A new system enabling the use of drugs and medical technology at the request of patients even though they not been approved in Japan will start in fiscal 2016. This legal change was included in a government bill for health insurance reforms approved by the Diet this week. Relevant parties need to be fully informed of the risks of the system, however, including the safety and efficacy of treatments yet to be tested in this country.
Medical technologies and drugs widely available overseas generally cannot be used under Japan's public health insurance program until they have been approved by Japanese authorities through clinical trials in this country. The fact that the approval process here takes much longer than in the United States and European countries raises criticism.
If patients choose to use drugs not yet domestically approved, they have to pay for the entire cost of the treatment — not just the cost of the unauthorized medicines but other expenses such as diagnoses, medical examinations and hospital bed charges — because Japan's public health insurance program does not in principle cover medical treatment that includes the use of unapproved drugs and technologies.
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