New Pharmaceuticals Overseas: Change Situation in Which Foreign Drugs are Not Available in Japan

Editorial

17:01 JST, July 28, 2025

If groundbreaking new drugs are available overseas but cannot be used in Japan, it puts many patients at a disadvantage. This situation must be changed immediately.

Cases referred to as “drug loss,” in which pharmaceuticals newly approved in other countries do not become available in Japan, are increasing.

For some time now, new drugs developed by overseas pharmaceutical companies have tended to face delays in being introduced to Japan, due to this country’s complicated application procedures for approval and additional clinical trials targeting Japanese patients. This problem has been dubbed “drug lag.”

The government’s efforts to proceed with measures, such as strengthening its review capabilities, have reduced delays. Instead of drug lag, however, there is now an increase in cases of drug loss. This is because more overseas companies have not even applied for approval of their products in Japan in recent years, making the situation even more serious.

Behind this lies a drastic change in development methods for pharmaceuticals.

Advances in life sciences have led to the production of complex biopharmaceuticals using genes and cells, shifting the primary developers from major pharmaceutical manufacturers to emerging companies. Many of them are small businesses, so they are not adequately established to expand globally.

Furthermore, in Japan, there is a strong tendency to lower the prices of drugs to curb medical expenses. This may lead many overseas drugmakers to make a business decision that there is little advantage to paying the high costs required to enter the Japanese market.

Traditionally, drug loss has been conspicuous for rare ailments and pediatric diseases. However, now that the problem will likely expand to more common diseases such as breast cancer and diabetes, it is feared that patients in Japan will be unable to widely benefit from new drugs that are available overseas.

To bring drugs developed overseas to Japan, it is necessary to provide more information to drugmakers and lower hurdles to applying for approval in Japan. To support U.S. companies in their applications, the Health, Labor and Welfare Ministry has established an office in the United States to assist them with the review process.

It is also essential to establish a system that maintains prices that reflect the value of new pharmaceuticals. In addition to attracting overseas makers, this would also promote technological innovation in the pharmaceutical industry as a whole.

However, public health cannot be steadily protected in Japan through an approach that relies on overseas companies. It is necessary to increase the number of new drugs originating in Japan. Japan’s research capabilities are not low, but universities and other institutions find it difficult to directly link their research results to businesses, and this environment is hindering the improvement of pharmaceutical development capabilities.

In the United States, many universities, startups and investors are concentrated in Boston to work together to produce a steady stream of new drugs. In Japan as well, it is important to create a similar hub, described as an ecosystem, for advanced academic-industrial collaboration.

(From The Yomiuri Shimbun, July 28, 2025)