Experts reveal plans to end ‘drug loss,’ where medicines approved overseas not used in Japan

TOKYO — A draft interim report by a Japanese government expert panel, which aims to eliminate “drug loss,” a situation in which pharmaceutical products approved overseas are not put to practical use in Japan, was revealed on May 16.

The draft includes the establishment of a one-stop service window to provide consultation and support to overseas start-up companies, a review of the conditions for approval of core clinical research hospitals, and the development of human resources, such as clinical trial coordinators, who will be responsible for international joint clinical trials.

The proposal recognizes that a “paradigm shift” in drug discovery is taking place, with biopharmaceuticals becoming the mainstream and the emergence of drug discovery using artificial intelligence (AI), and that this has led to a decline in international competitiveness within the Japanese pharmaceutical industry.

Citing the strengthening of drug discovery capabilities as an issue, the expert panel noted, “It is essential to have a wide range of related industries that can support and implement drug discovery from the initial stages of research to market sales. The country’s comprehensive strength is being tested.”

The draft then pointed out that there are few start-ups that are responsible for drug discovery at the basic research stage and few human resources in academia for research and development with an eye toward practical application.

In addition to attracting human resources from foreign pharmaceutical companies and U.S.-based venture capital (VC) firms with expertise in practical application, including regulatory approval, to Japan, the panel also mentioned the need for human resource development in Japan and proposed the establishment of a public-private council with foreign pharmaceutical companies and VC firms as members.

It also aims to encourage participation in clinical trials for drug development conducted on an international scale and to attract clinical trials in Japan by establishing a one-stop service window. Furthermore, the requirements for approval as a core clinical research hospital will be reviewed to take into account the results of international joint clinical trials and other activities.

The draft will be finalized at the expert panel’s meeting on May 22.

(Japanese original by Kouki Matsumoto, Lifestyle, Science & Environment News Department)