havelong been accustomed with the respect for harmony principle. On the other hand, tomany Westerners, the respect for harmony principle may be difficult to accept, since it
appears to infringe the respect for autonomy principle. To make the two apparently
contradictory principles go together, a solution is proposed here as follows: Theessential point that leads to the solution is in reconsideration of the idea of 'richness'.

Introduction of 'Respect for autonomy' principle using an alternative concept ofrichness･ Assumption A: Every one wants to be rich.
･ Assumption B: Here, richness means a state where one can extend his/her own
capability as much as possible. The primary value of 'Respects for autonomy' principle
is in that an autonomous action by itself composes the most fundamental manifestationof extending his/her own capability.
･ Assumption B' (An alternative assumption): Here richness means a state where thetotal sum of bio-sociological capability, either genetic or cultural, in and around whom
it may concern, is maximized. The primary value of 'Respects for harmony' principle
is in that it is the most essential element of life for one to attain the maximized
bio-sociological richness in and around himself/herself.
･ The consequence of Assumptions A and B→ 'Respect for autonomy' principle does not include 'Respect for harmony' principle.
･ The consequence of Assumptions A and B'→ 'Respect for autonomy' principle includes 'Respect for harmony' principle.

145

C-Ⅵ

Proposed international rules

In this section, what may be extrapolated as to fit for international rules from the
proposed Japanese rules are summarized.

1. Proposed uniform international rules
The author's stance here is to accept and appreciate diversity in ethical ways ofthinking among local communities. Taking this stance, the minimal rules may be
proposed as follows:
1 ) As to the minimum requirement for a country to join in an international community
in which human tissues may be mutually transported, and people can access to humantissue resources of other member countries, it is requested for a member country to
publicize its regulatory framework in the form of law.
2 ) It is requested to each of the member country that a foreign visitor to the country
must follow the law of the visiting country.
3 ) It is requested to each of the member country that, when a citizen of the member
country wants to make a trip to another member country, with an intention of receiving
human tissues there ( for transplantation for example) , the right to permit, or not topermit, the trip belongs to the member country to which the citizen belongs.
4 ) If a citizen of a member country visits another member country with an intention ofreceiving, or donating, human tissue outside of his/her home country, receives, or
donates, human tissues there, and then wants to re-enter his/her home country, and if
the citizen has not declared the intention of receiving, or donating, human tissues at
the time when he/she has left the home country, the home country is requested to
publicize by law the righteousness or injustice of such an action of the citizen.
5 ) At an occasion of transplantation of human tissues, the country to which the tissue
is destined has the right, as defined by the law of the country, to accept or to refuse
the importation, considering the law of the exporting country.

2. Proposed international rules for single body problems
As the minimum essential requirements for a country to join in the international
community, it is proposed here for the country to construct and publicize its basic rules
to handle human tissues in the form of law so that other countries could understandthem, and take appropriate action for any interaction with the country.

3. Proposed international rules for two body problems
Two body problems here are for those two countries between which human tissues
are transferred, or for those persons who travel with intention of using human tissues
outside of their own countries.
As minimum essential requirements for a country to join in the international
community, it is proposed here that a member country is requested to publicize andenforce their rules so that each member country can make contracts with other member
countries applying different rules. Such a contract may regulate importation andexportation of human tissues, or travelling of people with intention of using humantissues outside of their own country.

146

Because diverse rules among countries are admitted, a traveller outside of his/her own
home country may be free from his own home country's rules during travelling.
However, domestic rules may be effectively set to regulate travellers at the time ofdeparture and arrival.

4. Proposed international rules for three body problems
The three body problems here are for those two countries and human tissues with thatboth of the two countries are involved. Since the human tissues are transferred usually
not between two countries, but between two persons, or two organizations, there may
not be many cases to be considered here. One of rare cases that may have to be
categorized here may includes such a case where a foreign traveller carrying a donorcard dies in a foreign country. There may arise several questions here. For example, isit acceptable to procure organs from the dead following the rules of the foreign country?
Or should they pay any respects to the rules of mother country of the dead, where
his/her family reside?
The proposed rule for the single body problems may tell that the foreign country isable to procure human tissues from the donor in accordance with its own rules.
From the proposed rule for the two body problems, it is expected that an arrangement
has already to be made so that the traveller has already agreed at the time of departurethat he/she follows the rules of the foreign country during the travel. However, thefamily member of the home country might have heard nothing, and they may be those
who concern much, for example if they are Japanese.
Therefore, an international rule proposed here is that, if without any particulararrangement made between the two concerning countries, a country does not need to
pay any more attention to the foreign relatives of the dead than what is requested bytheir own law, and this rule must be well informed to every people of concerning
countries. There will be a good reason for many Japanese people to accept such rule,since it has been the Japanese tradition that one must follow foreign rules when he/she
is in a foreign country.

147

Summary and conclusion
In the above sections of this paper, a set of Japanese rules are proposed so that they
may solve some current Japanese problems related with human tissues, and may also be
accepted to people in other countries as well.
Before reaching those rules, the author has introduced several hypotheticalpostulations. Among them are the postulations that problems related to human tissues
can be categorized into three levels, that a fundamental ethical principle, such as
beneficence or justice, can be applied in different circumstances with different practicalpoints of stress, that 'respect for harmony principle', which is the ethical principle thathas long been cultivated in Japan, can be reconciled with 'respect for autonomy
principle', that the definition of richness can be extended using the biological concept ofrichness, that the concept of 'killing in mind' as defined in this paper may not totally be
excluded as non-ethical.
Without doubt, this paper is incomplete. Previous efforts on this line of study should
be properly referred in the introduction section, and compared critically with the present
effort in the discussion section. The author's interpretation of many general issues aspresented in this paper should critically be scrutinized for other possibilities ofinterpretation. The issues should be analyzed, and rules to be proposed not only using
qualitative terms, but also using quantitative terms.
As a whole, this paper may raise more questions than answers. For example, there
will be many questions before accepting the concept of 'killing in mind':
Is there any possibility to define the concept of killing in mind in terms of brain
science?
If it is, is that brain action related to the actual action of killing?
Is it an essential part for human being to survive as a species?
If so, can ethics deny such an essential and fundamental capability?
Etc. etc.
Not only with respects to brain science, we need careful treatise before talking the
ethics of killing in mind, since in those pantheistic days, killing did not mean thedisappearance of soul, but only the departure of soul from a body.
Nevertheless, to the author's knowledge, this paper may be the first of this kinddealing with human tissue issues from a Japanese point of view, and written in English
for soliciting international discussion.
The essential contents of this paper, except for those regarding the cultural
inheritance of the U.K. and Japan, Part B of the three body problems, and internationalrules, have previously been published by the author in Japanese.

Acknowledgments
The author acknowledges the members of Japanese Tissue Culture Association
Committee for Ethical Issues during 1995 and 2000, and Professor Shin Utsugi and themembers of his research group that had been supported by the Ministry of Health,Welfare and Labour from 2001 to 2006, for their valuable discussion. The author also
acknowledges the skilful help of Akiko Kihara, Rie Matsui, Hiroko Sasaki and
Shigehiro Shimosaka for secretarial and editorial help and also for discussion within theauthor's laboratory.

148

References
Since this paper was first composed as a handout material for the participants of theworkshop, and then modified in the form of a paper for the proceedings, references are poor,
and incomplete for which the author has to apologize.
Only some of key literature and the author's previous works are listed as follows:
Ref. 2, 3, 5, 6, 15 are textbook, handbook and some leading literature in the field ofbioethics either translated into Japanese or written by Japanese authors.
Ref. 17 and 27 are for the ethical principles to which essentially all ethical guidelines fromthe Japanese governmental offices follow.
Ref. 1, 10, 24-26 are books concerning animistic, polytheistic and pantheistics inheritancesof Japan and the east Asia.
Ref. 16, 19, 20 are for two Japanese classics, Kojiki Record of Ancient Matters and Tales ofGenji, for both of which English translations are available.
Ref. 9 is one of modern analyses of Tales of Genji with implication of Japanese people's
mind structure.
Ref. 4, 18, 21-23 are popular books written in English introducing Japanese traditional
philosophy and mind.
Ref. 8 is a comprehensive introduction to Confucianism and Buddhism and theirdevelopment in Japan.
Ref. 7 is a recent inquiry study for the health status of live liver organ donors.
Ref. 11-14 are the author's previous papers all written in Japanese.
Note 1: For those references with * marks are Japanese articles, the English titles of which arearbitrary attached for convenience without any consent of the authors of the articles.
Note 2: Those references with ** marks are Japanese articles, the English titles of which havebeen given by the authors of the articles.
1. Akada, Mitsuo, *Having Faith to the Ancestral Spirits and the View of the World to Come.
Jinbun Shoin, Kyoto (1986) [赤田光男, 祖霊信仰と他界観. 人文書院].
2. Baud, Jean-Pierre, L'affaire de la main volee. translated into Japanese by Nogami, Hiroyoshi,
Hosei University Press, Tokyo (2004) [ジャン=ピエール・ボー著, 野上博義訳, 盗まれた手の事件. 法政大学出版局].
3. Beauchamp, Tom L. and Childress, James F., Principles of Biomeical Ethics. Oxford University
Press, New York (2001).
4. Benedict, Ruth, The Chrysanthemum and the Sword. translated by Hasegawa, Matsuji,
Shakai-Shisosha, Tokyo (1967) [ルース・ベネディクト著, 長谷川松治訳, 菊と刀.社会思想社].
5. Dworkin, Ronald, Life's Dominion. translated by Mizutani, Hideo, Kojima, Taeko．Shinzansha,
Tokyo (1998) [ロナルド・ドゥオーキン著，ライフズ・ドミニオン．水谷英夫，小島妙子訳，
信山社]
6. Hishiyama, Yutaka, *Handbook of Bioethics. Tsukiji-Shokan, Tokyo (2003) [菱山豊, 生命倫理
ハンドブック．築地書館]．

