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国立健康危機管理研究機構法（一部未施行）
Act on Japan Institute for Health Security (Partially unenforced)

令和五年六月七日法律第四十六号
Act No. 46 of June 7, 2023

Table of Contents

第一章　総則（第一条―第六条）

Chapter I General Provisions (Articles 1 through 6)

第二章　役員及び理事会並びに職員（第七条―第十九条）

Chapter II Officers, Council, and Employees (Articles 7 through 19)

第三章　服務（第二十条―第二十二条）

Chapter III Services (Articles 20 through 22)

第四章　業務

Chapter IV Operations

第一節　業務の範囲等（第二十三条―第二十六条）

Section 1 Scope of Operations (Articles 23 through 26)

第二節　中期目標等（第二十七条―第三十二条）

Section 2 Medium-term Objectives (Articles 27 through 32)

第五章　財務及び会計（第三十三条―第三十九条）

Chapter V Finance and Accounting (Articles 33 through 39)

第六章　監督（第四十条―第四十二条）

Chapter VI Supervision (Articles 40 through 42)

第七章　雑則（第四十三条―第四十七条）

Chapter VII Miscellaneous Provisions (Articles 43 through 47)

第八章　罰則（第四十八条―第五十一条）

Chapter VIII Penal Provisions (Articles 48 through 51)

附　則

Supplementary Provisions

第一章　総則

Chapter I General Provisions

（目的）

(Purpose)

第一条国立健康危機管理研究機構は、厚生労働大臣の監督の下に、厚生労働大臣と密接な連携を図りながら、感染症並びにそれ以外の疾患でその適切な医療の確保のために海外における症例の収集その他国際的な調査及び研究を特に必要とするもの（以下「感染症その他の疾患」という。）並びに予防及び医療に係る国際協力に関し、調査、研究、分析及び技術の開発並びにこれらの業務に密接に関連する高度かつ専門的な医療の提供、人材の養成等を行うとともに、感染症その他の疾患に係る病原体等の検査等及び医薬品等の試験等を行うことにより、国内における感染症のまん延その他の公衆衛生上重大な危害が生じ、又は生じるおそれがある緊急の事態の予防及びその拡大の防止並びに国内外の公衆衛生の向上及び増進に寄与することを目的とする。

Article 1The purpose of Japan Institute for Health Security is, under the supervision and in close coordination with the Minister of Health, Labour and Welfare, to conduct research, studies, analysis, and technological development in connection with infectious diseases and other diseases for which the collection of information on overseas cases and international research and study are particularly required to ensure appropriate medical treatment (referred to below as "infectious and other diseases"), and with international cooperation on prevention and medical treatment; to engage in the provision of advanced and specialized medical treatment, the development of human resources, etc. closely relevant to the above operations; and to carry out examinations, etc. of the pathogens, etc. of infectious and other diseases and tests, etc. for medicine, etc.; thereby seeking to prevent the emergence and expansion of emergency situations in Japan in which the spread of an infectious disease or any other serious harm to public health occurs, or is likely to occur, and to contribute to the improvement and promotion of public health in and outside Japan.

（法人格）

(Legal Personality)

第二条国立健康危機管理研究機構（以下「機構」という。）は、法人とする。

Article 2Japan Institute for Health Security (referred to below as the "Institute") is a corporation.

（事務所）

(Office)

第三条機構は、主たる事務所を東京都に置く。

Article 3The Institute establishes its principal office in Tokyo.

（資本金）

(Stated Capital)

第四条機構の資本金は、附則第十二条第二項及び第十七条第一項の規定により政府から出資があったものとされた金額の合計額とする。

Article 4(1)The stated capital of the Institute is the total amount of the contributions that are deemed to have been made by the government pursuant to the provisions of Article 12, paragraphs (2), and Article 17, paragraph (1) of the Supplementary Provisions.

２政府は、必要があると認めるときは、予算で定める金額の範囲内において、機構に追加して出資することができる。

(2)If the government finds it necessary, the government may make additional capital contributions to the Institute within the amount specified in the budget.

３機構は、前項の規定による政府の出資があったときは、その出資額により資本金を増加するものとする。

(3)When capital contributions are made by the government under the provisions of the preceding paragraph, the Institute is to increase its stated capital by the amount of the capital contributions.

（名称の使用制限）

(Restriction on Use of the Name)

第五条機構でない者は、国立健康危機管理研究機構という名称を用いてはならない。

Article 5A person who is not the Institute may not use the name “国立健康危機管理研究機構” (pronounced “kokuritsu kenkou kiki kanri kenkyu kikou”; meaning “national health risk management research agency”).

（一般社団法人及び一般財団法人に関する法律の準用）

(Application Mutatis Mutandis of the Act on General Incorporated Associations and General Incorporated Foundations)

第六条一般社団法人及び一般財団法人に関する法律（平成十八年法律第四十八号）第四条及び第七十八条の規定は、機構について準用する。

Article 6The provisions of Articles 4 and 78 of the Act on General Incorporated Associations and General Incorporated Foundations (Act No. 48 of 2006) apply mutatis mutandis to the Institute.

第二章　役員及び理事会並びに職員

Chapter II Officers, Council, and Employees

（役員）

(Officers)

第七条機構に、役員として、理事長一人、副理事長一人、理事九人以内及び監事二人を置く。ただし、理事のうち四人以上は、非常勤の外部理事（次の各号に掲げる要件のいずれにも該当する理事をいう。以下この章において同じ。）でなければならない。

Article 7The Institute has, as its officers, a president, a vice president, up to nine directors, and two inspectors; provided, however, that not less than four directors must be part-time base outside directors (meaning those directors who fall under all of the requirements stated in the following items; the same applies in this Chapter below):

一機構の理事長、副理事長、理事（外部理事を除く。）若しくは職員（以下この条において「機構の役職員」という。）又は機構の子法人（機構がその経営を支配している法人として厚生労働省令で定めるものをいう。以下同じ。）の業務執行取締役（株式会社の会社法（平成十七年法律第八十六号）第三百六十三条第一項各号に掲げる取締役及び当該株式会社の業務を執行したその他の取締役をいう。）若しくは執行役若しくは支配人その他の使用人（以下この条において「機構の子法人の業務執行取締役等」という。）でなく、かつ、その就任の前十年間機構の役職員又は機構の子法人の業務執行取締役等であったことがないこと。

(i)a person who is not the Institute's president, vice president, director (excluding outside directors), or employee (referred to as the "Institute's officer or employee" in this Article below) or is not an executive director (meaning any of the directors of a stock company stated in the items of Article 363, paragraph (1) of the Companies Act (Act No. 86 of 2005) or other directors who executed the operations of that stock company), executive officer, manager, or other worker of a subsidiary corporation of the Institute (meaning a subsidiary corporation as specified by Order of the Ministry of Health, Labour and Welfare as a corporation whose management is controlled by the Institute; the same applies below) (referred to "executive director, etc. of the Institute's subsidiary corporation" in this Article below), and also who has not served as the Institute's officer or employee, or an executive director, etc. of the Institute's subsidiary corporations within ten years before assuming the office concerned;

二その就任の前十年内のいずれかの時において機構の監事若しくは会計監査人（会計監査人が法人であるときは、その職務を行うべき社員。以下この号において同じ。）又は機構の子法人の取締役、会計参与（会計参与が法人であるときは、その職務を行うべき社員。以下この号において同じ。）若しくは監査役であったことがある者（機構の子法人の業務執行取締役等であったことがあるものを除く。）にあっては、当該監事、会計監査人、取締役、会計参与又は監査役への就任の前十年間機構の役職員又は機構の子法人の業務執行取締役等であったことがないこと。

(ii)in the case of a person who served as an inspector or financial auditor (if the financial auditor is a corporation, the member of that corporation who is supposed to perform its duties; the same applies in this item below) of the Institute or as a director, accounting advisor (if the accounting advisor is a corporation, the member of that corporation who is supposed to perform its duties; the same applies in this item below), or corporate auditor of a subsidiary corporation of the Institute at any time within ten years before assuming the office concerned (excluding a person who was an executive director, etc. of the Institute's subsidiary corporation), the person who had not served as the Institute's officer or employee or as an executive director, etc. of the Institute's subsidiary corporation within ten years before assuming the above office of inspector, financial auditor, director, accounting advisor, or corporate auditor;

三機構の理事長、副理事長、理事又は重要な職員の配偶者又は二親等内の親族でないこと。

(iii)a person who is not the spouse or a relative within the second degree of kinship of the Institute's president, vice president, director, or other important employee of the Institute.

（理事会の設置及び任務）

(Establishment of a Council and Its Duties)

第八条機構に、理事会を置く。

Article 8(1)The Institute has a council in place under it.

２理事会は、理事長、副理事長及び全ての理事をもって組織する。

(2)The council consists of the president, the vice president, and all directors.

３理事会は、次に掲げる職務を行う。

(3)The council is responsible for performing the following duties:

一この法律（第四十三条において読み替えて準用する独立行政法人通則法（平成十一年法律第百三号）の規定を含む。第十条第六項において同じ。）の規定により厚生労働大臣の認可（第十一条第二項及び第十五条第四項の認可を除く。）又は承認を受けなければならない事項その他理事会が特に必要と認める重要事項の審議及び決定

(i)deliberation and determination of the matters for which the authorization (excluding the authorization referred to in Article 11, paragraph (2) and in Article 15, paragraph (4)) or approval of the Minister of Health, Labour and Welfare must be obtained pursuant to the provisions of this Act (including the provisions of the Act on General Rules for Incorporated Administrative Agencies (Act No. 103 of 1999), as applied mutatis mutandis pursuant to Article 43, following the deemed replacement of terms; the same applies in Article 10, paragraph (6)), and other important matters deemed particularly necessary by the council; and

二理事の職務の執行の監督

(ii)supervision of the execution of duties by directors.

４理事長、副理事長及び理事（外部理事を除く。）は、三月に一回以上、自己の職務の執行の状況を理事会に報告しなければならない。

(4)The president, the vice president, and directors (excluding outside directors) must report on the status of execution of their duties to the council not less than once every three months.

（理事会の会議）

(Meetings of the Council)

第九条理事会は、理事長が招集する。

Article 9(1)The president calls the meetings of the council.

２理事長は、理事会の議長となり、会務を総理する。

(2)The president serves as chairperson of the council and presides over its operations.

３理事会は、理事長、副理事長及び理事の過半数の出席がなければ、その議事を開き、議決することができない。

(3)The council may not hold meetings or make any resolutions unless a majority of the president, vice president, and directors are present.

４理事会の議事は、出席した理事長、副理事長及び理事の過半数で決し、可否同数のときは、議長の決するところによる。

(4)A decision of the council is made by a majority vote of the president, vice president, and directors who are present or, in the case of a tied vote, by the chairperson.

（役員の職務及び権限等）

(Duties and Authority of Officers)

第十条理事長は、機構を代表し、その業務を総理する。

Article 10(1)The president represents the Institute and presides over its operations.

２副理事長は、機構を代表し、理事長の定めるところにより、理事長を補佐して機構の業務を掌理し、理事長に事故があるときはその職務を代理し、理事長が欠員のときはその職務を行う。

(2)The vice president represents the Institute and, as determined by the president, assists the president in administering the operations of the Institute, acts on behalf of the president in the event the president is unable to attend to their duties, and performs those duties in the event the position of president is vacant.

３理事（外部理事を除く。）は、理事長の定めるところにより、理事長及び副理事長を補佐して機構の業務を掌理し、理事長及び副理事長に事故があるときはその職務を代理し、理事長及び副理事長が欠員のときはその職務を行う。

(3)A director (excluding outside directors), as determined by the president assists the president and the vice president in administering the operations of the Institute, acts on behalf of the president or vice president in the event the president or vice president is unable to attend to their duties, and performs those duties in the event the position of president or vice president is vacant.

４監事は、機構の業務を監査する。この場合において、監事は、厚生労働省令で定めるところにより、監査報告を作成しなければならない。

(4)An inspector audits the operations of the Institute. In this case, the inspector must prepare an audit report pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

５監事は、いつでも、役員（監事を除く。）及び職員に対して事務及び事業の報告を求め、又は機構の業務及び財産の状況の調査をすることができる。

(5)An inspector may, at any time, request reports on affairs and business from officers (excluding another inspector) and employees, or investigate the status of the operations and assets of the Institute.

６監事は、機構がこの法律の規定による認可、承認、認定及び届出に係る書類並びに報告書その他の厚生労働省令で定める書類を厚生労働大臣に提出しようとするときは、これらの書類を調査しなければならない。

(6)If the Institute intends to submit documents related to authorization, approval, certification, and notification under the provisions of this Act and any reports and other documents specified by Order of the Ministry of Health, Labour and Welfare to the Minister of Health, Labour and Welfare, an inspector must review those documents and reports.

７監事は、その職務を行うため必要があるときは、機構の子法人に対して事業の報告を求め、又はその業務及び財産の状況の調査をすることができる。

(7)If it is necessary for the performance of duties, an inspector may request reports on business from a subsidiary corporation of the Institute, or investigate the status of its operations and assets.

８前項の子法人は、正当な理由があるときは、同項の報告又は調査を拒むことができる。

(8)If reasonable grounds for refusal exist, the subsidiary corporation referred to in the preceding paragraph may refuse to submit the report, or to submit itself to the investigation, referred to in that paragraph.

９監事は、必要があると認めるときは、理事会に出席し、意見を述べることができる。

(9)An inspector may attend a meeting of the council and express its opinions, if the inspector finds it necessary.

１０監事は、必要があると認めるときは、理事長に対し、理事会の招集を請求することができる。

(10)An inspector may request the president to call a meeting of the council, if the inspector finds it necessary.

１１監事は、監査の結果に基づき、必要があると認めるときは、理事長又は厚生労働大臣に意見を提出することができる。

(11)An inspector may submit its opinions to the president or the Minister of Health, Labour and Welfare, if the inspector finds it necessary on the basis of an audit result,.

１２第四項から前項までに定めるもののほか、監査に関し必要な事項は、厚生労働省令で定める。

(12)Beyond what is provided for from paragraph (4) through the preceding paragraph, the matters necessary for audits are specified by Order of the Ministry of Health, Labour and Welfare.

（役員の任命）

(Appointment of Officers)

第十一条理事長及び監事は、厚生労働大臣が任命する。

Article 11(1)The president and inspectors are appointed by the Minister of Health, Labour and Welfare.

２副理事長及び理事は、理事長が厚生労働大臣の認可を受けて任命する。

(2)The vice president and directors are appointed by the president with the authorization of the Minister of Health, Labour and Welfare received.

３理事長は、前項の規定により副理事長及び理事を任命したときは、遅滞なく、これを公表しなければならない。

(3)When appointing the vice president and directors pursuant to the provisions of the preceding paragraph, the president must make public the appointment without delay.

（役員の任期）

(Term of Office of Officers)

第十二条理事長の任期は、任命の日から、当該任命の日を含む第二十七条第一項に規定する中期目標の期間（以下この項及び附則第二条第四項において「中期目標の期間」という。）の末日までとする。ただし、より適切と認める者を任命するため厚生労働大臣が特に必要があると認めるときは、中期目標の期間の初日以後最初に任命される理事長の任期は、任命の日から、中期目標の期間の初日から三年を経過する日までとすることができる。

Article 12(1)The term of office of the president begins on the date of appointment and ends on the last day of the period for the medium-term objectives, including the date of appointment, provided for in Article 27, paragraph (1) (referred to as the "period for the medium-term objectives" in this paragraph and Article 2, paragraph (4) of the Supplementary Provisions below); provided, however, that if the Minister of Health, Labour and Welfare finds it to be particularly necessary in order to appoint a person who is considered to be more suitable, the term of office of the first president appointed on or after the first day of the period for the medium-term objectives may be a period that begins on the date of appointment and ends on the day on which three years have passed since the first day of the period for the medium-term objectives.

２前項の規定にかかわらず、補欠の理事長の任期は、前任者の残任期間とする。

(2)Notwithstanding the provisions of the preceding paragraph, the term of office of the president appointed to fill a vacancy is the remaining term of the predecessor.

３監事の任期は、理事長の任期（補欠の理事長の任期を含む。以下この項において同じ。）と対応するものとし、任命の日から、当該対応する理事長の任期の末日を含む事業年度についての第三十三条第一項の規定による同項に規定する財務諸表の承認の日までとする。ただし、補欠の監事の任期は、前任者の残任期間とする。

(3)The term of office of an inspector corresponds to the term of office of the president (including the term of office of the president appointed to fill a vacancy; the same applies in this paragraph below), beginning on the date of appointment and ending on the date of approval, under the provisions of Article 33, paragraph (1), of the financial statements referred to in those for the business year in which the last day of the corresponding term of office of the president is included; provided, however, that the term of office of an inspector appointed to fill a vacancy is the remaining term of the predecessor.

４副理事長及び理事の任期は、二年とする。ただし、補欠の副理事長又は理事の任期は、前任者の残任期間とする。

(4)The term of office of the vice president and directors is two years; provided, however, that the term of office of the vice president or directors appointed to fill a vacancy is the remaining term of the predecessor.

５役員は、再任されることができる。

(5)An officer may be reappointed.

（役員の欠格条項）

(Disqualification of Officers)

第十三条政府又は地方公共団体の職員（非常勤の者を除く。）は、役員となることができない。ただし、教育公務員又は研究公務員で政令で定めるもの（次条各号のいずれかに該当する者を除く。）は、理事又は監事となることができる。

Article 13The national government or local government employee (excluding a part-time base employee) is ineligible to be an officer; provided, however, that a public employee in the field of education or research specified by Cabinet Order (excluding any person falling under either of the items of the following Article) may become a director or inspector.

