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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
71

專利法及藥事法上實驗例外之研究─以製藥產業為中心 / The Research of Experimental Use Exception on Patent Law and Pharmaceutical Affairs Act -Especially in Pharmaceutical Industry

孫小萍, Sun, Hsiao-ping Unknown Date (has links)
專利權具有獨占性,對一國產業發展具有重要影響,為了平衡該權利,各國專利法在給予發明人專利權的同時也加諸某些限制,以我國為例,於專利法第五十七條第一項列舉專利權效力所不及之情形有:(一)為研究、教學或試驗,實施其發明,而無營利行為者。此即所謂之「實驗例外」 (experimental use exception)條款。 實驗例外條款在各國司法實務運作上,最常被引起爭論者向來集中在處方藥市場中專利藥廠與學名藥廠間之競爭議題。因為學名藥廠為了能夠盡早進入市場,不免須在專利期間屆滿前實施原廠專利進行必要之研究、試驗,以符合各國對於藥物上市管理法令之要求。 雖然我國專利法與其他國家一樣也有試驗例外條款,但其中要件嚴格限定為「非營利行為」,從比較法之方式分析,該規定係受美國普通法之影響。美國普通法關於試驗例外係採取嚴格路線,必須行為人之試驗係出於非營利目的,單純追求真相、探求知識理論,或為滿足好奇心,才可主張普通法上之實驗例外,即始係不具營利色彩之公家機關、學術單位從事之試驗,只要背後具有實質的商業目的亦不得主張試驗例外。如此造成要成功適用試驗例外是愈來愈不可能。 國際間對於試驗例外之立法,除美國外,尚存在許多形式值得我國借鏡,以歐洲共同體專利規則草案(Proposal for a Council Regulation on a Community Patent)為例,其區分「私人且非商業性目的之行為」,以及「為試驗目的之行為」,後者要求必須係針對系爭專利技術本身所進行之試驗始非專利權效力所及,若係將該專利技術作為研究工具之用,仍非法之所許。這種區分方法不僅層次分明、無觀念上混淆之虞,判斷上也較具有可預測性。 美國於1984年通過Hatch-Waxman 法案鼓勵學名藥之發展,對於為滿足主管機關關於醫藥品上市要求之試驗,在專利法271(e)(1)明文規定排除在專利權效力之外,即所謂之「Bolar例外」。我國於九十四年二月五日亦增訂藥事法第四十條之二第五項:「新藥專利權不及於藥商申請查驗登記前所進行之研究、教學或試驗」關於Bolar例外之規定。惟或因立法匆促,致法條要件不符合實際狀況,例如限定「申請查驗登記前」之行為,實際上藥廠於提出查驗登記之申請後,往往在主管機關之要求下須進行其他試驗,這些行為均在立法者原欲保護之範圍內,僅因立法用語之不當,造成實務運用之困擾。 筆者最後從法律及商業管理觀點著眼,對國內立法提出下列修法建議,作為本研究之最終成果: 壹、對於專利法第五十七條第一項第一款修法之建議 一、刪除「教學」之行為態樣 二、刪除「而無營利行為」之要件 三、增列關於研究工具之專利則無本條之適用 四、放寬適用範圍為符合主管機關法規要求而實施他人專利亦有實驗例外之適用。 贰、對於藥事法修法之建議 一、刪除「申請查驗登記前」之要件,改以行為目的來限定範圍,即「為通過藥品查驗登記所進行之研究或試驗」,始有本款之適用。 二、明定「物品專利」及「方法專利」均有本條之適用
72

我國國小自然科學教科書之分析研究 / An Analysis of the Science Textbooks Used in the Elementary Schools of Taiwan

