Prime Minister Shinzo Abe has announced a plan to expand so-called mixed medical treatments (kongo shinryo), in which drugs and medical technologies not covered by public health insurance are used along with those that are. The new policy, to go into force in fiscal 2016 at the earliest, may help some patients who want to try and can afford to pay for new drugs and treatment methods, although the risk of safety problems may persist.
The Abe administration sees the expansion of mixed treatment as a key component of its economic growth strategy, hoping that businesses will increase investment in the development of advanced medical care. But this policy could result in more drugs and treatment methods that fall outside price controls of the public health insurance system and are out of reach for low-income patients. That would distort the nature of Japan’s medical services. The administration needs to realize that health care is not an industry but rather a social service to which every citizen is entitled.
The health insurance system covers drugs and medical technologies only after their safety and efficacy have been confirmed. To protect patients, the health and welfare ministry prohibits mixed medical treatments in principle. If patients opt for mixed treatment, they are currently required to shoulder the full cost of the drugs and technologies already approved and covered by public health insurance, in addition to paying the full cost of services not covered by the system. Under the plan pushed by the Abe administration, the full-payment principle will be applied only to drugs and medical technologies not covered by the health insurance system.
Under the plan, patients may take the initiative of applying for mixed treatments. The most likely requests would be for drugs already approved and used abroad but not yet authorized under Japan’s health insurance system.
At present, requests to receive mixed treatments typically take six to seven months for approval. The new policy will shorten the period to within six weeks.
For mixed medical treatments that have no precedents and may carry risks, hospitals designated as core institutions for clinical trials, which number 15 nationwide, will receive applications. A government panel of experts will examine them and decide within six weeks whether the requests should be accepted. Patients will receive the treatments at the core hospitals. For mixed treatments that have precedents, core hospitals that carried them out in the past will decide within two weeks whether patients’ requests should be approved. If they are approved, patients can receive the mixed treatments at local hospitals.
There are some problems with the new policy. It has not yet been decided what qualifications are required to be a member of the government panel. There is no guarantee that six weeks will be long enough to verify the safety of mixed medical treatments. It is also unclear who would pay the cost of dealing with the possible side effects from mixed treatments. If the costs are paid out of public health insurance, the financial burden on participants in the system will increase.
It is imperative that the government incorporate drugs and medical technologies repeatedly used in mixed medical treatments — and confirmed to be safe and effective — into the public health insurance system so that their benefits are accessible for a larger number of patients at reasonable prices.