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.
There are exceptions in which drugs and medical technologies not covered by health insurance will be used along with those covered by the program. This so-called mixed medical treatment is allowed when health care facilities try certain forms of advanced treatment, as well as when unapproved drugs are used in clinical trials, when authorized drugs are used before they are formally covered by the health insurance program, and when drugs covered by insurance are used in ways that have not been approved. When patients request hospital rooms with added amenities, the extra charge will not be covered by health insurance, but the other expenses in the treatment will be covered.
However, mixed treatment for advanced therapies is currently mostly carried out at the initiative of medical institutions for research purposes, and it takes an average of six to seven months for the government to screen and approve the use of unauthorized drugs in such cases. Therapies not tested in this country are basically not covered by public health insurance, and many patients travel overseas to receive them.
The new system introduced by the Health, Labor and Welfare Ministry paves the way for the use of unapproved drugs and therapies at the request of patients. It allows hospitals specially designated for clinical research and advanced therapies, upon the request of patients, to apply to the government for approval of the use of drugs and therapies that have not been tested in this country. The health ministry will hand down its decision within six weeks.
When unapproved drugs and therapies have already been used in Japan, regular hospitals can at their patients’ request apply to the designated institutions for approval of the therapies, and the institutions will check the hospitals’ fitness for such treatment. In either case, the patients will pay the full cost for the unapproved drugs and therapies, but the rest of their treatment will be covered by their insurance.
The system may be more convenient for patients seeking unapproved therapies for their ailments, and their cost burden will be mitigated by the partial insurance coverage of their treatment. But there are problems.
It is doubtful whether most patients can accurately understand the latest medical information in other countries. The fact that drugs and therapies have been used in other countries does not vouch for their safety and efficacy for patients here, and questions have been raised whether the shortened period for screening will lead to lax assessments of their potential risks. It will be the patients who bear the brunt of such risks. The responsibility of the doctors, the medical institutions and the health ministry if anything goes wrong needs to be clarified.
The Abe administration pushed for the new system as part of its drive to deregulate medical services. The government reportedly hopes that expanding the scope of mixed medical treatment will encourage the development of new drugs and technologies, thereby invigorating the medical industry.
But there are concerns that mixed treatment will shake the foundation of the public health insurance system — which is designed to ensure that all people receive the same quality of medical services — since it is likely that only wealthy patients will be able to afford costly therapies partially covered by the public insurance. An organization of patients with hard-to-cure diseases voiced opposition to the new system out of concern that the expansion of mixed treatment could make therapies they require unavailable under the public health insurance scheme.
The new system needs to be closely monitored in its implementation to see if such concerns are warranted.