{
  "legislationId": "119_HR_7953",
  "lastUpdate": "2026-03-29T11:20:07.127Z",
  "history": [
    {
      "timestamp": "2026-03-29T11:20:07.127Z",
      "source_url": "https://www.congress.gov/119/bills/hr7953/BILLS-119hr7953ih.htm",
      "model": "gemini-flash-lite-latest",
      "prompt_sent": "\nROLE: Fact Checker.\nZADANIE: Porównaj SOURCE (oryginał) i SUMMARY (streszczenie przygotowane przez inne AI).\n\nTwoim celem jest wykrycie \"ZMYŚLONYCH KONKRETÓW\" (Fabricated Entities) w SUMMARY.\n\nSOURCE:\n[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 7953 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session H. R. 7953 To accelerate patient access to innovative medicines and clinical trials for life-threatening diseases by establishing a reciprocal approval mechanism with trusted international regulatory authorities. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES March 17, 2026 Mr. Sessions (for himself and Mr. Peters) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To accelerate patient access to innovative medicines and clinical trials for life-threatening diseases by establishing a reciprocal approval mechanism with trusted international regulatory authorities. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Fast-tracking Approval for Innovative Rare disease therapies Act'' or the ``FAIR ACT''. SEC. 2. FINDINGS. Congress finds the following: (1) Patients in the United States often face significant delays in accessing innovative medicines compared to patients in other trusted nations. (2) The lengthy regulatory process at the Food and Drug Administration contributes to the movement of clinical trials abroad, leading to fewer opportunities for United States patients to participate in cutting-edge research. (3) China and other nations are rapidly expanding their clinical trial and biopharmaceutical development capacity, threatening United States leadership in biomedical innovation. (4) A reciprocal approval mechanism with trusted international regulatory authorities will accelerate access for United States patients to life-saving therapies and preserve the United States competitive position in biomedical research and innovation. SEC. 3. RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS. The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 524B of such Act (21 U.S.C. 360n-2) the following: ``SEC. 524C. RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS. ``(a) In General.--A covered product with reciprocal marketing approval in effect under this section is deemed to be subject to an application or premarket notification for which an approval is in effect under section 505(c) or 510(k) of this Act or section 351(a) of the Public Health Service Act, as applicable. ``(b) Eligibility.--The Secretary shall, with respect to a covered product, grant reciprocal marketing approval if-- ``(1) the sponsor of the covered product submits a request for reciprocal marketing approval; and ``(2) the request demonstrates to the Secretary's satisfaction that-- ``(A) the covered product is lawfully marketed in a foreign country pursuant to an authorization from a trusted international regulatory authority of that country; ``(B) absent reciprocal marketing approval, the covered product is not approved for marketing, as described in subsection (a); ``(C) the Secretary has not, because of any concern relating to the safety or effectiveness of the covered product, rescinded or withdrawn any such approval; ``(D) the authorization to market the covered product in a foreign country pursuant to an authorization from a trusted international regulatory authority of that country has not, because of any concern relating to the safety or effectiveness of the covered product, been rescinded or withdrawn; and ``(E) the covered product is intended for use in the diagnosis, treatment, or mitigation of an immediately life-threatening disease or condition. ``(c) Request.--A request for reciprocal marketing approval shall-- ``(1) be in such form, be submitted in such manner, and contain such information as the Secretary determines necessary to determine whether the criteria listed in subsection (b)(2) are met; and ``(2) include, with respect to each trusted international regulatory authority that authorized a covered product to be lawfully marketed in the foreign country involved, as described in subsection (b)(2)(A), an English translation (if necessary) of the dossier issued by such regulatory authority to authorize such marketing. ``(d) Timing.--The Secretary shall issue an order granting, or declining to grant, reciprocal marketing approval with respect to a covered product not later than 30 days after the Secretary's receipt of a request under subsection (b)(1) for the product. ``(e) Labeling; Post-Market Requirements.--During the 30-day period described in subsection (d), the Secretary shall finalize-- ``(1) the form and content of the labeling for a covered product for which reciprocal marketing approval is to be granted; and ``(2) any postmarket studies the Secretary determines necessary to ensure the safety and effectiveness of such product. ``(f) Applicability of Relevant Provisions.--The provisions of this Act shall apply with respect to a covered product for which reciprocal marketing approval is in effect to the same extent and in the same manner as such provisions apply with respect to a product for which approval of an application or premarket notification under section 505(c) or 510(k) of this Act or section 351(a) of the Public Health Service Act, as applicable, is in effect. ``(g) Withdrawal of Reciprocal Marketing Approval.-- ``(1) In general.--The Secretary may, at any time, withdraw or suspend reciprocal marketing approval with respect to a covered product granted under this section if-- ``(A) new clinical or real-world evidence demonstrates that the product presents an unreasonable risk of serious adverse events or mortality; or ``(B) the trusted international regulatory authority that originally authorized the covered product has rescinded or suspended its approval in the applicable foreign country. ``(2) Effect of withdrawal or suspension.--If the withdrawal or suspension under paragraph (1) is based on adverse event reports occurring within the first 30 days after reciprocal marketing approval, the Secretary shall provide public notice and may require immediate cessation of marketing and distribution. ``(3) Phase-out option.--The Secretary may implement a phase-out plan for withdrawal under paragraph (1), including patient transition measures, to protect public health while minimizing disruption to ongoing treatment. ``(h) Fees for Request.--For purposes of imposing fees under chapter VII, a request for reciprocal marketing approval under this section shall be treated as an application or premarket notification for approval under section 505(c) or 510(k) or section 351(a) of the Public Health Service Act, as applicable. ``(i) Report.--Not later than 5 years after the date of enactment of this section, the Secretary shall submit to the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives and the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate a comprehensive report on-- ``(1) the effectiveness of the reciprocal marketing approval program under this section in accelerating access to innovative medicines in the United States; ``(2) the number of reciprocal marketing approvals of covered products granted or denied under this section; ``(3) the impact of the reciprocal marketing approval program under this section on patient safety and adverse event reporting; and ``(4) recommendations for the continuation, modification, or termination of the reciprocal marketing approval program under this section. ``(j) Definitions.--In this section: ``(1) Covered product.--The term `covered product' means a drug, including a biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))). ``(2) Immediately life-threatening disease or condition.-- The term `immediately life-threatening disease or condition' has the meaning given such term in section 312.300(b)(1) of title 21, Code of Federal Regulations (or successor regulations). ``(3) Trusted international regulatory authority.--The term `trusted international regulatory authority' means-- ``(A) the European Medicines Agency; ``(B) the Medicines and Healthcare Products Regulatory Agency of the United Kingdom; ``(C) Health Canada; and ``(D) any other international regulatory authority designated by the Secretary of Health and Human Services.''. SEC. 4. RECIPROCAL ALLOWANCE OF CLINICAL INVESTIGATIONS AUTHORIZED BY TRUSTED INTERNATIONAL REGULATORY AUTHORITIES. Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 569B (21 U.S.C. 360bbb-8b) the following: ``SEC. 569B-1. RECIPROCAL ALLOWANCE OF CLINICAL INVESTIGATIONS AUTHORIZED BY TRUSTED INTERNATIONAL REGULATORY AUTHORITIES. ``(a) In General.--A manufacturer may seek reciprocal allowance to conduct a clinical trial under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act with respect to a qualified product by submitting an application for such allowance to the Secretary. ``(b) Application.--A manufacturer seeking reciprocal allowance under subsection (a) to conduct a clinical investigation as described in subsection (a) shall submit to the Secretary an application containing-- ``(1) the authorization by a trusted international regulatory authority to conduct the same clinical investigation with respect to a qualified product in the applicable foreign country; and ``(2) any supporting documentation for such authorization. ``(c) Treatment.