Effects of Genome-Based Medicine on Japanese Medical Regulation

The advent of genome-based medicine and pharmacogenomics (the medical field that analyzes the reasons why people have different reactions to similar treatment) is expected to transform the medical regulatory environment in Japan. As the human genome is decoded, development of new medicines will be based upon individuals and their unique genetic makeup. Instead of generic drugs, designer drugs developed specifically for individuals will become the norm. Due to these reasons, the current standards for clinical testing for new pharmaceutical products will no longer apply. Instead, testing for the safety and efficacy of a particular drug product would only need to be done on specific groups of people for which the drug was designed rather than on a pool of randomized subjects. Masatoshi Ishizuka, the Director of the Research and Development Promotion Department at the Organization for Pharmaceutical Safety and Research (OPSR) believes that genome-based research will vastly increase the success rate and shorten the time of medical product development in Japan. As a result, costs will be considerably lowered.

Dr. Stefan Wohlfiel, head of Bayer Yakuhin, Ltd.’s research center in Kyoto illustrated this quickening in product development as well as lowered costs when he said, “Our research goal has been to increase yearly CDs [candidate drugs] from two in 1995 to 20 by 2004. This entails increasing productivity by 30% and efficiency by 17% per year while, at the same time, decreasing CD costs by 75%.â€

Although changes are expected to occur in Japan’s regulatory environment due to the advances in genome-based medicines, these changes will not occur at a rapid pace. Hirotaka Yabuki, Vice President of The Boston Consulting Group K.K. believes that the approval process that currently averages 14.7 years “could be reduced by two to three years by a genomics-based approach, such as industrialization of target identification, pharmacogenetics and parallelization of the discovery process.†Even though the speed of regulatory approval may not decrease considerably, the differing quantity and quality of data will facilitate the job of the regulators significantly.