Urges Japan to honor its commitments under the Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and Pharmaceuticals by: (1) reducing regulatory barriers to the approval and adoption of new medical technologies; (2) meeting or exceeding agency performance goals for premarket approvals and adopting an appropriate, risk-based postmarket system consistent with globally accepted practices; (3) promoting pricing policies that encourage innovation and eliminating reimbursement policies based on inappropriate comparisons to markets outside Japan; (4) implementing fair and open processes and rules that do not disproportionately harm U.S. medical technology products; and (5) providing opportunities for consultation with trading partners.
[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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Ways and Means.
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