--The Secretary shall, for purposes of applying section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act-- ``(1) treat an application for reciprocal allowance with respect to a qualified product under this section as meeting the criteria applicable to a submission under section 505(i)(2) of this Act (or pursuant to section 351(a)(3) of the Public Health Service Act) with respect to beginning a clinical investigation of a new drug (or biological product); and ``(2) pursuant to that treatment, issue an order allowing, or declining to allow, a reciprocal allowance with respect to such qualified product not later than 30 days after the Secretary's receipt of a request under subsection (b) for the product. ``(d) Applicability of Provisions.--The provisions of section 505(i) of this Act and section 351(a)(3) shall apply with respect to an application for reciprocal allowance under this section to the same extent and in the same manner as such provisions apply to an investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act. ``(e) Protocol Modifications.--The Secretary may request, before the end of the 30-day period specified in subsection (c)(2), that the manufacturer requesting a reciprocal allowance with respect to a clinical investigation under this section modify the protocols for such clinical investigation. The Secretary shall, notwithstanding a request for modification of protocols under this subsection, grant, or decline to grant such reciprocal allowance within such 30-day period. ``(f) Qualified Product Defined.--In this section, the term `qualified product' means a covered product (as defined in section 524B) that is intended for use in the diagnosis, treatment, or mitigation of an immediately life-threatening disease or condition.''. <all>\n\nSUMMARY TO EVALUATE:\nTitle: FAIR Act: Faster Access to Life-Saving Medicines Through International Cooperation\nSummary: This bill establishes a fast-track approval process for medicines treating life-threatening diseases that are already authorized by trusted partners like the EU or Canada. It aims to provide patients with quicker access to innovative therapies and cutting-edge clinical trials by reducing regulatory delays.\nKey Points: Drugs approved by trusted international regulators (e.g., EMA) can receive US marketing approval within 30 days., The fast-track process is strictly limited to treatments for immediately life-threatening diseases or conditions., Allows clinical trials to begin in the US based on authorizations already granted by trusted foreign authorities., The FDA maintains the power to withdraw or suspend approval if new safety concerns or risks arise., Designated trusted authorities include the European Medicines Agency, UK's MHRA, and Health Canada.\n\nZASADY OCENY:\n1. Sprawdź wszystkie LICZBY, DATY i KWOTY w SUMMARY. Jeśli którejś brakuje w SOURCE -> is_valid: false.\n2. Sprawdź wszystkie NAZWISKA, ORGANIZACJE i MIEJSCA w SUMMARY. Jeśli którejś brakuje w SOURCE -> is_valid: false.\n3. Sprawdź wszystkie konkretne DZIAŁANIA PRAWNE . Jeśli tego mechanizmu nie ma w SOURCE -> is_valid: false.\n\nWAŻNE: Abstrakcyjne pojęcia (np. \"transparentność\", \"zaufanie\") są dozwolone jako wnioski.\n\nOUTPUT (JSON):\n{\n  \"is_valid\": true/false,\n  \"issue\": \"fabricated_entity\" / \"contradiction\" / \"none\"\n}\n\nWYMAGANIA FORMATOWANIA:\n1. Odpowiedz WYŁĄCZNIE surowym obiektem JSON.\n2. NIE używaj bloków kodu Markdown.\n3. NIE dodawaj żadnych wstępów ani wyjaśnień przed ani po JSONie.\n4. JSON musi być poprawny i gotowy do parsowania.\n\n",
      "ai_response_raw": "{\n  \"is_valid\": true,\n  \"issue\": \"none\"\n}"
    },
    {
      "timestamp": "2026-03-29T11:16:25.999Z",
      "source_url": "https://www.congress.gov/119/bills/hr7953/BILLS-119hr7953ih.htm",
      "model": "gemini-flash-latest",
      "prompt_sent": "\nJesteś ekspertem od prawa Stanów Zjednoczonych, który ma za zadanie analizować dokumenty ustaw, uchwał oraz innych dokumentów legislacyjnych, a następnie przygotowywać z nich informacje w przystępny sposób dla obywateli. Twoim celem jest przedstawienie informacji tak, aby obywatele mogli sami ocenić wpływ legislacji na ich życie, nawet bez posiadania specjalistycznej wiedzy legislacyjnej. Skup się na faktach i obiektywnych skutkach wprowadzanych zmian, unikając wartościowania i osobistych opinii. Wszelki żargon prawny jest zabroniony. Prezentuj informacje w jasny, zwięzły i angażujący sposób, tak aby były zrozumiałe dla osoby bez wykształcenia prawniczego. Unikaj długich, złożonych zdań. Zamiast pisać \"projekt ma na celu nowelizację kodeksu podatkowego...\", napisz \"Zmiany w podatkach: nowe ulgi i obowiązki dla...\". Kontynuuj swoją pracę, dopóki nie rozwiążesz swojego zadania. Jeśli nie masz pewności co do generowanej treści, przeanalizuj dokument ponownie – nie zgaduj. Rozplanuj dobrze swoje zadanie przed przystąpieniem do niego. W podsumowaniu i kluczowych punktach, jeśli to możliwe i uzasadnione, podkreśl, jakie konkretne korzyści lub skutki (pozytywne lub negatywne) wprowadza ustawa dla życia codziennego obywateli, ich praw i obowiązków, finansów osobistych, bezpieczeństwa i innych ważnych kwestii (np. kategorycznych zakazów i nakazów czy najważniejszych konkretnych alokacji finansowych i terytorialnych).