The purpose of this research aims to (1) construct the predict model by system dynamics on the outpatient visits; (2) investigate the influence on hospital performance after drug price policies made; and (3) offer feasible schemes by scenario simulation. National Health Insurance (NHI) system intends to safeguard the right to health care for all residents in Taiwan. NHI system has gained high public satisfaction so far. However, medical expenditures and pharmaceutical costs have propelled the rapid growth in recent years because of the stipulation of the insurance premium rate, the general push for improved health care quality, and inclusion of new drugs as well as new technologies. To prevent the deficit of the NHI system¡¦s finances from widening further, the Bureau of NHI is urged to reform the reimbursement policies, including Adjustments of Drug List and Payment Scheme, Global Budget Payment System, and Adjust Reasonably Reimbursement Criteria as well. Based on the statistics, a quarter of the total revenues were for the drug cost. Legally mandated drug price adjustments have a great influence on the financial burden of the medical institutions. On the basis of the simulation analysis, the major findings of this research are summarized as follows: (1) The adjustments of the prescription depend on the amount of the profit gained from the drugs; (2) The increase the refillable prescriptions for patients with chronic illnesses enhances the profit of the drugs; (3) With the implementation of the system dynamics, the counterintuitive phenomenon can be identified and used to guide the future policies of the medical institutions. This research also suggests that the total comprehension of finding the leader loop in the dynamic complexity system within the management of the medical institutions is beneficial in providing the relative adjustment policies for a hospital.

This dissertation comprises three discrete empirical papers, with an introductory essay that evaluates the impact of different federal policies on prescription drug prices, utilization, and spending. Two main databases are used: (a) Medicaid State Drug Utilization Data and (b) the Medical Expenditure Panel Survey (MEPS) data. These two databases are designed to track Medicaid drug utilization and overall medical use and expenditures, respectively. The variables of interest in this dissertation are prescription drug price, prescription drug use and spending, and overall drug expenditures. The objective of the first paper (Chapter 2) is to examine whether oncology drug prices have significantly changed because the Medicaid rebate increased under the Patient Protection and Affordable Care Act (ACA). The analytic sample includes top-selling oncology drugs, both branded and generic, over an 8-year time period. The prices of top-selling oncology drugs in 2006 were followed through 2013 to find the extent to which drug prices have changed while controlling for state fixed-effect, package size, type of manufacturer, brand or generic, and drug strength. Thus, this study examines whether and to what extent oncology drug prices have changed after the increase in the Medicaid rebate under the ACA. The second paper’s objective (Chapter 3) is to study whether Medicare Part D has reduced racial disparities in diabetes drug use, coverage, and spending since its implementation in 2006. The analytic sample includes individuals aged 55 years and older who had diabetes from 2001 to 2010. Although the impact of Medicare Part D has been studied from different perspectives, its impact on racial disparities in drug use, coverage, and expenditures among diabetics has not been studied yet. The third paper (Chapter 4) focuses on the association between closing the Medicare doughnut hole and prescription drug utilization and spending for Medicare Part D beneficiaries with chronic diseases through 2013. The objective of the third paper is to determine whether the provisions of the ACA that close the coverage gap have affected prescription drug utilization and out-of-pocket (OOP) spending among Medicare seniors with Part D coverage.

No description available.

