Medical Device Trade in Foreign Markets -- Investigation
BY HUYEN NGUYEN, APRIL 5, 2006
The U.S. International Trade Commission (ITC) issued a press release yesterday announcing the launch of a fact-finding investigation into conditions affecting U.S. trade of medical devices and equipment in principal foreign markets, particularly the Japanese market.
The House Ways and Means Committee has requested the ITC to look into the most recent five-year data on regulatory issues affecting U.S. sales and trade of medical devices and equipment in Japan and other foreign markets. The focus of the investigation will be on U.S. device exports and compare Japan's regulatory conditions to other foreign markets for U.S.-made devices.
According to Pacific Bridge Medical, a medical consulting firm for the Asian market, in 2000, Japan generated $23.4 billion in medical devices sales, second largest in the world behind the U.S. Over the next few years the U.S. import growth rate for medical devices in Japan is estimated to increase by 5-10%. With the current Japanese population reaching 127 million and 20% are over 65 years of age, opportunities for U.S. medical device makers are tremendous.
Unlike the United States, Japan currently has a universal healthcare coverage that covers the entire population. Since its aging population is on the rise, healthcare expenditures will continue to climb and this will become a social and economic problem. With U.S. device makers trying to enter this market, it seems that the Japanese government is "imposing more burdensome and costlier regulations [that] translate to higher costs for the medical technology industry", according to Avamed's Chairman, Michael Mussallem.
The announcement of this investigation was a result of a letter which was received by ITC on March 9, 2006. ITC will provide a report to the Committee by March 9, 2007. A public hearing will be conducted on July 11, 2006 at 9:30AM.