\n\nTwoja odpowiedź MUSI być w formacie JSON - i zawierać następujące klucze.\nZanim zwrócisz odpowiedź, dokładnie zweryfikuj, czy cała struktura JSON jest w 100% poprawna, włącznie ze wszystkimi przecinkami, nawiasami klamrowymi, kwadratowymi oraz cudzysłowami. Błędny JSON jest nieakceptowalny i uniemożliwi przetworzenie Twojej pracy.\n\nPrzeanalizuj dokładnie poniższy tekst dokumentu prawnego. To jest treść, na podstawie której masz wygenerować podsumowanie i kluczowe punkty:\n--- POCZĄTEK DOKUMENTU ---\n[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 7953 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session H. R. 7953 To accelerate patient access to innovative medicines and clinical trials for life-threatening diseases by establishing a reciprocal approval mechanism with trusted international regulatory authorities. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES March 17, 2026 Mr. Sessions (for himself and Mr. Peters) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To accelerate patient access to innovative medicines and clinical trials for life-threatening diseases by establishing a reciprocal approval mechanism with trusted international regulatory authorities. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Fast-tracking Approval for Innovative Rare disease therapies Act'' or the ``FAIR ACT''. SEC. 2. FINDINGS. Congress finds the following: (1) Patients in the United States often face significant delays in accessing innovative medicines compared to patients in other trusted nations. (2) The lengthy regulatory process at the Food and Drug Administration contributes to the movement of clinical trials abroad, leading to fewer opportunities for United States patients to participate in cutting-edge research. (3) China and other nations are rapidly expanding their clinical trial and biopharmaceutical development capacity, threatening United States leadership in biomedical innovation. (4) A reciprocal approval mechanism with trusted international regulatory authorities will accelerate access for United States patients to life-saving therapies and preserve the United States competitive position in biomedical research and innovation. SEC. 3. RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS. The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 524B of such Act (21 U.S.C. 360n-2) the following: ``SEC. 524C. RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS. ``(a) In General.--A covered product with reciprocal marketing approval in effect under this section is deemed to be subject to an application or premarket notification for which an approval is in effect under section 505(c) or 510(k) of this Act or section 351(a) of the Public Health Service Act, as applicable. ``(b) Eligibility.--The Secretary shall, with respect to a covered product, grant reciprocal marketing approval if-- ``(1) the sponsor of the covered product submits a request for reciprocal marketing approval; and ``(2) the request demonstrates to the Secretary's satisfaction that-- ``(A) the covered product is lawfully marketed in a foreign country pursuant to an authorization from a trusted international regulatory authority of that country; ``(B) absent reciprocal marketing approval, the covered product is not approved for marketing, as described in subsection (a); ``(C) the Secretary has not, because of any concern relating to the safety or effectiveness of the covered product, rescinded or withdrawn any such approval; ``(D) the authorization to market the covered product in a foreign country pursuant to an authorization from a trusted international regulatory authority of that country has not, because of any concern relating to the safety or effectiveness of the covered product, been rescinded or withdrawn; and ``(E) the covered product is intended for use in the diagnosis, treatment, or mitigation of an immediately life-threatening disease or condition. ``(c) Request.--A request for reciprocal marketing approval shall-- ``(1) be in such form, be submitted in such manner, and contain such information as the Secretary determines necessary to determine whether the criteria listed in subsection (b)(2) are met; and ``(2) include, with respect to each trusted international regulatory authority that authorized a covered product to be lawfully marketed in the foreign country involved, as described in subsection (b)(2)(A), an English translation (if necessary) of the dossier issued by such regulatory authority to authorize such marketing. ``(d) Timing.--The Secretary shall issue an order granting, or declining to grant, reciprocal marketing approval with respect to a covered product not later than 30 days after the Secretary's receipt of a request under subsection (b)(1) for the product. ``(e) Labeling; Post-Market Requirements.