{"attached_files_info":null,"law_info":{"law_type":"Act","law_id":"505AC1000000057","law_num":"令和五年法律第五十七号","law_num_era":"Reiwa","law_num_year":5,"law_num_type":"Act","law_num_num":"057","promulgation_date":"2023-06-16"},"revision_info":{"law_revision_id":"505AC1000000057_20230616_000000000000000","law_type":"Act","law_title":"良質かつ適切なゲノム医療を国民が安心して受けられるようにするための施策の総合的かつ計画的な推進に関する法律","law_title_kana":"りょうしつかつてきせつなげのむいりょうをこくみんがあんしんしてうけられるようにするためのしさくのそうごうてきかつけいかくてきなすいしんにかんするほうりつ","abbrev":"","category":"厚生","updated":"2024-07-22T04:09:11+09:00","amendment_promulgate_date":"2023-06-16","amendment_enforcement_date":"2023-06-16","amendment_enforcement_comment":null,"amendment_scheduled_enforcement_date":null,"amendment_law_id":null,"amendment_law_title":null,"amendment_law_title_kana":null,"amendment_law_num":null,"amendment_type":"1","repeal_status":"None","repeal_date":null,"remain_in_force":false,"mission":"New","current_revision_status":"CurrentEnforced"},"law_full_text":{"tag":"Law","attr":{"Year":"05","Num":"057","LawType":"Act","Lang":"ja","PromulgateMonth":"06","PromulgateDay":"16","Era":"Reiwa"},"children":[{"tag":"LawNum","attr":{},"children":["令和五年法律第五十七号"]},{"tag":"LawBody","attr":{},"children":[{"tag":"LawTitle","attr":{"Kana":"りょうしつかつてきせつなげのむいりょうをこくみんがあんしんしてうけられるようにするためのしさくのそうごうてきかつけいかくてきなすいしんにかんするほうりつ","Abbrev":"","AbbrevKana":""},"children":["良質かつ適切なゲノム医療を国民が安心して受けられるようにするための施策の総合的かつ計画的な推進に関する法律"]},{"tag":"TOC","attr":{},"children":[{"tag":"TOCLabel","attr":{},"children":["目次"]},{"tag":"TOCChapter","attr":{"Num":"1"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第一章　総則"]},{"tag":"ArticleRange","attr":{},"children":["（第一条―第七条）"]}]},{"tag":"TOCChapter","attr":{"Num":"2"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第二章　基本計画"]},{"tag":"ArticleRange","attr":{},"children":["（第八条）"]}]},{"tag":"TOCChapter","attr":{"Num":"3"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第三章　基本的施策"]},{"tag":"ArticleRange","attr":{},"children":["（第九条―第二十一条）"]}]},{"tag":"TOCSupplProvision","attr":{},"children":[{"tag":"SupplProvisionLabel","attr":{},"children":["附則"]}]}]},{"tag":"MainProvision","attr":{},"children":[{"tag":"Chapter","attr":{"Num":"1"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第一章　総則"]},{"tag":"Article","attr":{"Num":"1"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（目的）"]},{"tag":"ArticleTitle","attr":{},"children":["第一条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["この法律は、ゲノム医療が個人の身体的な特性及び病状に応じた最適な医療の提供を可能とすることにより国民の健康の保持に大きく寄与するものである一方で、その普及に当たって個人の権利利益の擁護のみならず人の尊厳の保持に関する課題に対応する必要があることに鑑み、良質かつ適切なゲノム医療を国民が安心して受けられるようにするための施策（以下「ゲノム医療施策」という。）に関し、基本理念を定め、及び国等の責務を明らかにするとともに、基本計画の策定その他ゲノム医療施策の基本となる事項を定めることにより、ゲノム医療施策を総合的かつ計画的に推進することを目的とする。"]}]}]}]},{"tag":"Article","attr":{"Num":"2"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（定義）"]},{"tag":"ArticleTitle","attr":{},"children":["第二条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["この法律において「ゲノム医療」とは、個人の細胞の核酸を構成する塩基の配列の特性又は当該核酸の機能の発揮の特性に応じて当該個人に対して行う医療をいう。"]}]}]},{"tag":"Paragraph","attr":{"Num":"2"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["この法律において「ゲノム情報」とは、人の細胞の核酸を構成する塩基の配列若しくはその特性又は当該核酸の機能の発揮の特性に関する情報をいう。"]}]}]}]},{"tag":"Article","attr":{"Num":"3"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（基本理念）"]},{"tag":"ArticleTitle","attr":{},"children":["第三条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["ゲノム医療施策は、次に掲げる事項を基本理念として行われなければならない。"]}]},{"tag":"Item","attr":{"Num":"1"},"children":[{"tag":"ItemTitle","attr":{},"children":["一"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["ゲノム医療の研究開発及び提供に係る施策を相互の有機的な連携を図りつつ推進することにより、幅広い医療分野における世界最高水準のゲノム医療を実現し、その恵沢を広く国民が享受できるようにすること。"]}]}]},{"tag":"Item","attr":{"Num":"2"},"children":[{"tag":"ItemTitle","attr":{},"children":["二"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["ゲノム医療の研究開発及び提供には、子孫に受け継がれ得る遺伝子の操作を伴うものその他の人の尊厳の保持に重大な影響を与える可能性があるものが含まれることに鑑み、その研究開発及び提供の各段階において生命倫理への適切な配慮がなされるようにすること。"]