IV 
108TH CONGRESS 
1ST SESSION 
H. CON. RES. 324
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 
NOVEMBER 12, 2003
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 324 IH 
$175,000,000,000 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 1,000,000 Americans in high-value jobs lo-
cated in every State, and the industry is a net contrib-
utor to the United States balance of trade, with a trade 
surplus of $3,300,000,000; 
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 1⁄3 share of Japan’s 
market; 
Whereas Japan has made little progress in implementing its 
commitments to cut product review times, improve their 
reimbursement system, and consult bilaterally 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, 
proposals currently under consideration in Japan would, 
in many cases, actually increase regulatory burdens on 
manufacturers and delay access without enhancing pa-
tient safety; 
Whereas the general cost of doing business in Japan is 
among the highest in the world and is driven significantly 
higher by certain factors in the medical technology sector,
•HCON 324 IH 
and inefficiencies 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-enhancing 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 at technologies predomi-
nately marketed by United States companies and is con-
sidering altering pricing rules to enable further cuts to 
these products; and 
Whereas these discriminatory pricing policies will allow the 
Japanese government 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 
United States and Japan (hereafter in this resolu-
tion referred to as the ‘‘MOSS Agreement’’), by—
•HCON 324 IH 
(A) reducing regulatory barriers to the ap-
proval and adoption of new medical tech-
nologies; and 
(B) establishing reasonable agency per-
formance goals for premarket approvals and an 
appropriate, risk-based postmarket system con-
sistent 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 
(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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