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The U.S.-Japan Regulatory Reform and Competition Policy Initiative (Regulatory Reform Initiative) continues to contribute to growth and opportunity for the citizens of both countries by promoting reforms that open new markets, reduce burdensome regulations, increase transparency, and stimulate competition.The Regulatory Reform Initiative, now in its seventh year, also remains a key forum for deepening and broadening our bilateral economic relationship.

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The Regulatory Reform Initiative was created in 2001 under the U.S.-Japan Economic Partnership for Growth to promote a pro-growth agenda of reform through sectoral and cross-sectoral reforms.As a result, this year¡Çs recommendations by the United States focus on making continuing progress in industry sector areas such as medical devices and pharmaceuticals, communications, financial services, information technologies, and agriculture, as well as advancing progress in several cross-sectoral issue areas such as intellectual property, commercial law, competition policy, and transparency.The United States continues to look to Japan to undertake important economic reforms in these and other areas in order to achieve the aims of this Initiative.

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This year¡Çs U.S. recommendations also place an emphasis on the United States¡Ç desire to continue to work closely with Japan both bilaterally and in regional and other fora to promote higher standards of intellectual property protection as well as transparency across the Asia-Pacific region and beyond.

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These comprehensive U.S. recommendations serve as the basis for discussions over the coming months in the Initiative¡Çs High-Level Officials Group as well as in four different working groups covering telecommunications, information technologies, medical devices and pharmaceuticals, and cross-sectoral issues.Progress achieved by each Government in response to the other Government¡Çs recommendations is then documented and presented to the President and Prime Minister in the Regulatory Reform Initiative¡Çs annual Report to the Leaders.

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The Government of the United States continues to look forward to constructive discussions on these recommendations and welcomes receiving the Government of Japan¡Çs recommendations under this Initiative.

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The United States continues to monitor Japan¡Çs regulatory reform efforts affecting its communications sector with a view to promoting competitive opportunities for innovative services and technologies.Key regulatory principles that enhance such opportunities include maximizing operators¡Ç choice of technology, ensuring efficient and minimally burdensome equipment approvals, transparency and impartiality of rulemaking (particularly in the wireless area).

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Promoting Competition and Efficiency in the Wireless Sector: Eliminate threat of fees for device manufacturers or users of license-exempt services (e.g. WiFi) to ensure robust usage of such services; expeditiously license new spectrum, or ¡Ère-farm¡É existing spectrum for wireless broadband systems on a technology-neutral basis; ensure new mobile entrants enjoy reasonable interconnection arrangements with other wireless operators to offer customers reasonable roaming arrangements as network build-out progresses.

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Promoting Streamlined Regulation of Convergent Services: Ensure that efforts to
develop new rules for video offered over telecom networks are implemented in a transparent manner with a view to minimizing unnecessary regulation.

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Strengthening Competitive Safeguards on Dominant Carriers: Ensure that NTT East and West offer cost-oriented interconnection rates once current regime expires; eliminate East-West subsidies and ensure interconnection offerings for their Next Generation Network are subject to sufficient transparency and consultation with affected companies; review financial conditions imposed on competing carriers.

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The United States¡Ç recommendations seek to promote competition and confidence in government procurement of information technologies (IT), improve mutual understanding of e-Accessibility policy, advance the adoption of information technology to improve the quality and efficiency of Japan¡Çs healthcare system, strengthen protections for intellectual property rights (IPR) focusing on infringement in the digital age, enhance IPR enforcement in the region and globally, and ensure any revisions in the implementation of the Privacy Act also enhance the business environment.

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IT and e-Commerce Policymaking: Facilitate private-sector input and transparency in policymaking; foster technology neutrality; promote compatibility with international practice.

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Health IT and e-Accessibility: Promote adoption of Health IT through effective implementation of the Grand Design and increased incentives for use of Health IT; exchange information on e-accessibility policies and activities.

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IPR and Copyright Protection: Strengthen protection, including through adoption of measures to defend against online piracy and increased term of protection for sound recordings and other works.

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IPR Cooperation: Promote strong standards for IPR protection and enforcement worldwide,especially in the Asia-Pacific, through enhanced cooperation in various fora; promote information exchange on trademarks and streamline patent procedures.