149

7. Japanese Liver Transplantation Society, *Report on Investigation about Donors of Live Liver
Transplantation. Japanese Liver Transplantation Society Home Page (2005) [日本肝移植研究会,
生体肝移植ドナーに関する調査報告書．日本肝移植研究会ホームページ]．
8. Kaji, Nobuyuki, *What is the Confucianism. Chuko Shinsho, Tokyo (1990) [加地伸行, 儒教とは何か. 中公新書].
9. Kawai, Hayao, *Murasaki-Mandala: Composition of The Tales of Genji. Shogakukan, Tokyo(2000) [河合隼雄, 紫マンダラ 源氏物語の構図. 小学館].
10. Kawai, Hayao, *Myth and the Japanese mind. Iwanami-Shoten, Tokyo (2003) [河合隼雄, 神話と日本人の心．岩波新書]
11. Matsumura, T., Umeda, M., Sato, K., Shibanuma, M., Tanaka, N., Hata, H., Hasumura, T.,
Hirai, R., Masui, T., Utsugi, S., **On handling human tissues and cells in non-clinical fields:with special references to the basic rules in law, ethics and safety for those who try to constructself-regulatory rules within their institutions. Tissue Culture Research and Communications,
17:117-171 (1998) [松村外志張, 梅田誠, 佐藤敬喜, 柴沼質子, 田中憲穂, 秦宏樹, 蓮村哲, 平
井玲子, 増井徹, 宇都木伸, 非医療分野におけるヒト組織・細胞の取り扱いについて－とくに組織培養研究での取り扱いを中心とした法・倫理・安全視点からの基本的遵守事項の自主ルール構築のための参考事項－].
12. Matsumura, T., **Handling human tissues and cells in biotechnology field: Techniques or
Principles?. BioScience and Industry (Official Journal of Japan BioIndustry Association)
61:262-264 (2003) [松村外志張, バイオテクノロジーのための人体組織・細胞・遺伝子の取り扱い－理念か技術か－. バイオサイエンスとインダストリー(バイオインダストリー協会)].
13. Matsumura, T., **On Rules for handling human subjects and human body parts without
therapeutic intention: Proposal of the basic rules (V1.1) and its comparison with classic rules.
Tissue Culture Research and Communications (Official Journal of Japanese Tissue Culture
Association) 23: 91-114 (2004) [松村外志張, 患者本人の治療以外の目的での人体ならびにその部分を対象とする取り扱いの在り方について－その基本原則たたき台（Ｖ１．１）の提案古典的倫理原則との対比-].
14. Matsumura, T., **A consideration of organ transplantation: Proposal of basic rules for handlinghuman tissues without therapeutic intention for the donor. Ishoku (Transplantation, Official
Journal of Japanese Association of Transplantation) 40:129-142 (2005) [松村外志張．臓器移植に思う－直接本人の医療に関わらない人体組織等の取扱いルールにたたき台提案－．]
15. Murakami, K., *Lecture of Ethics. Seibundo, Tokyo (2003) [村上恭一，倫理学講義. 成文堂].
16. Murasaki, Shikibu, The Tales of Genji.Vol. 1 & 2. Translated with an Introduction by
Seidensticker, E.G., C.E.Tuttle Co., Rutland, Bermont, & Tokyo (1976).
17. The National Commission for the Protection of Human Subjects of Biomedical and
Behavioural Research, Department of Health, Education, and Welfare, U.S.A., Belmont Report:
Ethical Principles and Guidelines for the protection of Human Subjects of Research. (1979).

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18. Nitobe, Inazo, **Bushido. Kodansha, Tokyo (1998) [新渡戸稲造, 武士道. 講談社].
19. Ohno, Yasumaro(ed.), **Kojiki. commented by Kurano, Kenshi, Iwanami Bunko, Tokyo (1963)[太安万侶(編),古事記. 倉野憲司校注, 岩波文庫].
20. Ohno, Yasumaro(ed.), The Kojiki. Records of Ancient Matters. Translated by Chamberlain,
B.H., C.E.Tuttle Co. Rutland, Vermont & Tokyo, (1981).
21. Okakura, Tenshin, and Sen, Soshitsu XV, **The Book of Tea. Kodansha, Tokyo (1998) [岡倉天心, 千宗室, 茶の本. 講談社].
22. Suzuki, Daisetz T., An Introduction to Zen Buddhism. Grove Press, New York (1964).
23. Suzuki, Daisetz T., Zen and Japanese Culture. Charles E. Tuttle Company, Tokyo (1988).
24. Suwa, Haruo, and Kawamura, Minato, *Asian View of Spirit. Yuzankaku, Tokyo (1995) [諏訪春雄, 川村湊, アジアの霊魂観. 雄山閣].
25. Tanigawa, Ken-ichi, *Gods, Human and Animals: Living in the World of Oral Literature.
Heibonsha, Tokyo (1975) [谷川健一, 神・人間・動物－伝承を生きる世界. 平凡社].
26. Umehara, Takeshi, *Japanese View of the World to Come. Chuko Sosho, Tokyo (1989) [梅原猛, 日本人の「あの世」観. 中公叢書].
27. World Medical Association, Declaration of Helsinki. (2002) [世界医師会, ヘルシンキ宣言].

151

Human Tissue Legislation – Culture and context
Veronica English, Deputy Head of Medical Ethics, British Medical Association
Tavistock Square, London, WC1H 9JP
In this session I am going to consider certain aspects of the culture of the UK and the context
within which the new human tissue legislation was made and to suggest ways in which these factors
influenced the shape of the legislation generally and transplantation specifically.
The changing doctor-patient relationship
One aspect of this is the way that the nature of the doctor-patient relationship has changed overtime.
Until the middle of the twentieth century, paternalism was the norm in the UK. The clinicalinterests of the patient were the doctor’s primary concern and patients deferred to their doctor to makedecisions for them. Doctors saw it as part of their duty to protect patients from bad news and frominformation that might be upsetting or distressing for them. So, it was common place for information
about serious illness to be given to the family, rather than the patient, and this was accepted by all.
The situation now in the UK is very different.
Social changes account for much of this change. Over time we have seen far less deference todoctors, more assertive attitudes towards individual rights and self-determination, a more diverse
cultural and religious mix within society, increasing breakdown of the extended family and thedevelopment of a system of internationally recognised human rights, all of which have helped tofacilitate this major change. In addition to these factors, medicine itself has changed offering
opportunities to prolong life for many years, in some cases without any possibility of the patientregaining awareness or understanding.
These changes have had two major impacts on medicine – first, there is now far greater emphasison personal autonomy and individual decision making. Secondly, and interestingly, an increasing
notion that medical ethics is not just a matter for doctors but a matter for society with individuals not
only claiming their right to make their own decisions but also to contribute to the decisions madeabout public policy and the shape of the society in which we live.
Autonomy
When we think about modern UK society and the practice of medicine and research, the mostimportant factor that has influenced practice and the regulation of practice is the primacy given topatient autonomy. Patients now expect to be the ones to decide whether treatment provides a benefit
for them, based not just on clinical factors but on whether treatment is able to provide a quality of lifethat they would find acceptable. In order to make these decisions, of course, patients need full andhonest information. Information may no longer be withheld from patients because it is thought betterthat they do not know.
Studies in the UK have found that virtually all patients want to know their diagnosis although
there is more diversity with regard to the amount of information they want about the likely
progression of the disease and their prognosis. Despite the fact that relatives frequently request that
information is withheld from elderly patients, one study found that the desire to know of a diagnosisof cancer was found in 88% of patients aged from 65 to 94 years old and this reflects anecdotalreports of a high demand for information among all patients. The general guidance in the UK is thathow much information to receive is a decision for the patient, not for the family and not for doctors.
If it is evident that the patient does not want detailed information, this should not be forced upon thembut it is generally believed that, in order to give valid consent, or to make a valid choice to delegate
decision-making to someone else, patients must be given some basic information. It is generally
considered to be a positive thing for patients to have information and so doctors are advised to support
patients and encourage them to receive information at a pace that is acceptable to them. There is,T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan152

