From the "Annual Reform Recommendations from the Government of the United States to the Government of Japan under the U.S.-Japan Regulatory Reform and Competition Policy Initiative"
December 5, 2006
Annex - 13
MEDICAL DEVICES AND PHARMACEUTICALS
I.
Changes in Japan’s Healthcare System. Japan faces dual challenges of limited
healthcare resources and aging populations. The United States has similar concerns.
Given our similar objectives and challenges,
the United States encourages the
Government of Japan and its advisory bodies to fully consider input from industry,
including U.S. industry, before making healthcare system changes.II.
Medical Device and Pharmaceutical Pricing Reform and Related Issues. The
Government of Japan is studying ways to limit medical spending growth, including
changes to reimbursement pricing systems for medical devices and drugs.
The United
States urges Japan to consider the budgetary and health benefits of pricing systems that
reward development of innovative products, and to take the following actions:
A. Pharmaceuticals.
1.
Improve transparency and industry’s ability to offer input by:
a.
Allowing a representative of the U.S.-research-based drug industry
to be a member of Chuikyo</i>’s Drug Pricing Expert Subcommittee;
and
b.
Sending Ministry of Health, Labor and Welfare (MHLW) pricing
recommendations to applicants well before the first Drug Pricing
Organization (DPO) meetings and ensuring DPO fully explains its
positions at such meetings.
2.
Implement as an alternative to the current pricing methods for new drugs a
flexible pricing method by which pricing authorities evaluate data
provided by applicants to assess the drugs’ long-term value to Japan.
3.
Use mid-points of premium ranges as defaults when granting premiums.
4.
Abolish the re-pricing criteria for market expansion based on the sales of a
product or its comparator for both a product’s initial indication and for
additional indications.
5.
Reverse the April 2006 revisions to the Foreign Price Adjustment rule for
drugs, including the change by which the rule will no longer be applied in
cases where only one foreign price is available.
6.
Refrain from implementing annual price revisions, which would
discourage the introduction of innovative drugs in Japan.
7.
Allow U.S. industry to present views directly to MHLW’s Council for
Improvement in the Distribution of Ethical Drugs (Ryukaikon) on issues
such as bulk-buying contracts.
PDF:
http://www.ustr.gov/assets/World_Regions/North_Asia/Japan/Regulatory_Reform_Initiative/asset_upload_file168_8516.pdfThere's all kind of other "advice" ostensibly from our government, but seemingly directly from the corporations, telling Japan to privatize and model its economy on the US one - as though the US one works well for its citizens...
The health care bit struck me the most - as though the US, with its failed, HORRIBLE, exorbitantly expensive and failed non-health-care system that serves only the top 60% of citizens, has ANY business advising ANY civilized country about health care! And they even insist on the right for US health care gouger corps to have a say on any changes to the Japanese system.
Hands off! F*CKWADS. The system here is far superior to the US one. Nobody here wants anything like the US system.
What nerve. :puke: