THIRD REPORT TO THE LEADERS ON THE
U.S.-JAPAN REGULATORY REFORM AND COMPETITION POLICY INITIATIVE
June 8, 2004
The Regulatory Reform and Competition Policy Initiative (Regulatory Reform Initiative) wasestablished by President George W. Bush and Prime Minister Junichiro Koizumi in June 2001.
Now in its third year, the Initiative is intended to promote economic growth by focusing on
sectoral and cross-sectoral issues related to regulatory reform and competition policy.
Consistent with the aim of achieving tangible progress and the principle of two-way dialogue,
the Governments of the United States and Japan exchanged detailed regulatory reform
recommendations in October 2003. These recommendations provided the basis for extensive
discussions between the two Governments for meetings of the High-Level Officials Group andthe Working Groups established under this Initiative. These Groups met throughout the year to
discuss reforms in key sectors and areas such as telecommunications, information technologies,
energy, medical devices and pharmaceuticals, competition policy, transparency and othergovernment practices (including Special Zones for Structural Reform), legal system reform,
commercial law revision, distribution, consular affairs, and trade and investment-related
measures. As in previous years of this Initiative, several of the Working Groups received input
from private sector representatives, who made presentations and provided their valuable
expertise, observations, and recommendations on important issues taken up under this Initiative.
The Government of Japan has taken a series of regulatory reform measures over the past year,
including the adoption by Cabinet Decision on March 19, 2004 of its new Three-Year Program
for the Promotion of Regulatory Reform. The Government of the United States welcomes thisdecision and the establishment of the Council for the Promotion of Regulatory Reform in April
2004 as the successor of the Council for Regulatory Reform, which over the years has worked toeffectively improve the regulatory environment in Japan. The Government of the United States
also continues to welcome the opportunity to cooperate with the Headquarters for Promotion ofSpecial Zones for Structural Reform in helping to ensure the success of the Special Zones
program and looks forward to successful reform measures in the Special Zones being applied ona national basis expeditiously.
The salient regulatory reforms and other measures by both Governments that relate to the work
under the Regulatory Reform Initiative are set out in this Report to the Leaders. (Financial
services measures taken up in the Financial Dialogue are also included.) The two Governments
welcome the measures specified in this Report and share the view that these measures will
improve market access for competitive goods and services, enhance consumers’ interests,
increase efficiency, and promote economic activity.
Seeking to ensure this Initiative remains forward-leaning, both Governments affirm a desire toplace greater focus in the coming year on areas that have assumed increased relevance to thebroader economic reform agenda. This may include placing more emphasis on issues related tocompetition policy and privatization, which are already being taken up under this Initiative tovarying degrees. In addition, the two Governments affirm their desire to consider taking up newareas where reform would further the objectives of this important Initiative.

Both Governments reaffirm their determination to further promote regulatory reform and, upon
the request of either government, will meet at mutually convenient times to address the measurescontained in this Report.

2

REGULATORY REFORM AND OTHER MEASURES BY
THE GOVERNMENT OF JAPANI.

TELECOMMUNICATIONSA.

Promotion of Competition
1.

The Government of Japan has formulated a competition policy in thetelecommunications field in line with rapid advances of technology, and has
thereby facilitated the development of a telecommunications market where
broadband services, affordability, and speeds are among the most advanced in theworld.

2.

The amended Telecommunications Business Law (TBL) came into effect on
April 1, 2004, aiming at promoting further competition in the telecommunications
business. The amended TBL introduces a variety of fundamental deregulatory
measures, which are expected to realize a more competitive telecommunications
market including the following:a.

Abolition of the Type I (facility-based) and Type II (others) businesscategories as well as the permission system for new entrants;b.

Abolition of obligations to file and publicize tariffs, enabling
individualized contract-based services; andc.

Abolition of the obligation to notify agreements regarding
interconnections with non-designated facilities.

3.

The Government of Japan revised the relevant ministerial ordinances to bring the
TBL into effect after consultation with the Telecommunication Council andsolicitation of public comments for five weeks. The Ministry of Public
Management, Home Affairs, Posts and Telecommunications (MPHPT)
incorporated some of the opinions received through the public comment process
into the revised ordinances as appropriate and articulated its views on all thecomments solicited therein.

4.

MPHPT is conducting a competition evaluation of the telecommunications
market, beginning in FY2003, in order to evaluate the status of competition in thetelecommunications market, which is becoming increasingly complex as a resultof the rapid evolution of Internet Protocol (IP) and broadband technologies andservices. In November 2003, MPHPT drafted the “Basic Approach Concerning
the Evaluation of the Competitive Situation in the Telecommunication Business
Field,” which outlined the process of this evaluation. Under the “BasicApproach,” MPHPT plans to choose a specific market sector and evaluate its
3competitive situation every fiscal year, after conducting public comment
procedures. With regard to FY2003, MPHPT chose “Internet access” as thescope of evaluation, and on April 27, 2004 released a draft of the evaluation
results for public comment.
B.

C.

Fixed Interconnection
1.

Revised charges, based on actual traffic data and revised inputs, retroactive toApril 2003 will be set by fall 2004.

2.

A report issued by the Telecommunication Council in March 2003 concluded thatthe method of calculating interconnection rates to be applied from FY2005 should
be based on major changes in the market environment, including a reduction in
the volume of traffic and a slowdown in new investment. Based on the report, in
April 2004, a study group on the Long-run Incremental Cost Model, reestablishedby MPHPT, outlined the process to be used to revise the current model after
soliciting public comments for a month.

3.

In April 2004, MPHPT consulted the Telecommunication Council on drafting areport on how to calculate the interconnection rates to be applied from fiscal year
2005, taking into consideration the evaluation of the new model based on factors
mentioned above, and how to treat the non-traffic sensitive (NTS) cost based on
the review of NTT East and West’s basic monthly charge. In addition, theTelecommunications Council will discuss whether it is appropriate to calculate
and set charges separately for NTT East and West.

4.

MPHPT expects the Telecommunications Council to release its final report in thefall of 2004, after conducting a public comment procedure.

Mobile Communications
1.

A study group established by MPHPT examined the setting of user rates of calls
originating from NTT East and West and terminating on mobile networks via
inter-exchange carriers. The study group completed its report in June 2003 after
soliciting public comments for a month. After evaluating the report, MPHPT
issued the “Policy for Setting User Rates of Calls Originating from NTT East andWest and Terminating on Mobile Networks Via Inter-Exchange Carriers,” andcarriers other than mobile network operators have been able to set user rates sinceApril 2004. As a result, rate reductions of up to 55 percent were realized for calls
originating from NTT East and West and terminating on mobile networks.

2.

NTT DoCoMo’s interconnection rates have been significantly reduced over thelast three years by approximately 22 percent, to among the lowest levels indeveloped countries with a calling-party-pays system. The rates filed in March
2004 resulted in a reduction of approximately 4 percent compared with rates filed
4

the previous fiscal year. Telecommunications carriers with Category
II-designated telecommunications facilities (mobile networks) continue to berequired to notify MPHPT of and publicize interconnection tariffs.
D.

E.

Promotion of Advanced Technologies and Services:1.

In November 2003 and March 2004, the Telecommunications Working Group of
the Regulatory Reform Initiative obtained information from private sector expertson the utilization and application of radio frequency identification (RFID) in bothcountries. The Working Group heard their views on current trends and issues inthe developing RFID market, including technology, market status, and policy.

2.

In March 2004, MPHPT solicited public comment on the “Draft Final Report of
the Study Group on Advanced RFID (Electronic Tag) Application in the
Ubiquitous Networking Age.” Based on the report, MPHPT will continue topromote testing of both passive and active tag technology in the UHF band.
Based on such testing, the Telecommunications Council will discuss technicalconditions and the Radio Regulatory Council will discuss regulations.

Network Channel Terminating Equipment (NCTE):
1.

2.

The Governments of Japan and the United States, having exchanged views on therelevance of the 1990 Exchange of Letters on Network Channel Terminating
Equipment (NCTE) (“the 1990 Letters”), share the following recognition, based
upon which the two Governments propose a process for terminating theprocedures established through this exchange of letters:a.

Significant competition among telecommunications carriers has emerged
and the development process of terminal equipment has changed
substantially.

b.

Because of the shortened life-cycle of products, the shortened lead-time of
product development, and the increased use of standards, timeframes
described in the 1990 Letters for the disclosure of information on
specifications for NCTE before the introduction of individual services
may hinder prompt supply of advanced services.

As a transitional measure, the procedures established through the 1990 Letterswill be streamlined as indicated below. Unless sufficient evidence demonstrating
the continued need for these revised procedures is introduced, following
solicitation of opinions from interested parties, these procedures will cease to be
applied beginning in FY2006.
a.

Scope of carriers subject to revised procedures: Main carriers that
determine specifications of NCTE and provide services (except those of5

sufficiently competitive areas), using Category I designatedtelecommunications facilities.
b.

Scope of information disclosure under revised procedures: Regarding
NCTE where network interface information has been made generally
available through a standardization process or by other means, disclosure
will not be required.

c.

Term of disclosure of technical specifications: In principle, three months
minimum, prior to introduction of a new service.

II.

INFORMATION TECHNOLOGIESA.

Removing Regulatory and Non-Regulatory Barriers
1.

Legal Framework: The Government of Japan has removed various barriers to
e-commerce, electronic notifications, and transactions by introducing new rules
and updating existing ones, such as the amendment of the Commercial Code andintroduction of the “No-Action Letter” system. The Expert Committee on IT
Strategy Evaluation (Expert Committee) under the IT Strategic Headquarters
indicated in its March 2004 e-Japan Evaluation report that while IT-related
regulations have been considerably improved through regulatory reforms,
continuous efforts to advance regulatory reform are critical to improve theefficiency of the overall social system through IT utilization. The Expert
Committee will study the causes of the slow pace of regulatory reform in some
sectors and propose necessary measures to address them. More broadly, theGovernment of Japan will ensure that each Ministry and Agency will continue torevise existing regulations that hinder e-commerce and establish rules asnecessary to further promote free and diverse e-commerce activities, and do so ina manner that promotes technology neutrality.

2.

Private Sector Leadership: Under the “e-Japan Strategy II” principle that “theprivate sector plays a leading role with government support,” the “e-Japan
Priority Policy Program 2003” articulates the necessity of facilitating smoothmarket operations, such as promoting free and fair competition and creating anenvironment where the private sector can maximize its leadership potential.
Based on these perspectives, the Government of Japan will continue to promote
the effective use of IT without unnecessary regulation and by removing
impediments to the development of e-commerce. In addition, as the Governmentof Japan develops its e-commerce policies under the “e-Japan Priority Policy
Program 2004,” it will promote the principle of private sector self-regulation to
the extent possible.

3.

Special Zones: The Government of Japan has so far approved four IT Special
Zones for Structural Reform and will seriously consider applying successful
6regulatory exemptions in those zones on a national basis as expeditiously as
possible.

B.

4.

IT Strategic Headquarters Coordinating Role and Resources: As the “e-Japan
Strategy II” requires consistent and effective implementation of related measuresby respective Ministries and Agencies, the Expert Committee has evaluated thestatus of implementation of the IT priority measures by relevant governmentalorganizations. The IT Strategic Headquarters will continue to produce andcoordinate IT policy direction for the entire Government and will encourage
related Ministries and Agencies to take further positive steps to promote
development of effective IT policy. The IT Strategic Headquarters will be
provided sufficient resources to fulfill its objectives. In line with this, a numberof staff were added to the IT Strategic Headquarters in April 2004. In addition,
the Inter-Ministerial Task Force (renraku kaigi), that is comprised of officials at
the Director-General level, was established in February 2004 to facilitate stronger
communication among Ministries and Agencies on IT policy.

5.

Private Sector Input:a.

The Government of Japan has sought opinions from the private sector in
the planning and implementation of its IT policy both through private
sectors’ participation in the IT Strategic Headquarters and through thesolicitation of public comments for the “e-Japan Strategy II” and the“e-Japan Priority Policy Program 2003.” Similarly, the IT Strategic
Headquarters made drafts of the “e-Japan Priority Policy Program 2004 ”
and other IT-related programs available for public comment, and will
ensure that all comments received are seriously considered and reflected,
as necessary, in the final measures and actions that are implemented.

b.

The IT Strategic Headquarters appointed specialists from the private
sector as members of the Expert Committee. In this course, theHeadquarters paid attention to the maintenance of neutrality andtransparency of this Committee, and chose private sector experts who
could advise the Headquarters from a wide range of visions that reflect thecurrent globalized IT society. To further expand that range of visions, theGovernment of Japan will actively seek input from experts, including
experts from non-Japanese entities, as it undertakes subsequentevaluations of e-Japan.

Strengthening the Protection of Intellectual Property Rights
1.

Copyright Term Extension: An amendment to the Copyright Law passed the Dieton June 18, 2003 that extended the term of protection for cinematographic works
from 50 years to 70 years from their first publication. The Government of Japan
will continue its deliberations on extending the terms of protection for other7

subject matter protected under the Copyright Law, in consideration of relevant
factors including global trends and the balance between right holders’ and users’
benefits.
2.

Statutory Damages: The aforementioned amendment to the Copyright Law also
eases the burden of right holders to prove infringement in copyright cases. The
Government of Japan will continue to consider further measures to decrease theburden on right holders, including statutory damages for infringement.

3.

Protection of Digital Content:a.

The Government of Japan affirms that it has issued a decree mandating theuse of only authorized software by its government ministries, which
provides effective and transparent procedures to ensure that software usedor procured by the government is appropriately licensed and legitimately
used. The Governments of Japan and the United States will continue toexchange information on protection of digital contents, including softwareand other intellectual property assets, on government-supported IT
resources as necessary.

b.

The Law Concerning the Liability of Internet Service Provider has had
some positive results with related guidelines since its enforcement in May
2002. Under the Law and the guidelines, right-infringing information on
the Internet, including digital content piracy, can be deleted upon requestfrom a Credibility Confirmation Organization. The Government of Japan
will continue to observe the status of implementation of the Law.

c.

The Government of Japan has made efforts to render its interpretation of
the scope of protection for a “temporary copy” known publicly throughappropriate measures.

d.

The Governments of Japan and the United States will continue to discuss
issues related to technological protection measures.

4.

Exceptions for Educational Institutions: The Government of Japan has issued
guidelines and presented examples of the “educational exceptions” of the
Copyright Law for educational institutions, teachers, and students to clarify thelimitations of the exception under the amended Copyright Law. The Governmentof Japan will continue a dialogue with the Government of the United States on thestatus of the application of these exceptions.

5.

Transmission of Broadcast Television Signals and Content over the Internet:
MPHPT has been conducting tests to establish a system by which copyrightholders and users can mutually and smoothly exchange information on content,
including information on copyrights, in order to promote circulation of content
8over the broadband network, including those already televised. These tests havebeen technical in nature and do not include compulsory, non-voluntary or
statutory licenses. In addition, these tests proceed under agreement by and based
upon cooperation with broadcasting companies and right-holder organizations.

C.

6.

Digital Rights Management System: The Governments of Japan and the UnitedStates will continue to discuss issues related to digital rights management
systems.

7.

IP Promotion Plan and Intellectual Property Policies:a.

The Intellectual Property Strategy Headquarters (IPSH) discussed various
policies to realize an IP-based nation and created the Intellectual Property
Strategic Program (IPSP) in July 2003. To further discussion on several
important issues on which IPSH did not reach final conclusions, IPSH
established three task forces in October 2003: (1) Task Force on
Enhancement of IP Protection; (2) Task Force on Patentability of Medical
Treatment Inventions; and (3) Task Force on Content Business. The law
provides that the IPSP shall be reviewed and revised at least once a year.
Consistent with this, IPSH finalized and published the IPSP for 2004 on
May 27, 2004.

b.

When reviewing the IPSP, IPSH will provide an adequate period for thesolicitation of public comments, in accordance with the general rules on
public comment procedure decided by the Cabinet. In doing so, IPSH will
ensure that comments from the Government of the United States and otherstakeholders are seriously considered and, as necessary, reflected in the
final measures and actions. The Government of Japan will also ensurethat the Basic Law on Intellectual Property and implementing measures
for the IPSP are in compliance with international obligations, standards,
and norms, and that IPSH will be provided with the necessary support andresources to implement the Basic Law and measures for the IPSP.

Promoting and Facilitating Public and Private Sector Use of E-Commerce1.

Privacy: On April 2, 2004, the Government of Japan adopted the Basic Policy for
the Protection of Personal Information based on Article 7 of the Law for theProtection of Personal Information. Based on the Basic Policy, each Ministry andAgency is considering introduction of new implementation guidelines, and/or
revision of existing ones, reflecting the current status of the individual businesssectors for which they are responsible.
a.

