The Protection of Patients against Ionizing Radiation in Japan
Toyohiro NOMURA
Emeritus Professor of Gakushuin University
President of Japan Energy Law InstituteI. Introduction
Japan started already in the 1950s the study and the use of the nuclear power. The
fundamental law on the atomic energy was enacted in 1950. However from the legal
perspective, in the early years, it was still the use of the atomic energy for theproduction of electricity which was taken into consideration. As a result, the legal
regime for the nuclear power plant develops gradually. In particular, the Government
attaches a great importance on the safety of nuclear facilities (in particular nuclear
power plants) and the compensation of nuclear damage.
On the other hand, as to the use of radiation in medical treatment the legal
discussion has not so evolved as to develop the legal system which is enforceable tothe related persons. Furthermore from the view point of management of nuclear
material there are few specialists on the medical radiation in Japan.
II. The Use of Radiation in Medical Treatment and Legal Rules on ThisMatter
1. The use of radiation in medical treatment
The Ministry of Health, Labour and Welfare researched the situation of the use ofradiation in medical treatment and published the analysis of investigations1. According
to this report, the medical radiation is used widely in many hospitals. In particular thecomputed tomography is used distinctively in Japan.
2. Legal rules concerning the use of radiation in medical treatment
As to the prevention of the radioactive contamination there are some laws inJapan. For example we can enumerate such laws as given below.
･ Law on the regulation of nuclear source material, nuclear fuel material andnuclear reactor (1957)･ Law on the prevention of radiation damage caused by the radioactive isotope
and the like (1957)･ Law on the technical standard of radiation damage (1958)
However these laws applies mainly to the workers who work at the facilities
which involves the risk of radiation damage and to the public at large who is exposed
1* cf. http://www.mhlw.go.jp/toukei/saikin/hw/iryosd/14/,
http://www.mhlw.go.jp/toukei/saikin/hw/iryosd/14/dl/1-3.pdf-1-

to danger by such facilities.
Concerning the protection of patient against the radiation in medical treatment,
there is almost no legal rules in Japan. This must be an important feature of Japan incomparison with foreign countries.
(1) Medical and paramedical professionals of radiation treatment
The qualification for radiation in medical treatment is strictly limited by law on
the medical treatment and law on the radiologist. According to these laws, only themedical doctor, the dentist and the radiologist are qualified for practicing radiation in
medical treatment.
In 1987 the profession "medical physicist" is introduced in Japan on the model ofEuropean and American countries, but as non-official qualification. In Japan themedical physicist is defined as specialist who takes initiative for resolving physical andtechnical problems in the field of radio therapeutics. Since 1987 more than 800
physicists are certified2. In comparison with European and American advanced
countries, the number of certified medical physicists is very few and their activities arelimited. Only a quarter of them work full-time. Nevertheless they contribute to preventan over exposure dose of radioactivity particularly in hospitals.
In 2007 the profession "radiotherapy quality manager" is newly created in Japan.
This is also non-official qualification. Since then more than 1,100 managers arecertified. Some of them are also qualified as medical physicist.
(2) Radiation standard
There are no legal rules on radiation standard of appropriate dose of radioactivity
for a patient subject of medical radiation. That is to say, it is the doctor himself who
determines the dose of radioactivity for the patient as he judges adequate. There are nolegal grounds which justify his decision.
As a substitute for legal regulations many associations of medical practitioners
establish a guideline for medical radiation. For example in 2012 Japanese Society forRadiation Oncology (JASTRO) published a guideline of radiation treatment planning.
In 2015 the guideline of diagnostic reference level was released by Japan Network for
Research and Information on Medical Exposures (J-RIME)3. In 2016 JapaneseSociety of Nuclear Medicine (JSNM) and Japanese Society of Nuclear Medicine
Technology (JSNMT) published jointly a guidance for making in safety an
examination of nuclear medicine.
On the whole these guidelines follow the model of recommendations ofInternational Commission on Radiological Protection (ICRP). However they are no2

On the other hand, there are about 70 thousand radiologists in Japan.

3

J-RIME is organized in 2010 in cooperation with many associations connected to the medicalradiation.

-2-more than guideline which has no enforceability. Furthermore these associations are allvoluntary organization and a specialist can work without affiliating with any medicalassociation.
In 2010, the Ministry of Health, Labour and Welfare issued a circular on a patient
who will leave a hospital after having radiological treatment4. This circular aims toprevent the radiological contamination to public caused by the patient who hasreceived radiation treatment. This is one of few examples of legal regulations at thenational level.
3. Radiation damage
Although there are no radiation standards which legally bind medical
practitioners, any serious case of accidental exposure to radiation did not so often
happen in Japan. As far as I know there is no judicial decision which reported on lawreports.
If such accident occurs unfortunately, as to the compensation of damage caused byover dose of medical radiation there are no special legal rules. Accordingly the generalrule of Civil Code applies to this matter. In most cases the patient, victim of accident
demands the compensation against the hospital or the doctor on the basis of contractualliability (article 415 of Civil Code). In a lawsuit the hospital or the doctor, defendantmust prove that the accident was not attributable to him. Even if they abided by theguidelines as cited above, this compliance is not sufficient for the proof of exemption.
Finally if they fail to prove this fact of irresponsibility, they cannot be exempted fromliability. As for the scope of damages which should be compensated the article 416
provides as in the following. At first all damages must be compensated as is the naturalconsequence of malpractice of the hospital or the doctor. Secondly even for suchdamages as have arisen from special circumstances, if the party concerned (defendant)
foresaw or ought to have foreseen such circumstances, such damages must be alsocompensated.
If the victim is not in the contractual relation with the doctor or hospital, thearticle 709 applies to this case. I have not enough time to enter into the details of thisissue.
III. Conclusion
Conclusion
In Japan the medical radiation treatment is in general carried out under theguidelines established by medical associations. And these guidelines are respected as4

On the other hand, Japanese Society of Nuclear Medicine (JSNM) and Japanese Society ofNuclear Medicine Technology (JSNMT) published jointly in 2014 a guideline concerning thismatter in extending a wider field. That is the guideline for ensuring the safety against the danger
which accompanies with entering and leaving the nuclear medical office.

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voluntary rules without any legal binding. After some accidents in hospital some
professions qualified to the adequate radiation treatment are established by medical
associations. In such a way the direct regulation by state has not developed in Japan.
But it does not mean that the Government is not interested in this matter. The
Government understands well the importance of security in the field of medical
radiation treatment. Nevertheless the Government seems to be reluctant to take apositive action by establishing any laws and regulations in this field. This attitude may
be one characteristics of Japan. In my personal opinion I would like to expect an active
intervention of the Government to secure the patient from the risk in which involves
the medical radiation treatment.

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