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| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 林明昕 | zh_TW |
| dc.contributor.advisor | Ming-Hsin Lin | en |
| dc.contributor.author | 徐曼綾 | zh_TW |
| dc.contributor.author | Man-Ling Hsu | en |
| dc.date.accessioned | 2024-05-02T16:08:36Z | - |
| dc.date.available | 2024-05-03 | - |
| dc.date.copyright | 2024-05-02 | - |
| dc.date.issued | 2024 | - |
| dc.date.submitted | 2024-04-13 | - |
| dc.identifier.citation | 壹、 中文文獻
一、 書籍 林子儀（1999），《言論自由與新聞自由》。臺北：元照。 許宗力（2007），《法與國家權力(二)》。臺北：元照。 二、 書之篇章 林子儀（2002），〈言論自由導論〉，收錄於：李鴻禧等合著，《台灣憲法之縱剖橫切》，頁103-179，臺北：元照。 許宗力（2007），〈比例原則之操作試論〉，收錄於：許宗力，《法與國家權力(二)》，頁121-159，臺北：元照。 三、 期刊論文 李建良（2001），〈藥物廣告的限制及其合憲性〉，《台灣本土法學雜誌》，28期，頁75-89。 林子儀（1988），〈言論自由之理論基礎〉，《臺大法學論叢》，18卷，1期，頁227-275。 張永健（2005），〈論藥品、健康食品之廣告管制〉，《法令月刊》，56卷5期，頁31-56。 陳仲嶙（2011），〈商業性言論憲法解釋十年回顧與評析〉，《中原財經法學》，27期，頁101-150。 陳仲嶙、蔡昌憲、劉冠佳（2022），〈企業社會揭露的法律管制模式：兼顧實效性與合憲性的觀點〉，《中研院法學期刊》，31期，頁163-254。 陳昱奉（2022），<網路犯罪與資訊安全的未來－從網域名稱扣押談網路治理>，《刑事政策與犯罪防治研究專刊》，32期，頁219-290。 黃昭元（2013），〈大法官解釋審查標準之發展(1996-2011)：比例原則的繼受與在地化〉，《臺大法學論叢》，第42卷，第2期，頁215-258。 黃舒芃（2007），〈數字會說話？- 從大法官釋字第584號解釋談事實認定在規範違憲審查中的地位〉，《中研院法學期刊》，第1期，頁1-44。 黃銘傑（1998），〈美國法上的言論自由與商業廣告－兼論司法院大法官會議釋字第四一四號解釋〉，《臺大法學論叢》，29卷2期，頁347-393。 賈文宇（2017），〈以言論自由為念的食藥安全控管憲法裁判－簡評司法院釋字第 744 號解釋〉，《法律與生命科學》，6卷1期，頁33-45。 蔡志宏（2022），<剝奪犯罪工具之數位轉型－域名之沒收與扣押>，《刑事政策與犯罪防治研究專刊》，31期，頁197-237。 楊智傑（2017），〈言論自由事前審查之審查標準－釋字第 744 號解釋與美國審查標準比較〉，《憲政時代》，43卷1期，頁89-143。 鄭慧文、陳慧佳、余萬能、林銅祿（2010），〈論處方藥直效行銷廣告與憲法言論自由及大法官釋字第 414 號解釋之關聯初探〉，《醫事法學》，17 卷，1 期，頁25-32。 四、 學位論文 林南廷（2013），《公共衛生法中限制商業言論之合憲性探討》，國立臺北大學法律學研究所碩士論文，臺北。 張永健（2003），《論藥品、健康食品、食品之管制》，國立臺灣大學法律學研究所碩士論文，臺北。 陳麒（2018），《論藥品廣告之管制－以藥事法之廣告規範為中心》，國立臺灣大學法律學研究所碩士論文，臺北。 劉文萱（2018），《言論事前審查之研究--以醫藥廣告為中心》，國立臺灣大學國家發展研究所碩士論文，臺北。 貳、 英文文獻 一、 書籍 Griffin, J. P., Posner, J. & Barker, G. R. (Eds.) (2013). The Textbook of Pharmaceutical Medicine (7th ed). London: BMJ Books. Lynch, H. F., & Cohen, I. G. (Eds.) (2015). FDA in the Twenty-First Century - The Challenges of Regulating Drugs and New Technologies. New York: Columbia University Press. Mantus, D. S. & Pisano, D. J. (Eds.) (2014). FDA Regulatory Affairs (3rd ed). Florida: CRC Press. 二、 期刊論文 Dabrowska, A. & Thaul, S. (2018). How FDA Approves Drugs and Regulates Their Safety and Effectiveness, Congressional Research Service Report, available at https://sgp.fas.org/crs/misc/R41983.pdf. Donohue, J. (2006). A history of drug advertising: the evolving roles of consumers and consumer protection. The Milbank quarterly, 84(4): 659–699. Encinosa, W., Meyerhoefer, C., Zuvekas, S. & Du, D. (2014). The Impact of Direct-to-Consumer Advertising on Health Insurance Markets. The Geneva Papers on Risk and Insurance. Issues and Practice, 39(4): 749-767. Evans, G. W., Friede, A. I., & Pfizer Inc. (2003). The Food and Drug Administration''s Regulation of Prescription Drug Manufacturer Speech: A First Amendment Analysis. Food and Drug Law Journal, 58(3)：365-437. Frosch, D. L., Grande, D., Tarn, D. M., & Kravitz, R. L. (2010). A