第十四条前条本文に定めるもののほか、次の各号のいずれかに該当する者は、役員となることができない。

Article 14Beyond what is provided for in the main clause of the preceding Article, a person who falls under either of the following items is ineligible to become an officer:

一物品の製造若しくは販売、工事の請負若しくは役務の提供を業とする者であって機構と取引上密接な利害関係を有するもの又はこれらの者が法人であるときはその役員（いかなる名称によるかを問わず、これと同等以上の職権又は支配力を有する者を含む。）

(i)a person whose business is to manufacture or sell goods, undertake contract construction work, or provide services, and who has close interests in transactions with the Institute, or, if this person is a corporation, an officer of it (including those with the equal or superior authority or controlling power irrespective of the officer's title)

二前号に掲げる事業者の団体の役員（いかなる名称によるかを問わず、これと同等以上の職権又は支配力を有する者を含む。）

(ii)an officer of any association of businesses stated in the preceding item (including those with the equal or superior authority or controlling power irrespective of the officer's title)

（役員の解任）

(Dismissal of Officers)

第十五条厚生労働大臣又は理事長は、それぞれその任命に係る役員が第十三条本文又は前条の規定により役員となることができない者に該当するに至ったときは、その役員を解任しなければならない。

Article 15(1)The Minister of Health, Labour and Welfare or the president must dismiss an officer appointed thereby if the officer has become ineligible to serve as an officer pursuant to the provisions of the main clause of Article 13 or the provisions of the preceding Article.

２厚生労働大臣又は理事長は、それぞれその任命に係る役員が次の各号のいずれかに該当するとき、その他役員たるに適しないと認めるときは、その役員を解任することができる。

(2)The Minister of Health, Labour and Welfare or the president may dismiss an officer appointed by them if the officer falls under either of the following items or is otherwise found to be unfit to serve as an officer:

一心身の故障のため職務の遂行に堪えないと認められるとき。

(i)if the officer is found to be unable to perform their duties due to a mental or physical disorder;

二職務上の義務違反があるとき。

(ii)if the officer violates an obligation in the course of their duties.

３前項に規定するもののほか、厚生労働大臣又は理事長は、それぞれその任命に係る役員（監事を除く。）の職務の執行が適当でないため機構の業務の実績が悪化した場合であって、その役員に引き続き当該職務を行わせることが適切でないと認めるときは、その役員を解任することができる。

(3)Beyond what is provided for in the preceding paragraph, the Minister of Health, Labour and Welfare or the president may dismiss an officer appointed by them, if the operational performance of the Institute has deteriorated due to the improper execution of duties by the officer (excluding inspectors), and if they find it inappropriate to have the officer continue to perform those duties.

４理事長は、前二項の規定によりその任命に係る役員を解任しようとするときは、厚生労働大臣の認可を受けなければならない。

(4)If the president is to dismiss an officer appointed thereby pursuant to the provisions of the preceding two paragraphs, the president must obtain the authorization of the Minister of Health, Labour and Welfare.

５厚生労働大臣は、副理事長又は理事が第二項又は第三項に規定する事由に該当すると認めるときは、理事長に対し、その役員の解任を命ずることができる。

(5)If the Minister of Health, Labour and Welfare finds that the vice president or a director falls under the grounds provided for in paragraph (2) or (3), the minister may order the president to dismiss the officer.

６理事長は、第二項又は第三項の規定によりその任命に係る役員を解任したときは、遅滞なく、これを公表しなければならない。

(6)Upon dismissing an officer appointed thereby pursuant to the provisions of paragraph (2) or (3), the president must make public the dismissal without delay.

（役員等の損害賠償責任）

(Officers' Liability of Damages)

第十六条機構の役員又は会計監査人は、その任務を怠ったときは、機構に対し、これによって生じた損害を賠償する責任を負う。

Article 16(1)If an officer or financial auditor of the Institute fails to perform their duties, the officer or financial auditor bears liability to compensate the Institute for damage arising from the failure.

２前項の責任は、厚生労働大臣の承認がなければ、免除することができない。

(2)The liability referred to in the preceding paragraph may not be exempted from without the approval of the Minister of Health, Labour and Welfare

（役員及び職員の地位）

(Status of Officers and Employees)

第十七条機構の役員及び職員は、刑法（明治四十年法律第四十五号）その他の罰則の適用については、法令により公務に従事する職員とみなす。

Article 17An officer and employee of the Institute are deemed to be employees engaged in public services pursuant to laws and regulations, regarding the application of the Penal Code (Act No. 45 of 1907) and other penal provisions.

（役員の報酬等）

(Remuneration of Officers)

第十八条機構の役員に対する報酬及び退職手当（以下この条において「報酬等」という。）は、その役員の業績が考慮されるものでなければならない。

Article 18(1)The remuneration and retirement allowances (referred to as the "remuneration, etc." in this Article below) of an officer of the Institute must take into consideration the performance of the officer.

２機構は、その役員に対する報酬等の支給の基準を定め、これを厚生労働大臣に届け出るとともに、公表しなければならない。これを変更したときも、同様とする。

(2)The Institute must establish standards for payment of the remuneration, etc. of its officer, notify the Minister of Health, Labour and Welfare of those standards, and make public them. The same applies when the Institute revises those standards.

３前項の報酬等の支給の基準は、国家公務員の給与及び退職手当（以下「給与等」という。）、民間企業の役員の報酬等、機構の業務の実績並びに役員のうち世界最高水準の高度の専門的な知識及び経験を活用して遂行することが特に必要とされる業務に従事するものについて国際的に卓越した能力を有する人材を確保する必要性その他の事情を考慮して定められなければならない。

(3)The standards for payment of remuneration, etc. referred to in the preceding paragraph must be established by taking into consideration the salaries and retirement allowances (referred to as "salaries, etc." below) of national government employees; the remuneration, etc. of officers of private enterprises; the operational performance of the Institute; the necessity to secure human resources with internationally outstanding abilities as officers to engage in the operations that are particularly required to be executed by utilizing the world's top-level expertise and experience; and other circumstances.

（職員の給与等）

(Salaries of Employees)

第十九条機構の職員の給与は、その職員の勤務成績が考慮されるものでなければならない。

Article 19(1)The salary of an employee of the Institute must take the work performance of the employee into consideration.

２機構は、その職員の給与等の支給の基準を定め、これを厚生労働大臣に届け出るとともに、公表しなければならない。これを変更したときも、同様とする。

(2)The Institute must establish standards for payment of the salaries, etc. of its employee, notify the Minister of Health, Labour and Welfare of those standards, and make public them. The same applies when the Institute revises those standards.

３前項の給与等の支給の基準は、一般職の職員の給与に関する法律（昭和二十五年法律第九十五号）の適用を受ける国家公務員の給与等、民間企業の従業員の給与等、機構の業務の実績、職員の職務の特性及び雇用形態並びに専ら調査、研究、分析及び技術の開発（以下「研究開発」という。）に従事する職員のうち世界最高水準の高度の専門的な知識及び経験を活用して遂行することが特に必要とされる業務に従事するものについて国際的に卓越した能力を有する人材を確保する必要性その他の事情を考慮して定められなければならない。

(3)The standards for payment of salaries, etc. referred to in the preceding paragraph must be established by taking into consideration the salaries, etc. of national government employees to whom the Act on Remuneration of Officials in the Regular Service (Act No. 95 of 1950) applies; the salaries, etc. of employees of private enterprises; the operational performance of the Institute; the nature of the duties of employees and their employment patterns; the necessity to secure human resources with internationally outstanding abilities as employees who are to solely engage in research, studies, analysis, and technological development (referred to as the "research and development" below) and whose operations are particularly required to be executed by utilizing the world's top-level expertise and experience; and other circumstances.

第三章　服務

Chapter III Services

（服務の本旨）

(Mission Statement of Services)

第二十条機構の役員及び職員の服務は、感染症その他の疾患に迅速かつ適確に対応するとともに、患者等が置かれている状況を深く認識し、これらの者の人権を尊重しつつ、感染症その他の疾患に関する高度かつ専門的な医療、医療に係る国際協力等を行うことができるよう、強い責任感を持って、誠実かつ公正にその職務を遂行し、国民の信頼に応えることを本旨としなければならない。

Article 20(1)The main purport of the services of an officer and employee of the Institute must be to promptly and accurately respond to infectious and other diseases, profoundly recognize the situations that patients, etc. are in, respect their human rights, and execute the duties faithfully and fairly with a strong sense of responsibility so as to facilitate advanced and specialized medical treatment for those infectious and other diseases, as well as international cooperation, etc. in connection with medical treatment, as a result earning the trust and confidence of the people.

２機構の役員及び職員は、厚生労働省令で定めるところにより、任命権者に対し、前項の服務の本旨に則して職務を遂行する旨を誓約する書面を提出しなければならない。

(2)Pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, each officer and employee of the Institute must submit to the appointer a document in which the officer or employee pledges to execute duties in light of the mission statement of services referred to in the preceding paragraph.

３機構の役員及び職員は、第二十三条第一項に規定する業務について、この法律若しくは感染症の予防及び感染症の患者に対する医療に関する法律（平成十年法律第百十四号。以下「感染症法」という。）、これらの法律に基づく命令若しくはこれらの法律に基づいてする厚生労働大臣の処分又は機構が定める業務方法書その他の規則を遵守し、機構のため忠実に職務を遂行しなければならない。

(3)Concerning the operations provided for in Article 23, paragraph (1), an officer and employee of the Institute must observe this Act or the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases (Act No. 114 of 1998; referred to "Act on Infectious Diseases" below), orders based on these Acts or dispositions made by the Minister of Health, Labour and Welfare based on those Acts, or the operational method statement and other rules established by the Institute, and must execute their respective duties faithfully for the Institute.

（役員及び職員の秘密保持義務）

(Obligation of Confidentiality of Officers and Employees)

第二十一条機構の役員及び職員は、職務上知ることのできた秘密を漏らし、又は盗用してはならない。その職を退いた後も、同様とする。

Article 21An officer and employee of the Institute must not reveal or misappropriate any confidential information learned in the course of their duties. The same applies even after they have left their jobs.

（制裁規程）

(Disciplinary Rules)

第二十二条機構は、業務開始の際、制裁規程を作成し、厚生労働大臣の認可を受けなければならない。これを変更しようとするときも、同様とする。

Article 22(1)On commencing operations, the Institute must prepare disciplinary rules and obtain the authorization of the Minister of Health, Labour and Welfare. The same applies when the Institute intends to revise those rules.

２前項の制裁規程においては、機構の役員及び職員が、この法律若しくは感染症法、これらの法律に基づく命令若しくはこれらの法律に基づいてする厚生労働大臣の処分若しくは機構が定める業務方法書その他の規則に違反し、又は機構の役員及び職員たるにふさわしくない行為をしたときは、当該役員及び職員に対し、免職、停職、減給又は戒告の処分その他の制裁を課する旨を定めなければならない。

(2)The disciplinary rules referred to in the preceding paragraph must provide that a sanction such as dismissal, suspension from work, reduction in pay, or admonition or any other discipline is imposed on an officer or employee of the Institute if this officer or employee violates this Act, the Act on Infectious Diseases, any order based on these Acts or any disposition made by the Minister of Health, Labour and Welfare based on those Acts or the operational method statement or other rules established by the Institute, or engages in any act unbecoming of an officer and employee of the Institute.

第四章　業務

Chapter IV Operations

第一節　業務の範囲等

Section 1 Scope of Operations

（業務の範囲）

(Scope of Operations)

第二十三条機構は、第一条の目的を達成するため、次に掲げる業務を行う。

Article 23(1)The Institute performs the following operations in order to achieve the purpose referred to in Article 1:

一感染症その他の疾患に係る予防及び医療に関し、研究開発を行うこと。

(i)to engage in research and development in connection with the prevention and medical treatment of infectious and other diseases;

二前号に掲げる業務に密接に関連する医療を提供すること。

(ii)to provide medical treatment closely relevant to the operation stated in the preceding item;

三予防及び医療に係る国際協力に関し、研究開発を行うこと。

(iii)to engage in research and development in connection with international cooperation on prevention and medical treatment;

四感染症その他の疾患に係る予防及び医療並びにこれらに係る国際協力に関し、人材の養成及び資質の向上を図ること。

(iv)to promote the development of human resources and the improvement of their quality in connection with international cooperation on the prevention and medical treatment of infectious and other diseases;

五感染症その他の疾患に係る病原及び病因の検索並びに予防及び医療に係る科学的知見に関する情報の収集、整理、分析及び提供を行うこと。

(v)to investigate the pathogens and causes of infectious and other diseases, and to collect, organize, analyze, and provide scientific information on prevention and medical treatment;

六感染症その他の疾患に係る病原体及び毒素の収集、検査及び保管並びにこれらの実施に必要な技術並びに試薬、試料及び機械器具の開発及び普及を行うこと。

(vi)to collect, examine, and store the pathogens and toxins of infectious and other diseases, and to develop and disseminate the technologies necessary for those activities, as well as reagents, samples, and machinery and appliances;

七地域保健法（昭和二十二年法律第百一号）第二十六条第二項に規定する地方衛生研究所等の職員に対する前二号に掲げる業務に係る研修、技術的支援その他の必要な支援を行うこと。

(vii)to provide the employees of prefectural and municipal public health institutes, etc. provided for in Article 26, paragraph (2) of the Community Health Act (Act No. 101 of 1947) with training, technological support, and other necessary support in connection with the operations stated in the preceding two items;

八感染症その他の疾患の予防及び医療に関する生物学的製剤、抗菌性物質及びその製剤、消毒剤、殺虫剤並びに殺そ剤の生物学的検査、試験及び試験的製造並びにこれらの医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和三十五年法律第百四十五号）第二条第一項に規定する医薬品及び同条第二項に規定する医薬部外品（専ら動物のために使用されることが目的とされているものを除く。）の生物学的検査及び試験に必要な標準品の製造を行うこと。

(viii)to conduct the biological inspection, tests, and trial manufacturing of biological preparations, antibacterial substances and preparations, disinfectants, insecticides, and rodenticides in connection with the prevention and medical treatment of infectious and other diseases, and to manufacture the standard items necessary for biological inspections and tests of the above pharmaceuticals which are provided for in Article 2, paragraph (1) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), and quasi-pharmaceutical products (excluding those intended exclusively for use on animals) in paragraph (2) of that Article;

九使用されることがまれである生物学的製剤又はその製造が技術上困難な生物学的製剤の製造を行うこと。

(ix)to manufacture biological preparations which are rarely used or which manufacturing is technologically difficult;

十食品衛生に関し、細菌学的及び生物学的試験及び検査を行うこと。

(x)to conduct bacteriological and biological tests and inspections in relation to food sanitation;

十一前各号に掲げる業務に係る成果の普及及び政策の提言を行うこと。

(xi)to disseminate the results of the operations stated in each of the preceding items, and to make suggestions on political measures;

十二機構及び高度専門医療に関する研究等を行う国立研究開発法人に関する法律（平成二十年法律第九十三号。以下「高度専門医療国立研究開発法人法」という。）第三条の二に規定する国立高度専門医療研究センターの職員の養成及び研修を目的として看護に関する学理及び技術の教授及び研究並びに研修を行う施設を設置し、これを運営すること。

(xii)to establish and operate facilities for teaching and researching theories and technologies related to nursing care and for providing training, with the aim for the cultivation and training of employees of the Institute and those of highly specialized national medical research centers provided for in Article 3-2 of the Act on National Research and Development Agencies that Conduct Research related to Advanced and Specialized Medical Care (Act No. 93 of 2008; referred to below as "Act on National Research and Development Agencies for Advanced and Specialized Medical Care");

十三機構の研究開発の成果の活用を促進する事業であって政令で定めるものを実施する者に対し、出資並びに人的及び技術的援助を行うこと。

(xiii)to make contributions and provide personnel and technical assistance to a person engaged in the business that promote the utilization of the results of research and development by the Institute and that are provided for by Cabinet Order;

十四感染症法第六十五条の四に規定する事務及び感染症法第六十五条の五に規定する権限に係る事務を行うこと。

(xiv)to process the affairs provided for in Article 65-4 of the Act on Infectious Diseases and affairs related to the authority provided for in Article 65-5 of the Act on Infectious Diseases; and

十五前各号に掲げる業務に附帯する業務を行うこと。

(xv)to perform operations incidental to operations stated in each of the preceding items.

２機構は、厚生労働省令で定めるところにより、前項各号に掲げる業務の実施状況を内閣総理大臣及び厚生労働大臣に報告するものとする。

(2)Pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, the Institute is to report the implementation status of the operations stated in the items of the preceding paragraph to the Prime Minister and the Minister of Health, Labour and Welfare.

３機構は、第一項各号（第十四号を除く。）に掲げる事務の遂行に必要な限度で、同項第十四号の事務を行うことにより保有することとなった情報を、その保有に当たって特定された利用の目的以外の目的のために内部で利用することができる。

(3)The Institute may, to the extent necessary for the execution of the affairs stated in the items of paragraph (1) (excluding item (xiv)), internally use the information that it has come to retain by processing the affairs referred to in item (xiv) of that paragraph, for purposes other than those that have been identified for the retention.

４機構は、第一項第十三号に掲げる業務のうち出資に関するものを行おうとするときは、厚生労働大臣の認可を受けなければならない。

(4)When intending to perform the operation of making contributions among the operations stated in paragraph (1), item (xiii), the Institute must obtain the authorization of the Minister of Health, Labour and Welfare.

（株式又は新株予約権の取得及び保有）

(Acquisition and Holding of Shares or Share Options)

第二十四条機構は、機構の研究開発の成果を事業活動において活用し、又は活用しようとする者（以下この項において「成果活用事業者」という。）に対し、機構の研究開発の成果の普及及び活用の促進に必要な支援を行うに当たって、当該成果活用事業者の資力その他の事情を勘案し、特に必要と認めてその支援を無償とし、又はその支援の対価を時価よりも低く定めることその他の措置をとる場合において、当該成果活用事業者の発行した株式又は新株予約権を取得することができる。

Article 24(1)In providing a person who utilizes, or intends to utilize the results of the Institute's research and development for business activities (referred to as the "result-utilizing enterprise" in this paragraph below) with necessary support for the promotion of dissemination and utilization of such results, the Institute may provide the support for free upon finding it particularly necessary to do so with the financial resources and other circumstances of the result-utilizing enterprise taken into consideration, or may acquire shares or share options issued by the result-utilizing enterprise in the case for which the Institute sets the value of the support lower than its market value or takes other measures.