however, a delicate balance for doctors to make in deciding when, and how much, information toprovide.
Increasingly the focus on autonomy is also represented in terms of legally enforceable humanrights. Cases that have been before the courts confirm that competent patients have the absolute rightto refuse treatment, even if that refusal will result in the death of the patient. It also extends to cases
where a woman’s refusal of a Caesarean section would result in the death of a healthy, viable fetus.
So a woman can, for no particular reason, refuse to have a caesarean section even if that decision will
result in the death of a healthy, viable fetus.
Autonomy and confidentiality
This emphasis on autonomy and “self rule” also extends to the sharing of information. Healthproviders owe a duty of confidentiality to their individual patients and information may only beshared with other family members with the patient’s consent. And, frequently, patients refuse to have
any information about their medical condition shared with their family and doctors must respect that.
Failure to do so would leave the doctor open to a charge of professional misconduct which could
bring the doctor’s registration into question and open to being taken to court by the patient for abreach of confidentiality. Patients can also refuse for information to be shared with others providing
care and treatment for them, even if that would have a negative impact on the ability to care for thepatient. They must of course be informed of the risks they are taking but if they still refuse, that must
be respected.
Rights and responsibilities
Interestingly, a debate is beginning to take place in academic circles about whether there are, or
should be, more limits on autonomy. The BMA has for a number of years been expressing the viewthat people have a moral obligation to take account of the impact of their decisions on other people –even though these moral obligations cannot be enforced. This has particularly, but not exclusively,
been raised in relation to genetics where decisions by one person can have a direct and serious effecton others.
The role of the family
It is fair to say that the importance of the family, in most of UK society, has declined over thelast few decades. Fewer people live in extended families than in the past and people rely on othersupport mechanisms, such as friends, more than family members in today’s society.
Where patients are competent, they expect to make decisions, rather than families making
decisions for them. An area where families are involved, and expect to be involved, however, iswhere patients lack capacity.
So in relation to treatment decisions, the view in the UK is that if the individual is competent andcapable of making a choice, then the decision rests with the patient who may or may not decide to
discuss the issue with other family members. If the patient lacks capacity then the family expect to be
involved and, although in most cases, it will be for the doctor ultimately to decide what is in thepatient’s best interests, the family will be involved in those decisions. Where someone has died,without expressing any wishes – about organ donation for example – then it is accepted that thefamily should make the decision.
The impact of the organ retention scandal
What the revelations about unauthorised organ retention did, was to lead to a crisis of confidence
in pathology generally and paediatric pathology in particular. The Royal College of Pathologist wasvery concerned for its members some of whom were subject to what were described as “hatecampaigns” and verbal attacks and there was great concern that we were heading for a severe shortageof pathologists as some left the specialty and students chose alternative career paths. At one stage it
was reported that a quarter of all paediatric pathology posts in the UK were unfilled. After the153disclosures the number of post-mortem examinations undertaken declined because pathologists were
worried about asking for consent and parents and relatives were reluctant to give it.
The situation was not helped by the rather chaotic way in which the issue was managed by many
hospitals once the extent of organ retention became apparent. Commissions were set up to oversee thecollections that had been accumulated and to return body parts to families where they wanted them –this was done in an piecemeal way and resulted in some families having two or three additional
funerals as, over a period of time, more body parts were found and returned.
Leaving aside the very extreme case of Alder Hey, what is more interesting is the other hospitals
that also retained organs and tissues without the knowledge or consent of the relatives. What becamevery clear from the inquiry is that the shift from paternalism to autonomy that had been made invirtually every other area of medicine had not reached pathology services. Pathologists were notacting maliciously in withholding information, they were seeking to protect the parents, or otherrelatives, by sparing them from distressing information – by not going into detail about what a postmortem examination involves and by not specifically seeking consent for organs to be retained forresearch once the post-mortem examination was complete. They genuinely thought they were helping
the parents and acting in their best interests.
This reflected a complete breakdown between the expectations of the public and the expectationsof a section of the medical profession. Whilst the public’s views had changed, those of pathologists
had not.
This gives you an idea of the context within which human tissue legislation was proposed andhelps to understand why consent was such an important issue.
Impact on human tissue legislation
This emphasis on autonomy in UK society, and in the aftermath of the organ retention scandal
the importance placed on consent, is reflected in the Human Tissue Act. Removing or retaining
organs after death, without consent, except under the authority of the coroner, is a criminal offence
punishable by up to 3 years’ imprisonment. In addition, the premises where any post-mortem
examination takes place needs to be licensed by the HTA which must satisfy itself that appropriate
staff and procedures are in place and that the guidance set out in its code of practice is followed. This
extremely tight regulation was inevitable after the organ retention scandal.
The same principles – of autonomy and consent – also underpinned changes in other areas, suchas transplantation. In the past, even if the individual had signed up to the Organ Donor Register, thefamily of the deceased patient would still be asked to give consent and it was considered to be theirdecision. Over the last few years we have seen shifting attitudes in this respect with individuals
expressing increasing unease and even anger at the notion that their wishes could be overridden by
their relatives. It has now been made clear in the new legislation that the family do not have any legal
right of veto and that the consent of the individual takes precedence over the wishes of the family.
This means, in theory, that donation could proceed in the face of opposition from the family although,in practice, if the family is extremely distressed, it is unlikely that donation would proceed. Those
who want to donate are advised to discuss their wishes with their family while they are alive to try to
avoid this scenario.
Where the individual has never made their wishes clear then it is the family who make thedecision – but the focus is still on the individual as the family are asked to base their decision on they
think the deceased person would have wanted.
Presumed consent for organ donation
During the passage of the Act, the BMA made unsuccessful attempts to achieve a shift, in thelegislation, to a system of presumed consent for organ donation. There is considerable support within
the UK for organ donation. In all studies around 90% said they supported organ donation but only
22% have made their wishes known by signing up to the organ donor register. The problem is reallyone of apathy – people intend to sign up but they never get around to doing so and many people do
not like to think about dying and so avoid it. So, during the passage of the legislation the BMA
lobbied Parliament to make donation the default position from which people may opt out during their154

lifetime if they so wish. Given the exceptionally high level of support for donation, this is simply
making it easier for people to achieve their wish to donate and so in our view it would have been
entirely consistent with the underlying principle of the legislation and, arguably, more consistent withautonomy than the current system. This is how it would work.
Presumed consent with safeguards•

In advance of the change there would be extensive and high profile publicity advising peopleof how to opt out if they do not wish to be donors;•

Mechanisms must be in place to ensure all sections of the public are informed and can registeran objection easily and quickly;•

After the system has come into effect, when a person dies in a situation that makes donation a
possibility, the opt-out register must be checked;•

If the individual had not opted out, the relatives would be informed of this and asked if they
are aware any objection to donation by the individual that had not been registered;•If the relatives are not aware of any objection, they would be informed that the intention
would be to proceed with donation;•

But donation would not proceed if it became evident that to do so would cause severe distressto those close to the deceased patient.

The major change would be in the approach to relatives. Rather than asking them to make thedecision, they would simply be asked to confirm whether they were aware of any unregisteredobjection. Those who operate such a system in other countries says that this is a much kinder systemsince the burden of making the decision at such a difficult time is removed from the relatives. Thissystem has been shown to be effective in other countries.
Public support
Public support is, of course, crucial for any change to presumed consent to work but we firmly
believe that there is growing support in the UK for such a shift. There have been a number of public
opinion surveys on this topic over the last five years, the most recent in March last year in which morethan 2,000 people were interviewed – 60% supported a shift to presumed consent – this finding is
consistent with other surveys undertaken.
This 60% is before there has been any concerted effort to educate and inform the public about theway such a system would work and to facilitate an informed public debate on the matter.
In our view, introducing a system of presumed consent for transplantation with a role for thefamily, as we were proposing would be:•

Good for those who are willing to donate – because it is a system that requires no effort on
their behalf to ensure their wishes are followed•

Good for those who are not willing to donate – because, unlike in the current system, theirwishes would be formally recorded and must be respected•

Good for the families of the deceased – because they would not be put in the position of
having to make a decision about donation at a time when they were recently bereaved.

155

•

Good for those waiting for an organ transplant – because there would be more organs
available for donation and thus shorter waiting lists.

It would also more accurately reflect the tremendous support there is within the public and theGovernment for transplantation.
So, why did we fail to get this accepted? I think there are two main reasons.
••

The principal one was that it came in to the aftermath of the organ retention scandal, whenpoliticians were understandably extremely sensitive about doing anything to the body of a
deceased person without consent. And, in fact, in responding to debates on presumed consent
in Parliament, the Minister made the point explicitly that after Alder Hey people expected tobe consulted and to give consent to any use of their body after death.
But that isn’t the only reason. The Government was afraid of a backlash – that people might
see this as the Government telling them what to do with their organs, and effectively taking
ownership of their bodies after death. They feared that a large number of people would optout as a matter of principle, rather than because they objected to donation per se. Certainly
there were a small number of people who made such threats during the debates. But this is areason for debate and consultation rather than avoiding any change.

The BMA will continue to monitor organ donation rates and the impact of the new legislation.
We will also continue to promote public debate about the option of presumed consent and, if
necessary, we will lobby again for the legislation to be changed in a few years time.
Definitions of death
This is a topical issue as a new code of practice is currently being prepared on the diagnosis ofdeath. This document, which previously just included diagnosing death by brain stem tests prior totransplantation, will now also include a formal protocol for diagnosing cardio-respiratory death. Thisis necessary partly because of the expansion of non-heartbeating donation. Before steps are taken topreserve the organs, it is necessary to be certain that the person is dead and this needs to take place as
quickly as possible to prevent any deterioration in the quality of the organs. In order to maintainpublic confidence it is important to have national guidance about how to diagnose death rather thandifferent protocols being used in different hospitals.
The definition of death has not really been a problem in the UK, although understanding among
the general population about how death is diagnosed is quite low. For most people it is sufficient toknow that their relative is dead and they do not want details of how death was diagnosed. There are asmall number of people who argue that when patients sign up to the organ donor register to donate
their organs “after their death” they are not giving consent to organs being removed following deathof the brain stem. Those who take this view are, however, in a very small minority.
The difficulty, of course, is that death is a process rather than a single event. The cells in the
body die at various rates and when considered logically, and given the high level of support for organ
donation, people would not expect that every cell in the body must be dead before death can be
declared. This would, of course, make organ donation impossible. Yet, most people probably do notreally think about what death means. When we are talking to patient groups we often talk about “thepoint of no return”. The stage at which the brain is no longer capable of sending or receiving therelevant information via the brain stem and thus recovery is impossible – vital centres in the brain
stem that are essential to maintain life are damaged making it impossible to continue living. For
relatives the important factors appear to be that the individual cannot experience any pain or any
sensation and life is no longer possible.
The guidance in the UK has defined death as “the irreversible loss of the capacity forconsciousness, combined with the irreversible loss of the capacity to breathe” and there are detailed
sets out tests that must be carried out by at least two doctors who have been registered for more than 5
years, one of whom must be a consultant.
There has, in the past, been a couple of occasions where the media has raised questions about
heartbeating organ donation. For example, one of the newspapers ran a big story about “dead” donors

156

being given anaesthetic during organ retrieval, implying that they might feel pain. In fact, it referred
to anaesthetic agents given to prevent reflex reactions and to make the retrieval procedure easier for
all concerned. When these stories have been raised in the media they have not had a major, or
sustained, effect on donation rates and proper explanation has provided reassurance. The otherconcern among some potential donors is that staff will not try so hard to save them if they are
registered to be a donor – to reassure people that this is not the case there is a clear separation between
the treating team and the transplant team.
Religious views
The population of the UK is made up of a mix of people of different ethnic background, religion
and culture.
In the 2001 census, when the population of England were asked to state their religion:
14.6% No religion
79.7% Christian
3.1% Muslim
1.1% Hindu
0.7% Sikh
0.5% Jewish
0.3% Buddhist
UK Transplant has had discussions with religious leaders in all of the main faiths to determine
the impact of different religious beliefs on views about donation. It uses this information to providing
training for transplant staff in order that they may help families to decide about donation where theindividual’s own views are not known. This is important because some people perceive their
particular religion to be opposed to donation when, in fact, discussions with religious leaders indicatethat no such objection exists.
It is clear from the work of UK Transplant than none of the major religions represented in UK
society are opposed to organ donation in principle. In some religions, there are different
interpretations and different traditions within the religion that take different views and so it isrecommended that relatives consult with a local religious leader if they are uncertain.
An interesting finding, from UK Transplant is that ethnicity has an impact on donation rates,
although the reasons for that are unknown. Donation rates are known to be much lower among black
Afro-Caribbean donors than among their white counterparts and campaigns have been set up targeting
those specific groups. The potential donor audit – of all deaths in intensive care units in the UK – also
indicates a significantly higher refusal rate among relatives of non-white as opposed to white donors(70% among non-white donors compared with 35% for white donors).
Culture of consultation
The UK public expect to be consulted about matters relating to society and medical ethics andpublic policy are seen not just as matters for doctors of politicians but for everyone.
Whenever a public body – such as the Human Fertilisation and Embryology Authority or the
Human Tissue Authority - or a Government department plans to make a policy decision, or put out
advice or guidance or make new legally binding regulations, there is public consultation. A
consultation paper or a draft code of practice or guidance will be sent to relevant professional bodies –such as the BMA – and will also usually be publicised in the media and made available to anybody
who wants to respond. There has been a noticeable shift in the extent of public consultation over thelast 10 years and now, very few decisions are made without prior consultation.
There is a legitimate question, however, about what the role of these consultation exercises is.
The HFEA for example, consulted on the question of whether people should be permitted to select thesex of their child by using sperm sorting techniques or preimplantation genetic diagnosis. A large
number of members of the public responded and the HFEA was criticised from some quarters for157

giving too much weight to the self-selecting respondents (the vast majority of whom opposed sex
selection for social reasons). There is a question about whether bodies like the HFEA are in place toreflect public opinion or, as I personally believe, to educate, inform and in some cases to shape public
opinion.