decade of controversy: balancing policy with evidence in the regulation of prescription drug advertising. American journal of public health, 100(1): 24-32. Gostin, L. O. and Javitt, G. H. (2001). Health promotion and the First Amendment: government control of the informational environment. The Milbank quarterly, 79(4)：547-578. Guttentag, M. D. (2017). Evolutionary Analysis in Law: On Disclosure Regulation. Arizona State Law Journal, 48: 963-993. Gyawali, B., Ross, J. S., and Kesselheim, A. S. (2021). Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway: The Need for Reforms, JAMA Internal Medicine, 181(10)：1275–1276. Hill, J. C. (2005). The Learned Intermediary Doctrine and Beyond. Defense Counsel Journal, 72(4)：362-379. Keighley, J. M. (2012), Can You Handle the Truth? Compelled Commercial Speech and the First Amendment, University of Pennsylvania Journal of Constitutional Law：539-617 (forthcoming). Klasmeier, C. & Redish, M. H. (2011). Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection. American Journal of Law and Medicine, 37: 315-357. Pomeranz, J. L. (2022). United States: Protecting Commercial Speech under the First Amendment. Journal of Law, Medicine & Ethics, 50(2): 265-275. Reichertz, P. S. (1996). Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers. Food and Drug Law Journal, 51(3): 355-365. Schuchman M. (2007). Drug risks and free speech: Can Congress ban consumer drug ads? New England Journal of Medicine, 356(22): 2236–2239. Ventola C. L. (2011). Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic? P & T : a peer-reviewed journal for formulary management, 36(10): 669–684. Vilhelmsson, A., Davis, C., & Mulinari, S. (2016). Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012. PLoS medicine, 13(1): 1-22. 三、 書之篇章 Baeten, R. (2020). EU pharmaceutical policies: direct-to-consumer advertising, Pp.173-200 in Social developments in the European Union 2009, edited by Christophe Degryse. Brussels: The European Trade Union Institute. Hutt, P. B. (2015), Historical Themes and Developments at FDA Over the Past Fifty Years, Pp. 17-32 in FDA in the Twenty-First Century - The Challenges of Regulating Drugs and New Technologies, edited by Lynch, H. F., & Cohen, I. G.. New York: Columbia University Press. Kesselheim, A. S. & Mello, M. M. (2015), Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, Pp. 184-203 in FDA in the Twenty-First Century - The Challenges of Regulating Drugs and New Technologies, edited by Lynch, H. F., & Cohen, I. G.. New York: Columbia University Press. 四、 其他 Food and Drug Administration (1999). Guidance for Industry Consumer-Directed Broadcast Advertisements. Available at https://www.fda.gov/media/75406/download. Food and Drug Administration (2009). Guidance for Industry：Presenting Risk Information in Prescription Drug and Medical Device Promotion (Draft Guidance). Available at https://www.fda.gov/media/76269/download. Food and Drug Administration (2014). Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Draft Guidance). Available at https://www.fda.gov/media/88551/download. Food and Drug Administration (2014). Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (Draft Guidance). Available at https://www.fda.gov/media/88545/download. Food and Drug Administration (2015). Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Draft Guidance). Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/brief-summary-and-adequate-directions-use-disclosing-risk-information-consumer-directed-print. Medicines and Healthcare products Regulatory Agency (2020). The Blue Guide: Advertising and Promotion of Medicines in the UK, Third Edition. Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/956846/BG_2020_Brexit_Final_version.pdf. Pharmaceutical Research and Manufacturers of America (2018). PhRMA GUIDING PRINCIPLES DIRECT TO CONSUMER ADVERTISEMENTS ABOUT PRESCRIPTION MEDICINES. Available at https://phrma.org/resource-center/Topics/Cost-and-Value/Direct-to-Consumer-Advertising-Principles. Post, R. (2000), The Constitutional Status of Commercial Speech. Available at https://ssrn.com/abstract=236032. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research (2012). Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad PreDissemination Review Program (Draft Guidance). Available at https://www.fda.gov/media/82590/download. | - |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/92600 | - |
| dc.description.abstract | 我國藥物廣告需經主管機關事前審查之制度，早於1970年的藥物藥商管理法制定時便已存在。1996年，司法院釋字第414號解釋結論認為，藥事法針對藥物廣告之事前審查規定為合憲。因此，目前實務上對於藥物廣告因未送審而被處以行政裁罰之案件中，仍然是固守釋字第414號解釋之結論，使藥物廣告事前審查之制度鞏固至今。然而，此項制度於實務多年運作下，早已有重新檢討之必要。
基此，本文首先針對現行藥物廣告之審查模式行完整介紹，包含如何認定藥物廣告、主管機關審查廣告之重點等，藉此釐清於現行藥物廣告事前審查之模式下將導致的問題。其次，基於釋字第414號、第744號解釋所帶來的啟發，重新檢驗現行藥物廣告事前審查規範（包含藥事法第66條規定、醫療器材管理法第41條規定）之合憲性。本文主張：現行針對藥物廣告事前審查之規定，其目的與手段間皆不具手段必要性及衡平性，從而應屬違憲，故於藥物廣告之審查與管制模式上，應朝向合於憲法價值之方向進行改制。 經本文進一步研析美國、英國針對藥物廣告之監管規範，發現英、美國家原則上雖不要求事前審查藥物廣告，但在特定情況下（例如所涉及之廣告內之藥品因有較高之致死或嚴重風險者），仍例外允許主管機關得事先審查此類廣告內容。此外，美國針對處方藥廣告也課予強制揭露風險之義務，以避免廣告造成誤導。 比較英、美及我國之制度後，本文也提出我國可以採行之管制模式及修法方向，包含：（1）鬆綁全面事前審查制度，授權主管機關課予特定藥物廣告備查義務，且僅授權機關於極特殊情形下得要求進行事前審查；及（2）廣告應「摘要」列出藥品副作用、禁忌症或器材使用警語等資訊。此外，為解決實務上對於偽、禁藥物廣告監管上之不足，本文也附帶建議應立法賦予衛生主管機關聲請資訊限制令之權限。 | zh_TW |
| dc.description.abstract | In Taiwan, drug advertisements shall undergo prior censorship by the competent authorities before publication and broadcast. Such a prior censorship system has existed since the enactment of the Pharmaceutical Affairs Act in 1970. In 1996, Taiwan’s Judicial Yuan Interpretation No. 414 concluded that the pre-censorship requirement for drug advertisements under the Pharmaceutical Affairs Act was constitutional. As a result, Taiwan’s practice still adheres to the conclusion of Judicial Yuan Interpretation No. 414 in relevant cases that drug advertisements are subject to administrative penalties for failing to be submitted for prior censorship. However, after experiencing so many years of practical operation, it’s time to analyze this issue again and reform this system.
This thesis first focuses on the current practical operation of drug advertisements, including how to recognize drug advertisements and the examination conducted by the competent authorities in practice, to clarify the existing problems caused by the current prior restraint. Secondly, based on the inspiration brought by Judicial Yuan Interpretation No. 414 and No. 744, the constitutionality of the existing prior restraint regulations (including the provisions of Article 66 of the Pharmaceutical Affairs Act and Article 41 of the Medical Devices Act) shall be re-examined. This thesis argues that the existing pre-censorship requirements for drug advertisements are unconstitutional since they are not necessary and not equitable in terms of the purpose and means. Therefore, these Acts shall be reformed to meet the constitutional values. This thesis analyzes the regulation of drug advertisements in the United States and the United Kingdom, and finds that although the U.K. and the U.S. do not require prior censorship of drug advertisements in principle, they still exceptionally allow the competent authorities to review the advertisements under specific circumstances (e.g., the advertised drug involves a higher risk of death or danger). In addition, the U.S. also imposes a mandatory disclosure obligation on prescription drug advertisements to avoid misleading advertisements. After comparing the systems in the U.K., the U.S. and Taiwan, this thesis also proposes the supervision model and a direction for legislative amendments, including: (1) loosening the comprehensive prior restraint system, authorizing competent authorities the rights to request the drug companies to submit the content of advertisement, and authorizing the competent authorities to request for prior censorship only under extreme circumstances; and (2) the advertisements should list the summary information of the side effects of the drugs, contraindications, or warnings for the use of devices. In addition, to solve the inadequacy of the monitoring of counterfeit and prohibited drug advertisements in practice, this thesis also suggests that authorizing health authorities to request for information restraining orders would be needed. | en |
| dc.description.provenance | Submitted by admin ntu (admin@lib.ntu.edu.tw) on 2024-05-02T16:08:35Z No. of bitstreams: 0 | en |
| dc.description.provenance | Made available in DSpace on 2024-05-02T16:08:36Z (GMT). No. of bitstreams: 0 | en |
| dc.description.tableofcontents | 第一章 緒論 1