The Government of Japan established the Inter-Ministerial Task Force(renraku kaigi) for the Protection of Personal Information in order topromote the protection of personal information, in a comprehensive and9uniform manner, via close and consistent coordination among Ministries
concerned. In the circumstances where businesses are under thejurisdiction of multiple Ministries and Agencies, sufficient liaison among
themselves will be sought to lighten the burden on these businesses.

2.

b.

The Ministry of Public Management, Home Affairs, Posts andTelecommunications (MPHPT) and the Ministry of Economy, Trade andIndustry will publicize their draft implementation guidelines forapproximately 30 days of public comment, and will reflect the commentsin the final guidelines or otherwise respond to them.

c.

In those sectors where the proper handling of personal information isstrictly required in view of the nature and the method of its use (forexample, the medical sector, financial services and credit sector, andinformation and communications sector), the relevant Ministries andAgencies are examining additional measures, such as guidelines,
regulations, or laws, based on the Basic Policy. Decisions about
additional measures will be made by the date of implementation of the
Law for the Protection of Personal Information (April 1, 2005). Any
additional measures will be implemented giving these industries asufficient time period to comply with them. The Government of Japan
will also seek the input from the private sector in a transparent manner,
utilizing appropriate means.

d.

In May 2004, the Governments of Japan and the United States held apublic-private sector roundtable (kondankai) concerning privacy, and willcontinue a dialogue and work together on privacy-related issues.

Alternative Dispute Resolution Framework:a.

In the 2003 Report to the Leaders, the Governments of Japan and theUnited States recognized that establishing a framework that allows for fairand effective Alternative Dispute Resolution (ADR) is important to thedevelopment of e-commerce. Subsequent to soliciting public commentson its August 2003 study on a possible legal framework for ADR, theGovernment of Japan considered stakeholder input that was received,
including those comments related to e-commerce. Based on the issues
raised, the Government of Japan is taking additional time to formulate
legislation that will address the cross-border online aspects of ADR.

b.

As it develops legislation with the aim of creating a flexible and open
legal environment for the development of ADR services, the Governmentof Japan will consider including measures that will promote the use of
online dispute resolution, including in the cross-border context. As part of
the new legislation, consideration is being given to such issues as whether
10non-lawyers should be allowed to act as a neutral in ADR proceedings.
The Government of Japan will continue to seek input from appropriate
stakeholders.
c.

3.

The Government of Japan will continue a dialogue and work together on
ADR issues with the Government of the United States.

Network Security: Under the Japan-U.S. Joint Statement on Promoting Global
Cyber Security adopted on September 9, 2003, the Governments of Japan and theUnited States recognized that critical infrastructure protection is a shared
responsibility of the public and private sectors. The Government of Japan isworking to improve and ensure the security and reliability of information systems
used by local and central government entities through developing network
security guidelines and standards, and affirms the importance of involving
stakeholders, including the private sector, in this process. Furthermore, topromote the use of e-government, such guidelines and standards will, whereappropriate, be open (non-proprietary) and consistent with standards developedby voluntary standardization bodies constituted upon consensus in industry,including the International Standards Organization (ISO).
a.

The e-Japan Strategy II Acceleration Package calls for the adoption of
security standards for central government information systems. The
Governments of Japan and the United States share the view thatinter-Ministerial consultation is important for realizing consistent
standards applicable to all central government systems. Thus, the IT
Security Office of the Cabinet Secretariat will develop standards for
information security in consultation with all Ministries and Agencies. It
will also seek professional advice, as necessary, from its expert researchteam, whose members include experts from the private sector, both
vendors as well as users. The Governments of Japan and the United States
also recognize that input from stakeholders representing a range ofperspectives can be beneficial. Thus, the IT Security Office will examine
if the use of a public comment period will enhance the effectiveness of
security standards. Furthermore, the Governments of Japan and theUnited States will continue a dialogue and exchange ideas on security
standards.

b.

Recognizing the increasing importance for the local governments toenhance information security measures in line with the development of
e-government at the local level, MPHPT developed voluntary “Guidelines
for Information Security Inspection for Local Governments” in December
2003. The guidelines are not intended to create discrimination between
domestic and foreign providers.

11

c.

D.

In developing these guidelines, MPHPT had discussions withrepresentatives of the local governments and experts from the private
sector to reflect a wide range of opinions and issues raised by them. The
Government of Japan will consider, as necessary, opening amendments orrevisions to these guidelines to a public comment process to gather input
from a wider range of stakeholders.

Promoting Procurement Reforms for Information Systems
1.

2.

Implementation of Reforms: In December 2003, a summary of the data compiled
from a follow-up survey on the implementation by 17 Ministries and Agencies ofseveral new procedures in FY2002 for information systems procurement was
published on MPHPT’s website. These procedures were adopted in accordancewith the memorandum of agreement among the Ministries (Memorandum) to takesteps to ensure nondiscriminatory, transparent, and fair procurements of
information systems by the Government of Japan.
a.

Recognizing the importance of consistent, government-wide
implementation of procurement reforms in this area, the Government ofJapan’s Chief Information Officer (CIO) Council will encourage all
Ministries to implement these reforms in a timely manner; andb.

The Government of Japan will also continue to conduct follow-up surveys
on the implementation of the Memorandum, and make the results publicly
available on the Internet.

Strengthening of Reforms: The Ministries originally agreed upon the
Memorandum on March 29, 2002, and subsequently have revised it three times,
most recently on March 30, 2004.
a.

The most recent changes included commitments to introducing Service
Level Agreements, clarifying liability for losses, and resolving IPRownership issues. In addition, to improve transparency and fairness ingovernment procurement, all Ministries will contribute applicable
information about their awarded procurements of information systems to a
database launched in April 2004 that is publicly available at
http://cyoutatujirei.e-gov.go.jp/.

b.

As the Ministries continue to implement and review the procedures in the
Memorandum, the Government of Japan recognizes the importance of
seeking input from the private sector in a transparent manner, and will
ensure opportunities for interested parties to provide their views on thesereforms. The Governments of Japan and United States will continue a
dialogue about ways to seek public input on these reforms.

12

3.

4.

Adopting New Methodologies:a.

In April 2004, the Government of Japan adopted and made publicly
available on the Internet the methodology that all Ministries will use forlife-cycle cost based evaluation of bids for multi-year information systems
projects. All Ministries are expected to implement this methodology on
projects to the extent possible.

b

The Cabinet Secretariat issued “Japan’s Government Procurement: Policy
and Achievements Annual Report (FY2003 version)” in March 2004,
which lists each award in order by the procuring Ministries and Agencies.
The report includes data and analysis on overall trends in Japan’s
government procurements, and the results of a survey of domestic andforeign suppliers about procurement procedures. During FY2004, theCabinet Secretariat will continue to conduct a survey of suppliers tocollect their opinions concerning the threshold used by Japan for theOverall Greatest Value Method (OGVM), including the OGVM thresholdfor, among others, computer products and services (currently 800,000
Special Drawing Rights). The results of the survey will continue to be
publicized on the website of the Prime Minister’s Office.

Strengthening Human Resources: As of December 2003, CIO Aides for 20
Ministries and Agencies were selected from among outside experts on the basis of
their professional skills, independence, and neutrality. One of their importantroles is to support and advise CIOs and other senior officials in analyzing,evaluating, and developing “optimization” plans for office systems of theirrespective Ministries and Agencies, so that procuring entities can obtain the bestsystems in the most cost-efficient and transparent manner.
a.

In order for the entire government to undertake its daily work in the mostefficient manner, CIO Aides work in accordance with the “Guideline for
Formulating Optimization Plan for Business Process and System” which
includes the concept of enterprise architecture.

b.

CIO Aides will coordinate with each other through an Inter-Ministerial
Task Force (renraku kaigi).

III.

ENERGYA.

Regulatory Authorities: The Government of Japan is undertaking significant reform of
its electricity and gas sectors to develop a competitive energy market with expanded
retail choice and opportunities for new market entry, all the while meeting the Basic
Energy Policy Act’s goals of ensuring a stable supply of energy and meeting
environmental protection aims. The Government of the United States welcomes Japan’sreform process. Vigilant market oversight is necessary to ensure the effectiveness of13

these reforms in the creation of a fair, efficient, and stable energy market. The
Government of Japan thus recognizes the importance of establishing an enforcement
mechanism equipped with the necessary number of staff, expertise, and independence toprovide such oversight. METI is preparing its own monitoring functions in theliberalized electricity and gas market.
B.

C.

Public Input: METI took steps to ensure that the development of related ministerial
ordinances and guidelines to implement Japan’s electricity and gas reform was an open
and transparent process.
1.

Electricity: In the fall of 2003, METI solicited and responded to publiccomments, including from the Government of the United States, on the Electricity
Industry Committee’s draft interim report titled “Detailed Design of the Desirable
Future Electricity Industry System.” In early 2004, METI also solicited publiccomment to the Electricity Industry Committee’s draft final report.

2.

Natural Gas: In the fall of 2003, METI solicited and responded to publiccomments, including from the Government of the United States, on the Small
Committee on System Design’s draft report titled “Detailed Design of theDesirable Future Gas Industry System.” In early 2004, METI also solicited
public comments on its draft ministerial ordinance to partially revise the gas
business accounting rules.

Electricity: The Electricity Utilities Industry Law (the “Electricity Law”) was amended
in June 2003, paving the way for a new electricity industry system. METI has amended,
and is preparing additional changes to, ministerial ordinances that will result in the
expansion of retail choice to about 63 percent of the market (2.4 times the 2003 level) byApril 2005. Also following the amendment of the Electricity Law, the Electricity
Industry Committee, an expert advisory body tasked by METI to recommend reform
measures, deliberated on next steps and issued its interim report titled “Detailed Designof Desirable Future Electricity Industry System.” METI is now preparing necessary
ministerial ordinances and other related documents based upon the amended Electricity
Law and the Electricity Industry Committee’s final report.
1.

Fairness and Transparency in Transmission/Distribution:a.

Neutral System Organization:(1)

The revised Electricity Law mandated that METI designate andoversee a Neutral System Organization (NSO). In December
2003, METI established criteria by which it will designate anentity as an NSO and issued the necessary ministerial ordinances
to examine an entity’s application.

14

b.

2.

(2)

METI will designate the NSO after reviewing proposed businessplans, including information on its financial and technicalpotential.

(3)

METI will supervise the NSO in order to secure fairness andtransparency, and will issue orders to the NSO if necessary tocorrect any inadequacies.

(4)

The NSO will issue rules that pertain to construction of facilities,
network access, system operation and information disclosure,taking into account input from the Electricity Industry Committee
and public comments.

Behavioral Regulation:(1)

METI will develop necessary ministerial ordinances and otherregulations, taking into account input from the Electricity Industry
Committee, that establish concrete methods to separatetransmission/distribution segment accounts from other segments
and that provide for separation of accounts in an income statement.

(2)

METI has been working with the Japan Fair Trade Commission(JFTC) to revise the Guidelines for Fair Power Trades in order toensure effective information firewalls and the prohibition of
discriminatory treatment pertaining to wheeling services. If METI
finds that a general power utility has performed an act contrary to
the legal text and these guidelines, it will issue a stop or changeorder to the general power utility to remedy the problem.

System Design for a New Electricity Market:a.

Wholesale Electric Power Exchange: To improve market efficiency,
utilities will establish a new power exchange market beginning in April
2005 to handle forward market and day-ahead spot market transactions.
JFTC will monitor trades in the power exchange under the Antimonopoly
Act. METI is preparing the necessary language in the joint guidelines
with JFTC in order to ensure the fairness of wholesale transactions.

b.

Liberalization Schedule:(1)

As a result of the December 2003 amendment of the ministerial
ordinance, the scope of retail liberalization was expanded in April
2004 to include customers using high voltage electric service at orexceeding 500kW (part of high-voltage customers).

15

3.

The ministerial ordinance will be amended again to expand thescope to customers using high voltage electric service at orexceeding 50kW (all high-voltage customers) from April 2005.

(3)

Discussion on full retail liberalization, including household
customers, will start around April 2007, taking into account theresults of partial liberalization up to that point in time.

(4)

The Government of Japan has been publicizing expansion of retailliberalization through public advertisements in the newspaper andthrough leaflets.

Review of the Wheeling Services System:
a.

4.

(2)

Balancing Rules:(1)

METI will relax the balancing rules in April 2005 so that a new
entrant can choose the second fluctuation range from 3 percent to10 percent, in addition to the primary fluctuation range of 3
percent.

(2)

A new balancing support system will be introduced toward thestart of a new wheeling services system in April 2005 so that a
new entrant can access customers’ demand data every 30 minutes.
The data is collected and owned by general power utilities, using
remote metering systems or other systems.

(3)

METI will prepare ministerial ordinances and other regulatory
texts in order to undertake such measures by the end of this year.

b.

Abolition of Pancaking: To facilitate nationwide electricity transactions
through fair and transparent wheeling service charges, METI will prepare,by April 2005, ministerial ordinances and other regulations in order toeliminate the “pancaking” problem.

c.

Clarification of Standards to Issue Orders to Change Rules of WheelingServices: METI will clarify its standards and issue necessary regulations
for implementing “change orders” in order to ensure an appropriate
enforcement mechanism for network regulation.

Review of Regulatory Reform: The Government of Japan is committed toreviewing on an ongoing basis the efficiency of the competitive market and theeffectiveness of regulation. While doing so, it will take into account the need for
additional steps, such as additional regulatory reforms, to ensure that an open,
fair, and competitive market emerges.
16

D.

Natural Gas: The amendment of the Gas Utilities Industry Law (the “Gas Law”) wasapproved by the Diet in June 2003, a step that will expand the scope of retail choice toapproximately 50 percent of users (1.25 times the 2003 level) by 2007. Following thisamendment, the Small Committee on System Design of the Urban Heat Energy
Subcommittee deliberated on a design for a new gas industry regulatory system, and in
January 2004 issued its report titled “Detailed Design of Desirable Future Gas Industry
System.” METI is now developing necessary implementing regulations and ordinances
based on the amended Gas Law, the published report of the Small Committee on System
Design, and public comments.
1.

2.

E.

Fairness and Transparency of Third-Party Access (TPA) to Pipelines:a.

TPA Rates: METI established a ministerial ordinance for setting TPA
tariffs, based on the report of the Small Committee on System Design.

b.

Accounting Separation: METI will issue in June 2004 a ministerial
ordinance setting out rules on the separation of accounts of the gastransportation/distribution sector from those of other sectors and also on
the publication of these separated accounts in financial statements.

c.

Behavioral Regulation: METI has been working with the JFTC to revise
the Guidelines for Fair Gas Trades in order to ensure effective information
firewalls and the prohibition of discriminatory treatment against particular
TPA users as stipulated in the amended Gas Law. If METI finds that agas utility has performed an act contrary to the legal text and thisguideline, it will issue a stop or change order to remedy the problem.

Development of Pipeline Network:a.

Incentives for Pipeline Investment: METI established ministerial
ordinances in February 2004 to allow owners of new pipelines that fulfill
certain conditions to choose to receive, for five years, either (i) a higher
rate of return in setting TPA rates for their pipelines; or (ii) an exemption
from their obligation to notify METI of the terms, conditions, and rates for
TPA to their pipelines.

b.

Public Utility Privileges: Necessary ordinances and regulations weredeveloped and will be applied to facilitate approvals and administrative
procedures for the new pipeline owners that do not currently receive theprivileges accorded to gas utility companies.

Liquefied Natural Gas: Recognizing that liquefied natural gas (LNG) is an importantfuel source for both new power and gas market suppliers, the Government of Japan has
begun taking steps to encourage access to LNG facilities to third parties. The
17

Government of Japan will issue guidelines to establish a framework relating tonegotiations for third-party use of LNG terminals.
IV.

MEDICAL DEVICES AND PHARMACEUTICALSA.

Medical Device and Pharmaceutical Pricing Reform and Related Issues
1.

In Japan, the environment surrounding medical care continues to change
drastically due to factors such as the aging of Japanese society and advances of
medical technology. It is therefore important to maintain the universal healthcare
system and to provide people with high-quality, efficient medical care both now
and in the future.

2.

Recent severe economic conditions have imposed financial constraints on thehealth system in Japan, and the Government of Japan is now tackling afundamental reform of the medical insurance system. As part of this effort, inMarch 2003, the Cabinet decided to review the reimbursement prices of medical
devices and pharmaceuticals with a view to reducing the price difference between
domestic and foreign markets and taking current market prices into account. At
the same time, it is important to ensure efficient, high-quality healthcare forJapanese patients and to encourage the development of better medical devices andpharmaceuticals.