黃瓊瑱, Huang, Chiung-Chen Unknown Date (has links)
本研究是以1980年代以後的科學教育目標來分析我國國小自然科學教科書 之課本、教學指引及習作,探討教科書的內容、實驗活動及作業問題型態 ,並調查國小自然科教師對教科書的使用意見,了解現行教科書的優缺點 ,以供編撰教科書及學校、教師選擇教科書的參考。 為達上述之目的,本研究在內容分析部份採用的工具有科學知識本質年齡 層次分類表、STS科學教育目標、實驗活動發現開放層次分類法、科學 過程探究技能、教科書作業問題型態評估工具、以及 Bloom的目標分類法 ,在問卷調查方面採用國小自然科學教科書之意見調查表來蒐集和分析資 料。 本研究的主要發現如下: 一、國小自然科學教科書之課本內容在文字敘述上涉及科學知識本質的僅 佔0.084%,而這些文字敘述只提到科學知識是實證性的,雖如此,但其內 容仍含有科學知識本質之正面教學功能。 二、國小自然科學教科書的每個單元都提及個人需要及學術準備的科學教 育目標,而有25.53%的單元提及與科學有關的社會議題,但無提及有關生 涯職業教育的內容。 三、國小自然科學教科書的實驗活動無屬於層次0的單元,有55.32%的單 元屬於層次1,42.55%的單元屬於層次2,2.13% 的單元屬於層次3,是 屬相當不錯的實驗活動設計。 四、國小自然科學教科書習作的作業問題型態以及層次之分佈,有1.94% 的問題屬於非經驗性問題,98.06%的問題屬於經驗或實驗性問題;且屬於 高層次問題的比例較多,亦有一些價值性問題的設計,是相當重視學生高 層次問題解決的學習。以 Bloom目標分類來看,幾乎所有的作業問題都屬 於認知領域的問題,佔了99.72%,其中以理解和應用的問題為最多。 五、國小自然科教師對教科書的整體意見為滿意。可是教師對於教科書的 內容並不滿意但尚可接受;其他各項來說,教師對教科書的組織、閱讀層 次、圖表說明、課文中的實驗活動及習作、教學指引、教科書的容貌均呈 滿意的態度。 The purpose of this study was to analyze the science textbooks used in the elementary schools of Taiwan in terms of goals for science education. The following five components were studied and analyzed:(1)the nature of scientific knowledge, (2)the interaction of science, technology and society, (3)openness and process/skills of laboratory activities, (4)type and level of questioning style, and(5)opinions of science teachers concerning science textbooks. For the purposes described above, seven methods were adopted for this study; that is, the classification of the nature of scientific knowledge, the desired state of science in the elementary school, the level of discovery/openness, science process or inquity skills, and textbook questioning strategies assessment instrument, Bloom's taxonomy classifies educational objectives and science textbook rating system. The major findings include: 1.Only about 0.084% of the narrative page space is devoted to the nature of scientific knowledge in the science textbooks used in elementary school. Only empirical scientific knowledge was presented. 2.Every unit in the science textbooks used in elementary school is associated with the goals of personal needs and academic preparation. 25.53% of units are associated with the goals of societal issues, but no unit associated with the goals of career education. 3.Most of the laboratory activities in the science textbooks used in elementary schools, which provided the problems and the procedures to student's performance, belong to level 1 or 2. 4.Most of the questions are experiential questions(98.06%). And almost of the questions are cognitive domain(99.72%), and most of them are comprehension questions and application questions. 5.Most of the elementary school science teachers are satisfied with the science textbooks used in elementary schools , and their satisfaction goes beyond the contents of the textbooks.
73

田口式品質工程方法在電子業應用之研究-華通電腦公司個案研究 / Application Of Taguchi's Quality Engineering Method In Electronic Industry--A Case Study of COMPEQ

