Joseph Damond, senior vice president for International Affairs at the Biotechnology Innovation Organization (BIO), released the following statement in response to recent developments in Japan’s reimbursement and pricing system:

“As the world’s largest organization representing biotechnology innovators, including academic institutions, startup enterprises, and biopharmaceutical companies of all sizes in more than 30 countries around the world, BIO regrets recent developments in Japan’s reimbursement and pricing system that make it less predictable and more risky for innovators.

“In recent years, BIO has praised initiatives in Japan that have improved its regulatory regime for new medicines as well as improved the climate for biotechnology research, development and innovation. Thus, it is disappointing to learn of recent instances of ad hoc decisions to modify prices of innovative medicines, which undermine the predictable and relatively stable rules-based system in place. BIO understands the fiscal pressures that contributed to these decisions, but believes that such issues should be treated in a holistic and deliberative manner, both to ensure that patients are not hurt by unintended consequences of decisions and that the progress Japan has made in improving incentives for biomedical research is not undermined.

“With other relevant stakeholders in Japan, BIO stands ready to work with the Government of Japan to help establish policies that promote public health and access to innovative medicines, while advancing the progress of biopharmaceutical innovation in Japan.”