158

Human Tissue Legislation:
Culture and Context
䊍䊃⚵❱䈮㑐䉒䉎ᴺ઎:ᢥൻ䈫␠ળ⁁ᴫVeronica English
Deputy Head of Medical Ethics
British Medical Association

㪈

The changing doctor-patient relationship• Until mid 20th century
paternalism was the norm
• Doctors decide on clinicalinterests• Patients protected frombad news• Emphasis on patientautonomy• Medical ethics is not justfor doctors but for all ofsociety• 20਎♿䈱ඨ䈳䉁䈪䇮ῳሶਥ⟵䈏৻⥸⊛䈣䈦䈢• කᏧ䈏කቇ⊛್ᢿ䉕ਅ䈜• ᖚ⠪䈮䈲ᖡ䈇⍮䉌䈞䉕વ䈋䈭䈇• ᖚ⠪䈱⥄ᓞᕈ䉕ᒝ⺞• කቇ୶ℂ䈲䊄䊅䊷䈣䈔䈪䈭䈒␠ળో૕䈮ㆡ↪䈘䉏䉎㪉

159

Autonomy• Patients expect to decide
whether treatment will benefit
them• Patients must haveinformation to make decisions• Competent patients can refuse
any treatment• Information cannot be sharedwithout consent• Do patients have
responsibilities as well as
rights?

• ᖚ⠪䈲ᴦ≮䈏᦭⋉䈎䈬䈉䈎᳿ቯน⢻䈫⠨䈋䉌䉏䉎• ᖚ⠪䈲᳿ቯ䈮ᔅⷐ䈭ᖱႎ䉕⍮䉎ᔅⷐ䈏䈅䉎• ᱜᏱ䈭್ᢿ䈏䈪䈐䉎ᖚ⠪䈲ᴦ≮䉕ᜎุ䈪䈐䉎• ᖱႎ䈲หᗧ䈭䈚䈮౒᦭䈪䈐䈭䈇• ᖚ⠪䈲ᮭ೑䈱䉂䈭䉌䈝⽿છ䉅䈅
䉎䈱䈪䈲䋿

㪊

The role of the family• Importance of the family
has declined• Breakdown of extended
families• Competent patientsdecide for themselves• Families involved withdecisions for incompetentpatients• Families decide on behalfof deceased patients
whose views are not know• ኅᣖ䈱㊀ⷐᕈ䈏ૐᷫ• ኅᣖ䈱ᩭኅᣖൻ• ᱜᏱ䈭್ᢿ䈏䈪䈐䉎ᖚ⠪䈲⥄䉌᳿ቯ• ᱜᏱ䈭್ᢿ䈏䈪䈐䈭䈇ᖚ⠪䈲᳿ቯ䈮ኅᣖ䈏㑐ਈ• ್ᢿ䈏ਇน⢻䈪䈅䉎ᱫ૕䈲ઍ䉒䈦䈩ኅᣖ䈏᳿ቯ

㪋

160

The organ retention scandal• Crisis of confidence inpathology services• ∛ℂቇ䈏ឭଏ䈪䈐䉎䉰䊷䊎䉴䈱ା㗬ෂᯏ• ∛ℂቇ⠪䈱ਇ⿷• ᬌᱫ଀䈱ᷫዋ• ∛ℂቇ䈪䈲ଐὼ䈫䈚䈩ῳሶਥ⟵䈏৻⥸⊛䈣䈦䈢• ␠ળ䈫∛ℂቇ⠪䈱ᦼᓙ䈮ᩰᏅ• Shortage of pathologists• Number of post-mortem
examinations declined• Paternalism was still thenorm in pathology• Different expectations ofsociety and pathologists
㪌Impact on human tissue legislation• ⥄ਥᕈ䈫หᗧ䈏Human
Tissue Act䈱ᩮᐙ䈪䈅䉎• Autonomy and consent
central to Human TissueAct• ᬌᱫ䈮㑐䈜䉎ⷙ೙䉕ᭂᐲ䈮ᒝൻ• ⷫᣖ䈱ᜎุᮭ䈭䈚• ⋴஖หᗧ – ᫈ළ

• Extremely tight regulationof post-mortem
examinations• No relative veto
• Presumed consent –rejected㪍161

Presumed consent for donation• Everyone presumed to bedonor after death unlessthey have objected• Relatives asked about
unregistered objection• If no objection
presumption is to proceed• Severe distress of relatives
would prevent donation• ෻ኻ䈚䈭䈇㒢䉍䇮ᱫᓟ䈲⺕䈚䉅䊄䊅䊷䈫䉂䈭䈘䉏䉎• ⊓㍳䈘䉏䈩䈇䈭䈇෻ኻᗧ⷗䈏䈅䉎䈎ⷫᣖ䈮⏕⹺• ෻ኻ䈏䈭䈔䉏䈳ឭଏน䈫䉂䈭䈘䉏䉎• ⷫᣖ䈏ᭂᐲ䈱䉴䊃䊧䉴䉕ฃ䈔䈩䈇䉎႐ว䇮ឭଏਛᱛน
⢻㪎

Diagnosis of death• એਅ䇮ᣂᴺⷙౝኈ(੍ቯ䋩䋺• New code being prepared
covering:⣖⚦⢩䊁䉴䊃䈮䉋䉎ᱫ੢䈱⏕⹺䂾 ᔃ⤳෸䈶๭ๆ♽⛔䈱஗ᱛ䂾o Death confirmed by brain
stem tests
o Cardio-respiratory death• ⣖ᐙㇱ䊁䉴䊃䈲৻⥸䈮ᐢ䈒ℂ⸃䈘䉏䈩䈇䈭䈇

• Brain stem tests not widely
understood among public㪏

162

Religion
14.6%

No religion

14.6%

ήቬᢎ

79.7%
3.1%
1.1%
0.7%
0.5%
0.3%

ChristianMuslimHindu
Sikh
JewishBuddhist

79.7%
3.1%
1.1%
0.7%
0.5%
0.3%

䉨䊥䉴䊃ᢎ
䉟䉴䊤䊛ᢎ
䊍䊮䉵䊷ᢎ
䉲䊷䉪ᢎ
䊡䉻䊟ᢎ
੽ᢎ

No major religion opposestransplantation in principleේೣ䈫䈚䈩䇮䈬䈱ቬᢎ䉅⤳ེ⒖ᬀ䈮෻ኻ䈚䈩䈇䈭䈇㪐Culture of consultation• Public consultation is thenorm• ౏㐿⻁໧䈏৻⥸⊛• What is the role ofconsultation?

• ⻁໧䈱⋡⊛䈲૗䈎䋿

㪈㪇

163

Slide presentation 3

ｐ159、スライド No.2

Editors comments for Japanese readers regarding terminology
日本語訳に対する編者のコメント
父子主義→父権主義・パターナリズム
医学倫理はドナーだけでなく社会全体に適用される→医療倫理は医師のためだけでなく、社会全体のために存在する

ｐ160、スライド No.3

患者は治療が有益かどうか決定可能と考えられる→患者は治療が有益かどうか決定したいと考えている

ｐ160、スライド No.4

判断が不可能である死体は→判断が不明である死者には（英語の最後の文章の know は known であろう）

ｐ161、スライド No.5

病理学が提供できるサービスの信頼危機→病理学サービスの信頼に対する危機
父子主義→父権主義・パターナリズム

ｐ162、スライド No.7

提供中止可能→提供は中止されることになる

ｐ162、スライド No.8

脳細胞テスト→脳幹テスト
脳幹部テスト→脳幹テスト
イギリスは、いわゆる脳幹死説（脳幹の不可逆的機能停止をもって脳死とする）をとっている。もっとも、2004 年法は HTAuthority が死の定義についてガイダンスを出すよう規定している（26 条(2)(d)）
。