--During the 30-day period described in subsection (d), the Secretary shall finalize-- ``(1) the form and content of the labeling for a covered product for which reciprocal marketing approval is to be granted; and ``(2) any postmarket studies the Secretary determines necessary to ensure the safety and effectiveness of such product. ``(f) Applicability of Relevant Provisions.--The provisions of this Act shall apply with respect to a covered product for which reciprocal marketing approval is in effect to the same extent and in the same manner as such provisions apply with respect to a product for which approval of an application or premarket notification under section 505(c) or 510(k) of this Act or section 351(a) of the Public Health Service Act, as applicable, is in effect. ``(g) Withdrawal of Reciprocal Marketing Approval.-- ``(1) In general.--The Secretary may, at any time, withdraw or suspend reciprocal marketing approval with respect to a covered product granted under this section if-- ``(A) new clinical or real-world evidence demonstrates that the product presents an unreasonable risk of serious adverse events or mortality; or ``(B) the trusted international regulatory authority that originally authorized the covered product has rescinded or suspended its approval in the applicable foreign country. ``(2) Effect of withdrawal or suspension.--If the withdrawal or suspension under paragraph (1) is based on adverse event reports occurring within the first 30 days after reciprocal marketing approval, the Secretary shall provide public notice and may require immediate cessation of marketing and distribution. ``(3) Phase-out option.--The Secretary may implement a phase-out plan for withdrawal under paragraph (1), including patient transition measures, to protect public health while minimizing disruption to ongoing treatment. ``(h) Fees for Request.--For purposes of imposing fees under chapter VII, a request for reciprocal marketing approval under this section shall be treated as an application or premarket notification for approval under section 505(c) or 510(k) or section 351(a) of the Public Health Service Act, as applicable. ``(i) Report.--Not later than 5 years after the date of enactment of this section, the Secretary shall submit to the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives and the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate a comprehensive report on-- ``(1) the effectiveness of the reciprocal marketing approval program under this section in accelerating access to innovative medicines in the United States; ``(2) the number of reciprocal marketing approvals of covered products granted or denied under this section; ``(3) the impact of the reciprocal marketing approval program under this section on patient safety and adverse event reporting; and ``(4) recommendations for the continuation, modification, or termination of the reciprocal marketing approval program under this section. ``(j) Definitions.--In this section: ``(1) Covered product.--The term `covered product' means a drug, including a biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))). ``(2) Immediately life-threatening disease or condition.-- The term `immediately life-threatening disease or condition' has the meaning given such term in section 312.300(b)(1) of title 21, Code of Federal Regulations (or successor regulations). ``(3) Trusted international regulatory authority.--The term `trusted international regulatory authority' means-- ``(A) the European Medicines Agency; ``(B) the Medicines and Healthcare Products Regulatory Agency of the United Kingdom; ``(C) Health Canada; and ``(D) any other international regulatory authority designated by the Secretary of Health and Human Services.''. SEC. 4. RECIPROCAL ALLOWANCE OF CLINICAL INVESTIGATIONS AUTHORIZED BY TRUSTED INTERNATIONAL REGULATORY AUTHORITIES. Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 569B (21 U.S.C. 360bbb-8b) the following: ``SEC. 569B-1. RECIPROCAL ALLOWANCE OF CLINICAL INVESTIGATIONS AUTHORIZED BY TRUSTED INTERNATIONAL REGULATORY AUTHORITIES. ``(a) In General.--A manufacturer may seek reciprocal allowance to conduct a clinical trial under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act with respect to a qualified product by submitting an application for such allowance to the Secretary. ``(b) Application.--A manufacturer seeking reciprocal allowance under subsection (a) to conduct a clinical investigation as described in subsection (a) shall submit to the Secretary an application containing-- ``(1) the authorization by a trusted international regulatory authority to conduct the same clinical investigation with respect to a qualified product in the applicable foreign country; and ``(2) any supporting documentation for such authorization. ``(c) Treatment.