張金生, Chang, Chin-Sheng Unknown Date (has links)
近年來,我國對於田口式品質工程方法的運用,已漸漸普及於各個生產事 業。然而,在以往田口方法的應用實例中大多只使用一種數據分析法,即 傳統實驗設計的變異數分析法,或田口方法的信號雜音比( S/N ratio ),對於二者之間的比較及異同處,則較少提及﹔且絕大部分是只探討單 一品質特性最佳化的問題,對於同一製程中同時具有多個品質特性需最佳 化的問題,亦較少觸及。本研究首先分別引用二種數據分析法進行提昇自 動光學檢驗(AOI)偵測能力」}的數據解析、比較二種分析法在理論上及應 用上的差別,並依保守原則,初步決定各品質特性(本研究有三個品質特 性)的最佳因子水準組合。其次,針對各品質特性間因子水準互相矛盾的 情形,本文將引用下述3種分析方法於研究案例,並綜合各種方法的優缺 點及適用狀況,藉以找出多品質特性同時最佳化的因子水準組合。此三種 分析方法為: (1) 畫出各因子對個別品質特性之影響效果總調查表,再經 由人為的比較判斷後選取最佳的條件組合 (2) 以個別品質特性之信號雜 音比的加權和作分析 (3) 使用品質特性值標準化的方法做分析由分析結 果,吾人可知現有各種方法均有其優缺點,唯有熟悉各種方法並配合豐富 經驗與專業知識,視實驗狀況而選擇性的加以應用,方能獲致良好實驗效 果。
74

考量指標衝突之物流業者評選模式 / Logistics service provider selection model based on conflict criteria

蔡雅慧, Tsai, Ya Hui Unknown Date (has links)
在全球化競爭的條件之下,企業之專業分工漸趨精細,企業為了發展自己本身的核心能力,選擇將非核心能力委外給專業的第三方,以求獲得更佳的服務品質且為企業減少成本支出。其中物流相關費用占企業營運費用約5%~35%,物流在整體企業營運扮演重要角色,近年來供應鏈管理的興起,企業更加重視與上下游廠商間協調關係,物流管理受到重視,物流關係到整體供應鏈的穩定度,因此在選擇物流委外供應商時,企業需審慎的評估供應商各方面的能力,以選出最適物流委外供應商。   過去評選物流委外供應商,多數藉由專家主觀判斷,本研究提出一套完整的物流委外供應商評選模式,以客觀的角度評選物流委外供應商。過去文獻中多數假設評估準則間關係獨立,此假設與現實狀況不符,評估準則通常存在相互關聯。企業在評選過程中,針對特定評選準則會有限定標準,若單以績效值評估,不符企業之需求,本研究將其納入考量,建立出更加完整的物流委外供應商評選模式。此評選模式可給予參與評選之候選廠商改善建議,為雙方建立良好的關係,創造雙贏的局面。   本研究透過決策實驗室法建立指標之網路關係,以網路程序分析法計算指標之權重,於評分處理部份,針對企業特定評選指標,透過田口品質損失函數轉換成與目標之損失值,最後藉由VIKOR排序法評選出最佳物流委外供應商。受限於成本考量,本研究透過系統動態學模擬運送情形,藉由所獲得之營運資料驗證此評選模式。 / Under the global competitive conditions, enterprises become more sophisticated division of labor. Enterprises want to develop their own core competencies. Enterprises choose to outsource non-core capabilities to third-party professional,because of better service quality and reducing costs for enterprises. In recent years, enterprises pay more attention to coordination with the relationship between upstream and downstream firms. The logistics in the overall business operations play an important role. Therefore, in the choice of logistics outsourcing providers, enterprises evaluate all aspects of supplier's abilities to select the most suitable supplier of logistics outsourcing.   This study provides a complete model to evaluate logistic service providers. Enterprises in the selection process, selection criteria will be qualified for a particular standard. Selection criteria usually have interrelationship. Under the condition, this study use DEMATEL and ANP to create criteria relationship and compute criteria weights. Taguchi loss function is used to calculate some criteria loss value, which is the distance between enterprise’s target values. Finally, VIKOR combines loss value with performance value to select the best logistics service providers. These models also give candidates some suggestions to improve their performance.
75

兩岸治理新模式?-平潭綜合實驗區的規劃與發展 / The new Cross-Strait governance model?-the planning and the development of pingtan integrated testing zone

莊孟寰, Chuang, Meng Huan Unknown Date (has links)
改革開放為中國大陸創造了令人驚艷的經濟成長,卻也帶來區域不平衡的嚴重問題。近年來,中國大陸區塊化的發展受到各界關注,包括珠三角、長三角、環渤海區等。而長期以來受到忽略的福建省,終於在海西區的規劃中得到了來自中共中央的政策支持。福建擁有對台先行先試,探索兩岸進行區域合作試點的權力,在海西區的架構下,平潭綜合實驗區被中共中央寄與厚望,以「五個共同」積極與台灣進行各種創新合作,其中,最為人所注目的即是「共同治理」。本文認為,從目前中共中央給予平潭的各項政策利多及兩岸在此議題上的角力來看,兩岸「共同治理」,仍有許多問題亟待克服。
76