ｐ163、スライド No.9

原則として→原理的には

ｐ163、スライド No.10

公開諮問が一般的→「パブリックコンサルテーションをすることが規範である」の意

164

Fundamental differences between the U.K. and Japan in approving process
Mike Norton, Professor of Innovation Management Institute, Shinshu University
4-17-1 Wakasato, Nagano
I have to apologize because I am an amateur here amongst many experts in medicine law andethics. As a scientist (chemist) I have only general experience of ethics which I obtained in previous
jobs communicating science to policymakers, for instance I worked for 10 years in the British
Parliament briefing parliamentarians on issues with legal or ethical implications, such as the one weare discussing today. My job there was to explain complicated scientific issues in terms that
non-expert parliamentarians could understand, so that they could concentrate on the key legal, policyor ethical issues and not make mistakes about the science in their comments. So what I thought I
would do today is to give you some impressions about what I have absorbed from these two days ofexpert testimony and identify what seem to me to be the key issues, and I'm sorry that I cannot
contribute any fundamental expertise myself.
If we think about the transplantation process itself, then the key issue is really the interface
between the donor and the donor's relatives or the bereaved - and it is here that the difference between
Japan and the UK is perhaps most obvious. In Japan you have the donor - first of all he or she has toovercome the barrier of providing their own consent; then if that barrier is passed, there is a second
barrier to overcome which is that of the relatives’ consent. It is quite obvious that if it the chance of
having a donor card is 20% and the chance of the relatives also consenting is 20% then the overalloutcome is only 4% . This is very simple arithmetic but accounts for why so few transplants are taking
place in Japan today. In the UK, you have the donor and again the donor can choose to go over thatfirst barrier and agree to consent by using a donor card, but instead of the relatives’ decision being asecond barrier, you have a second route whereby the relatives can give consent even if the deceased
does not have a card. So if we use the same percentages, and the percentage with a donor card is 20%
and 20% of the relatives give approval, these are additive in the UK so that the overall percentage ofapproval can be as high as 40%.
So we have fundamental differences in the approval process -in Japan they are competitive whilein the UK they are additive. So perhaps we should think about why. The UK has just changed its
legislation so I suspect we are not going to change it again in the near future, but Japan is in thecurrent situation of discussing this issue. There seem to be two options for thinking about change. The
first one is related to donor/relatives wishes and which has priority – as we have heard this is reallyabout autonomy where the deceased who wishes to be a donor can be overruled by the relatives. Then
you have the case where the deceased has not made any indication about whether he/she would like todonate where the relatives could be given a role is deciding donation. So Japan has these two options
to consider in overcoming these barriers to donation.
And each of those raises different issues. The first is basically an autonomy issue; it is acompetition of priority - a competition between the rights of the donor and the rights of therelatives/bereaved. It isn't a case of harmonising these, it is a case of deciding which right has a higher
priority and this relates to the rights of the individual versus the group in society where as we know
there are quite large differences between Japan and UK on that issue. As Dr Matsumura pointed out,
our image of Japan is that the Japanese are very concerned about the effect of their actions (or theimage of their actions) on other people and are very sensitive to criticism or comment from otherpeople. Whereas in English society it is more individualistic and if we have the courage of ourconvictions, we are prepared to stick with that opinion in spite of the opinions of the people around us.
So I'm not saying you have a clash, but you do have an interaction with some fundamental aspects ofJapanese society here. Similar, though not quite the same considerations apply to the second policy
option which is the ability to decide in the absence of the donor's express wish whether to go ahead.
Now here you are looking at here what are the relatives weighing- what are they considering- when
they make that decision.
There is clearly no benefit to the relative who has died of becoming a donor; what they have toconsider is the balance of costs and benefits in a broader sense. I think that gets me into the field of
the philosophy of what is the role of the individual in relationship to Society, and I think there are
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan

165

differences here between the UK and Japan. In the UK, there is quite a strong feeling that we should,
where we can, be good for society- of course we all put ourselves first, but we also like to (where wecan) do something good for society. For instance I contribute to a charity which is saving rainforest
in South America; my daughter subscribes to a charity which is more concerned with politicalprisoners and human rights; the idea in the UK of charitable activity is very strong. This is why wehave some very large charities with a lot of money which are just not matched in Japan. So I'minterested in hearing what is the average image amongst Japanese of what they should do for society.
Dr Matsumura pointed out the Japanese preoccupation with gift reciprocity-I even found this with myneighbor when I gave them some spare vegetables and sure enough two days later there was a knockon the door and a reciprocal gift. (In England, we would have just said thank you very much andeaten them!)
Our image of how self interacts with society may be important and my suspicion in Japan is thatthe general image (of self interacting and contributing to society) is not as strong as in England.
Which is contradictory in some extent because Japanese also have this identification with the groupwhich is stronger than in the UK. The key difference is that in Japan your identification with thegroup is generally with a close group whereas in the UK there tend to be only two groups-the family
and then not much between that and the whole of society.
So if you look upon it from the point of view of donating an organ to a person unknown to you,you are contributing to them - they are certainly getting a benefit-but the question is there a beneficial
feedback to the bereaved family. In this context, I did an Internet search and found one paper (fromHolland) which looked at the effects on the bereavement process of whether or not donation wasapproved. The study had three groups - one where the relatives had agreed to the deceased donating
an organ; one where the relatives had not been asked; and one where they had been asked but refused.
And the analysis asked if there might be some relationship between the donation (and the benefit
provided to someone else) and the grieving process. There was also the question that many hospital
staff are reluctant to ask about donation at a critical time because they believe it will distress therelatives. That work had a pretty negative outcome-they said there was no impact on the
bereavement process related to whether or not an organ was given. Neither was there an impact on
the bereavement process of whether or not you were asked. So we can't call on any hard evidence tosuggest that there are any personal benefits to the bereaved family by acting charitably. That is thefirst point which is on this key balance between the rights of the donor and the rights of the bereaved.
The second area I think we looked at today is really on the medical scientific front, and here I
sensed there isn't that much difference between the UK and Japan in terms of the medical profession. I
think the concept of death demonstrated by brain stem function test is accepted in Japan amongst the
medical community, although we heard from Dr Matsumura’s talk that there is a much bigger gap
between the medical concept of death and that amongst the public. But we also heard from Veronica
about the change in doctor-patient relationship and the critical point that it is not just the nature of
information but also its delivery method which are both important-it is not just the information but it's
the way in which it is presented as well. My personal experience having visited doctors in Japan isthat they are not the old paternalistic style-they do explain things and they do consult you on what isthe best procedure; in fact I've been surprised that doctors here take account of the patient’s wishes
perhaps even more than I have experienced in the UK. So I am not quite sure in terms of the doctorpatient relationship it is that different in Japan. It may be that the actual concept of brain death needs
to be far more carefully explained in Japan than in the UK perhaps because it's not so widely accepted
outside the medical profession. And there's also the point made in the paper I already mentioned,
about the interaction between the doctors and the bereaved immediately after death when donation is
being discussed. They did conclude that doctors need to not just explain but also show the actual
results or scan printouts which you get from the test procedures for brain death. There is thesuggestion that if you go through the diagnostic process of explaining what the tests mean and how
you have reached the conclusion about death, this is much more effective than just saying I'm afraid
he/she has died. So there may be some valuable insights there.
In terms of the societal beliefs however, I think there are some quite substantial differences
between the UK and Japan. In the UK you saw from Veronica’s slide on the religious affiliation in the
UK that about 80% are basically Christian origin although there is quite an important difference
between Protestant and Catholic origin. Around 10% are active Catholic (our Prime Minister is

166Catholic). The Human Fertilization and Embryology Act had a very high involvement by the Church
in the debate on the ethics and also in the legislative process. On that issue, the Catholic Church and
the Protestant Church were in disagreement but in terms of transplants, they are in agreement-bothregard it, if not a duty, at least something which is a good act; a charitable act. Not something which
has any negative aspects but not something which is compulsory either. However on the Human
Fertilization Act particularly on embryo research up to 14 days, there was a big split between
Protestant and Catholic. But the key point is that both of them engaged in the political process andboth of them contributed very good philosophical analysis which were useful for deciding theoutcome of the legislation. And in fact the Church of England has some specialized science andethics people on its staff including the Scottish church as well, and these are doctors and academicallytrained people who act as advisers on these issues. So I think that is a very important role but I do
not see that role possible in Japan, because Shinto does not get involved in policy processes andBuddhism is also fairly detached from the political process. So this means that there isn't any
mechanism in Japan for mediating or communicating religious concerns amongst the general public
into the political process.
I think that while this is an important difference, I don't think you can do much about it -thecurrent position of the religious faiths is very long established and they are unlikely to change theirrole in society very quickly. The other key area in societal considerations is of course trust in
professions- this is a key factor. In the UK we talked quite a lot in this meeting about consultation, andconsultation has really been increasing as trust decreases and consultation is a response to the loss oftrust. This loss of trust in government, in the media, also in the professions , is a problem which has
been affecting just about every aspect of government in the UK and has led to a great increase inpublic involvement at every stage.
So I think that the position of the UK 10 to 15 years ago, when there was a tendency to leavesuch matters (especially such sensitive matters) to the professional bodies and their guidelines andvoluntary self-regulation, is still the case in Japan. But you heard from Veronica's presentation, thatsituation has changed and a lot of these areas are now regulated. The danger of that of course is thatyou lose the basic freedom to use common sense and lose the flexibility of professional guidelines andwhen they become law, you can end up with idiotic or completely unforeseen implications such as thestory we heard about the doctor who was unable to establish whether he had a risk of HIV infection
from an accidental injection. So in my view there's a lot of advantage in retaining the flexibility ofprofessional guidance and self-regulation, and if that is the case and is working in Japan then the key
thing is to make sure that self-regulation is seen as effective by the public, because what happened in
the UK was that many of these areas were seen to be deficient. That is what caused the huge backlash
on certain issues which led to regulation and the threat of further regulation. So that is an impressionthat came out from today's discussions.
The final point I want to make today is concerned with internationalization since I know theoriginal agenda had the scope for internationalization on the list. I wonder if it's really possible tomove very far in this direction. The presentations this weekend have shown how policies are
influenced by religious and political considerations and how strong are the differences between
countries on this issue. There are already difficulties in reaching an international consensus on key
international issues such as stem cell research; that's been raised in the Council of Europe and has led
to a predictable split between Catholic countries who object and Protestant countries who think it issuitable to consider research. This disagreement has also extended into the United Nations andreflects the very fundamentals split between catholic and non-catholic countries (I am not sure where
Muslim countries lie on this). So I think that the chance of an international consensus is not that
good. However if you have international trade then you do need some basis on which to regulate, or atleast there will be pressures in that direction. So I think you saw the approach being taken in UK
under the Human Tissue Act to say that not only must UK law apply but you must also have theconsent and compliance with the regulations in the other country with which are trading. But I don't
think we have really discussed that, so that's just my initial reaction.
So I think that is all the time I have to make these comments, so I hope that my focusing on thesedifferences has been helpful.