}]}]},{"tag":"Item","attr":{"Num":"3"},"children":[{"tag":"ItemTitle","attr":{},"children":["三"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["生まれながらに固有で子孫に受け継がれ得る個人のゲノム情報には、それによって当該個人はもとよりその家族についても将来の健康状態を予測し得る等の特性があることに鑑み、ゲノム医療の研究開発及び提供において得られた当該ゲノム情報の保護が十分に図られるようにするとともに、当該ゲノム情報による不当な差別が行われることのないようにすること。"]}]}]}]}]},{"tag":"Article","attr":{"Num":"4"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（国の責務）"]},{"tag":"ArticleTitle","attr":{},"children":["第四条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、前条の基本理念にのっとり、ゲノム医療施策を総合的かつ計画的に策定し、及び実施する責務を有する。"]}]}]}]},{"tag":"Article","attr":{"Num":"5"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（地方公共団体の責務）"]},{"tag":"ArticleTitle","attr":{},"children":["第五条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["地方公共団体は、第三条の基本理念にのっとり、ゲノム医療施策に関し、国との連携を図りつつ、その地域の状況に応じて、施策を策定し、及び実施する責務を有する。"]}]}]}]},{"tag":"Article","attr":{"Num":"6"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（医師等及び研究者等の責務）"]},{"tag":"ArticleTitle","attr":{},"children":["第六条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["医師、医療機関その他の医療関係者（以下「医師等」という。）並びに研究者及び研究機関（以下「研究者等」という。）は、国及び地方公共団体が実施するゲノム医療施策及びこれに関連する施策に協力するよう努めなければならない。"]}]}]}]},{"tag":"Article","attr":{"Num":"7"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（財政上の措置等）"]},{"tag":"ArticleTitle","attr":{},"children":["第七条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["政府は、ゲノム医療施策を実施するため必要な財政上の措置その他の措置を講じなければならない。"]}]}]}]}]},{"tag":"Chapter","attr":{"Num":"2"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第二章　基本計画"]},{"tag":"Article","attr":{"Num":"8"},"children":[{"tag":"ArticleTitle","attr":{},"children":["第八条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["政府は、ゲノム医療施策を総合的かつ計画的に推進するため、ゲノム医療施策に関する基本的な計画（以下この条において「基本計画」という。）を策定しなければならない。"]}]}]},{"tag":"Paragraph","attr":{"Num":"2"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["基本計画は、次に掲げる事項について定めるものとする。"]}]},{"tag":"Item","attr":{"Num":"1"},"children":[{"tag":"ItemTitle","attr":{},"children":["一"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["ゲノム医療施策についての基本的な方針"]}]}]},{"tag":"Item","attr":{"Num":"2"},"children":[{"tag":"ItemTitle","attr":{},"children":["二"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["ゲノム医療施策に関し政府が総合的かつ計画的に実施すべき施策"]}]}]},{"tag":"Item","attr":{"Num":"3"},"children":[{"tag":"ItemTitle","attr":{},"children":["三"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["前二号に掲げるもののほか、ゲノム医療施策を総合的かつ計画的に推進するために必要な事項"]}]}]}]},{"tag":"Paragraph","attr":{"Num":"3"},"children":[{"tag":"ParagraphNum","attr":{},"children":["３"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["基本計画に定める施策については、原則として、当該施策の具体的な目標及びその達成の時期を定めるものとする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"4"},"children":[{"tag":"ParagraphNum","attr":{},"children":["４"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["政府は、基本計画を策定し、又は変更したときは、遅滞なく、これを公表しなければならない。"]}]}]},{"tag":"Paragraph","attr":{"Num":"5"},"children":[{"tag":"ParagraphNum","attr":{},"children":["５"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["政府は、適時に、第三項の規定により定める目標の達成状況を調査し、その結果を公表しなければならない。"]}]}]}]}]},{"tag":"Chapter","attr":{"Num":"3"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第三章　基本的施策"]},{"tag":"Article","attr":{"Num":"9"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（ゲノム医療の研究開発の推進）"]},{"tag":"ArticleTitle","attr":{},"children":["第九条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療の研究開発の推進を図るため、ゲノム医療に関し、研究体制の整備、研究開発に対する助成その他の必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"10"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（ゲノム医療の提供の推進）"]},{"tag":"ArticleTitle","attr":{},"children":["第十条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療の提供の推進を図るため、ゲノム医療の拠点となる医療機関の整備、当該医療機関と他の医療機関との連携の確保その他の必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"11"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（情報の蓄積、管理及び活用に係る基盤の整備）"]},{"tag":"ArticleTitle","attr":{},"children":["第十一条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、個人のゲノム情報及びその個人に係る疾患、健康状態等に関する情報を大量に蓄積し、管理し、及び活用するための基盤の整備を図るため、これらの情報及びこれに係る試料を大規模かつ効率的に収集し、並びに適切に整理し、保存し、及び提供する体制の整備、極めて高度な演算処理を行う能力を有する電子計算機による情報処理システムの整備及び的確な運用、国際間における情報の共有の戦略的な推進その他の必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"12"