臺大實驗林契約林地管理制度之研究 / A study of management institution on experimental forest lease forestlands of Nation Taiwan University

江瑞雄, Chiang, Jui Hsiung Unknown Date (has links)
摘 要 臺大實驗林因其特殊歷史背景,與契約林農訂立之三種契約,歷經社會與經濟變遷後,漸生契約林農基於經濟因素而違規利用契約林地、林管處無法具體落實造林管理政策、契約林地利用契約規範與實際利用現況不甚相符等諸多問題。按非都市土地使用管制規則予以檢視,臺大實驗林契約林地係編定為林業用地,惟依臺大實驗林「被墾地合作造林辦法」、合作造林契約書規定,造林地可於單筆總面積的三成內從事森林特產物或果樹之種植,此與上開規則規定林業用地容許使用項目不得作農業使用之規範有所牴觸,除人為的利用,以保存自然資源?還是兼顧人們需要和環境保育,得積極介入以亟待研析解決辦法。 從自然資源利用的歷史角度以觀,除天然災害影響之外,人為干擾似乎是造成土地健康受損的根源。然而,究竟要完全排負責保育自然資源?凡此引發激烈的辯論。若從林地利用究屬保存與保育觀點檢視,林管處秉持林地林用的概念,是希望避免林地農用與干擾,以達成完全造林的目標,近乎保存的概念;而林農希望契約林地做混農利用,並希望透過在地知識以人為方式主動管理,且在不破壞林地健康的前提下,以提升經濟收入與環境健康,似屬保育的概念。然為落實維護林地資源,採取何種觀念為宜? 本研究從臺大實驗林契約林地土地使用管制機制,藉由混農林業理論、保存與保育理論、土地使用管制等文獻評析,並透過深度訪談,分析臺大實驗林契約林地土地利用相關問題,最後得到以下結論:(1)臺大實驗林契約林地租地造林契約應予修正;(2)修正非都市土地使用管制規則之林業用地容許使用項目;(3)臺大實驗林繼續辦理國土復育計畫及獎勵造林計畫。本研究對於臺大實驗林契約林地土地利用,提出以下之建議:(1)修正臺大實驗林契約林地三種租地造林契約內容不適宜之規範,以符合現今法令規範;(2)重新查定臺大實驗林契約林地可利用限度並編定合適用地類別,以符土地使用管制規範;(3)修正非都市土地使用管制規則之林業用地容許使用項目,以利林地保育並導正使用;(4)臺大實驗林繼續辦理國土復育計畫及持續宣導獎勵造林計畫,以維護國土保育安全。最後,從導正土地使用管制機制,以利有效管理臺大實驗林契約林地,最終達成森林資源永續發展的目標。 關鍵詞:臺大實驗林契約林地、土地使用管制、保育與保存、混農林業、林業用地、違規使用 / Abstract Due to the unique historical background of the experimental forest of National Taiwan University (NTU), three types of contracts were signed with users of leased forest land. Many issues have now arisen after several social and economic changes. Such issues include the illegal use of the forest land, failure of the Forest District Offices to fully implement the relevant forestation management policies, and the inconsistency between the provisions of forest land use contracts and the conditions of actual use. According to the Regulations on Non-Urban Land Use Control, the NTU experimental forest is defined as forest land. On the other hand, however, according to the “Cooperation Guideline for Reclaimed Land Forestation” and the “Forestation Contract,” 30% of the total area of a parcel of forestation land may be used for the plantation of special forest products or fruit trees, which is inconsistent with the rule under the Regulations on Non-Urban Land Use Control prohibiting any agricultural use of forest land. As a result, a solution was to be analyzed and discussed to see whether the natural resources shall be preserved either without human use or with active intervention to balance human needs with environmental conservation. From the historical perspectives on natural resource use, human interference seems to be the main cause of damage to land. Heated discussions have been had regarding how to conserve natural resources. This issue might be viewed from the two points of view, i.e. preservation and conservation. The Forest District Office holds the view that forest land shall be used for the purpose of forestry to avoid agricultural use or interference and to achieve the goal of complete forestation. This is more of a concept of preservation. On the other hand, users of forest land would prefer agroforestry use of forest land and manage the land through local knowledge to improve economic returns and environmental health without destroying the forest land. This is more of a concept of conservation. Which concept is more ideal in terms of protection of forest land? In this study, we referred to publications in connection with agroforestry, preservation and conservation, and use control of land, along with in-depth interviews conducted to analyze the relevant issues regarding the use of the leased forest land at NTU experimental forest and concluded that: (1) the forestation contracts regarding the leased forest land at NTU experimental forest shall be amended; (2) the allowed use of forest land under the non-urban land use control regulations shall be revised; and (3) NTU experimental forest shall continue to participate in the national land recovery plan and encouraging plan for forestation. The possible measures for the use of leased forest land at NTU experimental forest as suggested by this study include: (1) amending the three types of forestation contracts regarding the leased forest land at NTU experimental forest for the purpose of legal compliance; (2) reinvestigating the scope of use of the leased forest land at NTU experimental forest and stipulating appropriate use types to be in conformance to the land use control regulations; (3) revising the allowed use of forest land under the non-urban land use control regulations for the purposes of forest land conservation and corrective use; and (4) the continuous participation of NTU experimental forest in the national land recovery plan and encouraging plan for forestation to maintain national land conservation. Finally, by correcting the mechanism of land use control, the leased forest land at NTU experimental forest will be effectively managed and the goal of perpetual development of forest resources achieved. Key words:Experimental forest leased forest land of National Taiwan University, Land use control, Conservation and preservation, Agroforestry, Forest land, Illegal use
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論製藥產業之實驗實施免責 / The Experimental Use Exemption of Pharmaceutical Industry

