[Congressional Record Volume 149, Number 162 (Monday, November 10, 2003)]
[Senate]
[Page S14364]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         SUBMITTED RESOLUTIONS

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SENATE CONCURRENT RESOLUTION 80--URGING JAPAN TO HONOR ITS COMMITMENTS 
  UNDER THE 1986 MARKET-ORIENTED SECTOR-SELECTIVE (MOSS) AGREEMENT ON 
     MEDICAL EQUIPMENT AND PHARMACEUTICALS, AND FOR OTHER PURPOSES

  Mr. COLEMAN (for himself and Mr. Bayh) submitted the following 
concurrent resolution; which was referred to the Committee on Foreign 
Relations:

                            S. Con. Res. 80

       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 
     $175,000,000,000 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 1,000,000 Americans in high-value jobs 
     located in every State, and the industry is a net contributor 
     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 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, 
     proposals currently under consideration in Japan would, in 
     many cases, actually increase regulatory burdens on 
     manufacturers and delay access without enhancing patient 
     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, 
     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 United States companies and is 
     considering 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 Senate (the House of Representatives 
     concurring), That Congress--
       (1) urges Japan to honor its commitments under the Market-
     Oriented Sector-Selective (MOSS) Agreement on Medical 
     Equipment and Pharmaceuticals, signed on January 9, 1986, 
     between the United States and Japan (hereafter in this 
     resolution referred to as the ``MOSS Agreement''), by--
       (A) reducing regulatory barriers to the approval and 
     adoption of new medical technologies; and
       (B) establishing reasonable agency performance goals for 
     premarket approvals and an appropriate, risk-based postmarket 
     system consistent with globally accepted practices;
       (2) urges Japan to honor its commitments under the MOSS 
     Agreement to improve the reimbursement environment for 
     medical technologies by actively promoting pricing policies 
     that encourage innovation 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 consultation with trading 
     partners.

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