3.

In consideration of fostering an attractive environment for development ofinnovative medical devices and pharmaceuticals, the Ministry of Health, Laborand Welfare (MHLW) will continue to implement reforms while recognizing thevalue of innovation.

4.

Pharmaceuticals and medical devices are important elements of medical care. It
is necessary to improve the environment for providing people with prompt accessto excellent medical devices and pharmaceuticals and to strengthen theinternational competitiveness of Japan’s medical device and pharmaceuticalmarkets and industries. To this end, MHLW published its “Vision” policy paper
for the pharmaceutical industry, “Enhancing the International Competitiveness of
the Pharmaceutical Industry for ‘the Century of Life,’” in August 2002, and its“Vision” paper for the medical device industry, “Toward the Provision of Betterand Safer Innovative Medical Devices,” in March 2003. In these two Visionpapers, action plans comprising a wide range of policies concerning the R&D
environment, regulatory system, and insurance reimbursement were presented as“concrete measures to be carried out in an intensive period (within five years) topromote innovation.” The Visions also recognize the role of the market and thevalue of innovation. Generally, in the Visions, MHLW recognized that thepricing system has important implications for encouraging investment ininnovative R&D. MHLW also recognized that providing market return incentives
is critical for fostering attractive and competitive pharmaceutical and medical
18

device industries and markets. On the reimbursement system, MHLW willcontinue to endeavor to: 1) further promote the expeditious introduction ofeffective and innovative products into the insurance system through appropriate
prices; and 2) conduct a medium-to-long range review of the pricing system toharmonize the achievement of global competitiveness of the industry with the
public health insurance system.
5.

MHLW is making steady efforts to implement the Visions. MHLW’s
Headquarters for the Promotion of Policies on the Pharmaceutical and Medical
Device Industries, which is led by the Vice-Minister and involves all relevant
units, collects and publishes information each year on the state of progress of thetwo plans. MHLW will continue to make efforts in FY2004 to accelerate theimplementation of the action plans, as recommended by the 2003 U.S.-Japan
Private Sector/Government Commission. MHLW will also verify the results ofimplementation on the basis of comments made by the industries and otherinterested parties. The Government of the United States welcomes healthcare
reform and the Visions papers as evidence that Japan is committed to promoting
rapid access to the most innovative medical devices and pharmaceuticals.

6.

In line with the Cabinet’s decision to review reimbursement policies, the pricing
system of medical devices and pharmaceuticals was revised in FY2004. During
this process, MHLW increased opportunities to communicate closely with the
medical device and pharmaceutical industries including those of the UnitedStates. MHLW continues to keep the practice of having a meaningful periodical
dialogue with industry, including U.S. industry. MHLW will continue to provide
industry, including U.S. industry, with meaningful opportunities to provide input
and with access to consultations prior to changes in pricing rules, and will givethis input sincere consideration. MHLW will continue to make serious efforts toensure that the price revision process is fully transparent.

7.

As a result of the discussions of the Central Social Insurance Medical Council(Chuikyo), where industries had opportunities to express their opinions, MHLW
did not alter the Foreign Price Adjustment rule or the Cost Calculation rule, did
not introduce a repricing rule for long-listed products that lack genericcompetition, and did not introduce a repricing rule that uses foreign pricecomparisons in the pharmaceuticals pricing revision of FY2004.

8.

In FY2002, MHLW substantially raised the rate of premium pricing forinnovativeness and usefulness to ensure appropriate evaluation of innovative
pharmaceuticals. Since then, this system has been implemented. In FY2004,
MHLW introduced a new premium pricing rule for those drugs with high medical
usefulness whose prices have been calculated only based on theinter-specification adjustment. MHLW will continue to review the results of theapplication of premiums to ensure that premiums are being used to fullyrecognize and encourage innovation. The Government of the United States19

pointed out the importance of discussing with industry, including U.S. industry,the order in which premiums and other pricing rules are applied.
9.

To better recognize the value of useful products, MHLW decided in FY2004,
when repricing pharmaceuticals, to decrease the price reduction rate which would
be applied to those products following market expansion, if true clinicalusefulness is verified directly by the results of data collected after their market
introduction. The premium that corresponds to the rate for Usefulness II is
integrated into the repricing process, ensuring that the process does not unduly
reduce the prices of truly useful products. MHLW will review data submitted bycompanies when considering whether to apply this premium.

10.

MHLW evaluates a pharmaceutical product’s innovativeness based on its
attributes. Regarding the evaluation of innovativeness, order of introduction into
the market is not considered because innovativeness is not dependent on order ofmarket entry.

11.

With respect to pricing rules for new medical devices, from April 1, 2004,
MHLW took steps to foster innovation in this sector. A rule was revised in
FY2004 to increase the frequency of granting reimbursement prices to C1
products from two to four times a year. In addition, the timing for granting
reimbursement prices to C2 products was changed from coinciding with theMedical Fee Revision to a system where the Chuikyo will deliberate on such
introductions when new medical technologies are introduced into the Medical Fee
Schedule. MHLW continues to provide companies, including U.S. companies,
with opportunities for consultations regarding the application of the criteria forC1 and C2 categories.

12.

According to the rule, which is set by the Chuikyo, MHLW should use available
prices of four countries including the U.S., the U.K., Germany and France in the
medical device pricing revision process. In the process of the FY2004 medical
device pricing revision, MHLW fully used price data, submitted by companies,
including the U.S. list prices, in the calculation of the Foreign Price Adjustment
rule, and the price data provided by U.S. companies played an important role.
MHLW will continue to work with industry, including U.S. industry, on the scopeof future data collection regarding medical devices. Also, MHLW is open to
discussion, upon request by industry, of data collected by industry on the specificcosts of bringing products to the Japanese market, while considering the
Chuikyo’s view regarding the price difference between domestic and foreign
markets for medical devices.

13.

MHLW will continue to ensure the transparency of the reimbursement
price-setting process. The Government of the United States pointed out theimportance of providing applicants with opportunities to make presentations at20

the first meeting of the Drug Pricing Organization (DPO) and Special
Organization for Insurance-covered Medical Materials (SOIMM) during CY2004.

B.

14.

MHLW will continue to ensure transparency for the diagnostics industry (e.g.,
imaging devices and in-vitro diagnostics) regarding the pricing process. MHLW
decided in FY2004 to include representatives of the imaging and in-vitro
diagnostics industries in regular meetings with the medical device industry to hear
opinions regarding the reimbursement of diagnostics.

15.

MHLW will continue to provide industry, including U.S. industry, withinformation and meaningful opportunities to provide input and with access toconsultations, upon request by industry, regarding the introduction or majorrevision of Diagnosis Procedure Combination (DPC) and other payment systems
such as Diagnostic Related Group (DRG), Prospective Payment System (PPS),
etc. MHLW recognizes the importance of innovative products regarding thesesystems.

16.

MHLW recognizes that there is a difference in market structures between blood
products and pharmaceuticals. MHLW will continue to apply pricing rules fairly
and transparently.

17.

The Governments of Japan and the United States will continue to discuss
pharmaceutical and medical device pricing reform issues.

Medical Device and Pharmaceutical Regulatory Reform and Related Issues
1.

On April 1, 2004, MHLW founded the Pharmaceuticals and Medical Devices
Agency (PMDA), fully integrating the functions of the Organization for
Pharmaceutical Safety and Research and the Pharmaceuticals and Medical
Devices Evaluation Center. The establishment of PMDA has led to fullconsolidation of services provided in the pre-market process and application
review process for approvals. This consolidation enables one team to deal with
consultations on clinical trials and reviews, and hence guidance to applicants islikely to become more consistent. MHLW will ensure that PMDA uses
procedures that will evaluate fairly and impartially the medical benefits and risksof pharmaceuticals and medical devices. The regulatory system will be based on
accountability, efficiency, international harmonization and the latest
internationally accepted science. The application review process for approvals
will be based on the consideration of product safety, efficacy and quality.
MHLW will ensure that PMDA seeks to both promote and protect public health,and to operate transparent, timely and sound science-based procedures. MHLW
will ensure that PMDA also carries out safety activities in the same manner.
MHLW will endeavor steadily to achieve the goals of the Industry Visions bycontinuing efforts to ensure a more timely introduction of safer and more
effective medical devices and pharmaceuticals.
21

2.

MHLW has provided industry, including U.S. industry, with meaningful
opportunities to exchange views regarding PMDA’s organization, user fee
system, performance measures, and other matters, as well as issues related toreform of the Pharmaceutical Affairs Law (PAL). MHLW will continue toprovide industry with meaningful opportunities to exchange views regarding theuser fee system, and MHLW will ensure that PMDA continues to offer suchopportunities to industry regarding matters other than the user fee system.
MHLW will ensure that PMDA continues to offer opportunities for timely accessto useful discussions with PMDA officials involved in consultations at key stagesof the development of medical devices and pharmaceuticals. MHLW will ensurethat PMDA discusses with industry methods that would enhance communication
between PMDA and applicants to facilitate efficient reviews.

3.

On April 1, 2004, PMDA established therapeutic-area review teams withappropriate technical expertise to manage application reviews for approval andconsultations. PMDA also set up a group dedicated to safety activities, which
will interact with the review section including the appropriate therapeutic-area
review teams. MHLW will ensure that PMDA’s experts have access tocontinuing education, and staff rotations are conducted in view of ensuringcontinuity within review teams.

4.

MHLW established a simple and precise user-fee system on April 1, 2004. User
fees are being used to supplement PMDA’s budget only for the purpose ofincreasing resources, including staff with relevant expertise, dedicated to theenhancement of review quality as well as faster approvals of medical devices andpharmaceuticals. MHLW will discuss any proposed fee changes with industry,including U.S. industry, and link increases in user fees to improvements in
PMDA’s performance measures.

5.

MHLW authorized PMDA to establish transparent performance measures withbaselines based on FY2003 performance. MHLW will ensure that, starting in
FY2004, PMDA reports annually and publicly on its performance and describes
its progress toward meeting performance goals. By law, MHLW’s Evaluation
Committee assesses progress in attainment of performance goals and the results
are published every year. The annual reports will include administrative time. To
ensure transparency, MHLW will ensure that PMDA also publishes each year
information specifying the revenues received, including fees collected for new
drug application (NDA) and medical device reviews and contributions forpostmarketing safety, and how the revenues were expended. MHLW, in
collaboration with PMDA, will continue to discuss with industry specificquantitative and qualitative goals for improving the approval time of productapplications and contents of the reports on performance goals and revenues within
the confines of Japanese law.

22

6.

For pharmaceuticals, currently about 50 percent of approved NDAs are approved
within 12 months of administrative time. On April 1, 2004, PMDA establishedthe performance targets of 70 percent of NDA approvals within 12 months ofadministrative time by March 31, 2008, and 80 percent of NDA approvals within
12 months of administrative time by March 31, 2009, the end of the first phase.

7.

While PMDA will continue to improve the NDA review process through themedium term, the Government of the United States will strongly encourage U.S.
companies that submit applications to decrease their response times during NDA
reviews. MHLW will examine the possibility of using total NDA review time asa performance measure in the second term, in consideration of the outcome of thefirst term.

8.

On April 1, 2004, PMDA implemented a priority review system with theperformance goal of approving 50 percent of priority NDAs in six months ofadministrative time by March 31, 2009. MHLW has clarified the criteria and has
expanded the scope of products considered for priority review to include products
deemed to be highly necessary in medical practice. MHLW will continue todiscuss the interpretation of the criteria for priority review with industry,including U.S. industry.

9.

For medical devices, on April 1, 2004, PMDA established performance goals thatwill ensure the completion of approvals in specified times through staged
improvements in the next five years. MHLW will ensure that PMDA completes
the reviews of 70 percent of new device applications within 12 months ofadministrative time by March 31, 2005; 80 percent of new device applications
within 12 months of administrative time by March 31, 2007; and 90 percent of
new device applications within 12 months of administrative time by March 31,
2009. In addition, by March 31, 2005, MHLW will ensure that PMDA completes
100 percent of priority reviews in 12 months of administrative time and 95
percent of reviews of improved devices in 12 months of administrative time.
Considering the implications of the April 2005 PAL reform, MHLW will ensurethat PMDA improves the performance goals for me-too devices and partialchange applications, and that PMDA discusses these improvements with industry,including U.S. industry.

10.

MHLW will ensure that PMDA establishes in the near future performance goals
for in-vitro diagnostics considering the implications of the April 2005 PAL
reform. MHLW will provide industry, including U.S. industry, with meaningful
opportunities to provide input when establishing performance goals for in-vitro
diagnostics.

11.

To encourage medical device companies to improve the quality of theirsubmissions, the U.S. Department of Commerce and the medical device industry

23

plan to hold a workshop in Tokyo in CY2004. MHLW is willing to actively
participate in the workshop with PMDA.
12.

In the process of developing and implementing safety-related activities, MHLW
will ensure that PMDA ensures transparency by providing manufacturers withmeaningful opportunities to be involved in the process. Safety-related activities
will be undertaken in a timely, science-based manner, taking into accountguidance from international organizations, namely ICH and GHTF.

13.

On April 1, 2004, PMDA implemented a two-tier system to handle appeals within
the pharmaceutical and medical device approval and safety-related processes. For
appeals concerning procedural matters, a hearing will be conducted between theapplicant and the senior PMDA staff member with responsibility for reviews. For
appeals regarding scientific details, opportunities will be given to the applicant(and its representatives) for a hearing with PMDA officials and outside experts.

14.

After the enforcement of the amended PAL in April 2005, PMDA will conduct
quality system audits for high-risk (class 3 or 4) medical devices. When planningwhether to conduct an audit in writing or in the field, MHLW will ensure that
PMDA considers risk level, which will be determined by factors including
product characteristics and the nature and extent of non-conformity identified
through past audits. Third-party recognized bodies will conduct audits for class 2
devices in domestic and foreign plants. In the regulatory auditing of quality
systems of medical device manufacturers, MHLW and the U.S. Food and Drug
Administration (FDA) will continue to draw upon such internationallyharmonized guidelines as those of GHTF within the confines of Japanese andU.S. law.

15.

On April 1, 2004, PMDA and its Inspectorate implemented the PAL reform that
stipulates new foreign manufacturing facility inspection requirements. MHLW
has stated that the time required for GMP inspections is not included in theperformance measures. MHLW will discuss with FDA necessary steps forfacilitating Japanese GMP inspections of U.S. manufacturing facilities. MHLW
will ensure that PMDA discusses with industry, including U.S. industry,administrative procedures for such inspections.

16.

On July 1, 2003, MHLW implemented full use of a common format (the CTD)
for NDAs, and MHLW will ensure that PMDA continues to use this policy.
MHLW will ensure that PMDA refrains from requesting summaries or documents
exceeding the scope agreed at ICH.

17.

MHLW will use, within the confines of Japanese law, the common format for
medical devices (the STED), which is now in a pilot phase, from April 1, 2005.

24

C.

D.

E.

18.

MHLW will ensure that PMDA continues to discuss with industry as it develops
guidance documents for medical devices, including imaging medical equipment,
and in-vitro diagnostics.

19.

As part of the postmarketing safety reform under the PAL, the In-Country
Caretaker system for medical devices is scheduled to end on March 31, 2005. To
inform companies of this change, the U.S. Embassy and MHLW held a seminarfor In-Country Caretakers on March 25, 2004. MHLW will continue to exchange
views with industry regarding the implementation of the revised PAL.

Blood Products
1.

MHLW will continue to ensure that implementation of the Supply and DemandPlan does not discriminate against foreign products and is fully consistent withJapan’s international trade obligations.

2.

MHLW will work actively with interested parties, including industry, to ensurethat doctors and patients receive accurate information about the risks and benefitsof various therapies, including those involving blood products. In CY2004,
MHLW will bring together all interested parties to discuss relevant concerns suchas patient care, declining demand, and other issues.

3.

In order to ensure smooth operation of the regulations on blood and blood
products, MHLW will continue to hear opinions of interested parties and provide
information to the United States at the meetings of the Working Group on
Medical Devices and Pharmaceuticals and through other means.

Nutritional Supplements
1.

The Japanese Market Access Ombudsman Council has recommended theliberalization of the food additive market. MHLW responded by undertaking ascientific study of 46 food additives. MHLW will consider approving additional
additives that are widely used internationally and whose safety has been verified
by the Joint FAO/WHO Expert Committee on Food Additives.

2.

MHLW will use scientific data when making regulatory decisions on nutritional
supplements.

3.

By holding open discussion meetings, MHLW has provided opportunities forindustry to express views on how to organize the system for health foods
including nutritional supplements. MHLW will continue to provide industry withmeaningful access to consultations regarding nutritional supplement regulations.