２機構は、前項の規定により取得した株式又は新株予約権（その行使により発行され、又は移転された株式を含む。）を保有することができる。

(2)The Institute may hold shares or share options acquired pursuant to the provisions of the preceding paragraph (including shares issued or transferred through the exercise of those share options).

（機構の施設及び設備の利用）

(Use of the Institute's Facilities and Equipment)

第二十五条機構は、第二十三条第一項に規定する業務のほか、当該業務の遂行に支障のない範囲内で、その建物の一部、設備、器械及び器具を、機構に勤務しない医師、歯科医師その他の医療関係者の診療又は研究若しくは技術の開発のために利用させることができる。

Article 25In addition to the operations provided for in Article 23, paragraph (1), the Institute may, to an extent that does not hinder the execution of those operations, allow doctors, dentists, or other healthcare personnel who do not work for the Institute to use part of the Institute's buildings or its equipment, instruments, and tools for medical care, research, or technological development.

（業務方法書）

(Operational Method Statement)

第二十六条機構は、業務開始の際、業務方法書を作成し、厚生労働大臣の認可を受けなければならない。これを変更しようとするときも、同様とする。

Article 26(1)On commencing operations, the Institute must prepare an operational method statement and obtain the authorization of the Minister of Health, Labour and Welfare. The same applies when the Institute intends to revise the method.

２前項の業務方法書には、役員（監事を除く。）の職務の執行がこの法律、感染症法又は他の法令に適合することを確保するための体制その他機構の業務の適正を確保するための体制の整備に関する事項その他厚生労働省令で定める事項を記載しなければならない。

(2)The operational method statement referred to in the preceding paragraph must contain matters concerning the development of a system for ensuring that the execution of duties by its officer (excluding its inspector) complies with this Act, the Act on Infectious Diseases, and other laws and regulations and any other system for ensuring the proper operations of the Institute, and other matters provided for by Order of the Ministry of Health, Labour and Welfare.

３機構は、第一項の認可を受けたときは、遅滞なく、その業務方法書を公表しなければならない。

(3)Upon obtaining the authorization referred to in paragraph (1), the Institute must make public the operational method statement without delay.

第二節　中期目標等

Section 2 Medium-term Objectives

（中期目標）

(Medium-term Objectives)

第二十七条厚生労働大臣は、六年間において機構が達成すべき業務運営に関する目標（以下「中期目標」という。）を定め、これを機構に指示するとともに、公表しなければならない。これを変更したときも、同様とする。

Article 27(1)The Minister of Health, Labour and Welfare must set objectives concerning the operational management of the Institute to be achieved during a period of six years (referred to below as the "medium-term objectives"), give instructions to the Institute about them, and make public them. The same applies when the Institute revises them.

２中期目標においては、次に掲げる事項について具体的に定めるものとする。

(2)The medium-term objectives are to specifically provide for the following matters:

一国民の生活及び健康に重大な影響を与えるおそれがある感染症の発生及びまん延に備えるための体制整備に関する事項

(i)matters concerning the development of a system to prepare for the outbreak and spread of infectious diseases that are likely to seriously affect the lives and health of the people;

二研究開発の成果の最大化その他の業務の質の向上に関する事項

(ii)matters concerning the maximization of the results of research and development and the improvement of the quality of any other operations;

三業務運営の効率化に関する事項

(iii)matters concerning the improvement of operational efficiency;

四財務内容の改善に関する事項

(iv)matters concerning the improvement of the financial conditions; and

五その他業務運営に関する重要事項

(v)other important matters concerning the operational management.

３厚生労働大臣は、中期目標を定め、又はこれを変更しようとするときは、あらかじめ、健康・医療戦略推進本部及び独立行政法人通則法第十二条に規定する独立行政法人評価制度委員会（以下「独立行政法人評価制度委員会」という。）の意見を聴かなければならない。

(3)When intending to set or revise medium-term objectives, the Minister of Health, Labour and Welfare must, in advance, hear the opinions of the Headquarters for the Healthcare Policy and those of the Committee on the System of Evaluating Incorporated Administrative Agencies provided for in Article 12 of the Act on General Rules for Incorporated Administrative Agencies (referred to below as the "Committee on the System of Evaluating Incorporated Administrative Agencies").

４厚生労働大臣は、前項の規定により中期目標に係る意見を聴こうとするときは、機構の研究開発の事務及び事業（軽微なものとして政令で定めるものを除く。第三十条第六項及び第三十二条第二項において同じ。）に関する事項について、あらかじめ、国家行政組織法（昭和二十三年法律第百二十号）第八条の規定に基づき厚生労働省に置かれる合議制の機関で政令で定めるもの（以下「研究開発審議会」という。）の意見を聴かなければならない。

(4)When intending to hear opinions concerning medium-term objectives pursuant to the provisions of the preceding paragraph, the Minister of Health, Labour and Welfare must, in advance, hear the opinions of an organ with a council system, that is established under the Ministry of Health, Labour and Welfare pursuant to the provisions of Article 8 of the National Government Organization Act (Act No. 120 of 1948), and that is provided for by Cabinet Order (referred to below as the "research and development council"), regarding matters concerning the affairs and business of the Institute's research and development (excluding those specified by Cabinet Order as minor affairs or business; the same applies in Article 30, paragraph (6), and Article 32, paragraph (2)).

５厚生労働大臣は、公衆衛生その他の分野の研究開発に関して高い識見を有する外国人（日本の国籍を有しない者をいう。次項において同じ。）を研究開発審議会の委員に任命することができる。

(5)The Minister of Health, Labour and Welfare may appoint a foreign national (meaning a person without Japanese nationality; the same applies in the following paragraph) who has valuable insight in research and development in a field such as public health or other field as a member of the research and development council.

６前項の場合において、外国人である研究開発審議会の委員は、研究開発審議会の会務を総理し、研究開発審議会を代表する者となることはできず、当該委員の数は、研究開発審議会の委員の総数の五分の一を超えてはならない。

(6)In the case referred to in the preceding paragraph, a member of the research and development council who is a foreign national may not preside over the business of the research and development council or represent it, and the number of those members must not exceed one-fifth of the total number of members of the research and development council.

７健康・医療戦略推進本部及び独立行政法人評価制度委員会は、第三項の規定により厚生労働大臣に意見を述べたときは、その内容を公表しなければならない。

(7)When the Headquarters for Healthcare Policy or the Committee on the System of Evaluating Incorporated Administrative Agencies states its opinions to the Minister of Health, Labour and Welfare pursuant to the provisions of paragraph (3), it must make public the details of those opinions.

（中期計画）

(Medium-term Plan)

第二十八条機構は、前条第一項の指示を受けたときは、中期目標に基づき、厚生労働省令で定めるところにより、当該中期目標を達成するための計画（以下「中期計画」という。）を作成し、厚生労働大臣の認可を受けなければならない。これを変更しようとするときも、同様とする。

Article 28(1)Upon receiving the instructions referred to in paragraph (1) of the preceding Article, the Institute must, based on the medium-term objectives, prepare a plan for achieving the medium-term objectives (referred to below as the "medium-term plan") pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, and obtain the authorization of the Minister of Health, Labour and Welfare. The same applies when the Institute intends to revise that plan.

２中期計画においては、次に掲げる事項を定めるものとする。

(2)The medium-term plan is to provide the following matters:

一国民の生活及び健康に重大な影響を与えるおそれがある感染症の発生及びまん延に備えるための体制整備に関する措置

(i)measures concerning the development of a system to prepare for the outbreak and spread of infectious diseases that are likely to seriously affect the lives and health of the people;

二研究開発の成果の最大化その他の業務の質の向上に関する目標を達成するためとるべき措置

(ii)the measures to be taken for achieving goals concerning the maximization of the results of research and development and the improvement of the quality of any other operations;

三業務運営の効率化に関する目標を達成するためとるべき措置

(iii)the measures to be taken for achieving goals concerning the improvement of operational efficiency;

四予算（人件費の見積りを含む。）、収支計画及び資金計画

(iv)the budget (including an estimate of personnel expenses), an income and expenditure plan, and a funding plan;

五短期借入金の限度額

(v)limits on the amount of short-term borrowings;

六不要財産又は不要財産となることが見込まれる財産がある場合には、当該財産の処分に関する計画

(vi)if the Institute has any unnecessary assets or any assets that are expected to be unnecessary assets, a plan for disposal of those assets;

七前号に規定する財産以外の重要な財産を譲渡し、又は担保に供しようとするときは、その計画

(vii)if the Institute intends to transfer or provide as collateral any important assets other than those provided for in the preceding item, a plan for the transfer or provision;

八剰余金の使途

(viii)use of surplus; and

九その他厚生労働省令で定める業務運営に関する事項

(ix)other matters concerning the operational management provided for by Order of the Ministry of Health, Labour and Welfare.

３厚生労働大臣は、第一項の認可をした中期計画が前条第二項各号に掲げる事項の適正かつ確実な実施上不適当となったと認めるときは、その中期計画を変更すべきことを命ずることができる。

(3)If the Minister of Health, Labour and Welfare finds that the medium-term plan authorized thereby as referred to in paragraph (1) has become inappropriate for properly and securely implementing the matters stated in the items of paragraph (2) of the preceding Article, the minister may order the medium-term plan to be revised.

４機構は、第一項の認可を受けたときは、遅滞なく、その中期計画を公表しなければならない。

(4)Upon obtaining the authorization referred to in paragraph (1), the Institute must make public the medium-term plan without delay.

（年度計画）

(Annual Plan)

第二十九条機構は、毎事業年度の開始前に、前条第一項の認可を受けた中期計画に基づき、厚生労働省令で定めるところにより、その事業年度の業務運営に関する計画（第三十一条において「年度計画」という。）を定め、これを厚生労働大臣に届け出るとともに、公表しなければならない。これを変更したときも、同様とする。

Article 29Before the start of each business year, the Institute must establish a plan for the operational management for the business year (referred to as "annual plan" in Article 31) on the basis of the medium-term plan authorized under paragraph (1) of the preceding Article, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, and must notify the Minister of Health, Labour and Welfare of the plan and make public it. The same applies when the Institute revises the plan.

（各事業年度に係る業務の実績等に関する評価等）

(Evaluation on Operational Performance in Each Business Year)

第三十条機構は、毎事業年度の終了後、当該事業年度が次の各号に掲げる事業年度のいずれに該当するかに応じ当該各号に定める事項について、厚生労働大臣の評価を受けなければならない。

Article 30(1)The Institute must undergo an evaluation conducted by the Minister of Health, Labour and Welfare after the end of each business year concerning the matters provided for in each of the following items according to the applicable business year among the years stated in these items:

一次号及び第三号に掲げる事業年度以外の事業年度　当該事業年度における業務の実績

(i)a business year other than the business years stated in the following item and item (iii): the operational performance during the relevant business year;

二中期目標の期間の最後の事業年度の直前の事業年度　当該事業年度における業務の実績及び中期目標の期間の終了時に見込まれる中期目標の期間における業務の実績

(ii)the business year preceding the last business year within the period for the medium-term objectives: the operational performance during the relevant business year and the operational performance during the period for the medium-term objectives that are expected to be achieved at the time of the end of the period for the medium-term objectives; or

三中期目標の期間の最後の事業年度　当該事業年度における業務の実績及び中期目標の期間における業務の実績

(iii)the last business year within the period for the medium-term objectives: the operational performance during the relevant business year and the operational performance during the period for the medium-term objectives.

２機構は、前項の規定による評価のほか、中期目標の期間の初日以後最初に任命される理事長の任期が第十二条第一項ただし書の規定により定められた場合又は附則第二条第三項の規定によりその成立の時において任命されたものとされる理事長の任期が同条第四項の規定により定められた場合には、それらの理事長（以下この項において「最初の理事長」という。）の任期（補欠の理事長の任期を含む。）の末日を含む事業年度の終了後、当該最初の理事長の任命の日を含む事業年度から当該末日を含む事業年度の事業年度末までの期間における業務の実績について、厚生労働大臣の評価を受けなければならない。

(2)In addition to the evaluation under the provisions of the preceding paragraph, if the term of office of the first president appointed on or after the first day of the period for the medium-term objectives is determined pursuant to the provisions of the proviso to Article 12, paragraph (1), or if the term of office of the president who is deemed to have been appointed at the time of incorporation of the Institute pursuant to the provisions of Article 2, paragraph (3) of the Supplementary Provisions is determined pursuant to the provisions of paragraph (4) of that Article, the Institute must undergo an evaluation conducted by the Minister of Health, Labour and Welfare, after the end of the business year in which the last day of the term of office of the relevant president (referred to as the "first president" in this paragraph below) (including the term of office of the president appointed to fill a vacancy) is included, regarding the operational performance during the period from the business year that includes the date of appointment of the first president until the end of the business year in which the above-mentioned last day is included.

３機構は、第一項の評価を受けようとするときは、厚生労働省令で定めるところにより、各事業年度の終了後三月以内に、同項第一号、第二号又は第三号に定める事項及び当該事項について自ら評価を行った結果を明らかにした報告書を厚生労働大臣に提出するとともに、公表しなければならない。

(3)When intending to undergo the evaluation referred to in paragraph (1), the Institute must, within three months from the end of each business year, submit to the Minister of Health, Labour and Welfare and make public a report which clearly indicates the matters provided for in item (i), (ii), or (iii) of that paragraph and the results of its self-evaluation on these matters, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

４機構は、第二項の評価を受けようとするときは、厚生労働省令で定めるところにより、同項に規定する末日を含む事業年度の終了後三月以内に、同項に規定する業務の実績及び当該業務の実績について自ら評価を行った結果を明らかにした報告書を厚生労働大臣に提出するとともに、公表しなければならない。

(4)When intending to undergo the evaluation referred to in paragraph (2), the Institute must, within three months from the end of the business year in which the last day provided for in that paragraph is included, submit to the Minister of Health, Labour and Welfare and make public a report which clearly indicates the operational performance provided for in that paragraph and the results of its self-evaluation on the operational performance, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

５第一項又は第二項の評価は、第一項第一号、第二号若しくは第三号に定める事項又は第二項に規定する業務の実績について総合的な評定を付して、行わなければならない。この場合において、第一項各号に規定する当該事業年度における業務の実績に関する評価は、当該事業年度における中期計画の実施状況の調査及び分析を行い、その結果を考慮して行わなければならない。

(5)The evaluation referred to in paragraph (1) or (2) must be conducted by comprehensively evaluating the matters provided for in paragraph (1), item (i), (ii), or (iii) or the operational performance provided for in paragraph (2). In this case, the evaluation on the operational performance during the relevant business year provided for in the items of paragraph (1) must be conducted by investigating and analyzing the status of implementation of the medium-term plan during the business year, and by taking into consideration the results of the investigation and analysis.

６厚生労働大臣は、第一項又は第二項の評価を行おうとするときは、機構の研究開発の事務及び事業に関する事項について、あらかじめ、研究開発審議会の意見を聴かなければならない。

(6)When intending to conduct the evaluation referred to in paragraph (1) or (2), the Minister of Health, Labour and Welfare must, in advance, hear the opinions of the research and development council regarding matters concerning the affairs and business of the Institute's research and development.

７厚生労働大臣は、第一項又は第二項の評価を行ったときは、遅滞なく、機構に対して、その評価の結果を通知するとともに、公表しなければならない。この場合において、第一項第二号に規定する中期目標の期間の終了時に見込まれる中期目標の期間における業務の実績に関する評価を行ったときは、健康・医療戦略推進本部及び独立行政法人評価制度委員会に対しても、遅滞なく、その評価の結果を通知しなければならない。

(7)After conducting the evaluation referred to in paragraph (1) or (2), the Minister of Health, Labour and Welfare must, without delay, notify the Institute of the results of the evaluation and make public these results. In this case, if the Minister of Health, Labour and Welfare has evaluated the operational performance during the period for the medium-term objectives that are expected to be achieved at the end of that period as provided in paragraph (1), item (ii), the minister must also notify the Headquarters for Healthcare Policy and the Committee on the System of Evaluating Incorporated Administrative Agencies of the results of the evaluation without delay.

８健康・医療戦略推進本部及び独立行政法人評価制度委員会は、前項の規定により通知された評価の結果について、必要があると認めるときは、厚生労働大臣に意見を述べるとともに、その内容を公表しなければならない。

(8)If the Headquarters for Healthcare Policy or the Committee on the System of Evaluating Incorporated Administrative Agencies finds it necessary, the headquarters or committee must state its opinions to the Minister of Health, Labour and Welfare on the evaluation results notified pursuant to the provisions of the preceding paragraph and make public the details of those opinions.

９厚生労働大臣は、第一項又は第二項の評価の結果に基づき必要があると認めるときは、機構に対し、業務運営の改善その他の必要な措置を講ずることを命ずることができる。

(9)If the Minister of Health, Labour and Welfare finds it necessary on the basis of the evaluation results referred to in paragraph (1) or (2), the minister may order the Institute to improve the operational management or take other necessary measures.

（評価結果の取扱い等）

(Treatment of Evaluation Results)

第三十一条機構は、前条第一項又は第二項の評価の結果を、中期計画及び年度計画並びに業務運営の改善に適切に反映させるとともに、毎年度、評価結果の反映状況を公表しなければならない。

Article 31The Institute must ensure that the results of the evaluation referred to in paragraph (1) or (2) of the preceding Article are appropriately reflected in the medium-term plan, the annual plan, and the improvement of the operational management, and must make public how the evaluation results have been reflected in these items in each business year.

（中期目標の期間の終了時の検討）

(Review at the End of the Period for the Medium-Term Objectives)

第三十二条厚生労働大臣は、第三十条第一項第二号に規定する中期目標の期間の終了時に見込まれる中期目標の期間における業務の実績に関する評価を行ったときは、中期目標の期間の終了時までに、機構の業務における個々の事務又は事業の継続の必要性、組織の在り方その他その業務及び組織の全般にわたる検討を行い、その結果に基づき、所要の措置を講ずるものとする。

Article 32(1)When the Minister of Health, Labour and Welfare conducts an evaluation on the operational performance during the period for the medium-term objectives that are expected to be achieved at the time of the end of that period as provided for in Article 30, paragraph (1), item (ii), the minister is to review, by the end of the period for the medium-term objectives, the necessity of having the individual affairs or business within the Institute's operations continued, the manner in which the Institute is managed as an organization, and other overall aspects of its operations and organization, and take the necessary measures based on the results of this review.

