AdvaMed Leadership Urges Japanese Officials to Speed Access to New Technology

The Advanced Medical Technology Association (AdvaMed), based in Washington, D.C., issued the following news release regarding medical device approval in Japan:

AdvaMed Chairman James V. Mazzo, President of Abbott Medical Optics, and Stephen J. Ubl, AdvaMed President and CEO, completed a successful series of meetings in Tokyo recently with senior Japanese officials to urge the government to adopt policies that would expedite patient access to innovative medical devices and diagnostics.

The meetings focused on ways Japan could improve its regulatory and reimbursement systems, which delay by several years Japanese patient access to medical technology available in the EU and U.S. Mazzo and Ubl highlighted that Japan’s policies are inconsistent with the Government’s “New Vision for the Medical Device and Medical Technology Industry” of encouraging a vibrant domestic medical technology industry.

“Japan is AdvaMed member companies’ largest market outside the U.S., but we are very concerned about policies that inhibit innovation in the medical technology industry for both U.S. and Japanese firms,” Mazzo said. “U.S. firms make a substantial contribution to Japan’s economy, employing more than 13,000 people, and some are considering whether they can afford to remain in Japan. In the end, it is Japanese patients who suffer when they cannot receive the most advanced therapies available.”

“Despite some recent improvements, Japan’s medical device approval process is still considered the most burdensome in the world,” Ubl said. “When you combine a difficult regulatory system with uncertain reimbursement rules – that are based not on the high costs of doing business in Japan but on comparisons with prices in completely unrelated foreign markets – it is easy to see why our members are increasingly passing Japan by.”

While in Tokyo, the AdvaMed leaders met with 21 members of the Japanese Diet; Seiji Maehara, the Minister of Foreign Affairs; the Senior Vice Minister of Health and Welfare Yoko Komiyama; the Chief Executive of the Pharmaceuticals and Medical Devices Agency, Tatsuya Kondo, as well as other senior government officials responsible for determining the country’s regulatory and reimbursement policies.

“Our meetings this week were very productive,” Mazzo added, “and we look forward to working with officials in Japan to ensure that regulatory and reimbursement policies are in place that facilitate Japanese patient access to the most safe and effective medical devices and diagnostics available.”