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（検査の実施体制の整備等）"]},{"tag":"ArticleTitle","attr":{},"children":["第十二条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療の提供に際して行われる個人の細胞の核酸に関する検査について、ゲノム医療を提供する医療機関及びその委託を受けた機関における実施体制の整備及び当該検査の質の確保を図るために必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"13"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（相談支援に係る体制の整備）"]},{"tag":"ArticleTitle","attr":{},"children":["第十三条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療の提供を受ける者又はその研究開発に協力してゲノム情報若しくはこれに係る試料を提供する者に対する相談支援の適切な実施のための体制の整備を図るため、これらの者の相談に応じ、必要な情報の提供、助言その他の支援を行う仕組みの整備、当該相談支援に関する専門的な知識及び技術を有する者の確保その他の必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"14"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（生命倫理への適切な配慮の確保）"]},{"tag":"ArticleTitle","attr":{},"children":["第十四条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療の研究開発及び提供の各段階において生命倫理への適切な配慮がなされることを確保するため、医師等及び研究者等が遵守すべき事項に関する指針の策定その他の必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"15"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（ゲノム情報の適正な取扱いの確保）"]},{"tag":"ArticleTitle","attr":{},"children":["第十五条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療の研究開発及び提供の推進に当たっては、生まれながらに固有で子孫に受け継がれ得る個人のゲノム情報について、その保護が図られつつ有効に活用されることが重要であることを踏まえ、ゲノム医療の研究開発及び提供において得られた当該ゲノム情報の取得、管理、開示その他の取扱いが適正に行われることを確保するため、医師等及び研究者等が遵守すべき事項に関する指針の策定その他の必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"16"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（差別等への適切な対応の確保）"]},{"tag":"ArticleTitle","attr":{},"children":["第十六条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療の研究開発及び提供の推進に当たっては、生まれながらに固有で子孫に受け継がれ得る個人のゲノム情報による不当な差別その他当該ゲノム情報の利用が拡大されることにより生じ得る課題（次条第二項において「差別等」という。）への適切な対応を確保するため、必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"17"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（医療以外の目的で行われる核酸に関する解析の質の確保等）"]},{"tag":"ArticleTitle","attr":{},"children":["第十七条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療に対する信頼の確保を図り、併せて国民の健康の保護に資するため、医療以外の目的で行われる個人の細胞の核酸に関する解析（その結果の評価を含む。）についても、科学的知見に基づき実施されるようにすることを通じてその質の確保を図るとともに、当該解析に係る役務の提供を受ける者に対する相談支援の適切な実施を図るため、必要な施策を講ずるものとする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"2"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、前三条の趣旨を踏まえ、前項の解析についても、生命倫理への適切な配慮並びに第十五条に規定するゲノム情報の適正な取扱い及び差別等への適切な対応を確保するため、必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"18"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（教育及び啓発の推進等）"]},{"tag":"ArticleTitle","attr":{},"children":["第十八条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、国民がゲノム医療及びゲノム医療をめぐる基礎的事項についての理解と関心を深めることができるよう、これらに関する教育及び啓発の推進その他の必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"19"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（人材の確保等）"]},{"tag":"ArticleTitle","attr":{},"children":["第十九条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療の研究開発及び提供に関する専門的な知識及び技術を有する人材の確保、養成及び資質の向上に必要な施策を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"20"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（関係者の連携協力に関する措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第二十条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["国は、ゲノム医療施策の効果的な推進を図るため、関係行政機関の職員、医師等、研究者等、関係事業者その他の関係者による協議の場を設ける等、関係者の連携協力に関し必要な措置を講ずるものとする。"]}]}]}]},{"tag":"Article","attr":{"Num":"21"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（地方公共団体の施策）"]},{"tag":"ArticleTitle","attr":{},"children":["第二十一条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["地方公共団体は、第九条から前条までの国の施策を勘案し、その地域の状況に応じて、ゲノム医療施策の推進を図るよう努めるものとする。"]}]}]}]}]}]},{"tag":"SupplProvision","attr":{},"children":[{"tag":"SupplProvisionLabel","attr":{},"children":["附　則"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphCaption","attr":{},"children":["（施行期日）"]},{"tag":"ParagraphNum","attr":{},"children":["１"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["この法律は、公布の日から施行する。"]}]}]},{"tag":"Paragraph","attr":{"Num":"2"},"children":[{"tag":"ParagraphCaption","attr":{},"children":["（検討）"]},{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{},"children":["政府は、この法律の施行後五年を目途として、この法律の施行の状況について検討を加え、必要があると認めるときは、その結果に基づいて所要の措置を講ずるものとする。"]}]}]}]}]}]}}