Special Zones for Structural Reform: The Government of the United States supports
the Special Zones for Structural Reform initiative. MHLW will study the feasibility of25

special zones for structural reform proposals regarding medical devices andpharmaceuticals, if such proposals are made, on the premise that health and hygiene
standards will not be jeopardized.
V.

FINANCIAL SERVICES

A.

In a step toward global best practice, members of the Investment Trusts Association
came into compliance over FY2003 with new guidelines for disclosure of investment
performance. These guidelines include clarification of the relevant benchmark,comparison with the benchmark in graphs, and explanation for deviations from thebenchmark. The guidelines also cover the use of clear, simple language and theprovision of contact information for investor inquiries.

B.

With a view to supplementing the public pension system, so as to secure sufficient
income for the aging population, the Government of Japan decided to raise contribution
limits of Defined Contribution (DC) Pension Plans in FY2004 from 432,000 yen to552,000 yen per year for employees benefited by only a DC pension system, and from
216,000 yen to 276,000 yen per year for employees benefited by other company
pensions. The contribution limit for private DC pension plans for employees for whom
the companies do not provide any company pensions will also be raised from 180,000
yen to 216,000 yen per year.

C.

The Government of Japan understands the Government of the United States request to
remove barriers to electronic commerce. The Government of Japan will continue careful
deliberations on whether or not to allow e-notification under the Money Lending
Business Law.

D.

The Financial Services Agency (FSA) has made more active use of its No-Action Letter(NAL) system over the past year. Moreover, it has taken a number of steps and isconsidering additional measures designed to enhance the usefulness of the NAL system.
These actions represent continued progress in enhancing the transparency of Japan’s
financial regulatory regime.
1.

The number of FSA no-action letters issued has increased recently, with nine
NALs issued since April 2003, compared to just four issued during the first two
years in which the FSA’s NAL system was in place.

2.

The FSA has also undertaken a review of its NAL system, following the March
2004 Cabinet Decision. The FSA will take the following steps to enhance theeffectiveness of its NAL system and increase the number of NAL requests,
including:a.

Continuing to make efforts to inform financial market participants thatthey can seek clarification of Japan’s financial laws and regulations via
the FSA’s NAL system.
26

3.

b.

Announcing that groups of firms and/or industry associations – includinginternational groups such as the American Chamber of Commerce inJapan and IBA, as well as domestic industry associations such as the
JSDA or JBA – can submit NAL requests on behalf of specific firms.

c.

Amending the bylaws of its NAL system: (i) to clarify that the FSA will
not issue a NAL finding if the individual or firm withdraws its NAL
request and asks the FSA not to issue a NAL; and (ii) to require future
NALs to include language clarifying the legal or regulatory basis of thefinding expressed in the NAL.

The FSA remains open to suggestions from the Government of the United Statesand members of the financial community as to how best to enhance its NAL
system and other efforts to increase the transparency of financial regulation in
Japan.

VI.

COMPETITION POLICYA.

Deterrence of AMA Violations and Strengthened JFTC Enforcement Powers
1.

The Study Group on Reviewing the Antimonopoly Act, held by the Japan Fair
Trade Commission (JFTC) since October 2002, issued a report in October 2003
on the results of its review of the Antimonopoly Act (AMA). The JFTC publishedthe “Outline of Amendment to the AMA” in December 2003 based on the Study
Group report and the public comments that were filed thereon. After further
consideration, the JFTC, on May 19, 2004, completed the proposal to amend theAMA. The Government of Japan will make every effort to submit the bill to theDiet this year. The proposed amendments include:a.

Approximately doubling the surcharge rates applicable to enterprises thatengage in certain violations of AMA Section 3 from the current rate ofe.g. 6 percent for large firms;b.

Further increasing the surcharge rate by another 50 percent for firms thatwere assessed another surcharge payment order within the last ten years;c.

Lengthening the cap on the maximum period of sales on which surcharges
will be assessed to four years, from the current maximum of three years;d.

Enlarging the scope of conduct subject to surcharge orders to include (i)private monopolization or restraints of trade concerning the price, volume
of supply, market share or customers of particular goods or services, and(ii) purchasing cartels;

27

e.

Introducing a leniency program whereby, before the commencement of
the investigation conducted by the JFTC, the first qualifying company
would be immune from assessment of surcharge and the second qualifying
company would receive a 50 percent reduction in the surcharge amount.
After the commencement of the investigation, the first or second
qualifying company would receive a 30 percent reduction in the surcharge
amount. The total number of companies eligible to apply for the leniency
program is limited to two.

f.

Introducing compulsory measures by the JFTC for criminal investigations;g.

Extending the statute of limitations for the JFTC to issue cease and desist
orders to three years after the termination of the violating conduct; andh.

Raising the maximum criminal fine for violating cease and desist orders of
the JFTC from 3 million yen to 300 million yen.

2.

In addition, the JFTC will announce that under the new leniency program the firstqualifying company before the commencement of the JFTC’s investigation will
not be the subject of a criminal accusation by the JFTC.

3.

The Government of Japan is committed to strengthening criminal enforcement of
the AMA through further enhancement of close cooperation between the Public
Prosecutors Office and the JFTC for effective implementation of the criminal
provisions of the AMA. In this regard:

4.

a.

In July 2003, JFTC filed a criminal accusation against four companies andfive individuals for bid rigging on water meter procurement contracts by
the Tokyo Metropolitan Government. All companies and individuals were
found guilty by the court. The companies were sentenced to pay criminalfines of 20-30 million yen (approximately $175,000-$260,000). The
prosecutors recommended sentences on the individuals of 12-14 monthsof jail time. The court imposed jail sentences on the individuals of 12-14
months, but suspended the execution of the sentences, with three years
probation.

b.

The JFTC will enhance its efforts to gather information on and toinvestigate alleged AMA violations, and will actively implement thecriminal provisions of the AMA when the JFTC finds concrete facts ofviolations. In this course, the JFTC will also exchange information andviews with the Public Prosecutors Office in a manner adequate to facilitate
the filing of criminal accusations.

With respect to merger review, the JFTC aims at further improving its economic
analysis ability by making use of post-graduate level economists, and published28

and will continue to publish the results of individual cases in which it has
conducted a detailed examination.
5.

B.

The JFTC established the “Competition Policy Research Center” in the General
Secretariat in June 2003 and has been making efforts to enhance the economic
analysis ability of its officials through joint studies with outside experts. The
Center released four reports based on such joint studies with visiting researchers
in FY2003.

Eliminating Bid Rigging: The Government of Japan is committed to dismantling thebid rigging system in Japan and eliminating bid rigging on all central government,
government-related entity and local government contracts. To this end, and with the
purpose of deterring and penalizing companies that engage in bid rigging:
1.

2.

In September 2003, MLIT strengthened its measures on suspension of designationof contractors that engage in illegal activities, including bid rigging. Under thosestrengthened measures:a.

Companies that engage in bid rigging will be subject to nationwide
suspension of designation by MLIT and all of its Regional Development
Bureaus if top executives or members of the board of directors of thecompany were complicit in the bid rigging activities, regardless ofwhether the bid rigging was on projects let by MLIT, other central
government agencies, public corporations or local governments;b.

The maximum term of suspension of designation for a company thatengages in bid rigging in violation of the Antimonopoly Act was extended
from 9 months to 12 months.

c.

Within the term mentioned in subparagraph b above, the term ofsuspension of designation that is actually imposed on a company thatengages in bid rigging will be made more severe in cases where (i) thebid rigging involved “government-led bid rigging” (kansei dango), and thecompany tried to induce public procuring entities to be complicit in thebid rigging in violation of the Bid Rigging Involvement Prevention Act, or(ii) the bid rigging was the subject of whistleblowing, and the company
clearly denied the allegations of bid rigging by the whistleblower,
although it, in fact, had committed the bid rigging.

In June 2003, MLIT introduced a new contract clause to be used in all MLIT
construction and design/consultation services contracts. It specifies
pre-established damages equal to 10 percent of the contract price that must be
paid by its contractors that commit bid rigging in order to compensate MLIT forthe damages caused by the bid rigging.

29

3.

C.

In June 2003, MLIT published the measures that it took to prevent the Economic
Research Association and the Construction Research Institute from engaging in or
repeating bid rigging. MLIT has taken measures mentioned above to prevent
recurrence of bid rigging by those organizations.

Promoting Competition in Industries Undergoing Deregulation
1.

With respect to the importance of promoting regulatory reform and competition
policy in an integrated manner, the Three-Year Program for Promoting
Regulatory Reform provides that:a.

In order to introduce competition in regulated sectors in which new entry
has been limited, the JFTC will continue to conduct surveys on the statusof competition in these sectors from the viewpoint of promoting
competition when policy recommendations are necessary, and will
actively make proposals when there is room for improvement. For theseregulated sectors, the regulatory agencies and the JFTC will consider amechanism under which they can work together on the establishment andreview of systems concerning competition, and will make related
guidelines as necessary.

b.

A system will be introduced to convey to the Council for Promotion ofRegulatory Reform the reports and recommendations by the JFTC to
relevant Ministries concerning the promotion of competition in regulated
sectors. The Council will follow-up on the status of consideration of such
recommendations.

c.

In view of the indivisibility of regulatory reform and the promotion of faircompetition, the Council for Promotion of Regulatory Reform and the
JFTC will continue to maintain close cooperation.

2.

The JFTC endeavors to have the perspectives of competition policy fully reflectedin the design of new regulatory systems by participating in study groups convenedby the Ministry of Economy, Trade and Industry (METI) and the Ministry of
Public Management, Home Affairs, Posts and Telecommunications (MPHPT) andby explaining its viewpoint on competition in relevant sectors. In particular, inthe past year, the JFTC attended study groups on the electricity and gas sectors.

3.

The JFTC has been active in preparing guidelines to clearly identify the conductthat may violate the AMA in regulated sectors.
a.

In April 2004, the JFTC and MPHPT published draft revisions to the
Guidelines Concerning the Promotion of Competition Policy in the
Telecommunications Business Field, and requested public comments. The
final revised guidelines are expected to be published this summer;
30

4.

D.

b.

In light of the amendments to the Electric Utilities Industry Law that willtake effect on April 1, 2005, the JFTC and METI have been working torevise the “Guidelines Concerning Appropriate Electric Power Dealings;”
andc.

In addition, the JFTC and METI have been working to revise the“Guidelines Concerning Appropriate Dealings in the Natural Gas Sector.”
JFTC and METI will publish the draft revisions for public comment.

For the promotion of regulatory reform, the JFTC has been holding the “Study
Group on Government Regulations and Competition Policy” and conducting
surveys and reviews on regulatory problems and directions of improvement ofregulations from the viewpoint of competition policy.

JFTC Resources
1.

The JFTC received an increase of 35 persons in its staff for FY2004, resulting in a
total staff of 672 as of March 31, 2005.

2.

The JFTC has aimed to enhance the professional knowledge and ability of its staff
through training and on-the-job experience, and has been endeavoring to recruit
experts from various fields, such as law, economics and telecommunications.

VII.

TRANSPARENCY AND OTHER GOVERNMENT PRACTICESA.

Furthering the Promotion of Regulatory Reform
1.

The Government of Japan adopted a Cabinet Decision on March 19, 2004 entitled“The Three-Year Program for the Promotion of Regulatory Reform” (newThree-Year Program) comprising 762 regulatory reform measures. In addition,
on April 1, 2004, the Government of Japan established The Council for the
Promotion of Regulatory Reform (CPRR) to replace the Council for Regulatory
Reform (CRR), whose mandate expired on March 31, 2004. Both steps
demonstrate the Government of Japan’s continued strong commitment tostructural reform, including regulatory reform.

2.

The Government of Japan has implemented approximately 5,000 regulatory
reform measures in a wide range of fields by establishing and promoting threesuccessive reform programs prior to the new Three-Year Program. Building on
past achievements, the new Three-Year Program is a compilation of measures tofurther accelerate structural reform of the Japanese economy and society anddetails specific regulatory reform steps that have been identified as the issues tobe addressed from FY2004 to FY2006. The new Three-Year Program includes
measures that will contribute to the following:

31

B.

a.

Significantly reduce the Central Government’s involvement in sectors of
the economy that can function more effectively without government
involvement;b.

Revitalize the Japanese economy by spurring new business, increasing
demand, and expanding employment; andc.

Create new opportunities for domestic and foreign businesses to build
markets in Japan that will increase consumer welfare.

3.

On April 12, Prime Minister Koizumi expressed his high expectation that the
CPRR will be a central body that promotes regulatory reform, including the
opening of governmental sectors for the participation by the private sector, for
improved consumer welfare and revitalization of the economy. In this new
structure, four of the CPRR’s members will attend meetings of the Headquarters
for the Promotion of Regulatory Reform and will have enhanced opportunities todirectly interact with the Cabinet to discuss the CPRR’s reform recommendations.
The CPRR will also closely coordinate with the Council on Economic and Fiscal
Policy, which submitted the Basic Policy on Economic and Fiscal Management
and Structural Reform to the Prime Minister on June 3, 2004 (the Basic Policy
was adopted by Cabinet Decision on June 4, 2004), as well as with the
Headquarters for the Promotion of the Special Zones for Structural Reform. The
CPRR will also monitor the implementation of the new Three-Year Program andhas the mandate to require, when it deems necessary, the heads of relevant
governmental organizations to submit materials, provide explanations, and extend
cooperation to the CPRR.

4.

On May 25, the Cabinet decided to establish the Headquarters for the Promotionof Regulatory Reform, which decided on the “Basic Policy for the Promotion ofRegulatory Reform” on the same day. The Headquarters, headed by the Prime
Minister and composed by all Ministers, will endeavor to ensure theimplementation of the new Three-Year Program, and revise it in March 2005
based upon the reports to be made by the CPRR. The Headquarters also provides
the CPRR with sufficient opportunities to work together closely, including thoseof attending meetings of the Headquarters, as mentioned above, as well as ofhaving discussions focused on specific topics with relevant Ministers.

Public Comment Procedures
1.

As reaffirmed by the new Three-Year Program for the Promotion of Regulatory
Reform, Japanese Ministries and Agencies continue to use the Public Comment
Procedure (PCP) in order to improve transparency and to ensure fairness in thedecision making process in the establishment, revision, and abolition ofregulations. The Three-Year Program decided by the Cabinet on March 19, 2004,32

also provides for numerous reform measures to improve the PCP in FY2004,
including:C.

a.

The PCP period should be 30 days in principle, and in exceptional cases
where less than 30 days are provided, Ministries and Agencies must makepublic the reason for this determination to shorten the period;b.

In cases where public comments are not incorporated, Ministries andAgencies should make public detailed explanations for these decisions;c.

Regulatory proposals subject to the PCP should include Regulatory
Impact Analyses (RIAs) as often as possible;d.

The Government of Japan is studying the incorporation of the PCP into
the Administrative Procedure Law;e.

Ministries and Agencies should make public, as much as possible, on theirwebsites the entire texts of comments and information submitted by the
public; andf.

The Ministry of Public Management, Home Affairs, Posts andTelecommunications (MPHPT), will undertake improved reviews of theimplementation and effectiveness of the PCP to, for example, ensurecomments are fully taken into account, and as appropriate, incorporated
into final regulations.

2.

MPHPT continues to conduct and publish an annual survey on theimplementation of the PCP, and will maintain close communications with
relevant Ministries and Agencies in this regard.

3.

In January 2004, MPHPT improved the web portal of the Government of Japan(www.e-gov.go.jp/) so as to allow the public to more easily find PCP solicitations
for draft rules and regulations.

Special Zones for Structural Reform: Prime Minister Koizumi and his Administration
continue to make the Special Zones for Structural Reform a priority component ofJapan’s economic revitalization plan. Since the approval of the first 57 Special Zones in
April 2003, the total number of zones has grown to 324. The Government of Japan istaking necessary steps to ensure that successful zones have the largest economic impact
on the greater Japanese economy. To this end, the Government of Japan is:1.

Operating the entire application and regulatory exemption process for the Special
Zones in a transparent manner;

2.

Working to expand market-entry opportunities in the Special Zones;
33

D.

E.

3.

Ensuring domestic and foreign companies alike have non-discriminatory access tooperate in the zones;

4.

Applying successful regulatory exemptions in the Special Zones on a national
basis as expeditiously as possible;

5.

Ensuring opportunities for U.S. and other foreign companies to submit proposals
for regulatory exemptions for Special Zones and to make proposals to local
municipalities to establish Special Zones; and6.

Ensuring the Evaluation Committee for the Special Zones undertakes thefollowing in determining which regulatory exemptions in the Special Zones
should be applied nationwide.
a.