全民健康保險制度在台灣開辦以來已經快二十年了，在全民都有保險、給付的範圍從基礎到複雜的醫療照護完整、合約醫療機構相當普遍、就醫的方便性等，得到大多數台灣民眾的肯定。 但全民健保這一路實施下來卻為台灣帶來的龐大國家赤字。健保局針對於每年五千餘億的健保費用其中的藥品費用(為第二大支出，占了其中的25%)多次長期進行多種的藥費及藥價管控措施，低廉的新藥核價加上每兩年的藥價調查後的藥價調降，國外藥廠除了要配合健保的藥價政策外，還需要面對醫療機構對於現有藥品再降價的要求。長久下來，藥廠利潤逐年下降影響甚劇。 其中以今年七月所要實施二代健保中「藥品三同」對於原開發藥廠藥衝擊最大。衛生署所實施的三同政策，即是針對健保給付超過15年的藥品，實施「同成分」、「同品質」、「同價格」，調整為同價格。此一政策倘若實施，原開發藥廠利潤嚴重下降，可能會導致會放棄台灣市場，民眾只剩下國產學名藥可以選擇。再者，三同政策最大的瑕疵，在於只單方面考慮健保給付的藥價，卻忽略了藥廠製藥成本，此舉明顯不顧成本不同卻硬性規定價格，明顯違反市場機制，也違反健保精神。 專利藥到期的原開發藥藥廠要如何因應以縮小品質及價格的爭端，只著眼於一昧砍藥價來填補健保財務虧損，不仔細思考同成分就一定同品質的問題而將藥品砍至同一價格的健保署藥物品質認定及給付標準。 本研究探討之研究問題包括: 1)在台灣健保逐年調降藥價的政策下藥品三同政策前，原開發藥廠在台的經營模式為何,2)在政府政策培育下的學名藥如何日益茁壯來影響專利藥到期的原開發藥廠市場活動，3)藥品三同政策實施後對專利藥到期的原開發藥廠的衝擊4)主要獲利的專利藥品皆到期的台灣武田藥品公司未來的經營模式從主要價值活動面該如何調整因應。 本研究以Afuah A.(2004)經營模式架構，先從過去健保政策下原開發藥廠的營運模式做說明，再以目前健保政策環境因素的變化，如何影響個案公司的市場行銷活動，而活動又如何影響公司的資源、定位及成本。 本研究發現「藥品三同」對台廠學名藥因具有較佳的成本競爭優勢，對原開發藥廠產生威脅，但因原料的不穩定性讓病患、處方醫師無法信任。所以原開發藥廠除了監督政府長期對學名藥廠品質加以把關、用訴訟延緩學名藥的上市外、另外一方面併購國內學名藥廠，以配合醫療院所對於低價高品質藥品的需求。最後，專利藥到期的原開發藥廠從健保政策中與學名藥廠價格競爭獲得利潤，就必須改變營運模式，首要的就是降低成本。如何從採購及製造方面有效降低成本著手，進一步調整有形、無形資產投入、人員配置培養與組織等策略資源，以及定價、市場區隔等定位修正，是原開發藥廠需要深入思考的問題。 / National Health Insurance (NHI) program has been implemented in Taiwan for almost 20 years. It has earned recognition for the compulsory enrollment for all residents in Taiwan, the benefits covered from basic to complicated medical care, the prevalence of contract medical facility and the convenience of going to doctors. NHI, however, has caused fiscal deficit for the past few years. Drug cost, among the over 500,000,000,000 NTD health insurance fee, is the second largest expenditure, which takes up 25 percent of health insurance fee. Therefore, Bureau of National Health Insurance has taken measures to manage and control drug cost and drug price multiple times for a long period. Foreign pharmaceuticals have cooperated on the low-priced pricing for new drugs and have lowered drug price after drug price evaluation every two year. However, there is still demand from medical institution for lowering drug price. The profit is therefore significantly affected in the long run. Among the impacts, the significant one for research-based pharmaceutical companies is “three sameness of drug” in the 2nd generation NHI, which will be implemented in this coming July. This three sameness policy is to adjust those drugs which are covered by NHI for over 15 years and are of the same ingredients and quality to the same price. If this policy is put into practice, the profit of research-based pharmaceutical companies would plunge, which may result in their leave of Taiwan market. The domestic generic drugs, as a result, would be the only choice for the general public. Moreover, the major flaw of this three sameness policy is that it merely considers the drug price NHI covers, not the costs of pharmaceutical companies. That the drug price is set inflexibly without taking costs difference into consideration is against not only market mechanism but also the essence of NHI. The questions this study aimed to investigate were: 1. What have been the operating models of research-based pharmaceutical companies in Taiwan in the circumstances of drug price drop year by year before “three sameness policy”? 2. How have the government-sponsored generic drugs affected the market activities of drug patent expiration of research-based pharmaceutical companies? 3. What have been the impacts of “three sameness policy” on drug patent expiration of research-based pharmaceutical companies? 4. How should the operating model of Takeda Pharmaceuticals Taiwan, Ltd. adapt to, from the aspect of primary value activities, the condition of drug patent expiration of its profitable drugs? Based on the framework of operating model by Afuah A.(2004), this study began with the operating model of research-based pharmaceutical companies in former NHI policy. It then elaborated on how changes of the present NHI policy have influenced the marketing activities of the case company and how these activities have influenced the company’s resources, position and costs. This study reveals that “three sameness policies” is favorable for Taiwanese generic manufacturers for their costs competition. However, the instability of raw materials could not gain the trust of patients and doctors. Therefore, in order to cooperate on the demand for low-price and high-quality drug, researched-based pharmaceutical companies supervise the government’s check on the quality of generic manufacturers, employ litigation to suspend the launch of generic drugs or merge domestic generic manufacturers. If research-based pharmaceutical companies with drug patent expiration would like to compete with generic manufacturers and make a profit in NHI policy, they would have to change their operating model. How to reduce costs of purchase and manufacture and go further to adjust the input of physical and intangible assets, strengthen professional training of personnel and organization and modify strategies for pricing and market segmentation are the main issues worth considering.