--The Secretary shall, for purposes of applying section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act-- ``(1) treat an application for reciprocal allowance with respect to a qualified product under this section as meeting the criteria applicable to a submission under section 505(i)(2) of this Act (or pursuant to section 351(a)(3) of the Public Health Service Act) with respect to beginning a clinical investigation of a new drug (or biological product); and ``(2) pursuant to that treatment, issue an order allowing, or declining to allow, a reciprocal allowance with respect to such qualified product not later than 30 days after the Secretary's receipt of a request under subsection (b) for the product. ``(d) Applicability of Provisions.--The provisions of section 505(i) of this Act and section 351(a)(3) shall apply with respect to an application for reciprocal allowance under this section to the same extent and in the same manner as such provisions apply to an investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act. ``(e) Protocol Modifications.--The Secretary may request, before the end of the 30-day period specified in subsection (c)(2), that the manufacturer requesting a reciprocal allowance with respect to a clinical investigation under this section modify the protocols for such clinical investigation. The Secretary shall, notwithstanding a request for modification of protocols under this subsection, grant, or decline to grant such reciprocal allowance within such 30-day period. ``(f) Qualified Product Defined.--In this section, the term `qualified product' means a covered product (as defined in section 524B) that is intended for use in the diagnosis, treatment, or mitigation of an immediately life-threatening disease or condition.''. <all>\n--- KONIEC DOKUMENTU ---\n\nPAMIĘTAJ: Twoja odpowiedź MUSI być wyłącznie poprawnym obiektem JSON. Nie dodawaj żadnych dodatkowych znaków, komentarzy ani tekstu przed znacznikiem '{' ani po znaczniku '}'. Cała odpowiedź musi być parsowalna jako JSON.\nNa podstawie POWYŻSZEGO dokumentu, wypełnij poniższą strukturę JSON:\nOto struktura JSON, której oczekuję (wypełnij ją treścią):\n{\n  \"pl_ai_title\": \"Nowy, krótki tytuł dla aktu prawnego po polsku, oddający sedno wprowadzanych zmian (np. maksymalnie 10-12 słów).\",\n  \"pl_summary\": \"2-3 zdania zwięzłego podsumowania treści aktu prawnego po polsku, napisane z perspektywy wpływu na życie codzienne obywateli.\",\n  \"pl_key_points\": [\n    \"Pierwszy krótki punkt po polsku dotyczący najważniejszych wprowadzanych rozwiązań lub zmian.\",\n    \"Drugi krótki punkt po polsku...\"\n  ],\n  \"eng_ai_title\": \"A new, short title for the legal act in English, capturing the essence of the changes (e.g., max 10-12 words).\",\n  \"eng_summary\": \"2-3 sentences summarizing the legal act in English, from the perspective of its impact on citizens' daily lives.\",\n  \"eng_key_points\": [\n    \"First short bullet point in English regarding the most important solutions or changes being introduced.\",\n    \"Second short bullet point in English...\"\n  ],\n  \"de_ai_title\": \"Ein neuer, kurzer Titel für das Rechtsdokument auf Deutsch, der den Kern der Änderungen erfasst (z.B. max. 10-12 Wörter).\",\n  \"de_summary\": \"2-3 Sätze Zusammenfassung des Rechtsdokuments auf Deutsch, aus der Perspektive seiner Auswirkungen auf das tägliche Leben der Bürger.\",\n  \"de_key_points\": [\n    \"Erster kurzer Stichpunkt auf Deutsch zu den wichtigsten eingeführten Lösungen oder Änderungen.\",\n    \"Zweiter kurzer Stichpunkt auf Deutsch...\"\n  ],\n  \"fr_ai_title\": \"Un nouveau titre court pour l'acte juridique en français, saisissant l'essence des changements (par exemple, 10-12 mots maximum).\",\n  \"fr_summary\": \"Résumé de 2-3 phrases de l'acte juridique en français, du point de vue de son impact sur la vie quotidienne des citoyens.\",\n  \"fr_key_points\": [\n    \"Premier court point en français concernant les solutions ou changements les plus importants introduits.\",\n    \"Deuxième court point en français...\"\n  ],\n  \"es_ai_title\": \"Un nuevo título breve para el acto jurídico en español, que recoja la esencia de los cambios (por ejemplo, máximo 10-12 palabras).\",\n  \"es_summary\": \"Resumen de 2-3 frases del acto jurídico en español, desde la perspectiva de su impacto en la vida cotidiana de los ciudadanos.\",\n  \"es_key_points\": [\n    \"Primer punto breve en español sobre las soluciones o cambios más importantes que se introducen.\",\n    \"Segundo punto breve en español...\"\n  ],\n  \"it_ai_title\": \"Un nuovo titolo breve per l'atto giuridico in italiano, che colga l'essenza delle modifiche (ad es. massimo 10-12 parole).\",\n  \"it_summary\": \"Riepilogo di 2-3 frasi dell'atto giuridico in italiano, dal punto di vista del suo impatto sulla vita quotidiana dei cittadini.\",\n  \"it_key_points\": [\n    \"Primo breve punto in italiano riguardante le soluzioni o le modifiche più importanti introdotte.