Japan needs speedier approval for medical devices
Last Updated: 2007-04-16 16:43:09 -0400 (Reuters Health)
By Aiko Wakao
TOKYO (Reuters Life!) - Japan is known the world over for its hot technology like portable game players and fuel-efficient cars, but its hospitals lack state-of-the-art medical equipment widely available elsewhere.
A sluggish and cumbersome regulatory process has delayed the sale of many medical devices in Japan compared to the rest of the world, and it may put off global makers from making further inroads in the future, says Dr. Huimin Wang, chair of medical devices committee at the American Chamber of Commerce in Japan.
Japanese citizens have enjoyed low-cost, universal medical care, contributing to the longest life expectancy in the world, but not many are aware that devices used at their local hospitals are typically a few generations behind the global standards, and some of world's newest technologies haven't yet been approved.
"A few years ago, some travel agencies were advertising a tour to South Korea where people could get PET (positron emission tomography) scans since they weren't available here," Wang said in an interview.
American firms like Johnson & Johnson and Boston Scientific are submitting fewer products for approval in Japan because the process takes three times longer than in their home market, the U.S. International Trade Commission said in a recent report.
But experts said the tight rules for Japan's 2.4 trillion yen ($20 billion) medical tool market is not an example of protectionism, as domestic makers such as Terumo Corp. and Olympus Corp. are subject to the same lengthy process.
"We think it's a serious problem too," said an executive of a Japanese medical equipment maker. "If the system doesn't change, our medical industry is going to collapse, and Japan won't be able to offer quality medical care for its citizens."
In Japan, inspection for drugs and medical tools is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), but the number of experts in the Japanese body is about a tenth the number in the U.S. Food and Drug Administration.
NEED FOR NEW TALENT
The number of inspectors for medical gear in Japan stood at 27 as of March 31, less than a fifth of all PMDA staff, and one twelfth the number of device inspectors in the United States.
Japan's total health-care cost is about 30 trillion yen, with about 25 percent of it spent on drugs and 8 percent on devices. The rest goes to pay hospitals and physicians.
Another factor slowing the approval of new devices is that many of the inspectors are trained as physicians or pharmacists and lack expertise in biotechnology or information technology.
"We're trying to hire more staff at PMDA but it's not easy," an official at the Ministry of Health, Labour and Welfare said.
While revisions made to Pharmaceutical Affairs Law that took effect in 2005 simplified the approval for less-advanced devices, they made the process more difficult and costly for more invasive products such as implants.
"The regulatory change was a mix of tightening and easing," the official said. "We're now aiming to become more flexible in some categories in the future."
The ministry is mapping out new guidelines for a speedier process for next-generation tools that are expected to be in high demand, such as robots used in surgery and artificial bones.
PRICING PRESSURE
But whether foreign makers can earn an attractive return on their investments in Japan remains unclear as local prices are set by regulators who base them on the average of global prices.
The current pricing method "does not reflect the reality of the Japanese market," Wang says. "Pricing pressures have been getting worse in Japan."
It took Cook Medical Inc., the world's top private medical gear maker, five years to win approval for its endograft devices, used to treat swollen abdominal arteries as an alternative to open surgery.
The product, which was approved in Europe in 1998, is the first of its kind to be sold in Japan from this month.
Barry Thomas, a Cook manager in charge of endovascular therapies division, said he had hoped the Japanese price would be close to double the world average where the product has been available for years, but the price set by the regulators was 1.62 million yen, just 16 percent above the U.S. price.
Wang, who is also vice president of heart valve maker Edwards Lifesciences' Japan unit, said it's costly for his firm to handle an older-generation product in Japan that it no longer sells anywhere else.
"Foreign makers may end up not coming to Japan if regulators continue to set prices at a level that don't take into account the high costs of entry into this market," said Takao Ohki, chairman and professor of surgery at Jikei University School of Medicine.
