[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H. Con. Res. 311 Introduced in House (IH)]







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 
                Pharmaceuticals, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            December 7, 2005

    Mr. Ramstad (for himself and Ms. Eshoo) submitted the following 
concurrent 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 technology industry produces 
        the majority of the $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 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 deficit 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 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;
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 United States 
        companies and is considering 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 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) meeting or exceeding agency performance goals 
                for premarket approvals and adopting 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 eliminating reimbursement policies 
        based on inappropriate comparisons to markets 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 consultation with 
                trading partners.
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