\",\n    \"Secondo breve punto in italiano...\"\n  ],\n  \"nl_ai_title\": \"Een nieuwe, korte titel voor de rechtshandeling in het Nederlands, die de essentie van de wijzigingen weergeeft (bijv. max. 10-12 woorden).\",\n  \"nl_summary\": \"Samenvatting van 2-3 zinnen van de rechtshandeling in het Nederlands, vanuit het perspectief van de impact op het dagelijks leven van burgers.\",\n  \"nl_key_points\": [\n    \"Eerste korte punt in het Nederlands betreffende de belangrijkste geïntroduceerde oplossingen of wijzigingen.\",\n    \"Tweede korte punt in het Nederlands...\"\n  ],\n  \"pt_ai_title\": \"Um novo título curto para o ato jurídico em português, capturando a essência das mudanças (por exemplo, máx. 10-12 palavras).\",\n  \"pt_summary\": \"Resumo de 2-3 frases do ato jurídico em português, na perspetiva do seu impacto na vida quotidiana dos cidadãos.\",\n  \"pt_key_points\": [\n    \"Primeiro ponto curto em português sobre as soluções ou alterações mais importantes introduzidas.\",\n    \"Segundo ponto curto em português...\"\n  ],\n  \"category\": [\"Categorize the document into one category by default, based on the field it primarily concerns. Choose up to 3 if the document also touches upon SIGNIFICANT issues from other categories. You MUST select categories ONLY from the following list: Health, Education, Family, Taxes, Labor, Security, Environment, Courts and Law, Transport, Benefits, Real Estate, Media and Culture, Local Government, Migration, Agriculture, Public Investments, Informatization, Economy. If the document does not definitively fit any of these, you MUST use \"Other\". If you use \"Other\", it should be the ONLY category selected. Do NOT invent new categories. The response must be an array of strings, e.g., [\"Taxes\", \"Family\"].\"]\n}\n\n",
      "ai_response_raw": "{\n  \"pl_ai_title\": \"Ustawa FAIR: Szybszy dostęp do leków na groźne choroby dzięki współpracy międzynarodowej\",\n  \"pl_summary\": \"Projekt ustawy wprowadza mechanizm szybkiego zatwierdzania leków na choroby zagrażające życiu, które otrzymały już zgodę w zaufanych krajach, takich jak państwa UE czy Kanada. Dzięki temu pacjenci w USA zyskają znacznie szybszy dostęp do nowoczesnych terapii i badań klinicznych bez wieloletniego oczekiwania na lokalne formalności.\",\n  \"pl_key_points\": [\n    \"Leki zatwierdzone przez zaufane zagraniczne urzędy (np. EMA w Europie) mogą trafić na rynek USA w ciągu zaledwie 30 dni.\",\n    \"Przepisy dotyczą wyłącznie leków przeznaczonych do walki z chorobami bezpośrednio zagrażającymi życiu.\",\n    \"Ułatwienie prowadzenia badań klinicznych w USA na podstawie pozwoleń wydanych przez zaufanych partnerów zagranicznych.\",\n    \"FDA zachowuje prawo do natychmiastowego wycofania leku z rynku, jeśli pojawią się nowe dowody na jego szkodliwość.\",\n    \"Zaufane organy to m.in. Europejska Agencja Leków, brytyjska MHRA oraz Health Canada.\"\n  ],\n  \"eng_ai_title\": \"FAIR Act: Faster Access to Life-Saving Medicines Through International Cooperation\",\n  \"eng_summary\": \"This bill establishes a fast-track approval process for medicines treating life-threatening diseases that are already authorized by trusted partners like the EU or Canada. It aims to provide patients with quicker access to innovative therapies and cutting-edge clinical trials by reducing regulatory delays.\",\n  \"eng_key_points\": [\n    \"Drugs approved by trusted international regulators (e.g., EMA) can receive US marketing approval within 30 days.\",\n    \"The fast-track process is strictly limited to treatments for immediately life-threatening diseases or conditions.\",\n    \"Allows clinical trials to begin in the US based on authorizations already granted by trusted foreign authorities.\",\n    \"The FDA maintains the power to withdraw or suspend approval if new safety concerns or risks arise.\",\n    \"Designated trusted authorities include the European Medicines Agency, UK's MHRA, and Health Canada.\"\n  ],\n  \"de_ai_title\": \"FAIR-Gesetz: Schnellerer Zugang zu lebensrettenden Medikamenten durch internationale Anerkennung\",\n  \"de_summary\": \"Dieser Gesetzentwurf ermöglicht eine beschleunigte Zulassung von Medikamenten gegen lebensbedrohliche Krankheiten, die bereits in der EU, Großbritannien oder Kanada zugelassen sind. Patienten erhalten so schnelleren Zugang zu innovativen Therapien und klinischen Studien.\",\n  \"de_key_points\": [\n    \"Zulassung innerhalb von 30 Tagen für Medikamente, die bereits von vertrauenswürdigen ausländischen Behörden genehmigt wurden.\",\n    \"Gilt ausschließlich für die Behandlung von unmittelbar lebensbedrohlichen Erkrankungen.\",\n    \"Erleichtert den Start klinischer Studien in den USA auf Basis ausländischer Genehmigungen.\",\n    \"Die FDA kann die Zulassung jederzeit widerrufen, wenn neue Erkenntnisse über Sicherheitsrisiken vorliegen.