IV 
109TH CONGRESS 
1ST SESSION 
H. CON. RES. 311 
Urging Japan to honor its commitments under the 1986 Market-Oriented 
Sector-Selective (MOSS) Agreement on Medical Equipment and Pharma-
ceuticals, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 7, 2005 
Mr. RAMSTAD (for himself and Ms. ESHOO) submitted the following concur-
rent resolution; which was referred to the Committee on Ways and Means 
CONCURRENT RESOLUTION 
Urging Japan to honor its commitments under the 1986 
Market-Oriented Sector-Selective (MOSS) Agreement on 
Medical Equipment and Pharmaceuticals, and for other 
purposes. 
Whereas the revolution in medical technology has improved 
our ability to respond to emerging threats and prevent, 
identify, treat, and cure a broad range of diseases and 
disabilities, and has the proven potential to bring even 
more valuable advances in the future; 
Whereas medical technology has driven dramatic productivity 
gains for the benefit of patients, providers, employers, 
and our economy; 
Whereas investment from the United States medical tech-
nology 
industry 
produces 
the 
majority 
of 
the
•HCON 311 IH 
$220,000,000,000 global business in development of med-
ical devices, diagnostic products, and medical information 
systems, allowing patients to lead longer, healthier, and 
more productive lives; 
Whereas the United States medical technology industry sup-
ports almost 350,000 Americans in high-value jobs lo-
cated in every State, and was historically a key industry 
that was a net contributor to the United States balance 
of trade, with a trade surplus of over $7,000,000,000 
just four years ago until the surplus became a trade def-
icit of $1,300,000,000, in part due to changes in trade 
balance with Japan; 
Whereas Japan is one of the most important trading partners 
of the United States; 
Whereas United States products account for roughly 1⁄2 of 
the global market, but garner only a 1⁄4 share of Japan’s 
market; 
Whereas Japan has made little progress in implementing its 
commitments to cut product review times and improve its 
reimbursement system in bilateral consultations on policy 
changes under the Market-Oriented Sector-Selective 
(MOSS) Agreement on Medical Equipment and Pharma-
ceuticals, signed on January 9, 1986, between the United 
States and Japan; 
Whereas although regulatory reviews in Japan remain among 
the lengthiest in the world and Japan needs to accelerate 
patient access to safe and beneficial medical technologies, 
recently adopted measures actually increase regulatory 
burdens on manufacturers and delay access without en-
hancing patient safety;
•HCON 311 IH 
Whereas the general cost of doing business in Japan is the 
highest in the world and is driven significantly higher by 
certain factors in the medical technology sector, and inef-
ficiencies in Japanese distribution networks and hospital 
payment systems and unique regulatory burdens drive up 
the cost of bringing innovations to Japanese consumers 
and impede patient access to life-saving and life-enhanc-
ing medical technologies; 
Whereas artificial government price caps such as the foreign 
average price policy adopted by the Government of Japan 
in 2002 restrict patient access and fail to recognize the 
value of innovation; 
Whereas less than 1⁄10 of 1 percent of the tens of thousands 
of medical technologies introduced in Japan in the last 
10 years received new product pricing; 
Whereas the Government of Japan has adopted artificial 
price caps that are targeted toward technologies predomi-
nately marketed by United States companies and is con-
sidering further cuts to these products; and 
Whereas these discriminatory pricing policies will allow the 
Government of Japan to take advantage of United States 
research and development: Now, therefore, be it 
Resolved by the House of Representatives (the Senate 
concurring), That Congress— 
(1) urges Japan to honor its commitments 
under the Market-Oriented Sector-Selective (MOSS) 
Agreement on Medical Equipment and Pharma-
ceuticals, signed on January 9, 1986, between the
•HCON 311 IH 
United States and Japan (hereafter in this resolu-
tion referred to as the ‘‘MOSS Agreement’’), by— 
(A) reducing regulatory barriers to the ap-
proval and adoption of new medical tech-
nologies; and 
(B) meeting or exceeding agency perform-
ance goals for premarket approvals and adopt-
ing an appropriate, risk-based postmarket sys-
tem consistent with globally accepted practices; 
(2) urges Japan to honor its commitments 
under the MOSS Agreement to improve the reim-
bursement environment for medical technologies by 
actively promoting pricing policies that encourage in-
novation for the benefit of Japanese patients and the 
Japanese economy and eliminating reimbursement 
policies based on inappropriate comparisons to mar-
kets outside Japan; and 
(3) urges Japan to honor its commitments 
under the MOSS Agreement by— 
(A) implementing fair and open processes 
and rules that do not disproportionately harm 
United States medical technology products; and 
(B) providing opportunities for consulta-
tion with trading partners. 
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