167

Short Comments on Session 3: Diversity in rules among countries with references to thecultural background of individual countries, and where to seek for international
harmonization
Katsunori Kai, Professor of Waseda Law School, Waseda University
1-6-1 Nishiwaseda, Shinjuku-ku, Tokyo
PrefaceThank you very much for Prof. Utsugi’s and Dr. Matsumura’s giving me this valuable
opportunity to comment on this session, but it is very difficult for me to comment on the wonderfulpresentation by Dr. Matsumura and Dr. English in this third Session. So please show my comment
paper. This is my only memorandum. Last night I hesitated to distribute this paper today, because it
has not yet been fixed.
I major in criminal law and medical law in Waseda University. I have studied various subjects inmedical law from the viewpoint of comparative law in my study life. Especially, I am interested inGerman law and English law, so I often compare the medico-legal system in Germany with the systemin the UK in connection with it in Japan; for example, on the problems of euthanasia, artificial
reproduction, human cloning and so on. I learn many things from these two countries. Recently, I am
interested also in Dutch and Oceanic system.
By the way, needless to say, every country has its own cultural legal history and therefore has
different legal system each other. In Germany, the notion of “human dignity” is taken very seriously inbioethics and medical law. In the UK, I think that utility is so. And for example, concerning thelegislation of protection of human embryo, German model is hard (see Embryonenschutzgesetz),
contra it in the UK’s model is more soft and flexible than in Germany. Personally, I think that HFEA
in the UK is more appropriate than Embryonenshutzgesetz in Germany. I often find out thesolution-model (mixed model) in these two legal systems. So, I was very interesting in the lecture of
Dr. English and the concrete discussions on it last night. Here I’d like to avoid duplication andcomment shortly on the basic problems from the viewpoint of comparison between the Japanesesystem and the UK’s system.
1. Differences of cultural background and bioethics or medico-legal rules
I think that there are some differences of cultural background between the UK and Japan andtherefore also some differences of bioethics or medico-legal rules between there.
From the viewpoint of religion, it is true that there are many Buddhists in Japan, but Buddhism isvarious. And in addition to it, many people are not religious in their daily life. So it is difficult to say
in a word, however, if I must find something characteristic to say about it, I’d mention its heteronomy(so called “Tariki Hongan” in Japanese, but it originally means another implication). Traditionally andculturally, we trend to rely on another person in deciding on important things in Japan. The notion of“autonomy” is not so strong in Japan. Many people think that they would like to escape fromtroublesome problems, and often say, “Don’t try to get me into anything troublesome”. Therefore it
appears for me that some important problems (e.g. on treating human embryo or human tissues) are
not being discussed daily in Japan. Nevertheless whenever an important problem is taken up by themass media, they trend to be very excessive and sensitive to it. So we are very week indecision-making or making a social agreement in the field of bioethics and medical law. Thus some
important subjects are often decided without our noticing. As the UK has a good tradition “rule oflaw” and autonomy, the system is originally different from Japan. I think that the internalization ofnorm is not so enough, but the role of family and medical paternalism are stronger in Japan than in theUK.
Incidentally, in the earlier time, Japanese norm consisted of the notion of “Haji” (we may safely
call it shame), which was a kind of emotion “not being criticized by others”. This is a very importantnotion in Japan. Once upon a time Ruth Benedict, who was a very famous cultural anthropologist in
USA, said that Japanese culture was the “Culture of Haji”.
T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan168

On the other hand, naturally we have many Christian and scientific citizens, persons who decidecalmly, and so on in Japan. And fortunately, we are very diligent in learning the foreign legal or
ethical systems and we have various influences mainly from Anglo-America and Europe in Japan.
Therefore recently the situation is gradually changing into westernization. So in a sense we havemulti-cultural aspects in Japan. The right of self-determination of the patient or informed consent isemphasized in the field of medical law and bioethics. However these trends often collide with thepresent Japanese situations because of Japanese spirit and combined with Western learning (so-called“Wakon Yousai”). Dr. Matsumura shows us one tentative proposal to help us focus our discussion
with being aware of it, and it is very useful. It is desirable to set more appropriate rules in Japan.
２．How can we make a reasonable rule in Japan ?
The question is how we can make a reasonable rule in Japan. It is often said that we are week inthe notion of “public health”. So that, especially recently, it is difficult to collect the medical
information and data (including cancer registration system) or materials for medical research. And e.g.
also IRB or committee system and genetic counseling or consultation system are not enough. That is
to say, the system can’t catch up the progress of technology. It is different situations from in the UK. I
ask to Dr. English how we can harmonize with international dimension with keeping the merits ofJapanese system. Please advise us from the viewpoint of “rule of law” in the UK, where is the mothercountry of the rule, in the field of this biomedicine.
As we’re running out of time, that’s all today. Thank you very much.

169

Discussion
Tamura: Collective autonomy
I just would like to add a little comment. First of all, as a genetic counselor I counsel a lot of
people who lost their family members and incidentally it was not a too long a presentation byProfessor Emiko Namihira, I guess. I think you people have already had that presentation that she
has talked, she is a cultural anthropologist and she investigated when we had a huge accident of theJet plane and then she investigated how family members who lost their families reacted in terms of
their feelings for the deceased body of the deceased. And then she concluded that somehow, I feelthe same way though, the Japanese people tend to feel that the soul, the happiness or unhappiness ofthe soul of the deceased could affect us in a way. So, for instance, we originally had this tragedy thata little girl was raped by a person, and the family, when the trial was held, the family, the parents, theyheld a picture in a frame of the girl but when they were sitting in the court and when the criminalcame into the court place, the parents wanted to cover the picture because they did not want the girl,the deceased, to see the criminal. And their behavior was almost like as if that the girl was still
living, and I think many Japanese people would understand that kind of feeling and we often say that
if we do this and then the deceased might feel unhappy or happy, and that kind of feeling of thedeceased could affect us in a way. That is one thing I would like to make a comment.
The other thing was autonomy or collective autonomy versus individual autonomy and as a
genetic counselor, often I am in a position where I have to help the people to make a decision and I
have to protect them from intertwined relationship among family members for instance, or pressure
from the society. And I do not quite agree with Dr. Matsumura’s position where he is thinking about
the collective autonomy because once we agree with the idea of collective autonomy, if there is, andthen if the family member knows that there is an option that an individual can involve other people
into the decision making process, then an individual, even if she or he wants to make a decision byhimself or herself, needs to think about the pressure of the other family member because they may
know that they can be involved. So, I do not think collective autonomy can exist if we really have toprotect individual autonomy…
Matsumura: Point of no return and the responsibilities of bereaved
If we go to discuss about the point of no return, it may always be endless, since there are somecases that make the discussion subtle and difficult. My position is Yes, we have one out of thousandcases in that a patient may come back, even after brain death is determined medically. But even so, I
am going to ask the agreement of the family member to decide for the procurement of organs fortransplantation. This is what I am proposing. So, I am not asking the medical entity to make thepoint of no return perfectly sure and scientific. I am asking the bereaved to decide organ donationeven if the scientific and medical bases of brain death is not perfect.
Another point: Ms. English mentioned that our family is becoming small, due to the increase of
nuclear family. This is the same in this country. There are a number of quasi families. Now for organ
donation, particularly for living organ donation, the current rule of the Japanese Society forTransplantation is that living donation is acceptable within a family, close relatives, or those who are
regarded as similar to a family.
Then, we are facing to the question what kind of relationship is acceptable or not as similar to a
family for live organ donation. Do you have any discussion on that point.
The third point is to Dr. Norton. Yes, because of this, the rate of organ transplantation from acadaver is small in Japan. I understand that the reason why the rate of living will for organ donation issmall is not because people do not want donate organs, but because, many times, they are hesitating toextend their wishes on things after their death. In Japan, we inherit the idea that things after one's
death are to be up to the bereaved. So, my proposal is to give more free choice for the bereaved, thanto encourage and appreciate signing to a donor card. I may even appreciate that sometime, thebereaved may even be permitted to disregard the wish written in the donor card. The rate of organtransplantation from a cadaver will increase in Japan, therefore, not by disregarding the will of the
bereaved, but by encouraging the bereaved to be more responsible for organ donation than the
deceased.

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EnglishThank you. That’s actually very helpful as it covers one of the questions that I wanted to ask
you. Let me take those three points.
The first is about the point of no return and informing relatives and discussing brain stem tests.
I think the point is that what relatives want to know is that it is impossible to go on living after thisstage. It’s not that there’s a small chance that they might go on living, it’s that it is impossible for themto go on living, and that is what medical opinion is about when brain stem tests are done. With thisset of tests, if these are satisfied, it is not possible for that person, under any circumstances, to carry on
living. That is very persuasive in the UK with explaining to relatives. That brings me on to one ofthe points that I wanted to raise about what you were saying and from what Dr Norton was saying
because it seems to me that this is a huge issue here. In Japan it’s about understanding – not justunderstanding but accepting this concept of death. Dr Norton talked about explaining to the public
and entering into a debate with the public and informing the public, but I wonder whether in fact that
information is enough. Based on what you have said in terms of the tradition, culture and religion do
you think if people have more information about the diagnosis of death by brain stem tests that theywould still accept it or that they would not accept it? That’s a question I wanted to ask you but
which follows on.
The second point is this one about the role of the family. It’s very interesting that you said that
donors do not want to make the decision because they see it as the responsibility of the bereaved andthe right of the bereaved and that’s what I had expected the situation to be here, having read a little bit
about the cultural background, which is why it surprised me so much to hear yesterday that in fact if
you are talking about a heartbeating donor, you have to have the consent of the individual and you
cannot proceed with only the authorization or consent of the family. That surprised me and that
obviously is a reason why the rates are so low. It would be same in the UK because the number ofpeople who have made their wishes known are 22% in the UK – that’s the people who are signed up
to the Organ Donor Register, where there is evidence of their wishes. So if we were only relying onthat, we would also have a very small number of cadaveric organ donations, but because we allow the
relatives to make the decisions if the individual hasn’t consented, that obviously takes the numbers up.
That’s something that I think is really interesting.
You also asked me about how we define “family” in relation to living donation but, presumably,
generally with consent, and the Human Tissue Act sets out who should be consulted and it actuallyprovides a hierarchy, so it starts off with the spouse – husband or wife – or partner, and then parents orchild. It includes things like niece or nephew, aunt or uncle, and it ends with a friend of longstanding. So if you have no relatives, and you haven’t given consent, then a friend of long standing,however that is defined, could actually give consent to transplantation, to a post mortem examination,
to the use of organs or tissue in research. So the relationships are actually set down. In terms ofliving donation, which is the context in which you mentioned it, a lot of living donation is between
family members but not all and in fact a lot is between partners – long-term partners or friends – so it
isn’t necessary for there to be a genetic relationship but there would be a DNA test if you wereclaiming a family relationship, to ensure that there is a genetic link. If there is not a genetic link but
it’s somebody with whom you have a long-standing relationship or emotional attachment, then the
independent assessors I mentioned yesterday would consider every case to check that there isevidence that you do actually have a long-standing relationship with that person. Who the family
member is, is less important I think in living donation but it is specified in the legislation about who
can actually give consent.
Mitsuishi: Presumed consent
Thank you very much, Ms. English. I’d like to ask about presumed consent for donation. You
said everybody be a doner after death What is the social or cultural background for this presumed
consent?
EnglishThe main reason for supporting presumed consent is that we do know, from many surveys andpublic opinion polls, that the vast majority – at least 90% – of people are willing to donate theirorgans after death. So that’s our starting point. If the majority of people are willing to donate

