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影響企業於中國建構醫藥品通路的因素分析─台商未來的因應之道 / An analysis on pharmaceutical industry’s channel strategy in China ─ suggestions for Taiwan’S enterprises黃淑媛, Huang, Shu Yuan Unknown Date (has links)
中國13億人口的內需市場已為各產業的新興目標,尤其是在醫藥產業,中國政府於2009年宣布將投注8,500億人民幣改革中國整體醫藥建設,更為目前身處於台灣飽和市場的本土藥廠的發展契機,加上兩岸近期簽署的兩岸經濟合作架構協議(ECFA),未來兩岸商業互動將更為頻繁。台商藥廠如何在這各界搶占的中國市場占有一席之地?掌握通路即掌握市場。
影響通路建構的因素分析,是企業市場營銷的首要步驟,公司對影響通路建構的因素越是瞭解,越是能掌握變動的市場,做出調整以因應環境的變化。本研究首先從中國醫藥品生產企業發展概況的分析,引導出跨國藥廠(歐美等國與台灣企業)進入中國市場常見的問題,並研究影響其通路建構須掌握的三大分析構面,包括醫療體制、藥品管理相關法令,以及流通企業等。
在醫療體制部分,中國的醫療市場主要集中在國有醫院(public hospitals),但國有醫院的營銷環境複雜,受到許多來自政策、地方主義、關係資本等因素的影響,使得外來投資企業在經營中國國有醫院市場上,皆需要各方面相當的營銷資源才足以支撐。
在藥品相關法令部分,中國政府為了整頓醫藥市場混亂的景象以及減輕民眾的用藥負擔,於1998年起陸續頒布了許多藥品管理相關法令,包括國家基本藥品目錄、藥品價格管理制度,以及藥品集中招標採購制度等,這些法令雖然規範與體制化了中國醫藥市場,但也約束了醫藥通路終端市場的藥品採購,並使藥廠的通路建構彈性大幅受限。另外,雖然過去由於中國專利法發展遲滯,致使許多歐美企業無法在中國發揮藥品發明專利之市場壟斷的作用,但中國於2007年再次修定並頒布新實施的藥品註冊管理辦法,已將中國的藥品專利保護之法律與行政制度進行初步連結,未來兩者整合性的發展,將塑造出更有利於擁有強大技術與專利能量的藥廠生存的環境,此為台商不可忽視的重要課題。
在流通企業部分,中國流通企業不僅了解當地行規,通常又擅長多角化經營,掌握了大多的終端客戶,往往能夠提供藥廠代銷、物流、倉儲、收款等服務,故在流通企業在中國醫藥通路上扮演著不可或缺的角色,藥廠對流通企業的通路功能依賴性極大。
台商過去進入中國醫藥市場發展十幾年來的商業模式,是否還能足以因應未來更變化多端的市場環境?而後進中國市場的台灣藥廠又該採取怎樣的進軍策略?面對未來,台商更應「衡外情、量已力」,從各面向深入瞭解影響中國醫藥品通路建構的因素,除了鞏固既有醫藥市場與通路資源外,更應積極思考如何提高通路系統的附加價值,開創嶄新的獲利模式。本研究後續將針對前述三大影響因素,分章論述分析,最後歸納與整理影響因素對台灣藥廠所造成的困難,並提具因應上的建議,期能提供在中國發展醫藥品市場的台商企業作為未來發展策略的參考依據。 / China’s great market demand has become the new target for international enterprises, especially in pharmaceutical industry. China government announced the investment of 850 billion RMB to ameliorate the medical infrastructure in China, which indicates an opportunity for Taiwan pharmaceutical companies. The Economic Cooperation Framework Agreement (ECFA) between Taiwan and China will encourage a more enthusiastic interaction across the strait. Channel strategy will be the key to predominate the highly competent China market for Taiwan pharmaceutical companies.
Analysis on channel construction will be the first step for industrial marketing strategy. The better a company understands the factors influential for channel construction, the better it can get control in the ever-changing market and adjust itself to cope with any alteration in the environment. This thesis will begin with an introduction on the development of pharmaceutical industry in China and thus induce some common issues with which international pharmaceutical companies are confronted in China market. It will analyze the channel construction from three important perspectives, healthcare system, pharmaceutical regulations, and logistics industry.
Public hospitals play a major role in the healthcare system of China market. The marketing in public hospital involves complicated variables, including policy, local protectionism, and relationship capital. Non-local companies need every considerable resource to manage the marketing in public hospitals.
In order to reform the healthcare market and lower the medical expense, China government announced several pharmaceutical regulations, including National Reimbursement Drug List (NRDL), Medicine pricing policy, and Pharmaceutical Centralized Public Bidding Procurement process. On one hand, these regulations help to put the market into order; on the other hand, it sets restricts on the retail sales and the channeling flexibility of the pharmaceutical company. Due to the slow development of China patent law in the past, moreover, a lot of American or European pharmaceutical companies could not develop an exclusive market for their drug through patent system. New Provisions for Drug Registration revised and announced by China government in 2007 established an initial connection between legal and administrative system of drug patent protection. Such integrated development will form an environment more suitable for pharmaceutical companies which possess powerful technology and patents, a significant trend for Taiwan companies’ attentions.
