Japan to allow some hospitals to use drugs tested in U.S., Europe

TOKYO, June 16 Kyodo -
The Japanese government is planning to allow selected health care institutions
in the country to use anticancer treatments and other medications as well as
medical devices approved in the United States and European countries,
government sources said Tuesday.
The plan, expected to be included in the government's economic growth strategy,
aims to address the problem of the lag until such foreign-approved medications
and devices are authorized for use in Japan, the sources said. Japan has been
criticized for particularly extended lags.
While the plan may give hope to patients who are waiting for new therapies, it
may face opposition from the Japan Medical Association, which represents
doctors, who have concerns about the safety and efficacy of such drugs and
equipment.
The plan envisages designating by 2020 some 200 institutions where
foreign-approved drugs and devices may be used for treatment at the discretion
of staff at each institution. Costs would be borne basically by patients.
The so-called drug or device lag in Japan is believed to be one of the longest
in the world. Foreign drugs are estimated to require around 3.9 years on
average for approval in Japan.
Extended periods for screening and clinical testing are cited among the reasons
for slow approvals in Japan.
The growth strategy is also expected to feature plans to encourage developments
by Japanese manufacturers of drugs and healthcare devices to create a 750
billion yen market and to promote regenerative medicines to expand to a 50
billion yen market.
==Kyodo