*EPF412 07/20/00
Text: Acting Commerce Secretary Mallett on Japan's Deregulation
(News release, fact sheet on market access, health industry) (880)
On July 19, Acting Commerce Secretary Robert L. Mallett welcomed the Japanese Government's decision to adopt new deregulation measures designed to improve market access for the American health industry.
Japan is the world's second largest market for medical devices, pharmaceuticals, and nutritional supplements. Deregulation, according to Mallett, will give the Japanese people greater access to innovative American products and improve the business climate for U.S. manufacturers.
Following is the text of the press release followed by the fact sheet:
(begin press release)
COMMERCE NEWS
United States Department of Commerce
July 19, 2000
Acting Commerce Secretary Mallett Welcomes Japan's Announcement
to Open Markets for U.S Health Industry
Washington, D.C. -- Acting Commerce Secretary Robert L. Mallett today welcomed the Japanese Government's announcement of important new deregulation measures designed to improve market access for U.S. medical devices, pharmaceuticals, and nutritional supplements.
"These measures create a win-win situation for the U.S and Japan," Mallett said. "The Japanese people will stand to benefit from these innovative products, and U.S. manufacturers stand to gain further access and the opportunity to compete in one of the largest markets for these products."
As the world's second largest market for medical devices, pharmaceuticals, and nutritional supplements, Japan's plans to deregulate and reform this sector are of great interest to both countries. Japan has agreed to take important measures to address key U.S. concerns in this sector that include:
-- Offering, beginning October 2000, an unbiased and transparent appeals mechanism for medical device and pharmaceutical pricing decisions;
-- Working to increase the availability of innovative products through its pharmaceutical pricing reform process;
-- Implementing, in October 2000, a transparent and expeditious process to create new medical device pricing categories while providing appropriate provisional prices. This process will involve taking appropriate steps to absorb excessive price changes from restructured categories.
-- Taking specific steps to improve the transparency and speed of the medical device and pharmaceutical approval processes, including increasing the use of foreign clinical data;
-- Abolishing restrictions on shape and maximum daily intakes of several common vitamins and minerals, and allowing manufacturers to make nutritional and health benefit claims
The Department of Commerce leads the U.S. Government's medical device, pharmaceutical, and nutritional supplements market access effects through the Market Opening Sector Selective (MOSS) and the Enhanced Initiative on Deregulation and Competition Policy.
"Agreement on these measures are a direct result of the strong working relationship that the Department shares with Japan's Ministry of Health and Welfare," Mallett said. "We look forward to continuing our positive bilateral engagement."
(end press release)
(begin fact sheet)
MEDICAL DEVICE AND PHARMACEUTICAL DEREGULATION FACT SHEET
Pricing Problems: Medical devices and pharmaceutical pricing decisions under Japan's universal national health insurance scheme often lack transparency, are slow, fail to appropriately reflect improvements, and the means of challenging an unfavorable pricing decision are unclear.
Solution: In October 2000 Japan will create an appeals mechanism for medical device and pharmaceutical pricing decisions that will be heard and decided in a transparent and unbiased manner by an independent body of experts of balanced membership who have objective scientific experience. Also, Japan will implement a transparent and expeditions process to create new medical device pricing categories to appropriately reflect product improvements and provide appropriate provisional prices within 4 months. On implementing Japan's restructuring plan, appropriate steps will be taken to absorb excessive price changes.
With the aim of finalizing measures by April 1, 2002, Japan will continue to study drug pricing and discuss the scientific basis for product evaluation with U.S. industry. Japan has recognized the role of the market, the need to promote innovation, and to increase the availability of innovative products which bring more effective and cost-efficient treatments to patients.
U.S. industry will have meaningful input into Japan's medical device and pharmaceutical pricing reform processes as proposals for improvements are developed and implemented. The United States will continue to work with Japan to ensure that these processes are transparent, recognize the value of innovation, and do not to place disproportionate burdens on U.S. products.
Regulatory Problems: Delays in approving new medical devices and pharmaceuticals cause cost burdens not only on manufacturers but also on the Japanese health care system.
Solution: The approval processing period for new drug was shortened to 12 months in April 2000, and review times have been decreasing. Building on this progress, Japan has agreed to specific steps to further improve the drug approval processes. Regarding medical device approvals, Japan clarified the review categories, and thereby exempted certain applications from redundant review by different evaluation bodies. Consultations are improving consistency and transparency.
Nutritional Supplement Problems: Strict regulation of vitamins, herbs, and minerals as drugs has severely limited U.S. industry's ability to market and sell such products in Japan.
Solution: Japan will promote the liberalization of nutritional supplements by treating such products as foods, to the greatest extent possible. Japan abolished the restrictions on shape and maximum daily intakes of several common vitamins and minerals, and will allow manufacturers to make nutritional and health benefit claims.
(end fact sheet)
(Distributed by the Office of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)
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