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Privacy: Ensure that any revisions of Privacy Act implementation enhance the business environment and do not restrict trans-border data flows.

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The United States encourages Japan to implement rapidly many proposals in its August 2007 ¡ÈVision¡É report on its drug industry, including those on improved clinical trials, accelerated approval reviews, and fair value of innovation.Several of these proposals would also benefit the medical device market if applied in that sector.As Japan strives to provide excellent healthcare despite the challenges of an aging society, the United States also recommends that reimbursement pricing policies provide appropriate incentives for development of innovative medical devices and drugs and that regulatory policies help end the device and drug lag.

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Pricing Reform: Ensure reimbursement pricing of medical devices and pharmaceuticals appropriately values the benefits of innovative products; increase opportunities for producers of innovative devices and pharmaceuticals to explain to reimbursement pricing authorities the benefits of their products.

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Regulatory Reform: End the lag in the introduction of innovative medical devices and drugs by streamlining reviews and approvals; improve the clinical-trial environment and encourage simultaneous global development of drugs; facilitate approvals of and reform regulatory requirements for minor changes in medical devices.

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Blood Products: Ensure the pricing system for plasma protein therapies is based on the unique characteristics of those products; provide industry with meaningful opportunities to discuss labeling requirements and other regulatory issues.

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Nutritional Supplements: Create a new category for foods that allow ingredient-specific claims; provide meaningful opportunities for industry input during the development of health food safety regulations; shorten approval times for new food additives.

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Cosmetics / Quasi-Drugs: Increase transparency and efficiency in the quasi-drug approval system; allow claims based on significant and verifiable data.

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The United States commends the Government of Japan for committing to develop a ¡ÈPlan for Enhancing the Competitiveness of Financial and Capital Markets.¡ÉThe United States believes that competitive financial and capital markets are a key element contributing to sustained economic growth, efficient capital allocation, job creation, and innovation.The United States encourages Japan to adopt measures necessary to assure global financial center status.

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Financial Regulatory Transparency: Expand the body of published written interpretations of financial laws, including by active use of no-action and interpretive letters; ensure all stakeholders to provide input on draft laws and regulations.

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Credit Bureaus: In order to promote sound credit underwriting: deter excessive lending and improve consumer welfare and competitive credit markets; create a legal and regulatory framework for a credit bureau system that facilitates more accurate risk pricing for consumers and small businesses by collecting and providing fair; open access to comprehensive full-file credit information.

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Information Sharing and Firewalls: Identify and define the scope of required firewalls through written guidance and continue an active dialogue with foreign financial institutions regarding appropriate revisions to the current firewalls regime, including the Financial Instruments and Exchange Law and the Personal Information Protection Law.

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Strong and effective Antimonopoly Act (AMA) enforcement against anticompetitive practices will provide great benefits not only to Japanese consumers, but also to the Japanese economy as a whole.At the same time, care must be given to ensure that AMA enforcement policy does not interfere with procompetitive conduct and that Japan Fair Trade Commission (JFTC) procedures are perceived to be fair and transparent.The United States welcomes the report of the Advisory Panel on Basic Issues Regarding the AMA and looks forward to the implementation of many of its recommendations.he United States urges Japan to take measures to improve further Japan¡Çs competition environment.

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Improving Antimonopoly Compliance and Deterrence: Strengthen administrative sanctions against cartels; promote use of JFTC¡Çs leniency program; increase effectiveness of criminal enforcement; avoid surcharges on unilateral conduct; review AMA exemptions on international aviation and shipping; revise Distribution Guidelines; adopt pre-notification system for stock acquisitions; ensure competition during postal privatization; hire more outside legal professionals and economists.

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Improving Fairness and Transparency of JFTC Procedures: Enhance credibility of hearing procedures; clarify conditions necessary to move to a pre-order hearing procedure; improve regulations on JFTC warnings.

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Addressing Bid Rigging: Strengthen penalties against bid rigging; prevent government-assisted bid rigging and address conflicts of interest in procurement; expand administrative leniency programs; improve procurement practices.

