The higher costs associated with conducting clinical trials in Japan is forcing many of Japan’s top pharmaceutical manufacturers to perform their clinical studies in other countries. This has resulted in the reduction of the number of clinical trials performed in Japan. Contract Research Organizations (CROs) are seeing their market shrinking as more companies opt for clinical trials overseas.
For example, Japan’s number one pharmaceutical manufacturer, Takeda Chemical Industries, as well as another top drug maker, Yamanouchi Pharmaceutical Co., have been conducting their clinical trials overseas for their key drug development. Costs for late stage clinical trials in Japan can cost between two to four times more than in other countries. Yamanouchi’s Director of Drug Development, Shinji Usada said, “None of our new drugs undergo clinical trials in Japan before the United States or Europe.”
A major factor contributing to the high costs of clinical trials in Japan is the lack of willing patients for clinical studies. Compared to 10 willing patients in one particular disease area in the United States, the Japan Pharmaceutical Manufacturers Association (JPMA) found there was only one Japanese patient willing to be tested for a new drug. In some other disease areas, the ratio grew to 18 willing US patients to one willing Japanese patient.
In order to promote clinical trials in Japan, the Ministry of Health, Labor, and Welfare (MHLW) is trying to implement networks to assist companies conducting clinical trials. Mitsue Hirota, R&D Division Deputy Director of the MHLW stated, “We aim to create a useful medical network to help speed up clinical trials for new drugs, which in turn will lower costs.” Japan’s revised Pharmaceutical Affairs Law (PAL) will also enable doctors and medical institutions to conduct clinical trials utilizing non-approved products or medical products for their own “personal” use. Data obtained from clinical trials utilizing these non-approved products for personal use will be admissible for future registration of the product, thus, facilitating the drug’s registration and approval process. Drugs which are deemed necessary for certain patients but have not received approvals due to the high costs to perform clinical trials are also expected to gain approval under the new regulations.
However, drug makers are doubtful that the current initiatives taken by the Japanese government would do much to help alleviate costs relating to clinical trials. Thus, many pharmaceutical manufacturers in Japan will continue to focus on drug development overseas.