Ensure transparent decision-making process through open meetings andpublicly available information to determine nationwide regulatory
exemptions; andb.

Publication of the decisions and supporting information on evaluations
after the decisions are made so that all interested parties can fully
understand the evaluation process.

Public Input Into the Development of Legislation: Some Ministries and Agencies, attheir discretion, have been opting for public input into draft legislation during its
development, before it is submitted to the Diet.
1.

A law revising the Insurance Business Law to introduce the new Life Insurance
Policyholder Protection Corporation (PPC) went into effect on June 8, 2003. The
Insurance Working Group of the Financial Systems Council in May 2004 began
discussions on the review of the Life Insurance PPC and the Non-Life Insurance
PPC systems.

2.

The Government of Japan will continue to provide interested parties withmeaningful opportunities to be informed of, comment on, and exchange views
with officials on proposed amendments to the Insurance Business Law and/or
other existing laws and regulations related to the Life and Non-Life PPCs. These
opportunities would include actively contributing to the deliberations, to be
finalized by the end of FY 2005, on reforming the Life PPC, including conveying
opinions as appropriate for future deliberations of the Financial Systems Council
and its working groups, which will continue to act as the focus of discussions on
PPC review.

Privatization of Public Corporations

34

F.

1.

On December 19, 2001, the Cabinet adopted the “Reorganization andRationalization Plan for Public Corporations.” In implementing this Program, by
the end of 2003, the Government of Japan conducted necessary measures(amendment of relevant laws, etc.) to organizationally reform 127 of the 163
public corporations subject to the Program.

2.

The Government of Japan remains committed to the continued restructuring andprivatization of Japan’s public corporations and will continue to undertake thisprocess in a transparent manner.

3.

Established by the Government of Japan, an advisory committee consisting ofwell-informed experts from the private sector to monitor and evaluate theimplementation of the Program has met 23 times since its launch in July 2002.
The summaries of the minutes of those meetings and discussion papers have been
made public.

Postal Financial Institutions
1.

The Government of Japan is aware that the Government of the United States has
expressed its strong concern to the Government of Japan regarding the differences
between Kampo and private insurance companies, and has stressed theimportance of establishing a level playing field in which all participants are
subject to the same regulatory, legal, and tax requirements. The Japan Post Law
and the Japan Post Law Enforcement Law bring Kampo inspection and taxation
requirements closer to those of private life insurance companies than they were in
the past. The Ministry of Public Management, Home Affairs, Posts andTelecommunications (MPHPT) will continue to provide opportunities for private
life insurance and other financial companies, upon request, to exchange views
with MPHPT officials on Kampo and Yucho inspection and taxation
requirements. Discussions on topics relating to the differences between Kampo
and the private sector will be conducted in the Council on Economic and Fiscal
Policy within the context of the privatization of Japan Post. The Government ofJapan furthermore is aware that the Government of the United States hasrequested that no new or altered Kampo products should be introduced until alevel playing field is established between Kampo and private sector companies.
The Government of Japan confirms that Japan Post now has no plans to introduce
any new or altered Kampo products or riders.

2.

With regard to the formulation of proposals to seek from the Diet amendments to
law related to Kampo products and distribution or origination by Japan Post of
non-principal-guaranteed investment products, MPHPT recognizes theimportance of informing the general public of such formulation of proposals andwill provide meaningful opportunities for private sector interested parties uponrequest to exchange views with MPHPT officials. Japan Post cannot originate
any non-principal-guaranteed investment products, nor introduce new lending35

services not offered at present, as the Japan Post Law does not include any
provisions describing these products or services.
3.

In response to the strong concern raised by the Government of the United Statesover the introduction of a new Kampo product in January 2004, the Governmentof Japan has regularly provided the Government of the United States with data
related to sales of this product, and will continue to provide information on thesales of this product upon request. The Governments of Japan and the UnitedStates will also continue to maintain communication on this subject.

4.

The insurance products or riders underwritten or sold on consignment by Japan
Post are offered pursuant to law. Approval from the Diet is required to expand orchange the products or riders offered by Japan Post, except for limited alterations
within the scope of the products or riders authorized by law.

5.

Concerning the privatization of postal services, the Council on Economic andFiscal Policy on April 26, 2004, issued a paper listing issues it considers
necessary to discuss, and will continue discussions to complete its final reportaround the fall of this year. On the same day, Prime Minister Koizumi
established the Office for Privatization of Japan Post in the Cabinet Secretariat.
The Office will work on drafting legislation on postal privatization for submission
to the Diet in 2005.

6.

Steps have been taken to ensure transparency in the discussions on privatizationby the Council on Economic and Fiscal Policy. The Minister of State in charge of
Economic and Fiscal Policy holds a press conference on the outline of discussionsof each meeting of the Council. In addition, the handouts and minutes of Council
meetings are publicized on the website of the Cabinet Office. Moreover, to hear
the circumstances of various districts and the views of the people there, Postal
Privatization Local Meetings have been held. With regards to the discussions on
and decisions relating to the privatization of Japan Post, the Government of Japan
recognizes the importance of informing the general public of such information. In
the process of privatization, MPHPT and the newly created Office forPrivatization of Japan Post will also provide in a timely manner meaningful
opportunities for private sector interested parties upon request to exchange views
with relevant officials, including on the potential impact of the Government ofJapan decisions on private sector companies in the market.

G.

Insurance Cooperatives: On April 15, 2004, the Insurance Working Group of the
Financial Systems Council started discussions regarding unregulated kyosai which are
currently operating without the benefit of regulatory oversight. The Government of Japan
will seek opinions broadly in the process of the discussions.

H.

No-Action Letter: In a March 2004 Cabinet Decision, the Government of Japan
broadened the scope of its No-Action Letter (NAL) Procedures. The Cabinet Decision36

clarified that firms in all industries subject to government regulation may seek written
clarification of those regulations, not merely firms in “new industries such as IT, finance,
etc.”
VIII. LEGAL SERVICES AND JUDICIAL SYSTEM REFORM
A.

Legal Services
1.

Freedom of Associationa.

In July 2003, the Diet enacted an amendment to the Special Measures Law
Concerning the Handling of Legal Business by Foreign Lawyers (Gaiben
Law) that introduced completely new mechanisms regarding theassociation between Japanese lawyers (bengoshi) and registered foreign
lawyers (gaiben), including lifting the ban on employment of bengoshi bygaiben, abolishing the specified joint enterprises (tokutei kyodo jigyo)
system and establishing joint enterprises between bengoshi and gaiben(gaikokuho kyodo jigyo) (GKJ), through drastic deregulation based upon afundamental revision of the existing systems.

b.

The amended Gaiben Law provides that the Law shall come into force on
the day designated by government ordinance within two years from thepromulgation of the Law (July 25, 2003), to enable completion ofnecessary preparatory measures, including the adoption of necessary newrules and regulations by the Japan Federation of Bar Associations(Nichibenren). The Government of Japan will decide the actual effective
date of the amended Law after consulting with Nichibenren about the needfor new rules and regulations and the time it will take to complete
necessary work.

c.

Nichibenren has begun the process of drafting rules and regulations for the
implementation of the new amendments, including regulations concerning
the employment of bengoshi by gaiben and concerning GKJ. The
Government of Japan actively supports the provision to gaiben by
Nichibenren and the local bar associations of full and effective
opportunities to participate in the formulation of such proposed rules andregulations, including by permitting them to attend all relevant meetingsand proceedings of Nichibenren and the local bar associations and to
express their views on the proposed rules and regulations.

d.

The Ministry of Justice (MOJ) has been making efforts to seek
Nichibenren’s correct understanding of the amended law and theappropriate handling of related procedures in bar associations throughconsultations with Nichibenren so that Nichibenren will make its rules and37

regulations consistent with the fundamental idea and interpretation of theamended Gaiben Law.
2.

B.

Professional Corporations and Branches: Concerning the establishment of gaiben
professional corporations which are able to establish branch offices, MOJ has
conducted a preliminary study of the issue and has decided to study whether
gaiben should be permitted to form professional corporations from the standpointof trends in the needs for international legal services in Japan and for the actual
operation of GKJ, the experience of the bengoshi professional corporation systemand principles of non-discrimination.

Judicial System Reform
1.

2.

The Government of Japan submitted a bill to amend the Administrative Case
Litigation Law to the ordinary session of the Diet in March 2004. This billaddresses the following broad points with regard to judicial review ofadministrative actions:a.

Enlarging the scope of remedy, including the expansion of standing forthird parties;b.

Consolidating and speeding up of administrative litigation;c.

Making administrative litigation easier to use and to understand; andd.

Providing relief pending review in advance of judgment on the merits.

The bill sets out considerations that the court must use in determining whether
third parties other than the person at whom the administrative disposition was
aimed have the requisite legal interest for standing. This provision requires thecourt to consider not only the wording of laws and regulations on which anadministrative disposition is based, but also the intention and purpose of the laws
and the content and nature of the interest which should be considered in theadministrative disposition. In these considerations, the courts are also directed toconsider the intention and purpose of other related legislation with common
purposes, the content and nature of the interest which would be harmed if theadministrative disposition is in breach of authorizing law, how the interest will beharmed and the severity of the injury, in determining whether standing
requirements are satisfied. The Government of Japan expects that, through theseprovisions, standing will be in substance broadly construed.

IX.

COMMERCIAL LAW

A.

Adoption of Modern Merger Techniques

38

B.

1.

The Corporate Law Committee of the Ministry of Justice’s Legislative Council iscurrently discussing the modernization of Japanese corporate law. A preliminary
outline of the bill to modernize Japan’s corporate law, which included theintroduction of modern merger techniques, was published for public comment on
October 29, 2003. In particular, the preliminary outline included provisions thatwould introduce flexibility in merger currency so as to allow for the use oftriangular mergers, cash mergers and share exchanges using foreign shares, andalso included provisions to permit short form (squeeze out) mergers. Based on
the results of the discussions of the Corporate Law Committee, and taking into
account the comments received on the preliminary outline, the Government ofJapan intends to submit legislation to modernize Japan’s corporate law, including
with respect to the introduction of modern merger techniques, during the next
regular session of the Diet in 2005.

2.

The Government of Japan is studying ways to facilitate corporate restructuring
and investment in Japan, including tax treatment of modern merger techniques inline with the decision made by Japan Investment Council in March 2003.

3.

In the past year, two foreign companies, through their Japanese subsidiaries, wereable to take advantage of the exceptions to the Commercial Code allowed by the
Revised Special Measures Law for Industrial Revitalization (IRL) to effect atake-over of a Japanese company using an equity-swap/merger mechanisms withcash consideration. METI will continue to review corporate restructuring
techniques and the trend of mergers conducted under the IRL, and will study
impediments to using modern merger techniques in Japan.

Promoting Shareholder Value through Active Proxy Voting
1.

Pension Funds: The Government of Japan recognizes the important role of active
shareholder voting in strengthening corporate governance and shareholder value
to the benefit of the beneficiaries of pension funds. In this light, the Governmentof Japan supports the promotion of proxy voting by managers of public andprivate pension funds as a mechanism for increasing investment returns topension funds, and has taken the following actions in this regard:a.

In 2001 the Minister for Health, Labour and Welfare (MHLW) issued the
Basic Policy for pension fund managers of the Government Pension
Insurance Fund (GPIF). That Basic Policy encourages GPIF outside
pension fund managers to exercise their voting rights to improveshareholder value.

b.

GPIF has issued general guidelines applicable to all of its pension fundmanagers requiring them to exercise proxy voting rights to maximize
shareholder value and to report to GPIF annually on their actual record ofproxy votes. GPIF makes public the record of proxy voting reported by39

each of its fund managers. Each fund manager, in turn, has prepared theirown internal policies regarding how proxy voting rights will be exercised,
and these policies are reported to MHLW. MHLW will study whether tomake public the proxy voting policies of each fund manager.

2.

C.

c.

In 2003, the Pension Fund Association, a government-related organization(ninka hojin) established under the Employee Benefit Law that manages 8
trillion yen in pension fund assets, issued detailed proxy voting guidelines
for its internal and outside fund managers and is working to integrate theindividual proxy voting guidelines adopted by each fund manager. In
addition, the Local Government Official Pension Fund (chikyoren)
recently issued proxy voting guidelines that its fund managers must
follow, and the Central Government Official Pension Fund (kokkyosai) is
considering whether to adopt such guidelines as well.

d.

With regard to private pension funds, the scope of the fiduciary duties offund managers under the Employees Pension Insurance Law is developing
under the law. The Government of Japan supports the continued
development of fiduciary duties for pension fund managers with respect tothe exercise of proxy voting rights.

Mutual Funds:a.

The Government of Japan supports the promotion of proxy voting by
mutual fund and investment trust managers as a mechanism for increasing
corporate value. In 2003, the Investment Trust Association, aself-regulatory association established under the Investment Trust Law
and under the jurisdiction of the Financial Supervisory Agency (FSA) andcomposed of virtually all mutual fund companies in Japan, haspromulgated rules on proxy voting which must be followed by member
mutual fund and investment trust managers. Those rules require member
companies to disclose their proxy voting policies, including the objectives
and basic stance of the company with regard to proxy voting, the decision
making process on exercising proxy voting rights and the screening
criteria used in determining how the proxy voting rights will be exercised.

b.

FSA will encourage the Investment Trust Association to amend their rules
on proxy voting to also require members to publicly disclosure their actual
proxy voting record.

Promoting Good Corporate Governance through Protection of Whistleblowers:
Based on the report released by the Consumer Policy Committee of the Quality-of-Life
Policy Council, the Government of Japan submitted the Whistleblower Protection Bill to
the Diet on March 9, 2004. The bill provides civil remedies to protect employees who
blow the whistle for public interests from dismissal or mistreatment, provided that certain40

requirements are met. The bill covers whistleblowing on crimes or violations concerning
laws and ordinances related to human life, health, and property, which include violationsof the Securities and Exchange Law. As a result, employees who blow the whistle on
fraudulent misrepresentations to shareholders or other unlawful practices under securities
laws that may interfere with corporate governance or shareholder oversight will beprotected against termination or other retaliation by their employers.
D.

Alternative Dispute Resolution
1.

The Government of Japan recognizes that alternative dispute resolution (ADR)
mechanisms can play an important role in helping individuals and businesses
resolve disputes in an efficient and economical manner. The Government ofJapan will continue to study, through the Consultative Group of Experts for the
Study of ADR under the Office for Promotion of Justice System Reform, ways tostrengthen and revitalize ADR in Japan so that it will become an attractive
alternative to court litigation as a measure of dispute settlement. The Governmentof Japan has as its goal the creation of a flexible and open legal environment thatfacilitates the development of ADR services including those operated by theprivate sector and will take steps to provide the necessary infrastructure for ADR
in that regard as soon as possible.

2.

The Government of Japan noted the recommendations of the Government of theUnited States regarding ADR, including allowing non-lawyers to act as neutrals
in ADR proceedings and not adopting any mandatory certification system fororganizations or individuals offering ADR services. The Government of Japan
indicated that consideration is being given to such matters.

X.

DISTRIBUTION

A.

Landing and Airport Fees
1.

The Government of Japan expressed its views on the concerns held by theGovernment of the United States regarding reduction of landing fees at Narita andKansai International Airports.

2.

In accordance with the bill passed by the Diet in July 2003, the New Tokyo
International Airport Authority was transformed in April 2004 into the Narita
International Airport Corporation, a special company currently wholly owned by
the Government of Japan, as a means to achieve full-privatization in the future.

3.

During discussions with the Government of the United States, the Government ofJapan outlined the mid-term management plan made by the Narita International
Airport Corporation, which aims to reduce landing fees as soon as possible,
following a thorough assessment of the Corporation’s business conditions.

41

B.

Airfares: The Government of Japan expressed its views on the concerns of theGovernment of the United States regarding airlines sales distribution and double
disapproval pricing.

C.

Further Reduce Overtime Charges in International Physical Distribution Special
Zones: The 50 percent reduction in overtime charges within the International PhysicalDistribution Special Zones in April 2003 increased the competitiveness of Japan’sinternational ports. The Government of Japan subsequently decided to reduce overtime
charges nationwide by 50 percent as of April 1, 2004. Japanese consumers andbusinesses now benefit from an overtime rate in the International Physical Distribution
Special Zones that is only 25 percent of the rate charged before April 2003. These
decisions are a positive signal to international markets that Japan intends to continue tooperate as an important trans-shipment hub for air and sea distribution. The Governmentof the United States highly appreciates this progress.

D.