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organs, then if you have a system whereby that is the default position, those who do not wish to
donate organs can opt out of that. So you are protecting their interests but you are making it easy forpeople to follow the wishes that they have. There have also been a number of surveys of public
opinion about whether the public would support such a shift and in those surveys I think that I
mentioned that 60% of people said that they would support such a change.
The reason why most people say they will support the change is because they always intend toregister their wishes about donation but they never get around to doing it. So they want somethingthat is easier for them. But of course there is the issue – I think a genuine concern – about people notwanting to be told what to do and feeling that it should be a gift which is positively given – a positive
gift as opposed to something that is assumed, and I think that there are people who take that view as
well.
But because the majority view is in support of transplantation our view is that we should make it
as easy as possible. We also believe that more attention should be given to the people who are dying
waiting for an organ and who may die if they don’t get an organ. Because we don’t have the sameview as you do here about the soul after death, for the vast majority of people in the UK, once
somebody is dead then that’s it. They may believe, if people have a particular religious view, thatthe soul leaves the body and goes to heaven but that does not prevent them from donating organs after
death. We also have the background, as Dr Norton said, about giving and a view that if something
positive can come out of this, then that is a good thing. Although the survey that he quoted didn’t
show, or the research didn’t show, that bereaved people benefited, talking to families who havedonated – and it is only anecdotal evidence –we find that they do get a lot of satisfaction from thefeeling that something positive has come from their bereavement.
Mitsuishi: Brain stem death
I understand that .But I am asking, because you said that brain stem death is not widely
understood among public.
Brain stem death is quite British Idea. That is not undestood by public. Why it is presumed
concent for donation, because informed consent doctrine requests four requirements for consent, i.e.
①competance, ②explanation, ③understanding, and ④voluntary, so that it lacks the requirement③.
EnglishI think the reason it is not widely understood is because people see it as just one way of
diagnosing death and so, in the same way that they might not have information about how particular
medical conditions are diagnosed, there is an acceptance that it is death which is simply diagnosed indifferent ways.
Mitsuishi
So that professionals think they should teach people about brain stem death, but people do notunderstand or have no interest, so that professionals can presume that people consent for donation.
Brain stem death even if people do not understand, but you say people are dead. And then people
are suppsed to say “OK, I will donate.” Is this UK way?
EnglishWell, it’s saying that people agree to donation after their death and death may be diagnosed indifferent ways. If they want information, they can get information. There is information available,
for example, when people sign up to the Organ Donor Register. So there is information available forthose who want it. And it is explained to families, when they are in a situation where they have arelative on a ventilator. There is a lot of discussion with families I think a lot of hospitals do actuallytake them through the tests, and actually show them what they’re doing, and explain the tests so inthat situation there is information but I also think that most people are not interested in how death isdiagnosed – they’re dead, and they accept that.
Mitsuishi
Your system shows lack of informed consent because understanding is a very important factor of
informed consent.

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EnglishWell, no, I don’t think that’s true. I think it comes back to the point I made yesterday about how
much information people want to have. If people want to have information about how death isdiagnosed, that information is widely available and is easily accessible for them. But most people
really don’t want that information – they’re not interested in how death is diagnosed. That doesn’t
make the consent invalid, because the information is there and available if they want it. What theyneed to know is that they are dead when their organs are removed. So I would challenge thesuggestion that it isn’t consent, because I think it is.
Masui
Evaluating autonomy is something different and contradictory to the trusting scheme. As Yonas
once mentioned that trust is not based on the equal partnership, therefore, it may be different from thephilosophy of negotiation or conversation. In the medical practice people are interested in the
diagnosis but not interested in the process and doctors attitude supported by trust may different from
evaluating autonomy. This seems the point that Dr. Mitsuishi mentioned.
Kurihara: Credibility of diagnosis
I would like to add one thing. There is not only social issue but also issue of medical science,
which means that there is a complete difference between the Anglo-Saxon style of measurement of thediagnosis and Japanese way of diagnosis. This may depend upon a culture of medicine, culture of
medical science, not only social issue. For example, my husband is working in the field of psychiatry,
and then we know that Japanese psychiatrists hesitate to accept operational measurement of diagnosis
such as ICD or DSM. On the other hand, Anglo-Saxon people have conducted many, many
epidemiological studies whether this kind of operational type of measurement of diagnosis is credibleor not, but Japanese people, Japanese medical scientists did not conduct such kind of epidemiologicalstudies.
So that may be one of reasons why Japanese people do not trust medical diagnosis, this is samein the case of brain death. You know, Mr. Mitsuishi is an expert who surveyed such a thing, he foundthat in Japan there have been several kinds of misdiagnosis, incorrect, misdiagnosis of brain death.
So this is a feeling of Japanese people, they cannot trust in medical science.
EnglishI think that is an important point. One of the things that does help in the UK is that for many
years we have had a very clear code of practice which is agreed by all medical groups, about how todiagnose death. There are very clear tests that have to be done, that have to be repeated twice. You
have to have doctors of a certain level, including a consultant. The people who are diagnosing death
have to be separate from the transplant team. So all of these safeguards have been built in for anumber of years. I think I mentioned that one or two doctors have questioned the diagnosis of deathbut even they have not questioned the fact that people cannot carry on living, but rather they havequeried whether those people are actually dead or are in the process of dying. They’re simply sayingthat this is a stage where this person cannot continue to live, but it is not the same as death. So there
is a lot of trust and a lot of confidence in the system for diagnosing death which I think does help.
Kato (interpreted by Sato): Donor-recipient relations
The Japan Society for Transplantation will be held in this hotel in this afternoon, so I would liketo ask you. I would like to be told on what we should think of “related”, it is now based on emotional
relationship. Problems arise on the procedure of transplant in related, but mass media do not question
on the notion of related. Should we restrict it, say, as within the third degree of relationship?
Sato
It would be helpful if you would explain the definition of “genetically related” in OTA 1989.

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EnglishThis act was repealed, so it is no longer in use. That is now taken over by new HTA. And I am
sorry that I am not sure about the definition now.

叔父／叔母

父

母

いとこ

叔父／叔母
いとこ
姉妹

兄弟
息子

娘

甥 姪

甥 姪

「半血の」を含む
I could, except that that Act has now been repealed and is no longer in use. It has been takenover by the Human Tissue Act so I’m not sure how helpful that would be and I’m not sure I know off
the top of my head what the relations are, to be honest, which were permitted, so I can’t answer that –I’m sorry.
Shinozaki
As attending the WHO meeting, this is a big problem, for especially in the United States andmany of the European countries, starting a living donation, which is not limited between geneticallyrelated persons. Then we had realized that for the status, it is genetically limited, so then we expand
it to start using a terminology of emotionally related as a WHO guiding principle. That caused alittle problem in last decade, due to the fact that in the United States, the population of the pairedorgan was getting larger. In some of the European countries, they also decided to start the pairedorgan. The meaning of paired organ is, if you post your HLA with your spouse’s, and an unrelated
person who has the matched HLA typing, switches the organ to other spouses. The recent data shows
about 50 percent of living kidney transplantations in the United States are done by the paired organ.
The meaning of the emotionally related is too vague and which also caused the problem in thedeveloping countries i.e. the Philippines, for exchange of the organ with the some compensation. And
now renewing the WHO guiding principle regarding the meaning of the compensation is also
discussed. In this manner, the word emotionally related has no limitation to the donor from therecipient of the organ. The new guiding principle could not prohibit such an act due to the severe
shortage of donors. Moreover, it is very important to keep in mind that the WHO guiding principle
based on goodwill not to limit illegal acts.
EnglishAs I mentioned yesterday, in the UK the Human Tissue Act does now allow paired and pooled
donation, so we are now specifically starting to do that in the UK and also going further than that andallowing donation to strangers. So I could go and just say “I would like to donate a kidney to anyone
that needs one” and that would now be considered whereas previously such requests would have been
rejected. Having said that, we have developed a system which includes checks to avoid the risks oftrafficking and payment and coercion which I think are big issues both within families and withpeople who are emotionally related. The feeling in the UK was that if people are willing to donate toa stranger, then why not allow them to do it? What reason is there to stop them from doing that,provided you have safeguards in place to ensure that they are doing it for a reasonable motive and thatthey are not motivated by money or some other reward that they may be getting? So that issomething that is developing in the UK and we don’t know yet how much that will take off. We

