Japan trails in new drug trials

Japan ranks far behind other countries in clinical trials for new drugs, according to a survey conducted by the Office of Pharmaceutical Industry Research. Japan ranked 24th worldwide in the number of international joint clinical trials necessary to approve new drugs.

Consequently Japan has a “drug lag.” Approval of drugs takes much longer than in many other countries.

The survey found that between 2008 and 2012, Japan conducted fewer joint clinical trials than almost every other developed country.

Japan’s 358 trials put it at the same level as India, far below 13th-ranked South Korea and even farther behind the top three countries, the United States with 1,630 trials, Germany with 1,209 and Canada with 1,003. The problem is not size of the population, since Canada’s total population is about the same as the greater Tokyo area, and Germany has two-thirds the population of Japan.

South Korea, with a population of roughly 50 million, conducted 553 trials. Japan is simply not conducting trials, despite the fact that Japan is the world’s second-largest drug market, after the U.S.

Consequently Japanese patients may not be getting access to potentially effective medicines. If Japan does not increase efforts to ensure that the best medicines are available, Japan’s health care system, one of the most commonly used institutions in the country, will fall behind.

The reality is that Japan is simply not testing enough new drugs that may hold the potential to cure diseases, treat symptoms and improve the health of citizens.

The issue is particularly urgent as Japanese society continues to have a larger and larger percentage of elderly people. Many new drugs will be needed to treat the health problems that accompany the aging process. The process of setting up trials, following through with them and seeking approval is also a long one, especially in Japan.

Japan has fallen behind not because of being reasonably cautious in approving potentially dangerous drugs. Part of the problem is that Japan’s health care system is highly decentralized, a positive point in terms of neighborhood access to clinics and hospitals, but a negative one when it comes to collecting data and conducting larger trials.

Decentralization is said to add to the difficulties, and the costs are more expensive in Japan. The government should improve the feasibility and efficiency of conducting more trials.

Japan’s failure to hold sufficient numbers of clinical drug trials may also be another example of the inward turn of society. But with drug trials, Japan needs to turn outward and work together with other countries to expand the development of potential treatments that may be of tremendous benefit to people and help keep the standards of Japanese health at a high level.