Nippon Automated Cargo Clearance System (Air-NACCS): A third party panel,comprised of domestic and foreign interests, is reviewing Air-NACCS pricing and isdrafting a report on NACCS user fee reforms, on which the Government of the Untied
States noted its appreciation. The NACCS Operating Center intends to post the panel’s
recommendations on its web site (www.naccs.go.jp) in June or July of this year, andintends to invite public comment for a user fee reform draft reflecting therecommendations. The report is expected to improve the Air-NACCS fee system for allusers, further advancing Japan’s air customs clearance process.

E.

Interline Contracts: In the course of the third year of the Regulatory Reform Initiative,
the Government of Japan explained to the Government of the United States thatdoor-to-door air transport service is available by interline contracts between Japanese andforeign carriers, and that there are no governmental regulations on this business activity.

F.

Credit/Debit Cards
1.

The Government of Japan took note of the request from the Government of theUnited States to promote the use of credit and debit cards as means of payment
for government services. The Government of Japan also noted that, for instance,
approximately 100 hospitals belonging to the National Hospital Organization
have declared their intention to accept credit/debit card payments, some of whichhave already started to accept them and others are now under preparation.

2.

The Government of Japan recognizes the importance of maintaining a sufficientlevel of security standards in ATM networks for banks in Japan. The
Government of Japan also noted that hosts of banks’ ATMs decide encryption
standards for their networks, including complying with international PIN security
and encryption standards.

42

3.

The Credit Authorization Terminal (CAT) system, which is promoted by the
initiative of the Japan Credit Card Association (JCCA) to be placed at member
stores, is specified to accept credit cards issued overseas. The total number of
installed CATs is increasing steadily, and there are approximately 950,000 units
throughout Japan. The installation of these terminals is a step toward improving
the environment for the use of foreign credit cards.

4.

The National Police Agency (NPA) is tightening regulations related tocredit/debit card fraud in Japan. NPA is reinforcing cooperation with customs
and immigration authorities and credit and debit card issuers and merchants toprevent smuggling and use of “raw” cards into Japan, which do not carry any
personal information and could be used as materials for false cards, as well as
illegal entry of criminal groups.

43

REGULATORY REFORM AND OTHER MEASURES BY
THE GOVERNMENT OF THE UNITED STATESI.

CROSS-SECTORAL ISSUES CONCERNING REGULATORY REFORM AND
COMPETITION POLICYA.

Consular Affairs
1.

Biometric Identifiers on Passports:a.

The Department of Homeland Security (DHS) and Department of State
have asked Congress to pass legislation that would extend until November
30, 2006 the deadline for Visa Waiver Program (VWP) countries to havemachine readable passports that include biometric identifiers, and also for
DHS to have readers for these biometric passports at all ports of entry.

b.

Concurrently with this request, DHS announced that it will begin
processing visitors traveling under the VWP in US-VISIT beginning by
September 30, 2004 at air and sea ports of entry. US-VISIT requires thatmost foreign visitors traveling to the United States on a visa and arriving
at an air or sea port have their two index fingers scanned and a digital
photograph taken to verify their identity at the port of entry. By
September 30, 2004, this process will also apply to visitors traveling under
the VWP at all air and sea ports of entry and will be expanded to landborder ports of entry as US-VISIT is deployed to those locations. Since
January 5, 2004, the Government of the United States has been making
efforts to ensure Japanese citizens traveling to the United States withvisas, who are subject to US-VISIT requirements, could enter the UnitedStates without significant delays or difficulties and will continue to do so.

c.

The National Institutes of Standards and Technology (NIST)
recommended, and the Secretary of Homeland Security and the Secretaryof State have approved, the use of fingerscans in addition to digital facial
image as the biometrics that will be used in the US-VISIT system for
U.S.-issued travel documents. The biometric requirements for US-VISIT
differ from the International Civil Aviation Organization (ICAO)
recommendations in that US-VISIT will utilize both digital facial image
and fingerscans to verify identity and conduct appropriate checks. U.S.
border security policy is under constant review and will be subject tocontinued review to ensure both the safety and security of the UnitedStates and the facilitation of international travel. In this regard, theGovernment of the United States will make further efforts to provide
Japanese travelers with sufficient information in advance.

44

2.

d.

The Government of the United States is working with and will continue towork with the Government of Japan to ensure that the Government ofJapan’s program for production of ICAO-compliant biometric passports
will meet the requirements to remain in the VWP. The Government of theUnited States will work with the Government of Japan to test various
technologies that will be used to produce and read these documents.

e.

The Government of the United States will continue to inform theGovernment of Japan on the status of legislation to extend the deadline for
VWP countries to issue machine-readable passports that include biometricidentifiers.

Collection of Biometric Information at Ports of Entry:a.

The Government of the United States understands the Government ofJapan’s concerns about protecting the information of Japanese citizens
obtained through the new biometric requirements. That information will
be stored in databases maintained by DHS and the State Department as
part of an individual’s travel record. The system will be available to U.S.
Customs and Border Protection Officers at ports of entry, special agents in
U.S. Immigration and Customs Enforcement, adjudications staff at U.S.
Citizens Immigration Services offices, and United States consular offices and appropriate federal, state, and local law enforcement personnel. The
program will be implemented in compliance with US-VISIT establishedprivacy policies and our privacy impact assessment. Authorized officials
will have access to the data for official business on a need-to-know basis.
Safeguards have been implemented to ensure that the data is not used oraccessed improperly. While the Government of the United States plans toretain this data for security purposes and to improve the efficiency of portsof entry, it fully understands the position of the Government of Japan thatthe data of an individual traveler should be erased upon his/her departurefrom the United States. In addition, the DHS privacy officer will review
pertinent aspects of the program to ensure that proper safeguards are inplace.

b.

The US-VISIT program’s budget is $330 million for FY2004, $380
million for FY2003. These funds are primarily intended to covertechnology acquisition and improvements. DHS has established processes
to enable officers to obtain and process this information in an expeditious
manner. While it has no plans for significant additional staff at this time,
DHS will continue to monitor the situation at ports of entry to ensure thatit has adequate human and physical resources to fully and efficiently
implement US-VISIT as the program expands at the end of September
2004 to include visitors traveling under the Visa Waiver Program (VWP),

45

which will result in a substantial increase in the number of travelers going
through US-VISIT.
3.

4.

Visa Process: The Government of the United States has taken a number of steps
to improve visa processing in Japan and North America.
a.

The Visa Branches at the U.S. Embassy in Tokyo and Consulate Generalin Osaka, the two largest U.S. visa-issuing offices in Japan, have adopted
an improved, web-based appointment system, and allow applicants toapply at the visa branch of their choice. These measures havesignificantly reduced the visa processing backlog in Tokyo and Osaka.

b.

The Department of State has added two new visa officers at the U.S.
Embassy in Tokyo and three more will be added over the next several
months. Osaka has added one visa officer and will add one more.

c.

The Department of State currently exempts certain Japanese nationals in
the H and L categories from personal interview requirements.

d.

The new appointment system allowing appointments to be made up to
three months in advance at U.S. missions in Japan eases the difficulties ofscheduling trips to Japan to renew visas. The Government of the UnitedStates reiterated to the Government of Japan that the applicant’s legal
status in the U.S. does not expire with the visa; therefore the applicant
need only apply for a new visa when planning on traveling abroad. The
U.S. Embassy has also upgraded its web site with more detailed
information for visa applicants.

e.

In order to allow applicants to plan their travel, the Department of State
publicizes visa revalidation processing times on its website(www.travel.state.gov). This information is also available through theAmerican Immigration Lawyers Association.

f.

As an alternative, for efficient processing, Japanese citizens can also apply
to renew their visas at U.S. embassies and consulates in Canada or
Mexico. These embassies and consulates offer an appointment systemthrough their websites, accessible at http://www.nvars.com.

Social Security Numbers:a.

The Social Security Administration (SSA) continues its dialogue with
States concerning driver’s license requirements. At this time it is the
SSA’s understanding that the State of Illinois is the only State that will not
substitute an alternative identifier for a Social Security Number (SSN) for
driver licensing purposes. The SSA has informed the State of Illinois of46its concern for the ability of some lawfully admitted non-citizens to obtaindriver’s licenses in Illinois.
b.

The Illinois General Assembly has passed HB 5320, which would enable
Japanese citizens lawfully admitted to the U.S., and other lawfully
admitted non-citizens, without work authorization, to get Illinois driver’s
licenses. Once implemented, the amended Illinois Vehicle Code Sec.
6-105.1 will provide as follows:(1)

The Secretary of State may issue a temporary visitor’s driver’s
license to a foreign national who (i) resides in this State, (ii) is
ineligible to obtain a social security number, and (iii) presents to
the Secretary documentation, issued by United States Citizenshipand Immigration Services, authorizing the person’s presence inthis country.

(2)

A temporary visitor’s driver’s license is valid for three years, orfor the period of time the individual is authorized to remain in thiscountry, whichever ends sooner.

(3)

The Secretary shall adopt rules for implementing this Section,
including rules regarding the design and content of the temporary
visitor’s driver’s license.

c.

The SSA and the Department of Homeland Security (DHS) continue towork to improve the verification process for immigration status, which is
required to issue SSNs to non-citizens. SSA and DHS are working toverify all cases electronically in place of paper verification.

d.

The SSA is working to expand enumeration at entry (EAE) to include
some nonimmigrant classes. Expanded EAE will alleviate many problems
for nonimmigrants needing to work immediately upon arrival in the
United States.

5.

Permission to Stay: The Citizenship and Immigration Services Office of the
Ombudsman (OCIS) within the Department of Homeland Security is exploring
ways to improve the process of applying for extension of permission to stay.
OCIS will continue to make efforts so that the processing period for applications
to extend the period of permission to stay will be reduced for non-immigrant visa
holders.

6.

Driver’s Licenses: According to an April 2004 report by the National
Immigration Law center, 14 states now link visa and driver’s license expiration
dates. The Government of the United States will seriously consider the requestsof the Government of Japan when formulating its position on this issue.
47

B.

Distribution
1.

Counterterrorism Measures in Maritime and Other Sectors:a.

The United States is working closely with numerous internationalorganizations, including the World Customs Organization (WCO), in
developing and refining guidelines, benchmarks, and best practices
surrounding supply-chain security in order to ensure that robustinternationally common and unified systems come to fruition.

b.

The United States strives to be consistent with existing international
practices where they exist. In cases where no internationally recognizedpractices exist, the United States works to develop, with international
cooperation, new best practices.

c.

The Government of the United States appreciates the Government ofJapan’s comments concerning requirements for advance electronicpresentation of cargo information. The United States Bureau of Customs
and Border Protection (CBP) is considering providing a grace period toallow companies to adjust after the advance manifest rules for air cargo
are implemented in late summer or early fall 2004.

d.

The CBP is currently developing the mechanism and strategy to enroll
additional domestic and foreign supply chain sectors into C-TPAT. The
intent is to construct a supply chain characterized by active C-TPAT links
at each point in the logistics process.

e.

The CBP will continue to work to ensure that C-TPAT members realize
the benefits of the program.

f.

The CBP appreciates the close cooperation of the Japanese Customs andTariff Bureau, and all interested parties, on the implementation of theContainer Security Initiative (CSI), and will continue to consult with thoseparties regarding CSI.

g.

In 2004, the Automated Commercial Environment (ACE) program will
experience the greatest amount of growth to date, providing significant
capabilities to government and the trade community. In addition,
coordination with other government agencies on ACE will intensify andparticipation will grow. The current ACE development focus is on
Periodic Payment and e-Manifest, which are scheduled for release insummer 2004 and winter 2005 for truck capabilities. Periodic Payment
features provide centralized payment processing by account to allow formonthly periodic statement and payment capabilities. The e-Manifest
feature will enable quicker entry for pre-filed and pre-approved cargo for48

trucks and will be delivered first to the seven busiest land border ports.
The ACE will ultimately be delivered to all port, locations, andtransportation modes.
2.

Customs Liquidation: The Bureau of Customs and Border Protection willcontinue to discuss with the Government of Japan its concerns regarding the 314
day customs liquidation cycle.

3.

Merchant Marine Act of 1920: The Government of the United States and theGovernment of Japan exchanged views regarding the Merchant Marine Act of1920. The executive agencies of the United States will continue to consult andexchange information with the Government of Japan and will keep the Federal
Maritime Commission (FMC) informed of the situation of Japanese ports.

4.

Maritime Security Program: The Government of the United States took note of
the request of the Government of Japan to abolish the Maritime Security Program.

5.

a.

The Maritime Security Program (MSP) is intended to ensure that an active
U.S. merchant fleet and the trained personnel needed to operate bothactive and reserve vessels will be available to meet U.S. national andglobal security requirements for sealift capacity. On November 24, 2003,
the President signed the National Defense Authorization Act for Fiscal
Year 2004, which includes authorization of the Maritime Security Act of2003 (MSA 2003), and a $1.734 billion reauthorization of the MSP for 60
ships for fiscal years 2006 through 2015.

b.

The Government of the United States will ensure that the Government ofJapan be kept informed of the list of the dedicated vessels and] anychanges in the MSP. The Government of the United States believes the
MSP is important to meet global security needs at this time.

Cargo Preference Measures: The Government of the United States and theGovernment of Japan exchanged views on Cargo Preference Measures, including
the law requiring that the transport of Alaskan North Slope crude oil be done on
U.S.-flag ships. The Government of the United States took note of the opinion of
the Government of Japan that measures such as cargo preferences may distortconditions for free and fair competition in the international maritime market.
With respect to these issues, the Government of the United States explained thefollowing:a.

United States Government-owned cargoes covered by cargo preference
laws, including the transport of U.S. military cargo, represent less than
one percent of the United States’ total ocean borne foreign trades; and

49

b.

6.

C.

The last Alaskan crude oil to be exported was in April 2000. Since thattime all Alaskan crude oil production has moved to the U.S. West Coast
market for refining and domestic consumption.

Ocean Shipping Reform Act of 1998: The Government of the United States andthe Government of Japan exchanged views on the Ocean Shipping Reform Act of
1998. The Government of the United States took note of the concern of theGovernment of Japan.

Trade/Investment-Related Issues
1.

2.

3.

The Federal Buy-American Act and Other Related Rulesa.

The Government of the United States recognizes that the issue of
Buy-American is important to the Government of Japan.

b.

The bill referred to in the Government of Japan’s submission was enacted
as Public Law 108-136 on November 24, 2003. As passed, this law does
not impose additional “buy national” requirements on the Department of
Defense, and does not require application of any provision determined to
be inconsistent with international agreements.

c.

The Government of the United States emphasizes that the implementing
regulations of the Federal Buy America Act provide that public interest
and non-availability waivers may be granted for a component of rollingstock, and in such cases, the component would be treated as domestic
when calculating the overall component content of the vehicle.

Anti-Dumping and Safeguard Measures:a.

The Government of the United States will ensure that its anti-dumping laws
conform to its WTO obligations. In that regard, the Administration
supports legislation that would repeal the Anti-Dumping Act of 1916 andbring relevant provisions of the Continued Dumping and Subsidy Offset
Act into compliance with WTO recommendations and rulings. In addition,
the Administration will continue to work closely with Congress on
legislation to implement the WTO recommendations and rulings in the
Hot-Rolled Steel dispute.

b.

The Government of the United States withdrew its steel safeguard
measures on December 4, 2003.

Exon-Florio Provision: The Government of the United States recognizes theGovernment of Japan’s concerns on the “Exon-Florio” clause regarding, inter alia,
50

predictability of regulations, legal stability of completed transactions, and ensuring
due process. In operating the clause, the Government of the United States is
mindful of the Government of Japan’s concerns, and will ensure the clause’s
consistency with WTO rules.
4.

5.

The Patent System of the United States: The Government of the United States andthe Government of Japan reaffirm mutual support for effective substantive patentlaw harmonization efforts, and at the same time:a.

The Government of the United States will continue to discuss with theGovernment of Japan its concerns with the United States’ first-to-invent
patent system. The United States acknowledges that its first-to-invent
system is unique, but despite its shortcomings the United States believes
that the system has worked well in and for the United States. While there
is some growing interest in first-to-file, this remains a controversial issue inthe United States. The Government of the United States will continue todiscuss with the Government of Japan its requests to modify the Hilmer
Doctrine. The United States would like to note that this issue has been
discussed in the ongoing substantive patent law harmonization talks at
WIPO and was discussed in detail at the Trilateral Working Group on
Patent Law Harmonization, which met at the United States Patent andTrademark Office in February 2004.

b.

The Government of the United States will continue to consider the requestsof the Government of Japan to ease requirements for the unity of invention.
It should be noted that the United States is currently studying adoption of a
Unity of Invention standard.

c.