第一節 研究動機與目的 1 第二節 研究範圍與架構 2 壹、 研究範圍 2 貳、 研究架構 6 第二章 我國藥物廣告規範架構及制度評析 8 第一節 藥物廣告規範之沿革 8 壹、 1970年公布施行之「藥物藥商管理法」 8 貳、 1993年「藥事法」之成形 10 參、 醫療器材管理法之制定 13 第二節 藥物廣告事前審查規範之重點 17 壹、 廣告內容審查原則 18 貳、 廣告類別（刊載地點）之限制 19 參、 廣告許可證之期限及展延 21 肆、 「非屬藥物廣告」之宣傳 22 第三節 藥物廣告廣泛認定之爭議 24 壹、 藥物廣告與「產品資訊」之爭議 25 貳、 藥物廣告與「衛教廣告」之區別 27 參、 影射、暗示醫療效能之爭議 30 第四節 我國藥物廣告審查制度問題 34 壹、 事前審查制度之鞏固 34 貳、 事前審查制度與藥物廣告廣泛認定之連結 34 參、 事前審查的功能式微 35 第三章 事前審查藥物廣告之合憲性爭議 38 第一節 我國廣告及言論自由事前審查之釋憲實務 40 壹、 司法院釋字第414號解釋 40 貳、 司法院釋字第744號解釋 42 參、 本文見解 47 第二節 釋憲實務之影響 49 第三節 再探藥物廣告事前審查制度之合憲性 51 壹、 前言 51 貳、 事前審查規定之實質合憲性分析 53 第四節 小結 57 第四章 英、美國家藥物廣告審查及管制比較 58 第一節 美國藥物廣告審查及管制模式 59 壹、 美國聯邦藥物廣告監管體制 60 貳、 處方藥廣告審查與規範—原則上非事前審查 61 參、 處方藥廣告事前審查之例外規定 63 肆、 處方藥廣告內容規定與不當標示 69 伍、 非處方藥及醫療器材廣告規範之比較 77 陸、 處方藥直效行銷廣告之爭議 78 柒、 仿單外行銷爭議 80 第二節 英國藥物廣告審查及管制模式 84 壹、 英國藥物廣告監管體制及法規 84 貳、 英國藥品廣告之審查 86 參、 醫療器材之廣告規定 87 肆、 處方藥廣告行銷限制 88 伍、 仿單外行銷之限制 89 第三節 小結 91 壹、 英、美監管單位及分工之不同 91 貳、 英、美事前審查制度之異同 91 參、 英、美自律團體及其規範之影響 92 肆、 美國處方藥廣告之「內容衡平性」及強迫揭露明文規範 92 伍、 英、美處方藥直效行銷廣告及仿單外行銷之異同 93 陸、 我國與英、美制度上比較 94 第五章 我國現行藥物廣告規範之重建 99 第一節 全面事前審查之鬆綁 99 壹、 立法建議 99 貳、 小結 101 第二節 強迫揭露規範之設計 101 壹、 我國法現有之揭露規範 102 貳、 藥物廣告強制揭露規範之建議提出 105 第三節 兼論偽禁藥物網路廣告之管制 108 壹、 實務上管制及查緝難題 108 貳、 本文建議 110 第六章 結論 112 參考文獻 117 | - |
| dc.language.iso | zh_TW | - |
| dc.subject | 言論自由事前限制 | zh_TW |
| dc.subject | 商業性言論 | zh_TW |
| dc.subject | 事前審查 | zh_TW |
| dc.subject | 醫療器材管理法 | zh_TW |
| dc.subject | 藥事法 | zh_TW |
| dc.subject | 藥物廣告 | zh_TW |
| dc.subject | prior restraint on speech | en |
| dc.subject | Pharmaceutical Affairs Act | en |
| dc.subject | Medical Devices Act | en |
| dc.subject | drug advertisement | en |
| dc.subject | commercial speech | en |
| dc.subject | prior censorship | en |
| dc.title | 藥物廣告監管之研究—以事前審查為中心 | zh_TW |
| dc.title | Research on Overseeing the Drug Advertisement: Focusing on Prior Restraint | en |
| dc.type | Thesis | - |
| dc.date.schoolyear | 112-2 | - |
| dc.description.degree | 碩士 | - |
| dc.contributor.oralexamcommittee | 蘇慧婕;賈文宇 | zh_TW |
| dc.contributor.oralexamcommittee | Hui-chieh Su;Wen-Yu Chia | en |
| dc.subject.keyword | 藥事法,醫療器材管理法,藥物廣告,商業性言論,事前審查,言論自由事前限制, | zh_TW |
| dc.subject.keyword | Pharmaceutical Affairs Act,Medical Devices Act,drug advertisement,commercial speech,prior censorship,prior restraint on speech, | en |
| dc.relation.page | 122 | - |
| dc.identifier.doi | 10.6342/NTU202400856 | - |
| dc.rights.note | 同意授權(全球公開) | - |
| dc.date.accepted | 2024-04-15 | - |
| dc.contributor.author-college | 法律學院 | - |
| dc.contributor.author-dept | 法律學系 | - |
| dc.date.embargo-lift | 2026-07-31 | - |
| 顯示於系所單位： | 法律學系 | |
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| ntu-112-2.pdf 此日期後於網路公開 2026-07-31 | 2.45 MB | Adobe PDF |
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