２厚生労働大臣は、前項の規定による検討を行うに当たっては、機構の研究開発の事務及び事業に関する事項について、研究開発審議会の意見を聴かなければならない。

(2)When conducting a review under the provisions of the preceding paragraph, the Minister of Health, Labour and Welfare must hear the opinions of the research and development council regarding matters concerning the affairs and business of the Institute's research and development.

３厚生労働大臣は、第一項の検討の結果及び同項の規定により講ずる措置の内容を健康・医療戦略推進本部及び独立行政法人評価制度委員会に通知するとともに、公表しなければならない。

(3)The Minister of Health, Labour and Welfare must notify the Headquarters for Healthcare Policy and the Committee on the System of Evaluating Incorporated Administrative Agencies of the results of the review referred to in paragraph (1) and the details of the measures to be taken pursuant to the provisions of that paragraph, and make public those results and details.

４健康・医療戦略推進本部及び独立行政法人評価制度委員会は、前項の規定により通知された事項について、必要があると認めるときは、厚生労働大臣に意見を述べるとともに、その内容を公表しなければならない。

(4)If the Headquarters for Healthcare Policy or the Committee on the System of Evaluating Incorporated Administrative Agencies finds it necessary, the headquarters or committee must state its opinions to the Minister of Health, Labour and Welfare on the matters notified pursuant to the provisions of the preceding paragraph and make public the details of those opinions.

５前項の場合において、独立行政法人評価制度委員会は、機構の主要な事務及び事業の改廃に関し、厚生労働大臣に勧告をすることができる。

(5)In the case referred to in the preceding paragraph, the Committee on the System of Evaluating Incorporated Administrative Agencies may make recommendations to the Minister of Health, Labour and Welfare regarding the reform or discontinuation of any major affairs and business of the Institute.

６独立行政法人評価制度委員会は、前項の勧告をしたときは、当該勧告の内容を内閣総理大臣に報告するとともに、公表しなければならない。

(6)If the Committee on the System of Evaluating Incorporated Administrative Agencies makes recommendations as referred to in the preceding paragraph, it must report the details of the recommendations to the Prime Minister, and make public those details.

７独立行政法人評価制度委員会は、第五項の勧告をしたときは、厚生労働大臣に対し、その勧告に基づいて講じた措置及び講じようとする措置について報告を求めることができる。

(7)If the Committee on the System of Evaluating Incorporated Administrative Agencies makes recommendations as referred to in paragraph (5), it may request a report from the Minister of Health, Labour and Welfare regarding the measures that the minister has taken and intends to take on the basis of the recommendations.

第五章　財務及び会計

Chapter V Finance and Accounting

（財務諸表等）

(Financial Statements)

第三十三条機構は、毎事業年度、貸借対照表、損益計算書、利益の処分又は損失の処理に関する書類その他厚生労働省令で定める書類及びこれらの附属明細書（以下この条及び第五十条第一項第八号において「財務諸表」という。）を作成し、当該事業年度の終了後三月以内に厚生労働大臣に提出し、その承認を受けなければならない。

Article 33(1)For each business year, the Institute must prepare a balance sheet, a profit and loss statement, documents concerning the appropriation of profits or the disposition of losses, other documents provided for by Order of the Ministry of Health, Labour and Welfare, and any detailed statements annexed to those documents (referred to as the "financial statements" in this Article and Article 50, paragraph (1), item (viii) below), submit them to the Minister of Health, Labour and Welfare within three months from the end of the relevant business year, and obtain the approval of the minister.

２機構は、前項の規定により財務諸表を厚生労働大臣に提出するときは、これに厚生労働省令で定めるところにより作成した当該事業年度の事業報告書及び予算の区分に従い作成した決算報告書並びに財務諸表及び決算報告書に関する監査報告及び会計監査報告を添付しなければならない。

(2)When submitting the financial statements to the Minister of Health, Labour and Welfare pursuant to the provisions of the preceding paragraph, the Institute must attach to it a business report prepared for the relevant business year pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, a statement of accounts prepared in accordance with budget categories, and also an audit report and a financial audit report concerning the financial statements and the statement of accounts.

３機構は、第一項の規定による厚生労働大臣の承認を受けたときは、遅滞なく、財務諸表を官報に公告し、かつ、財務諸表並びに前項の事業報告書、決算報告書、監査報告及び会計監査報告を、主たる事務所に備えて置き、厚生労働省令で定める期間、一般の閲覧に供しなければならない。

(3)When obtaining the approval of the Minister of Health, Labour and Welfare under the provisions of paragraph (1), the Institute must give public notice of the financial statements in the Official Gazette without delay, keep the financial statements as well as the business report, statement of accounts, audit report, and financial audit report referred to in the preceding paragraph in the principal office of the Institute, and make them available for public inspection for the period provided for by Order of the Ministry of Health, Labour and Welfare.

４機構は、第一項の附属明細書その他厚生労働省令で定める書類については、前項の規定による公告に代えて、次に掲げる方法のいずれかにより公告することができる。

(4)The Institute may give public notice of the detailed statements annexed to the documents referred to in paragraph (1) and other documents provided for by Order of the Ministry of Health, Labour and Welfare by either of the methods stated below, in lieu of giving public notice under the provisions of the preceding paragraph:

一時事に関する事項を掲載する日刊新聞紙に掲載する方法

(i)method of publication in a daily newspaper that publishes matters on current affairs; or

二電子公告（電子情報処理組織を使用する方法その他の情報通信の技術を利用する方法であって厚生労働省令で定めるものにより不特定多数の者が公告すべき内容である情報の提供を受けることができる状態に置く措置であって厚生労働省令で定めるものをとる公告の方法をいう。次項において同じ。）

(ii)electronic public notice (meaning a method of public notice using an electronic data processing system or other information and communication technology, which is provided for by Order of the Ministry of Health, Labour and Welfare and which implements what Order of the Ministry of Health, Labour and Welfare provides for as the measure to put the information that should be given through public notice into a form that enable a large number of unspecified people to access the relevant information; the same applies in the following paragraph).

５機構が前項の規定により電子公告による公告をする場合には、第三項の厚生労働省令で定める期間、継続して当該公告をしなければならない。

(5)If the Institute gives public notice by means of electronic public notice pursuant to the provisions of the preceding paragraph, the Institute must continually maintain the public notice for the period provided for by Order of the Ministry of Health, Labour and Welfare under paragraph (3).

（利益及び損失の処理）

(Management of Profits and Losses)

第三十四条機構は、毎事業年度、損益計算において利益を生じたときは、前事業年度から繰り越した損失を埋め、なお残余があるときは、その残余の額は、積立金として整理しなければならない。ただし、第三項の規定により同項の使途に充てる場合は、この限りでない。

Article 34(1)For each business year, when profits accrue in the calculation of profits and losses, the Institute must offset any losses carried forward from the preceding business year and, if there is still any remaining amount, record the remaining amount as a reserve fund; provided, however, that this does not apply if the remaining amount is allocated for the use referred to in paragraph (3) pursuant to the provisions of that paragraph.

２機構は、毎事業年度、損益計算において損失を生じたときは、前項の規定による積立金を減額して整理し、なお不足があるときは、その不足額は、繰越欠損金として整理しなければならない。

(2)For each business year, when losses arise in the calculation of profits and losses, the Institute must record the losses after reducing the amount of the reserve fund under the provisions of the preceding paragraph and, if there is still any shortfall, dispose of the amount of the shortfall as a loss carried forward.

３機構は、第一項に規定する残余があるときは、厚生労働大臣の承認を受けて、その残余の額の全部又は一部を第二十八条第一項の認可を受けた中期計画（同項後段の規定による変更の認可を受けたときは、その変更後のもの。以下同じ。）の同条第二項第八号の剰余金の使途に充てることができる。

(3)If there is any remaining amount under paragraph (1), the Institute may allocate all or part of the remaining amount for the use of surplus referred to in Article 28, paragraph (2), item (viii) under a medium-term plan authorized under paragraph (1) of that Article (or a revised plan if the Institute has obtained authorization for revision under the provisions of the second sentence of that paragraph; the same applies below) upon obtaining the approval of the Minister of Health, Labour and Welfare.

（積立金の処分）

(Disposition of Reserve Funds)

第三十五条機構は、中期目標の期間の最後の事業年度に係る前条第一項又は第二項の規定による整理を行った後、同条第一項の規定による積立金があるときは、その額に相当する金額のうち厚生労働大臣の承認を受けた金額を、当該中期目標の期間の次の中期目標の期間に係る中期計画の定めるところにより、当該次の中期目標の期間における機構が行う第二十三条第一項及び第二十五条に規定する業務の財源に充てることができる。

Article 35(1)After the Institute settles accounts under the provisions of paragraph (1) or (2) of the preceding Article for the final business year of the period for the medium-term objectives, if there remains any reserve funds under the provisions of paragraph (1) of that Article, the Institute may allocate the portion, out of an amount equivalent to the reserve funds, that has been approved by the Minister of Health, Labour and Welfare to the financial resources for the operations provided for in Article 23, paragraph (1) and Article 25, and to be conducted by the Institute during the next medium-term objective period after the above-mentioned period for the medium-term objectives, pursuant to the medium-term plan associated with the next medium-term objective period.

２機構は、前項に規定する積立金の額に相当する金額から同項の規定による承認を受けた金額を控除してなお残余があるときは、その残余の額を国庫に納付しなければならない。

(2)If any surplus remains after deducting the amount approved under the provisions of the preceding paragraph from the amount equivalent to the reserve funds provided for in that paragraph, the Institute must pay the remaining surplus to the national treasury.

３前二項に定めるもののほか、納付金の納付の手続その他積立金の処分に関し必要な事項は、政令で定める。

(3)Beyond what is provided for in the preceding two paragraphs, the procedure for making payments and other necessary matters concerning the disposition of reserve funds are provided for by Cabinet Order.

（借入金等）

(Borrowings)

第三十六条機構は、中期計画の第二十八条第二項第五号の短期借入金の限度額の範囲内で、短期借入金をすることができる。ただし、やむを得ない事由があるものとして厚生労働大臣の認可を受けた場合は、当該限度額を超えて短期借入金をすることができる。

Article 36(1)The Institute may make short-term borrowings within the limits on the amount of short-term borrowings stated in the relevant medium-term plan, as referred to in Article 28, paragraph (2), item (v); provided, however, that the Institute may make short-term borrowings in excess of the limits if the authorization of the Minister of Health, Labour and Welfare is obtained on unavoidable grounds.

２前項の規定による短期借入金は、当該事業年度内に償還しなければならない。ただし、資金の不足のため償還することができないときは、その償還することができない金額に限り、厚生労働大臣の認可を受けて、これを借り換えることができる。

(2)Short-term borrowings under the preceding paragraph must be redeemed within the relevant business year; provided, however, that, if short-term borrowings cannot be redeemed due to a shortage of funds, only the amount that cannot be redeemed may be refinanced, upon obtaining the authorization of the Minister of Health, Labour and Welfare.

３前項ただし書の規定により借り換えた短期借入金は、一年以内に償還しなければならない。

(3)Short-term borrowings that have been refinanced pursuant to the provisions of the proviso to the preceding paragraph must be redeemed within one year.

４機構は、政令で定める施設の設置若しくは整備又は設備の設置に必要な費用に充てるため、厚生労働大臣の認可を受けて、長期借入金をし、又は国立健康危機管理研究機構債券（以下「債券」という。）を発行することができる。

(4)Upon obtaining the authorization of the Minister of Health, Labour and Welfare, the Institute may take out long-term borrowings or issue Japan Institute for Health Security bonds (referred to below as "bonds") in order to allocate those borrowings or bonds for the expenses required in the installation or maintenance of facilities provided for by Cabinet Order or in the installation of equipment.

５前項に規定するもののほか、機構は、長期借入金又は債券で政令で定めるものの償還に充てるため、厚生労働大臣の認可を受けて、長期借入金をし、又は債券を発行することができる。ただし、その償還期間が政令で定める期間のものに限る。

(5)Beyond what is provided for in the preceding paragraph, the Institute may, upon obtaining the authorization of the Minister of Health, Labour and Welfare, take out long-term borrowings or issue bonds in order to allocate them for the redemption of the long-term borrowings or bonds provided for by Cabinet Order; provided, however, that those long-term borrowings and bonds to be taken out or issued for redemption are limited to those in which redemption periods are provided for by Cabinet Order.

６前二項の規定による債券の債権者は、機構の財産について他の債権者に先立って自己の債権の弁済を受ける権利を有する。

(6)Creditors holding bonds under the provisions of the preceding two paragraphs have the right to receive payment of their own claims in preference to other creditors regarding the assets of the Institute.

７前項の先取特権の順位は、民法（明治二十九年法律第八十九号）の規定による一般の先取特権に次ぐものとする。

(7)The order of statutory lien under the preceding paragraph is ranked next to the general statutory lien under the provisions of the Civil Code (Act No. 89 of 1896).

８機構は、厚生労働大臣の認可を受けて、債券の発行に関する事務の全部又は一部を銀行又は信託会社に委託することができる。

(8)Upon obtaining the authorization of the Minister of Health, Labour and Welfare, the Institute may entrust a bank or trust company with all or part of affairs concerning the issuance of bonds.

９会社法第七百五条第一項及び第二項並びに第七百九条の規定は、前項の規定により委託を受けた銀行又は信託会社について準用する。

(9)The provisions of Article 705, paragraphs (1) and (2), and of Article 709 of the Companies Act apply mutatis mutandis to the bank or trust company entrusted pursuant to the provisions of the preceding paragraph.

１０第四項から前項までに定めるもののほか、第四項又は第五項の規定による長期借入金又は債券に関し必要な事項は、政令で定める。

(10)Beyond what is provided for in paragraph (4) through the preceding paragraph, the necessary matters concerning long-term borrowings or bonds under the provisions of paragraph (4) or (5) are provided for by Cabinet Order.

（債務保証）

(Guarantee of Obligations)

第三十七条政府は、法人に対する政府の財政援助の制限に関する法律（昭和二十一年法律第二十四号）第三条の規定にかかわらず、国会の議決を経た金額の範囲内において、前条第四項又は第五項の規定による機構の長期借入金又は債券に係る債務（国際復興開発銀行等からの外資の受入に関する特別措置に関する法律（昭和二十八年法律第五十一号）第二条の規定に基づき政府が保証契約をすることができる債務を除く。）について保証することができる。

Article 37Notwithstanding the provisions of Article 3 of the Act on Restrictions on Financial Assistance by the Government to Corporations (Act No. 24 of 1946), the government may, within the limits of the amount determined by a National Diet resolution, guarantee obligations relating to the Institute's long-term borrowings or bonds under the provisions of paragraph (4) or (5) of the preceding Article (excluding obligations for which the government may enter into guarantee contracts pursuant to the provisions of Article 2 of the Act on Special Measures Pertaining to the Acceptance of Foreign Capital from the International Bank for Reconstruction and Development, etc. (Act No. 51 of 1953)).

（償還計画）

(Redemption Plan)

第三十八条機構は、第三十六条第四項又は第五項の規定により、長期借入金をし、又は債券を発行するときは、毎事業年度、長期借入金及び債券の償還計画を立てて、厚生労働大臣の認可を受けなければならない。

Article 38When taking out long-term borrowings or issuing bonds pursuant to the provisions of Article 36, paragraph (4) or (5), the Institute must formulate a redemption plan for its long-term borrowings and bonds for each business year and obtain the authorization of the Minister of Health, Labour and Welfare.

（財源措置）

(Granting of Financial Resources)

第三十九条政府は、予算の範囲内において、機構に対し、その業務の財源に充てるために必要な金額の全部又は一部に相当する金額を交付することができる。

Article 39(1)The government may, within the limits of budget, grant the Institute an amount of money equivalent to all or part of the amount required to be allocated to the financial resources for the operations of the Institute.

２機構は、業務運営に当たっては、前項の規定による交付金について、国民から徴収された税金その他の貴重な財源で賄われるものであることに留意し、法令の規定及び中期計画に従って適切かつ効率的に使用するよう努めなければならない。

(2)For the purpose of its operational management, the Institute must bear in mind that a grant provided under the provisions of the preceding paragraph is procured from taxes collected from the people and other invaluable financial resources, and must strive to use such a grant in an appropriate and efficient manner in accordance with the provisions of laws and regulations and the medium-term plan.

第六章　監督

Chapter VI Supervision

（緊急時の命令）

(Orders in Emergencies)

第四十条厚生労働大臣は、災害が発生し、若しくはまさに発生しようとしている事態又は感染症その他の疾患に関して、公衆衛生上重大な危害が生じ、若しくは生じるおそれがある緊急の事態に対処するため必要があると認めるときは、機構に対し、第二十三条第一項第一号から第十号までに掲げる業務に関し必要な措置をとるべきことを命ずることができる。

Article 40If the Minister of Health, Labour and Welfare finds it necessary in handling a situation in which a disaster occurs or is imminent, or an emergency situation in which serious harm to public health occurs or is likely to occur in connection with any infectious and other diseases, the minister may order the Institute to take the necessary measures concerning the operations stated in Article 23, paragraph (1), items (i) through (x).

（監督命令）

(Supervision Order)

第四十一条厚生労働大臣は、前条に定めるもののほか、中期目標を達成するためその他この法律及び感染症法を施行するため必要があると認めるときは、機構に対し、その業務に関し監督上必要な命令をすることができる。

Article 41Beyond what is provided for in the preceding Article, if the Minister of Health, Labour and Welfare finds it necessary for achievement of the medium-term objectives or for enforcement of this Act and the Act on Infectious Diseases, the minister may issue an order to the Institute as necessary for supervision of its operations.