The Government of the United States will continue to discuss with theGovernment of Japan its requests regarding abolition of the exceptions to
the publication of patent applications within 18 months from the filing datefound in the U.S. early publication system. The United States hopes thatits experience with the early publication system will reveal that the needfor exceptions will be proven to be unwarranted. The Government of theUnited States, however, explained that, in the current political climate, any
attempt to narrow or eliminate the exceptions would be unlikely to
succeed.

d.

The Government of the United States will continue to consider the requestsof the Government of Japan regarding further improvements of thereexamination system.

Metric System: The Government of the United States will continue measures toexpand and increase the use of the metric system in the private sector and at the51

federal and local government level. In the meantime, the Government of theUnited States has taken the following interim measures:

6.

a.

On November 6, 2003, the National Institute of Standards and Technology(NIST) at the Department of Commerce hosted a forum in Washington,
D.C. to develop industry support for the update to the Fair Packaging andLabeling Act (FPLA). The industry support for the amendment for
permissible metric only labeling now includes trade associations
representing more than 500 U.S. businesses. NIST reports that it willcontinue to work with other industry groups to expand support for thisinitiative. The latest report on NIST’s activities is available at:
http://ts.nist.gov/ts/htdocs/200/202/forum/forumdir.htm.

b.

This initiative includes working with state weights and measures directors,
in those states that have not implemented the Uniform Packaging andLabeling Regulation (UPLR) to promote adoption of regulations for
permissive metric only labeling. NIST reports that 45 states now accept
goods labeled with metric only in retail stores. NIST will continue
working with the remaining states over the next year to gain acceptance for
metric only labeling at the local level.

Re-Export Control: The Government of the United States recognizes the concernsof the Government of Japan regarding the operation of the re-export system.
a.

In response to Japanese concerns, in 2003, the Department of Commerce
posted updated “Guidance on Reexports and other Offshore Transactions
Involving U.S.-Origin items” in English at:www.bis.doc.gov/Licensing/ReExportGuidance.htmand in Japanese atwww.bis.doc.gov/InternationalPrograms/Foreign_Language/Welcome_Jap
anese.htm.

b.

The Department of Commerce has personnel who are specifically trainedin U.S. export control regulations available in Tokyo to assist withinquiries regarding export control regulations. The Government of theUnited States takes note of the Government of Japan's continuing request to
have the United States station experts with more experience on export
control regulation at the U.S. Embassy and Consulates in Japan to meet theneeds of Japanese re-exporters more fully.

c.

Requiring U.S. exporters to provide export control classification numbers(ECCNs) of U.S.-origin items to Japanese importers would pose asignificant burden, and potential liability, on U.S. exporters who would
need to ensure that the item remains as classified under the exported
ECCN. The Government of the United States will continue to discuss thisissue with the Government of Japan.
52

d.

7.

D.

The Department of Commerce may seek to increase its international
industry outreach program on U.S. export and re-export controls in Asia,
including new seminars in Japan, in the near future. The Department ofCommerce will continue to work with its counterparts in the Governmentof Japan on this issue.

Import Tariff Calculation Method and Labeling Requirements of Origin for Clocks
and Watches: The Government of the United States recognizes the concerns of theGovernment of Japan regarding tariffs and labeling requirements for clocks andwatches. The Government of the United States will continue to discuss with theGovernment of Japan regarding these issues, taking full account of the position
held by the Government of Japan concerning a review of the U.S. tariff scheduleand labeling requirements as well as discussions underway at the WTO.

Sanctions Acts
1.

Iran and Libya Sanctions Act:a.

The Government of the United States appreciates having the views of all its
trading partners in this matter, including those of the Government of Japan.
In response to the issues raised by the Government of Japan, theGovernment of the United States explained that by its terms, the Iran and
Libya Sanctions Act (ILSA) applies to those who engage in activities
covered by the statute, without distinction by nationality. It was explainedthat the legislative history of the Act indicates a concern by Congress thatthe law be applied in a manner consistent with the international obligationsof the United States. The Government of the United States will continue tohave a dialogue with the Government of Japan on these issues.

b.

The United States notes that the scope of the law was significantly changedin April 2004, when its application to Libya was terminated in response to
Libya’s progress in dismantling its weapons of mass destruction and themissiles capable of delivering them.

2.

Cuban Liberty and Solidarity Act of 1996: The Government of the United States
understands the concerns of the Government of Japan regarding the Cuban Liberty
and Democratic Solidarity Act of 1996.

3.

Burmese Freedom and Democracy Act of 2003: The Government of the UnitedStates understands that the Government of Japan has concerns regarding theBurmese Freedom and Democracy Act of 2003 and Executive Order 13310. The
Office of Foreign Assets Control (OFAC) has made available on its website
comprehensive information on the Burma sanctions program. There is also a
contact number there for those with questions on the sanctions program. OFAC
has a Compliance office which deals with questions specifically on whether certain53

transactions are compliant or not. The ban on the exportation of financial services
is as written a very broad one. Listed on the OFAC site are the general licenses
already issued and to what they apply.
4.

E.

F.

Sanctions Acts Instituted by Local Governments:a.

Over the years, the United States has made considerable effort to reach out
to state and local authorities – in Massachusetts, California and elsewhere –to help ensure that sanctions initiatives at the state or local level support
U.S. foreign policy and are consistent with U.S. international obligations.
The United States will continue those efforts when needed.

b.

According to the City Purchasing Office in Berkeley, California, the City
has not enforced its Selective Purchasing Ordinance targeting Burma since
the Supreme Court struck down the Massachusetts’ Burma Law in June
2000.

c.

The Town Council of the City of Chapel Hill, North Carolina, rescinded its
policy barring service contracts with businesses doing business in Burmaon June 26, 2000.

d.

A listing of state and local sanctions, and their status, is available at thewebsite of the NGO USA*Engage.

Competition Policy
1.

The Government of the United States’ antitrust agencies continue to look foropportunities to express their views on the appropriate scope and reach oflimitations on and exemptions to the applicability of federal antitrust laws.

2.

In that regard, in May 2003, the United States filed an amicus curiae brief with theUnited States Supreme Court in Verizon Communications v. Trinko arguing thatan implied antitrust immunity should not be found by the Court.

Legal Services and Other Legal Affairs
1.

Legal Services:a.

In August 2002, the American Bar Association (ABA) adopted a resolution
to encourage all states to adopt foreign legal consultant systems based on
the ABA’s Model Rule. Since that time, the ABA has been working
diligently to gain acceptance of its resolution in this regard. In January
2004, the ABA distributed its resolution to the Chief Justice of each state
Supreme Court and to the President of each state’s bar association and54

requested that the states report back on the status of their implementationof the ABA’s resolution.

2.

G.

b.

In response to the ABA’s efforts, the bar associations of the States ofGeorgia, Pennsylvania and Idaho, among others, have recommended totheir Supreme Courts that they adopt the ABA’s model Foreign Legal
Consultant rule.

c.

The Government of the United States supports the adoption of foreign legal
consultant rules consistent with the ABA Model Rule in all States and will,in that regard, continue to work closely with the ABA in the ABA’s efforts
to achieve full implementation of its resolution. The Government of theUnited States will continue to convey to the ABA the request of theGovernment of Japan that States that already have adopted foreign legal
consultant systems consider reducing the period of practicing experience
required for acceptance of foreign lawyers as foreign legal consultants andabolishing any rule that only practicing experience in the period
immediately preceding the date of application can be considered aspracticing experience, and will continue to encourage the ABA to informthe appropriate State authorities of that request. At the next meeting of the
U.S.-Japan Regulatory Reform and Competition Policy Initiative, theGovernment of the United States will inform the Government of Japan
whether it has received from the ABA any formal response by Stateauthorities to the Japanese request, and the content of any such response.

Product Liability: The Administration is firmly committed to alleviating theundue burden on the business community from inappropriate tort litigation andunreasonable awards. President Bush has expressed his strong support for tort
reform at the federal level in various speeches. The Administration is supporting a
number of bills that have been introduced in Congress to further tort reform,
including bills in the areas of medical liability, class action lawsuits,asbestos-related litigation and gun manufacturer liability. The Administration willcontinue to work for their passage in both houses of Congress.

Public Construction Works – Facilitation of the Settlement of Disputes in theConstruction Business: The United States continues to recommend that firms seek tonegotiate provisions for an ADR process directly with state and municipal authorities, orto suggest ADR as a mechanism to resolve problems that arise in procurement contracts inwhich they are involved. In addition, firms are encouraged to raise their concerns
regarding dispute resolution directly with the local or state governments that have issued
the procurement. The Government of the United States has established a contact point forJapanese firms that experienced problems related to dispute resolution at the state or local
level and encourages Japanese firms having problems to use this contact point. The
contact point will listen to the firms’ concerns regarding the problems they are55experiencing related to public works procurement, and will take additional steps as
appropriate.
II.

TELECOMMUNICATIONSA.

Participation in the U.S. Wireless Market

B.

1.

The Government of the United States acknowledges the Government of Japan’sinterest in the restrictions on the ratio of foreign direct investment in the U.S.
wireless market, and will continue a dialogue with the Government of Japan on
this issue.

2.

Taking account of Japan’s concern in this area, the Government of the UnitedStates clarifies that U.S. law does not prohibit private foreign entities from holding
up to 100 percent direct or indirect investment in non-broadcast,non-common-carrier or non-aeronautical en route or non-aeronautical fixed radio
station licenses. In addition, such entities may directly own up to 20 percent andmay indirectly own up to 25 percent in broadcast, common carrier and aeronauticalen route or aeronautical fixed radio station licenses without special Federal
Communications Commission (FCC) approval; up to 100 percent indirectownership is also possible in principle, if it is found that this would be in the
public interest. With respect to indirect investment relating to common carriers,
the FCC makes a rebuttable presumption in favor of entry if the foreign investor isfrom a WTO member country. Under the above framework, several foreigncompanies have entered the U.S. market. The Government of the United States
will continue to provide information to the Government of Japan on theclassification between common carriers and non-common-carriers in the UnitedStates.

Certification and Licensing Criteria for Foreign Carriers’ Entry into the U.S.
Telecommunications Market
1.

The Government of the United States will continue a dialogue, based on
consultations involving relevant agencies, with the Government of Japan on issues
relating to the transparency of U.S. certification and licensing criteria, and theapplication of foreign policy, trade policy, and competition concerns to licensing
decisions.

2.

A review of regulations relating to international services is underway as a part ofthe 2004 Biennial Review. The Telecommunications Act of 1996 requires the
FCC to review the rules issued under the Communications Act that apply totelecommunications service providers to determine whether any regulations are nolonger necessary in the public interest due to meaningful economic competition
and whether such regulations should be repealed or modified. The comment

56

period for the 2004 is now open, and the Government of the United States
welcomes Japan to enter its recommendations on the record.

C.

D.

3.

The FCC will decide whether to act on staff recommendations by issuing Noticesof Proposed Rulemaking as appropriate to effectuate the recommendations in the
Staff Reports. Any Notice of Proposed Rulemaking would invite comments frominterested parties, including from the Government of Japan.

4.

The Government of the United States acknowledges Japan’s interest inclarification of procedures regarding Section 214 and Section 310 (b) (4) of theCommunications Act and current reporting requirements on carriers regarding
traffic and revenue data.

State-Level Regulations
1.

The Government of the United States will continue a dialogue with theGovernment of Japan regarding state-level regulations, including licensing
procedures, the Government of Japan’s interest in regulatory harmonization amongstates, and adoption of unified reporting requirements.

2.

Taking account of concerns raised by the Government of Japan in this area, theGovernment of the United States notes that all carriers - domestic as well as
foreign - are required to file forms unique to each state in which they operate. The
Government of the United States welcomes efforts by the Governments of Japanand other countries to work with the National Association of Regulatory Utility
Commissioners (NARUC) on items relating to state-level regulations, and has
communicated to NARUC Japan’s interests. The Government of the United States
will provide the Government of Japan with information on NARUC’s work.

3.

The FCC’s newly established the Office of Intergovernmental Affairs will foster abetter understanding of FCC programs, policies, rules and decisions, facilitate a
two-way exchange of information and communications on telecommunications
issues between FCC, state, local, and other federal agencies, and promote
cooperation and coordination in areas of overlapping jurisdiction.

Access Charges and Interconnection
1.

In the Notice of Proposed Rulemaking, Developing a Unified Intercarrier
Compensation Regime (NPRM), the FCC begins a fundamental re-examination of
all currently regulated forms of intercarrier compensation. The FCC will test theconcept of a unified regime for the flows of payments among telecommunications
carriers that result from the interconnection of telecommunications networks undercurrent systems of regulation. Specifically, the NPRM seeks comment on thefeasibility of a bill-and-keep approach for such a unified regime, as well as
modifications to existing intercarrier compensation regimes, taking into account57

the CALLS Agreement, which is in force until superceded by new rules. In sum,
the FCC seeks to move forward from the transitional intercarrier compensation
regimes to a more permanent regime that consummates the pro-competitive visionof the Telecommunications Act of 1996.
2.

E.

F.

The Government of the United States will continue a dialogue with theGovernment of Japan to further clarify rules for TELRIC pricing, UNEs, and otherrelated issues, based upon the final decision to be made by the court concerning
the Triennial Review as well as with a view to promoting competition andinvestment.

Procedures for Processing Export Licenses and TAA Approval of Commercial
Satellites: In 1998 the United States Congress directed the United States Government totreat all satellite exports as munitions exports, subject to munitions licensing procedures,
including case-by-case review. The Directorate of Defense Trade Controls of the
Department of State considers each application for the export of a satellite, satellite
components, or technical data on its merits, including whether or not security
considerations will allow the release of technical data. Detailed information about theArms Export Control Act and ITAR (International Traffic in Arms Regulations),
including information on the licensing process, is also available on the web at<http://pmdtc.org/reference.htm>.
1.

The electronic licensing system has been active since January 15, 2004, and wasformally inaugurated by Secretary Powell on February 18, 2004. Additional
information is available on the web at http://www.pmdtc.org. This system will
make the licensing process more streamlined and efficient. The Governments of
the United States will respond to the extent possible to requests for informationfrom the Government of Japan regarding improvements resulting from this new
system.

2.

The Government of the United States will continue its efforts to minimize delays
and maximize transparency of procedures in export licensing and TAA approval
for commercial communications satellites in accordance with U.S. laws,
regulations, and policies. The United States Government and the Government ofJapan have conducted an informative dialogue on export licensing for commercial
satellites. Recognizing the importance of U.S.-Japan relations, the Department ofState is prepared to discuss specific cases with the Government of Japan if
necessary.

Promotion of Advanced Technologies and Services: In November 2003 and March
2004, the Telecommunications Working Group of the Regulatory Reform Initiative
obtained information from private sector experts on the utilization and application of radio
frequency identification (RFID) in both countries. The Working Group heard their views
on current trends and issues in the developing RFID market, including technology, market
status, and policy.
58

G.

Network Channel Terminating Equipment (NCTE):
1.

2.

The Governments of Japan and the United States, having exchanged views on therelevance of the 1990 Exchange of Letters on Network Channel Terminating
Equipment (NCTE) (“the 1990 Letters”), share the following recognition, based
upon which the two Governments propose a process for terminating the procedures
established through this exchange of letters:a.

Significant competition among telecommunications carriers has emerged
and the development process of terminal equipment has changed
substantially.

b.

Because of the shortened life-cycle of products, the shortened lead-time of
product development, and the increased use of standards, timeframes
described in the 1990 Letters for the disclosure of information on
specifications for NCTE before the introduction of individual services mayhinder prompt supply of advanced services.

As a transitional measure, the procedures established through the 1990 Letters will
be streamlined as indicated below. Unless sufficient evidence demonstrating thecontinued need for these revised procedures is introduced, following solicitation of
opinions from interested parties, these procedures will cease to be applied
beginning in FY2006.
a.

Scope of carriers subject to revised procedures: Main carriers that
determine specifications of NCTE and provide services (except those of
sufficiently competitive areas), using Category I designatedtelecommunications facilities.

b.

Scope of information disclosure under revised procedures: Regarding
NCTE where network interface information has been made generally
available through a standardization process or by other means, disclosure
will not be required.

c.

Term of disclosure of technical specifications: In principle, three months
minimum, prior to introduction of a new service.

III.

INFORMATION TECHNOLOGY

A.

Protection of Intellectual Property Rights
1.

The Government of the United States recognizes the importance of ensuring theprotection of the right of making available, rights concerning live performances,and moral rights, and the Government of the United States also recognizes theimportance the Government of Japan places on the protection of unfixed works.
59

Concerning the Government of Japan’s requests for clear and reliable protection ofthese items under the U.S. Copyright Law, the Government of the United States
has had a series of productive discussions with the Government of Japan. The
Governments of the United States and Japan will continue discussions on theseissues.