張睿麟, Chang, Jui Lin Unknown Date (has links)
隨著醫療科技的進展,人類對於疾病的成因、機轉、病程、及治療,在不斷地研究突破下,有著持續的進步而對人類的健康有著不可或缺的貢獻。其中藥品,正是人類對抗疾病最關鍵、也最普遍的方式之一,對公共衛生的重要性自不待言。 其中,由於生命科學的本質使然,開發新的藥品對於研究發展的倚賴,遠勝於其他產業,因此,創新研發藥廠對於開發一項新藥的平均投資,已達十三億美元之譜;此外,由於藥物對人體的生理功能、體內恆定能造成極大的影響,因此世界各國的醫藥衛生主管機關無不對於藥品的上市加以嚴格的管制,使得現今開發一項藥品平均約耗時十至十五年。藥品開發的巨大投入與耗時極長的開發期間,使得製藥產業亟需經由智慧財產權的制度來提供其投入研發創新之誘因。然而,因為智慧財產之保護,也使得新藥往往售價高昂而造成公眾近用之阻礙。而學名藥正是解決這樣的問題的關鍵之一,亦為世界各國所大力推動。在推動學名藥產業上,實驗實施免責為制度上極為重要的考量之一。本文及希望藉由對製藥產業特質之探究,美國普通法上以及成文法上實驗實施免責的探討,我國實驗實施免責之規定與判決之研究,來找出我國當下實驗實施免責的規定於製藥產業中適用時所可能發生的問題,以及相對應的可能改進方案。 本文第二章本章先行探討製藥產業之特質;第三章討論美國普通法上實驗實施免責之概念,並歸結出美國普通法上實驗實施免責的三項適用要件;第四章探討美國成文法上實驗實施免責之立法背景、相關判決以及對生物科技領域各層面的影響;第五章則先行探討世界貿易組織於「與貿易相關智慧財產權協定」中對於專利權之限制基礎。其後探討我國專利法中之一般實驗實施免責以及藥事法中針對製藥產業之實驗實施免責之相關規定,並由學者論述以及相關判決中,探討我國實驗實施免責之相關規定於製藥產業實務上所可能面臨之問題,並提出可能之解決方案。 / With the progress of medical technology, humans have been furthering the understanding of the etiologies, mechanisms, courses, and treatments of diseases. Such continued progresses have contributed significantly to improving human health. Among all the treatments, the pharmaceutical is one of the key and common ways with which humanity fight diseases. Its importance to public health is beyond doubt. Due to the nature of the life sciences, the pharmaceutical industry depends more on research and development than other industries do. Therefore, on average, it costs innovative pharmaceutical companies 1.3 billion U.S. dollars to develop a new drug. Furthermore, countries around the world pose strict regulations on new drugs’ entering the market since drugs cause huge impacts on the physiological functions and internal balances of the human body. Hence, it generally takes ten to fifteen years for a new drug to be fully developed. The enormous investment and lengthy developing period makes the pharmaceutical companies extremely dependant on the intellectual property system to provide them with the incentive for research and development. However, it is also because of the intellectual property protection that makes new drugs expensive and difficult for the public to access. The Generic drug, however, is one of the key solutions to solve this problem and is intensively promoted by countries all over the world. Regarding the promotion of the generic drug industry, the experimental use exemption is one of the vital systemic considerations. There are discussions on the characters of the pharmaceutical industry, on the common law and statutory experimental use exemptions of the United States, and on the related regulations and precedents of the experimental use exemption in Taiwan. Through the above discussions, the thesis is aimed at identifying the possible problems the regulations on experimental use exemption might cause when applied to the practice of the pharmaceutical industry and at proposing possible solutions to such problems. The characters of the pharmaceutical industry are discussed in Chapter two. The concepts and the criteria of the common law experimental use exemptions are discussed in Chapter three. The legislation background, related precedents, and impacts on the field of biotechnology of the statutory experimental use exemptions in the United States are illustrated in Chapter four. Lastly, in chapter five, the restrictions on patent right in the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization is first discussed. The related regulations on experimental use exemptions in Taiwan are later discussed. Lastly, through the scholars’ opinions and related precedents, the possible problems of application of the experimental use exemption in Taiwan are illustrated and the probable solutions are proposed.
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日本產業競爭力強化法之研究—兼論我國金融科技發展與創新實驗條例— / A Study of Japan’s Act on Strengthening Industrial Competitiveness: Focusing on the Comparison of Taiwan’s Act on Financial Technology Innovations and Experiments