China logistics companies understand local law and regulation and are usually familiar with multi-business strategy. They control most of the retailers and can offer sales agency, logistics, storage, and agency receipt. Logistic industry plays an important role in China pharmaceutical channel and is indispensable to pharmaceutical companies.
It will be questionable whether Taiwan companies’ old business model can be sufficient for the changing China pharmaceutical market in the future. The newcomers should ponder more on their strategy for the market as well. Taiwan companies need to take the external condition and their own strength into consideration, understanding every factor of China pharmaceutical channel construction. Besides strengthening the original market and channels, Taiwan companies should aggressively enhance the add-value of channel system and find out new profit model. This thesis will focus on and elaborate the three perspectives and analyze the difficulties they bring upon Taiwan pharmaceutical companies, proposing possible solutions and future strategy for those who aim to develop their pharmaceutical business in China.
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基改種子專利到期對於基因改造作物產業之影響-以Monsanto抗嘉磷塞轉基因大豆為例 / The patent expiration of genetic modified seeds and its impact to the agricultural biotech industry- a case study of Monsanto’s roundup ready soybeans林家綺, Lin, Chia Chi Unknown Date (has links)
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.
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美國母子公司合併子公司少數股東保護之研究—兼評台灣實務案例與相關規範設計之缺憾盧曉彥, Lu, Hsiao-Yen Unknown Date (has links)
本文研究重點係母子公司合併時子公司少數股東權益保障的爭議問題,並嘗試從美國法之觀點檢討我國母子公司合併案例與相關之規範設計。
從美國德拉瓦州法院對於母子公司合併規範模式之演變,應可察覺一國法制總體面因素的變化,以及合併基礎法制變遷,對於母子公司合併規範設計之影響。總體面因素諸如當代公共政策的游移、投資人與市場周邊機制之成熟度、公司內部治理機制的健全、社會思潮的偏向等;合併基礎法制幾個重大變遷,包括可決合併門檻多數決原則之確立、簡易以及制式現金逐出合併之陸續完成立法等,在在都影響了法院對於母子公司合併之規範態度。法院的態度變化,也顯現在子公司少數股東所擁有之兩項救濟,亦即股份收買請求權以及違反受任人義務訴訟救濟,在近一世紀以來,其起初係平行發展、繼而相互競爭至目前走向調和之變遷過程。而在過程中,違反受任人義務的內涵與課責標準一直持續變化,連帶地也影響股份收買請求權理論基礎的汰換、調整與新生。
德拉瓦州法院對於母子公司合併的處理方式,是區分簡易合併與制式合併而適用不同的規範模式。制式合併係適用「財產法則」概念下之常規交易審查模式,違反常規交易標準即屬違反受任人義務;簡易合併則因為協商成本太高,所以適用「補償法則」,以股份收買請求權為唯一救濟。此項規範模式,很顯然地是一種妥協之處理方式。尤其股份收買請求權之相關配套設計,包括評價得否採計合併綜效、救濟成本之負擔方式以及程序障礙設計猶存諸多問題,採取「補償法則」背後的考量因素或許正是為便利母公司執行合併。
從美國德拉瓦州公司法母子公司合併規範設計之歷史演變,比較我國目前現階段的母子公司合併規範之設計,大體說來,由於我國公司法與企業併購法之規範設計不利於子公司與母公司進行協商、再加上董事以及控制股東(亦即母公司)對於子公司之股東並無直接負受任人義務,在子公司股東無法對於不公平的合併對價,直接請求董事或母公司負擔損害賠償責任的情況下,將很難期待子公司的董事會盡力為子公司少數股東,向母公司爭取公平的合併對價。
換言之,由於我國受任人義務體系之不完備,少數股東縱然認為合併對價涉及不公情事,似乎也祇能依照民法侵權行為之規定,向董事或母公司請求損害賠償。按照民法第一八四條之規定,其舉證責任門檻事實上即相當於美國法對於簡易合併場合之規範。亦即是說,我國法似乎並無特別針對母子公司合併此項具有利益衝突之重大交易,提出任何有別於常規交易之差異規範,此即導致子公司少數股東僅能按照一般侵權行為之規範,請求母公司或董事負擔損害賠償責任,這對於少數股東而言,自是甚為不利。
短期而言,從經濟政策上係鼓勵合併,抑或從我國公司內部治理機制以及市場機制尚未健全發展至足以提供子公司相當之協商力量以與母公司抗衡的角度,我國似乎都無法在仿效美國於制式合併場合,建立偏向「財產法則」概念下之「近似常規交易協商模式」。因此,現階段或應思考從改善我國股份收買請求權設計開始著手。對此,ALI Principles與RMBCA有關股份收買請求權設計之立法例,我國應擇其優而加以援用。
長期而言,按照我國現階段的規範趨勢,似乎係在仿效美國法制,逐漸朝向市場導向之公司治理機制(market-oriented style of corporate governance),因此持續開拓我國資本市場的深度與廣度,以及建立適合於我國公司生態的公司內部治理機制,都將是繼續努力的目標。倘若未來我國市場之周邊機制與公司內部治理機制皆能發揮適當的治理功能,前述偏重於「補償法則」概念下規範模式之股份收買請求權設計,即有必要加以調整,以避免美國現階段在現金逐出合併場合所發生之「規範重疊」(regulation overlap)問題。
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