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.

面對未來全球人口成長、可耕地減少等現象，生物技術在農業上的應用日益增加。其中，基因改造技術等基因層次相關的平臺應用技術更是提升農作物價值的關鍵—透過跨物種功能應用，大幅提升育種效率。自1996年基改作物商業化種植開始至今，美國都是全球最大種植國家，也是基改作物研發先驅國家。生技農業政策以及和基因改造作物有關法規之制訂使基改作物在美國蓬勃發展，尤其是專利保護對於種子產業之影響尤為深遠。專利權所提供的完善保護使大量資本進入種子產業，投入資源將農業生物技術應用於種子培育上，此舉也促成Monsanto等跨國農業生技公司之興起，主導全球基因改造作物之市場。 Monsanto將研發重心放在基改種子之研發，其在生技種子相關營業比重遠高於同業，同時，其投入特殊性狀之基改種子研發之回收遠高於其他公司之相同營業項目之投資報酬率。Monsanto積極藉由併購取得基因、基因轉殖技術以及種子種源。掌握關鍵基因、基因轉殖技術以及大量且優良種源使含有Monsanto轉殖基因作物在市場上佔有極大的比例。在美國，超過一半以上之主要作物種植面積為基因改造作物，尤其是基因改造大豆，佔大豆總種植面積之比例高達94%。市面上絕大多數基改大豆係Monsanto的抗嘉磷塞（RounupReady，RR1Y）基改大豆種子。藉由智慧財產保護策略，Monsanto並進一步限制RR1Y及其他基改作物之使用方式。 惟RR1Y專利將在2014年到期，農民可在2014年時留種種植基改大豆種子而不用每年購買種子，或購買學名（generic）抗嘉磷塞轉基因大豆種子。在美國所種植之大豆約有四成會外銷，而外銷國家基改作物規範法規是出口與否之關鍵。若未取得歐盟、中國等主要外銷國家基改作物主管機關之批准，呈交包括基因之轉殖植物對環境衝擊之風險評估、包含該基因之轉殖植物所製成食品之安全性評估等基改作物資訊，則抗嘉磷塞基因大豆無法進入該國糧食市場。然而，在目前美國農業生技基改作物相關規範下，學名基改種子廠必須在專利種子專利到期後，才能進行實驗及田間試驗，呈交相關資料以符合基改作物主管機關之要求。透過建立學名基改作物快速獲得核准查驗登記之程序，允許學名廠依賴專利基改作物原廠之實驗及田間試驗資料以建立其學名基改作物之安全性與性狀表現有效性，同時，允許學名基改作物在原基改作物開發廠專利期滿前即可開始進行試驗，可以使學名抗嘉磷塞大豆種子以及其他學名基改種子能在原專利基改作物種子專利到期後順利進入市場，促使基改作物種子價格競爭，並對於專利基改作物研發公司進行適度之補償，以促進產業發展。 / The development of new technologies in plant breeding has led to improvements in the efficiency scientists produce improved plant varieties. Genetic modification is among the developments that support plant breeding. The introduction of genetically modified crops has revolutionized the agriculture industry. With patent protection available on GM traits, varieties and other aspects of seed production, private R&D investments in the seed industry have increased tremendously. Monsanto has been the leading company in investing agricultural biotechnology and has obtained a dominant position in the GM traits found in soybeans, cotton, corn and other commercialized crops. Currently, over 90 percent of soybeans planted in the United States were herbicide-resistant, with Monsanto’s Roundup Ready being the dominant soybeans planted. In 2014, however, the agriculture industry will be facing the expiration of a patent for Roundup Ready soybeans. Despiate the fact that the patent expiration date is approaching, the agricultural biotech industry has no guideline in place to tell its players exactly how to transition seamlessly from patent monopolies to generic competition. The transition problem is espectially significant for soybeans exported to oversea markets as more than 40 percent of the soybeans grown in the U.S. are exported. In order for those soybeans to be accepted in the grain channel, regulatory approvals are required in countries that import soybeans. Obtaining data, which includes scitific data on the trait being developed, for regulatory approvals can take years to complete. If a generic trait is to reach market immediately after the original trait go off patent, the data generation process should begin before patent expiration. A Hatch-Waxman type patent infringement defense for activities necessary to obtain regulatory approvals for biotech traits can ensure that seed companies have sufficient time to obtain registrations for a generic Roundup Ready trait or other generic traits. Current legislation should be modified to adequately oversee the transition to the generic use of genetically modified crops and, in the mean time, ensure the availability of generic modified crops.