戴凡芹, Tai, Fan Chin Unknown Date (has links)
金融科技在近年來已成為企業界與學術界所討論的顯學,但如何有效兼顧監理、法令遵循與促進產業發展,並因應創新商業模式,設計出法規與監理措施,已成為一道難題。基於上述背景,監理沙盒的概念與制度應運而生。我國版的金融監理沙盒,已於2018年1月31日公布。然而,除了金融科技創新,其他產業同樣有創新的必要,在面臨既有法規的限制,同樣有所掣肘。金融科技以外的領域,是否有類似「監理沙盒」的機制,在不分產業別的狀況下,應用在創新的實驗?日本在2014年1月20日起施行的「產業競爭力強化法」,用於創新技術或服務的「企業實證特例制度」及「灰色地帶消除制度」兩項機制,即為不限金融科技領域,適用於各個產業的沙盒制度。 本研究透過檢視日本產業競爭力強化法,深究其內容及機制的優缺點,與推行實績及具體的兩個個案後,據以反思我國是否可透過參考「灰色地帶消除制度」、「企業實證特例制度」的運作,與各產業內的潛在創新者更緊密合作,以有利於未來當主管機關面臨創新與法規的衝撞時,掌握對於各產業的影響。回歸我國法制,本研究針對「金融科技發展與創新實驗條例草案」,包括立法目的、概要,條例中的申請及審查、監督及管理,及實驗期間法令之排除適用及法律責任豁免等議題進行研析,並針對日本推動新事業活動特例措施,與我國金融科技發展與創新實驗條例,進行比較。同時亦將監理沙盒模擬演練的過程中,針對演練的架構、步驟、實際狀況、回饋與心得,提出歸納成果,並針對業者與主管機關進行協商與溝通的階段,歸納出具有邏輯性與合理性的執行步驟與方法論,做為當業者在準備階段與主管機關往返溝通與提案時的參考。 本研究認為,當創新與科技在與金融結合時,創新服務與法規監管的本質不同,所造成的緊張與衝突在所難免,也因此更應該體認到數位時代下主管機關對於法規調適與鬆綁之必要性。在臚列我國於發展第三方支付立法的經驗作為前車之鑑,及剖析日本產業競爭強化法的制度與實績作為他山之石後,本研究認為新創事業無論在籌備階段、實驗階段、營運階段,對於法規的特例需求的確不同於一般事業。因此政府應秉持以下三項原則予以協助:(一)法規對新創企業應更友善且主動輔導、(二)抱持產業永續發展的思維看待新創產業、(三)消費者權益維護與企業營運必須兼顧。 本研究的另一研究結果為,經過個案模擬演練的操作後,歸納並提出七個執行步驟,並建議業者可針對此七個步驟進行腦力激盪與預先演練模擬,在有限的時間內以最高的效率備齊相關文件,以減少審核等待期。最後,本研究認為,業者與主管機關在議題協商時須充分考量有關於創新、業務、消保、法遵等四個面向的議題,且以公私協力的前提下,隨時調整並良性溝通。而主管機關更應加速金融科技的法規革新速度,並適度鬆綁不適用的法規,創造一個對於新創產業相對友善的法規環境,協助新創業者在業務上的發展,使我國能在金融科技戰場上決勝。 / In recent years, financial technology, aka FinTech, has become a significant study discussed by industries and academics. However, how to effectively manage supervisory, compliance with laws and promote industrial development, and how to design regulatory and supervisory measures in response to innovative business models have become a big challenge. Based on the abovementioned facts, the concept of Regulatory Sandbox came into being. Taiwan’s Act on Financial Technology Innovations and Experiments was released on January 31, 2018. Besides FinTech, innovation is equally necessary and indispensable for other industries that also restrained by the limitations of the existing laws and regulations. Are there any mechanisms similar with Regulatory Sandbox for those innovators in other industries? Japan released the Act on Strengthening Industrial Competitiveness on January 20, 2014, which provided two mechanisms, Special System for Corporate Field Tests and System to Remove Gray Zone Areas, for innovative technologies and services for all industries. This essay targets Japan’s and Taiwan’s Acts on