Price Disparity of Medical Devices Between Japan and Foreign Countries
1996年の日本貿易振興会による報告と，1997年の医療経済研究機構による報告を契機に，医療材料の内外価格差問題は活発に議論され，複数の論者によっていくつかの原因が指摘されてきた。公定償還価格制度，立会いなどの付帯的サービス，業界保護的な法規制，暗黙の共謀など種々の原因が挙げられている。厚生労働省は2002年に外国価格参照制度を導入し，内外価格差の是正を試みた。しかし，2007年に出版された２つの報告によれば，内外価格差は上記の制度導入後も依然として存在していた。内外価格差を抜本的に解消する手段として，高額医療材料のコストを手技料に包括すること，薬事法規制改革による承認番号制度の見直し，行過ぎた立会いの是正などが重要と考えられる。
Price differences between Japan and the US for medical materials and how to reduce them.
INTRODUCTION
Previous reports (1996, 1997) have revealed that the market prices of medical materials in Japan were two to four times higher than those in the US. The Japanese government introduced the foreign price adjustment rule (FPA) in 2002 to reduce reimbursement prices in Japan. We aimed to investigate the current price differences between Japan and the US in the first half of 2005 and to evaluate the effectiveness of the FPA.


METHODS
The investigation was performed at two joint purchasing organizations (JPO) and a hospital group in the US, and at a university hospital in Japan. Forty-one items in 14 categories were selected in advance.


RESULTS
The price ratio (Japanese price/US price) was largest at 4.5-6.8 for percutaneous transluminal coronary angioplasty (PTCA) balloon catheters and 1.4-6.0 for vascular grafts. The price ratio was smallest at 1.2-2.4 for automatic sutures, 1.4-1.6 for Swan-Ganz catheters, and 1.5-2.3 for mechanical valves.


DISCUSSION
The price differences between Japan and the United States were found to have rather widened with the exception of the pacemaker, because their market prices decreased more markedly in the United States. The investigation suggests several problems with the FPA: (1) the determination process of reimbursement prices is inappropriate, which has made the Japanese market less competitive, (2) the FPA needs too much time for the resolution of price differences, and (3) price data collected according to the FPA lacks strictness.


CONCLUSIONS
The high prices of medical material in Japan need to be adjusted down with more appropriate measures such as the full cost or cost inclusion methods.
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