174think there will be small numbers. I think for paired and pooled donations, there will be quite a few
of those. Again, the feeling there is that if I want to donate to my spouse or my partner but I am
unable to do that because we are not compatible, and there is another couple in the same situation,
what objection is there to swapping, because the motivation is still the same and, again, there aresafeguards to protect against abuse of that?
Shinozaki
What are the safeguards?
EnglishThe safeguards are that with any living donation an application has to be made to the Human
Tissue Authority in every single case and then there is an independent assessor who is accredited andtrained by the Human Tissue Authority who has to interview the donor and the recipient and has toensure that the donor has understood the issues, they have to ensure that there is no money
exchanging hands. They have to ensure that the relationship is as claimed, so that might be a genetic
test or it might be, if they claim to have been friends or partners for 20 years, it might be a wedding
photograph or some evidence of the relationship. Once the accredited independent assessor is happy,
then the case needs to go to the Human Tissue Authority in order to get approval and all of that has tohappen before the donation can go ahead. That’s whether they’re related or unrelated. There are
additional safeguards where the donor is a child who is not able to give consent or an adult who lacks
capacity, and for paired donations and for donations to strangers approval has to be given by a panelof at least three members of the Human Tissue Authority. So there are these safeguards built into thesystem.
Shinozaki
Is the Human Tissue Authority set up by law?
EnglishThe Human Tissue Authority was set up by legislation, by the Human Tissue Act, so it’s a bodyset up with statutory powers.
Matsumura
One comment to Dr. Norton. You mentioned that you appreciate the mind of 'good to society'very much. I just want to say that we did have that mind in Japan. But we spent out, we were
exhausted of, great amount of that mind during the second world war, because the government
squeezed to the last drop of this mind from Japanese people. We are now coming back, but not to thelevel that you have in the U.K.
As to the collective decision. I am not saying this is the primary choice. This should be done on
the basis of self decision. If you want to do this, then, I think, it is acceptable.
The point is that our decision mechanism is still very brittle in Japan. In old Japan, there was asaying that you must not go shopping by your self. You must go with someone else. Otherwise you
will drop in an impulse buying.
Please imagine if you are involved in liver organ donation to your own baby. Many times parents
are very keen to donate their own liver organ to the baby. I just do not want say that such a decision is
not a good decision. But a decision in such cases is made very emotionally, particularly when it ismade by a single person.
TamuraI hear your point. I think, I counsel many families in the United States and in Japan too, andfrom my experience, there are not many difference between two countries and the important thing forme is to have a good mechanism or process where we can have an individual to make a decision
whereas this individual came and think about your family member’s values or friend’s value or
individual value at the same time and it happens in United States too.
So, I think we can still have an individual autonomy by having a process where this individual
can think about their family or involve other’s value, but we can still protect this person to make his or175her own decision. And I do not think it is a good idea to just announce that the family can be
involved into one individual decision-making process because if we do that, then other family
member can mad at the person because this person may not involve the other person into this process.
But we can still, you know, make an individual think how other people can affect. And then having
said that, I would like to also make a comment for Dr. Kato that I have been counseling a lot of family
members, and families are so different even among Japanese people or even among American people
or Western people, and then it really depends on them. And I think it is very, very important to havea good mechanism or process where we can have a good counsel session with a family or anindividual so that they can think about all of the things. And there are many, many intertwined
yayakoshii relationship in Japanese families, so I think you said cohesion is important to think about.
But I think especially in Japanese society, people may have internal sort of responsibility or cohesion.
Even if other people do not put a lot of pressure on this person, they may feel like I have a pressure byothers even if it does not exist. So, the family is very, very difficult to, I mean, they may havedifferent values and they have different generations and the family member have disagreement
sometimes and so we have to have really good process where an individual can have a good insightand to think about him or herself plus other family members and we really, it is hard and I have been
still trying to improve my counseling skills but it is enormous.
Norton
You want a conclusion? I think one very important area that we have touched on but haven't
really delved into enough is what People feel but they don't express. And I think you touched on that.
In English we have this thing called the yuck factor-it means I don't want to think about it or talkabout it- and death is obviously one of those things, and so too having things cut out of your body andput on a silver tray is also something we don't like to think about. I think quite a lot of individual
decisions are actually motivated not by high ethics, not by philanthropy or even self-promotion, butjust by that feeling of uneasiness or queasiness about the whole issue. How to address this is quite a
big challenge and I am quite surprised that the number of permissions in the UK has been so high andhas maintained itself at such a high-level. We do still have such a big difference between the intuitiveor automatic reaction of Japanese people and English people to the same situation we all have to deal
with.
I saw some figures and the results of public opinion polls on whether you agree to your own
Organ being used, or your relative’s organ being used is quite startlingly different between Japaneseand English people, and while we can rationalize this difference in very clear ethical or religious
terms, it may basically reflect a wish not to have to confront the messy business of life and death. Oneof the cultural anthropologists you mentioned has the dubious distinction of being the only person
who comes up on any Internet search on Shinto and death. You find her words requoted on manyother web pages on transplantation. Shinto really sees death as a very messy and decaying businessto be ignored and avoided if at all possible, and these things have I think combined with the naturaltendency of people not want to think about things which are really distressing, to prevent the Japaneseapproaching it in a more rational and detached manner. That's my final point.

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Facts on human tissue issues and factors that influence differently the UK and Japan:
Concluding remarks for mutual understanding as attached after the workshop
Toshiharu Matsumura, Director, Cell Technology Center, Roman Industries Co. Ltd.,
1-10-4 Fukuura, Kanazawa-ku, Yokohama
Availability of organs and tissues
Throughout of this workshop, the U.K. and Japan have been compared extensively in facts
regarding human tissue issues and in background factors which might cause differences in the facts
between the two countries.
As to facts, a remarkable difference has been noted between the two countries in the availabilityof organ and tissues from cadavers, particularly of brain-dead donors, for transplantation as well as forresearch uses, which is high in the U.K. in comparison with that in Japan.
Another remarkable difference noted is in the high incidence of live-donor organ transplantationin Japan as compared to that in the U.K.
As to factors causing these differences, it has been noted that brain-death as defined in thepresent form is accepted only very narrowly in Japan, while widely in the U.K. In other words, it isaccepted in Japan only in restricted circumstances where Japanese organ transplantation law permits
it. Here, the restricted circumstances permitted by the law are where donor-card holders, with theirwills for organ transplantation, die. Otherwise, it is not accepted as death in Japan.
However, other causative factors have also been pointed out: Japanese law permits organtransplantation from a heat-beating brain-dead donor only when donor's written will is in anagreement with the bereaved. Further, any organs once removed and not used for transplantation bysome and other reasons must be cremated, and not be used for other purposes including researches.
This is in a sharp contrast with the HTA, 2004, in which the donor's will is appreciated in the firstpriority, the intervention of the bereaved to the donor's will being accepted only in limited cases
where it is inevitable, and the research use of those organs that have been removed for transplantation
but not used for that purpose being widely accepted.
Still another point mentioned is that the Japanese law does not permit a donor to appoint thedestination of one's organ in his/her will, the destination of which being controlled by the Japaneseorgan transplant authority (Japan Organ Transplant Network) is not revealed to any of the donor's
bereaved.
Why the Japanese law system is so severe and narrow in accepting the concept of brain death,and in admitting the organs for social uses while poor domestic availability of organ and tissues could
cause serious international problem.
In discussion, at least three points in term of causative background culture have been raised inrelation to the above differences between the U.K. and Japan. In one, it is pointed out that, generally
speaking, Japanese people do not have will to serve to the society altruistically as much as British
people. Another point raised has been that the common Japanese way of understanding death, which
has been strongly influenced by the polytheistic inheritance of Japanese culture, cannot meet wellwith the process of organ removal from heat-beating, and even non-heart beating donors. The thirdand possibly most fundamental point raised is that putting the highest priority to the appreciation ofdonor's will, or respect for autonomy principle, is in a sharp contrast to what Japanese people havebeen appreciating for more than a thousand of years, i.e., respect for harmony principle, and therefore,
there are many cases where donation is not accomplished due to the bereaved negative wish which isagainst the positive will of a donor.
Analyses in Japanese cases may suggest what is required, and what not, to establish rules forhandling human tissues that can be understood and appreciable by people in other countries. Althoughtime was limited for discussion in the workshop, a set of Japanese rules and a set of international rules
haves been proposed with the speaker's hope that they may be understood and accepted to British
people and to people of other countries.

T. Matsumura et al. (eds). Law and Ethics of Human Tissue Uses: A Comparison of the Approach to Regulation in
England(Human Tissue Act 2004) and Japan, 2008, Published by T. Matsumura, Fujisawa, Japan

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Organs from live donors verses heart-beating donors
A remarkable difference has been noted between the U.K. and Japan in the incidence of live
donor organ transplantation, particularly for liver organ transplantation. The relative incidence of liverorgan transplantation from brain-dead donor to live donor is around fifty to one in the U.K. while it isless than one to a hundred in Japan!
It has seriously been discussed in the workshop that the risks to liver donor's health may have to
be considered more seriously, at the present circumstances where available research data are still
limited regarding the donor's health.
While people are so reserved for taking organs from brain-dead donors in Japan, why do theyeasily accept live organ donation, and tend to give their own live organs for transplantation while theaccompanying risks are not much known? The point mentioned has been that, in the case of donationfrom a cadaver, one cannot appoint the destination of one's organ in one's will, and the destination is
not revealed to any of the donor's bereaved, while in the case of live organ transplantation, thedestination can be determined by the donor, if a donation is allowed only within a family.
At the presence when demands for organs for transplantation are increasing, the risks andbenefits of live organ donation is to be carefully studied and discussed in further chances.
Law-based regulatory system verses guidance-based regulatory system
As to facts in regulatory system, a contrastive difference between the two countries has been
mentioned in that laws regarding human tissue issues with wide views, as represented by Human
Tissue Act, 2004, have been developed in the U.K. much more than in Japan where such laws havebeen very limited within a certain narrow views, such as of organ transplantation, pathological use ofhuman tissues, and of a couple of other special subjects.
No laws, applicable to research and industrial uses and banking of cells and tissues have beendeveloped in Japan.
On the other hand, Japanese government has been developing a special regulatory system theessence of which lays in a set of guidelines delivered from the government ministries underbureaucratic leadership. In most of cases, they are delivered without little law bases.
It may be generally agreed that law-based regulatory system is essential in the democraticsociety. However, causative factors which discourage law making in Japan are also pointed out, as
well as those with which such guideline-based regulation have long been in effects in Japan .
Where is the motivation for law making, if Japanese people rather lack strong motivation for it
while people in the U.K. do? It has been pointed out that high pressure for law making in the U.K. isrelated to the high activity of non-governmental authorities in the country, and that many of these
non-governmental authorities are particularly sensitive to ethical issues. On the other hand, thecapability and authority of non-governmental organizations are generally low in Japan, which may
results in the insufficient motivation to promote law-making here in Japanese society.
It has been pointed out that the poor development of non-governmental organizations, or
relatively low motivation to devotion to the society in other words, is not unrelated with the second
world war, since the Japanese government during that war strongly suppressed people's free activities,
and squeezed the altruistic mind of people to the society to its last drop. Since then, it appears thatJapanese people are, although recovering from it, still skeptic about the governmental readership for
altruistic action and for devotion to the society.
It is easily understood that guidelines can be issued, and can be updated promptly following theadvancement of science and technology, while law making takes time. It is also pointed out that, withhistorical background, Japanese people tend to obey bureaucratic leadership.
The central difficulty with the Japanese guideline system, as pointed out, is in that it lacks any
penalty clause, except for some administrative sanction, such as withdrawing governmental researchmoney from ethically doubtful researches. Can the basic understanding that all modern Japanesepeople are faithful to follow rules with no mentioning about sanctions when breached? Recent casesof live-organ transplantations from diseased donors cast strong doubts to this question.
Although law-based system is preferable, a question has been raised as to the difficulty in its
enforcement, particularly when it requires money and men. Successful enforcement of the THA 2004
is therefore anticipated and looked forward to. As expected, Human Tissue Authority (HTA) as

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introduced in THA 2004 has received the most attention in the workshop. Considering that modern
science reveals the potential human capability of human tissues more and more, and that HTA
indicates to set the first registering authority in the world for human tissues, we may anticipate that, in
future, it may grow to the first ministry for the protection of human life out of our body.

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