（報告及び検査）

(Report and Inspection)

第四十二条厚生労働大臣は、この法律及び感染症法を施行するため必要があると認めるときは、機構に対し、その業務並びに資産及び債務の状況に関し報告をさせ、又はその職員に、機構の事務所その他その業務を行う場所に立ち入り、業務の状況若しくは帳簿、書類その他の必要な物件を検査させることができる。

Article 42(1)If the Minister of Health, Labour and Welfare finds it necessary for enforcement of this Act and the Act on Infectious Diseases, the minister may have the Institute report on the status of its operations, assets, and debts or have the ministry's employee enter the Institute's offices and other places of its operations, and inspect the status of its operations or its books, documents, and other necessary items.

２前項の規定により職員が立入検査をする場合には、その身分を示す証明書を携帯し、関係人にこれを提示しなければならない。

(2)When an employee of the competent ministry conducts an on-site inspection pursuant to the provisions of the preceding paragraph, the employee must carry an identification card and present it to the person concerned.

３第一項の規定による立入検査の権限は、犯罪捜査のために認められたものと解してはならない。

(3)The authority for the on-site inspection pursuant to the provisions of paragraph (1) must not be interpreted as having been accorded for the purpose of a criminal investigation.

第七章　雑則

Chapter VII Miscellaneous Provisions

（独立行政法人通則法の規定の準用）

(Application Mutatis Mutandis of the Provisions of the Act on General Rules for Incorporated Administrative Agencies)

第四十三条独立行政法人通則法第八条第一項及び第三項、第九条、第十九条の二、第二十一条の五、第二十四条、第二十五条、第二十六条、第三十六条第一項、第三十七条、第三十九条から第四十三条まで、第四十六条の二、第四十七条から第五十条まで並びに第五十条の三から第五十条の九までの規定は機構について、同法第十二条の二第二項、第二十八条の二、第二十八条の三及び第三十五条の二の規定は機構の中期目標及び評価について準用する。この場合において、これらの規定中「主務大臣」とあるのは「厚生労働大臣」と、「主務省令」とあるのは「厚生労働省令」と読み替えるほか、次の表の上欄に掲げる同法の規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句に読み替えるものとする。

Article 43The provisions of Article 8, paragraphs (1) and (3), Articles 9, 19-2, 21-5, 24, 25, and 26, Article 36, paragraph (1), Article 37, Articles 39 through 43, Article 46-2, Articles 47 through 50, and Articles 50-3 through 50-9 of the Act on General Rules for Incorporated Administrative Agencies apply mutatis mutandis to the Institute, and the provisions of Article 12-2, paragraph (2) and Articles 28-2, 28-3, and 35-2 of that Act apply mutatis mutandis to the Institute's medium-term objectives and evaluation. In this case, the term "competent minister" in these provisions is deemed to be replaced with "Minister of Health, Labour and Welfare"; the term "order of the competent ministry" is deemed to be replaced with "Order of the Ministry of Health, Labour and Welfare"; and the terms listed in the middle column of the following Table and used in the provisions of that Act listed in the left-hand column of the Table are deemed to be replaced with the terms listed in the right-hand column of the Table, respectively.

読み替えられる独立行政法人通則法の規定 Provisions of Act on General Rules for Incorporated Administrative Agencies to be Replaced	読み替えられる字句 Terms to Be Replaced	読み替える字句 Terms to Replace
第八条第三項 Article 8, paragraph (3)	（当該独立行政法人を所管する内閣府又は各省の内閣府令又は省令をいう。ただし、原子力規制委員会が所管する独立行政法人については、原子力規制委員会規則とする。以下同じ。）で定める (meaning Cabinet Office Order or Ministerial Order of the Cabinet Office or each ministry that has jurisdiction over the relevant Incorporated Administrative Agency; provided, however, that the Rules of the NRA apply to Incorporated Administrative Agencies under the jurisdiction of the NRA; the same applies hereinafter)	で定める Be specified in
	第四十六条の二又は第四十六条の三 Article 46-2 Or Article 46-3.	第四十六条の二 Article 46-2
第十二条の二第二項 Article 12-2, paragraph (2)	前項第一号若しくは第二号に規定する規定又は同項第五号若しくは第六号 The provisions prescribed in item (i) or (ii) of the preceding paragraph, or item (v) or (vi) of that paragraph	国立健康危機管理研究機構法（以下「機構法」という。）第四十三条において準用する第二十八条の二第二項 Article 28-2, paragraph (2) as applied mutatis mutandis pursuant to Article 43 of the Act on Japan Institute for Health Security ( referred to below as the "Institute Act")
第十九条の二 Article 19-2	この法律、個別法 This Act and the relevant Individual Act	機構法 Institute Act
	法人の長 The Agency President	理事長 President
第二十四条 Article 24	法人の長その他の代表権を有する役員 The Agency President or any other officer with the authority of representation	理事長又は副理事長 President or Vice President
第二十五条 Article 25	法人の長その他の代表権を有する役員 The Agency President or any other officer with the authority of representation	理事長又は副理事長 President or Vice President
	代表権を有しない役員 Officers without the Authority to Represent	理事（機構法第七条ただし書に規定する外部理事を除く。） Directors (excluding external directors prescribed in the proviso to Article 7 of the Institute Act)
第二十六条 Article 26	法人の長 The Agency President	理事長 President
第二十八条の二第一項 Article 28-2, paragraph (1)	第二十九条第一項の中期目標、第三十五条の四第一項の中長期目標及び第三十五条の九第一項の年度目標の策定並びに第三十二条第一項、第三十五条の六第一項及び第二項並びに第三十五条の十一第一項及び第二項 The establishment of the medium-term objectives referred to in Article 29, paragraph (1), the medium to long-term objectives referred to in Article 35-4, paragraph (1), and the annual objectives referred to in Article 35-9, paragraph (1), as well as the establishment of the medium-term objectives referred to in Article 32, paragraph (1), Article 35-6, paragraphs (1) and (2), and Article 35-11, paragraphs (1) and (2)	機構法第二十七条第一項に規定する中期目標（以下「中期目標」という。）の策定（同条第二項第一号に掲げる事項に係る策定を除く。）並びに機構法第三十条第一項及び第二項 Formulation of the medium-term goals prescribed in Article 27, paragraph (1) of the Institute Act ( referred to below as the "medium-term goals") (excluding formulation related to the matters stated in paragraph (2), item (i) of the same Article) and Article 30, paragraphs (1) and (2) of the Institute Act
第二十八条の二第三項 Article 28-2, paragraph (3)	第二十九条第一項の中期目標、第三十五条の四第一項の中長期目標及び第三十五条の九第一項の年度目標 The medium-term objectives referred to in Article 29, paragraph (1), the medium to long-term objectives referred to in Article 35-4, paragraph (1), and the annual objectives referred to in Article 35-9, paragraph (1);	中期目標 Medium-Term Goals
	第三十二条第一項、第三十五条の六第一項及び第二項並びに第三十五条の十一第一項及び第二項 Article 32, paragraph (1), Article 35-6, paragraphs (1) and (2), and Article 35-11, paragraphs (1) and (2)	機構法第三十条第一項及び第二項 Article 30, paragraphs (1) and (2) of the Institute Act
第三十五条の二 Article 35-2	前条第四項 Paragraph (4) of the preceding Article	機構法第三十二条第五項 Article 32, paragraph (5) of the Institute Act
第三十九条第二項第二号 Article 39, paragraph (2), item (ii)	総務省令 Order of the Ministry of Internal Affairs and Communications	厚生労働省令 Order of the Ministry of Health, Labour and Welfare
第三十九条第三項 Article 39, paragraph (3)	子法人に From a subsidiary	子法人（機構法第七条第一号に規定する子法人をいう。以下同じ。）に From a subsidiary corporation (meaning a subsidiary corporation prescribed in Article 7, item (i) of the Institute Act; the same applies below)
第三十九条の二第一項 Article 39-2, paragraph (1)	この法律、個別法 This Act and the relevant Individual Act	機構法 Institute Act
第四十二条 Article 42	財務諸表承認日 Date of approval of financial statements	機構法第三十三条第一項の規定による同項に規定する財務諸表の承認の日 The date of approval of the financial statements prescribed in Article 33, paragraph (1) of the Institute Act under the provisions of that paragraph;
第四十六条の二第一項ただし書 Proviso to Article 46-2, paragraph (1)	中期目標管理法人の中期計画において第三十条第二項第五号の計画を定めた場合、国立研究開発法人の中長期計画において第三十五条の五第二項第五号の計画を定めた場合又は行政執行法人の事業計画において第三十五条の十第三項第五号 When the plan referred to in Article 30, paragraph (2), item (v) is specified in the Medium-term Plan of an Agency Managed under the Medium-term Objectives, when the plan referred to in Article 35-5, paragraph (2), item (v) is specified in the Medium to Long-term Plan of a National Research and Development Agency, or when the plan referred to in Article 35-10, paragraph (3), item (v) is specified in the Annual Objective Plan of an Agency Engaged in Administrative Execution	機構法第二十八条第一項に規定する中期計画（以下「中期計画」という。）において同条第二項第六号 In the medium-term plan prescribed in Article 28, paragraph (1) of the Institute Act ( referred to below as the "medium-term plan"), the provisions of paragraph (2), item (vi) of that Article
	これらの These	その That
第四十六条の二第二項ただし書 Proviso to Article 46-2, paragraph (2)	中期目標管理法人の中期計画において第三十条第二項第五号の計画を定めた場合、国立研究開発法人の中長期計画において第三十五条の五第二項第五号の計画を定めた場合又は行政執行法人の事業計画において第三十五条の十第三項第五号 When the plan referred to in Article 30, paragraph (2), item (v) is specified in the Medium-term Plan of an Agency Managed under the Medium-term Objectives, when the plan referred to in Article 35-5, paragraph (2), item (v) is specified in the Medium to Long-term Plan of a National Research and Development Agency, or when the plan referred to in Article 35-10, paragraph (3), item (v) is specified in the Annual Objective Plan of an Agency Engaged in Administrative Execution	中期計画において機構法第二十八条第二項第六号 In the medium-term plan Article 28, paragraph (2), item (vi) of the DICJ Act
	これらの These	その That
第四十八条ただし書 Proviso to Article 48	中期目標管理法人の中期計画において第三十条第二項第六号の計画を定めた場合、国立研究開発法人の中長期計画において第三十五条の五第二項第六号の計画を定めた場合又は行政執行法人の事業計画において第三十五条の十第三項第六号 When the plan referred to in Article 30, paragraph (2), item (vi) is specified in the Medium-term Plan of an Agency Managed under the Medium-term Objectives, when the plan referred to in Article 35-5, paragraph (2), item (vi) is specified in the Medium to Long-term Plan of a National Research and Development Agency, or when the plan referred to in Article 35-10, paragraph (3), item (vi) is specified in the Annual Objective Plan of an Agency Engaged in Administrative Execution	中期計画において機構法第二十八条第二項第七号 In the medium-term plan, Article 28, paragraph (2), item (vii) of the Institute Act
	これらの These	その That
第五十条の四第二項第一号 Article 50-4, paragraph (2), item (i)	政令 Cabinet Order	厚生労働省令 Order of the Ministry of Health, Labour and Welfare
第五十条の四第二項第三号 Article 50-4, paragraph (2), item (iii)	の研究者 Researcher of	において専ら研究又は教育に従事する者 A person who exclusively engages in research or education in
	研究に In research	研究又は教育に In research or education
第五十条の四第二項第四号 Article 50-4, paragraph (2), item (iv)	第三十二条第一項 Article 32, paragraph (1)	機構法第三十条第一項 Article 30, paragraph (1) of the Institute Act
第五十条の四第二項第五号 Article 50-4, paragraph (2), item (v)	第三十五条第一項 Article 35, paragraph (1)	機構法第三十二条第一項 Article 32, paragraph (1) of the Institute Act
第五十条の四第二項第五号 Article 50-4, paragraph (2), item (v)	政令 Cabinet Order	厚生労働省令 Order of the Ministry of Health, Labour and Welfare
第五十条の四第三項 Article 50-4, paragraph (3)	政令 Cabinet Order	厚生労働省令 Order of the Ministry of Health, Labour and Welfare
第五十条の四第四項 Article 50-4, paragraph (4)	総務大臣 Minister for Internal Affairs and Communications	厚生労働大臣 Minister of Health, Labour and Welfare
第五十条の四第五項 Article 50-4, paragraph (5)	政令 Cabinet Order	厚生労働省令 Order of the Ministry of Health, Labour and Welfare
第五十条の四第六項 Article 50-4, paragraph (6)	この法律、個別法 This Act and the relevant Individual Act	機構法 Institute Act
第五十条の六、第五十条の七第一項、第五十条の八第三項及び第五十条の九 Article 50-6, Article 50-7, paragraph (1), Article 50-8, paragraph (3), and Article 50-9	政令 Cabinet Order	厚生労働省令 Order of the Ministry of Health, Labour and Welfare

（財務大臣との協議）

(Deliberation with the Minister of Finance)

第四十四条厚生労働大臣は、次に掲げる場合には、財務大臣に協議しなければならない。

Article 44The Minister of Health, Labour and Welfare must deliberate with the Minister of Finance in any of the following cases:

一第二十七条第一項の規定により中期目標を定め、又は変更しようとするとき。

(i)when the minister intends to set or revise medium-term objectives pursuant to the provisions of Article 27, paragraph (1);

二第二十八条第一項、第三十六条第一項ただし書、第二項ただし書、第四項、第五項若しくは第八項、第三十八条又は前条において読み替えて準用する独立行政法人通則法第四十八条の規定による認可をしようとするとき。

(ii)when the minister intends to grant authorization under the provisions of Article 48 of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to Article 28, paragraph (1), the proviso to paragraph (1) or that to paragraph (2) of Article 36, Article 36, paragraph (4), (5), or (8), Article 38, or the preceding Article following the deemed replacement of terms;

三第三十四条第三項又は第三十五条第一項の規定による承認をしようとするとき。

(iii)when the minister intends to grant approval under the provisions of Article 34, paragraph (3) or Article 35, paragraph (1);

四前条において読み替えて準用する独立行政法人通則法第四十六条の二第一項、第二項又は第三項ただし書の規定による認可をしようとするとき。

(iv)when the minister intends to grant authorization under the provisions of Article 46-2, paragraph (1) or (2), or the proviso to paragraph (3) of that Article of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to the preceding Article following the deemed replacement of terms;

五前条において読み替えて準用する独立行政法人通則法第四十七条第一号又は第二号の規定による指定をしようとするとき。

(v)when the minister intends to designate as under the provisions of Article 47, item (i) or (ii) of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to the preceding Article following the deemed replacement of terms.

（財政上の配慮）

(Financial Considerations)

第四十五条国は、機構の業務の特性に鑑み、機構における研究開発の進捗状況を踏まえつつ、機構の研究開発を行う能力の強化並びにその研究開発の効果的な推進及びその成果の普及を図るため、必要な財政上の配慮をするものとする。

Article 45In light of the characteristics of the operations of the Institute and on the basis of the progress of research and development at the Institute, the national government is to give the financial consideration necessary to enhance the capability of the Institute to engage in its research and development, and to promote the effective implementation of its research and development and the dissemination of their results.

（他の法令の準用）

(Application Mutatis Mutandis of Other Laws and Regulations)

第四十六条医療法（昭和二十三年法律第二百五号）その他政令で定める法令については、政令で定めるところにより、機構を国とみなして、これらの法令を準用する。

Article 46The Medical Care Act (Act No. 205 of 1948) and other laws and regulations provided for by Cabinet Order are applied mutatis mutandis with the Institute deemed to be the national government, pursuant to the provisions of Cabinet Order.

（解散）

(Dissolution)

第四十七条機構の解散については、別に法律で定める。

Article 47The dissolution of the Institute is provided for by a separate Act.

第八章　罰則

Chapter VIII Penal Provisions

第四十八条第二十一条の規定に違反して秘密を漏らし、又は盗用した者は、一年以下の拘禁刑又は五十万円以下の罰金に処する。

Article 48A person who has divulged or misappropriated any confidential information in violation of the provisions of Article 21 is punished by imprisonment for not more than one year or a fine of not more than five hundred thousand yen.

第四十九条第四十二条第一項の規定による報告をせず、若しくは虚偽の報告をし、又は同項の規定による検査を拒み、妨げ、若しくは忌避した場合には、その違反行為をした機構の役員又は職員は、二十万円以下の罰金に処する。

Article 49If the Institute fails to make a report under the provisions of Article 42, paragraph (1), or makes a false report, or refuses, obstructs or avoids an inspection under the provisions of that paragraph, its officer or employee who has committed the violation in question is punished by a fine of not more than two hundred thousand yen.

