Japan is taking several steps toward providing patients with better access to innovative technologies, according to a regulatory reform report finalized in June. The progress should help U.S. companies that market devices in Japan.

The U.S.-Japan Regulatory Reform and Competition Policy Initiative was launched in June 2001 to encourage economic growth via regulatory improvements. Part of the fifth annual Report to the Leaders includes commitments from Japan to expedite the review of medical devices to provide the country's aging population with innovative technologies. This year's report was presented to President Bush and Japanese Prime Minister Junichiro Koizumi at the end of June.

Since Japan has been reducing reimbursement on devices that are manufactured by non-Japanese companies, patients in Japan, especially elderly patients, haven't had equal access to new technologies. Japan's senior citizen population is expected to rise from one in five to one in four by 2015, according to the joint report. This makes access to the newest technologies even more crucial.

Japan will be making several pricing and regulatory strides in its efforts to improve device regulations and reimbursement. For example, when making changes to its reimbursement pricing system, Japan's Ministry of Health, Labor, and Welfare (MHLW) will take into account the value and role of innovation in medical devices. It will also give the United States and other countries the opportunity to submit opinions before changes in its rules for establishing reimbursement prices are made.

“We expect the changes in Japan's reimbursement and regulatory systems that are described in the report to enable U.S. companies to provide Japanese patients with faster access to innovative, life-enhancing medical technologies,” says David Bohigian. Bohigian is assistant secretary for market access and compliance at the U.S. Department of Commerce. AdvaMed also commended the measures in the report.

According to the report, the U.S. government opposes a system in which reimbursement prices can change each year. It also wants MHLW to eliminate the Foreign Average Price rule for devices, which sets reimbursement rates based on prices paid for devices in the United States, France, Germany, and the United Kingdom. This rule means that Japanese prices are not based on market factors in Japan.

“We look to Japan to ensure that its reimbursement pricing system rewards the development of innovative pharmaceuticals and medical devices, and that its regulatory system expedites the introduction of such products to patients,” says U.S. trade representative Susan Schwab.

Japan is making progress in improving patient access to innovative technology. However, more needs to be done to reward the development of these products and speed up patient access to devices, commerce officials told MD&DI.

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