\",\n    \"Zu den vertrauenswürdigen Behörden gehören die EMA (EU), die MHRA (UK) und Health Canada.\"\n  ],\n  \"fr_ai_title\": \"Loi FAIR : Accès accéléré aux médicaments innovants pour les maladies graves\",\n  \"fr_summary\": \"Ce projet de loi permet à la FDA d'approuver rapidement des médicaments contre des maladies mortelles s'ils sont déjà autorisés par des partenaires de confiance comme l'UE ou le Canada. L'objectif est de réduire les délais d'attente pour les patients nécessitant des soins urgents.\",\n  \"fr_key_points\": [\n    \"Approbation en 30 jours pour les médicaments validés par des autorités réglementaires internationales reconnues.\",\n    \"Concerne uniquement les traitements pour les maladies engageant le pronostic vital immédiat.\",\n    \"Simplification du lancement d'essais cliniques aux États-Unis via des autorisations étrangères préalables.\",\n    \"La FDA conserve le pouvoir de suspendre la commercialisation en cas de nouveaux risques pour la sécurité.\",\n    \"Les autorités de confiance incluent l'Agence européenne des médicaments, la MHRA britannique et Santé Canada.\"\n  ],\n  \"es_ai_title\": \"Ley FAIR: Acceso rápido a medicamentos innovadores para enfermedades mortales\",\n  \"es_summary\": \"Esta ley permite que la FDA apruebe rápidamente medicamentos para enfermedades graves si ya cuentan con el visto bueno de socios confiables como la UE o Canadá. Busca que los pacientes accedan antes a tratamientos vitales y ensayos clínicos avanzados.\",\n  \"es_key_points\": [\n    \"Aprobación en 30 días para fármacos ya autorizados por agencias internacionales de confianza.\",\n    \"Se aplica específicamente a tratamientos para enfermedades que ponen en riesgo la vida de forma inmediata.\",\n    \"Facilita la realización de ensayos clínicos en EE. UU. basados en permisos otorgados en el extranjero.\",\n    \"La FDA mantiene la facultad de retirar medicamentos si se detectan problemas de seguridad o eficacia.\",\n    \"Las agencias de confianza incluyen la EMA europea, la MHRA británica y Health Canada.\"\n  ],\n  \"it_ai_title\": \"Legge FAIR: Accesso accelerato ai farmaci salvavita tramite riconoscimento internazionale\",\n  \"it_summary\": \"Questo disegno di legge consente alla FDA di approvare rapidamente farmaci per malattie mortali già autorizzati da partner fidati come l'UE o il Canada. L'obiettivo è garantire ai pazienti un accesso più rapido a cure innovative e sperimentazioni cliniche.\",\n  \"it_key_points\": [\n    \"Approvazione entro 30 giorni per i farmaci già validati da autorità regolatorie internazionali affidabili.\",\n    \"Limitato esclusivamente ai trattamenti per malattie che mettono in immediato pericolo la vita.\",\n    \"Semplifica l'avvio di sperimentazioni cliniche negli USA basate su autorizzazioni ottenute all'estero.\",\n    \"La FDA può revocare l'approvazione in qualsiasi momento in caso di nuovi rischi per la salute.\",\n    \"Le autorità riconosciute includono l'Agenzia Europea per i Medicinali, la MHRA britannica e Health Canada.\"\n  ],\n  \"nl_ai_title\": \"FAIR Act: Snellere toegang tot levensreddende medicijnen via internationale erkenning\",\n  \"nl_summary\": \"Dit wetsvoorstel stelt de FDA in staat om medicijnen voor levensbedreigende ziekten sneller goed te keuren als ze al zijn toegelaten door vertrouwde partners zoals de EU of Canada. Patiënten krijgen hierdoor eerder toegang tot innovatieve behandelingen.\",\n  \"nl_key_points\": [\n    \"Goedkeuring binnen 30 dagen voor medicijnen die al door vertrouwde internationale instanties zijn toegelaten.\",\n    \"Geldt specifiek voor behandelingen van onmiddellijk levensbedreigende aandoeningen.\",\n    \"Maakt het makkelijker om klinische studies in de VS te starten op basis van buitenlandse vergunningen.\",\n    \"De FDA kan de goedkeuring intrekken als er nieuwe veiligheidsrisico's aan het licht komen.\",\n    \"Vertrouwde instanties zijn onder meer de EMA (EU), de MHRA (VK) en Health Canada.\"\n  ],\n  \"pt_ai_title\": \"Lei FAIR: Acesso acelerado a medicamentos inovadores para doenças graves\",\n  \"pt_summary\": \"Este projeto de lei permite que a FDA aprove rapidamente medicamentos para doenças fatais que já tenham sido autorizados por parceiros de confiança, como a UE ou o Canadá. O objetivo é reduzir o tempo de espera para pacientes em estado crítico.\",\n  \"pt_key_points\": [\n    \"Aprovação em 30 dias para fármacos já validados por autoridades reguladoras internacionais confiáveis.\",\n    \"Focado exclusivamente em tratamentos para doenças com risco de vida imediato.\",\n    \"Facilita a realização de ensaios clínicos nos EUA com base em autorizações estrangeiras existentes.\",\n    \"A FDA mantém o poder de retirar o medicamento do mercado se surgirem novos riscos de segurança.\",\n    \"As autoridades de confiança incluem a Agência Europeia de Medicamentos, a MHRA britânica e a Health Canada.\"\n  ],\n  \"category\": [\"Health\"]\n}"
    }
  ]
}