第五十条次の各号のいずれかに該当する場合には、その違反行為をした機構の役員は、二十万円以下の過料に処する。

Article 50(1)If the Institute falls under any of the following items, its officer who has committed the violation in question is punished by a civil fine of not more than two hundred thousand yen:

一この法律（第四十三条において読み替えて準用する独立行政法人通則法の規定を含む。次号において同じ。）の規定により厚生労働大臣の認可又は承認を受けなければならない場合において、その認可又は承認を受けなかったとき。

(i)the Institute fails to obtain the authorization or approval of the Minister of Health, Labour and Welfare when the authorization or approval is required pursuant to the provisions of this Act (including the provisions of Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to Article 43 following the deemed replacement of terms; the same applies in the following item);

二この法律の規定により厚生労働大臣に届出をしなければならない場合において、その届出をせず、又は虚偽の届出をしたとき。

(ii)the Institute fails to make a notification or makes a false notification to the Minister of Health, Labour and Welfare when a notification to the minister is required pursuant to the provisions of this Act;

三この法律の規定により公表をしなければならない場合において、その公表をせず、又は虚偽の公表をしたとき。

(iii)the Institute fails to make a public announcement or makes a false public announcement when a public announcement is required to be made pursuant to the provisions of this Act;

四第十条第五項若しくは第六項又は第四十三条において読み替えて準用する独立行政法人通則法第三十九条第三項の規定による調査を妨げたとき。

(iv)the Institute obstructs an investigation under the provisions of Article 39, paragraph (3) of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to Article 10, paragraph (5) or (6), or Article 43, following the deemed replacement of terms;

五第二十三条第一項及び第二十五条に規定する業務以外の業務を行ったとき。

(v)the Institute performs any operations other than those provided for in Article 23, paragraph (1) and Article 25;

六第二十八条第三項、第三十条第九項、第四十条又は第四十一条の規定による命令に違反したとき。

(vi)the Institute violates an order under the provisions of Article 28, paragraph (3), Article 30, paragraph (9), Article 40, or Article 41;

七第三十条第三項又は第四項の規定による報告書の提出をせず、又は報告書に記載すべき事項を記載せず、若しくは虚偽の記載をして報告書を提出したとき。

(vii)the Institute fails to submit a report under the provisions of Article 30, paragraph (3) or (4), or fails to state any matters required to be stated in a report or submits a report with false statements;

八第三十三条第三項の規定に違反して財務諸表、事業報告書、決算報告書、監査報告又は会計監査報告を備え置かず、又は閲覧に供しなかったとき。

(viii)the Institute fails to keep in its principal office or make available for public inspection its financial statements, business reports, statements of accounts, audit reports, or financial audit reports, in violation of the provisions of Article 33, paragraph (3);

九第四十三条において準用する独立行政法人通則法第九条第一項の規定による政令に違反して登記することを怠ったとき。

(ix)the Institute fails to register in violation of Cabinet Order under the provisions of Article 9, paragraph (1) of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to Article 43;

十第四十三条において読み替えて準用する独立行政法人通則法第四十七条の規定に違反して業務上の余裕金を運用したとき。

(x)the Institute has invested surplus funds accrued in the course of its operations in violation of the provisions of Article 47 of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to Article 43 following the deemed replacement of terms; or

十一第四十三条において読み替えて準用する独立行政法人通則法第五十条の八第三項の規定による報告をせず、又は虚偽の報告をしたとき。

(xi)the Institute fails to make a report or makes a false report under Article 50-8, paragraph (3) of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to Article 43 following the deemed replacement of terms.

２機構の子法人の役員が第十条第七項又は第四十三条において読み替えて準用する独立行政法人通則法第三十九条第三項の規定による調査を妨げたときは、二十万円以下の過料に処する。

(2)If an officer of a subsidiary corporation of the Institute obstructs an investigation under Article 39, paragraph (3) of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to Article 10, paragraph (7), or Article 43, following the deemed replacement of terms, the officer is punished by a civil fine of not more than two hundred thousand yen.

第五十一条第五条の規定に違反した者は、十万円以下の過料に処する。

Article 51A person who has violated the provisions of Article 5 is punished by a civil fine of not more than one hundred thousand yen.

附　則
Supplementary Provisions

（施行期日）

(Effective Date)

第一条この法律は、公布の日から起算して三年を超えない範囲内において政令で定める日から施行する。ただし、次条から附則第四条まで並びに附則第十二条第三項及び第四項、第十六条第四項及び第五項、第十七条第二項及び第三項並びに第二十六条の規定は、公布の日から施行する。

Article 1This Act comes into effect on the date provided for by Cabinet Order within a period not exceeding three years from the date of promulgation; provided, however, that the provisions of the following Article through Article 4 of the Supplementary Provisions, and the provisions of Article 12, paragraphs (3) and (4), Article 16, paragraphs (4) and (5), Article 17, paragraphs (2) and (3), and Article 26 of the Supplementary Provisions come into effect on the date of promulgation.

（理事長等となるべき者の指名等）

(Nomination of Persons Who Are to Assume the Position of President and Other Positions)

第二条厚生労働大臣は、この法律の施行の日（以下「施行日」という。）前に機構の理事長となるべき者及び監事となるべき者を指名する。

Article 2(1)The Minister of Health, Labour and Welfare nominates a person to serve as the president and those to serve as inspectors of the Institute before the date on which this Act comes into effect (referred to below as the "effective date").

２前項の規定により指名された理事長となるべき者は、厚生労働大臣の認可を受けて機構の副理事長となるべき者及び理事となるべき者を指名する。

(2)The person nominated to serve as the president pursuant to the provisions of the preceding paragraph nominates a person to serve as the vice president and those to serve as directors of the Institute, upon obtaining the authorization of the Minister of Health, Labour and Welfare.

３前二項の規定により指名された理事長、副理事長、理事又は監事となるべき者は、機構の成立の時において、第十一条第一項及び第二項の規定により、それぞれ理事長、副理事長、理事又は監事に任命されたものとする。

(3)The persons who are nominated to serve as the president, vice president, directors, or inspectors pursuant to the provisions of the preceding two paragraphs are deemed to be appointed as the president, vice president, directors, or inspectors, respectively, at the time of incorporation of the Institute pursuant to the provisions of Article 11, paragraphs (1) and (2).

４第十二条第一項の規定にかかわらず、厚生労働大臣は、第十一条第一項の規定により理事長となるべき者としてより適切と認める者を任命するため特に必要があると認めるときは、前項の規定により機構の成立の時において任命されたものとされる理事長の任期を、任命の日から、中期目標の期間の初日から三年を経過する日までとすることができる。

(4)Notwithstanding the provisions of Article 12, paragraph (1), if the Minister of Health, Labour and Welfare finds it particularly necessary in order to appoint a person considered more suitable for the position of president pursuant to the provisions of Article 11, paragraph (1), the minister may set the term of office of the president deemed to be appointed at the time of incorporation of the Institute pursuant to the provisions of the preceding paragraph so that it starts from the date of appointment and ends on the day on which three years have passed from the first day of the period for the medium-term objectives.

（設立委員等）

(Organizing Committee Members)

第三条厚生労働大臣は、設立委員を命じて、機構の設立に関する事務を処理させる。

Article 3(1)The Minister of Health, Labour and Welfare appoints organizing committee members to process affairs concerning the incorporation of the Institute.

２設立委員は、業務方法書、制裁規程その他厚生労働省令で定める規則を作成し、厚生労働大臣の認可を受けなければならない。

(2)Organizing committee members must prepare an operational method statement, disciplinary rules, and other rules provided for by Order of the Ministry of Health, Labour and Welfare, and obtain the authorization of the Minister of Health, Labour and Welfare.

３前項の規定によりした厚生労働大臣の認可は、厚生労働省令で定めるところにより、施行日において、第二十二条第一項、第二十六条第一項その他厚生労働省令で定める規定によりした厚生労働大臣の認可とみなす。

(3)Pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, the authorization of the Minister of Health, Labour and Welfare granted pursuant to the provisions of the preceding paragraph is deemed to be the authorization of the Minister granted on the effective date pursuant to the provisions of Article 22, paragraph (1), Article 26, paragraph (1), and other provisions provided for by Order of the Ministry of Health, Labour and Welfare.

４設立委員は、機構の設立の準備を完了したときは、遅滞なく、その旨を厚生労働大臣に届け出るとともに、その事務を前条第一項の規定により指名された理事長となるべき者に引き継がなければならない。

(4)Upon completing the preparation for incorporating the Institute, organizing committee members must, without delay, notify the Minister of Health, Labour and Welfare to that effect and hand over the affairs of the Institute to the person nominated to serve as the president pursuant to the provisions of paragraph (1) of the preceding Article.

（健康・医療戦略推進本部等への意見聴取等）

(Hearing of Opinions from the Headquarters for Healthcare Policy and the Committee on the System of Evaluating Incorporated Administrative Agencies)

第四条厚生労働大臣は、最初の中期目標の策定に必要な準備として、施行日前においても健康・医療戦略推進本部、独立行政法人評価制度委員会及び研究開発審議会の意見を聴くこと並びに財務大臣との協議を行うことができる。

Article 4As a necessary preparation for the formulation of the first medium-term objectives, the Minister of Health, Labour and Welfare may, even before the effective date, hear opinions from the Headquarters for Healthcare Policy, the Committee on the System of Evaluating Incorporated Administrative Agencies, and the research and development council and deliberate with the Minister of Finance.

（機構の成立）

(Incorporation of the Institute)

第五条機構は、この法律の施行の時に成立する。

Article 5(1)The Institute is incorporated at the time when this Act comes into effect.

２機構は、機構の成立後遅滞なく、政令で定めるところにより、その設立の登記をしなければならない。

(2)The Institute must register its incorporation without delay after its incorporation pursuant to the provisions of Cabinet Order.

（職員の引継ぎ等）

(Succession of Employees)

第六条機構の成立の際現に厚生労働省の機関で政令で定めるものの職員である者は、厚生労働大臣が指名する者を除き、別に辞令を発せられない限り、機構の成立の日において、機構の職員となるものとする。

Article 6Persons who are actually employees of the organs of the Ministry of Health, Labour and Welfare provided by Cabinet Order at the time of incorporation of the Institute, except for those persons designated by the Minister of Health, Labour and Welfare, become employees of the Institute on the date of incorporation of the Institute unless any notice of appointment stating otherwise is issued.

第七条前条の規定により機構の職員となった者に対する国家公務員法（昭和二十二年法律第百二十号）第八十二条第二項の規定の適用については、機構の職員を同項に規定する特別職国家公務員等と、前条の規定により国家公務員としての身分を失ったことを任命権者の要請に応じ同項に規定する特別職国家公務員等となるため退職したこととみなす。

Article 7Concerning the application of the provisions of Article 82, paragraph (2) of the National Public Service Act (Act No. 120 of 1947) to a person who has become an employee of the Institute pursuant to the provisions of the preceding Article, the employee of the Institute is deemed to be a national public employee in the special service, etc. provided for in that paragraph, and the loss of status as a national public employee pursuant to the provisions of the preceding Article is deemed to be due to retirement upon the request of the relevant appointer for the person to become a national public employee in the special service, etc. provided for in that paragraph.

第八条附則第六条の規定により厚生労働省の職員が機構の職員となる場合には、その者に対しては、国家公務員退職手当法（昭和二十八年法律第百八十二号）に基づく退職手当は、支給しない。

Article 8(1)When an employee of the Ministry of Health, Labour and Welfare becomes an employee of the Institute pursuant to the provisions of Article 6 of the Supplementary Provisions, no retirement allowance under the Act on National Public Officers' Retirement Allowance (Act No. 182 of 1953) is paid to that employee.

２機構は、前項の規定の適用を受けた機構の職員の退職に際し、退職手当を支給しようとするときは、その者の国家公務員退職手当法第二条第一項に規定する職員（同条第二項の規定により職員とみなされる者を含む。）としての引き続いた在職期間を機構の職員としての在職期間とみなして取り扱うべきものとする。

(2)When the Institute intends to pay a retirement allowance to its employee to whom the provisions of the preceding paragraph have been applied upon that employee's retirement, the Institute is to handle the retirement allowance by deeming the employee's continuous period of service as an employee provided in Article 2, paragraph (1) of the Act on National Public Officers' Retirement Allowance (including a person who is deemed to be an employee pursuant to paragraph (2) of that Article) to be the employee's period of service as an employee of the Institute.

３機構の成立の日の前日に厚生労働省の職員として在職する者が、附則第六条の規定により引き続いて機構の職員となり、かつ、引き続き機構の職員として在職した後引き続いて国家公務員退職手当法第二条第一項に規定する職員となった場合におけるその者の同法に基づいて支給する退職手当の算定の基礎となる勤続期間の計算については、その者の機構の職員としての在職期間を同項に規定する職員としての引き続いた在職期間とみなす。ただし、その者が機構を退職したことにより退職手当（これに相当する給付を含む。）の支給を受けているときは、この限りでない。

(3)In the case of a person who had been serving as an employee of the Ministry of Health, Labour and Welfare on the day before the date of incorporation of the Institute, who then became an employee of the Institute without interruption pursuant to the provisions of Article 6 of the Supplementary Provisions, and who has become, after serving as an employee of the Institute without interruption, an employee provided in Article 2, paragraph (1) of the Act on National Public Officers' Retirement Allowance without interruption, the calculation of the length of service as the basis for calculation of the retirement allowance to be paid to that person in accordance with that Act deems the person's period of service as an employee of the Institute to be the continuous period of service as an employee provided in that paragraph; provided, however, that this does not apply if the person has received an retirement allowance (including any payment equivalent to this) due to retirement from the Institute.

４機構は、機構の成立の日の前日に厚生労働省の職員として在職し、附則第六条の規定により引き続いて機構の職員となった者のうち機構の成立の日から雇用保険法（昭和四十九年法律第百十六号）による失業等給付の受給資格を取得するまでの間に機構を退職したものであって、その退職した日まで厚生労働省の職員として在職したものとしたならば国家公務員退職手当法第十条の規定による退職手当の支給を受けることができるものに対しては、同条の規定の例により算定した退職手当の額に相当する額を退職手当として支給するものとする。

(4)Among persons who had been serving as employees of the Ministry of Health, Labour and Welfare on the day before the date of incorporation of the Institute, and who became employees of the Institute without interruption pursuant to the provisions of Article 6 of the Supplementary Provisions, a person who retired from the Institute during the period between the date of incorporation of the Institute and the time when the person was to become qualified for receiving benefits for unemployment, etc. under the Employment Insurance Act (Act No. 116 of 1974), and who would be able to receive a retirement allowance under the provisions of Article 10 of the Act on National Public Officers' Retirement Allowance if the person had served as an employee of the Ministry of Health, Labour and Welfare up until the day of retirement from the Institute, the Institute is to pay an amount equivalent to the retirement allowance calculated in accordance with the provisions of that Article to the person as a retirement allowance.

第九条附則第六条の規定により機構の職員となった者であって、機構の成立の日の前日において厚生労働大臣又はその委任を受けた者から児童手当法（昭和四十六年法律第七十三号）第七条第一項の規定による認定を受けているものが、機構の成立の日において児童手当の支給要件に該当するときは、その者に対する児童手当の支給に関しては、機構の成立の日において同項の規定による市町村長（特別区の区長を含む。）の認定があったものとみなす。この場合において、その認定があったものとみなされた児童手当の支給は、同法第八条第二項の規定にかかわらず、機構の成立の日の前日の属する月の翌月から始める。

Article 9If a person who became an employee of the Institute pursuant to the provisions of Article 6 of the Supplementary Provisions and who has been certified by the Minister of Health, Labour and Welfare or a person entrusted thereby under the provisions of Article 7, paragraph (1) of the Child Allowance Act (Act No. 73 of 1971) on the day before the date of incorporation of the Institute satisfies the requirements for receiving child allowances on the date of incorporation of the Institute, the certification of the mayor of the relevant municipality (including of the mayor of a special ward) is deemed to have been granted under the provisions of that paragraph on the date of incorporation of the Institute, regarding the payment of child allowances to the person. In this case, the payment of child allowances or special benefits for which the certification is deemed to have been granted starts in the month following that which includes the day before the date of incorporation of the Institute, notwithstanding the provisions of Article 8, paragraph (2) of that Act.

（厚生労働省の機関で政令で定めるものの職員から引き続き機構の役職員となった者についての国家公務員共済組合法の適用に関する経過措置）

(Transitional Measures Concerning the Application of the National Public Officers Mutual Aid Association Act to Persons Who Had Been Employees of the Organs of the Ministry of Health, Labour and Welfare Provided for by Cabinet Order and Who Subsequently Became Officers and Employees of the Institute Without Interruption)

第十条施行日の前日に附則第六条の政令で定める厚生労働省の機関の職員として在職する者（同日において国家公務員共済組合法（昭和三十三年法律第百二十八号）第三条第一項の規定により厚生労働省に属する同法第二条第一項第一号に規定する職員をもって組織された国家公務員共済組合（以下この項及び第三項において「厚生労働省共済組合」という。）の組合員であるものに限る。）が施行日において引き続いて機構の役員又は職員（同法第百二十四条の三の規定により同号に規定する職員とみなされるものに相当するものに限る。以下この条において「役職員」という。）となる場合であって、かつ、引き続き施行日以後において機構の役職員である場合には、同法の規定の適用については、当該役職員は、施行日から起算して二十日を経過する日（正当な理由があると厚生労働省共済組合が認めた場合には、その認めた日）までに厚生労働省共済組合に申出をしたときは、施行日以後引き続く当該役職員である期間厚生労働省共済組合を組織する同号に規定する職員に該当するものとする。

Article 10(1)If a person who was serving, on the day before the effective date, as an employee of any of the organs of the Ministry of Health, Labour and Welfare provided for by Cabinet Order under Article 6 of the Supplementary Provisions (limited to a person who was, on that day, a member of a national public employee mutual aid association organized by employees provided for in Article 2, paragraph (1), item (i) of the National Public Officers Mutual Aid Association Act (Act No. 128 of 1958) and belonging to the Ministry of Health, Labour and Welfare pursuant to Article 3, paragraph (1) of that Act (referred to as the "MHLW mutual aid association" in this paragraph and paragraph (3) below)) becomes an officer or employee (limited to an officer or employee equivalent to what can be deemed to be an employee provided for in the above item pursuant to the provisions of Article 124-3 of that Act; referred to as an "officer or employee" in this Article below) of the Institute on the effective date without interruption and continues to be an officer or employee of the Institute on and after the effective date, and if this officer or employee makes a request to the MHLW mutual aid association by the day on which twenty days have passed from the effective date (if the MHLW mutual aid association finds that there are reasonable grounds, by the day authorized thereby), the officer or employee is to, concerning the application of the provisions of that Act, fall under the category of employees provided in that item and constituting the MHLW mutual aid association during the period that has continued since the effective date and in which the officer or employee has served.

２前項に規定する機構の役職員が同項に規定する期限内に同項の申出を行うことなく死亡した場合には、その申出は、当該期限内に当該役職員の遺族（国家公務員共済組合法第二条第一項第三号に規定する遺族に相当する者に限る。次項において同じ。）がすることができる。

(2)If the officer or employee of the Institute referred to in the preceding paragraph dies without making the request under that paragraph by the time limit provided for in that paragraph, that request may be made by a surviving family member (limited to a person who is equivalent to a surviving family member provided for in Article 2, paragraph (1), item (iii) of the National Public Officers Mutual Aid Association Act; the same applies in the following paragraph) of the officer or employee within the time limit.

