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Ministry may grant patients in dire need access to unapproved drugs

Kyodo

The health ministry is planning to allow the use of drugs in the final clinical testing phase but not yet officially approved for cancer and other critically ill patients starting in fiscal 2015 if there is no alternative treatment.

This is in response to strong requests by people who have not been able to participate in clinical trials of pre-approved drugs that might benefit them, because of their age, disease history and other factors, ministry sources said.

Some patients are also importing drugs approved in other countries but not in Japan through hospitals and clinics and asking the government to approve the use of such drugs in Japan.

The Health, Labor and Welfare Ministry is considering allowing physicians to undertake clinical trials in which drugs in the final phase of clinical testing by pharmaceutical companies may be tried on patients.

A doctor would be required to present a treatment plan to the government and follow regulations set out by the ministry.

Initially, the ministry is mulling starting the plan with anti-cancer drugs, the sources said. A pilot project has already been implemented at the National Cancer Center.

Before starting a full-scale project in fiscal 2015, the ministry will decide on what drugs to be added and whether they should be provided for free, the sources said.