IV THE LICENSING OF HEALTHCARE PROVIDERS AND PROFESSIONALS
I Regulators
The MHLW regulates the licensing and overall practice of healthcare professionals including physicians and dentists.
Licensed physicians and licensed dentists, however, are not automatically registered with the NHIS. They need to register as insurance physicians or insurance dentists with the Local Bureau of Health and Welfare where they are located.
Prefectural governments are also responsible for overseeing the management and operation of medical institutions on a regional basis.
As can be seen in the adoption of the Medical Care Plan and the Regional Healthcare Vision, there is a tendency to shift administrative powers over medical practitioners and institutions from national government to prefectural governments.
Ii Institutional healthcare providers
Under the Medical Care Act, medical practice can only be performed in medical institutions that are categorised as 'hospitals' (with 20 or more beds) and 'clinics' (with zero to 19 beds).
The Medical Care Act also provides for requirements for establishment permits (e.g., staff deployment standards, facility standards, and responsibilities of managers) for each category of hospitals (such as 'general hospitals', 'special functioning hospitals', 'regional medical care support hospitals', 'clinical research core hospitals', 'psychiatric hospitals' and 'tuberculosis hospitals') and the names that hospitals can use.
The setting up of clinics requires notification if the applicant is a physician or dentist, or a permit if the applicant is a corporate body or is neither a physician nor a dentist.
In addition to the licensing requirement, medical institutions must be separately registered as insurance medical institutions to be included in the NHIS system.
Iii Healthcare professionals
Healthcare professionals such as (1) physicians, (2) dentists, (3) pharmacists, (4) public health nurse, midwives, nurses and assistant nurses, and (5) others are regulated under:
a the Medical Practitioners Act;
b the Dental Practitioners Act;
c the Pharmacists Act;
d the Act on Public Health Nurses, Midwives and Nurses; and
e other laws, respectively.
A graduate of a medical school (or medical department of university) outside Japan, or a physician licensed outside Japan must be accredited by the MHLW in order to take the National Examination for Medical Practitioners.4 However, (1) a physician, dentist or nurse licensed outside Japan who visits Japan for purposes of acquiring medical knowledge and skills, or (2) a physician or dentist licensed outside Japan who visits Japan for purposes of teaching or researching medicine or dental medicine, may provide medical services to the extent that such services are rendered within the said purposes by special permit from the MHLW. 5
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To our knowledge, foreign entities who approach the Japanese medical industry sometimes involve foreign medical practitioners in their R&D or commercial activities. But the performance of any medical act in Japan always requires a licence or its equivalent under the Medical Practitioners Act.6
V NEGLIGENCE LIABILITY
I Overview
Because of an information asymmetry between medical practitioners and their patients, as well as the physicians' expertise, the medical hierarchy or the locked-room nature of the medical profession, medical practitioners do not typically lose medical malpractice cases. In 2016, the average trial period of medical malpractice cases was approximately 24.2 months and their settlement rate was approximately 53.3 per cent, while the average trial period of civil cases (other than overpayment claims) was approximately 8.8 months and their settlement rate was approximately 34.7 per cent.7 This means that medical malpractice cases tend to end in settlement in over 50 per cent of the cases, after prolonged trial periods.
Technically, a 'reasonable causal relationship' between a negligent conduct and damages or death is not easy to establish. Therefore, Japanese courts have eased the plaintiff's burden of proof under various theories, such as 'violation of patient's expectation right' and 'possibility of patient's survival to a reasonable extent at the time of death', among others.
Moreover, it is important to mention that no punitive damages are allowed under Japanese law, and the amount of damages paid to the elderly is generally not large.
Ii Notable cases
In a decision issued on 22 September 2000, the Supreme Court adopted the concept of 'possibility of patient's survival at the time of death to a reasonable extent' by holding that in cases where the causal relationship between a doctor's negligent medical act and a patient's death is not proved, but the possibility of the patient's survival to a reasonable extent at the time of death if medical services satisfying fair medical standards were rendered is proved, the doctor shall be liable.
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There have been two recent high-profile medical malpractice incidents in Japan. The first is the use of propofol, which is banned for use on children, on 63 children at the Tokyo Women's Medical University Hospital in 2014. The second is the high incidence of deaths in patients who underwent complex liver surgery by laparoscopic operation at the Gunma University Hospital in 2015. Both hospitals involved are 'special functioning hospitals' that provide advanced medical care, develop and evaluate advanced medical technologies, and provide advanced medical research. These incidents led to the eighth major revision of the Medical Care Act (the '8th Revision'), which became effective on 1 June 2018, which reformed the governance of special functioning hospitals, including requiring due procedures for the appointment of hospital managers, establishment of an audit committee to ensure the safety of medical care, and establishment of a compliance system.
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