３施行日の前日において附則第六条の政令で定める厚生労働省の機関の職員として在職する者（同日において厚生労働省共済組合の組合員であるものに限る。）が施行日において引き続いて機構の役職員となる場合であって、かつ、当該役職員又はその遺族が第一項に規定する期限内に同項の申出を行わなかった場合には、当該役職員は、国家公務員共済組合法の適用については、施行日の前日に同法第二条第一項第四号に規定する退職をしたものとみなす。

(3)If a person who serves, on the day before the effective date, as an employee of any of the organs of the Ministry of Health, Labour and Welfare provided for by Cabinet Order under Article 6 of the Supplementary Provisions (limited to a person who is, on that day, a member of the MHLW mutual aid association) becomes an officer or employee of the Institute on the effective date without interruption, and if this officer or employee or their surviving family member does not make a request under the provisions of paragraph (1) by the time limit provided for by that paragraph, the officer or employee is, concerning the application of the National Public Officers Mutual Aid Association Act, deemed to have retired on the day before the effective date as provided for by Article 2, paragraph (1), item (iv) of that Act.

（機構の職員となる者の職員団体についての経過措置）

(Transitional Measures on Employee Organizations of Persons to Be Employees of the Institute)

第十一条機構の成立の際現に存する国家公務員法第百八条の二第一項に規定する職員団体であって、その構成員の過半数が附則第六条の規定により機構に引き継がれる者であるものは、機構の成立の際労働組合法（昭和二十四年法律第百七十四号）の適用を受ける労働組合となるものとする。この場合において、当該職員団体が法人であるときは、法人である労働組合となるものとする。

Article 11(1)Any employee organization that is provided for in Article 108-2, paragraph (1) of the National Public Service Act and that actually exists at the time of incorporation of the Institute, and of which the majority of members are persons to be succeeded to by the Institute pursuant to the provisions of Article 6 of the Supplementary Provisions, is to become a labor union to which the Labor Union Act (Act No. 174 of 1949) applies upon the incorporation of the Institute. In this case, if the employee organization is a corporation, it is to become a corporate labor union.

２前項の規定により法人である労働組合となったものは、機構の成立の日から起算して六十日を経過する日までに、労働組合法第二条及び第五条第二項の規定に適合する旨の労働委員会の証明を受け、かつ、その主たる事務所の所在地において登記しなければ、その日の経過により解散するものとする。

(2)An employee organization that has become a corporate labor union pursuant to the provisions of the preceding paragraph is to obtain certification from the labor relations commission indicating that the organization conforms to the provisions of Article 2 and Article 5, paragraph (2) of the Labor Union Act by the day on which sixty days have passed from the date of incorporation of the Institute, and is to register at the location of its principal office, or else the organization is to dissolve upon the passage of that day.

３第一項の規定により労働組合となったものについては、機構の成立の日から起算して六十日を経過する日までは、労働組合法第二条ただし書（第一号に係る部分に限る。）の規定は、適用しない。

(3)The proviso to Article 2 of the Labor Union Act (limited to the part relating to item (i)) does not apply to an employee organization that has become a labor union pursuant to the provisions of paragraph (1) until the day on which sixty days have passed from the date of incorporation of the Institute.

（権利義務の承継等）

(Succession of Rights and Obligations)

第十二条機構の成立の際、第二十三条第一項に規定する業務に関し、現に国が有する権利及び義務のうち政令で定めるものは、機構の成立の時において機構が承継する。

Article 12(1)At the time of its incorporation, the Institute succeeds to the rights and obligations which are actually held by the national government as of the incorporation in relation to the operations provided for in Article 23, paragraph (1) and which are provided for by Cabinet Order.

２前項の規定により機構が国の有する権利及び義務を承継したときは、機構に承継される権利に係る資産で政令で定めるものの価額の合計額から、承継される義務に係る負債で政令で定めるものの価額の合計額を差し引いた額に相当する金額は、政令で定めるところにより、政府から機構に対し出資されたものとする。

(2)When the Institute succeeds to the rights and obligations held by the national government pursuant to the provisions of the preceding paragraph, an amount equivalent to that obtained by deducting the total value of liabilities that are associated with the obligations succeeded to by the Institute and are provided for by Cabinet Order from the total value of assets that are associated with the rights succeeded to by the Institute and are provided pursuant to the provisions of Cabinet Order is deemed to have been contributed to the Institute by the government pursuant to the provisions of Cabinet Order.

３前項の資産の価額は、機構の成立の日現在における時価を基準として評価委員が評価した価額とする。

(3)The value of assets referred to in the preceding paragraph is the value evaluated by evaluation committee members on the basis of the market value on the date of incorporation of the Institute.

４前項の評価委員その他評価に関し必要な事項は、政令で定める。

(4)The evaluation committee members referred to in the preceding paragraph and other necessary matters concerning evaluation are provided for by Cabinet Order.

（特定一種病原体等所持者に係る権利義務の承継等）

(Succession of Rights and Obligations Related to Holders of Specified Class I Pathogens)

第十三条施行日の前日において附則第六条の政令で定める厚生労働省の機関であって感染症法第五十六条の三第二項の規定による特定一種病原体等所持者の指定を受けているもの（以下この条において「指定機関」という。）があるときは、機構は、その成立の時において同項の規定による特定一種病原体等所持者の指定を受けたものとみなす。この場合において、当該指定機関が所持していた特定一種病原体等（感染症法第五十六条の三第一項第一号に規定する特定一種病原体等をいう。次項において同じ。）は、感染症法第五十六条の五の規定にかかわらず、機構の成立の時において機構が譲り受けるものとする。

Article 13(1)If, on the day before the effective date, any of the organs of the Ministry of Health, Labour and Welfare provided for by Cabinet Order under Article 6 of the Supplementary Provisions was designated as a holder of specified class I pathogens and toxins under the provisions of Article 56-3, paragraph (2) of the Act on Infectious Diseases (referred to as a "designated organ" in this Article below), the Institute is deemed to be designated as a holder of specified class I pathogens and toxins under the provisions of that paragraph at the time of incorporation of the Institute. In this case, the Institute is to take over, at the time of its incorporation, the specified class I pathogens and toxins (meaning specified class I pathogens and toxins provided in Article 56-3, paragraph (1), item (i) of the Act on Infectious Diseases; the same applies in the following paragraph) that the designated organ held, notwithstanding the provisions of Article 56-5 of that Act.

２前項の場合において、機構は、この法律の施行前に国の責任において指定機関が行ってきた特定一種病原体等に係る試験研究について、その社会的必要性及び重要性に鑑み、国の監督指導の下で試験研究を実施するものとする。

(2)In the case referred to in the preceding paragraph, the Institute is to carry out, under the supervision and instructions of the national government, the tests and research that the designated organ had been carrying out in relation to specified class I pathogens and toxins under the responsibility of the national government before the enforcement of this Act, in light of the social necessity and importance of those tests and research.

（国有財産の無償使用）

(Gratuitous Use of National Government Assets)

第十四条国は、機構の成立の際現に附則第六条の政令で定める厚生労働省の機関に使用されている国有財産及び当該機関に属する者の住居の用に供されている国有財産であって政令で定めるものを、政令で定めるところにより、機構の用に供するため、機構に無償で使用させることができる。

Article 14The national government may, pursuant to the provisions of Cabinet Order, allow the Institute to use, for its own purposes and without compensation, the national government assets that are actually used, at the time of incorporation of the Institute, by the organs of the Ministry of Health, Labour and Welfare provided for by Cabinet Order under Article 6 of the Supplementary Provisions and the national government assets that are used as the residences of persons belonging to the organs concerned and are provided by Cabinet Order.

（国の利害に関係のある訴訟についての法務大臣の権限等に関する法律に関する経過措置）

(Transitional Measures Concerning the Act on the Authority of the Minister of Justice over Suits Relating to the Interests of the State)

第十五条機構の成立の際現に係属している附則第六条の政令で定める厚生労働省の機関の所掌事務に関する訴訟事件又は非訟事件であって機構が受け継ぐものについては、政令で定めるところにより、機構を国の利害に関係のある訴訟についての法務大臣の権限等に関する法律（昭和二十二年法律第百九十四号）に規定する国又は行政庁とみなし、同法を適用する。

Article 15Concerning the suits or non-contentious cases that are actually pending at the time of incorporation of the Institute, that are related to the administrative functions under the jurisdiction of the organs of the Ministry of Health, Labour and Welfare provided for by Cabinet Order under the provisions of Article 6 of the Supplementary Provisions, and that the Institute is to succeed to, the Act on the Authority of the Minister of Justice over Suits Relating to the Interests of the State (Act No. 194 of 1947) applies with the Institute deemed to be the national government or administrative authority provided for in that Act, pursuant to the provisions of Cabinet Order.

（国立国際医療研究センターの解散等）

(Dissolution of the National Center for Global Health and Medicine)

第十六条国立研究開発法人国立国際医療研究センター（以下「国立国際医療研究センター」という。）は、この法律の施行の時において解散するものとし、次項の規定により国が承継する資産を除き、その一切の権利及び義務は、その時において機構が承継する。

Article 16(1)The National Center for Global Health and Medicine (referred to below as "NCGM"), a national research and development agency, is to dissolve at the time of enforcement of this Act, and the Institute is to succeed to all the rights and obligations of NCGM at that time, excluding the assets to be succeeded to by the national government pursuant to the provisions of the following paragraph.

２この法律の施行の際現に国立国際医療研究センターが有する権利のうち、機構がその業務を確実に実施するために必要な資産以外の資産は、この法律の施行の時において国が承継する。

(2)Of the rights actually held by NCGM at the time of enforcement of this Act, assets other than those necessary for the Institute to securely implement its operations are succeeded to by the national government at that time.

３前項の規定により国が承継する資産の範囲その他当該資産の国への承継に関し必要な事項は、政令で定める。

(3)The scope of assets to be succeeded to by the national government pursuant to the provisions of the preceding paragraph and other necessary matters concerning the succession to those assets by the national government are provided for by Cabinet Order.

４国立国際医療研究センターの解散の日の前日を含む事業年度（同日が三月三十一日である場合の当該事業年度を除く。）は、独立行政法人通則法第三十六条第一項の規定にかかわらず、国立国際医療研究センターの解散の日の前日に終わるものとする。

(4)The business year of NCGM that includes the day before the date of its dissolution (excluding the business year for the case in which that day is March 31) is to end on the day before the date of dissolution of NCGM, notwithstanding the provisions of Article 36, paragraph (1) of the Act on General Rules for Incorporated Administrative Agencies.

５国立国際医療研究センターの解散の日の前日を含む中長期目標の期間（独立行政法人通則法第三十五条の四第二項第一号に規定する中長期目標の期間をいう。以下この条において同じ。）は、同日に終わるものとする。

(5)The period for the medium to long-term objectives including the day before the date of dissolution of NCGM (meaning the period for the medium to long-term objectives provided for in Article 35-4, paragraph (2), item (i) of the Act on General Rules for Incorporated Administrative Agencies; the same applies in this Article below) is to end on that day.

６国立国際医療研究センターの解散の日の前日を含む事業年度及び中長期目標の期間における業務の実績に関する評価については、独立行政法人通則法第三十五条の六第一項、第三項及び第五項から第九項までの規定を適用する。この場合において、同条第一項の規定による評価は機構が受けるものとし、同条第三項の規定による報告書の提出及び公表は機構が行うものとし、同条第七項前段の規定による通知及び同条第九項の規定による命令は機構に対してなされるものとする。

(6)The provisions of Article 35-6, paragraphs (1) and (3) and paragraphs (5) through (9) of the Act on General Rules for Incorporated Administrative Agencies apply to the evaluation of the operational performance during the business year including the day before the date of dissolution of NCGM and during the period for the medium to long-term objectives including that day. In this case, the Institute is to undergo an evaluation under the provisions of paragraph (1) of that Article and submit and make public a report under the provisions of paragraph (3) of that Article, and any notice under the provisions of the first sentence of paragraph (7) of that Article and any order under the provisions of paragraph (9) of that Article are deemed to be made to the Institute.

７国立国際医療研究センターの解散の日の前日を含む事業年度に係る独立行政法人通則法第三十八条の規定による財務諸表、事業報告書及び決算報告書の作成等については、機構が行うものとする。

(7)The Institute is to carry out the preparation, etc. of financial statements, a business report, and a statement of accounts for the business year including the day before the date of dissolution of NCGM under the provisions of Article 38 of the Act on General Rules for Incorporated Administrative Agencies.

８国立国際医療研究センターの解散の日の前日を含む事業年度における独立行政法人通則法第四十四条第一項及び第二項の規定による利益及び損失の処理に関する業務は、機構が行うものとする。

(8)The Institute is to carry out operations concerning the processing of profits and losses for the business year including the day before the date of dissolution of NCGM under the provisions of Article 44, paragraphs (1) and (2) of the Act on General Rules for Incorporated Administrative Agencies.

９前項の規定による処理において、独立行政法人通則法第四十四条第一項又は第二項の規定による整理を行った後、同条第一項の規定による積立金があるときは、当該積立金の処分は、機構が行うものとする。この場合において、国立国際医療研究センターに対する国立健康危機管理研究機構法の施行に伴う関係法律の整備に関する法律（令和五年法律第四十七号）第十三条の規定による改正前の高度専門医療国立研究開発法人法（以下「旧高度専門医療国立研究開発法人法」という。）第二十条の規定（同条の規定に係る罰則を含む。）は、なおその効力を有するものとし、同条第一項中「通則法第三十五条の四第二項第一号に規定する中長期目標の期間（以下この項において「中長期目標の期間」という。）の最後の」とあるのは「国立研究開発法人国立国際医療研究センターの解散の日の前日を含む」と、「当該中長期目標の期間の次の中長期目標の期間に係る通則法第三十五条の五第一項の認可を受けた中長期計画」とあるのは「国立健康危機管理研究機構法（令和五年法律第四十六号）の施行の日を含む同法第二十七条第一項に規定する中期目標の期間に係る同法第二十八条第一項の認可を受けた中期計画」と、「次の中長期目標の期間における当該国立高度専門医療研究センターが行う第十三条から前条まで（第十八条の二を除く。）」とあるのは「中期目標の期間における同法第二十三条第一項及び第二十五条」とする。

(9)In the processing under the provisions of the preceding paragraph, if there remain any reserve funds under the provisions of Article 44, paragraph (1) of the Act on General Rules for Incorporated Administrative Agencies after the settlement of accounts under the provisions of paragraph (1) or (2) of that Article, the Institute is to carry out the disposition of those reserve funds. In this case, the provisions of Article 20 (including penal provisions related to the provisions of this Article) of the Act on National Research and Development Agencies that Conduct Research Related to Advanced and Specialized Medical Care before amendment under the provisions of Article 13 of the Act on Development of Laws Related to Enforcement of the Act on the Japan Institute for Health Security (Act No. 47 of 2023) (referred to "Former Act on National Research and Development Agencies for Advanced and Specialized Medical Care" below) are to remain in force in relation to NCGM, and the term "the final business year of the period for the medium to long-term objectives provided for in Article 35-4, paragraph (2), item (i) of the Act on General Rules (referred to as the "period for the medium to long-term objectives" in this paragraph below)" is to be replaced with "the business year including the day before the date of dissolution of the National Center for Global Health and Medicine"; the term "the medium to long-term plan for which the authorization referred to in Article 35-5, paragraph (1) of the Act on General Rules has been obtained regarding the next period for the medium- to long-term objectives after the relevant period for the medium- to long-term objectives" is to be replaced with "the medium-term plan for which the authorization referred to in Article 28, paragraph (1) of the Act on Japan Institute for Health Security (Act No. 46 of 2023) has been obtained regarding the period for the medium-term objectives provided in Article 27, paragraph (1) of that Act and including the date on which that Act comes into effect"; and the term "Article 13 through the preceding Article (excluding Article 18-2) and implemented by the relevant highly specialized national medical research center during the next period for the medium to long-term objectives" is to be replaced with "Article 23, paragraph (1), and Article 25, of that Act during the period for the medium-term objectives."

１０第一項の規定により国立国際医療研究センターが解散した場合における解散の登記については、政令で定める。

(10)The registration of dissolution when NCGM dissolves pursuant to the provisions of paragraph (1) is provided for by Cabinet Order.

（機構への出資）

(Contribution to the Institute)

第十七条前条第一項の規定により機構が国立国際医療研究センターの権利及び義務を承継したときは、その承継の際、機構が承継する資産の価額（同条第九項の規定によりなおその効力を有するものとして読み替えて適用される旧高度専門医療国立研究開発法人法第二十条第一項の規定による承認を受けた金額があるときは、当該金額に相当する金額を除く。）から負債の金額を差し引いた額は、政府から機構に対し出資されたものとする。この場合において、機構は、その額により資本金を増加するものとする。

Article 17(1)When the Institute succeeds to the rights and obligations of NCGM pursuant to the provisions of paragraph (1) of the preceding Article, the amount obtained by deducting the amount of liabilities succeeded to by the Institute from the value of the assets succeeded to by the Institute (if there is any amount approved under the provisions of Article 20, paragraph (1) of the Former Act on National Research and Development Agencies for Advanced and Specialized Medical Care remaining in force with its relevant terms replaced pursuant to the provisions of paragraph (9) of the preceding Article, excluding an amount equivalent to the approved amount) is deemed to have been contributed by the government to the Institute at the time of succession. In this case, the Institute is to increase its stated capital by that amount.

２前項に規定する資産の価額は、施行日現在における時価を基準として評価委員が評価した価額とする。

(2)The value of assets referred to in the preceding paragraph is the value evaluated by evaluation committee members on the basis of the market value on the effective date.

３前項の評価委員その他評価に関し必要な事項は、政令で定める。

(3)The evaluation committee members referred to in the preceding paragraph and other necessary matters concerning evaluation are provided for by Cabinet Order.

