University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

智慧財產權保護的利益包括道德利益，社會利益與經濟利益，然而三種利益彼此可能互相衝突，醫藥品專利便是其中一種常見案例，若醫藥品在專利權的保護下，價格與可得性皆容易成為取得必需醫藥品的高門檻。關於如何使病人取得所需的專利藥物，「強制授權」制度被認為是一種可使用的彈性手段。 本篇論文旨在分析專利強制授權制度對藥物可近性可能造成之影響。第二章從國際公約中對於強制授權的規範切入，說明目前國際上強制授權的運作條件；第三章說明強制授權的功能，其在專利權制度中可達到之經濟與公共利益的調和與平衡，對於反對者所認為「強制授權造成的經濟傷害」論點予以駁斥，並說明強制授權造成專利權人的經濟損失並不如反對者宣稱的巨大，反而因強制授權制度的存在，能有效減少濫用權利的誘因；第四章則著重分析強制授權對公共衛生政策的影響，對於開發中國家而言，建立起穩定的強制授權制度，有助於他們跨過初始的專利障礙，開始扶植本國藥廠並建立本國的藥物供應鏈，以達到獲取藥物的自主性；第五章以美國、加拿大、印度等國實施強制授權的案例，闡述強制授權在已開發國家與開發中國家的實施和效果，強調無論是以強制授權或是其他更為強勢的手段，在專利的壟斷性下，為社會利益保留一項具有彈性與最後手段的措施之必要性；第六章則就我國的專利法修法沿革分析，提出關於現行專利法中強制授權的彈性不足會造成的影響及修改的方向。 / The protection of intellectual property rights includes moral interests, social interests and economic interests, but the three interests may conflict with each other. Patents of pharmaceutical product are the common cases. If the products are under the protection of patents, the price and accessibility will become the obstacles for obtaining essential medicines. The "compulsory license" system is considered to be a flexible instrument that can be used when patented drugs are required by patients. This research aims to analyze the possible impact of patent compulsory license system on accessibility of medicines. In the second chapter, I points out the rule of operation of compulsory license from international conventions, introducing the current international conditions. Chapter 3 describes the function of compulsory license, that the reconciliation and balance between the economic and public interests can be achieved in the patent system. The opponents consider that economic harm would be caused by compulsory license. However, the actual economic loss of the patent owner is not as great as the opponents describe. In contrast, the incentive for the abuse of the right can be effectively reduced through the existence of the compulsory license system. Chapter 4 focuses on how compulsory license system affects public health policies. For developing countries, the establishment of a stable compulsory license system helps them to cross the initial barriers and start to foster their own pharmaceuticals industry. Building their own medicines supply chain helps them to achieve the accessibility of medicines. Chapter 5 illustrates the attitude toward compulsory license in developed and developing countries. The chapters introduce means of compulsory license in the United States, Canada, India and other countries. It emphasizes that, whether compulsory license or other more powerful means, to retain a flexible method for social interests is important in the patent law system. Chapter 6 analyzes the history of Taiwan's patent law. This chapter emphasizes the impact on lack of flexibility about compulsory license, and it mentions the direction of the amendment to Taiwan Patent Law.

近年來，毒品氾濫問題日益嚴重，而毒品犯罪亦成為社會最關注的焦點，甚至衍生毒品危害及黑幫勢力入侵校園等校園危安事件，導致學生藥物濫用案件逐年攀升，而施用毒品年齡層亦有下降的趨勢，再加上臺灣人口成長趨緩，社會面臨少子化的危機，如何有效防制學生藥物濫用，不論在社會治安維護，或是經濟發展面向，甚至於國家安全層面，已成為刻不容緩的重大國安議題。 而國內毒品濫用狀況日趨複雜，常見報章媒體報導青少年群聚在PUB、KTV及汽車旅館等場所集體轟趴嗑藥，或是販毒集團利用學生擔任藥頭角色，透過類似「老鼠會」的運作模式，引誘同儕加入吸毒或販毒行為，更甚者如黑道勢力入侵校園，幫派角頭以毒品控制青少年從事暴力討債或性交易，使青少年藉此換取金錢及毒品等危害社會治安及校園安全案件， 在在顯示我國青少年藥物濫用情形持續惡化。 隨著台灣快速地發展，由傳統社會拓展到工業社會，如今又逐漸進展至網絡社會，並朝向全球化的趨勢發展之中，社會組織結構產生非常急遽的變化，傳統的道德倫理觀念已不復存在，而青少年在生理及心智方面未臻成熟，進而衍生許多負面問題，如飆車、狂野派對等偏差行為，導致吸食毒品人口年輕化、吸食毒品種類多樣化。近年我國毒品問題確實產生相當變化，不僅是青少年藥物濫用問題，也包括新興合成毒品之盛行、毒癮者傳染愛滋病與其他傳染病等公共衛生議題，而毒品防制措施雖持續精進，唯國內毒品問題仍然嚴重，吸食毒品人口並無減少，而施用非法藥物人口也早已侵入青少年階層。

University of Macau / Institute of Chinese Medical Sciences

在製藥工業中，藥量特性之研究常被應用於藥理學、毒物學及臨床試驗中。藥量特性之研究同時在臨床試驗中的第一階段的藥物安全性及第二階段的藥物有效性中扮演著重要的角色。透過藥量特性的研究，使我們對於藥物的開發有著更深一層的認識，並可藉此縮短藥物核准上市的時間。 在多數的情況下，我們對於藥物動力學之參數與藥物劑量間的線性關係，有著特別的興趣。基於這個目的，一些典型的方法即是由一般線性模式發展而成的。然而，這些典型的統計方法常遇到下列的難題而違反其假設：（一）不同藥物劑量間的異質變異性。（二）不滿足常態性的假設。針對這些問題，我們藉由比較不同劑量間的斜率關係的無母數檢定程序來評估其線性關係並刻劃出藥物的反應曲線，文中並藉此方法舉出交叉實驗之實例。 / The problem of characterizing dose response curve for a pharmacokinetic parameter over a specific dose range is considered. In many cases, it is of interest to determine dose linearity (or dose proportionality) between the pharmacokinetic parameters and dose levels. For this purpose, several classical methods based on a general linear model procedure are available. However, two difficulties commonly encountered, namely (i) heterogeneity of the varibility at different dose levels and (ii) violation of the normality assumptions, often make the classical methods not applicable. To account for these problems, we propose a general nonparametric test procedure by comparing the slopes at different dose level to asses dose linearity and to characterize dose response curve. An example concerning the study of dose response of a compound based on a four-way crossover experiment is presented.

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences