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標題: | 藥物廣告監管之研究—以事前審查為中心 Research on Overseeing the Drug Advertisement: Focusing on Prior Restraint |
作者: | 徐曼綾 Man-Ling Hsu |
指導教授: | 林明昕 Ming-Hsin Lin |
關鍵字: | 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, Pharmaceutical Affairs Act,Medical Devices Act,drug advertisement,commercial speech,prior censorship,prior restraint on speech, |
出版年 : | 2024 |
學位: | 碩士 |
摘要: | 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。 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. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/92600 |
DOI: | 10.6342/NTU202400856 |
全文授權: | 同意授權(全球公開) |
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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