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A commercial law and legal systems regime in Japan that recognizes the realities of the global market and reflects best international practices will encourage efficient business practices and structures that will strengthen the Japanese economy. Essential aspects of a modern commercial law system include laws that will facilitate rather than impede cross-border investment and corporate governance mechanisms that promote management accountability to, and full participation by, shareholders. Japan should also ensure that international legal services can be provided in an efficient and cost-effective manner. The United States urges Japan to take measures to further improve Japan¡Çs commercial and legal environments.

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Promoting Efficient Restructuring and Shareholder Value: Review the success of introducing triangular merger techniques for cross-border acquisitions; protect shareholder interests in anti-takeover measures.

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Strengthening Good Corporate Governance: Encourage active and appropriate proxy voting; protect shareholder interests through independent directors; ensure sufficient protection of minority shareholders.

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Protecting Foreign Firms Legitimately Doing Business in Japan: Adopt redomestication procedures that allow a foreign company to merge or convert into a Japanese corporation; ensure that Article 821 does not have adverse effects on the legitimate operations of foreign companies.

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Achieving Legal System Reform: Permit professional corporations and branching by foreign lawyers (gaiben); allow Japanese lawyers to associate freely with international legal partnerships; revise minimum qualification criteria for gaiben; promote arbitration and other alternative dispute resolution.

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Transparent regulatory and policy-making practices are a cornerstone of any good business environment. While a number of improvements have been made in Japan in recent years, such as the introduction of a more meaningful public comment procedure, actual experience clearly indicates that such improvements are not being uniformly implemented across the Japanese Government. The United States continues to urge Japan to further improve its business environment by taking new steps that ensure consistent application of high transparency standards, including by creating new rules as well as promoting best practices. The United States looks forward to cooperating with Japan to promote higher transparency standards in the Asia-Pacific region.

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Advisory Groups: Implement new rules to ensure transparency and access for stakeholders to provide input into government-appointed advisory groups; develop and promote transparency best practices for such groups on a government-wide basis.

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Public Comment Procedures(PCP): Ensure agencies give public comments ample consideration; take steps to lengthen the public comment period; evaluate the current effectiveness of the PCP to identify other areas to improve its implementation.

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Regulatory Transparency: Require Ministries and Agencies to make public in writing their regulations and any statements of policy or generally applicable interpretations regarding those regulations; promote use of ¡Æplain language¡Ç regulations.

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Strengthen International Cooperation: Intensify bilateral work to promote higher transparency standards in the Asia-Pacific, such as through ensuring active implementation of APEC Transparency Standards.

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The United States urges Japan to undertake regulatory reform in a number of other areas to help create new opportunities as well as ensure efficient competition by creating a level playing field. Full liberalization of sales of insurance products through banks, for example, will help enhance competition and consumer choice. Holding insurance cooperatives to the same regulatory supervision that private insurers must meet will also help provide for a sound, competitive insurance market for Japanese consumers. In addition, the U.S. urges Japan take a number of steps to facilitate trade in agricultural products in ways that expand consumer choice while rooted in science-based international standards to ensure a safe food supply for Japanese consumers. The business environment for foreign nationals can be improved via streamlined consular requirements.

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Liberalize Bank Sales of Insurance: Ensure the bank sales channel for insurance products is fully liberalized no later than the end of 2007.

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Insurance Cooperatives: Build on recent progress to secure a level playing field between private companies and cooperatives (kyosai) that offer insurance by taking new steps to hold them to the same obligations as applied to private insurers.

Êݸ±¶¨Æ±Áȹç: ¸Ä¿ÍŪ¤ÊÊݸ±²ñ¼Ò¤ËŬÍѤµ¤ì¤ë¤Î¤ÈƱ¤¸µÁ̳¤Ë¤½¤ì¤é¤òÊݤĤ¿¤á¡¢¿·¤·¤¤ÊýË¡¤ò¼è¤ë¤³¤È¤Ë¤è¤Ã¤ÆÊݸ±¤òÄ󶡤¹¤ë̱´Ö´ë¶È¤È¶¨Æ±Áȹç(¶¦ºÑ)¤Î´Ö¤ÎÊ¿Åù¤Ê¶¥Áè¾ò·ï¤òÊݾڤ¹¤ë¡£
Consular Issues: Revise the re-entry permit requirements to minimize burdens on visa holders in Japan.

