III 

109TH CONGRESS 

1ST SESSION S. CON. RES. 67 

Urging Japan to honor its commitments under the 1986 Market-Oriented 

Sector-Selective (MOSS) Agreement on Medical Equipment and Pharmaceuticals, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 18, 2005 

Mr. COLEMAN submitted the following concurrent resolution; which was 

referred to the Committee on Foreign Relations 

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 technology industry produces the majority of the 
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$220,000,000,000 global business in development of medical devices, diagnostic products, and medical information 

systems, allowing patients to lead longer, healthier, and 

more productive lives; 

Whereas the United States medical technology industry supports almost 350,000 Americans in high-value jobs located in every State, and was historically a key industry, 

as it was a net contributor to the United States balance 

of trade with Japan, which was a trade surplus of over 

$7,000,000,000 in 2001, and continued to be a surplus 

until 2005, when the trade balance became a trade deficit 

of $1,300,000,000, due in part to changes in the policies 

of Japan that impact medical devices; 

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 

their reimbursement system in bilateral consultations on 

policy changes under the Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and 

Pharmaceuticals, 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 enhancing patient safety; 
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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 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 toward technologies predominately marketed by companies from the United States 

and is considering further cuts to these products; and 

Whereas these discriminatory pricing policies will allow the 

Japanese Government to take advantage of research and 

development from the United States: Now, therefore, be 

it 

1 Resolved by the Senate (the House of Representatives 

2 concurring), That Congress— 

3 (1) urges Japan to honor its commitments 

4 under the Market-Oriented Sector-Selective (MOSS) 

5 Agreement on Medical Equipment and Pharma6 ceuticals, signed on January 9, 1986, between the 
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1 United States and Japan (in this resolution referred 

2 to as the ‘‘MOSS Agreement’’), by— 

3 (A) reducing regulatory barriers to the ap4 proval and adoption of new medical tech5 nologies; and 

6 (B) meeting or exceeding agency perform7 ance goals for premarket approvals and adopt8 ing an appropriate, risk-based postmarket sys9 tem consistent with globally accepted practices; 

10 (2) urges Japan to honor its commitments 

11 under the MOSS Agreement to improve the reim12 bursement environment for medical technologies by 

13 actively promoting pricing policies that encourage in14 novation for the benefit of Japanese patients and the 

15 Japanese economy and eliminating reimbursement 

16 policies based on inappropriate comparisons to mar17 kets outside Japan; and 

18 (3) urges Japan to honor its commitments 

19 under the MOSS Agreement by— 

20 (A) implementing fair and open processes 

21 and rules that do not disproportionately harm 

22 medical technology products from the United 

23 States; and 
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1 (B) providing opportunities for consulta2 tion with trading partners. 

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