IV.

2.

To ensure adequate continuing protection, the Government of the United States
will continue to monitor the development of case law concerning the protection of
moral rights.

3.

The Government of the United States will continue discussions with theGovernment of Japan on the protection of the right of rental for computer
programs with special emphasis on video game programs.

4.

The Government of the United States shares with the Government of Japan anunderstanding on the importance of the protection of intellectual property in Asia.
Under this recognition, the Government of the United States will work with Japan
at the IT Working Group to explore and consider cooperative measures to combat
piracy of digital contents and strengthen protection of other IT-related intellectual
property rights in Asia.

ENERGYThe Government of the United States has taken market reform measures to improve andnormalize the U.S. energy market. This process is welcomed by the Government of Japan.
A.

Power Outage in the Northeast of North America and the Improvement of Network
Reliability
1.

Following the August 14, 2003, blackout that affected 50 million people in the
United States and Canada, the two leaders created a task force to investigate its
cause and recommend corrective measures. The task force released its final reporton April 5, 2004, which specifically identified the causes of the blackout and why
it spread. It also recommended steps to minimize the probability of future
blackouts, including the need to establish mandatory reliability standards forelectric utilities. The task force’s recommendations included the following:a.

Mandatory and enforceable electricity reliability standards should be
implemented with penalties for noncompliance, backed by appropriate
government oversight.

b.

The institutional framework of the North American Electric Reliability
Council (NERC) and its initiatives on compliance should be strengthened.

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2.

B.

c.

A funding mechanism approved by regulators for NERC and the regionalreliability councils should be developed in order to ensure their
independence from the parties they oversee.

d.

Deficiencies identified in one local utility and some reliability
organizations in the United States should be addressed.

e.

A range of technical recommendations made by NERC on February 10,
2004, should be supported and strengthened.

f.

Near-term and long-term training and certification requirements for
operators, reliability coordinators and operator support staff should be
improved.

g.

The physical and cyber security of the network should be increased.

The Government of the United States is strongly supportive of measures toimprove reliability in electricity supply and supports the recommendations
outlined in the final report. Most of the 46 recommendations listed in the final
report have already been assigned specific time frames for implementation.

Improving the Two-Layer Structure of Federal and State Regulations and Disparity
Among States
1.

While our system of government provides for separate federal and state
responsibility over energy regulation, Congress and the Federal Energy Regulatory
Commission (FERC) continue to take steps to limit any adverse impact of multiple
state systems.

2.

The most recent version of the Energy Policy Act of 2003 pending in the Congressstates: “It is the sense of Congress that, in order to promote fair, open access toelectric transmission service, benefit retail consumers, facilitate wholesalecompetition, improve efficiencies in transmission grid management, promote gridreliability, remove opportunities for unduly discriminatory or preferential
transmission practices, and provide for the efficient development of transmission
infrastructure needed to meet the growing demands of competitive wholesale
power markets, all transmitting utilities in interstate commerce should voluntarily
become members of independently administered Regional Transmission
Organizations (RTO) that have operational or functional control of facilities used
for the transmission of electric energy in interstate commerce and do not own orcontrol generation facilities used to supply electric energy for sale at wholesale.”3.

Various versions of the Energy Policy Act of 2003 currently under considerationby the U.S. Congress would acknowledge FERC’s authority to establish andsupervise RTOs, including enforcement of mandatory reliability standards for the61interstate transmission grid; to police market transparency and manipulation anddirect unregulated utilities to open access to their transmission; to assess penalties
for violations commensurate with the harm resulting from anti-competitive
behavior; and to review electric and natural gas mergers in order to reinforce
FERC’s ability to maintain competition.

C.

4.

FERC is vigorously pursuing the establishment of RTOs with both operational andplanning responsibilities for wide geographical regions. The standard market
design rule would harmonize RTOs’ wholesale electric markets in the different
regions.

5.

To ensure that standards of reliability continue to be maintained as electricity
markets become more competitive, the Energy Policy Act of 2003 legislation
would make all owners and operators of the bulk power system subject toenforceable reliability standards. Under the legislation, FERC would haveauthority over an Electric Reliability Organization (ERO), including the ability toorder compliance with the ERO’s standards and to enforce this compliance.

The Comprehensive Energy Bill
1.

The Energy Policy Act of 2003 (the Comprehensive Energy Bill), intended tomodernize our energy production and distribution systems, is currently being
deliberated in Congress. The proposed Act includes provisions in the following
areas.
a.

Modernization of the electricity grid by reforming outdated laws,
promoting open access to the transmission grid, promoting regional
planning and coordination, protecting consumers, and developing anddeploying new technology.

b.

Establishment of mandatory and enforceable reliability standards forelectric utilities to lessen the likelihood of transmission grid failures andblackouts.

c.

Expansion of investment in transmission and generation facilities by
providing increased rates of return on new transmission investments.

d.

Elimination of transmission bottlenecks by providing for last-resort federal
siting authority for high-priority transmission lines and expeditedtransmission permitting activities on federal land.

e.

Establishment of regulatory certainty to attract needed investment in newand expanded Liquefied Natural Gas (LNG) facilities.

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2.

Both President Bush and Secretary of Energy Abraham have issued recent
statements calling for U.S. Congress to pass comprehensive energy legislation.
Provisions for mandatory standards for the electric transmission system havebipartisan support and are an important aspect of the legislation.

D.

PUHCA Repeal: The Energy Policy Act of 2003 legislation would help encourage
expanded investment in transmission and generation facilities by repealing the Public
Utility Holding Company Act (PUHCA), to be carried out within one year after it isenacted.

E.

Publicly Owned Entities: The Government of the United States continues to assess theimpact of Publicly Owned Entities (POEs) on fair competition in a liberalized market.
Many POEs have already submitted to FERC policies on rates and tariffs. The Energy
Policy Act of 2003 would provide that federal Power Marketing Authorities,municipalities, and the Tennessee Valley Authority open access to their transmission, thus
making them subject to competition in the same way as private companies in their region.

F.

Standard Market Design: The Government of the United States recognized theabundance of new generation planned in regions with RTOs, with electricity marketsorganized in a manner similar to FERC’s proposed Standard Market Design (SMD). The
Government of the United States further clarified that SMD facilitates more coordinateddevelopment of generation and transmission facilities. SMD proposes to eliminate
pancaking problems that take place in inter-RTO transactions. To ensure full transparency,
the Government of the United States will continue to ensure opportunities for publiccomment, as is the case in the SMD process.

G.

Clarification of Market Regulation Policies and Measures of the Federal Energy
Regulatory Commission
1.

Once a Notice of Proposed Rulemaking (NOPR) is issued, it is open to a regularpublic comment period, frequently followed with an additional 30 day period forrebuttal comments. This is mandated by law and consistently applied, andguarantees that the rule is subject to inquiry and reflects input from those mostaffected by the rule. Since the regulatory authority carefully takes the comments
into account, the final rule may differ significantly from the proposed rule. FERC
issues two to three NOPRs every year.

2.

As part of FERC’s comprehensive outreach to the states and other stakeholders,
FERC regularly continues to hold open conferences in which all parties have an
opportunity to address policy decisions. For example, there are frequent and open
regional technical conferences announced regarding the White Paper on Bulk
Power Market Design. FERC uses these opportunities to discuss with states,
market participants, and interested parties reasonable timetables for RTO
development activities to benefit customers within the region.

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3.

FERC recently modified the indicative market power screens it uses in assessing
generation market power. The screens will apply on an interim basis to all initial
market-based rate applications and triennial reviews. The policy was adopted after
substantial public comments and is a response to requests by the public for arehearing of an earlier order. The policy provides applicants procedural options,several types of generation dominance tests and the option of proposing mitigation
tailored to the particular circumstances of the applicant.

H.

Price Cap Regulation in the Wholesale Market: FERC can impose price caps or bid
caps on wholesale electricity when necessary to prevent the abusive exercise of market
power. Since FERC does not make arbitrary changes in prices, but uses transparent
mitigation measures, market participants are able to assess the market and make soundbusiness decisions even when wholesale bid caps are implemented. After careful
examination of the costs and benefits of price cap regulation, this can be the mosteffective and efficient measure to prevent abusive exercise of market power.

V.

MEDICAL DEVICES AND PHARMACEUTICALSA.

Participation of the U.S. Food and Drug Administration (FDA) in the Meeting of theWorking Group on Medical Devices and Pharmaceuticals: MHLW had informed
FDA of its wish to hold beneficial and productive discussions on MHLW’s requests, byattending the sessions held in Tokyo and Washington, D.C. of the Working Group on
Medical Devices and Pharmaceuticals. MHLW appreciates FDA for the participation of
its officials in discussions at the session of the Working Group meeting in March 2004.
FDA and MHLW recognize the importance of cooperative relationships, and FDA will
henceforth delegate staffs who are familiar with MHLW’s requests as appropriate. The
U.S. Department of Commerce and FDA will work collaboratively to advance thediscussions with MHLW in the Working Group on Medical Devices and Pharmaceuticals.

B.

FDA’s Regular Meeting with Foreign Industry: MHLW has continuously offered
meaningful opportunities for directly exchanging views with U.S. and other foreign
medical device and pharmaceutical industries operating in Japan. FDA, too, will provide
continuous and meaningful opportunities for discussions concerning its regulations on
medical devices and pharmaceuticals with Japanese and other foreign pharmaceutical andmedical device companies who have submitted an application with FDA and provide
opportunities for regulatory discussions with Japanese and other foreign industry
associations. FDA will also seek to provide the Japanese pharmaceutical industry withsimilar opportunities when the latter’s representatives visit the United States.

C.

Mutual Recognition Agreement (MRA) on Good Manufacturing Practices (GMP) of
Medical Devices and Pharmaceuticals: As the revised Pharmaceutical Affairs Law will
be put in force in April 2005 in Japan, which will require GMP certification for medical
device and pharmaceutical approval, an MRA on GMP or establishment of a similar
cooperative relationship will enable innovative medical devices and pharmaceuticals to bebrought to market more quickly. With the goal of achieving GMP mutual recognition, or64

a similar cooperative arrangement, MHLW has urged FDA to advance GMP cooperation
between the United States and Japan on medical devices and pharmaceuticals in a positive
manner. FDA acknowledges that closer cooperation between FDA and MHLW could
lead to improved patients’ access to medical devices and pharmaceuticals developed by
U.S. companies and that it will be beneficial for the relevant industries of both the UnitedStates and Japan. FDA and MHLW are pursuing and are close to achieving an agreement
to share confidential information. As a means to pursue enhanced cooperation, FDA has
promised to give MHLW access to the FACTS database, a computerized inventory of
regulated firms, which contains the results of inspections into medical device andpharmaceutical manufacturers, and to promptly respond when MHLW requests further
details. FDA and MHLW will continue to discuss procedures for sharing medical device
information and GMP inspection reports on pharmaceuticals.
D.

MRA on Good Clinical Practices (GCP): In view of Japan’s growing accumulation ofexperiences following the introduction of ICH Good Clinical Practice standards, FDA is
willing to provide training to personnel of MHLW and PMDA in order to promote theexchange of information on GCP between Japan and the United States within its resource
constraints. MHLW and FDA will study how to carry out personnel exchanges andmutual inspections.

E.

Compliance with Guideline of the International Conference on Harmonization(ICH):
1.

Based on the intention of the timely implementation of internationally harmonized
guidelines, FDA and MHLW are discussing the incorporation of and compliancewith such guidelines at meetings of ICH.

2.

As has been discussed at ICH, FDA continues to fully support the use of MedDRA
terminology in the international setting for which it was designed.

3.

With regard to the test duration of chronic toxicity testing of new drugs in
non-rodents, FDA would be willing to provide updated information about the
number of cases requiring longer duration than that according to the ICH guideline
in response to a request from MHLW through the ICH steering committee.

F.

Early Implementation of Matters Agreed Upon by the Global Harmonization Task
Force (GHTF): In recognition of the importance of the global convergence of regulatory
systems, FDA is striving within the confines of U.S. law toward implementation of“Essential Principles of Safety & Performance of Medical Devices” and other matters thathave not been fully implemented in the United States.

G.

Acceptance of Test Data Obtained by Means of Harmonized Pharmacopoeial Test:
FDA is considering handling data obtained by harmonized test methods at ICH as thosehandled according to the U.S. Pharmacopoeia (USP).

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H.

Simplification of Data Requirements for Investigational New Drugs (IND)
Applications: At ICH, FDA is willing to discuss what data on manufacturing and control
should be required in the investigational stage for new drug applications.

VI.

FINANCIAL SERVICES

A.

Registration Requirements for Foreign Issuers in Case of Mergers, Consolidation, or
Reclassification of Securities:
1.

Under the U.S. federal securities laws, all public offerings of securities in the
United States are required to be registered with the U.S. Securities and Exchange
Commission. A public offering of securities includes share exchange offers, suchas when an acquiring company makes a bid to acquire a target company by issuing
its shares in exchange for target's shares. In 1999, the SEC adopted a rule thatexempts from registration offers where the acquiring company and the target
company are foreign companies, and where U.S. residents hold less than 10
percent of the shares of the target company. SEC staff is aware of Japan’s interestin raising this level. However, at the time of adopting this rule, the SEC carefully
considered the level of U.S. ownership that was desirable and appropriate forpurposes of this exemption and in the interest of investor protection. The SEC
believes that, at the 10-percent level, U.S. holders’ interest are best served bybeing able to participate in, rather than be excluded from, the acquisition offer,even though they do not receive the full protections of the U.S. federal securities
laws.

2.

In addition, even above the 10-percent level of U.S. ownership, more tailored
relief has been adopted that addresses conflicting regulatory mandates and offering
practices. Accordingly, Japanese companies engaged in merger and acquisition orother transactions that fail to meet the 10-percent threshold are encouraged to raise
specific concerns with SEC staff.

B.

Qualification of Financial Holding Companies: Pursuant to the Gramm-Leach-Bliley
Act, a foreign bank with U.S. banking operations may become a financial holding
company (FHC) if the bank meets certain prudential criteria. These criteria arecomparable to the prudential standards applied to the U.S. bank subsidiaries of U.S. bankholding companies that are FHCs, giving due regard to the principle of national treatment
and equality of competitive opportunity. The standards are applied to all foreign banks ona nondiscriminatory basis. More than thirty foreign banks are FHCs. The Government of
the United States welcomes applications for FHC status by any foreign financial
institutions that meet these prudential criteria.

C.

Regulation on Sales and Offers of Foreign Investment Trusts/Companies: All funds
that seek to sell their shares publicly in the United States generally must register with the
SEC as investment companies under the Investment Company Act of 1940 (Company
Act). Section 7(d) of the Company Act requires that any non-U.S. fund that wishes to66

register as an investment company and publicly offer its securities in the United States
must first obtain an order from the SEC. To issue such an order, the SEC must find that“by reason of special circumstances or arrangements, it is both legally and practicallyfeasible effectively to enforce the provisions of [the Act against the non-U.S. fund,] andthat the issuance of [the] order is otherwise consistent with the public interest and theprotection of investors.” Section 7(d) represents a prudential standard that generally
ensures that U.S. investors receive the same essential investor protections, whether theyacquire shares in a non-U.S. fund or in a U.S. fund. The section provides nondiscriminatory, national treatment for non-U.S. funds; that is, any non-U.S. fund that can
provide the investor protections required by the Company Act may legally access the U.S.
market to the same extent as any U.S. fund upon receiving a Section 7(d) order from theSEC. The SEC recognizes that non-U.S. investment companies, such as those in Japan,
may have difficulties meeting the prudential standards of Section 7(d). However, staff
interpretations and innovations in the mutual fund industry have significantly increased
the ability of foreign advisers to offer their services to U.S. investors and to establish
funds that are organized in the United States.
D.

Participation of US Investors to Foreign Exchange Traded Funds (ETFs): The
regulation of foreign ETFs under the U.S. federal securities laws will depend on theparticular structure and characteristics of the ETF. In general, however, the SEC would
treat the offer and sale of non-U.S. ETF securities to U.S. investors in the same mannerthat it treats the offer and sale of any non-U.S. fund securities to U.S. investors, which ison a national treatment basis. As described above, all non-U.S. funds that seek to sell
their shares publicly in the United States must obtain 7(d) orders from the SEC and thenregister as investment companies under the Company Act. In addition, because ETFs
operate differently from traditional investment companies, U.S. ETFs have had to seek
exemptive relief from certain provisions of the Company Act. Non-U.S. ETFs likely
would also have to seek exemptive relief to register under the Company Act.

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