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Practices Related to Agriculture: Facilitate trade by applying science-based standards to assess substances used on organic crops; complete the review of food additives recognized as safe by relevant international organizations and used widely throughout the world; ensure measures that enforce maximum residue levels are the least trade restrictive possible; implement international standards in animal health and related measures.

ÇÀ¶È¤È´ØÏ¢¤·¤¿½¬´·¡§Í­µ¡ÇÀ»ºÊª¤Ç»ÈÍѤµ¤ì¤ëʪ¼Á¤òɾ²Á¤¹¤ë¤¿¤á¤Ë²Ê³Ø¥Ù¡¼¥¹¤Îµ¬³Ê¤òŬÍѤ¹¤ë¤³¤È¤Ë¤è¤ê¡¢¾¦Çä¤ÎÊØµ¹¤ò¿Þ¤ë; ´ØÏ¢¹ñºÝµ¡´Ø¤Ç°ÂÁ´¤ÇÃæ¸Å¤Ç¤¢¤ë¤È¤·¤ÆÀ¤³¦Ãæ¤Ç¹­¤¯Ç§¼±¤µ¤ì¤¿¿©ÉÊź²ÃºÞ¤Î¥ì¥Ó¥å¡¼¤ò½ªÎ»¤¹¤ë; µöÍÆ»ÄαÎ̤ò¼Â»Ü¤¹¤ë¬Ä꤬²Äǽ¤ÊºÇ¾¯¤ÎËǰ׸ÂÄê¸ì¤Ç¤¢¤ë¤³¤È¤ò³Î¼Â¤Ë¤¹¤ë; ưʪ·ò¹¯¤È´ØÏ¢¤¹¤ëÄøÅÙ¤ÎÀ¤³¦µ¬³Ê¤ò¼Â¹Ô¤¹¤ë¡£
Special Zones for Regulatory Reform: Strongly promote new approaches in Japan¡Çs Special Zones program; apply more zone measures nation-wide.

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The United States continues to take great interest in Japan¡Çs effort to privatize and reform Japan Post. The United States recognizes the potential benefits for Japan¡Çs economy if these steps are taken in a fully market-oriented manner. The United States also views it essential that these reforms are undertaken transparently and bring about a level playing field between Japan Post and private sector competitors in Japan¡Çs banking, insurance, and express delivery markets. The United States continues to urge Japan to take necessary steps to ensure equivalent conditions of competition are achieved in these markets.

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Level Playing Field - Savings and Insurance: Ensure the new postal financial institutions meet tax, legal, and regulatory obligations and are subject to the same supervisory standards as private firms; ensure these institutions do not actively leverage their Government ties to secure new advantages.

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Competitive Conditions and New Products: Create a level playing field in Japan¡Çs banking and insurance sectors before postal financial institutions are permitted to introduce new lending services, underwrite new or altered insurance products, and originate non-principal-guaranteed investment products.

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Level Playing Field - Express Delivery: Apply equivalent customs clearance procedures for items handled by Japan Post Service as applied to private express carriers for similar actions, including application of the ¡Èduty declaration¡É system to EMS items; adequately disclose relationships and ensure cross-subsidization does not occur between competitive and non-competitive services.

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Transparency: Ensure strong transparency in the implementation of Japan Post reforms, including providing interested parties meaningful opportunities for input and exchanges of views as the process proceeds; conduct regular reviews of the impact of the reforms on markets and invite input from all parties.

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Boosting productivity, increasing efficiency, and opening new opportunities in Japan's distribution system is critically important for sustaining Japan's economic growth. The United States therefore applauds Japan¡Çs efforts to lower fees for airport use and the results of the recent U.S.-Japan Civil Aviation agreement that provide for increased access for cargo and commercial airlines. The United States requests that Japan take further steps to lower distribution costs, increase transparency, and ensure a level playing field for all industries, including retailers, airlines, and express delivery companies.

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De minimis: Streamline customs procedures by increasing the Customs Law¡Çs de minimis level.

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Airport Expansion and Operations: Ensure all airport operational changes develop with appropriate public input and transparency.

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Parking Spaces: Expand the availability of temporary parking slots in urban areas for distribution vehicles.

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Customs Procedures: Standardize customs procedures for all packages to ensure a level playing field for all delivery agencies.

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