Financial Technology Innovations as research objectives, discusses the investigations in both countuires, and provides suggestions for future works. Firstly, this study explores the strengths and weaknesses of its contents and mechanisms by examining Japan’s Act on Strengthening Industrial Competitiveness, and aims at extending the practical angle to Taiwan for the future when facing the conflict between innovation and regulation. Secondly, the essay aims at studying Taiwan’s Act on Financial Technology Innovations and Experiments, and comparing the differences between Japan’s and Taiwan’s Acts. Finally, by observing the results of sandbox simulation exercises, this study elaborates implemental procedures, and logical methodologies as a reference for practitioners to communicate with and submit proposals to the authorities during the preparatory phase. Due to the nature difference of innovation technology and financial supervision, it is considered that the tensions and conflicts are inevitable. Therefore, it is more necessary to amend the existing regulations or even deregulate for start-up. Furthermore, by learning from Taiwan's experience in developing third-party payment legislation and Japan's legislations and actual practices released, this study obtains that deregulation and coordination from government agencies considered highly important to startup operators in every stage. In terms of industry development, further suggestions are concluded in this research for government agencies, including (1) laws and regulations should be more friendly for new start-up, (2) to maintain the sustainable development of start-up industries and operators, and (3)-to achieve balance between the protection of consumer rights and business continuity. After conducting sandbox case simulation exercises, this essay proposes seven procedures for start-up to efficiently go through with internal brainstorming while in preparation stage under a limited time. The last part of the study sets out four topics for practitioners and the competent authorities that are related to innovation, business, consumer protection and law compliance when negotiating the regulatory issues during experiments, hoping to provide a solid methodology beneficial to FinTech practitioners.

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