A regular press conference Comments by Dr.Aoki,President

At a regular press conference held on May 27, JPMA president Dr. Hatsuo Aoki commented on issues within the pharmaceutical industry. His comments are summarized as follows:

Over the past year, we have endeavored to improve the social environment to conduct clinical trials more efficiently, counteracted revisions to the Pharmaceutical Affairs Law, and promoted international alliances and publicity activities. Now, I wish to fortify the presence of the Japanese Pharmaceutical industry as a leading industry globally through the creation of innovative drugs and the contribution to global healthcare.

There are many challenges and issues to be dealt with; however, I will concentrate on the issues that are of high priority.

In regard to clinical trial of new drugs in Japan, the number of initial clinical trial notifications to the Pharmaceuticals and Medical Devices Agency (PMDA) has drastically decreased in recent years and the expected number of upcoming new drugs to be launched does not look favorable. There have been the widening differences in R&D expenditure between the US and Japan and it has been pointed out that the clinical research in Japan is "hollowing out" as revealed by the large number of initial human trials being conducted first in foreign countries. The "4th survey of public perception on the pharmaceutical industry in 2005", periodical survey conducted every three year by the Public Affairs Committee of JPMA, indicates that 85.4% of the people responded negatively to the question "How do you feel about the situation that the new drug R&D is recently more advanced in foreign countries than in Japan?" This result implies that the general public recognizes the importance of conducting clinical and other types of research of new drugs in Japan. I plan to exert my utmost efforts to better organize and strengthen the environment in order to accelerate the research of innovative drugs.

Concerning the issue of drug pricing in Japan, I consider it necessary to have a reimbursement system that better reflects the drug's innovative value, as well as their global appraisal and contribution to global healthcare. The ratio of drug costs to total medical expenditure is approximately 20% in recent years. I wish strongly to secure this ratio in order to ensure the source of revenue for new drug innovation. In July this year, JPMA will complete drafting its plan on the direction of the future drug pricing system in Japan.

I think Japan, as one of only 7 main countries that create new drugs in the world, has an obligation to continue to contributing to global healthcare. I wish to fortify the presence of JPMA as representative of one of the leading industries by contributing to the global healthcare through supplying innovative drugs originated in Japan.