（国立国際医療研究センターの職員から引き続き機構の職員となった者の退職手当の取扱いに関する経過措置）

(Transitional Measures Concerning the Handling of Retirement Allowances for Persons Who Were Employees of NCGM and Who Subsequently Became Employees of the Institute Without Interruption)

第十八条機構は、施行日の前日に国立国際医療研究センターの職員として在職する者（高度専門医療国立研究開発法人法附則第五条第一項の規定の適用を受けた者に限る。）で引き続いて機構の職員となったものの退職に際し、退職手当を支給しようとするときは、その者の国家公務員退職手当法第二条第一項に規定する職員（同条第二項の規定により職員とみなされる者を含む。）としての引き続いた在職期間を機構の職員としての在職期間とみなして取り扱うべきものとする。ただし、その者が高度専門医療国立研究開発法人法の施行の日以後に旧高度専門医療国立研究開発法人法第三条の二に規定する国立高度専門医療研究センター（次項において「国立高度専門医療研究センター」という。）を退職したことにより退職手当（これに相当する給付を含む。）の支給を受けているときは、この限りでない。

Article 18(1)When the Institute intends to pay a retirement allowance to a person, upon this person's retirement from the Institute, who had been serving as an employee of NCGM on the day before the effective date (limited to a person to whom the provisions of Article 5, paragraph (1) of the Supplementary Provisions of the Act on National Research and Development Agencies for Advanced and Specialized Medical Care were applied) and who subsequently became an employee of the Institute without interruption, the Institute is to handle the retirement allowance by deeming the person's continuous period of service as an employee provided in Article 2, paragraph (1) of the Act on National Public Officers' Retirement Allowance (including a person who is deemed to be an employee pursuant to paragraph (2) of that Article) to be the person's period of service as an employee of the Institute; provided, however, that this does not apply if the person has received a retirement allowance (including any payment equivalent to that) due to retirement from a highly specialized national medical research center provided in Article 3-2 of the Former Act on National Research and Development Agencies for Advanced and Specialized Medical Care on or after the date on which the Act on National Research and Development Agencies for Advanced and Specialized Medical Care came into effect (referred to as a "highly specialized national medical research center" in the following paragraph).

２施行日の前日に国立国際医療研究センターの職員として在職する者（高度専門医療国立研究開発法人法附則第五条第一項の規定の適用を受けた者であって、高度専門医療国立研究開発法人法の施行の日以後引き続き国立高度専門医療研究センターの職員として在職する者に限る。）が、引き続いて機構の職員となり、かつ、引き続き機構の職員として在職した後引き続いて国家公務員退職手当法第二条第一項に規定する職員となった場合におけるその者の同法に基づいて支給する退職手当の算定の基礎となる勤続期間の計算については、その者の高度専門医療国立研究開発法人法の施行の日以後の国立高度専門医療研究センターの職員としての在職期間及び機構の職員としての在職期間を同項に規定する職員としての引き続いた在職期間とみなす。ただし、その者が高度専門医療国立研究開発法人法の施行の日以後に国立高度専門医療研究センター又は機構を退職したことにより退職手当（これに相当する給付を含む。）の支給を受けているときは、この限りでない。

(2)In the case of a person who had been serving as an employee of NCGM on the day before the effective date (limited to a person to whom the provisions of Article 5, paragraph (1) of the Supplementary Provisions of the Act on National Research and Development Agencies for Advanced and Specialized Medical Care were applied and who continued to serve as an employee of a highly specialized national medical research center on and after the date on which the Act on National Research and Development Agencies for Advanced and Specialized Medical Care came into effect), who then became an employee of the Institute without interruption, and who has become, after serving as an employee of the Institute without interruption, an employee provided for in Article 2, paragraph (1) of the Act on National Public Officers' Retirement Allowance without interruption, the calculation of the length of service as the basis for calculation of the retirement allowance to be paid to that person in accordance with that Act deems the person's period of service as an employee of the highly specialized national medical research center on and after the date on which the Act on National Research and Development Agencies for Advanced and Specialized Medical Care came into effect, as well as the person's period of service as an employee of the Institute, to be the person's continuous period of service as an employee provided for in that paragraph; provided, however, that this does not apply if the person has received a retirement allowance (including any payment equivalent to that) due to retirement from the highly specialized national medical research center on or after the date on which the Act on National Research and Development Agencies for Advanced and Specialized Medical Care came into effect, or due to retirement from the Institute.

（国立国際医療研究センターに属する者の住居の用に供されている国有財産の無償使用）

(Gratuitous Use of National Government Assets Used as the Residences of Persons Belonging to NCGM)

第十九条国は、機構の成立の際現に国立国際医療研究センターに属する者の住居の用に供されている国有財産であって政令で定めるものを、政令で定めるところにより、機構の用に供するため、機構に無償で使用させることができる。

Article 19The national government may, pursuant to the provisions of Cabinet Order, allow the Institute to use, for its own purposes and without compensation, the national government assets that are actually used at the time of incorporation of the Institute as the residences of persons belonging to NCGM and that are provided for by Cabinet Order.

（機構の役員又は職員についての独立行政法人通則法の適用に関する経過措置）

(Transitional Measures Concerning the Application of the Act on General Rules for Incorporated Administrative Agencies to Officers or Employees of the Institute)

第二十条機構の役員又は職員についての第四十三条において準用する独立行政法人通則法第五十条の四第一項、第二項第四号及び第六項並びに第五十条の六の規定の適用については、次の表の上欄に掲げるこれらの規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句とする。

Article 20In the application of the provisions of Article 50-4, paragraph (1), paragraph (2), item (iv), and paragraph (6), and Article 50-6 of the Act on General Rules for Incorporated Administrative Agencies to an officer or employee of the Institute, as applied mutatis mutandis pursuant to Article 43, the terms listed in the middle column of the following table and used in those provisions listed in the left-hand column of the table are deemed to be replaced with the terms listed in the right-hand column of the table, respectively.

第四十三条において準用する独立行政法人通則法第五十条の四第一項 Act on General Rules for Incorporated Administrative Agencies as applied mutatis mutandis pursuant to Article 43 Article 50-4, paragraph (1)	を、当該密接関係法人等の地位に就かせることを目的 For the purpose of seeking a position with the closely-related corporation, etc.;	（国立健康危機管理研究機構法（令和五年法律第四十六号。以下「機構法」という。）附則第十六条第一項の規定により解散した旧国立研究開発法人国立国際医療研究センター（以下「旧国立国際医療研究センター」という。）の役員又は職員（非常勤の者を除く。）であった者を含む。以下同じ。）を、当該密接関係法人等の地位に就かせることを目的 (including persons who were officers or employees (excluding part-time officers or employees) of the former National Center for Global Health and Medicine dissolved pursuant to the provisions of Article 16, paragraph (1) of the Supplemental Provisions of the Act on Japan Institute for Health Security (Act No. 46 of 2023; referred to below as the "Institute Act") ( referred to below as the "Former National Center for Global Health and Medicine"); the same applies below ) for the purpose of seeking a position with the closely-related corporation, etc.;
第四十三条において準用する独立行政法人通則法第五十条の四第二項第四号 Act on General Rules for Incorporated Administrative Agencies as applied mutatis mutandis pursuant to Article 43 Article 50-4, paragraph (2), item (iv)	の組織 Organization of	（旧国立国際医療研究センターを含む。）の組織 Organization of the (including the Former National Center for Global Health and Medicine)
第四十三条において準用する独立行政法人通則法第五十条の四第六項 Act on General Rules for Incorporated Administrative Agencies as applied mutatis mutandis pursuant to Article 43 Article 50-4, paragraph (6)	したこと Done	したこと（高度専門医療に関する研究等を行う国立研究開発法人に関する法律（平成二十年法律第九十三号。以下「高度専門医療国立研究開発法人法」という。）又は旧国立国際医療研究センターが定めていた業務方法書、第四十九条に規定する規程その他の規則（以下この項において「旧国立国際医療研究センター規則」という。）に違反する職務上の行為をしたことを含む。次条において同じ。） (including committing an act in the course of duties that violates the Act on National Research and Development Agencies that Conduct Research related to Advanced and Specialized Medical Care (Act No. 93 of 2008; referred to below as the "Act on National Research and Development Agenciesfor Advanced and Specialized Medical Care") or the operational method statement, rules prescribed in Article 49, or other rules established by the Former National Center for Global Health and Medicine ( referred to below as the "Former Rules of the National Center for Global Health and Medicine" in this paragraph); the same applies in the following Article)
	させたこと Cause	させたこと（旧国立国際医療研究センターの役員又は職員に高度専門医療国立研究開発法人法その他の法令又は旧国立国際医療研究センター規則に違反する職務上の行為をさせたことを含む。次条において同じ。） (including causing an officer or employee of the Former National Center for Global Health and Medicine to engage in conduct in the course of duties that is in violation of the Act on National Research and Development Agencies for Advsnced and Specialized Medical Care, other laws and regulations, or the Former Rules of the National Center for Global Health and Medicine; the same applies in the following Article)
	であった者 Person who was	であった者（旧国立国際医療研究センターの役員又は職員であった者を含む。） (including those who was an officer or employee of the Former National Center for Global Health and Medicine)
第四十三条において準用する独立行政法人通則法第五十条の六第一号 Act on General Rules for Incorporated Administrative Agencies as applied mutatis mutandis pursuant to Article 43 Article 50-6, item (i)	定めるもの Items to be specified	定めるもの（離職前五年間に在職していた旧国立国際医療研究センターの内部組織として厚生労働省令で定めるものが行っていた業務を行う機構の内部組織として厚生労働省令で定めるものを含む。） What is specified (including what is specified by Order of the Ministry of Health, Labour and Welfare as an internal organization of the OTIT that carries out the operations that were carried out by the organization specified by Order of the Ministry of Health, Labour and Welfare as an internal organization of the former National Center for Global Health and Medicine in which the relevant person had held office during the five years before the separation from service);
第四十三条において準用する独立行政法人通則法第五十条の六第二号 Act on General Rules for Incorporated Administrative Agencies as applied mutatis mutandis pursuant to Article 43 Article 50-6, item (ii)	の役員又は管理 Officer or Management of	（旧国立国際医療研究センターを含む。）の役員又は管理 Officer or Manager of (including Former National Center for Global Health and Medicine)
第四十三条において準用する独立行政法人通則法第五十条の六第三号 Act on General Rules for Incorporated Administrative Agencies as applied mutatis mutandis pursuant to Article 43 Article 50-6, item (iii)	と営利企業等 And enterprise for profit	（旧国立国際医療研究センターを含む。以下この号において同じ。）と営利企業等 (including the Former National Center for Global Health and Medicine; the same applies below in this item) and enterprise for profit

（名称の使用制限に関する経過措置）

(Transitional Measures Concerning Restriction on Use of the Name)

第二十一条この法律の施行の際現に国立健康危機管理研究機構という名称を使用している者については、第五条の規定は、この法律の施行後六月間は、適用しない。

Article 21The provisions of Article 5 do not apply for a period of six months from the enforcement of this Act to any person who actually uses the name “国立健康危機管理研究機構” (pronounced “kokuritsu kenkou kiki kanri kenkyu kikou” (“Japan Institute for Health Security (JIHS)”)) at the time of enforcement of this Act.

（外部理事の任命に関する経過措置）

(Transitional Measures Concerning the Appointment of Outside Directors)

第二十二条機構の成立の日から遡って十年間において、附則第六条の政令で定める厚生労働省の機関の職員又は国立国際医療研究センターの役員（監事を除く。）若しくは職員であった者は、第七条第一号に規定する機構の役職員であったものとみなして同号及び同条第二号の規定を適用する。

Article 22(1)Any person who served as an employee of any of the organs of the Ministry of Health, Labour and Welfare provided for by Cabinet Order under Article 6 of the Supplementary Provisions or as an officer (excluding an inspector) or employee of NCGM during the past ten years from the date of incorporation of the Institute is deemed to have been the Institute's officer or employee provided for in Article 7, item (i), and accordingly the provisions of that item and item (ii) of that Article apply to this person.

２機構の成立の日から遡って十年間において、国立国際医療研究センターの監事又は会計監査人（会計監査人が法人であるときは、その職務を行うべき社員）であった者は、第七条第二号に規定する機構の監事又は会計監査人であったものとみなして同号の規定を適用する。この場合において、同号中「機構の役職員又は機構の子法人の業務執行取締役等」とあるのは、「機構の役職員若しくは機構の子法人の業務執行取締役等、附則第六条の政令で定める厚生労働省の機関の職員又は国立研究開発法人国立国際医療研究センターの役員（監事を除く。）若しくは職員」とする。

(2)Any person who served as an inspector or financial auditor of NCGM (for the case in which a corporation served as a financial auditor, its member who was responsible to perform the duties of a financial auditor) during the past ten years from the date of incorporation of the Institute is deemed to have been an inspector or financial auditor of the Institute provided for in Article 7, item (ii), and accordingly the provisions of that item apply to this person. In this case, the term "as the Institute's officer or employee or as an executive director, etc. of the Institute's subsidiary corporation" in the item is deemed to be replaced with "as the Institute's officer or employee, as an executive director, etc. of the Institute's subsidiary corporation, as an employee of any of the organs of the Ministry of Health, Labour and Welfare provided by Cabinet Order under the provisions of Article 6 of the Supplementary Provisions, or as an officer (excluding an inspector) or employee of the National Center for Global Health and Medicine."

（事業年度に関する経過措置）

(Transitional Measures Concerning Business Years)

第二十三条機構の最初の事業年度は、第四十三条において準用する独立行政法人通則法第三十六条第一項の規定にかかわらず、その成立の日に始まり、その後最初の三月三十一日に終わるものとする。

Article 23Notwithstanding the provisions of Article 36, paragraph (1) of the Act on General Rules for Incorporated Administrative Agencies, as applied mutatis mutandis pursuant to Article 43, the first business year of the Institute begins on the date of its incorporation and ends on the first March 31 later.

（年度計画に関する経過措置）

(Transitional Measures Concerning Annual Plans)

第二十四条機構の最初の事業年度の第二十九条に規定する業務運営に関する計画については、同条中「毎事業年度の開始前に」とあるのは、「機構の成立後遅滞なく」とする。

Article 24Regarding a plan for the operational management provided for in Article 29 for the first business year of the Institute, the term "before the start of each business year" in that Article is deemed to be replaced with "without delay after the incorporation of the Institute".

（調整規定）

(Adjustment Provisions)

第二十五条この法律の施行の日が刑法等の一部を改正する法律（令和四年法律第六十七号）の施行の日（以下この条において「刑法施行日」という。）前である場合には、刑法施行日の前日までの間における第四十八条の規定の適用については、同条中「拘禁刑」とあるのは、「懲役」とする。刑法施行日以後における刑法施行日前にした行為に対する同条の適用についても、同様とする。

Article 25If the date on which this Act comes into effect is earlier than the date on which the Act Partially Amending the Penal Code (Act No. 67 of 2022) comes into effect (referred to as the "Penal Code effective date" in this Article below), the provisions of Article 48 apply with the term "imprisonment under the new Penal Code" in that Article is deemed to be replaced with "imprisonment under the former Penal Code" during the period until the day before the Penal Code effective date. The same applies to the application of the provisions of that Article on or after the Penal Code effective date to acts committed before the Penal Code effective date.

（政令への委任）

(Delegation to Cabinet Order)

第二十六条この附則に定めるもののほか、この法律の施行に関し必要な経過措置（罰則に関する経過措置を含む。）は、政令で定める。

Article 26Beyond what is provided for in these Supplementary Provisions, transitional measures necessary for the enforcement of this Act (including transitional measures concerning penal provisions) are provided for by Cabinet Order.

附　則　〔令和六年六月十二日法律第四十七号〕〔抄〕
Supplementary Provisions [Act No. 47 of June 12, 2024] [Extract]

（施行期日）

(Effective Date)

第一条この法律は、令和六年十月一日から施行する。ただし、次の各号に掲げる規定は、当該各号に定める日から施行する。

Article 1This Act comes into effect on October 1, 2024; provided, however, that the provisions stated in the following items come into effect on the dates specified respectively in those items:

一第四条中児童福祉法第二十五条の二の改正規定、第二十条の規定及び第二十一条中子ども・子育て支援法の一部を改正する法律附則第四条第一項の改正規定（「施行日から起算して五年を経過する日」を「令和十二年三月三十一日」に改める部分に限る。）並びに附則第四十六条の規定　この法律の公布の日

(i)the provisions of Article 4 that amend Article 25-2 of the Child Welfare Act, the provisions of Article 20, and the provisions of Article 21 that amend Article 4, paragraph (1) of the Supplementary Provisions of the Act Partially Amending the Child and Childcare Support Act (limited to the part that amend the phrase "the day on which five years have elapsed from the effective date" to "March 31, 2030"), and the provisions of Article 46 of the Supplementary Provisions: the date of promulgation of this Act.

（罰則に関する経過措置）

(Transitional Measures Concerning Penal Provisions)

第四十五条この法律（附則第一条第四号から第六号までに掲げる規定については、当該規定。以下この条において同じ。）の施行前にした行為及び附則第十三条第一項の規定によりなお従前の例によることとされる場合におけるこの法律の施行後にした行為に対する罰則の適用については、なお従前の例による。

Article 45Prior laws and regulations continue to govern the applicability of penal provisions to conduct that a person engages in before this Act comes into effect (for the provisions stated in Article 1, items (iv) through (vi) of the Supplementary Provisions, those provisions; the same applies in this Article below), and to conduct that a person engages in after this Act comes into effect but which, pursuant to Article 13, paragraph (1) of the Supplementary Provisions, is to continue to be governed by prior laws and regulations.

（その他の経過措置の政令への委任）

(Delegation of Other Transitional Measures to Cabinet Order)

第四十六条この附則に定めるもののほか、この法律の施行に関し必要な経過措置（罰則に関する経過措置を含む。）は、政令で定める。

Article 46Beyond what is provided for in these Supplementary Provisions, transitional measures necessary for the enforcement of this Act (including transitional measures concerning penal provisions) are specified.