[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. Con. Res. 80 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
S. CON. RES. 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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 10, 2003

    Mr. Coleman (for himself and Mr. Bayh) 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 $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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